Medicinal Product Regulation and Product Liability in the United Arab Emirates: An Overview (Part I of II)
1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?
Federal Law Number 4 of 1983 (Pharmaceuticals Law 1983) governs and applies to:
· Pharmaceutical establishments.
· Import, manufacture, and distribution of pharmaceutical products.
Federal Law Number 14 of 1995 (Counter Measures against Narcotic Drugs and Psychotropic substances) regulates the import of medicines into the United Arab Emirates (the UAE).
Federal Law Number 5 of 1984 deals with regulating the licensing and registration of physicians, pharmacists and other healthcare specialists within both public and private healthcare establishments.
Federal Laws Number 7 of 1975 and No. 2 of 1996 define the specific requirements for the establishment and licensing of public and private medical laboratories, clinics and hospitals in the UAE.
The regulatory authorities for pharmaceuticals in UAE are the:
· UAE Ministry of Health (MOH).
· Health Authority-Abu Dhabi (HAAD).
· Dubai Health Authority (DHA).
· Emirates Health Authority (EHA).
These authorities monitor the licensing of pharmacists and pharmacies, the registration of pharmaceuticals and advertising guidelines for drugs.
The MOH formulates nationwide health policies and regulates the healthcare market in the Northern Emirates. The healthcare system of the country’s two largest Emirates, Dubai and Abu Dhabi, are governed by DHA and HAAD respectively.
There did not exist a separate entity to regulate the healthcare system in the Northern Emirates prior to 2009. Therefore, the healthcare system of these Emirates fell under the ambit of the MOH before the formation of the Emirates Health Authority vide the Federal Law Number 13 of 2009. This institution was primarily organized with the view to facilitate inter-departmental co-operation between the authorities. EHA is based in Sharjah.
2. Briefly, outline how biologicals and combination products are regulated in Emirate of Abu Dhabi, Dubai, and the United Arab Emirates.
All biological and combination products (therapeutic and diagnostic products that combine drugs, devices, and/or biological products) are heavily regulated by the UAE Ministry of Health (MOH).
A drug must be registered by the Ministry of Health before importing the same within the UAE market (Pharmaceuticals Law 1983).
The Pharmaceuticals Law 1983 also prohibits anyone from engaging in the pharmaceutical profession without a valid license. "Pharmaceutical profession" is defined as the preparation, composition, separation, manufacturing, packaging, selling or distribution of any medicine or pharmaceutical preparation for the prevention or cure of illnesses in human beings or animals (Article 1, Pharmaceuticals Law 1983).
Pharmacists who practice without a valid license or in breach of its conditions face disciplinary measures (Refer Question 8).
Imprisonment of up to one year and/or a fine may be imposed on anyone submitting false documents or data to gain a license; or otherwise practicing as a pharmacist illegally (Articles 83 and 84, Pharmaceuticals Law 1983).
Other offense(s) including adulterating or imitating substances attract imprisonment of up to three years and/or fines of up to AED10,000 (Article 86, Pharmaceuticals Law 1983).
3. Law surrounding registration and compliance by Pharmaceutical establishments – Registration of Pharmacies, Medical Store(s), Pharmaceutical Factories in Dubai, Abu Dhabi and the United Arab Emirates.
Pharmacies, medical store(s) and pharmaceuticals factories require registration and a valid license issued by the Ministry of Health (the MOH).
Only licensed medical stores and pharmacies are permitted to import and distribute pharmaceutical products. Applicants for a pharmacy or a medical store license must be UAE nationals.
The Pharmaceuticals law requires any medical company planning to market its products in the UAE to register with the MOH on the recommendation of the Medicine Companies and Pricing Committee. (see Question 9).
Registration requirements vary based on the types of products being marketed; and are determined by the classification committee of the MOH on the basis of the information submitted by the applicant.
See Question 8 for compliance powers in relation to all types of pharmaceutical establishments as well as the penalties for non-compliance.
4. Briefly, outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?
All medical devices and diagnostics need approval from the UAE Ministry of Health (the MOH).
The Registration Guidelines issued by the MOH govern the registration and regulation of medical devices. The Registration Guidelines are modeled on international standards for rules and regulations, in particular, those issued by the US Food and Drug Administration and contained in the EU Medical Device Directive (Directive 93/42/EEC concerning medical devices).
Medical device companies intending to export their products into the UAE must appoint a local representative or distributor who has a licensed medical store.
The Registration Guidelines provide for four different classes of a medical device for the purposes of registration, based on risk factors including, for example, how long the device is intended to be used for and how invasive it will be.
The appointed local representative or distributor must submit a medical device registration application form to the MOH's drug control department along with the prescribed documents, including:
· Regulatory Approval (certificates of regulatory approval and clearance to manufacture, import or export the device from the export country);
· risk assessment reports;
· regulatory status of the device in other countries;
· details of the device including instructions, warnings, and contraindications;
· labeling information;
· declaration of conformity to safety standards and other data on safety and clinical studies;
· manufacturing process; and
· other miscellaneous requirements
If the application is approved, a registration number authorizing the import and sale of the device is given, which is valid for five years.
Diagnostics services must submit an application to the Health Regulation Department (HRD) for a license to establish a new diagnostic center.
There is currently no specific regulation of health IT issues and mobile medical applications.
5. Pricing, Funding, and Reimbursement - What is the structure of the national healthcare system in the UAE, and how is it funded?
The national healthcare system in the UAE is divided into public and private healthcare providers.
Public healthcare services are operated and regulated by government regulatory authorities such as the:
· Ministry of Health (MOH).
· Dubai Health Authority (DHA).
· Health Authority Abu Dhabi (HAAD).
· Abu Dhabi Health Services Company (SEHA).
These authorities work in partnership with foreign healthcare organizations for the day to day running of hospitals and clinics throughout the UAE.
Private healthcare providers are non-government run hospitals and clinics providing specialty or multi-specialty healthcare.
A mandatory health insurance model funds the national healthcare system in the UAE.
The main sources of funding in Abu Dhabi are:
· Employers or sponsors: employers are responsible for obtaining insurance for their staff. Those who are not in employment must be funded by a sponsor.
· Government: the single-payer health insurance scheme for nationals is funded by the government, administered by the national health insurance company and regulated by the MOH.
· Individuals: individuals pay out-of-pocket payments and insurance premiums.
6. How are the prices of medicinal products regulated?
Article 64 of the UAE Pharmaceuticals Law 1983 governs the regulation and fixing of prices for drugs in the UAE.
The medicine pricing and companies committee, established under Article 63, is responsible for registering new medicines and regulating the price of medicinal products.
Profit margins of distributors and pharmacies are fixed by law (Ministerial Resolution No. 171 for 2011) which means that pharmacies cannot offer discounts to patients above the permitted margins.To understand the technical issues surrounding pricing, effects and implications under UAE competition law, implications under UAE Commercial Agency Law and other regulations, please contact one of our lawyers in Dubai, Abu Dhabi or other offices across the UAE.
7. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?
The UAE government can reimburse private health providers for treating government-funded or insured patients.
The patient should submit the reimbursement claim within one month of filing of the original claim. The patient and the doctor must fill the claim form along with the policy number, card number, break-up of expenses and bank details. The patient is also under the obligation to provide other information such as - the name of the hospital, date of treatment, amounts claimed and the like. Further, the consulting doctor must provide treatment details to the patient. Subsequent to this, the claim will be assessed by the health providers/insurers within a specific period and in addition to a claim report.
Any person meeting the following criteria would be eligible for health and medical claim in the UAE:
· Persons under 65 years of age;
· UAE Nationals;
· UAE Residents;
· Direct family members who are listed as the 'dependants'; and
· Unmarried children under 18 years of age and children under 23 years of age who are on a student visa.
Pharmacies and insurance companies come into contract with a discount percentage ranging from 5% to 10%, in order to ensure that the claims for the products are efficiently dealt with.
The increase in the need for better healthcare and high medical costs led to a public-private partnership by the government. In this partnership, the health institutions are publicly and managed by private parties with the view of improving facilities and infrastructure. Governmental funding primarily depends upon the annual budget that is formulated by the government. However, there is no specific legislative provision which provides that a specific amount should be disbursed into the healthcare industry.
8. What is the process for this? How do the health providers/insurers claim back the costs? Is there a maximum cost which will be reimbursed? Is it limited to citizens or available to any user? Is there an equivalent to the prescription charge?
In what circumstances will medical products/medicines be reimbursed e.g. means tests/types of medical conditions? What kinds of products will be paid for/are there any which will not be paid for?
Does funding have legislative authority? How is the annual health budget/medicines cost calculated by the state?
The Ministry of Health administers all the governmental spending in the healthcare sector. This budget is formed and is administered after taking into consideration the growing need for healthcare reforms and technology in the sector.
The cost of a medical product may be funded by the state in public healthcare facilities or on grounds of charity.
Process and Procedures followed by Health Providers and Insurers, Maximum Costs that can be Reimbursed, Circumstances where such costs can be reimbursed, Products that will be paid and allowable v/s products that will not be allowed
The process and procedures followed by health providers/insurers in claiming back the costs are same as that of the private sector. Also, in response to maximum costs that can be reimbursed and persons entitled to it (citizen, residents, etc) is also similar to that of the private sector as clarified in Question 7 above.
Additional question: how does the funding of medical products for public health-care differ from that in private healthcare?
Healthcare sector of UAE is segregated into the private and public sector. Public health service providers are regulated and managed by the MOH, DHA, HAAD, and SEHA. Whereas on the other hand, private healthcare service providers are those institutions which are not managed by the government.
What are the legal requirements of providers/pharmacies/responsibilities of government?
The International Pharmacy Federation and WHO with a combined effort have published Good Pharmacy Practice guidelines in order to maintain a minimum standard in pharmacies worldwide. The inspectors in the Ministry of Health follow these guidelines while inspecting the pharmacies.
· Legal and ethical requirement: pharmacies must adhere to Pharmacies Law 1983 and MOH code of conduct.
· Guidelines on Personnel:
· Guidelines on Environment and Equipment
· Documents Required
· Dispensary requirements
9. Please explain standardized coding systems recently adopted by, for example, Dubai and Abu Dhabi to improve the accuracy of the system of reimbursement from payers to providers and insurance payments system. ? Are there similar schemes planned for the other Emirates?
A comparable standardized coding system of reimbursement have been prescribed in UAE by various health care authorities such as DHA and HAAD. Further, DHA has adopted a US-style coding system including ICD 10 (diagnosis), CPT 4 (medical, surgical, diagnosis procedures) and the Healthcare Common Procedure Coding System (HCPCS). Moreover, the other Emirates such as Abu Dhabi, Sharjah and AL Ain, have a similar standardized coding system in place.
10. Clinical Trials: An outline on Regulations Pertaining Clinical Trials
Legislation and regulatory authorities:
The regulatory authorities for clinical trials in UAE are the:
· UAE Ministry of Health (MOH).
· Health Authority-Abu Dhabi (HAAD).
· Dubai Health Authority (DHA).
Guidance on the conduct of clinical trials involving human subjects is based on good clinical practice rules formulated by international bodies including the:
· World Health Organization (WHO).
· US Food & Drug Administration (FDA).
· European Agency for the Evaluation of Medicinal Products (EMEA).
· International Conference of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH).
All clinical trials carried out in the UAE must follow the ethical principles set down by the Declaration of Helsinki, which aims to protect the individual rights of human subjects.
For MOH areas (including Dubai, Sharjah, Fujairah and Ras AL Khaimah) the study proposal must be submitted to the ethics committee together with the fees.
The application form can be found here
For hospitals covered by the DHA, submission of the study must be made to the medical research committee (MRC) along with the fee by the closing date and decided by the committee at its regular meetings which are held every six weeks or so.
The primary goals of the MRC are to:
· protect the mental and physical welfare, rights, dignity, and safety of participants in research;
· facilitate ethical research through efficient and effective review processes, to promote ethical standards of human research; and
· review research in accordance with the DHA code of ethics and the ICHGCP guidelines, ensuring that all investigations conform to ethical principles.
HAAD covers hospitals in Abu Dhabi and Al Ain, with research proposals submitted to the ethics committee of the authorized research facility in question. To conduct human clinical research, the facilities themselves need to be licensed and authorized.
HAAD's Medical Research Section aims to:
· develop the Health Research Strategy;
· define research ethics policies and standards;
· create research funding/grant administration procedures; and
· apply evaluation methods and measure key performance indicators of Abu Dhabi’s progress in health research.
Decisions on the authorization of trials must be made within 60 days of the committee meeting.
Clinical trials authorized by the MOH are reviewed by the MOH's drug control department, which also issues guidelines based on internationally accepted standards.
Trial protocols must follow the principles of good clinical practice standards relating to:
· Recording, analyzing and reporting data and results.
Freely given, informed consent should be obtained from every subject before clinical trial participation. A written agreement to participate in the trial should also be obtained from the trial subjects or their legal representatives.
The sponsor must provide adequate insurance to the patients or healthy volunteers participating in the trial to cover any potential treatment-related injuries during the course of the trial.
Trials must be conducted in compliance with approved protocols and all clinical trial information must be recorded, handled and stored accurately and transparently.
Requirements in the good practice code include:
· All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification;
· the confidentially of records that could identify subjects should be protected respecting the privacy and confidentiality rules in accordance with regulatory requirements;
· investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice used in accordance with the approved protocol; and
· quality assurance of each stage the trial should be built in into the system used.
11. Manufacturing: Regulatory, Compliance and Authorization Process involved in Manufacturing Medicinal Products in Dubai and UAE
The Pharmaceuticals Law 1983 sets out the requirements for establishing factories for the manufacture of medicines. No-one is allowed to open such a factory a without obtaining a license.
Applications for a medical products factory license must be made to the licensing committee of the UAE Ministry of Health (MOH) along with:
· The memorandum or articles of association of the factory including names of the shareholders;
· Details of the factory manager's license to practice as a pharmacist and of all the licensed pharmacists who will work at the factory; and
· other documents as determined by the MOH.
Conditions imposed on licenses include those relating to (Articles 47 to 57, Pharmaceuticals Law 1983):
· Site location and premises;
· mandatory requirements and maintenance;
· supervision of the factory and laboratories; and
· storage of raw or dangerous materials and manufactured preparations.
Restrictions on foreign applicants
Foreign applicants can have a maximum shareholding of 49% in a medical products factory.
The MOH can collect the fees for licenses and registration made on condition that the fees collected do not exceed AED10,000 for the factory license and AED 2,000 for other licenses and records.
The level of fees is determined by the MOH at the recommendation of the licensing committee.
Monitoring compliance and imposing penalties
Articles 77 to 88 of the Pharmaceuticals Law 1983 govern compliance powers in relation to all types of pharmaceutical establishments including medical products factories.
Inspectors are appointed by the Minister of Justice, Islamic Affairs and Awqaf in consultation with the Minister of Health and Prevention, MOH (Article 77, Pharmaceuticals Law 1983), to monitor pharmaceutical establishments that are suspected of operating without a valid license or in breach of any other rules.
Inspectors can confiscate any substances found on the premises and refer the case to the competent authority (in this case, the licensing committee of the MOH) to investigate suspected violations of the Pharmaceuticals Law 1983 or other relevant rules.
A hearing is held and the case decided by the committee whether or not the alleged offender turns up. The licensing committee then decides on the penalty, with the approval of the UAE Ministry of Health (MOH).
The Licensing Committee of the MOH can impose disciplinary measures on licensed pharmacists who commit offenses as follows (Article 79, Pharmaceuticals Law 1983):
· suspension for up to one year; and
· withdrawal of the license.
The Licensing Committee can impose similar measures on owners (Article 79, Pharmaceuticals Law 1983):
· closure of the pharmaceutical establishment for up to 60 days;
· if the offense is repeated, the establishment can be closed for several periods not exceeding six months in total in the same year: and
· the license can be withdrawn.
The offender can appeal the decision within 15 days from notification to the Minister of Health and Prevention, who must decide on the appeal within 30 days. In all cases, punishments involving suspension from work, withdrawal of a license or closure of a facility cannot be imposed before the expiry of the period prescribed for submitting the appeal or deciding on it.
Further punishments of fines or imprisonment can be imposed on factory managers, owners or practitioners (Articles 83 to 87, Pharmaceuticals Law 1983) (see Question 2). For more information, please connect with our team of criminal lawyers in Dubai.
12. Marketing: Regulatory, Compliance and Authorization Process involved in Marketing of Medicinal Products in Dubai and UAE
Any medical company planning to market its products in the UAE must be registered by the UAE Ministry of Health (MOH). The process is covered in Chapter 10 of the Pharmaceuticals Law 1983. Both, the company and the drug must be authorized. Only entities that are themselves registered with the Ministry of Health can apply for product registration.
Article 1 (9) of the Pharmaceuticals Law 1983 defines ‘medicine’ as ‘any medicine that contains one or more element for treatment or protection of human beings and animals.
Authorization conditions are governed by Chapter 6 of the Pharmaceutical Law 1983.
To register a medical store or pharmacy with the MOH, the following must be submitted online at the MOH website (Note: The fees are subject to timely revision):
· a valid copy of the commercial license and/or tenancy agreement;
· details of all commercial and medical pharmacies owned by the marketing group and a table showing the entire group structure;
· license of the pharmacist who would manage the pharmacy with their issue and expiry dates, and contact details of the marketing group;
· owner’s passport/Emirates ID;
· internal layout of the proposed location;
· initial inspection fees of AED 100;
· engineering drawing of the location;
· planning map for the pharmacy location approved by the municipality plus photos;
· details of the pharmacist appointed or transferred from another firm to be in effective charge of the pharmacy; and
· licensing fees of AED 7500.
Key stages and timing
The key stages and timing are:
· submission of the application online with the required documents;
· inspection of the composition and ingredients of drugs to be marketed; and
· compliance checking.
The MOH generally conducts inspections in pharmacies. However, the DHA and HAAD also has the jurisdiction to conduct such inspections in the Emirate of Dubai and Abu Dhabi, respectively.
The initial response time for license applications is about one week.
Fees depend on the type and composition of the medicine to be marketed, advertising guidelines and media type. Our team of lawyers in UAE can provide updated information on Fees.
Period of authorization and renewals
The authorization is valid for one year and must be renewed 90 days before expiry.
The license is renewed for a period of one year after fulfilling the renewal requirements for the re-licensing assessment
The license is automatically canceled in these circumstances (Article 25):
· Transfer of the ownership of the pharmacy to another person;
· closure of the pharmacy for six consecutive months without excuse acceptable to the Licensing Committee; and
· failure to commence work in the pharmacy within six months from the date of issue of license.
Monitoring compliance and imposing penalties
Imported medicines and pharmaceutical products cannot be put into circulation without being registered by the MOH (Article 65, Pharmaceuticals law 1983).
In order for a company to import pharmaceuticals and medical devices into the UAE, a company must:
· Both incorporate in the UAE and obtain a medical importation and distribution license from the Ministry.
· Engage a local agent or distributor, who is already registered with the Ministry, to import the pharmaceuticals and medical devices on their behalf.
Any medicine or pharmaceutical preparation which undergoes a change to its constituents must be re-registered (Article 66, Pharmaceuticals law 1983).
Medical products must also comply with strict packaging requirements (see Question 18).
Inspectors appointed by the MOH to the Medical Empowerment and Compliance Department are authorized to inspect any pharmaceutical establishment or store suspected to be dealing in drugs, medicines, and poisons without a license. (Article 77, Pharmaceuticals law 1983).
How is Compliance Actually Monitored?
Compliance is monitored since the pharmacies are required to keep the medical prescriptions of controlled medicines for 5 years from the date of dispensing. Strict action is usually taken against defaulters who fail to produce the inspectors with the requested documents. The registration of the pharmacy with the MOH could be terminated and license canceled if the inspectors have found any non-compliance depending on its severity.
· The inspectors:
· Review the pharmaceutical firm’s file and violations history.
· Inspect the premises.
· Write a report and carry out a further investigation if necessary.
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…