СТА - ведущая юридическая компания в Дубае с офисами по всему мируhttps://www.stalawfirm.com/ru.htmlSTA Law Firm - Блоги - Law on BiotechnologyruCopyright 2024 STA Law Firm All Rights Reserved<![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[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[Фармацевтические правила в Дубае и ОАЭ]]> PHARMACEUTICAL INDUSTRY IN THE UAE

 What are the main laws and regulations governing pharmaceutical companies in the United Arab Emirates?

  • The primary piece of legislation governing pharmaceutical companies in the United Arab Emirates is Federal Law Number 4 of 1983 concerning the Pharmaceutical Profession and Pharmaceutical Institutions (the Pharmaceutical Law). This law applies to pharmacists, pharmaceutical establishments, and governs the import, manufacture, and distribution of pharmaceutical products. Articles 63 to 67 of the Pharmaceutical Law deals with the registration of pharmaceuticals. Article 47 of the Pharmaceutical Law states that a company must obtain a license to open a pharmaceutical company and Article 48, 55 and 56 lists the conditions that the company should meet to obtain the license. These include, among others, the requirement that the company is composed of different sections (production section, chemical section, disinfection section, and bacteriological laboratories) and that licensed pharmacists should supervise the factory. Article 49 mandates that the application for a license to open a pharmaceutical company should be accompanied by the factory's contract of establishment/ articles of association and also the permit issued to the manager and the pharmacists, among other documents.
  • Federal Law Number 14 of 1995 regarding counter-measures against narcotic drugs and psychotropic substances regulate the import of (pharmaceutical products and) medicines into the United Arab Emirates.
  • Federal Law Number 5 of 1984 governs the licensing and registration requirements of physicians, pharmacists, and other professionals within the country's pharmaceutical industry.
  • Federal Laws Number 7 of 1975 and Number 2 of 1996 has laid down specific requirements for the establishment and licensing of public and private medical laboratories, clinic and hospitals in the country.
  • Federal Law Number 1 of 1979 on the Organization of Industry Affairs affect pharmaceutical companies located in the mainland as a local Emirati agent must be appointed, and their shares in the company's capital should not fall below a certain percentage.
  • Federal Law Number 2 of 2015 regarding Commercial Companies, provides further requirements applicable to companies on a general note, over matters such as licensing, the trade name, the Memorandum of Association (Articles 12 to 15).
  • The governmental regulators of each Emirate (such as the Dubai Health Authority or DHA and Health Authority - Abu Dhabi or HAAD) also issue regulations from time to time to regulate the pharmaceutical companies in their jurisdiction. The 'Dubai Community Pharmacy Licensure and Pharmaceutical Practices Guide' (February 2013) issued by the Health Regulation Department of the Dubai Health Authority focuses primarily on the licensing and protocol of institutions and professionals. This guide provides information on the administrative procedures required to set up a pharmaceutical company. It also offers instructions on purchasing, storing, dispensing, and prescribing medication and drugs. The Ministry of Health Code of Conduct also outlines the standards expected of professionals providing medical services.
  • Which governmental authorities regulate the licensing of pharmaceutical companies?

    The Ministry of Health and Prevention (MoH) is the primary body regulating the licensing of pharmaceutical companies in the United Arab Emirates. Article 65 of the Pharmaceutical Law specifies that imported pharmaceuticals should be registered with the MoH, regardless of whether or not they have been approved or registered in their country of origin. The MoH is also responsible for the regulation and implementation of health care policies in the country. Moreover, individual Emirates have also established their local health regulators to oversee the healthcare and pharmaceutical sector of their specific jurisdiction (Dubai Health Authority in Dubai, and the Health Authority - Abu Dhabi). These regulators monitor the licensing of pharmacists and pharmacies, the registration of pharmaceuticals and advertising guidelines for medications. The MoH formulates federal health policies and regulates the healthcare market in the Northern Emirates.

    What is the registration process to set up a pharmaceutical company in the UAE?

    As mentioned earlier, under the Pharmaceutical Law, pharmaceutical products, and preparations must be registered with the MoH before being imported into the national market. The market authorization holder, along with its local representatives (such as licensed distributors) are mandated to submit a new drug application to the MoH before importing or manufacturing a pharmaceutical. The local agent is wholly liable for any complaints made by customers and non-compliance with the regulations set out by the Ministry.

    The Pharmaceutical Law prohibits anyone from preparing, composing, separating, manufacturing, packaging, selling or distributing any medicine without a valid license from the MoH (Article 1). This law also mandates that companies importing pharmaceutical products or medical devices must be locally established in the United Arab Emirates and have a pharmaceutical importation license. A sole natural person may also import these products if he is UAE national.

    Are there any exceptions to the requirement that pharmaceutical products to be registered in the United Arab Emirates?

    The Pharmaceutical Law states that all pharmaceutical products imported into the United Arab Emirates must be registered with the Ministry of Health, with NO exceptions. However, the general practice has confirmed that the Ministry of Health has authorized the import of unregistered products in exceptional circumstances such as:

  • Emergency situation medicines
  • Drugs and medications required by government or semi-government health institutions
  • Registered and unregistered medication that is not available in the local market
  • Narcotic and psychotropic drugs (as per Federal Law Number 14 of 1995)
  • However, pharmaceuticals that are not registered in the country of origin cannot be imported to the UAE even under the above-mentioned circumstances.

    How can a foreign manufacturers trade, distribute and advertise pharmaceutical products in the United Arab Emirates?

    Foreign manufacturers have two options to trade and distribution of pharmaceutical products in the United Arab Emirates. They can either establish a local presence (a company in the UAE) or appoint a local agent. Given that the MoH requires all pharmaceutical products be registered, a foreign manufacturer with no local presence will have to appoint a domestic partner to obtain the necessary approvals for trade, distribution, and advertisement of the product. This allows foreign manufacturers to access the network and resources of the local agent, who may have nurtured their business relationships in the country over an extended period. The United Arab Emirates imposes restrictions on such foreign ownership and sponsoring arrangements.

    Are local agents of pharmaceutical companies regulated? If so, how?

    The appointment of a local licensed agent by pharmaceutical companies is governed by Federal Law Number 18 of 1981 concerning organizing of trade agencies. Under this statute, the local agent will distribute the pharmaceutical companies' products in the United Arab Emirates vide an agency agreement registered with the Ministry of Economy. However, the following conditions must be met by the local agent:

  • the local agent should be a UAE national, or an entity fully owned by UAE nationals (i.e., hundred percent stake owned by UAE nationals);
  • the agent's appointment will be granted exclusively for one Emirate or several Emirates; and
  • the agreement must be notarized in Arabic, and the foreign manufacturer must provide a letter confirming they have no objection to the registration;
  • The local agent will have the right to trade, distribute and advertise the pharmaceutical products, exclusively and within the confines of the territory agreed on in the distribution agreement after meeting the above criterion. The agent's exclusivity to manage the registered products means that they can block third parties from dealing with them. Agents are also entitled to a commission on the sale of the registered products and will have the right to claim compensation upon the termination of the agreement.

    Which license should a company obtain to open a medical store in the UAE?

    A person (legal or natural) that intends to set up a medical store or warehouse for medical products should obtain a medical store license to conduct their activities in the country. This is not limited to companies that deal with pharmaceutical products but also applies to businesses that store medical equipment. To obtain this license, the company must employ at least two licensed pharmacists to regulate the medical store, and these pharmacists must be in charge of the regulation of medical devices and pharmaceutical products.

    What are the responsibilities of a licensed pharmacist in the United Arab Emirates?

    A license issued to a pharmaceutical will bear the name of the 'licensed pharmacist' and he or she would be responsible for the following:

  • Importing pharmaceutical products;
  • Storing pharmaceutical products;
  • Enter into contracts regarding pharmaceutical products and/ or medical devices; and
  • Complying with the regulations of the MoH and local regulator and the provisions of the Pharmaceutical Law.
  • Are there any sanctions for submitting false documents to obtain a license to undertake the pharmaceutical profession?

    Articles 83 and 84 of Federal Law Number 4 of 1983 states that the offenders may face imprisonment of up to (1) one year along with a fine for anyone who submits false documents or information to obtain a license, and on anyone practicing as a pharmacist illegally. Article 86 of the law states that people who adulterate or imitate substances may face imprisonment of up to three (3) years and fines of up to AED 10,000.

    Are there any restrictions on the ownership of pharmacies in the United Arab Emirates?

    In the United Arab Emirates, one can obtain a license for more than one medical facility. As for pharmacies, they must either be owned by UAE Nationals or a UAE National must own at least 51% of the company's shares. Federal Law Number 2 of 2015 states that pharmacies may also be wholly owned by GCC nationals. One cannot obtain a license to open more than two stores except for pharmacies that are located in hospitals.

    What happens when the licensed pharmacist is terminated from the pharmaceutical company?

    When a licensed pharmacist resigns or is terminated from their employment, the pharmaceutical company should submit a request through the Ministry of Health's online portal for the cancellation of the current pharmacist's license. Upon the revocation of the license, the company should then apply for a new license with another licensed pharmacist-in-charge. After this step, an application should be filed with the Department of Economic Development for the amendment of the trade license to replace the name of the licensed pharmacist with the new one.

    The Ministry of Health may take approximately 3-4 weeks to cancel a license and issue a new license and the Department of Economic Development would take approximately 2-3 weeks to replace the license.

    Can a company's pharmacovigilance and regulatory affairs be handled and managed by the same person or is there a requirement for separate people to do the job?

    Pharmacovigilance is known popularly as drug safety and is the pharmacological science to collect, detect, assess, monitor and prevent adverse effects of the pharmaceutical products. Generally, the pharmaceutical companies assign the same licensed pharmacists to handle pharmacovigilance also; although, the MoH has not mandated that the same person should undertake both the assignments. A company is also entitled to appoint separate officials for each of these functions.

    Can a company outsource the importation of medical goods or storage in the United Arab Emirates?

    Outsourcing the function of importation or warehousing to a third party is not authorized by the MoH. All medical equipment imported by a pharmaceutical company should be registered under the name of the same entity before the MoH. These medical devices and pharmaceutical products have to be stored in warehouses and/ or medical stores which should also be under the license of that company.

     

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    Thu, 25 Jan 2018 12:00:00 GMT
    <![CDATA[Dry Cleaning Your Genes - A Comparative Analysis on Biotechnology Law(s)]]>  

    Since the early eighties, the member states of European Union (the "Union") had realized that Biotechnology was emerging as one of the most innovative and promising technologies1. It was also realized that the United States was dominating the biotechnology market2. Member states had also recognised that importance of protection of biotechnological inventions was significant for European Community's industrial growth, and that harmonization of European patent law can improve legal certainty, improve research and development investment and improve job spin-off

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Dry Cleaning Your Genes

    'The good thing about science is that it's true whether or not you believe in it'

    -        Dr. Neil deGrasse Tyson

    During the early eighties, the member states of European Union recognized the importance of Biotechnology. Whilst the United States had long held a dominating position, the European Members States decided to strenghten the European Community's industrial growth by harmonizing their patent law thereby paving way for development and investment in the Biotechnology sector. Shruti Tiwari, Giulia Sibilla, George SK, Ridwana Ahmed collectively present this interesting article on Biotechnology Laws with special emphasis on United States, European Union, Dubai (covering Dubiotech and other recent initiatives) and the law in UAE.

    While human nature is steered towards fretting about daily challenges, what we actually fail to comprehend is the variety of solutions that biotechnology offers to mankind. Since the birth of Louise Brown, the first test tube baby in 1991, we have witnessed remarkable advances in the field of Biotechnology. However, such breakthroughs have raised significant questions on moral and ethical grounds. Ethicists, like John Harris, have pointed out numerous concerns on the imbalance that biotechnology causes on the nature. Think about a scenario where superheroes like Spiderman and Wonder-woman would be seen walking around in the streets of Dubai! This is most likely to cause large scale chaos and mayhem as they need not always be the good guys who fight the evil in the world.

    Why hassle over the 'tiny' things?

    The concept of 'stem cells' were first coined by renowned scientists, McCulloch and Till, in 1961. Presently, it is one of the most popular concepts in the field of biotechnology due to its potential applications and the legal and ethical issues that are associated with its usage. The evolution of the extensively funded industry of biotechnology has manifested itself to become one of the most dynamic branches of present day science and technology. Therefore, law regarding the patentability of stem cells mainly revolves around jurisprudence, biotechnology and regional moral or ethical standards. Morals are values that act as a guiding compass in our daily life as we face the complexities of the world around us. Law, on the other hand, is considered to be a vital instrument in regulating human conduct in the society. It is paramount to analyse how scientists, media and lawmakers have hyped the concept of stem-cells in order to understand the application of law and ethics in the field.

    Stem cells have the capability of dividing and renewing themselves. However, the cardinal importance of stem cells lies in its ability to produce specialized custom cells as it helps in treating lethal diseases such as Parkinson's, Diabetes, Arthritis and Cancer by using the specialized cells to revamp the affected tissues. Thus the progress in the field of stem cells has been stupendous, but the question is, if the progress is good enough for it to be made patentable? As biological advancement begin to take prominence, investors and innovators are compelled to turn to intellectual property rights with the objective of ensuring their exclusive rights over their investments. These rights work in unison with World Intellectual Property Organization (the WIPO). The patent system provides exclusive rights to inventors and innovators for a designated period of time In exchange for public disclosure of their inventions.

    Patent Compatibility – A European View

    European Patent Convention (the EPC) is a multilateral treaty which has laid down the legislations regarding patents in the European Union. The EU Biotech Directives (the Directives), issued by the European Commission, had been enacted for the purpose of protecting and promoting biotechnological inventions. Subsequently, the Directives were incorporated by EPC under its legislation. Thus the scheme for patentability of stem cells in Europe should be studied with the clauses under EPC simultaneously with the provisions of the Directives. Article 52 (1) of the EPC states that patentable inventions should:

    ·        be novel;

    ·        include an inventive step; and

    ·        be capable of industrial use.

    However, article 52 (2) of the EPC provides for an exclusion which states that discoveries, scientific theories and mathematical methods cannot be a subject matter of patent. It further states that inventions whose publication or exploitation is opposed to 'ordre public' or 'morality' cannot be patented. Therefore, one may argue on the basis of morality that the European Patent Office refrains from permitting patents for stem cells which are obtained though the destruction of human embryos. However, article 53 (a) explicitly states that the exploitation of an invention would not be deemed to be contrary merely because it is protected by the laws of any of the contracting states of the EU. This succours in blending the differences in moral beliefs that could be inspired by the domestic religion and traditions of the countries. This can be explained with the help of the following illustration: suppose a country has a law, 'X', which limits use of stem cells. It is not upon the law 'X' to determine if stem cells or invention made by the use of stem cells are patentable or not. Hence, a patent could be granted to an invention when it is capable of being exploited in the industry. Thus it is an attempt of harmonizing the patentability of inventions among various countries.

    However, rule 23 (d) of the EPC specifically excludes the cloning of human beings, modifying germ line genetic identity of human beings, using of human embryos for industrial or commercial purposes and lastly modifying genetic identity of animals. This can be apprehended as an explicit exclusion to the patentability of biotechnological inventions as the inventions which result from the destruction or modification of human embryos cannot be patented in the EU. The infamous dispute in the patent application of Technion Research and Development Foundation Ltd. provides considerable insight on the position of the EU with regard to the patentability of human foreskin cells suitable for culturing stem cells. This dispute aided in explaining the status of patentability of 'HES' cells, as it was laid down that inventions which relied on commercially available 'HES' cells are excluded from patentability. The judges rejected the appellant's claim that the inventions using commercially or publically available HES cells can be patented as it was obtained without the prior destruction of human embryos. Further, it was ruled that the appellant's invention cannot be patented as the commercially available HES cell lines were also developed with the destruction of the human embryo.

    Further, the judgment by the High Court of Justice (England and Wales) in the case of International Stem Cells vs. Comptroller General of Patents, Designs and Trademarks provides a substantial insight on the scope of term 'human embryo'. The court held that an unfertilized human ovum does not fall under the ambit of the term 'human embryo' if it does not have the inherent capacity of developing itself into a human being. This means that a stem cell could be patentable if it has been developed from a cell which does not have the capability to transform itself into a human being over a period of time. In the light of these cases, it can be comprehended that an invention involving the use of stem cells can be protected by the European Patent Office only if the cells used for inventing them are obtained without destructing or modifying a human embryo.

    The American Approach

    The patentability scheme in the United States is relaxed, compared to that of Europe. Title 35 of the United States Code (the Code) has laid down the provisions regarding the patentability of inventions in the US. The Code has explicitly provided for the eligibility of the inventions or discoveries that could be protected under the jurisdiction of the United States Patent and Trademark Office. An invention or a discovery would be eligible to be patented only if:

    ·        it is a new and useful process, machine, manufacture, composition of matter or any improvement thereof (article 101);

    ·        it is novel (article 102); and

    ·        it is non-obvious (article 103).

    Politics has broadly affected the patentability in the industry of biotechnology as there are no specific regulations in the US that deals with the patentability of stem cells. However, the US has emerged as a global leader in its spending towards research and development in the biotechnological industry. The decision of the US Supreme Court decided the celebrated case of Diamond vs. Chakrabarty has helped in determining the patentability of stem cells in the US. A living micro organism was modified by the defendant in order to develop a bacterium that had wide usage in treating oil spills. Subsequently, the employer of the defendant applied for the patent of:

    1.      bacteria;

    2.      the process/ method of producing the bacteria; and

    3.      claims for an inoculum which comprised of a carrier material floating on water.

    Subsequently, the patent examiner granted patents for items 2 and 3 but rejected the application for patenting the bacteria. He contended that living micro organisms which were found in the nature could not be attended under the Code. However, the defendant claimed that the genetic engineering which he performed on the micro organism was a manufacturing process and it had covered the objects of patentability of the Code. The apex court took the view that a human-made micro organism is patentable under the Code. Further, the court also stated that the genetic engineering which the defendant had performed on the micro organism would constitute the 'manufacture' and the bacterium would fall under the ambit of the term 'composition of matter' for the purpose of interpretation.

    Whereas, the landmark case of Association for Molecular Pathology vs. Myriad Genetics aided in further establishing the patentability of stem cells in the US. The main issue in this case was whether the genes of DNA and CDNA were eligible for patent protection? Myriad Genetics, a foremost player in the biotechnology industry, had found the precise sequence and location of genome genes called BRCAI 1 and BRCAI 2. A detailed study on these genes proved that it increased the risk of breast and ovarian cancer. They subsequently obtained patents on these genes. The validity of these patents was challenged by the plaintiff on the ground that genes were naturally occurring components in human body and the mere discovery of their location cannot be a subject matter of patent. Therefore, the court held that DNA was not admissible to be patented. However, the court observed that CDNA was eligible for patent protection as it was not a product of nature completely.

    Peroration

    The regulations on legality and patentability of stem cells in Europe are highly influenced by socio-ethical factors. While USA has a laid back policy and does not exclude the patentability of stem cells exclusively while it also provides federal funding. Although members of EU are gaining pace in the industry, it continues to struggle in harmonizing the regulations governing stem cells among the various contracting states.

    With advances in Biotechnology taking its stand on the platform of many international pedestals today, it is an honour to note that the UAE is regarded as the leading stand of the Arab world in Biotechnology. Recently, UAE has witnessed tremendous growth in the industry as it has been included in the Scientific American Worldview Report and the Bio Innovation Scorecard. UAE has also successfully incorporated the Khalifa Center for Biotechnology and Genetic Engineering (KCBGE) at the UAE University in Al Ain which aims at increasing agricultural production by developing genetic fertilization of plants., This centre facilitates in dealing with the issue of healthier food consumption, sustainability and food security as the growing number of food disorders amongst the youth today has an adverse effect on the society.

    The commencement of operations at the Dubai Biotechnology and Research Park (DuBiotech) provides the Arab nation with substantial investment into the development of biotechnological industry. The park includes a bio headquarter towers, a nucleotide lab complex and warehousing facilities to support a growing body of research, development, manufacturing, distribution and services amongst others.

    If we ought not to fear mortal truth, still less should we dread scientific truth. In the first place it cannot conflict with ethics? But if science is feared, it is above all because it can give no happiness? Man, then, cannot be happy through science but today he can much less be happy without it- Henri Poincare!

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

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    Sun, 05 Jun 2016 15:47:57 GMT