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Healthcare Issues / 16 Dec 2017

Ministry of Health and Prevention issues guide on marketing & distribution of medical products

Ministry of Health and Prevention issues guide on marketing & distribution of medical products

The Ministry of Health and Prevention (MOHAP) has issued a guide on the marketing and distribution of medical products that formalizes the relationship between medical product companies or their representatives and health care professionals with the goal of developing health care practices that benefit patients.

The guide aims to regulate the marketing of medical products to ensure adherence to the highest ethical standards and other applicable rules of conduct. The scope covers all organizations involved in the marketing of medical products in the UAE, local agents, marketing consultants, hospital health care providers, health centers, pharmaceutical companies, doctors, pharmacists and other medical professionals.

Ethically-based governance and leadership of health sector 

H.E. Dr. Amin Hussein Al Amiri, MOHAP’s Assistant Undersecretary for Public Health Policy and Licensing, said that the guide was issued in accordance with Ministerial Decree No. 1412 of 2017 by H.E. Abdul Rahman Bin Mohammed Al Owais, Minister of Health and Prevention as part of the ministry’s strategy to provide legislative framework, vital governance and excellent regulatory services for the health sector. This is part of the development of the national health legislations in line with the objectives of  UAE Vision 2021 and in accordance with the Federal Law No. 7 of 1975 regarding the practice of medicine and amendments to Federal Law No. 4 of 1983 on the pharmaceutical profession and pharmaceutical institutions, which aim to regulate the marketing of medical products in line with medical and pharmaceutical ethics and to promote an environment where drug choices are based on the merits of each product and patient needs. The code also determines a cap for the percentage of commission allowed in the country. 

The Ministry emphasizes how the flexibility of the leaders of the country’s health sector has made the sector a pioneer, and how the Ministry is committed to achieving the best performance and building quality systems and health safety measures as well as creating an environment where community members are confident that the choices related to their medicines are based on the merits of each product and the health care needs of patients.

All violations related to the guide shall be referred to MOHAP’s Pharmaceutical Licensing Committee or to the local health authorities in accordance with their competence in investigating violations and taking the necessary measures.

The rationale for issuing the guide

The guide was issued following a round of consultations with private medical and pharmaceutical institutions which MOHAP considers as strategic partners in achieving the sustainable development especially in relation to the development of policies and the preparation of executive plans for regulating the distribution of pharmaceutical products to ensure the protection of public health. It will also identify and analyze legal challenges and variables related to the pharmaceutical industry and coordination with the concerned parties to ensure that the nationwide needs of pharmaceutical products are met. 

The guide will help enhance the competitiveness of the medical and pharmaceutical sectors to keep pace with global best practices. It has been adopted by local health authorities, the Board of Trustees of medicine in the UAE, international pharmaceutical companies (Phrmag), medical equipment companies (MECOMED), and the Executive Council of the Ministry.

Value of drug market is developing rapidly

H.E. Dr. Al Amiri said that in 2016, the UAE’s pharmaceutical market was worth AED 9.61 billion. He added that spending on medicine is expected to reach AED 13.13 billion in 2020. By 2025, he said that medicine expenditures will hit AED 21.74 billion, driven by population growth, changing morbidity, and the use of modern medicines such as biotechnology drugs.

The Assistant Undersecretary also pointed out that there are 18 pharmaceutical factories in the UAE and that the number is expected to reach 34 by 2021. He added that there are 54 scientific offices representing international pharmaceutical companies in the state; with the number expected to grow to 75 by 2021 at annual investments of AED 2 billion.

The system of marketing practices provides sustainable solutions

H.E. Dr. Al Amiri explained that the provisions of the code on good promotional practices in the UAE cover vital topics such as marketing license and approval of the product card and the provision of information in marketing materials in a manner consistent with the approved medical label. In terms of marketing and supporting information, the marketing material must be accurate, balanced, objective and complete. The material must be based on a recent assessment of all relevant evidence, and it must encourage the rational use of medical products, , and be consistent with policies adopted for health care facilities.

The guide refers to the Event and Hospitality Management Framework which includes all meetings, marketing, scientific, educational, professional and other similar events organized or sponsored by or on behalf of a medical product company to be held in an appropriate venue that serves the main purpose of the event, and all forms of hospitality provided to health care professionals must be reasonable and exclusively limited to the primary purpose of the event. Hospitality should not exceed the level at which health care professionals are willing to pay for themselves. Medical product companies may not provide or pay the value of any entertainment or other recreational or social activities. No gift, benefit or cash may be given to a health care professional to entice him to prescribe, supply, sell or use a medical product.

Controls on the distribution and circulation of medical products

The guide allows medical product companies and their agents the right to offer pharmacies a quantity of free goods (bonus) of up to 15 per cent of the amount of pharmaceuticals sold / recorded in the invoice. Otherwise, no cash or equivalent benefits such as additional bonuses, discounts or other forms should be accepted by pharmacies or health care facilities in exchange for doing business.

It is not the intention of the Ministry to deny government-funded institutions the right to negotiate with medical product companies and their local agents for orders and prices of medicines and medical products. This process continues through the usual bidding and procurement methods of each institution. 

Medical product companies can sponsor continuing medical education for healthcare professionals exclusively to improve patient care.

Health care professionals can be used as consultants, whether individually or collectively, to provide services such as talking in and heading meetings, participating in medical / scientific studies, clinical trials or training services, participation in consultative council meetings, and participation in market research if such participation includes bonus and / or travel.

Regarding clinical research (including drug safety studies), the manual states that clinical assessment studies, drug safety control studies, experience programs and post-licensing studies should not be carried out under the guise of marketing. These assessments, programs and studies must be conducted for scientific or educational purposes only.

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