СТА - ведущая юридическая компания в Дубае с офисами по всему мируhttps://www.stalawfirm.com/ru.htmlSTA Law Firm - Блоги - Healthcare LawruCopyright 2024 STA Law Firm All Rights Reserved<![CDATA[Insurance Developments in KSA]]> Insurance Developments in KSA

In 2023, the Saudi Arabian insurance sector underwent significant transformations driven by regulatory reforms, technological advancements, and strategic initiatives aimed at fostering growth, stability, and competitiveness. These developments underscore the Kingdom's commitment to modernizing its insurance industry and aligning it with international standards while supporting broader economic diversification goals outlined in Vision 2030.

Establishment of the Insurance Authority (IA)

A pivotal moment in the sector was the establishment of the Insurance Authority (IA) in August 2023, marking a shift from the previous regulatory oversight by the Saudi Arabian Monetary Authority (SAMA). The IA, an independent regulator, assumed responsibility for regulating and supervising the insurance sector, aiming to enhance effectiveness, stability, and consumer protection. This move signified a proactive approach towards strengthening regulatory supervision and fostering a conducive environment for industry growth.

Adoption of International Financial Reporting Standards (IFRS)

Another noteworthy development was the adoption of International Financial Reporting Standards (IFRS) 17 Insurance Contracts and IFRS 9 Financial Instruments by the Saudi insurance sector. This alignment with international accounting standards, effective from January 2023, aimed to improve transparency, comparability, and accuracy in financial reporting, thereby enhancing investor confidence and facilitating global market integration.

Gradual Reinsurance Cession

The implementation of a mechanism for gradual reinsurance cession to the local reinsurance market, mandated by SAMA, aimed to bolster the domestic reinsurance sector and enhance retention capacity. This phased approach, commencing in January 2023, demonstrated a strategic initiative to strengthen the local market while ensuring adequate risk management practices among insurance companies.

Regulatory Amendments and Initiatives

Throughout 2023, several regulatory amendments and initiatives were introduced to modernize the insurance landscape and address evolving market dynamics:

  • Amendments to Compulsory Motor Insurance Policy: Revisions to the Unified Compulsory Motor Insurance Policy aimed to streamline claim settlement procedures, enhance consumer protection, and accommodate industry developments.
  • Licensing of Foreign-Owned Health Insurance Branch: The licensing of the first foreign-owned health insurance branch, Cigna Worldwide Insurance Company, underscored efforts to attract foreign investment and enhance sector competitiveness.
  • InsurTech Rules: The approval of InsurTech Rules by SAMA in July 2023 aimed to regulate insurance technology activities, fostering innovation while safeguarding consumer rights and compliance with regulations.
  • Licensing of Insurance Aggregators: The licensing of insurance aggregation companies aimed to promote competition and provide consumers with a wider range of insurance products and services.
  • Marine Insurance Coverage Instructions: Issuance of Marine Insurance Coverage Instructions aimed to enhance the regulatory framework for marine insurance, ensuring adequate coverage and benefits while addressing industry requirements.
  • Licensing of Online Reinsurance Brokerage: The licensing of ReTech Reinsurance Brokers Co. to provide online reinsurance brokerage services reflected support for technological advancements and innovative financial solutions in the insurance sector.
  • Amendments to Comprehensive Motor Insurance Rules: Revisions to Comprehensive Motor Insurance Rules aimed to expand coverage and protect the rights of beneficiaries, catering to diverse consumer needs.
  • Merger between Insurance Companies: The merger between Alinma Tokio Marine Company and Arabian Shield Cooperative Insurance Company highlighted a trend towards consolidation in the sector, aiming to create stronger entities capable of meeting market expectations.
  • Localization of Insurance Sales Jobs: The decision to localize all sales positions in insurance products aimed to empower national competencies and contribute to Saudization efforts, aligning with broader national strategies for economic development and employment.

Conclusion

The year 2023 witnessed a series of transformative developments in the Saudi Arabian insurance sector, driven by regulatory reforms, technological advancements, and strategic initiatives aimed at fostering growth, stability, and competitiveness. From the establishment of the Insurance Authority to the adoption of international accounting standards and the introduction of regulatory amendments and initiatives, the sector demonstrated resilience and adaptability in navigating evolving market dynamics. As the Kingdom continues its journey towards economic diversification and modernization under Vision 2030, the insurance sector remains poised for further innovation and growth, supported by a robust regulatory framework and a commitment to excellence.

 

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Mon, 18 Mar 2024 00:00:00 GMT
<![CDATA[Proposed Regulation Regarding the Allocation of Grants by the SNIH]]> Proposed Regulation Regarding the Allocation of Grants by the SNIH

The Saudi National Institute for Health Research (SNIH) has taken a significant step towards enhancing healthcare research and innovation in the Kingdom of Saudi Arabia (KSA) by inviting public comments on a draft regulation concerning the issuance of grants. This draft regulation, announced on January 3, 2024, aims to organize funding for translational research and clinical trials within areas and programs supported by the SNIH.

The draft regulation outlines several key objectives aimed at promoting translational research and clinical trials while ensuring transparency and efficiency in the grant allocation process. These objectives include organizing support for translational research and clinical trials, enabling individuals and entities to obtain research grants transparently, and managing the technical, financial, and administrative aspects of various grant programs.

Within the framework of Saudi Arabia's healthcare sector, the creation of the SNIH marks a noteworthy advancement in the nation's endeavors to tackle the scarcity of clinical trials, especially those designed to cater to the unique genetic makeup of the Saudi populace. Approved by the Saudi Cabinet in August 2023, the SNIH is tasked with supervising and promoting translational research and clinical trials, aligning with the objectives of Saudi Arabia's national development and diversification plan, Vision 2030.

Role of the SNIH

The primary mandate of the SNIH is to oversee and promote translational research and clinical trials within the Kingdom. Translational research, which bridges the gap between basic scientific research and practical applications in clinical settings, holds immense potential for accelerating medical advancements. By focusing on translational research, the SNIH aims to catalyze the development of innovative healthcare solutions tailored to the needs of the Saudi population.

Key Objectives

  • Streamlining Funding: One of the key objectives of the SNIH is to streamline the allocation of funds for translational research and clinical trials. Through collaboration with relevant authorities, the institute seeks to ensure transparency and efficiency in obtaining research grants, thereby facilitating the flow of resources into critical areas of healthcare R&D.
  • Enhancing Collaboration: The SNIH recognizes the importance of collaboration in driving impactful research outcomes. By fostering partnerships with academia, industry stakeholders, and governmental bodies, the institute aims to create a collaborative ecosystem conducive to knowledge exchange and innovation.
  • Promoting Transparency: Transparency is paramount in the realm of healthcare research, particularly when it comes to obtaining research grants and conducting clinical trials. The SNIH is committed to promoting transparency in its operations, ensuring that grant applications and funding allocations adhere to rigorous standards of accountability and integrity.
  • Supporting Capacity Building: Building research capacity is essential for nurturing a vibrant healthcare research ecosystem. The SNIH endeavors to support capacity-building initiatives, including training programs, mentorship opportunities, and infrastructure development, to empower researchers and institutions across the Kingdom.

Currently, the Saudi Food and Drug Authority (SFDA) plays a crucial role in overseeing clinical trials in Saudi Arabia through its clinical trials administration and the Saudi Clinical Trials Registry (SCTR). However, there is a recognized need for expanded research and development efforts, particularly in the areas of translational research and early-phase clinical trials.

Looking ahead, further announcements regarding the development of the SNIH and its role are expected to unfold during 2024. As Vision 2030 and national health priorities continue to prioritize research, development, and innovation (RDI), the SNIH is poised to play a pivotal role in shaping the regulatory landscape for healthcare research in Saudi Arabia.

Impact and Anticipated Developments

The establishment of the SNIH marks a significant milestone in Saudi Arabia's journey towards becoming a hub for cutting-edge healthcare research and innovation. By focusing on translational research and clinical trials, the institute aims to address critical healthcare challenges, improve patient care, and drive economic growth through the commercialization of innovative healthcare solutions.

In the coming years, the SNIH is expected to play a pivotal role in shaping the regulatory landscape for clinical trials in Saudi Arabia. As the institute continues to unfold its initiatives and programs, further developments and announcements are anticipated in 2024 and beyond. These developments are poised to usher in a new era of healthcare research in the Kingdom, characterized by increased collaboration, transparency, and innovation.

In conclusion, the draft regulation released by the SNIH underscores the institute's commitment to promoting translational research and clinical trials while fostering transparency and efficiency in the grant allocation process. With public comments open until January 18, 2024, stakeholders have a valuable opportunity to contribute to the ongoing transformation of healthcare research and innovation in Saudi Arabia. As the SNIH continues to evolve and expand its role, it holds the potential to drive meaningful advancements in healthcare outcomes and contribute to the broader goals of Vision 2030.

 

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Fri, 15 Mar 2024 00:00:00 GMT
<![CDATA[UAE's New Insurance Law of 2023 and Its Notable Changes]]> UAE's New Insurance Law of 2023 and Its Notable Changes

The United Arab Emirates (UAE) has recently implemented a significant overhaul of its insurance sector regulatory framework through the introduction of Federal Law No. 48 of 2023, also known as the New Insurance Law. This law, which took effect on November 30, 2023, supersedes the previous Federal Law No. 6 of 2007. Its primary objective is the codification of the transfer of regulatory authority from the Insurance Authority to the UAE Central Bank, a move that represents a substantial shift in the oversight of the insurance industry.

One of the key aspects of the New Insurance Law is its scope and application as outlined in Article 2. Notably, Article 2(b) brings certain holding companies under its purview, specifically those acquiring 15% or more of insurance activity in the UAE, or where their insurance-related revenues exceed 50% of their total income. Additionally, the law differentiates between Financial Free Zones and non-Financial Free Zones, applying only to companies operating outside the Financial Free Zones. This distinction marks a significant change from the 2007 Insurance Law, which did not make such a specific separation.

Another major change is the replacement of the Emirates Insurance Association with the Emirates Insurance Federation, as stipulated in Article 100. This new body falls under the supervision of the Central Bank, which also has the authority to approve its articles of association. This development indicates an increased emphasis on structured governance within the insurance sector.

Perhaps one of the most critical changes is in the dispute resolution process for insurance claims. Under Article 101, the New Insurance Law replaces the Insurance Settlement Dispute Committee (IDC) with the Banking and Insurance Dispute Resolution Unit (BIDRU). BIDRU, established under the Central Bank Law, functions as an independent entity dedicated to resolving complaints against insurance companies. The New Insurance Law outlines a specific claims procedure that varies depending on the claim's value, offering different resolution avenues for claims exceeding AED 50,000.

 

Article 104 of the New Insurance Law further strengthens the regulatory framework by empowering the Central Bank to intervene in lawsuits involving insurance and reinsurance companies or insurance-related professionals. This intervention can take the form of providing clarifications, data, or information to the competent authority after an investigation. This provision reflects the Central Bank's proactive approach to ensuring compliance and fairness in the insurance sector.

The implications of these changes are significant. The shift of regulatory authority to the Central Bank underscores a strategic move towards centralized oversight and enhanced governance. The establishment of BIDRU as an independent dispute resolution entity streamlines the complaint and resolution process, potentially leading to more efficient and equitable outcomes. Furthermore, the distinction between Financial Free Zones and non-Financial Free Zones could have implications for how insurance companies structure their operations in the UAE.

The New Insurance Law represents a substantial development in the UAE's approach to regulating its insurance sector. With the Central Bank at the helm, the changes usher in an era of heightened oversight, improved corporate governance, and a more structured dispute resolution process. As the industry adapts to these changes, stakeholders should remain vigilant and informed about the evolving regulatory landscape to ensure compliance and understand the full impact of these new regulations.

 

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Tue, 27 Feb 2024 00:00:00 GMT
<![CDATA[Patent waiver on vaccines]]> Patent waiver on vaccines

A patent right is an absolute right given for an invention of a product or process which will proscribe others from utilizing, distributing or retailing the product without the consent of the owner. The patent protection is subjected under the TRIPS agreement. The patent holders have the prerogative to manufacture, sell, and use the vaccine for the entire term of 20 years from the date of the filing of the patent. Such protection could give wider accessibility to vaccines. Today the patent right on vaccine takes prominence, as the world tussle with Covid-19. The vaccines that have been developed for the battle against the Covid-19 provide a silver lining to the catastrophe. 

It is in this context that the joint manifesto of India and South Africa at the WTO for a short-term waiver of the Patent rights on Covid-19 vaccines needs to be discussed. The campaign was supported by international organizations including the World Health Organization and by more than 100 countries. The main goal of the joint proposal is to minimize the barriers in producing their own vaccine by the countries, especially for the low-income nations. The high and middle-income countries have the core companies in vaccine manufacturing and their research and development. Most of the companies holding patent right are from these countries and they sell their vaccines to their own government or to the high-middle income nations. This is the main reason that the high income countries were not happy with the proposal. In their opinion, the proposal will clog the availability of vaccines and drugs at affordable prices.

Without granting waiver during public emergencies, the governments can still allow the companies to produce a product without the patent holders' consent and it is called compulsory licensing. But the nations which are in support of patent waiving state that this process is much more complicated than that of patent right waivers. Most of the nations were not happy with granting the compulsory licenses. 

Article IX.3 of the WTO Agreement states that in "exceptional circumstances", the Ministerial Council may waive an obligation of the WTO AgreementArticle IX.4 of the WTO Agreement states that when granting the waiver the ministerial council will determine the exceptional circumstances justifying their decision and conditions that prompted them for granting the waiver. Once the waiver is granted, the WTO member countries will not be under an obligation, for a short term on Patent associated rights.

Impact of the patent waiver

The covid-19 pandemic is a worldwide health crisis that prompted the WHO to declare this as extraordinary circumstances calling for extraordinary measures. In light of the US's declaration, the European Union stated that they were ready to discuss the proposal, but other high-income countries and Pharmaceutical companies stays against the move of the developing countries. They pointed out that waiving patents will not give an answer to the present emergency situation in the world. Some other strategies should be considered for addressing the real scenario.

The patent rights to COVID-19 immunizations will give the patent holder an exclusive right to manufacture the vaccine. So those with the patent can decide to whom they can sell, distribute etc. There is a very chance by the big shots to utilize the crisis to yield gain and reputation to their company.

Supply chain

The vaccines should be made in extremely controlled and high-tech facilities which are not present across the globe. This indicates that the few nations will not be able to produce their own vaccines. The pharmaceutical companies like Modena, Pfizer and BioNTech should take good steps to transfer the technology to manufacturing sites all throughout the planet. A need to build out manufacturing capacity worldwide is required for safe and effective vaccines. Unless vaccines are around the world open to everybody, there will consistently be a danger of a COVID variation that makes antibodies ineffectual making all the efforts in vain. The nations which are having surplus vaccines that are not required for the present may distribute those surpluses with the countries who are in need of the vaccine for their present need. This may be regarded as an apt solution for the worldwide crisis during this pandemic era than waiving the patent right.

Infrastructure

The approval to manufacture has to satisfy the required infrastructure for the capacity to manufacture the vaccine. The latter requires a significant degree of knowledge, experience and innovative framework for earning clean and safe vaccines. The manufacturing skill in regard to the vaccines using mRNA technology is significantly more expensive and complex than that for the established vector vaccines. These require high tech facilities for preparation and storage as the vaccines and drugs produced are very sensitive. Most of the vaccines are extremely sensitive to temperature fluctuations and they require a steady temperature of up to -80° Celsius and should be stored at the same temperature. Because of these interesting difficulties of manufacturing COVID-19 vaccines, the patent waiver alone will not help inexperienced hands to produce safe vaccines.

Research and development

Another risk limitation of patent right protection is the intricacy in the advancement of drugs. The awful part is that even if we invest billions of money for the research and development of a vaccine there is no guarantee of success. In a worst case scenario, the billions invested may be lost. The companies look forward for the final result to their research to cover up the losses that occurred during the initial phase. After the end of the waiver of patent rights for short term the imitators and conventional manufacturers will get profited from the original inventor's fundamental research work. Also the waiver will not accelerate vaccine manufacturing as there is the short supply of materials and this might take several years to build up capacity from nothing.

Alternatives

A waiver on the patent rights is not a suitable means of enhancing the global supply of vaccines in the short term. A removal of patent protection will have health risks from vaccines that were not expertly prepared and have a chance of political risks in the form of uncertainty. This will cause a negative impact to the pharmaceutical industry on their financial and innovative strength.  So it is better to support the existing companies and expand their production capacities. The companies who have found the vaccine can share their license and ideas of research with other reputed companies of similar infrastructure. Certain companies like Astra Zeneca have shared their innovative idea with other companies so that vaccines can be manufactured at various sites. Likewise, an expansion of existing products can be done by entering into partnerships.

Waiver of patent protection as a nightmare

A waiver on the patent initiated by the government could discourage pharmaceutical companies from taking on the costly research and development required to deliver essential drugs in the future. The Pharmaceutical companies would have to fear that they would not be able to earn back their risky investment. So instead of waiving the patent right the companies will always look forward to tying up with the equally reputed companies situated in other countries. They will sell or give license for their invention to those companies receiving remuneration. In this way they can recoup the initial investment.

Conclusion

The patent right on vaccines take importance as the world is troubled by the Covid-19 pandemic. All inventions are under patent protection under the TRIPS agreement. A patent holder has the right to manufacture retail and exploit the vaccine for the entire term of 20 years from the date of the filing of the patent. Waiving of patent right will be for one year or if exceeds the council has to mention the time limit in the description regarding the reasons for the waiver.

Waiving patent rights is not a suitable means of enhancing the global supply of vaccines in the short term. The patent waiver will discourage pharmaceutical companies to take risks from taking on the costly research and development work required to provide critical medicines in the future. Instead of waiver of patent rights the areas to be focused on are by improving the infrastructure, enhancing the production of the vaccines and distributing vaccines throughout the globe.

All these are done with an aim to irradiate this pandemic. The countries supporting the patent right waiver are asking for the right to develop their own vaccines without having the fear of getting sued for the breach of the patent right. But the whole scenario looks like these countries are asking for charity.

 

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Sun, 07 Nov 2021 10:15:00 GMT
<![CDATA[Economic and Fraud Provisions in Middle East]]> Economic and Fraud Provisions in the Middle East

"There is one and only one social responsibility of business – to use its resources and engage in activities designed to increase its profits so long as it stays within the rules of the game, which is to say, engages in open and free competition without deception or fraud."

- Milton Friedman

Economic fraud is a term that has been repeated over the years, so much so that the consequences it bears do not have any precedence or impact on the ones that hear it. For many companies and capitalist machinery, this term essentially triggers them to explore options to hide their fraudulent tracks and continue operating in the same manner. To have governments help them cover the tracks in certain jurisdictions ultimately defeats the purpose of the assignment.

Despite the incongruent activities of individuals, companies, and governments from the expected norm of justice in many jurisdictions, other countries are tenacious to implement a regulatory framework that will eradicate such fraudulent activities in the market. This article will discuss the economic and fraud provisions established in the Middle East, their effectiveness, and the scope of reach it possesses about financial crime.

What are the Economic and Fraud provisions in the Middle East?

If one area of the economy has seen a steady increase in the past years, it would be the economic fraud prevalent in society. Regardless of the number of provisions that jurisdictions and international organizations establish to combat financial fraud, none of them seems sufficient. The parties involved in economic fraud and other fraudulent practices are constantly evolving to cover their tracks efficiently.

Infamous scandals like Bernie Madoff and the Ponzi scheme leave one in absolute awe as it remains unclear, what is the culprit: the crime or the criminal? Many innocent parties, including employees and clients, were adversely affected by the ill-doings of these financial schemes. After the outburst of many scandals and its impact on many innocent individuals, jurisdictions are trying to fasten their pace to stay a step ahead of wrongdoers and hopefully eliminate the potential threats in the market.

The introduction of new anti-economic fraud regulations has paved the way for potential investors to feel a sense of security over their investments within the market, along with the ability of the regulations to enforce justice. Over time, people have understood that the formation and establishment of an anti-fraud legal framework are not sufficient to ensure peace and harmony in the market, an iron fist must be imposed on fraudulent parties and companies to deter them from doing such activities in the future and serving it as a lesson for other participants in the market who bear similar intentions.

The types of economic fraud can be quite varied and are spread across different industries and the scope of nature. These could include housing benefit fraud, tenancy fraud, council tax fraud, blue badge fraud, social care fraud, business rates fraud, insurance fraud, bribery, and money laundering. These are just a top layer of economic crimes prevalent in an ocean of fraudulent activities in the market. The crimes that are more coherent to the wrongdoings in the market include not declaring the business location, stating that a property is not in use while it is, dishonestly requesting for an exemption to pay for charges that are owed, or any unauthorized movement of money to make ill-gains.

Often, economic crime is caused not by companies but by customers towards companies. The highest reported crime boost in the Middle East is through customer fraud and procurement fraud, which have proved to be the most disruptive fraud within an economic crime. In a survey conducted on a global platform, the number of customer frauds was comparatively more in the Middle Eastern region.

In an ongoing effort to combat fraud together, many companies in the Middle East began investing in more stringent controls and implementation of the rules to avoid economic crime, while many others conducted a thorough examination into reasons after the occurrence of a crime in the company. Another issue that stands alongside customer fraud about its prominence is procurement fraud. This fraud entails the practice of favoring associates with vendor and supplier contracts.

All these efforts are measures taken to mitigate the risks involved and ensure that proper prevention is taken by instilling the right technology and talent to deviate from any fraudulent prone routes.

However, it is not easy to ensure that accountability will be maintained and transparent feedback is provided. Another limitation of this procedure is that advanced technologies to combat financial crime can be costly, which would further deplete if the company possesses insufficient resources to acquire and install the platform and is not equipped with properly trained employees to manage the technology. The lack of proper expertise to handle the in-place technology could attract various cyber threats, which allows a wrongdoer from any part of the world to infiltrate the company's system.

With this in mind, companies must equip themselves from the arsenal of defenses to protect themself and the financial and reputational facets of the company. The extent of damage that infiltration of the company's system can cause to the operations is quite unfathomable. It would be better for companies to leave their vault of secrets wide open than installing an IT platform that is managed poorly. The necessity of combating such insecurities is proliferating and must be countered at the earliest. One would like to believe that the efforts of the legal jurisdictions in the Middle East to battle economic crime are practical and promptly applied. However, many of the jurisdictions still fail to provide a proper implementation of the provisions established against economic crime.

The readiness of companies in the Middle East to confront the indecisive nature of economic crime and report any issues as they arise is still moving at a stagnant rate. The stark increase in cyberattacks and its potential threats is not a mystery to the companies in these regions. Nevertheless, they decide against preparing themselves in defense of such risks and attacks. The firms in the region and the governmental organizations must understand the types of threats that could arise in the economy and the nature of such economic crimes. Although this would seem like an insignificant step, this particular action could help achieve a more profound revelation of the gaps and vulnerabilities of the economy and its protective framework.

Many would argue that the relationship of the Middle East with economic crime and fraud dates back ages. All the glitz and glamour and the boom of economies are incongruent with the fraudulent activities occurring within the firms and regions. A region's legal systems cannot enforce the regulatory frameworks established to fight against economic crime if the country's government does not implement the rulings.

To know more about Economic and Fraud Provisions in the Middle East in Singapore Click here 

 

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Thu, 30 Sep 2021 14:28:00 GMT
<![CDATA[UAE Healthcare Q-A]]> Q&A guide to the commercialisation of healthcare in the United Arab Emirates

Question Set:

Medicines

Question Body:

  • What is the definition of medicine (or equivalent) in your jurisdiction?
  • Answer Body:

    "Medical products" are defined in UAE law as "all drugs, medical devices or healthcare products".

    "Drug" is defined as "any product that contains an active ingredient or a group of active ingredients that have an intended biological effect on or in humans or animals. Drugs are products which are manufactured, sold or made available to be applied for the:

    • Diagnosis, treatment, cure, relief, or prevention of illness.
    • Restoration, renovation, modification or correction of organ functions.

    (Article 1, Federal Law No. 8 of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments (Pharmaceutical Law)).

    Question Body:

  • What authorities are responsible for regulating the manufacture, marketing and advertising of medicines?
  • Answer Body:

    The UAE Ministry of Health and Prevention (MOHAP) is the primary regulatory authority that regulates all healthcare services for the Northern Emirates. The MOHAP supervises the healthcare policies, all medicinal products, manufactured and imported, as well as the licensing and registration for all medical products and institutions. Additionally, the Emirates Health Authority (EHA) also regulates public healthcare services.

    In addition to the MOH, the following regulatory authorities oversee the UAE:

    • Health Authority Abu Dhabi (HAAD), which supervises all healthcare in the capital of the UAE (Abu Dhabi) and was established under Abu Dhabi Law No. 1/2007.
    • Dubai Health Authority (DHA), which runs the medical necessities in the Emirate of Dubai and was established under Dubai Law No. 13/2007.
    • Sharjah Health Authority (SHA), which oversees all healthcare needs in Sharjah and was established under Federal Law No. 13/2009.
    • Abu Dhabi Health Services Company (SEHA), which manages and owns, either indirectly or directly, public health facilities and other services approved by HAAD in the Emirate of Abu Dhabi.

    Question Body:

  • What notifications, registrations, approvals and licences are required to manufacture and market medicines and their active pharmaceutical ingredients?
  • Answer Body:

    Manufacturing

    A medical product cannot be manufactured in the UAE without obtaining the approval of the MOHAP, provided that it is manufactured by a licensed or approved factory in the UAE according to the standards and criteria issued by a resolution of the Minister (Article 22, Pharmaceutical Law). The process is as follows:

    • The companies must seek prior approval from the relevant authorities (that is, the MOHAP or the relevant health ministry) (see Question 2), before establishing a manufacturing unit or setting up factories to produce medical products.
    • Individuals must apply to the Board of the MOHAP to obtain a licence.
    • Applications must be submitted with all necessary documents to support the application.
    • Companies must also:
    • provide all proposals and full details of any machinery to be installed in the unit;
    • give details of all medicinal products to be manufactured in such a factory and any other vital information required by the MOHAP.
    • The Minister or their deputy must cancel the medical product manufacturing authorisation licence in the UAE if:
    • it is proved that the manufacturing authorisation or factory's accreditation is based on false documents;
    • a resolution has been issued to prohibit product manufacturing in the country or the country of origin or any of the reference entities approved by MOHAP;
    • it is proved that the factory does not apply the principles of good manufacturing practice, which affects the quality of the medical product;
    • the product is found unsafe or has repeatedly failed to comply with the approved quality standards at the time of laboratory tests performed in the accredited laboratories in the country. The Minister must specify by resolution the number of failures that require cancellation of manufacture authorisation; or
    • a resolution is issued to ban the factory's activities in the country, country of origin or any of the reference entities approved by the MOHAP.

    (Article 24, Pharmaceutical Law)

    There are no exceptions concerning the requirements as the Pharmaceutical Law explicitly lays down that no clinical studies of a medical product may be conducted on humans, unless approval from the MOHAP or the concerned authority has been obtained. Any company which complies with the following requirements is entitled to hold the required approvals and licences and undertake approved activities:

    • The company must meet required sanitary manufacturing standards.
    • Full quality control of the whole pharmaceutical product must be assured.
    • An MOHAP-approved qualified pharmacist or other suitable professional must supervise the manufacturing process of the medicinal products.

    Marketing

    Individuals and companies are not permitted to circulate or advertise medical products without obtaining a marketing authorisation or exclusive marketing authorisation licence and approval from the MOHAP (Pharmaceutical Law). Also, under Federal Law No. 15/1980 regarding the regulation of Publications, companies and individuals cannot distribute publications without prior approval from the MOHAP or relevant health ministry. Additionally, UAE Cabinet Resolution No. 7/2007 states that anyone that does not have MOHAP approval and an issued licence is forbidden from advertising and promoting medical products.

    Under Article 7 of the Pharmaceutical Law, the medical product marketing authorisation applicant must:

    • Appoint one or more qualified persons residing in the country according to a resolution from the Minister.
    • Provide a medical warehouse to carry out the import, storage, distribution and wholesale of marketing approved products.
    • Monitor medical products through distribution channels.
    • Provide the necessary capabilities and systems to comply with the requirements of the medical product marketing authorisation.
    • Monitor the performance of the licensed medical product and receive reports from pharmaceutical facilities about its effectiveness, safety, usage and quality.
    • Inform the MOHAP and the concerned authority within 15 days of the date of noticing any unexpected side effects or adverse effects or critical side effects or adverse effects reported or monitored during circulation or local or global clinical researches conducted on the product(s).
    • Monitor procedures of medical product withdrawal.
    • Monitor product patent and manufacture right protection.

    There are no exceptions to the requirements as the Pharmaceutical Law explicitly lays down that no clinical studies of a medical product may be conducted on humans, without obtaining approval from MOHAP or the relevant authority.

    The MOHAP governs and regulates all manufacturing, advertising and sale of medical products in the UAE and is the only authority that issues licences for these activities. However, specific Emirates have authorities that regulate the policies and overall healthcare quality, for example, the:

    • DHA governs all policies, rules and regulations applicable in the Emirate of Dubai.
    • HAAD governs all policies, rules and regulations applicable in the Emirate of Abu Dhabi.
    • SEHA manages and owns, either indirectly or directly, public health facilities and other strategies approved by HAAD in the Emirate of Abu Dhabi.

    Question Body:

  • What are the differences between the regulation of new innovative medicines and generic or biosimilar versions of those medicines?
  • Answer Body:

    There are no differences in the regulation of new innovative medicines and generic or biosimilar versions of those medicines regarding the registration, advertising and manufacturing of medical products. The medical products must be licensed in accordance with the guidelines set out in the Pharmaceutical Law (see Question 3). The MOHAP regulates licences and approvals for obtaining, advertising and selling medical products and healthcare products. Additionally, the Higher Committee of Drug Policies is a committee under the supervision of the MOHAP which is in charge of the development of medical product circulation, pricing and control policy in the UAE.

    Question Body:

  • What are the differences between the regulation of prescription and over-the-counter medicines?
  • Answer Body:

    "Prescribed products" are regulated under Article 31 of the Pharmaceutical Law. These are medical products that require a medical prescription and which cannot be sold, displayed, stored or circulated by non-pharmaceutical facilities.

    Non-pharmaceutical facilities are defined as a facilities licensed to operate in any pharmacy, pharmacy chain, medical warehouse, marketing office, marketing consultation office, pharmaceutical laboratory, pharmaceutical research offices, factory and other facilities stipulated by the executive decree of the Pharmaceutical Law.

    The prescription must be a written or electronic document issued by a healthcare professional duly licensed to dispense medicines. An oral order issued by a healthcare professional is deemed a prescription, as long as it is documented later under the terms of a ministerial resolution.

    However, non-pharmaceutical facilities are allowed to sell, display, store or circulate medical products that can be dispensed without a prescription and which are the over-the-counter medicines under Article 32 of the Pharmaceutical Law.

    Question Body:

  • Are there fewer or different requirements for the approval of medicines that have already been licensed or approved in another jurisdiction?
  • Answer Body:

    Under the Pharmaceutical Law, companies must obtain a licence for selling or manufacturing medical products. However, there are a few exceptions, which usually involve emergency medical products that must be flown into the UAE or sporadic forms of medication that are required at short notice.

    An applicant wishing to obtain medical products from another country in an unregistered way must submit an application to the MOHAP. Only specific bodies such as hospitals and health authorities can import in this manner. All other medical products must pass through the standard licensing process whether or not they have been approved in another country.

    Question Body:

  • Is it possible to sell medicines to or buy medicines from other jurisdictions?
  • Answer Body:

    Import of medicines. Medical products and the raw materials contained in them cannot be imported, exported or re-exported without the MOHAP's approval (Article 26, Pharmaceutical Law). Individuals and companies must adhere to the specific requirements of the MOHAP. The following rules must be considered before selling medical products from other jurisdictions:

    • Only medical products listed as permitted under the Pharmaceutical Law can be imported into the UAE.
    • Individuals who do not have a MOHAP approved permit cannot import permitted medical products.

    A marketing authorisation holder must appoint one pharmaceutical establishment as an importer and appoint one or more distributors to distribute the medical products within the UAE. The importers and distributors must be duly licensed by the MOHAP to ensure oversight and security of supply chains and their appointment by the marketing authorisation holder must also be approved by the ministry.

    Export of medicines. Companies must adhere to different rules to sell pharmaceuticals to other jurisdictions. Pharmaceutical products cannot be sold to other jurisdictions if such products have not been registered under the appropriate authorities. A manufacturer which holds authorisation in its home jurisdiction and a local representative from the UAE must apply jointly for registration. The local representative can only act as an authorised representative with the manufacturer's authorisation. The local representative oversees each element needed to market the product, which includes:

    • A document of proof stating that the products are manufactured using manufacturing processes that adhere to the relevant laws.
    • A "free-of-sale" certification, that is, clearance for sale certification required to certify that the pharmaceuticals are freely sold in the exporting country.
    • A document of proof stating that the appropriate goods can be manufactured and exported from the specific country.
    • Authorisation for the location where the product was produced.
    • Approval indicating that the laws of the manufacturing country have approved the product.
    • Proof that the product meets and is approved by all safety laws of the manufacturing country.
    • All instructions and labelling for the products.
    • A detailed plan of financial activity and marketing prospects.

    However, parallel imports of medical products are not allowed in the UAE.

    Question Body:

  • How is medicine promotion and advertising activity regulated, and what are the general requirements to advertise medicines?
  • Answer Body:

    A medical product dispended by a medical prescription cannot be publicised or advertised to the public by any means (Article 39(1), Pharmaceutical Law).

    The following are permitted with the MOHAP's approval:

    • Announcing, advertising or promoting a medical product in magazines or scientific resources intended for healthcare practitioners.
    • Announcing, advertising or promoting to the public any non-prescription medicine or healthcare product that has marketing authorisation.

    (Article 39(2), Pharmaceutical Law)

    The marketing authorisation holder must ensure that medical product advertisements and promotions comply with the terms and conditions set out by the MOHAP.

    The principal legislation that governs the medical industry's advertisements is Regulation No. 430/2007 of the Health Advertisement Regulations. Additionally, Federal Law No. 15/1980 concerned with Publications and Public Matters (Article 83) states that advertisements are prohibited without the prior approval of the MOHAP. Advertisements for medicines must:

    • Be in line with the law and must not breach any rules in the UAE.
    • Not undermine UAE traditions, Islamic beliefs and customs.
    • Be clear and concise and must not misdirect individuals.
    • Not disrupt public morale.
    • Not promote the unwanted and excessive use of medicinal products.
    • must not be accompanied by the giving of samples.

    (Federal Law No. 15/1980.)

    Some medical advertising is explicitly prohibited because of its content. It is an offence to advertise the following products and services:

    • Abortions.
    • Embryo freezing.
    • Products that are proven to be harmful to individuals.
    • Treatment or preventing the following diseases: cancer, sexually transmitted diseases (STDs), Acquired Immune Deficiency Syndrome (AIDS), hepatitis, mental and psychological disorders.

    (Federal Law No. 15/1980.)

    Pharmaceutical products can be advertised on the internet. However, they must not be advertised online if they do not have professional approval from the appropriate authority. Breach of the approval requirement results in penalties, including imprisonment (Federal Law No. 15/1980).

    Question Body:

  • Are there additional or alternative regulations for special types of medicines or medicines intended for particular types of patients or diseases?
  • Answer Body:

    The Department of Health (DoH) Standard on Stem Cell Therapies and Products & Regenerative Medicine, approved in July 2019, applies to all DoH-licensed healthcare professionals, providers and suppliers of:

    • Stem cell products and laboratories engaged in the provision of stem cells.
    • Stem-cell based-products, and related cellular therapies.
    • Somatic-cell therapy and tissue-engineered products and regenerative medicine products for the purpose of human use.

    This standard also applies to insurers, third party administrators (TPAs) and Medical Billing Offices.

    The main aim is to set DOH's criteria for the provision of safe, effective and quality stem cells, stem-cell based-products and related cellular therapies, somatic-cell-therapy and tissue-engineered products and regenerative medicine products for the purpose of human use in Abu Dhabi.

    Question Body:

  • What controls apply to medicines or components of medicines that derive from humans or animals or incorporate modified genetic material?
  • Answer Body:

    The MOHAP, along with other health regulatory authorities, issues all policies for medical products. If a product contains an ingredient (active or excipient, for instance, magnesium or calcium stearate, stearic acid, gelatin, lactose) that is, or potentially is, of animal origin, or comes into contact with the material of animal origin during manufacture, the source of the material (or contact) must be declared, and evidence must be provided that the product is free from viruses, other micro-organisms and Transmissible Spongiform Encephalopathy (TSE) agents.

    The European Pharmacopoeia Commission Certificate of Suitability (CEP) is acceptable as evidence of freedom from TSE agents.

    In the UAE the following information must be submitted for the General Sales List (GSL), that is medicines that can be sold at non-pharmaceutical facilities such as supermarkets:

    • Statement issued by the principal company showing that the product is devoid from hormones, heavy metals, antibiotics, steroids, derivatives of pork and any natural and chemical ingredients having harmful effects on human biological and behavioral functions.
    • If the product contains an ingredient from an animal source, the kind of animal and part extracted from it must be specified.
    • The percentage of alcohol if any must be mentioned together with reasons for its inclusion.
    • Halal certificate issued by recognisable organisations and authorities.

    Question Set:

    Biological medicines

    Question Body:

  • What is the definition of biological medicines in your jurisdiction and what are the main laws that specifically apply to them (if any)?
  • Answer Body:

    See Question 1 for the definition of medical products and drugs.

    Under Ministerial Decision No. 1412 of 2017, the definition of "medical products" includes pharmaceutical products, including original drugs, generic drugs, herbal drugs, biological products and vaccines. There is no specific definition of biological medicines. .

    Question Body:

  • Are there any additional or alternative regulations that apply specifically to biological medicines?
  • Answer Body:

    Biological medicines are considered as medical products and all regulations that apply to medical products (see Questions 2 to 10) also apply to the biological medicines under the Pharmaceutical Law and the other relevant regulations.

    Question Set:

    Medical devices

    Question Body:

  • What is the definition of medical device (or equivalent) in your jurisdiction? What is the significance of any legal classifications?
  • Answer Body:

    A medical device is defined as a medical product that contains any element, instrument, tool, machine, appliance, implant, in vitro reagent, calibrator or a system, including its accessories and operating software, which achieves the intended purpose to be applied in or on humans or animals, without pharmacological, immunological or metabolic effect.

    A medical device is intended by the manufacturer to be used, alone or with something else, for humans, for one or more of the following purposes:

    • Diagnosis, treatment, cure, relief, monitoring or prevention of illness, injury or disability.
    • Investigation, replacement or modification of an anatomical condition.
    • Contraceptive control.

    Medical devices come within the definition of Medical Products (Article 1 of Pharmaceutical Law). The medical device definition incorporates the idea that a drug can be used for more than its intended purpose, for example, for an anatomical position as well as pregnancy control.

    Question Body:

  • What authorities are responsible for regulating the manufacture, marketing and advertising of medical devices?
  • Answer Body:

    The MOHAP's Higher Committee of Drug Policies is in charge of medical product circulation, pricing and control, including of medical devices. The DHA regulates the policies and overall healthcare quality in the Dubai. The HAAD governs all policies, rules and regulations to be administered in Abu Dhabi.

    Question Body:

  • What notifications, registrations, approvals and licences are required to manufacture and market medicinal devices?
  • Answer Body:

    Manufacturing

    The classification system for medical devices must be undertaken by the manufacturers according to the system set out by the Global Harmonisation Task Force on Medical Devices (GHTF) and the International Medical Devices Regulations Forum (IMDRF).

    The regulatory authorities set out the responsibilities to be followed by manufacturers, such as the design, process of manufacturing, advertising and marketing of medical devices. Manufacturers must conform with the relevant guidelines to assure safe use of the particular medical devices. Further, classification of the medical devices must be undertaken carefully following the GHTF and IMDRF system, where Class A, represents the lowest level of risk to patients, and Class D represents the highest level.

    The primary classification requirements followed by the UAE for medical devices follow those of other countries, such the US Food and Drug Administration's Regulations and the following EU Directives:

    • Directive 93/42/EEC concerning medical devices (Medical Devices Directive).
    • Directive 98/79/EC on in vitro diagnostic medical devices (IVD Directive).
    • Directive 90/385/EEC on active implantable medical devices (Active Implantable Medical Devices Directive).

    Under the GHTF, medical devices must meet specific requirements such as essential safety standards and design and manufacturing requirements. Manufacturers must also adhere to all UAE health and safety and other laws.

    They must also meet all expectations of the MOH at the registration process to obtain approval for the production process.

    Marketing

    Manufacturers of medical devices must be registered with the Higher Committee of Drug Policies before marketing the products in the UAE.

    Documentation required for registering is as follows:

    • Application form (in Arabic and English to the MOH).
    • Proof of conformity.
    • Authorisation of company registration.
    • Prices to be charged.
    • Evidence of essential principles (safety regulations, quality management).
    • Manufacturing process.
    • Labelling and samples.
    • Risk assessment.

    Question Body:

  • Are there fewer or different requirements for medical devices that have already been licensed or approved in another jurisdiction?
  • Answer Body:

    The MOHAP is the authority in charge of all medical products and devices within the UAE. They cover all matters set out in the Pharmaceutical Law.

    All medical devices must be registered and licensed whether including those registered in other jurisdictions. This is so that the MOHAP is aware of and has ensured that all medical devices that are available to be sold in the UAE are safe and documented.

    The only exception to the above requirement is if a medical device is required in an emergency or on short notice in which case only a health authority or hospital is permitted to order the device(s), and they must complete the necessary application.

    Question Body:

  • Is it possible to sell devices to or buy devices from other jurisdictions?
  • Answer Body:

    To sell products in the UAE, the company must be legally established in the UAE. Additionally, companies wishing to sell these devices must either contact a local representative already registered with the MOHAP to sell devices or use a company in which they have a shareholding. If using a company, the seller wishing to sell the products in the UAE the local or the foreign company must begin the registration process. Companies must also ensure that they have a trade licence in the UAE (see Question 7).

    Question Body:

  • What are the general requirements to advertise medical devices?
  • Answer Body:

    Advertising of medical devices is regulated and supervised by the Higher Committee of Drug Policies of the MOHAP. Advertisers must adhere to the rules provided by the MOHAP, including that advertisers cannot advertise without MOHAP approval, which is only granted if all necessary requirements are met (see Question 8).

    All related medical products must first receive an approval from the MOHAP before they can be advertised. Once the product receives the approval and licence(s), it can move to the next stage. The UAE has not passed any federal law governing the advertisements for medical products or devices. However, the UAE has passed numerous resolutions and decisions on pharmaceutical products. This includes laws such as the printing and publication law, and national media council regulations. Federal Law No. 15/1980 relates to printing and publication and under this law specific strict guidelines must be adhered to before anything can be published, including advertisements. Companies must:

    • Send two copies of all upcoming publications to the competent department in the MOHAP.
    • Seek adequate approvals from the appropriate ministry department before publishing any journal. If approved, notification of approval will be given within 14 days of applying.

    (Articles 11 and 12, Federal Law No. 15/1980)

    On receiving approval, a company can publish in the relevant journal. Additionally, companies in the UAE must ensure that advertisements do not cause any negative impact on society. Advertisements must not be offensive to any religious groups and must be mindful of countries' cultures and ways.

    Question Body:

  • What product marking is required for authorised medical devices?
  • Answer Body:

    Medical device approvals or clearances from a recognised regulatory authority (US, Canada, Japan, or Europe) can be used to abridge the evaluation process for medical devices to be marketed within the UAE. Evidence of regular approval or clearance of a medical device in the form of certification and relevant, authenticated documents must be submitted. For devices not certified in the US, Canada, Japan, or Europe, these will be examined, and if approved, will be exempted from recognised country certification for Class A devices (those devices which require the lowest level of regulation and pose the lowest level of risk to patients).

    Question Set:

    Combination products

    Question Body:

  • Does your jurisdiction recognise combination products? What are the main laws that specifically apply to them (if any)?
  • Answer Body:

    The MOHAP is responsible for the regulation of combination products in the UAE. Under the Pharmaceutical Law, all medical products must be registered by the MOHAP before they are imported into the UAE for sale and distribution. A medical product manufacturer must successfully register with the MOHAP before its medical products can be registered in the UAE.

    Question Body:

  • Are there any additional or alternative regulations that apply specifically to combination products?
  • Answer Body:

    See Questions 13 to 19 . The same regulations apply to the commercialisation of combination products.

    Question Set:

    Natural health products

    Question Body:

  • Is there a category for natural health products (or equivalent) (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?
  • Answer Body:

    "Healthcare products" are defined in the Pharmaceutical Law as any medical product used for general human health and not specific for diagnosis, treatment or cure, which do not require a prescription on dispensing or direct medical supervision when applied.

    Natural health products are covered by the MOHAP and their guidelines, in the same way as any other healthcare product. However, depending on the purpose or effect of the product. the regulations may vary slightly.

    The Dubai public health and safety department manages vitamins and minerals and other health supplements.

    Question Body:

  • What authorities are responsible for regulating the manufacture, marketing and advertising of natural health products?
  • Answer Body:

    The bodies responsible for the regulation of manufacturing, advertising and sales of natural health products are mostly the same as those responsible for general health products and medical products (see Question 2, Regulatory authorities).

    Question Body:

  • What notifications, registrations, approvals and licences are required to manufacture and market natural health products?
  • Answer Body:

    Manufacturing

    Generally, the processes and legislation applicable to manufacturing natural health goods are the same as for conventional health products. A licence must be obtained to produce the goods. The process to apply for the licence and its requirements include the following requirements:

    • The applicant must be a citizen of the UAE.
    • A licensed pharmacist must be managing the production factory.
    • The nearest road between the subject of the licence, and the closest pharmacy must be no more than 200 metres away.
    • The pharmacy must follow the technological and health conditions as determined by the Minister.

    (Chapter 6, Federal Law No. 4/1983)

    A factory to manufacture healthcare products can be set up when these conditions are fulfilled.

    Marketing

    Similar to medical products, no healthcare product can be circulated within the UAE without obtaining marketing authorisation or exclusive marketing authorisation from the MOHAP according to the terms and procedures set out by a ministerial resolution (Article 3, Pharmaceutical Law) (see Question 3).

    Question Body:

  • Are there fewer or different requirements for natural health products that have already been licensed or approved in another jurisdiction?
  • Answer Body:

    The requirements for marketing/selling natural health products licensed or approved outside the UAE are no different from those that are licensed in the country.

    Such products must be accompanied by the necessary import licence/authorisation documents (see Question 26) on their arrival into the UAE.

    There are two methods of entry for imported products:

    • Mainland entry points. Entry into the mainland incurs the standard tariffs of importing into the country as stated in the Gulf Co-operation Council Common Customs Law.
    • Free zone entry points. Importing a product into one of the country's free zones will not incur the above tariffs.

    Question Body:

  • Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?
  • Answer Body:

    Natural healthcare products must be registered to be allowed to enter the country or to be sold online. This includes approval and licensing by the MOHAP. Once a product is approved, the requirements for natural healthcare products under the Pharmaceutical Law must be met. This means that at least the following must be present on the bottle in both Arabic and English:

    • Name of the medicine or preparation and its registration number in the MOHAP, mentioning the pharmacopeia or scientific or cultural references according to which the medication was prepared, if any.
    • Names and amounts of the active natural substances that are used in the composition of the medicine.
    • Date of production of the medicine or preparation, and expiry date if validity is time-barred.
    • Name of the manufacturer of the drug or preparation.
    • The instructions and warnings associated with the use of the medication or preparation.

    .When a product is approved, licensed and is fully legally compliant, it can be sold within the UAE.

    Imported products can only be sold in the UAE if they meet the necessary requirements and must enter the country with all required paperwork present on entry.

    Companies may face several difficulties in selling medicines online. Certain products such as vitamin and mineral tablets can be purchased online as long as they are approved by the MOHAP. However, other controlled substances are not permitted to be sold online. They must be prescribed to an individual and collected from a pharmacy. Controlled medical substances and products include:

    • Toxic substances and plants.
    • Prohibited veterinary substances.
    • Narcotic and psychotropic substances, whether in form of raw materials or incorporated in a medical product.
    • Hazardous medical products.

    Question Body:

  • What are the general requirements to advertise natural health products?
  • Answer Body:

    Advertising of natural health products in the UAE is permissible provided the products being advertised are licensed in the UAE from the relevant ministry. When the licence is issued, the advertisement must be sent to the MOHAP to receive approval. The import, manufacture, market or export medicines and preparations derived from a natural source or sources is not permitted unless the product has obtained a licence from the MOHAP. The company must apply to the MOHAP for their approval. The MOHAP will review the application according to the requirements of the Pharmaceutical Law and the printing and publishing laws (see Question 8).

    Advertisements must not be offensive and overly explicit, especially to religious groups and individuals. Additionally, advertisements must take local culture into account and must be sensitive towards the ways and customs of the UAE. When approval is received, the company can publish the advertisement in the public domain.

    Question Set:

    Data

    Question Body:

  • What data and information laws must be complied with by life sciences businesses that collect, use or otherwise deal in patient data (including through health apps)?
  • Answer Body:

    The Federal Law No. 2 of 2019 regulates the use of information and communications technology in healthcare (ICT Law) throughout the UAE, including the free zones. The objectives of the ICT Law are to ensure:

    • Optimal use of ICT in the health sector the security and safety of health data and information.
    • That the bases, standards and practices adopted adhere to international standards.
    • That the MOHAP can collect, analyse and maintain health information at the national level.

    (Article 3, ICT Law)

    Article 4 of the ICT Law prohibits the processing of data and information without authorisation, aiming to:

    • Ensure the authenticity and credibility of health data and information by preventing its unauthorised destruction, variation, misrepresentation, deletion or addition.
    • Allow health data and information to be available to authorised parties and make it accessible whenever needed by those parties.

    Health data and information cannot be stored, processed, generated or transferred outside the UAE, other than through a resolution issued in favour of the healthcare data and information processors in co-ordination with the MOHAP (Article 13, ICT Law).

    Under Article 16, data only be used and processed in relation to the patient's specific health matter unless the patient consents to the data being used processed for a different reason) or if exceptions apply. Exceptions include the data processing:

    • Of health financing or health insurance services and benefits.
    • Of clinical trial and research, provided that the identity of the patient is not disclosed.
    • For taking preventive and treatment measures for public health or to maintain the safety and health of the patient or for supervision, inspection and maintaining public health at the request of the healthcare data and information processors.
    • At the request of the judicial authorities.

    Research

    Question Body:

  • What restrictions and regulatory requirements apply to the testing of life sciences products on human and animal subjects?
  • Answer Body:

    No clinical or bio-equivalence or bio-availability studies of a medical product can be conducted on humans, without obtaining approval from the MOHAP or the relevant authority. In addition, the necessary medical investigations must be carried out on the human subjects of a clinical study to ensure their safety after obtaining written approval by the trial subjects for their part in the clinical study and acknowledging its potential risks (Article 13, Pharmaceutical Law).

    Clinical trials and tests cannot be conducted on bio-samples of trials by any entities other than those approved under Article 13. The following types of bodies can be approved by the MOHAP or the relevant authority to conduct clinical trials:

    • Public and private hospitals.
    • Universities and specialised scientific research centres. Where clinical trials are not able to be conducted on such institutions' premises, trials can be conducted in authorised hospitals.
    • Laboratories.

    The entity that conducts the clinical trial is obliged to:

    • Develop the trial plan to be performed, including scientific justifications.
    • Provide licensed physicians to supervise the safety of subjects of the trial.
    • Conclude an insurance contract at an insurer operating within the UAE to cover any damages that may result from the trial.
    • Comply with the:
    • code of good clinical trials practices adopted by the MOHAP;
    • Higher Committee of Clinical Trials ethics.

    Question Set:

    Reform

    Question Body:

  • Are there any plans to reform the rules on the development, manufacture, marketing and advertising of life sciences products and services?
  • Answer Body:

    On 19 December 2019, the UAE adopted Federal Law No. 8 of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments and abrogated Federal Law No. 4 of 1983 and Federal Law No. 20 of 1995. The New Pharmaceutical Law modernises the legal framework for the regulation of medical products in the UAE. The legal and regulatory reforms contemplated in the UAE strongly convey the desire of the UAE to be at the forefront of medical care. The UAE is propelled to focus on its national agenda, which is to achieve a world-class healthcare system in the UAE. In the pharmaceutical sector, reform is directed at drastically increasing the manufacturing capacity, and for investing in pharmaceutical manufacturing and research and development. The UAE aims to manufacture and provide healthcare like the top countries in the world. This includes a renewed focus on research and development as well as attracting qualified medical professionals and researchers.

     

    Question Set:

    Contributor profiles

    Simarata Randhawa, Trainee Associate

    STA Law Firm

    T +9712 694 8534 F +971 2 644 919 E legal@sta.law W www.stalawfirm.com/en.html  

    Professional qualifications. B.Com; LLB; LLM with emphasis on Corporate Law and Arbitration, Boston University.

    Areas of practice. Corporate law; Healthcare.

    Recent transactions.

    • Advising on the healthcare sector of the UAE and other jurisdictions.
    • Assisting various healthcare institutions, healthcare professionals and individuals in different jurisdictions on matters relating to healthcare.

    Languages. English, Hindi and Punjabi.

     

     

    ]]>
    Thu, 11 Feb 2021 17:07:00 GMT
    <![CDATA[A Guide to Medical Malpractice]]> A Guide to Medical Malpractice: A Medico-Legal Team Is Central to Your Case

    A patient goes to the doctor or hospital, trusting the ability of the healthcare professional in curing any ailment. Complete trust is placed upon the doctor's skills and knowledge, his specialty, and the various professional degrees suffixed to the doctor's name. Most of the time, a patient goes to a specific hospital or doctor based on their reputation. The number of healed patients, the number of successful surgeries all play a big role, the bigger the name, the higher the expectations by the patient and family members. 

    But what if the doctor or the hospital fails to carry out the expected duties in saving a life or properly treating an ailment?

    Everybody has read the horrific tabloid stories about surgeons removing the wrong organ or, perhaps just as horrific, patients not being anesthetized properly and feeling every ounce of pain during an operation but unable to alert anyone. 

    According to WHO, medical negligence causes nearly 2.6 million deaths a year (WHO news release on 13 September 2019).

    This number is scary high when compared to deaths related to seasonal flu (6,50,000) (WHO news release on 13 December 2017) and road accidents (1.35 million) (WHO news release on 7 February 2020). Medical Malpractice is a dainty issue most of us would rather never think about.

    It is indeed a perplexing issue as medicine is far from a perfect science. In most cases, the professional will have to take a trial and error approach, eradicating one possible diagnosis at a time. The trying of alternatives until the goal is attained, be it diagnosis or treatment, is very different from improper or negligent care, despite the fine line between the two. Therefore, the official charged with investigating Medical Malpractice has to be extremely skilled.

    Medical negligence is when a healthcare professional causes a harm to a patient due to ignorance or a harm occurs unknowingly or not taking a diligent action that could have reduced the discomfort or life threating complication.

    Medical malpractice occurs when the healthcare professional is aware of the complications or potential consequences and still proceed.

    The most common examples of Medical Malpractice or Negligence 

  • Surgical Error
  • When the doctor tells the patient that they need to undergo a surgery, it brings a slight fear or discomfort for the patient. There is a common misconception that nothing can go wrong if it is a minor surgery. The truth is that regardless of the type of surgery, whether minor or major, a surgical error can occur. "Surgical Error" is an avoidable mistake during any surgery. There are different reasons why a surgical error can occur:

  • Incompetency of the surgeon;
  • Not following the surgical protocol;
  • Too many cases to handle at one time which may drain out the surgeon;
  • Overconfidence due to experience;
  • Insufficient planning;
  • Missing the patient's medical history or comorbidities (other diseases the patient has) that may cause a complication during the surgery.
  • Every patient is different. No matter how many years of experience a surgeon has and how many successful surgeries they have seen, it is always a trial and error approach for each patient. In any case, if negligence should take place, this can lead to physiological and psychological trauma for the patient. Every year we hear stories on how a small mistake by the surgeon costs loss of a body part or someone's life.

    ]]>
    Wed, 23 Sep 2020 09:08:01 GMT
    <![CDATA[Distribution of Pharmaceutical Products Kuwait]]> Distribution of Pharmaceutical Products: Kuwait

    Introduction

    The area of the Gulf Cooperation Council (GCC) is regarded as an "emerging market" for pharmaceutical exports and bilateral trade. Learning this region's regulatory requirements can be beneficial for pharmaceutical exports. The Gulf countries ' regulations promote the importation of quality generic products, which facilitates a boost in the trade and economy.

    In GCC countries, the drug industry reaches USD 6 billion approximately. This demand is rapidly growing and is expected to reach around USD 10 billion by 2020. Given this market's rise, local manufacturing is unable to meet the growing demand, and GCC countries continue to import most (90%) of their drug needs from abroad. Therefore, there are substantial opportunities for growth and development of this sector in GCC Besides, expanding growth in this industry will help achieve the region's strategic objectives in terms of industrial diversification into knowledge-based sectors.

    The emerging sector aims at achieving the following objectives:

    • Establish a forum for the exchange of ideas and dialogue between pharmaceutical companies in the GCC
    • Propose a multi-client study to address the needs of the region's pharmaceutical industry
    • Identify the need for GCC producers to create a pharmaceutical trade association.

    With Kuwait accelerating its plan for healthy growth as part of Kuwait's 2035 dream, the Ministry of Health (MoH) is also focusing on expanding their projects. Both the pharmaceutical and healthcare industries in Kuwait have been identified as high-priority sectors, with many initiatives under public-private partnerships (PPPs) are being carried out.

    Kuwait Pharmaceuticals Market Overview

    With the boost from the government's healthcare initiatives, the pharmaceuticals market in Kuwait is currently at a growing stage. Initially, the domestic manufacturing of medicines in the country was low due to the focus inclining towards the booming oil and gas industry coupled with limited diversification into various other sectors. It is pertinent to note that the pharmaceutical industry is closely monitored by the government, and the demand for branded and patented products has stretched the government's budget for the same. The growing trend of preventive healthcare such as the demand for pseudo pharmaceutical products like supplements and vitamins, smoking cessation aids, weight loss formulations, etc, have supported the expansion of healthcare awareness, thereby witnessing the inception of government initiatives for driving pharmaceuticals to build factories which are in line and in collaboration with the Public Authority for Industry.

    The Regulation Process

    Medicines in Kuwait are regulated on the basis of standards of quality, safety and efficacy, price control and patent protection. The nation has 40 years of regulatory framework experience and plays a leading role in the regulatory environment of the GCC.

    The pharmaceutical sector of Kuwait entertains various multi-source products which are imported from multiple countries and regions. The regulatory framework set in place attempts to ensure the following objectives:

    • The product has been licensed and sold for at least twelve months in countries with recognized and competent regulatory authorities
    • That the product follows the desired quality standards, globally accepted, to ensure that the product is manufactured for its intended use
    • That the product remains stable throughout the projected shelf life
    • For local patients, the price of the product must be reasonable and affordable.

    The regulation framework consists of different phases to ensure that the pharmaceuticals products that help ensure that the products are of the best quality to provide steady growth and development; the stages are as follows:

    1. The Submission Phase

    The review process begins with the local agent (or sponsor) sending the registration dossier together with a covering letter to the Kuwait Drug and Food Control Manager (KDFC) formally demanding the pharmaceutical material registration.

    2. The Evaluation Phase

    In this phase, the reviewer will evaluate the Chemical and Manufacturing Control (CMC) data after entering the scientific review stage, focusing on the following data:

    •  Material descriptions and detailed analytical methods for finished products
    •  Total stability analyses of the expected consumer shelf life 
    • Specifications of raw materials and their procedures of analysis

    3. The Authorization Phase

    Upon completion of the full evaluation, the final approval decision is taken by the DRRS, which is officially endorsed by the authority's director

    The Data Required for Registration of Pharmaceutical Products

    In accordance with Ministerial Decree 302/8, the Kuwait Food and Drug Authority (KuFDA) is the head regulatory agent to register pharmaceutical products.

     

     

    ]]>
    Sun, 08 Dec 2019 11:46:00 GMT
    <![CDATA[Regulation on Pharmaceutical Industry in the UK]]> Regulation on Pharmaceutical Industry in the UK

    Imagine that you are an entrepreneur in the pharmaceutical industry having recently made a scientific breakthrough in a critical field. Your first instinct is to get this breakthrough certified and licensed, so it can be manufactured and sold to the masses who require it. You approach 'Authority A' only for them to tell you to get approval from 'Authority C' first. While trying to get approval from 'Authority C', the lack of required documentation from 'Authority B' causes the application to be rejected.  The lack of the technical know-how of how to go about with this process makes it seem like a very expensive, daunting and confusing task, making you nearly reach the point of not going through with it. The seemingly complex nature of multiple regulations can appear this way to countless individuals, whereas in reality, it is merely a straightforward and structured path that has been set up to follow. This article aims to provide a guidance for the same by explaining in detail how simple the regulations that govern the pharmaceutical industry are.

    In the UK, the pharmaceutical industry is primarily governed and regulated by the Department of Health and Social Care (DHSC). The primary objective of the department is to improve the quality of care through the issue of guidelines and policies that are to be followed by all personnel and establishments involved. The legislation adhered by the DHSC is:

    • The Medicines Act, 1968
    • The Poisons Act, 1972
    • The Health and Social Care Act, 2008
    • The Pharmacy Order, 2010
    • The Human Medicines Regulations, 2012

    The Department of Health and Social Care oversees 15 bodies that help provide healthcare-related services across the United Kingdom. With respect to pharmaceuticals, there is an executive agency under the DHSC, known as the Medicines and Healthcare Products Regulatory Agency (MHRA) which is responsible for regulating and assessing medicines and devices. The General Pharmaceutical Council established using the Health and Social Care Act 2008, is an independent statutory regulator which regulates pharmacists, pharmacy technicians and pharmacies.

    Regulations on Medicinal Products

    The Human Medicines Regulations, 2012 govern medicinal products across the UK. As per the guidelines, only an individual with a license may manufacture, import or distribute medicinal products. The MHRA is the competent authority to grant such permissions and has the right to refuse any application if it deems to be appropriate. It also has the power to suspend or revoke licenses, if it thinks fit, on the following grounds:

    • The information in the application was false.
    • There is a material change of circumstances in relation to the matters of the form.
    • The license holder has contravened any provisions of the license.
    • The license holder fails to provide the competent authority with relevant information regarding the medicinal products of the license.

    Regulation on Pharmaceutical Establishments

    Pharmaceutical establishments in the UK are regulated by the Medicines Act, 1968 and the Pharmacy Order 2010. The regulations require these establishments to acquire a license prior to setting up shop and prohibit anyone apart from the pharmacist who is responsible, from being in charge of the registered store. The establishments must comply with the guidelines set forth in the legislation, for which the registrar shall be the competent governing authority. Medical devices, on the other hand, are regulated by the MHRA.

    Regulation on Medical Devices

    The MHRA has issued a set of instructions that are to be followed for the registration and usage of any medical device in the UK market. The Medical Devices Directive (MDD), a directive issued by the European Union, describes a medical device as any instrument, apparatus or article that is used to diagnose, prevent, monitor, treat or alleviate diseases or injury, or investigate and modify a physiological process, or control conception. According to the MHRA, there are three types of medical devices, which are:

    • Active Implantable Medical Devices: Powered/partial implants left in the human body.
    • In Vitro Diagnostic Medical Devices: Equipment intended to use in vitro to examine specimens from the human body.
    • General Medical Devices: Devices that usually relate to other medical devices.

    Depending on the level of risk associated with them, medical devices are given the following classification:

    • Class I (regarded as low risk)
    • Class IIa (regarded as medium risk)
    • Class IIb (regarded as medium risk)
    • Class III (regarded as high risk)

    Once it has been established as to how the medical device will be classified, it is required to go through a conformity assessment as set out by the MDD. All classes of medical devices are required to have a declaration stating that the requirements set out in the MDD are met and inform the competent authority, in this case, the MHRA, in order to get approval and certification for the same.

    National Healthcare System and Funding

    The United Kingdom has a national public healthcare policy in the form of the National Health Service (NHS), an executive public body under the DHSC. The range of services offered by the NHS covers every aspect of healthcare, including medical services from general practitioners and medical treatment in NHS hospitals (for both emergency and non-emergency cases). There also exists a private health insurance system within the UK, although a relatively lower number of people opt for this due to the range of services covered under the NHS. Patients opting for a private health insurance program have quicker access to specialists, can avoid long waiting times and can avail better facilities. The premiums for these private health insurance programs on the level of coverage the person has enrolled for, their age and lifestyle, and any pre-existing medical condition.

    Within the UK, there are two arrangements of pricing that exist for medicinal products. They are:

    • The Voluntary Scheme for Branded Medicines Pricing and Access
    • The Statutory Scheme

    The Voluntary Scheme for Branded Medicines Pricing and Access is a voluntary agreement that exists (DHSC) and the Association of British Pharmaceutical Industry (ABPI). This scheme is applicable only within the NHS and aims to give the NHS access to good quality medicines at a reasonable price and at the same time, allowing the body to research and develop improved drugs. The decision to change prices lies with the DHSC upon evidence that suggests a need for the same in order to preserve an economical supply of drugs. Another way in which a member of the Voluntary Scheme can initiate a price change is if their assessed profits exceed the 'Return on Capital' percentage of 21%, by 50%. If such is the case, then the member reduces prices by an equivalent amount. If the member's profit exceeds 50%, but from below 21%, then they are entitled to a price increase.

    The Statutory Scheme of regulating the price of medicinal products is governed by the Branded Health Service Medicines (Cost) Regulations, 2018. According to the regulations, manufacturers are required to pay a rebate to the DHSC at a fixed percentage, which initially was at 7.8%, but subsequent amendments set the rates at 9.9%, 14.7% and 20.5% for the year 2019, 2020 and 2021. The Statutory Scheme can further establish a maximum price for a specific drug, at the discretion of the DHSC.

    Regulation on Clinical Trials

    Clinical trials are a critical part of any pharmaceutical product. In order to conduct clinical trials of medicinal products, there are a set of guidelines issued by the MHRA that must be followed. No clinical trial can be performed without prior authorization from the MHRA. An application for permission to conduct clinical trials must be submitted to the MHRA, while simultaneously getting an opinion from the Ethics Committee, which must be positive in nature. The application for clinical trials can also be submitted through the Common European Submissions Portal, which was created for the purpose of having a secure and straightforward mechanism to communicate with the regulatory authorities. Once the necessary approvals have been secured, the clinical trials can begin and are divided into 4 phases. It must be noted that only if a product passes the safety and effectiveness tests of one phase, can it go to the next one. The phases are as follows:

    • Phase I: In-human trials. The product is tested on a small number of subjects and aims to find the lowest effective dose and the highest non-harmful dose.
    • Phase II: The subject size is increased to several hundred who have a particular disease or a condition. This phase primarily finds out the common side effects and how the treatment is effective in more significant numbers.
    • Phase III: The therapy is now spread across several thousand patients in order to gather detailed information, and the results are utilized for prescription and patient information.
    • Phase IV: After the medicine has been licensed, trials continue in order to assess the long term harms and benefits of the drug.

    Upon submission of the application along with the relevant documents, an initial assessment will be conducted within 30 days (14 days in the case of healthy volunteer trials and Phase I trials in non-oncology patients). The possible outcomes that can arise are either an unconditional acceptance for authorization of the clinical trial, or conditional approval for authorization of the clinical trial, or non-acceptance for authorization of the clinical trial with specific grounds. Applications which are not given approval are given a chance to amend and resubmit.

    Medical devices, on the other hand, are required to a clinical investigation in order to obtain the CE marking before they can be used. An application must be made to the MHRA at least 60 days before the start of the investigation. Once the MHRA receives the request for an application that is supported by the necessary documents and upon payment of the fees, a reply will be sent within five working days regarding any issues with the form. Any problems that arise will only be cleared after a valid response is given, only after which the 60-day assessment will start. Either at the end of 60 days or before, a definite decision (either an objection or no-objection) will be given as to whether the clinical investigation can happen or not.

    Parallel Imports

    With regards to parallel imports of medical devices, the MHRA has issued a set of advisory guidelines that are expected to be followed. Once the medical device is in compliance with the CE standard of conformity, in accordance with the Medical Devices Directive, the importer will not be recognized as a parallel importer of the medical device unless:

    • Repackaging and rebranding of the product are done in a different market.
    • The medical device is modified in a certain way which is no longer covered by the initial CE standard of conformity

    Regulations on manufacturing and marketing of medicinal products

    The manufacturing and marketing of medicinal products in the UK are governed by the Human Medicines Regulations, 2012. Manufacturing is only allowed to those who have been issued a license for the same by the competent authority (MHRA). The holder of the manufacturing license must ensure that the manufacturing process must comply with Good Manufacturing Practice Directive set forth by the MHRA. Any manufacturing or assembling of medicinal products other than those specified in the license is prohibited, and the license holder must ensure that all staff, equipment and facilities provided at the place of manufacture are appropriate enough to maintain the quality of the medicinal products. In order to market the medicinal products in the UK, an application has to be made to the licensing authority specifying as to how the product would be marketed, i.e. on prescription, from a pharmacy or on general sale. The licensing authority must make a decision whether as to grant or refuse approval for marketing within 210 days from the date of application. Once the authorization has been given, the holder of the authorization must submit periodic safety update reports to the licensing authority. The licensing authority further has the following duties:

    • Make public any such approval.
    • Draw up and revise assessment reports with regards to the quality, safety or efficacy of the medicinal product.
    • Include a summary of the assessment reports in a manner that is understandable for the general public.

    The authorization for marketing is valid for an initial period of five years, which can be renewed for another period of 5 years subsequently. The MHRA has the discretion of revoking any such authorization if:

    • The positive therapeutic effects do not outweigh the risks of the product to the public.
    • The product is harmful.
    • The product lacks therapeutic efficacy.
    • The product composition is not in accordance with that on the application of authorization.

    Pharmacovigilance

    Pharmacovigilance is the practice of monitoring the effects a drug has once it has been authorized and licensed for marketing. In the UK, pharmacovigilance is regulated by the MHRA under the Human Medicines Regulations 2012. According to the regulations, the licensing authority is tasked with creating a creating and operating a competent pharmacovigilance system where suspected adverse effects arising from the use of medicinal products can be reported. The MHRA is empowered to take appropriate regulatory action it deems fit if any and must perform regular audits of its system. The authorization holder is obligated to ensure that it continuously has qualified persons at its disposal for the maintenance of the pharmacovigilance system. They are also tasked with monitoring the system to:

    • Scientifically evaluate the product.
    • Minimize and prevent risks associated with the product.
    • Take appropriate measures whenever applicable.

    The holder of the authorization is mandated to conduct periodic audits, make a report of the main findings and take an appropriate corrective action plan and implement it, whenever applicable.

    All data in the pharmaceutical industry is governed and protected EU General Data Protection Regulation effective from May 2018. This coexists with the pharmacovigilance system that is present throughout the country.

    Liability

    The MHRA is regulatory authority for medicinal products across the UK and under the Human Medicines Regulations 2012, penalties in the event of a breach of obligations by the manufacturer can be imposed by the authority. License and authorization holders have extensive obligations that are to be fulfilled, especially with respect to pharmacovigilance and risk management. The regulations place that for defective medicines, distributors, sellers, and prescribing physicians can potentially be held liable. The provisions are further protected by the Consumer Protection Act, 1987 (CPA). As per the CPA, the liability of the damage lies with the producer of the product. There exists a limitation time period of three years from the date at which the cause of action occurred in order to file a tortious claim, as per the Human Medicines Regulations 2012. The CPA provides a further time period of ten years after the date of the action. The remedies that are usually given out are in the form of damage and is decided by the court after considering the circumstances of the claimant, in accordance with the guidelines issued by the Judicial College and precedents.

    The license and authorization holders can also be held criminally liable for any breach of obligations under the Human Medicines Regulations 2012, which can result in a possible conviction and fine, with the maximum time period of imprisonment not exceeding two years.

    Conclusion

    The extensive regulations that govern the pharmaceutical industry in the UK are necessary to ensure that there is a fair practice in existence and the interest of patients and consumers alike are catered to and upheld. Without these regulations, it will be difficult to govern the ever-growing industry.

     

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    Mon, 07 Oct 2019 15:11:00 GMT
    <![CDATA[Artificial Intelligence in healthcare]]>  

    Abu Dhabi's New Policy on the use of Artificial Intelligence in the Healthcare Sector

    Scientists throughout history have delivered many inventions that have continuously made human life much easier. The most recent technology that has changed all our lives is Artificial Intelligence. Artificial Intelligence (AI) would be termed by many as the "greatest thing since sliced bread". Despite the difference in opinions, no one can deny the effect AI has had on our daily lives. We have several examples of Artificial Intelligence in our daily lives such as Virtual Personal Assistance (like Siri, Alexa, Cortana), video games like the 2014 "Middle Earth: Shadow of Mordor", smart cars, the automated customer support on websites, fraud warning software used by emails and banks, and even a robotic chef! The development of AI has been said to have ushered the fourth industrial revolution, on a scale as we have never seen before. In fact, the World Economic Forum commented that "AI is disrupting almost every industry in every country."

    What is Artificial Intelligence?

    It is a term used for simulated intelligence in machines. Simply explained, it is an area of computer science where machines are programmed to think like and mimics humans. It emphasizes the creation of machines that work and react like a human with the ability to rationalize and take actions with the best possibility for the success of a particular goal. Machines with artificial intelligence are designed to perform activities like speech recognition, planning, learning, analyzing and problem-solving.

    Benefits And Risks Involved

    Benefits

    • Error Reduction - AI facilitates the reduction of error and the chance of being more accurate with a greater degree of precision.
    • Difficult Explorations- AI combined with the science of robotics can overcome human limitations and be put to use in difficult explorations such mining and for exploring the ocean floor.
    • Every day Use- machines with AI continuously make lives easy for us. With Siri or Cortana in offering personal assistance, self-driving cars for long journeys, the smart chef to make our meals.
    • Digital Assistance- Since robots do not possess emotional capabilities, they are capable of thinking logically and making the right program decisions, making highly advanced organizations to use "avatars" which are digital assistants to interact with the users.
    • Machine intelligence can be employed to perform dangerous or monotonous tasks.
    •  In the medical field, AI assists doctors in the diagnosis of their patients' health and the side effects of certain medications. A popular AI application is the use of Radiosurgery in operating tumors and can actually help in the surgery by protecting the surrounding tissues from damage.

    Risks

    • Unlike human beings, AI machines cannot improve with experience, that changes their responses in accordance with the changing environments. The way AI machines process data cannot be said to be the same as human intelligence.
    • There is also an ethical argument against replicating human intelligence. Advocates of this argument state that since AI machines do not possess emotions, they also lack the moral compass to make a judgment of the right or wrong. They cannot perform in situations unfamiliar to their programming.
    • The development of Artificial Intelligence can lead to the replacement of humans, causing large-scale unemployment. In the current economy, the demand for jobs is already in excess of the available employment opportunities.
    • A common fear is the machines will be so highly developed, so as to surpass humans and take off on their own, redesigning themselves at an exponential rate.

    Need For Legislation Of Artificial Intelligence

    Research by Pricewaterhouse Coopers (PwC) predicted that by 2030, AI could boost global GDP by 14%, which is equivalent to $15.7tn. The fields of finance and healthcare are the most benefitted from AI. In the finance sector, the detection of frauds, algorithm trading, portfolio management, loan or insurance underwriting has significantly contributed to the growth of the industry. In healthcare, the data gathering, and analysis capabilities of AI enables faster diagnosis; earlier and better treatments; risk analysis of medications and treatment methods, has helped to save and improve many lives.

    The development of AI has given rise to a new field of law, requiring governments of countries to develop a legal framework to address legal concerns over this technology, such as:

    Liability

    Companies making and selling AI software need to be accountable for damages caused by unreasonable practices. However, the question of liability in Artificial Intelligence is very complicated. In a dispute regarding a building, it is relatively straightforward in pinpointing the accountability. In the scenario of Artificial Intelligence, however, the supply chain is longer with multiple participants involved in its creation. To avoid these complications and a long drawn out litigation process, it is necessary to define the parameters of liabilities of the market players in case of machine failure.

    Human control

    Another significant component is ensuring that humans have control over and can override the decisions made by the Artificial Intelligence.

    Automated Weapons

    A huge factor of concern is the use of Artificial Intelligence to develop automated weapons, which in the wrong hands can cause mass causalities. Moreover, this could also lead to an AI arms race, with the machines being designed in such a way as to make it impossible for a human to turn it off.

    AI IN THE UNITED ARAB EMIRATES

    In October 2017, UAE appointed His Excellency Omar Bin Sultan Al Olama as the first Minister of State for Artificial Intelligence, making UAE the first country in the world have a designated Minister for AI. This was done expressing UAE's ambition and resolve to be at the forefront of the global technological revolution. The Ministry aims to improve government performance and create a highly productive and innovative environment for the investment of AI in UAE.

    In a recent report by the Ministry for AI, UAE is predicted to have a boost of $182 billion added to its economy by 2035. The UAE economy continues to witness an increasing use of AI in the following sectors:

    Education institutions in UAE use AI and machine learning to assist in the prediction of students at the risk of dropping out, employability of graduates along with other patterns.

    Banks and financial organizations in UAE increasingly use AI technology for advanced customer services, fraud detections and management, risk assessments.

    In the healthcare sector, new technologies are being slowly introduced to test its effectiveness. For example, the Government of UAE is currently testing and introducing the following new innovations into healthcare:

    • The Body of health analysis pods to be rolled out in government buildings to assist the staff to monitor health and detect early any signs of illnesses.
    • An application by Babylon, which uses AI to provide 24/7 video consultancy to patients from all around the world will be soon available in UAE.
    • Health Care and Innovative New Technology (HINT) neuro band helps detect strokes; and
    • The flow cell sensors by Admetsys to alert doctors to sudden drops in the vitals of ICU patients.

    New Policy on use of Artificial Intelligence in Healthcare in the Emirate of Abu Dhabi

    On May 28, 2018, Abu Dhabi's health sector regulator, the Department of Health (DOH) introduced a new policy to govern Artificial Intelligence, its use and implementation in the healthcare. The Department is in full support for the development, adoption, and use of AI technologies to enhance the healthcare quality in Abu Dhabi.

    Analysis Of The Provisions Of The Policy

    •  Definition of AI and AI Technologies:

    The policy defines

    Artificial Intelligence as "the mimicking of human thought and cognitive processes to solve complex problems automatically."

    Artificial Intelligence Technologies such as "machine learning, distributed intelligent systems, expert systems."

    • Scope

    It applies to all

  • Government Licensed Healthcare Providers
  • Licensed healthcare researcher involved in human research
  • Healthcare insurers; and
  • Every local, national and locally based international end-user directly or indirectly utilizing or wishes to utilize clinical and non-clinical data of patients or population of Abu Dhabi in its AI endeavors.
    • Minimum Acceptable Requirements for AI and Tools

    The department of health requires all kinds of artificial intelligence and its tools introduced in Abu Dhabi for the purpose of health care delivery, public health, pharmaceutical production or medical research to

  • Obtain certification of the AI software being robust and responsive and for each upgrade major versions of the software from recognized international agencies;
  • Compliance with the regulations by Abu Dhabi Smart Solutions and Services Authority (ADSSSA);
  • Possess validation statements which are auditable;
  • Equip the AI used in healthcare with "Graceful Degradation" mechanisms by integrating automatic alerts and with the ability to cease gradual operation in the event of any hardware or software malfunctioning;
  • Be exposed to continuous cycles of improvements and updates based on the feedback of accuracy from the end-users. The feedback should be sent to the Drug and medical Products Regulation Department, Department of Health and to the manufacturing company;
  • Subject the AI System to be audited and examined by the technology provider and set up by relevant methods; and
  • Comply with all the policies by the DOH Health Information Exchange Policy especially with regard to the terms of the privacy and transparency.
    • Responsibilities of Healthcare End Users

    The policy places the following duties on the Healthcare End-Users other than patients:

    • Develop clear governance on the use of AI.
    • Provide clarity on
  • the entry point of AI for any of the healthcare uses mentioned in the policy;
  • the role of the physician or other practitioners according to the scope of AI use;
  • the role of AI; and
  • the boundaries between the practitioner and the AI.
    • For the protection of the confidentiality and ownership of patient information, provide clear guidelines and boundaries on access to and sharing of any such information.
    • To educate all those involved including the patients and end-users on the AI and its effective use.
    • Conduct regular audits by the owning entities on the functionality of the AI and report the same to the DOH as required.
    • Comply with all the necessary certification of the AI software and its major upgraded versions from recognized international agencies
    • Comply with all National and DOH regulatory requirements (both old and new) governing E-Health, data protection, HIE, information security or AI.9.
    • Submit end-user feedback to the DOH, Drug & Medical Products Regulation Department, and to the manufacturing company.
    • Insurers' Responsibilities

    The insurers shall:

  • Comply with all the DOH requirements for robust and responsive AI
  • Ensure clear governance in the use of AI in their service
  • Maintain clarity on the point of entry of AI in its intended use and the role of the insurer, AI and the boundaries between them.
    • Enforcement and Monitoring of the Provisions

    Enforcement: All those specified to be within the scope of this policy must comply with the terms and requirements of this Policy. In the event of failure by any such party, the DOH can impose sanctions in relation to the breach in accordance with the Chapter XI of the healthcare Regulator Manual.

    Monitoring: the DOH shall develop a framework to monitor and evaluate the Policy, involving all the entities within the purview of this policy and adopt changes wherever necessary to ensure continuous improvement within the healthcare system

    DOH shall through audit, inspection, and reports received from healthcare end-users, monitor the compliance of the Policy. A framework shall be adopted to evaluate the effectiveness of the AI in healthcare including the inputs, activities, outputs, and outcomes. End-users other than patients and insurers shall report to the DOH or other regulatory bodies of all known or suspected incidents or deficiencies related to AI use in their respective domains or any issues arising from the implementation of AI in the healthcare that could threaten the patient safety.

     

     

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    Sat, 05 Jan 2019 12:05:00 GMT
    <![CDATA[Development in Auh Healthcare]]> Recent Development in Abu Dhabi Healthcare Sector

    "It is health that is real wealth"- Mahatma Gandhi

    Introduction

    Over the past decades, the UAE health sector has witnessed a dramatic change along with impressive growth. UAE has a federal government which oversees the entire country's health sector. The government also finances almost all the non-private healthcare organizations and institutions. One of the highest level strategic plans of UAE Government is Vision 2021 which mainly plans to achieve the "world-class healthcare". The government is planning to do it by accrediting all the government and non-governmental hospitals, clinics and other healthcare organizations following the various international standards. The main focus of the UAE government and the other Emirati states to develop the modern healthcare infrastructure to ensure that adequate services and facilities are made available in the Emirates.

    In UAE healthcare is regulated at both the federal and emirates level. At the Emirates level, there are multiple health regulatory authority to administer the various health service in the Emirates level.

    It is possible to divide the entire health care sector of the UAE into the following segments:

  • The Ministry of Health of UAE
  • Department of Health which (DHO) was previously known as Health Authority Abu Dhabi (HAAD).
  • Dubai Health Authority. (DHA)
  • Dubai Health Care City Free Zone. (DHCC)
  • In keeping with a new vision of healthcare development, the Emirati state of Abu Dhabi has also developed its Emirate level strategic health care plans for the people and residents of Abu Dhabi. In the year 2014, a broad strategy and initiative were taken by Sheikh Mohammed bin Zayed Al Nahyan, Abu Dhabi Crown Prince and Deputy Supreme Commander of the Armed Forces to improve the healthcare facilities in the Emirati state of Abu Dhabi. This strategy included 85 initiatives that mainly aims to promote the various facilities and quality of the healthcare system in Abu Dhabi.

    Department of Health (DOH)

    Each entity within the healthcare sector has their own set of policies, principles, and responsibilities like taking care of essential health care services, licensing the doctors and the nurses etc. The DOH is the regulatory body of the healthcare sector in the Emirate of Abu Dhabi. This regulatory body shapes the regulatory framework in the healthcare sector in Abu Dhabi.

    DOH which was previously known as HAAD (Health Authority Abu Dhabi) first arose through the Law Number 1 of (2007). As mentioned in the Article 1 (Clause 1 and 2) of the Law Number 1 (2007), the main purposes of DOH are to achieve the highest standards in health and medicinal services and health insurance and to follow-up and monitor the operations of the health sector to deliver an exemplary standard in provision of health and curative services and health insurance. To achieve its purpose, the establishing Law Number 1 of 2007 empowers the DOH in the following ways:

  • DOH is authorized to apply the various laws, rules, regulations, and policies with a vision of developing the health sector in Abu Dhabi. (Article 5 Clause 2)
  • DOH approves the various rulings and procedures regarded as being necessary for operating health and curative establishments in Abu Dhabi.
  • DOH develops and applies the integrated systems to control the public and private health sector in the Emirates level. (Article 8 clause 12).
  • Polices and key Principles of DOH

    DOH's policies refer to decisions, plans, and activities which are undertaken to achieve various healthcare goals. DOH policies mainly focus on to outline the priorities and the expected roles of different groups related to health.

    Some of the critical principles of DOH are:

  • DOH regulations have their bases in evidence. It is mentioned in Law Number 1 of (2007), that the DOH regulatory controls will be evidence-based as far as possible.
  • DOH follows a seamless, coherent and transparent regulatory framework.
  • DOH seeks to optimize resources and reduce administrative burdens.
  • Role of DOH

    DOH has the prime responsibility of licensing and setting various standards of the healthcare professionals.

  • DOH has to determine the Healthcare professionals who require a license.
  • To establish the criteria for the practice within the law.
  • DOH has the responsibility to take regulatory actions concerning healthcare service providers.
  • DOH also sets out a framework for disciplinary action.
  • As per the Law Number 1 of (2007) the Healthcare service providers who obtain licenses will be the responsible party and ensure that they are competent to and how they act in the best interest of patients.

    Roles of Healthcare Service Providers as per Law No.1 of (2007)

    The roles are as follows:

  • Healthcare professionals have to ensure that the  Healthcare Professionals employed by them hold a license issued by DOH,
  • Healthcare professionals have to develop job descriptions for all staff employed at Healthcare Facilities operated by them,
  • The healthcare professionals have to provide medical liability insurance and professional hazard insurance for Healthcare Professionals employed by them,
  • Healthcare professionals have to co-operate with any audit carried out by DOH.
  • Licensing of Healthcare professionals in Emirates of Abu Dhabi

    The DOH establishing law requires all that all the health care professionals to be licensed by DOH to practice in Abu Dhabi. To obtain a license, health professionals must meet the PQR requirements, the language requirements, the current national or similar foreign license requirement etc. Again there is the examination requirement that applies to all Healthcare Professionals other than those who are determined by DOH to be exempt from this. As such all the healthcare professionals have to pass the examination. DOH may reject an application for a license of a healthcare professional that has not to meet all the requirements. DOH also has the power to suspend and revoke the permissions of the healthcare professionals.

    As per the DOH law, it requires that all the healthcare professionals have the duty to comply with the various policies and standards that apply to them. In general, healthcare professionals must respect the integrity of the patient. They should carry due regard for every patient and should not discriminate against any patient based on gender, race, religion, customs, economic status etc.

    Other Health Sector Entities

    As mentioned in the Law Number 1 of (2007), the government health sector entities include Abu Dhabi Health Services Company (SEHA) incorporate under the Emiri Decree Number (10) of 2007 and the National Health Insurance Company (DAMAN) consolidated through the Emiri Decree Number (39) 0f 2005.

    SEHA: (Abu Dhabi Health Service Company)

    SEHA, an independent and public joint stock company that mainly operates in all the public hospitals and health organizations in Abu Dhabi. Emiri Decree Number 10 of 2007 established the company. SEHA is a leading participant in Abu Dhabi's health sector. The company seeks various kinds of reforms to upgrade and improve the healthcare service of Abu Dhabi. For the last two decades, SEHA is promoting different types of healthcare excellence for the people of Abu Dhabi, and it is achieving goals with a competitive advantage. SEHA assume the responsibility for public health care centers and hospitals. SEHA has entered into many partnerships with the international healthcare institutions with a view of identifying the best global practices.

    Abu Dhabi Occupational Safety and Health System Framework

    This code applies to all the employers within the Emirates of Abu Dhabi for the provisions of medical emergency and first aid treatment to employees, workers and the other persons. As per this framework, any medical professionals providing services beyond the first aid should have a license to practice medicine as required by the Department of Health of Abu Dhabi. The framework mentions various kinds of training requirements for the first aiders in Abu Dhabi; for instance, all the trainers should have the valid training certificate from the recognized training providers.

    Conclusion

    In today's world more and more innovations are put into practice in the healthcare system. People are witnessing more and more transformation in healthcare. Because of this enormous transformation, we need a balanced regulatory system which can provide us with a quality health service. The regulations should be flexible and protective against risky practices.

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    Tue, 04 Dec 2018 14:04:00 GMT
    <![CDATA[Embryonic Stem Cell Research and Its Relation to the Destruction of Foetus Introduction]]> Embryonic Stem Cell Research and Its Relation to the Destruction of Foetus

    Introduction

    Embryonic stem cell research is a cause of great contention globally, and the regulation and stigma around such research is and will continue to be a heated topic. In the governance of every country, the murder of another human being is a crime punishable by law, and the removal of embryonic stem cells is the act of causing such stem cells for not developing into a human being. Where is the line is drawn in the sand, at what point is the destruction of an embryo for science murder and when is it not? At what point of conception does a fetus being a human being in the eyes of the law and is granted protection as such.

    Common law jurisdictions such as South Africa provide a fiction regarding which the law can grant unborn fetus protection; this is the nasciturus fiction which was derived from the Roman law. Regarding this legal principle whenever there is a situation which would have been to the advantage of the fetus if she/he was already born, all rights that are conferred on persons that are already born alive, are also consulted on the embryo. The fetus then becomes a legal persona and carries legal capacity from the date of conception.

    Embryonic stem cell research in China

    In the past, China was without a comprehensive regulatory framework to govern embryonic stem cell research. It has led to a large number of unproven treatments derived from embryonic stem cell research used on the open market. It has created an environment which was not only detrimental to those patients participating in such unproven treatments but also cast doubt on the research of those scientists who were breaking new ground in the stem cell research field.

    In 2003, the People's Republic of China's Ministry of Science and Technology and the Ministry of Health released official ethical guidelines for human embryonic stem cell research. The guidelines formally forbid any research targeted at human reproductive cloning and necessitate that the embryos that are utilized for stem cell research come only from:

  • Spared gamete or blastocyst after in-vitro fertilization procedures;
  • Fetal cells from accidental, spontaneous or voluntary selected abortions;
  • A blastocyst or parthenogenetic split blastocysts obtained by somatic nuclear transfer technology; or
  • Germ cells voluntarily donated.
  • In January 2012, the Chinese government implemented a ban on unapproved stem-cell therapies and a temporary moratorium on new clinical trials. With this ban, the government promised to establish a much-needed regulatory framework for future research.

    However, regardless of the regulations put in place by the government, rogue research facilities continued to operate. The only impact that was evident was a restraint on stem-cell scientists with valid research agendas.

    In 2015, the Chinese government brought into effect more stringent regulations on embryonic stem cell research, which they believed would curb the use of unproven treatments. These regulations include:

    •  'obtaining patients' informed consent;
    • Using clinical-grade stem cells that have been authorized by an independent body;
    • Stem cell clinical studies will only be carried out at authorized hospitals; and
    • No costs will be involved for recipients of stem cell research-based treatment."

    Presently, the Chinese Ministry of Science and Technology's aim for China is to become one of the leading countries in the field of embryonic stem cell research. The nation is supplying institutes conducting such research with funds from multiple sources.

    Guidelines on Chinese Embryo Stem Cell Research

    The director of the Chinese Society of Medical Ethics, Professor Benfu Li laid down the following principles to be abided by when conducting embryonic stem cell research in China:

  • The Principle of Respect – an embryo must be considered as human biological life and as such demands a specific value – this requires that a fetus cannot be damaged or controlled without enough reason. The medical potential of human embryonic stem cell research is so vast that such research should undoubtedly be permitted and supported.
  • The Principle of Informed Consent – donors, must be informed of all aspects of the research before such a donation. They must consent to all procedures to be undertaken during the investigation, and such consent must be kept a secret. 
  • The Principle of Safety and Utility – this principle determines that before any research may be conducted with human embryonic stem cells, it must have been tested on animals to avoid bringing damage to patients and donors alike. The study will not be used in clinical medicine until it has been proved that experiments on animals are safe and useful.
  • The Principle of Non-commercialisation – this principle prohibits the buying and selling of gametes, embryos and fetal tissue. If such buying and selling were not banned, it could lead to the exploitation of donors.
  • As was discussed above, the ethical concerns regarding embryonic stem cell research spark much debate around the world. The use and destruction of the embryo for research purposes is a controversial part of the research process. However, in China, this is not the case. In fact, most Chinese citizens view the embryo as not containing any inherent moral value.

    The Chinese citizens have followed a Confucian way of life for two millennia. According to a Confucian view, "a person being with birth; a person is an entity that has a body or shape and psyche, and has a rational, emotional and social-relational capacity for a lifetime of learning and innovation."

    This way of thinking, therefore, results in the Chinese population viewing a human embryo as not having the characteristics of a human being and thus cannot be equated morally to a person requiring the protection of the law.

    Regulation in the UAE

    In the majority of the countries in the Middle East, there is no regulation for stem cell research and the scientists, and research institutes mostly rely on religious decrees. The UAE does not have any national legal framework or rules governing Embryonic Stem Cell research. However, as per the Sharia law, an individual will be required to pay 10% of the blood money even for accidentally killing a fetus. This principle of Sharia law was applied by The Dubai Traffic Court of First Instance where it fined a Lebanese woman for accidentally killing a nine-month embryo in a traffic accident.[1] In another incident, a man was convicted for killing his wife who was two months pregnant and unborn child. The Abu Dhabi Criminal Court of First Instance's judgment was also upheld by the Appellate Court too upheld the decision.[2] Moreover, in 2012, the Dubai Health Authority ordered a stem-cell company to stop operations after it discovered to be promoting a treatment which is linked with the death of two children.[3]

    [1] https://gulfnews.com/news/uae/transport/mother-convicted-of-killing-foetus-in-traffic-accident-1.67532

    [2] https://www.thenational.ae/uae/courts/death-sentence-upheld-in-pregnant-woman-s-murder-1.494069

    [3] https://www.thenational.ae/uae/embryo-research-a-moral-and-ethical-minefield-1.362764

     

    ]]>
    Thu, 06 Sep 2018 10:36:00 GMT
    <![CDATA[CRISPR Gene Editing Technology]]> CRISPR Gene Editing Technology

    The Human Advancement

    Human often marvels at the things they create. From large structure to technologically mind-blowing machines, many impressive achievements warrant awe and amazement. A close look at these things will reveal their workings and both their strengths and their flaws. However, surrounded by all of this, one may forget from time to time to look, not only atones surroundings but also at one's self. Humans are vastly complex beings; perhaps more complicated than anything we will ever create. And yet for our entire history, we have concentrated on advancing the world around us while never genuinely having advanced ourselves.

    One of the latest things we will hear about in the news and from the top scientific professionals is the matter of gene editing technology, most notably CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats). To be more specific to human use, CRISPR-Cas9, as before it was ever considered to use on humans, it was used to alter the genetics of other organisms. This scientific technique, which came into existence in around 2012, allows for the editing of the very genetic structure of an individual. The implications are massive, though the topic is quite decisive. Gene editing is something even scientist are still learning about, and the idea and practice are very much in its infancy.

    One of the most significant areas of the whole practice is the idea and viability of using the CRISPR to edit the genes of embryos. Modifying the genes of embryos will allow for potential genetic mutations and genetic diseases to be removed from the child's genome before birth and could save a child from having to live with a potentially harmful or detrimental trait. The achievement can be by removing the specific set of coding in the embryos DNA that would be mutated and would cause the negative character, and to then use the CRISPR technology to implant the new genetic structure. It may sound all positive, though there are many implications and ethical dilemmas to consider.

    The UK at the Forefront

    The UK is making quite some progress in the matter of gene editing. They can see the potential benefits of the process when done correctly and are looking to move their knowledge of the topic forward. Around the start of 2016, UK scientists were given the go-ahead to begin testing and using CRISPR on human embryos for research purposes. It was approved of by the UK Human Fertilisation and Embryo Authority (HFEA) and was the first time something like this received approval outside China.

    One thing to note is that this is not the first type of human genetic editing that has occurred. There have previously been gene therapies available, but not in the same way that CRISPR looks to move things forward. Prior, there was the possibility to have the genetics of somatic cells within an adult human edited for medical purposes. This form of editing was managed in the UK by the Human Tissue Authority (HTA), which received acknowledgment under the Human Tissue act of 2004. Now, this is a little divergent from the CRISPER concept, though it does show how the UK has been highly progressive in the matter of human genetic engineering. Having been established in 2004, this occurred around 11 years before the first human trials of CRISPER, and may very well have paved the way for the UK's future as a world leader in the area of early gene editing technology.

    The hope is that the technology will, in time, be used for the curing of diseases and disabilities in embryos before they are born. The technology works by editing the DNA structure of the cells of an organism, by cutting away unwanted segments and adding in preferred portions. The research for the moment is concerned with fighting diseases that we have, up to this point, had no answer, and is mainly interested in the most negatively impacting diseases that there are. Since the science is not yet fully understood, it would more often than not, be seen as too high a risk to take for less problematic issues, though for the time, the research is being performed on spare IVF embryos usually only a few cells in size.

    It is because gene editing is still looked upon skeptically by quite a few due to what it could lead to as it advances. There are ethical issues concerning the topic. The biggest of these seems to be the fear some have that there may come a time when designer babies become a thing. It will allow for certain individuals to pay to have their children's genetics altered to have favorable traits, including the appearance of the individual, and though we have an insufficient understanding of it at the moment, we may be able even genetically to modify individuals for higher intelligence and certain personality traits. It is very much a distant prospect, as we are still in the early stages of using the technology for simple and vital issues, though with the research into the issue growing, we will inevitably start to look into controversial areas such as these when they become a more comfortable thing to achieve. 

    The Chinese have been attempting to use gene editing technology since around 2015, as far as we know, and have used the technique on approximately 86 or more people. Matters such as these in China are not as well known about regarding the details and results of tests. Further to this, the regulations regarding the issue are also different from much of the rest of the world, and so the Chinese may be more open to and freer regarding the matter and the research they perform. With this considered, it was in this year that a group of scientists did what no other individual or organization had done before. The concept had been extensively tested and was watertight. The biggest issue in testing for humans is that we are generally more complicated than the test analogs that we use. However, the Chinese researchers went ahead and performed the test as per their precise calculations on the previously mentioned 86 non-viable zygotes. In the end, the test was in many ways a failure though. Only 26 of the zygotes had their genomes successfully cleaved, and from a scientific standpoint, that is not a success rate. However, and more importantly, the research was underway

    Outside of China though, the UK is at the forefront. The first law regarding the issue of genetic manipulation was the Genetic Manipulation Regulations of 1989. However, this law does not extend to humans. Preferably it is more concerned with the genetic manipulation of animals for the research purposes, which is something that has been allowed by the law for quite some time now, though it was not at that time see that it would be an issue for a human. The next big step in the UK was the limited go-ahead to certain scientific organizations to begin using and researching the practice in 2016

    Regarding the human side of things, all matters to do with embryology are under the governance of the Human Fertilisation and Embryology Authority (HFEA). The HFEA has been given its powers through the Human Fertilisation and Embryos Act of 2008, though this was before the rise of CRISPR. As Crisper has come around, the HFEA has come up with their guidelines for researchers to abide. While the HFEA is most prominently known to cover the issues of fertility treatment etc. they now also deal with related matters including CRISPR.

    Now while some scientists have been given the go-ahead by the HFEA to perform research using gene editing technologies, this by no stretch means that it is legal on a larger scale. The individuals allowed to conduct this research are insufficient in number, and since the HFEA is the only body in the UK that is permitted to provide the license required to do this research. Individuals should submit an application to them on the matter, and their issuing of the permit would be insufficient and strict, though not impossible. As recently as early as 2018, grants are issued in small numbers of new individuals and organizations.

    The reason for the severe limitations to the number of groups that can use CRISPR to do research is because the issue is one that can be seen to be quite sensitive. There are many ethical dilemmas one must consider and not all will agree on the matters raised.

    It is apparent that the HFEA has a policy that no gene editing research may take place without first obtaining research ethics approval, even by the approved bodies. What this means is that to perform analysis in genetic engineering for humans, one would first have to be approved of by the HFEA to be eligible to do this type of research, and then for every potential project of research they would look to perform, they would have to receive a further approval.

    It ensures two things. Firstly, the research that scientists are doing is known to the regulatory bodies, and they are aware and up to date on what the licensed parties wish to do. Parties will get information about the research, and then the authorized bodies must wait until these proposals are accepted. Secondly, it allows people other than scientists to look into the issues that are for research and the methods that are being used to perform the investigation, and it provides for them to discuss them from an ethical standpoint. Once in-depth consideration is on the matter from multiple parties, it can then commence. As seen here, this is a highly regulated area, as it rightly should be, and it ensures we do not move forward into areas that can be dangerous.

    Where is the Rest of the World?

    While the UK is one of the countries at the forefront of gene editing research; other countries are also becoming more open to the prospect. While there are no laws that govern this field, too, there are generally no countries which allow for genetic engineering. It is often a banned practice except, as previously mentioned, for certain entities that have received the necessary approvals.

    Considering the US, they were first given a yellow light (much like the UK, only the approved and licensed bodies may research into the field) to perform research in the area of human genetic engineering towards the beginning of 2017. They showed their first CRISPR genetic engineering to embryos towards the latter stages of 2017. With the case of the US, this allowance was only for research at first, with no editing to perform viable embryos that would go on to later be born, and substantial research would be required before this technology would become available to a further degree.

    The issue was a scorching one during the year of 2016, with many on both sides of the table. Some were calling for a complete ban on the editing of human genetics in embryos, as they saw it leading to unethical practices and other who saw it as unnatural. In general within the country though, the method is still illegal, as none may perform practical research on the matter, and the only bodies that are allowed to, are highly official and highly regulated bodies. It would be near impossible for smaller organizations to obtain the license.

    The US's governing body for the matters concerning the issue is the FDA (Food and Drug Administration). The FDA is in charge of promoting and protecting public health, and they enforce laws covered under this area. The department was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, and that is their general purpose. Much like the HFEA, they have also allowed and approved of certain organizations performing research on embryos under 14 days old.

    A case in the US that shows the earlier stages of the legal developments about genetics was the Association for Molecular Pathology v. Myriad Genetics. It was quite a lengthy case, beginning in 2010. Myriad Genetics Inc. was looking to patent genetic sequences. There was a considerable amount of back & forth in this case. Initially, two of Myriad's patents had been denied, though, upon appeal, the court reversed the decision. The legal battle between these parties continued, with arrangements being changed multiple times across a plethora of suits.  In the end, the case finally came to a close in 2013 with the conclusion that a genetic structure cannot receive a patent, as it is naturally occurring thing which does not meet the requirements for something to obtain a license. However, and this is where things become interesting, that manipulated genes, such as those created within a lab, were indeed eligible to be patented as they were not considered wholly natural and instead of a construct of human creativity. This entire issue occurred before CRISPR, though with the advancements that have occurred, the ruling is now more relevant than ever.

    Looking to the Horizon

    Regarding this issue, there may be those whose minds evoke images from horror movies, of genetic engineering going wrong. The scientist is performing illegal experiments and creating monsters that will be impossible to stop. However, in the real world, there are far too many guidelines, and far too many barriers to allow for any overly dramatic to occur. There is a reason the practice is still technically illegal, and only the bodies of the FDA and HFEA have, in their respective countries, empowered may progress. There is a reason that an ethics committee must approve of any of the planned activities. Also, this is to ensure a safe progression into the future, and a sequence which all can agree is acceptable and safe.

    Looking beyond this and to the future though, the practice is one which has the potential to save the lives and improve quality of life for so many. As our understanding towards this topic increases, the legislators will pass more guidelines and laws to safeguard everyone's interest. There will be a more significant number of organizations and groups permitted to perform research in the fields. Also, as our knowledge expands, the areas we will be allowed to research will also grow. We are stepping forward on all the fronts, and the future awaits and looks brighter than ever

    ]]>
    Tue, 17 Apr 2018 00:00:00 GMT
    <![CDATA[Исцеление на Расстоянии]]> Исцеление на Расстоянии:

    Робот сегодня поможет обходиться без врачей завтра.

    «Через несколько лет получение медицинской помощи в кабинете врача или в больнице будет казаться странным».

    - Бизнес обзор Гарварда

    В то время, когда технологическое развитие ускорило распространение информации и революционизировало наши способы общения, прогресс и влияние этих технологий не остались незамеченными для сектора здравоохранения. Технологии телекоммуникации в настоящее время используются для поддержки предоставления медицинских услуг, а именно посредством предоставления виртуальных медицинских услуг.  Этот новый метод был назван телемедициной и первоначально использовался для контакта с пациентами, находящимися в отдаленных местах. Хотя телемедицина относится исключительно к клиническим услугам, телездравоохранение может  также относиться к таким неклиническим услугам, как административная и образовательная деятельность.

    Всемирная Организация Здравоохранения установила, что история телемедицины начинается с середины 19 века с военной и космической промышленности, и что ее современная форма началась с конца 1960-х и начала 1970-х годов. Слово «телемедицина» означает «исцеление на расстоянии» и позволяет людям предоставлять медицинские услуги даже в случаях, где расстояние является критическим фактором, что свидетельствует о значительном прогрессе, достигнутом сферой здравоохранения.

    Непосредственный Доступ к Специализированной Консультации

    Инновационные технологии не смогли проскользнуть мимо Объединенных Арабских Эмиратов, которые запустили целый ряд проектов по телемедицине и телездравоохранению. В июле 2015 года Управление Здравоохранения Дубая (DHA)  инициировало тестовое использование «Робо Док» в больнице Хатты. Исследование касалось использования технологии «Робо Док», которая может обследовать пациентов на расстоянии. По сути, использование этой технологии значительно снижает затраты на консультации для пациентов, а именно с 90 до 30 долларов. Кроме того, технология «Робо Док» оказалась особенно полезной в чрезвычайных ситуациях. Робот «Робо Док», медицинский аппарат, который контролируется со смартфона, на котором изображается доктор, использовался для оценки состояния тяжелораненных в результате дорожно-транспортных происшествий пациентов. Робот во многом ускорял лечение пациента, генерируя результаты лабораторных исследований, важные признаки и рентгеновские снимки. 

    Новаторский метод диагностики пациентов с «Робо Док», как до, так и после получения травмы, позволил команде травматологов напрямую сообщать о состоянии пациента врачам скорой помощи, вместо необходимости посещения специалистом госпиталя для проведения тестов. Доктор Моин Фикри, руководитель инициативы телемедицины Управления Здравоохранения Дубая и директор Центра Травматологии объяснил, что «посредством робота врачи могут одновременно консультироваться с двумя и более специалистами в различных медицинских учреждениях, чтобы получить моментальную специализированную консультацию». Специалисты здравоохранения теперь могут находиться в двух местах одновременно, таким образом работать с большим количеством пациентов. Ускоряя процесс лечения, технология телемедицины может не только экономить деньги пациента, но также время и, следовательно, их жизни. Испытания прошли с огромным успехом и призвали правительство Объединенных Арабских Эмиратов инвестировать средства в дальнейшие технологии телездравоохранения. Управление Здравоохранения Дубая анонсировало, что оно будет стремиться расширить проекты телемедицины и телездравоохранения во всех своих медицинских учреждениях, и что это первая государственная организация в регионе, внедряющая подобные технологии. 

    Регулирование Инновации

    Изначально в Объединенных Арабских Эмиратах присутствовали только ограниченные правила, касающиеся телездравоохранения. Специалисты здравоохранения не знали, могут ли они участвовать в проектах телездравоохранения, что привело к замедлению развития данных проектов. Проблема регулирования инновационных технологий заключается в том, что разработка политики - это медленный и жесткий процесс, который обычно отстает от быстрого развития этих достижений. Ранее в Дубае регулирования Управления Здравоохранения только позволяли выполнять услуги телерадиологии и запрещали лицензирование других услуг телемедицины. Новые правила DHA, выпущенные 21 февраля 2017 года, теперь разрешают лицензирование услуг телездравоохранения. Административное решение Номер 30 от 2017 года («Решение»), касающееся регулирования служб здравоохранения, было выпущено недавно Управлением Здравоохранения Дубая. В статье 3 Решения указывается, что его цель заключается в обеспечении ясности требований к предоставлению услуг телездравоохранения и обеспечении наивысших стандартов безопасности и доступности для своих клиентов. В статье 4 Решения указывается, что необходима лицензия для любого представителя данных услуг.

    Управление Здравоохранения Абу Даби (HAAD) обладает нормативной базой для услуг телездравоохранения с 2013 года, согласно которой Центр Телемедицины Абу Даби получил соответствующую лицензию. HAAD разрешает широкий спектр услуг телемедицины и специальную телемедицинскую лицензию. Тем не менее, одним из факторов, ограничивающих развитие данных услуг, является невозможность провайдеров назначать лекарства обследованным пациентам. Если в плане лечения необходимо назначение лекарства, пациент должен  получить индивидуальную консультацию в больнице, чтобы его получить.

    Стандарты Телеконсультации в Абу Даби

    Что касается телеконсультационных услуг в Абу Даби, Управление HAAD выпустило Стандарты для Телеконсультаций в эмирате Абу Даби ("Стандарты"), которые вступили в силу в марте 2014 года. Согласно статье 8.1.1, медицинские учреждения, желающие предоставлять телеконсультационные услуги, должны либо получить соответствующую лицензию HAAD, либо быть авторизованными HAAD для предоставления услуг  телеконсультации. Телеконсультирование позволяет предоставлять следующие услуги:

  • Сортировка (определение приоритетности пациентов в зависимости от срочности их потребностей)

  • Диагностика

  • Видео наблюдение за симптомами тела

  • Рекомендации по лечению, исключая выписку лекарств

  • Запрос на патологию, уход за больным, радиологические исследования

  • Теле-направление, в соответствии с политикой HAAD по перенаправлению пациентов

  • Последующий уход и ведение дел

  • Домашний мониторинг состояния здоровья пациента и его жизненных сил

  • Другие медицинские услуги, такие как предоставление обучения пациентам, консультирование и услуги, связанные с программами борьбы с болезнями.

  • В статье 2.3 Стандартов говорится, что консультации могут проводиться с использованием ряда телекоммуникационных средств, таких как телефоны, интернет-видео, электронные письма и аналогичные электронные сообщения. В статье 3 Стандартов перечислены обязанности, которые должны выполнять провайдеры услуг телеконсультации, такие как обязательство обеспечить профессионализм и конфиденциальность (3.1.3), а также обязательство обеспечить доступность услуг для всех пациентов (3.1.2). В дополнение к этим обязанностям, которые аналогичны обязанностям медицинских работников в целом, некоторые из обязательств, более специфичных для услуг телеконсультации: обязательство обеспечения качества и безопасности телеконсультационных услуг (3.1.4), обязательство проводить политику в области Информационно-Коммуникативных Технологий (ИКТ) (3.1.7) и обязательство предложения ИКТ технологий и их соответствия техническим требованиям и нормативным документам Системно-Информационного Центра Абу Даби и HAAD. Кроме того, статья 7.1.3.1 требует создания комитета по качеству в случае, если в учреждении работают 10 и более специалистов. Что касается объектов, в которых работает менее 10 специалистов, необходимо назначение врача, ответственного за качество. Существуют также другие стандарты, которые предлагают руководство по услугам телездравоохранения, такие как Стандарты Обслуживания HAAD по Телеконсультациям в эмирате Абу Даби.

    Объединенные Арабские Эмираты предприняли ряд мер для регулирования динамики услуг телездравоохранения, но все еще существуют области, требующие регулирования. Правительство проявило явный интерес к использованию этих инновационных услуг для повышения эффективности системы здравоохранения. В чрезвычайных случаях, когда расстояние стоит на пути человека, требующего медицинской помощи, телемедицина предложила доступный, эффективный и революционный способ оказания этой помощи нуждающимся.

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    Sat, 30 Dec 2017 03:24:00 GMT
    <![CDATA[Закон о Медицинской Ответственности в ОАЭ: Новые Горизонты]]> Закон о Медицинской Ответственности в ОАЭ: Новые Горизонты

    "Если бы люди поняли, что врачи не боги, то не ожидали бы от них чудес".

    {C}-        Ричард Зельцер

    Люди обращаются за помощью к специалистам для получения профессиональных консультаций по вопросам, выходящим за рамки их компетенции или опыта. При этом они полагаются на специалистов в этих вопросах. Хотя специалисты также могут ошибаться в своих решениях. Подобные ошибки считаются актом профессиональной халатности. Но профессиональная халатность существенно отличается от небрежности в целом, поскольку профессионалы обязаны продемонстрировать стандарт знаний в своей работе. Кроме того, последствия профессиональной халатности сильным образом влияют в медицинской сфере, где неправильное решение может повлечь за собой травму пациента. Однако, врач, допустивший профессиональную халатность, будет рассматриваться иным образом, нежели обвиняемый (преступник), который умышленно причинил вред другому лицу.

    Развитие науки и техники за последнее время унесло нас далеко от того, где мы были еще десятилетие назад, и заставило правовую  систему задуматься об устаревших положениях, которые изначально касались гораздо более простых ситуаций. В данной статье команда юристов STA в Абу Даби обсуждает новую сферу ответственности медицинских работников Объединенных Арабских Эмиратов (ОАЭ), причинившим пациентам вред по неосторожности.

    Медицинский режим

    Законодатели страны приняли Федеральный Закон №4 от 2016 года (Новый Закон) в целях улучшения положений, касающихся ответственности медицинских работников, выполняющих свои обязанности недобросовестным образом.  Новый Закон отменил Федеральный Закон №10 от 2008 года (Старый Закон) и, как ожидается, внесет значительные изменения в существующий режим медицинского обслуживания в ОАЭ.  Говоря в общем, врачи должны соблюдать стандарты «врачебного долга», выполняя свои профессиональные обязанности перед пациентами. Следовательно, любой акт халатности может нанести тяжелый вред пациентам, ожидающим стандарты «врачебного долга»  от своих врачей.

    С юридической точки зрения пациент может подать гражданский иск против врача или медицинского работника, если они причинили вред или смерть пациенту по небрежности или неосторожности. Пациент должен доказать следующее для возмещения ущерба: (а) профессиональный долг и ответственность врача по отношению к пациенту; (б) нарушение врачом обязательств по стандартам ухода за пациентом; (в) вред здоровью, нанесенный пациенту, является подлежащим компенсации ущербом; (г) соблюдение требований стандартов ухода помогло бы избежать нанесению серьезного вреда здоровью пациента.

    Понятие Медицинской Халатности

    Следующая иллюстрация поможет читателю понять сферу медицинской халатности: Джеймс Тернер, 50-летний инженер-механик, прошел операцию на открытом сердце в больнице XYZ.  Однако, на следующий день после операции он начал терять зрение и полностью потерял его в течение двух (2) дней. Медицинский персонал больницы не сообщил во время врачу об этом заболевании, и поэтому было слишком поздно консультироваться с офтальмологом и оказывать соответствующую медицинскую помощь. Впоследствии врач был привлечен к ответственности за ошибочное диагностирование пациента и предоставление ему лечения, вызвавшего неудачный поворот событий. У Джеймса был перенесенный ишемический инсульт зрительных нервов  из-за потери крови во время операции, анемии и низкого кровяного давления. Впоследствии выяснилось, что больница могла предотвратить слепоту пациента, если бы ему была оказана своевременная медицинская помощь. Кроме того, больница была привлечена к ответственности за действия врача и отсутствие медицинской помощи, вызвавшие нарушение зрения. Вышеприведенный пример демонстрирует явный случай медицинской халатности, в данном случае пациент получил компенсацию в размере четырех миллионов четырехсот тысяч долларов (USD 4,400,000) от госпиталя из–за небрежности в отношении своевременного сообщения важного вопроса соответствующему врачу.

    Значительные изменения

    С ростом экономики правительство ОАЭ ощутило необходимость внесения изменений в существующее медицинское законодательство и внесло новый закон в августе 2016 года в целях регулирования медицинской практики и согласования ответственности. Старый Закон был результатом постоянных изменений в индустрии здравоохранения ОАЭ и роста числа медицинских жалоб в стране. Тем не менее, ряд важных изменений, отражающих развитие технологий, еще предстоит признать наряду с признанием новых концепций, таких как эвтаназия, операции по изменению пола, клонирование, аборты и т.д. Следовательно, Новый Закон вступил в силу и внедрил следующие изменения для борьбы с растущим числом случаев медицинской халатности:

  • Разрешение Споров  – Первичное изменение в соответствии с новым законом касается процедуры подачи заявления в споре о медицинской халатности. Старый Закон не наделял потерпевшую сторону возможностью подать жалобу в соответствующие органы здравоохранения. Статья 18 Нового Закона учредила Комитет Медицинской Ответственности (Комитет), который должен рассматривать дела, касающиеся медицинской халатности. Согласно новому закону, стороны должны подать заявление в случае халатности и злоупотребления служебным положением в органы здравоохранения соответствующего эмирата, которые, в свою очередь, направят дело в Комитет в соответствии со статьей 19. Комитет выносит свое мнение по этому вопросу в течение 30 дней с даты направления в орган здравоохранения после рассмотрения фактов дела, медицинских записей, отчета о расследовании и других документов. Виновная по решению Комитета сторона может подать возражение в соответствующий орган здравоохранения в течение 30 дней от даты получения уведомления о решении. Затем орган здравоохранения направит этот вопрос в Верховный Комитет Медицинской Ответственности (Верховный Комитет), чье решение будет окончательным  и обязательным для сторон. Говоря короче, врачи и пациенты имеют следующие варианты для возбуждения судебного иска против медицинского специалиста или поставщика медицинских услуг: (а) подать жалобу в местный орган здравоохранения; (б) возбудить гражданское дело в соответствующем суде; (в) возбудить уголовное дело, если есть грубый случай медицинской халатности.
  • Урегулирование - Статья 35 Нового Закона устанавливает, что мирное урегулирование между сторонами может привести с остановке любого уголовного преследования и приостановлению наказания, даже если оно примирение происходит во время исполнения приговора. Однако урегулирование между сторонами не лишает пациента прав обратиться к гражданским  средствам защиты для получения компенсации. Это положение явилось коренным изменением Старого Закона, так как он не предусматривал подобного механизма урегулирования.
  • Раскрытие Информации Медицинскими Работниками  – Статья 5(6) Нового Закона позволила медицинским работникам раскрывать информацию, касающуюся здоровья пациента, соответствующему органу здравоохранения с целью защиты общественного здоровья и доказательства своей невиновности в споре. Следовательно, врачам разрешено раскрывать конфиденциальную информацию о пациентах для своей защиты перед властями.
  • Наказания - Новый Закон предоставил подробный перечень санкций против медработников, совершивших следующие нарушения: (а) врачи, которые проводят операции по перемене пола пациентов (кроме как в соответствии со статьей 7, в которой говорится, что половая коррекция разрешается, в случае если человек страдает от запутанности между мужским и женским полом; психологические особенности человека противоречат его физиологическим, биологическим и генетическим характеристикам) понесут наказание в виде тюремного заключения минимум 3 года и не более 10 лет в соответствии со статьей 31. (б) Врачи, которые отказываются лечить пациентов в чрезвычайных ситуациях или прерывают лечение, будут облагаться штрафом в размере не менее 10,000 дирхамов в соответствии со статьей 32. Такое же наказание применимо к врачам, которые проводят ненужные медицинские или хирургические процедуры без согласия пациентов. (с) Статья 32 предусматривает, что врачи, совершившие грубые медицинские ошибки, будут подвергаться тюремному заключению на срок до одного (1) года и (или) штрафу в размере не более 200,000 дирхамов. Однако, врачу грозит лишение свободы на срок не более двух лет и (или) штраф в размере не более 500,00 дирхамов, если грубая медицинская ошибка приводит к смерти пациента. Кроме того, в положении также указывается, что если  медицинская ошибка совершается под воздействием алкоголя или наркотиков, врачу грозит лишение свободы на срок не более двух (2) лет и (или) штраф в размере не более 1,000,000 дирхамов.
  • Другие изменения  - Новый Закон также признает другие методы, которые не существовали в рамках Старого Закона, как, например, эвтаназия. В статье 10 прямо указано, что врачу не разрешается отключать систему жизнеобеспечения пациента, даже если пациент и его семья настаивает на этом. Кроме того в положении указано, что врач может отказаться от поддержи жизни, если сердце и дыхательная способность или мозг пациента перестали функционировать. Однако, для этого врач должен получить соответствующее разрешение Министерства Здравоохранения. Кроме того в статье 16 Нового Закона рассматривается вопрос об абортах и говорится, что врач может совершить аборт после рассмотрения следующих вопросов: (а) жизнь беременной женщины находится под угрозой; (б) срок беременности не превышает 120 дней; (в) процедура проводится с согласия пациента; (г) отчет медицинского комитета формируется на основе медицинских тестов и других научных методов; (д) плод страдает от патологии и в дальнейшем может причинить страдания ребенку и его семье.
  • Вывод

    Первым шагом в рассмотрении дела о медицинской халатности является консультация эксперта-юриста. В отличие от некоторых других областей права, представление своих интересов самому не является столь эффективным. Тем не менее, адвокаты часто не принимают дела о медицинской халатности из-за необходимости обширных ресурсов и судебных экспертиз. Поэтому при подаче жалобы следует искать авторитетную юридическую фирму, которая предоставляет юридические консультации по медицинской халатности.

     

     

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    Fri, 14 Jul 2017 12:00:00 GMT
    <![CDATA[Medicinal Product Regulation and Product Liability in the United Arab Emirates: An Overview (Part II of II)]]> Medicinal Product Regulation and Product Liability in the United Arab Emirates: An Overview (Part II of II)

    In Part I, we discussed technical aspects pertaining to Pharmaceutical Product Regulations applicable in Dubai and the United Arab Emirates. Part I explored varied areas including regulatory bodies and applicable law, regulation of biological and combination products in Dubai and the UAE, law surrounding registration and compliance by pharmaceutical establishments, regulation applicable to medical devices and diagnostics, pricing, funding and reimbursement process involved within Dubai and UAE's national healthcare system, pricing of medicinal products, insurance obligations to be observed by healthcare providers, pharmaceutical companies, pharmacies, law pertaining to clinical trials, and other key factors. This Part II covers detailed areas covering product liability, parallel importation in Dubai and the UAE, applicability of US Sunshine Act or similar regulation, advertising, sales and marketing of pharmaceutical products, medicines, medical devices, diagnostics besides other key and relevant questions. 

    13.   What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorization?

    Response:

    Healthcare providers are under a duty (overseen by the UAE Ministry of Health (MOH), Health Authority-Abu Dhabi (HAAD) or the Dubai Health Authority (DHA)) to promptly report any suspected adverse reaction from a medical product even if they are not certain that a particular medical product is a cause. 

    An advisory committee made up of representatives from a wide variety of medical disciplines provides expert opinion and recommendations on reported cases, including on: 

    ·     Maintaining quality standards in data collection and assessment procedures.

    ·     Data interpretation.

    ·     Publication of information.

    ·     Follow-up action required. 

    Based on the advisory committee's recommendation, the MOH will decide whether action needs to be taken against the particular entity that manufactured and sold the medicine in the light of the information obtained, by changing product safety information, for instance, or adding a new adverse event, interaction, warning or contraindication notice.

    Are there further conditions concerning how the drug is distributed and accessible to patients?

    Controlled and semi-controlled drugs are distributed to patients only after a prescription from a physician registered and licensed by a health authority in the UAE has been produced by the patients.

    Are foreign marketing authorizations recognized in your jurisdiction? 

    Foreign marketing authorizations are not recognized in the jurisdiction. A supplier or distributor which has been authorized for marketing outside the UAE still has to go through the licensing process even if the marketing entity is a shareholder in a UAE company.

    Alternatively, the foreign company can engage a distributor or agent which is already licensed through the ministry of health.

    Foreign authorizations are strictly prohibited in the healthcare sector in UAE. Therefore, all the entities wishing to sell their medicinal products in UAE must obtain a license from the MOH.

    14.         Parallel Importation in Dubai and/or the UAE

    Are parallel imports of medicinal products into Abu Dhabi, Dubai or within the United Arab Emirates allowed? 

    Response:

    Parallel imports of medicinal products are not allowed into any Emirate and/or the UAE. 

    15. Marketing – US Sunshine Act or similar Legislation Applicability

    What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners? Is there any anti-bribery legislation and has it affected the life sciences industry? Are national restrictions intended to apply outside your jurisdiction? Are there any actual or proposed US "Sunshine Act" style registration requirements?

     Response:

    The UAE does not have a dedicated anti-corruption or anti-bribery legislation in place. However, provisions of the UAE Penal Code (Federal Law No. 3 of 1987) and the Federal Human Resources Law (Federal Law No. 11 of 2008) helps in tackling corruption in the country. The UAE Penal Code imposes criminal liability on an individual that offers a gift or the like to a public official. However, the anti-corruption provisions in this legislation apply to non-public official also. These legislations have a very wide ambit and therefore applies to corruption and bribery offenses in the life sciences industry also.

                   Marketing practices are regulated by the:

    • Pharmaceuticals Law 1983.

    • Ministerial Resolution No. 171 of 2011 (2011 Resolution). 

    • Health Insurance Law No. 23 of 2005 (Law No. 23).

    • Federal Law No. 10 of 2208 (Law No. 10).

    • HAAD Circular (DG 16/14): Kickbacks in Medical Laboratory Services (HAAD circular).

    Insurance companies, third party administers and health service providers have to comply with provisions of Law No. 23 and Law No. 10, which prohibit the payment and receipt of commissions, financial incentives or making illegal profits when referring patients for medical tests.

    Measures involving federal laws, local laws and the health policy of each Emirate are helping to curb the unfair practice of paying commissions and the aim is to stop these practices throughout the UAE.

    The GCC countries are signatories to the United Nations Convention against Corruption (UNCAC). Federal Decree No. 8 of 2006 implements UNCAC in the UAE. 

    16.            Sales and Marketing

    What are the restrictions on selling medicinal products? Are there specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order?

     Response:

    The UAE Ministry of Health (MOH), the Health Authority-Abu Dhabi and Dubai Health Authority require that prescription medication is sold in accordance with an appropriate prescription form completed by a qualified and registered medical practitioner or another authorized health professional. 

    Although federal law does not allow for internet-based selling, an applicant can seek prior approval from the MOH and the relevant local regulatory authority to be allowed to sell medicines online.

    What is the scope of this approval and how is it obtained?

    Since the MOH is the primary authority that deals with medicinal and other healthcare related products and its advertising, this approval could enable its applicant to advertise the particular product within the scope of the regulations that are prescribed by MOH from time to time.

    Can pharmacy medicines and prescription only medicines only be sold from premises that are a registered pharmacy, and by a person who is lawfully conducting a retail pharmacy business?

    Pharmacy medicines and medicines given on prescription can only be sold by a registered pharmacy or through a person who is lawfully allowed to conduct the pharmacy business. In accordance with the Article 2 of Pharmacy Law, no person is permitted to practice pharmaceuticals profession without obtaining a pre-hand license from the MOH. Also, an assistant pharmacist is required to obtain a license from the authority in accordance with the Article 3 of the said law. Article 18 of the said law strictly prohibit a person to open a pharmacy without obtaining a license from MOH

    17.            Advertising

    What are the restrictions on advertising medicinal products? 

    Legislation and regulatory authority

    Advertising of medicinal products is governed by the Pharmaceuticals Law 1983 and by regulatory authorities such as the UAE Ministry of Health (MOH), the Health Authority-Abu Dhabi and Dubai Health Authority.

    Publication of printed or broadcast advertising material for any medicine or pharmaceutical preparation must be approved by the Minister of Health or the relevant authority (section 83, Pharmaceuticals Law 1983). 

                    What restrictions apply to advertising medicinal products?

    Regulation 430 of 2007 on Health Advertisement Regulation is the primary piece of legislation in regards to an advertisement in the medical field. Further, Article 83, of Federal Law no. 15 of 1980 on Printed Matters and Publications strictly prohibit the entities from publishing any advertisements regarding medicinal products without the prior approval of MOH

    Article 4 of the abovementioned regulation has stated a few restrictions, in the field of advertisements relating to medicinal products, such as:

    ·                  should not breach country laws and regulations;

    ·                  must not contradict with UAE customs and Islamic traditions;

    ·                  text must not be misleading;.

    ·                  should not cause harm to public decency;

    ·                  not to encourage excessive or unsuitable consumption; and

    ·                  samples should not be presented in advertisements  

    Internet advertising 

    Internet advertising of medicines or pharmaceutical products may not be shown without special permission from the relevant authority. 

    Federal Law No. 15 of 1980 (governing Printed Matters and Publications) deals with advertising standards and penalties to be imposed in case of non-compliance (Sections 86 to 103).

    Penalties include jail sentences of between one and six months and fines of between AED 100 and AED 5,000

    18.          Data Protection

    Do data protection laws impact on pharmaceutical regulation in your jurisdiction?

    Data protection law in the UAE is based on the guidelines of Directive 95/46/EC on data protection (Data Protection Directive) and the UK Data Protection Act 1998. The Dubai International Financial Centre (DIFC) has formulated its own data protection law, DIFC law No.1 of 2007 which is broadly consistent with the Data Protection Directive (which is broadly consistent with the Data Protection Directive.) 

    Under the good practice code, healthcare providers' reporting of data and results of clinical trials are subject to compliance monitoring, through inspection visits and regular audits (see Question 7). 

    The healthcare providers are under an obligation to maintain timely records and documents in order to present to the inspectors at the time of inspections. The data of clinical trials should be maintained from time to time and the same should also be conveyed to the MOH, as and when required.

    The National Pharmacovigilance Program was launched in 2008 in the UAE. HAAD encouraged pharmacovigilance to vide the development of a Unified Prescription Form in order to enhance pharmaceutical care and quash the errors in medical practice.

    19.          Packaging and Labeling

    Outline the regulation of the packaging and labeling of medicinal products.

    Legislation and regulatory authority

    Packaging and labeling of medicinal products are governed by the Pharmaceuticals Law 1983 and overseen by the relevant health authorities (see Question 1, Regulatory authorities).

    Information requirements

    The following information and data must be written in both Arabic and English on leaflets and containers of medicines and other pharmaceutical preparations (Article 67, Pharmaceuticals Law 1983):

    ·        Name of the medicine or pharmaceutical preparation, and the registration number.

    ·        Compounds of the medicine and their amounts.

    ·        Date of expiry.

    ·        Name of the factory producing the medicine or pharmaceutical preparation.

    ·        Directions for use and cautionary warnings.

    20.          Product Liability

    Outline the key regulators and their powers in relation to medicinal product liability.

    The key regulators are listed in Question 1.The Health Minister can recall any medicinal product which is found to pose danger to the public (Article 64, Pharmaceuticals Law 1983). Under Article 64(2), the Minister can:

    ·        Ban the substance from circulation.

    ·        Delete the substance from the Ministry's records if it is registered.

    ·        Order all quantities of the substance to be confiscated and destroyed.

    Are there any mandatory requirements relating to medicinal product safety?

    The entities that deal in the sale and distribution of medicinal products have to maintain distribution records and other records and documents relating to complaint handling. Complaints have to be handled diligently and should also be reported to the authorities as and when required. The registration guidelines that have been issued by the MOH has conferred entities with the obligation to monitor and handle safety issues that could take place. The entities should also have a procedure that states the process in case of a defect or a safety issue. They should also endeavor to ensure that this procedure will allow complainants to easily file complaints in order to conduct effective investigations on the matter.

    Outline the key areas of law applicable to medicinal product liability, including key Legislation and recent case law. 

    Federal Law No. 24 of 2006 deals with Consumer Protection in the UAE. This law aims to protect the interests of the consumers and it addresses two critical issues relating to the supplier of goods:

    ·     Liability to consumers as a result of defects in the nature of the products sold. 

    ·     Obligations relating to labeling requirements, warranties and after sales service, among other things. 

    The law protects consumers against harm caused by a defective commodity, which is defined as an industrial, agricultural, animal or transformational product including the primary elements of materials and internal components of the product. The wide ambit of the provision of this legislation could also bring medicinal products under it. However, this ultimately depends upon the interpretation that would be given by the courts

    A medicinal manufacturer can be criminally liable for causing harm to consumers.

    Who is potentially liable for defective medicinal products? 

    Licensed pharmacists and licensed medical manufacturing units (see Question 8) are potentially liable for defective medicinal products under the various controls set out in the UAE Pharmaceuticals Law 1983.

    Both the suppliers and the distributors are usually placed with product liability. However, the liability of defective medical products falls under the jurisdiction of the MOH. Therefore, the liability of suppliers and distributors of medical products may vary from case to case depending upon the circumstances.

    What defenses are available to product liability claims? Is it possible to limit liability for defective medicinal products? 

    Supplier of a defective product has the inherent responsibility to submit to any regulatory investigation. The supplier is also offered the opportunity to explain his case in order to contend that his product is not defective. The supplier may also recall the products at this stage if he deems it necessary.

    How can a product liability claim be brought?

    As product liability claims can be categorized as torts, the limitation period for bringing a claim is three years from the date on which the victim became aware of the occurrence of the harm and the identity of the other party. (Article 298, Civil Code). 

    Class Actions

    Class actions suits are not permitted under the UAE law. Therefore, when circumstances arise in which multiple causes of action arises against the same party, then multiple suits must be filed separately in the respective courts that have jurisdiction in the matter.

    What remedies are available to the claimant? Are punitive damages allowed for product liability claims?

    Monetary remedies and compensation are available to the claimant. If there is any bodily harm, the liable medicinal products company bears the costs of corrective or medical treatment.

    How are damages calculated? Can a claimant claim for loss of earnings? Are punitive damages awarded?

    Articles 283 to article 302 of Federal Law No. 8 of 1985 on UAE Civil Transactions Law deal with damages that are generally granted to parties who suffer in a civil transaction. However, the damage that was caused should be certain, sustained and directly or occurred by causation. The extent of damages mainly depends upon the loss that is suffered by the party and the contractual obligations between the parties in case of a defect. In certain cases, the underlying contract between the parties may have specified the accurate amount of damages that would be payable in the event of default of the product.

    21.          Are there proposals for reform and when are they likely to come into force? Are there any reforms pending in the area of medicinal product regulation in general, including product liability? For example, in the areas of regulation, reimbursement and access to medical products in the UAE and in clinical research.

    There have been explicit regulations issued by the MOH and other healthcare authorities regarding the industry. However, the government has observed various gray areas in the regulation of medical product and healthcare industry. One of the primary issues is that continue to startle the industry is the lack of coordination between federal and local health institutions. Further, the rapid changes in the healthcare industry made it necessary for the authorities to prescribe regulations from time to time to keep up with the modern day healthcare industry.

    22.          What about evolving procedures and treatments such as gene therapy?

    UAE does not have a separate legislation in order to govern gene therapy and other genetic procedures. However, UAE's bio-genetic sector has been flourishing recently with the formation of Dubai Biotechnology and Research Park (DuBioTech).

    ]]>
    Mon, 02 Jan 2017 00:00:00 GMT
    <![CDATA[Zooming In On Public Health Institutions]]> Corporate Governance In The UAE

    "When it comes to health, your zip code matters more than your genetic code.

    &Dr. Tony Iton 

    when one thinks of a hospital, the image that pops up in one's head is that of doctors, emergency rooms, operating theatres and ambulances. What we fail to recognize is that for all of these elements to come together and provide effective medical treatment, it is imperative that the hospital is properly managed. A hospital is not just a medical institution but also a business and it will or should have a corporate structure in place. Hospitals and health systems across the world are constantly struggling with issues of governance, especially in the aspects of standardization and quality improvement. It has been difficult to establish clear channels of communication and clear lines of accountability for the innumerable committees, departments and business functions in a healthcare environment. This can certainly result in poor standards of care towards patients. What is compulsory for the efficient governance of hospitals? It is necessary for there to be an effective use of funds, professional and competent management and streamlined governing and reporting structures. By establishing and maintaining the public's trust, being good stewards of the community's resources, and ensuring high quality care Hospital Administrators can be an important asset on the governing board in fulfilling those duties.

    Administrators add the perspective of the patient care process as well as a unique understanding of family issues; they grapple with overall health care concerns such as staff shortages, patient safety and quality of care; and they are the most knowledgeable about diseases and new treatment modalities, as well as
    being aware of the ethical dilemmas posed by new technologies. His Excellency Sultan Bin Saeed Al Mansoori, the UAE Minister of Economy, has called for institutions to embrace corporate governance as "an institutional capacity, rather than a regulatory requirement".

    Let's take a look at a few example of countries where such principles have been embraced in the systems of governance in medical institutions. The Healthcare Governance & Transparency Association (HeGTA) is an Egyptian non-governmental, non-profit organization founded in 2012 with the vision of promoting governance and transparency in the healthcare sector, in order to enable healthcare reform and to create investment opportunities. HeGTA aims to contribute to a healthcare system which is based on accountability, equality, fairness, efficiency and quality by the creation, pooling and dissemination of knowledge. Similarly in the United States, the U.S. Agency for International Development (USAID) is an independent federal government agency that receives overall foreign policy guidance from the Secretary of State. Its work supports long-term and equitable economic growth and advances U.S. foreign policy objectives by supporting agriculture and trade, global health, democracy, conflict prevention and humanitarian assistance.

    Governance is important work, and how well it is done has significant consequences for health care organizations, the communities they serve, their patients, medical staff and employees. A technology is a set of principles for solving problems and seizing

    opportunities. A key element of the public sector is that services are provided for the public good, suggesting that the public sector may have a higher sense of purpose in what it does than the private sector. Another difference lies in the fact that people who use public services may not be 'willing customers' – as may be the case with health care. Hospital governance is based on the two pillars of accountability and transparency. As the provision of health care is a 'social good' each group of stakeholders merit recognition. Resources are one of the most pressing issues in hospitals. Issues such as value for money, the reorganization of the health service and patient satisfaction has served to drive the governance process forward. International organizations like Joint Commission International, which is a US-based body, are now in place to award accreditation to institutions based on their compliance with various international standards. However these not only assess elements such as patient care and medical standards, but also consider systems of corporate governance and management.. Therefore such schemes would appear to have put governance on the agenda of the health service and hospitals in particular across the world.

    Currently the prevailing conditions in so many hospitals in the UAE are the subject of discussion in terms of the management and facilities being provided. This may well be as a result of the fact that there is as such no regulatory framework available for the governance of public health institutions. However health institutions are supervised by the health authorities and there are provisions for internal committees, such as committees for ethics and compliance, wherein an employee can lodge his complaints against the management or report any mishaps in the system as a whistleblower. Moreover in a region with a low percentage of listed companies and a high percentage of family businesses, a lack of regulation cannot be seen as an excuse not to adopt a formal corporate governance framework.

    In order to reach this level of integrity and reform, some structural solutions need to be taken into consideration. Research and interviews reassured the idea that the most promising way to solve current grievances is the implementation of governance. If leveraged upon, the efforts for a promising solution to do this have the potential to create unparalleled success in hospitals. It also bridges the gap between the social and humanitarian mission of the hospital on one side, and its organizational nature on the other.

    According to the Millennium Development Goals access to basic health care is central to the poverty reduction worldwide. Hospitals constitute a very significant part of the overall health care sector and they provide essential services to the public.

    ]]>
    Mon, 04 May 2015 12:00:00 GMT
    <![CDATA[IVF- Maybe Baby]]> "And the question is always "When are you going to have kids?" Rather than "Do you want to have kids?" 

    The World Health Organization (WHO) defines infertility as the inability to conceive a child. It should not come as a surprise that owing to lifestyle changes, food habits and the societal encumbrances in general, it is now indicated that one in every six couples experiences some degree of difficulty when attempting to have a child. As natural as a phenomenon it may be, the conception and delivery of a child has been a medical challenge for many years.

     On July 25, 1978, a young couple Lesley and John Brown who had to bear the brunt of media attention amidst controversy and accusations of encouraging the creation of "frankenbabies," had their dream of becoming parents come true when Lesley gave birth to a baby girl who remains known as the world's first test tube baby in the United Kingdom. Over the years, with medical technology grown leaps and bounds, in vitro fertilization (IVF) has become a conventional medical treatment. In vitro fertilisation (IVF) is a process where an egg is fertilised by sperm outside the body. The technique involves monitoring and stimulating a woman's ovulatory process, removing eggs from the ovaries and letting sperm fertilise them in a laboratory. 

     Yes, the treatment still remains reserved by those who can afford the costly technology and has also been a topic of discussion relating to legal implications it gives rise to. This article discusses the approach of the UAE legal regulators and policy makers to this medical treatment.

    When a woman undergoes IVF treatment, she may end up with multiple fertilized eggs which are better known as embryos. Upon testing, the best one or two are implanted into the woman and the other embryos are frozen in case the treatment fails or if the couple wishes to have another child in the future. Federal Law no.11 of 2008 outlawed the process of freezing and storing eggs which resulted in innumerable embryos having to be destroyed. The medical experts believed that this increased the cost of the treatment and was also counterproductive in terms of treatment that had to be administered to the woman. The treatment is a complex one as it employs stimulating a woman's ovaries to produce more eggs than normal which is arduous for the body. The hormones that are administered have been linked with causing significant harm which have resulted in death. A number of studies conducted in the United Kingdom and other European countries have linked an increase in female mortality where the women have undergone or are undergoing IVF treatment. There is no known biological limit for how long the frozen embryos are viable but a number of countries have set limits of 10 (ten) years.

    United Arab Emirates has been at the forefront of driving medical tourism towards the region. In the year 2012, the number of medical tourists that visited Dubai was over 100,000 and the revenue generated was over 600 million Dirhams. The Dubai Health Authority has armed itself with a striving strategy which they hope will attract more than 500,000 medical tourists a year. Reproductive assistance is the most sought after and traveled for treatment in UAE. The reasons for the rise in its popularity has been significant since the implementation of the Cabinet Resolution no.36 of 2009 which changed the law and allowed for medical centers to preserve and freeze the excess embryos. This resolution also allowed private clinics and specialists to be granted licences for this treatment. Prior to this resolution's implementation, only government hospitals and clinics could administer this treatment.

    The treatment is not new but all across the world there are different regulations that govern this practice. In some countries, there is strict legislation regarding who can have IVF treatment. In Turkey the legislation insists that only married couple have access to IVF. In New Zealand, there is a requirement of being a nuclear family to raise the child. The United States of America has a much more lax approach and they permit single people and people in same sex relationships to have access to IVF and surrogacy. There are also religious restrictions placed on this treatment. A Catholic and Sunni muslims are not permitted to consider this form of treatment for infertility problems. It must be noted that most of the legislation focuses on prohibiting negative practices and places a moral bandwidth to the treatment.

    In the case of Evans v United Kingdom which was a landmark case at the European Court of Human Rights had a significant impact on fertility law not only in the United Kingdom but also on other European Union nations. In this case, Ms. Evans and her fiancé separated after the eggs had been fertilized. The man in question decided to approach the medical facility and have them destroy the eggs as he wished to withdraw consent. In the UK and other EU nations, the legislation states that both parties must provide consent. Ms. Evans went to the High Court to pursue the treatment and to request the court to dismiss her ex-fiancé's wishes. The High Court and then House of Lords both ruled against Ms. Evans. She approached the European Court of Human Rights where the ruling of the UK courts was upheld. It is essential to note that this case was one of the many that have raised unprecedented issues for a number of legal regulators.

    It is imperative that policy makers, government bodies and medical experts come together to understand that the value and significance of any embryo is relational, personal and thus infinitely variable. An embryo cannot be granted a moral or legal significance as distinct entities. 

    ]]>
    Thu, 04 Dec 2014 12:00:00 GMT
    <![CDATA[Medical Negligence - Frequently asked Questions]]> Q1. What exactly do you mean by medical malpractice?

    Ans.      All doctors and medical practitioners have an obligation to their patients to ensure that they are providing a certain standard of care. When a doctor or medical practitioners fails to meet this standard, it can come to be known as medical malpractice.

     

    2. Is there a particular law in the UAE about medical negligence and malpractice?

    Ans.      Yes, The Government of UAE enacted Federal Law number 10 of 2008 which governs specific aspects of doctor and patient relationship. Article 3 and Article 4 of this particular law outline in great detail the duties and obligations of a doctor or medical practitioner towards his/her patients. It is important to understand that the law does not wish to make it difficult for the doctors to treat their patients but to ensure that they are practicing this noble profession with accuracy, honesty and in accordance with recognized scientific and technical principles.

    3. I recently had an outpatient treatment for psoriasis which is a skin condition. This treatment entails being exposed to radiation for treatment. I am certain that I was exposed to radiation for longer than I should have. This resulted in me fainting and suffering from second degree burns on some part of my body. What do you suggest I do?

    Ans.      I am sorry to hear about your condition. Legally speaking, you should obtain an opinion from another doctor at the earliest. It is important to understand and determine that the cause for the burns and your fainting can be directly attributed to the negligent treatment you received. If it is proven that the treatment caused second degree burns, then you can file a complaint at the Ministry of Health and/or bring a civil action against the medical institution. The procedures for filing a complaint at the Ministry of Health in Dubai and at the Health Authority in Abu Dhabi vary slightly.

     

    4. Are there any criterias which have to be met with in order for a case to fall within the purview of a Medical Malpractice?

    Ans.      The law on medical malpractice is liable to be misused leading to serious implications being drawn on either party. In order to safeguard the interest of both the patient and the doctor, certain conditions must be established. At a preliminary stage, the court shall examine the duty of care cast upon the doctor towards his patient. Subsequently, the court must also ascertain that the standard of care expected to be exhibited by the medical practitioner was in fact lacking and that it was consequent to the doctor's negligence that the patient suffered injury and damages.

    5. What is the procedure that one must follow to file a case of medical malpractice in Dubai?

    Ans.      The aggrieved party alleging the medical malpractice has the option of following any one of the following procedures:

      (a) By filing a civil case in the Dubai Court; or

      (b) Report the malpractice to the Dubai Police or Public Prosecutor, which shall result in initiation of a criminal case against the           physician involved; or

      (c) By filing a complaint with the Dubai Health Authority.

     

    6. What are the remedies available to the victim of medical malpractice?

    Ans.      The decision of the court pertaining to cases dealing with the subject matter shall vary according to different facts of the case. If the charges against the medical practitioner are proved and he is convicted, he is liable for punishment of imprisonment of minimum two years but not exceeding five years or be also liable for payment of compensation ranging between AED 200,000 and AED 500,000.

     

    7. What is a "Medical Error" as per law?

    Ans.      Article 14 of the Medical Liability Law defines the term 'Medical Error'. It refers to 'Medical Error' as an error occurring due to lack of knowledge in the technical matters which is expected in the profession or due to negligence or not paying due attention. In general terms, it refers to a deviation from the normal course of action which a medical practitioner would have adopted in similar circumstances.

     

    8. Does disclosing the medical condition of the patient to another doctor or a family member without his consent and knowledge, amount to a medical malpractice?

    Ans.      The Medical Liability Law explicitly prohibits a doctor from disclosing any confidential information of the patient which he was entrusted with during the course of practice. The exception to the above law being, if the disclosure was made upon the patient's request or for the best interest of the spouse by informing them in person about the disease. The doctor may also report the matter in order to prevent a criminal act or if he assigned by a judicial authority or an official investigation authority in the State.

     

    9. Will a wrong diagnosis fall within the ambit of medical negligence?

    Ans.      In the event where the diagnosis of a patient is wrong, the Ministry of Health holds the authority to cancel the license on grounds of negligence and misconduct.

     

    10. I am an expatriate and prior to arriving at UAE, I was diagnosed for a stomach ailment and prescribed medication by my home country doctor. After five months of stay in the UAE, I suffered a relapse and was clinically examined by a UAE doctor to whom I showed the medical prescription of my home country doctor. The UAE doctor diagnosed me for a different ailment and prescribed medication but did not inform me of the change in diagnosis. Presuming I was suffering from the same ailment, I continued with the medication prescribed earlier by my home country doctor but my health deteriorated.  Please advise whether the UAE doctor should have informed me of the change in my diagnosis thereby advising me against following the prescription of my home country doctor?

    Ans.      In such circumstances, the case can be decided for either of the parties. In your defense, the law provides that the physician must inform the patient about his illness and must instruct to strictly adhere to the physician's prescription and course of treatment. But however, if the patient refuses for any reason whatsoever or fails to follow the medical treatment, the physician shall not be liable for the same.

    11. I recently read about a case where the hospital couldn't diagnose the disease suffered by a child leading to his death. In such circumstances, what is the remedy available to the aggrieved party?

    Ans.      After filing the complaint with the relevant authorities, the committee shall review the matter. It shall examine the sequence of events and the child's previous medical records. After hearing both the parties and evaluating the evidence, the committee shall give its judgment. As the laws relating to medical negligence are vague and liable to be misused, leading to serious implications, the judge must look into the facts of the case in its totality and arrive at his findings of whether or not adequate standard of care was exhibited by the medical practitioner.

     

    12. Would it amount to negligence on part of the hospital if it denies medical treatment to a person on grounds of insufficient funds?

    Ans.      Individuals practicing medicine in the UAE shall perform their duties accurately, honesty and in accordance with the recognized scientific and technical principles to provide the necessary care for patients, in addition they shall not make use of the patients' needs for illegal benefit to themselves or others and without discrimination between patients. (Article 3)

     

    13. I was diagnosed for an infection and was assigned a lady gynecologist. On the day of my follow up, the lady doctor wasn't available and I was instructed to see another doctor. I resented this due to the fact that he was a male physician and I felt uncomfortable the whole time. My question to you is, whether I had a right to object to being examined by a doctor of an opposite gender?

    Ans.      Yes, you have the right under the Medical Liability Law to ask for a doctor of the same gender. It has been elaborated under Article 5 (clause 6) which affirms that the patient shall not be examined by a doctor from an opposite gender, without the presence of a third person and without attaining a prior consent of the patient.

     

    14. What are the provisions governing emergency surgeries? I have a close friend whose fetus was aborted without her consent when she came in as an accident case?

    Ans.      In emergency situations, the doctor has to first try and obtain the consent of the patient or her husband. But if it is impossible in the given situation, the physicians are instructed to prepare a report stating the abortion justifications. This report has to be signed by the patient and her husband or her guardian. The concerned parties shall also be given the copy of the report. However, the consent of the husband is not necessary in emergency cases where an immediate surgery is required.

    ]]>
    Mon, 10 Nov 2014 12:00:00 GMT
    <![CDATA[Врачебная халатность в Дубае ОАЭ]]> ""Неправильное лечение является обычно следствием недостаточных профессиональных знаний практикующего врача, вследствие небрежности или недостаточных усилий"."

    На пути становления, когда Объединенные Арабские Эмираты начали превращаться в страну потрясающих небоскребов, разнообразных бизнес возможностей и объектов инфраструктуры мирового уровня, Правительство ОАЭ стало осознавать, что собственные жители, включая элиту местного населения, предпочитали обращаться на Запад для получения медицинских услуг, таким образом эта ниша бизнеса могла быть упущена. Для страны, которая развивается и меняется с огромной скоростью, это был сигнал к действию. Помимо развития медицинской инфраструктуры высокого уровня и медицинского туризма, требовалась безусловная законодательная база.

    В свете вышесказанного в ОАЭ был принят Федеральный Закон номер 10 от 2008 года (Закон о Медицинской Ответственности). Этот закон регулирует конкретные аспекты медицинской профессии и отношения между врачами и пациентами. До 2008 года жалобы на медицинскую халатность основывались на положениях Гражданского Кодекса ОАЭ (Федеральный Закон номер 5 от 1985 года) или Уголовного Кодекса (Федеральный Закон номер 3 от 1987 года).  Запрос должен быть сделан в Министерство Здравоохранения Дубая (DHA), чтобы рассмотреть каждый случай и назначить эксперта для оценки степени медицинской халатности. Гражданские иски рассматривались исходя из Гражданского Кодекса ОАЭ, аналогично уголовные претензии основывались на Уголовном Кодексе для определения степени ответственности.  Однако, очевидно, что в этом случае были расхождения в решениях в результате применения различных принципов Судами гражданского или уголовного права. Таким образом, применение нового закона стало необходимым для предполагаемого развития медицинского сектора, тем более с юридической точки зрения. Закон предусматривает лишение свободы на срок от двух до пяти лет или штраф в размере от 200,000 до 500,000 дирхам.

    Настоящий Закон о Медицинской Ответственности не гарантирует, что врачи начнут творить чудеса для своих пациентов. Что закон гарантирует – это то, что они будут соблюдать осторожность при лечении больных и будут профессионалами в своей области. Этот закон признает обязательный долг каждого врача по уходу за пациентом и наказание за небрежность и недостаток профессионализма, если при этом страдает пациент. Закон четко утверждает, что ущерб здоровью (в отношении которого выдвигается обвинение) получен только и исключительно вследствие медицинской халатности, или, другими словами, говорит о том, что любой другой врач такого же уровня, обладающий такой же степенью технической и научной компетенции и в таком же случае поступил бы по-другому.

    Как и многие другие, Закон о Медицинской Ответственности сталкивается с определенными проблемами. Сам закон, имея федеральный уровень, сталкивается с серьезной проблемой в том, что жалоба на медицинскую халатность может быть подана в разные инстанции в зависимости от законов Эмирата. В Дубае, например, человек может подать жалобу в Министерство Здравоохранения Дубая, открыть уголовное дело в полицейском участке или зарегистрировать гражданский иск в Суде Дубая.

    Министерство Здравоохранения Дубая является нормативно-административной единицей, регулирующей систему здравоохранения в Дубае, и имеющей установленную административную систему санкций к врачам, виновным в медицинской халатности. Например, в 2010 году доктор был уволен с запретом практиковать на территории ОАЭ, после того, как было доказано, что ее действия повлекли за собой смерть ребенка. Однако, следует отметить, что хотя подача жалобы в Министерство Здравоохранения является бесплатной, оно является только регулирующим органом, не уполномоченным поддерживать судебное разбирательство. Поэтому толкование Закона о Медицинской Ответственности Министерством Здравоохранения может отличаться от интерпретации суда.

    В сущности, многочисленные интерпретации одного и того же закона разными субъектами оставляют мало места для согласованности и последовательности решений – таких нужных в решении столь щепетильных и важных вопросах. 

    Одна из основных проблем, с которыми сталкиваются пациенты, это отсутствие законодательного положения для врача, чтобы подтвердить, что его пациент был подвергнут неправильному лечению со стороны предыдущего врача. Некоторые люди также утверждают, что этот закон слишком передовой для культуры ОАЭ. «Их система очень продвинута и общество высоко образованно. Здесь они реализовали многие правила и нормы, не принимая во внимание социальные изменения. Это создает много проблем, особенно для хирургов», сообщил в интервью The National  врач, имя которого не разглашается. В недавнем случае в Абу Даби женщина получила ожоги второй степени на бедрах во время процедуры лазерного удаления волос. Когда ожоги почернели, она решила подать в суд на больницу, требуя в качестве компенсации 60,000 дирхам за физический и моральный ущерб и 25,000 дирхам за стоимость лечения. Несмотря на то, что больница утверждала, что это не медицинская ошибка, выдвигая в качестве защиты аргументы, что такого рода повреждения могут появиться у людей с чувствительной кожей, и что они предупреждали истца о подобных последствиях, суд отверг все доказательства и присудил выплатить истцу 100,000 дирхам, что оказалось больше суммы заявления. 

    Поэтому, приветствуя инициативу, закон должен быть тщательно изучен, учитывая тот факт, что злоупотребление этим законом может вызвать серьезные последствия, начиная от нежелания экспертов в медицинской сфере выбирать ОАЭ для своей профессиональной практики, нарушения прав и даже до крушения целой идеи и инвестиций, вложенных страной в медицинский туризм. 

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    Mon, 31 Mar 2014 12:00:00 GMT