Pricing of medicines in the UAE
The United Arab Emirates (UAE) is rapidly establishing itself as a leading hub for healthcare investment, driven by ambitious economic agendas like the Dubai Industrial Strategy 2030 and the Abu Dhabi Vision 2030. These strategic initiatives highlight the pharmaceutical industry as a pivotal subsector primed for growth, owing to its promising expansion opportunities, export potential, and substantial long-term economic influence.
As part of the market-oriented approach endorsed by the GCC (Gulf Cooperation Council) states, such as the UAE, Health Ministers have implemented a range of legislative and regulatory changes. These reforms are designed to oversee medication pricing and guarantee the provision of safe and efficient medicines.
Through an examination of relevant laws, penalties, and services provided by the relevant authorities, this article aims to provide a comprehensive understanding of medicine pricing regulations in the context of the United Arab Emirates (UAE).
Codified Laws Governing Medicine Pricing
In the UAE, the Ministry of Health and Prevention (“MOHAP” or the “Ministry”) serves as the regulatory body for pharmaceuticals. In recent years, the UAE has undergone significant legislative changes aimed at ensuring the accessibility, safety, and fairness of medical products within its borders. Central to these changes is the repeal of Federal Law No. 4 of 1983 on the Pharmacy Professional and Pharmaceutical Establishments and the subsequent enactment of Federal Law No. 8 of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments (the “New Law”).
Part II of the New Law outlines crucial provisions related to the regulation and circulation of medical products. Article 3 (Marketing Authorization) (Article 3) of the law mandates that no medical product may be circulated in the UAE without obtaining marketing authorization or exclusive marketing approval from MOHAP. This authorization is subject to specific rules, conditions, and procedures set forth by the Minister. Further Article 5 (Product Pricing) clearly states “For the circulation of a medical product that has obtained the marketing authorization, it must have a price…”
Article (8) titled ‘Sale of Priced Medical Product’ discusses regulations pertaining to the sale of medical products with established prices. It stipulates that such products cannot be sold at prices exceeding those set by the Ministry. To quote “8(1) The priced medical product may not be sold at a price higher than that set by the Ministry” Additionally, Article 8 (2) prohibits granting discounts from the Ministry-set prices, except under specific circumstances outlined in the executive regulations of the law. These regulations aim to ensure fair pricing practices and prevent price manipulation in the pharmaceutical sector.
More emphasis has been paid to prohibition on quoting higher prices other than the one set by the Ministry under the New Law vide Article 48 which addresses the responsibilities and prohibitions imposed on pharmacy licensees regarding pricing practices. It emphasizes that pharmacy licensees must adhere to professional standards of integrity, honesty, and duty. Specifically, the article prohibits pharmacy licensees from engaging in actions such as withholding or concealing medical products or selling them at prices higher than those established by the Ministry. These regulations aim to uphold ethical conduct and ensure transparency in pricing within the pharmaceutical industry. To quote “Licensee's Prohibitions: Pharmacy licensee may not carry out any act involving a breach of the professional duties, honor or honesty, and, in particular, the following acts shall be prohibited sub clause 4. Withholding or hiding medical products or selling them at a price other than the one set by the Ministry.”
The Ministry has clearly outlined measures which aim to enforce adherence to pricing standards, enhance consumer transparency, and prevent any discrepancies in medicine pricing as apparent under Article (73) ‘Affixing Price Label’ “The Medical Warehouse shall affix the Ministry-approved price label on the outer cover of the medical product in a clear way before the same is sold and delivered. The Authorized Marketer, pharmacists in charge at pharmaceutical establishments and their owners shall all be held jointly liable for affixing the Ministry-approved price label on the outer cover of the medical product.”
Legal Consequences for Violations
Notably, the article outlines penalties for individuals found violating the Ministry's set prices for medical products. Art. 109 explicitly states “a fine not exceeding (AED 100,000 – One Hundred Thousand Dirhams) shall be imposed on whoever:…acts in violation of the Ministry-set price of medical products; and the penalty shall be doubled in case of recidivism.” These penalties serve as a deterrent to ensure compliance with pricing regulations and protect consumer interests. Additionally, the provision for doubling penalties upon recurrence of violations underscores the Ministry's proactive stance in maintaining integrity in medicine pricing.
MOHAP's Services for Medicine Pricing
Pricing And Repricing Proposals: The Ministry of Health and Prevention (MOHAP) in the UAE offers a comprehensive online portal for submitting pricing proposals for medical products. This portal serves as a centralized platform for healthcare providers and pharmaceutical companies to submit their pricing proposals conveniently. Through the portal, users can access regulatory guidance, submit documentation, and track the progress of their pricing submissions. This online platform streamlines the price approval process, enhancing efficiency and transparency. Users can also find relevant information, updates, and resources related to pricing regulations on the MOHAP website, facilitating compliance with regulatory requirements. MOHAP additionally facilitates the process for pharmaceutical companies registered to import and market their products within the UAE to request a re-pricing of a specific medicine.
Tatmeen: The Ministry of Health and Prevention (MOHAP), in collaboration with EVOTEQ, has introduced Tatmeen, a groundbreaking initiative aimed at enhancing pharmaceutical traceability in the UAE. Tatmeen leverages serialization technology aligned with the GS1 standard to facilitate the tracking of medications from manufacturer to end-user. This initiative is designed to combat counterfeit drugs, enable efficient recalls of expired products, and improve visibility across the pharmaceutical supply chain. Through Tatmeen, MOHAP seeks to strengthen regulatory compliance, enhance patient safety, and protect public health in the UAE. With Tatmeen, authorities can better regulate pricing by accessing detailed information on the origin, distribution, and handling of pharmaceuticals, thereby facilitating fair pricing practices, and minimizing discrepancies. Tatmeen's capabilities contribute to combating counterfeit medications, which can distort market prices and endanger public health. Overall, Tatmeen plays a crucial role in promoting transparency, regulatory compliance, and fairness in medicine pricing within the UAE.
WhatsApp Service: Residents of the UAE have convenient access to medication prices and details through a recently launched WhatsApp service available 24/7. This initiative, spearheaded by the Ministry of Health and Prevention, introduces a Registered Medical Product Directory accessible via the Ministry's website. Subscribing to this service is simple: users can add the number 0097142301221 to their WhatsApp contacts and initiate engagement with a welcoming message in English, such as "Hi." This collaborative effort between the Ministry and health authorities underscores the UAE government's dedication to bolstering patient rights and providing vital services to foster individual empowerment and societal inclusion.
DHA's Involvement in Medicine Pricing
In addition to the Ministry, the Dubai Health Authority (DHA) is a governmental body in Dubai, United Arab Emirates, tasked with the supervision of healthcare services and the formulation of healthcare policies. Here are some essential elements concerning the DHA and its involvement in medicine pricing.
The DHA exerts an indirect influence on medicine pricing through its regulatory framework and policy directives. Pricing strategies for pharmaceuticals may differ depending on factors such as patent status, availability of generic alternatives, and local manufacturing capacity. The Healthcare providers operating in Dubai are required to seek approval from the DHA prior to implementing any adjustments to their gross prices.
Dubai Health Authority (DHA) follows MOHAP in listing the medications in use in UAE, which contain:
- Narcotic, Controlled & Semi-controlled Medications,
- Prescription only Medications (POM)
- Pharmacist only Medications
- Over the Counter Medications (OTC)
On January 11, 2024, the Dubai Health Authority (DHA) made a significant announcement regarding the coding of over 14,000 medicines across the UAE using the Dubai Drug Code (DDC). This initiative, which was launched by the Authority three years ago, represents a milestone in aligning with cutting-edge international technologies and standards. The implementation of the DDC is integral to the DHA's ongoing endeavors to ensure optimal health sustainability in the region. The DDC List serves as a comprehensive inventory of all drugs registered with the DHA’s Pharmacy Services department. Each drug on the list is assigned a unique DDC code, facilitating differentiation based on various parameters such as route of administration, dosage, form, pack size, price, manufacturer, registered owner, and source. By employing this system, patients gain improved access to their prescribed medications, while also mitigating the risk of counterfeit drugs infiltrating the local pharmaceutical market.
The guidelines provided by the Dubai Health Authority (DHA) for pharmacies, as per Version 1 of the Pharmacy Guidelines, are detailed under Clause 12, specifically Subclause 12.1.5 for the mandate not to exceed the selling price indicated by MOHAP on medication packaging. Subclause 12.1.6 addresses the prohibition on offering discounts beyond those set by MOHAP. Additionally, Subclause 12.1.7 outlines the requirement for medications to be retailed in their original packaging, with provisions for partial packs or strips as described.
In the past year, Abu Dhabi initiated the distribution of "generic" prescription medications, aiming to optimize value for money. Medical professionals and insurers, as reported by a leading official gazette, advocate for the broader implementation of this policy, recognizing its potential for significant cost savings. They stress the importance of physicians reducing unnecessary prescriptions. With mandatory private medical insurance in Dubai and Abu Dhabi for all residents, prescription medication coverage is often comprehensive, with some basic packages requiring patients to contribute approximately 20 percent of the cost.
The UAE is expected to experience a significant population surge, with projections from the World Bank indicating an increase from 9.4 million in mid-2017 to nearly 11.1 million by 2030. Moreover, the Joint Commission International (JCI), a renowned US organization responsible for accrediting healthcare institutions and programs, has recognized the UAE as the global pioneer in healthcare, boasting over 200 accredited health facilities. These encompass a wide array of establishments, ranging from hospitals and medical laboratories to specialized centres, primary health centres, and home health facilities. Therefore, maintaining fair and transparent pricing practices in the pharmaceutical sector is vital for promoting economic stability and ensuring the health and welfare of the population.
Author: Sarah Rizwan.