09 May 2018

Marketing and Distributing medical products in the UAE – the new Code of Ethics

Authored by: Hadef & Partners, Sector Groups

Background

At the end of last year, in accordance with Ministerial Resolution 1412 of 2017, the Ministry of Health and Prevention (‘MoHAP’) issued a code of ethics regarding the marketing and distribution of Medical Products in the UAE (the ‘Code of Ethics’).

What is the scope of the Code of Ethics?

The Code of Ethics applies to:

  1. Institutions engaged in marketing Medical Products inside the UAE, including holders of the right of marketing or their representatives, local agents, marketing consultants and others (‘Medical Product Company/Companies’);
  1. Healthcare specialists which are all the individuals and companies involved in writing, dispensing, purchasing, inserting and paying for prescriptions in both private and public sectors (‘Healthcare Specialists’); and
  1. Medical Product Company’s sales representatives who visit Healthcare Specialists, pharmacies, hospitals or other healthcare institutions in relation to marketing Medical Products, which are defined as ‘Medical Sale Representatives’.

The Code of Ethics defines Medical Products as pharmaceutical products, medical appliances, consumer medical materials and medical equipment (‘Medical Product’).

What is the aim of the Code of Ethics?

The Code of Ethics sets out the minimum standards that should govern interactions between Medical Product Companies or Medical Sale Representatives and Healthcare Specialists. It aims to enhance the medical care practices and promote the interests of patients.

The MoHAP stated that the Code of Ethics ‘aims to regulate the marketing of Medical Products to ensure adherence to the highest ethical standards and other applicable rules of conduct.’

What are the main provisions of the Code of Ethics?

  1. Marketing License and Approval of Product Card

Medical Product Companies must not promote any Medical Product unless the promotion of that Medical Product has been authorised by the MoHAP. The MoHAP would not permit the promotion of a Medical Product unless such Medical Product has been duly registered with the MoHAP. The Medical Product must be promoted only for the purposes that it was authorised for and as set out on its approved labeling.

Under applicable UAE laws, each Emirate requires that individuals are only licensed to carry out their activities in the Emirate in which they conduct business and may only carry out the activities noted in the licence. Therefore, companies should ensure that their Medical Sale Representatives are sponsored by the relevant entity of the distributor, depending on where they conduct their activities.

  1. Marketing materials

Article 3 mandates that the marketing material should be accurate, balanced, neutral, objective, and comprehensive enough to enable the recipient to form his/her own opinion as regards the therapeutic value of the relevant Medical Product.

Marketing materials shouldn't be misleading for the recipient by distortion of information, exaggeration, unjustified focus, omission or by any other means. For example, no findings of a study may be quoted if there is another valid, clinically relevant scientific study which contradicts or questions such findings. Further, statements of comparison between different drugs or generic drugs should be drafted in a manner that shows the statistical validity and clinical relevance. All comparisons should be made in a scientifically appropriate and balanced manner.

  1. Event and Hospitality Management Framework

Article 6 regulates the manner of how medical events ('Event(s)') should be organised. It sets out certain conditions that must be met by Medical Product Companies. For example, the venue of the conference must be held in an “appropriate" place to serve the main objective of the conference and therefore holding a conference in a resort or similar place know as a leisure place would not be accepted. Further, Medical Product Companies must not provide or pay for any entertainment or any other entertainment activities or social activities to Healthcare Specialists that are unrelated to the main objective of the Event.

  1. Controls on the distribution and circulation of Medical Products

The marketing materials of Medical Products shall be directed to persons who can be reasonably assumed to require this specific information or to be interested in it. Hence, mass distribution of marketing materials to the public is not allowed. Further, whenever a Healthcare Specialists requests to opt out from receiving such marketing materials (whether received via fax, e-mail, automatic communication systems, text messages etc.) his or her desire must be respected.

It is allowed under Article 8 of the Code of Ethics for Medical Product Companies and their agents to give pharmacies free-of-charge goods up to 15% of the pharmaceutical products sold to such pharmacies. However, Medical Companies are not allowed to make cash payments or offer equivalent benefits (e.g. additional bonuses, deductions or any other form of financial benefits in exchange of prescribing Medical Products of such Medical Companies to patients.

Private pharmacies and hospitals are obliged to maintain sufficient supply of drugs for their patients based on the needs of patients and doctors' prescriptions and it is completely prohibited for any pharmacy to link the amount of supply of certain drugs with the benefits received from certain Medical Companies.

  1. Medical Sale Representatives

As set out in the Code of Ethics, Medical Sale Representatives should be adequately trained and have sufficient scientific knowledge to be able to provide precise and complete information about the Medical Products they promote. However, the Code of Ethics does not include any specific professional qualifications required for Medical Sale Representatives to carry out their activities in the UAE.

Conclusion

We believe that Code of Ethics clearly identifies the rights and obligations of the various parties involved in the marketing and promotion of Medical Products in the UAE. This greatly assists in the creation of fair competition in the industry and results in more effective protection for the public.

For more information, please contact us on sectors@hadefpartners.com.