Our first edition of 2022 focuses on Healthcare and Life Sciences. It is a sector that will once again have the spotlight on it this year as we continue to tackle COVID-19 and its subsequent variants. While the pandemic continues to challenge the sector, governments across the region forge ahead with their plans to expand and upgrade healthcare systems and develop robust world-class healthcare infrastructure.
For the region, healthcare is a vital pillar in diversifying its economies, both locally and as medical tourism hubs. To underpin this, healthcare authorities across the region continue to implement frameworks and regulations that provide structure and accountability.
In this edition, you have unique access to great insights and expert commentary on a number of pertinent healthcare regulatory developments. You will find a topical mix of articles; for example, our lawyers discuss vaccines and returning to work during the pandemic. They take you through several other areas, including stem cell research in Bahrain, clinical research laws in Egypt, and Saudi medical device and pharmaceutical laws.Take a read of the edition
December 2015 – January 2016
Medical devices are regulated by the Drug Control Department of the Ministry of Health. To this end, the UAE Medical Device Regulation Guideline is aimed to maintain a balance between ensuring product safety, quality and effectiveness and providing the public with timely access to medical devices and preventing the entrance of unsafe or ineffective devices into the UAE market. The UAE Medical Device Registration Guideline states that medical device manufacturers must register with the MOH before they can market their products in the UAE. Accordingly, companies who wish to export their products into the UAE must do so via a local representative or distributor who is licensed.
Where the subject matter of advertising is medical products and services, advertisers must comply with special requirements. It is prohibited to publish any advertisements and / or to advertise medicine or pharmaceutical products without the approval of the Ministry of Health. Such an approval shall only be granted if the relevant advertisement complies with the requirements of the applicable regulations.
In the UAE, Regulation No. 430 of 2007, also known as the Health Advertisement Regulation is the body of law regulating the field of advertising in the medical field. As part of the definitions in article 1 of the regulation, the following definitions need to be highlighted:
“ Advertisement: any information about the Medical Product in written , photographic and broadcasting form, in the form of a design, in the form of a product packaging in any of the media whether audio, visual and printed, in the form of posters in public places or in promotional form through the means of personal, technical or electronic messages communication.”
“ Medical Product: Everything linked to the human health, such as medicine and drugs, including herbal medicine – health food, nutritional supplements and beauty centers – medical apparatus and supplies – medical institutions – people who is practicing the medical profession of physicians and technicians – ways and methods of medical treatment by traditional or alternative methods.”
Articles 2 and 3 of the Regulation clearly sets out that the Ministry of Health is the exclusive body allowed to license the Advertisement for medical products. Accordingly, the advertisement for medical products shall not be licensed unless such products are licensed or authorized in accordance with the laws and regulations.
Article 4 of the Regulation provides a list of do’s and don’ts when it comes to Medical Advertising, amongst others the advertising must be accurate and should not contain exaggerated, misleading or alarming statements. Furthermore, if the medical advertising is to contain statements such as “number 1 prescribed medicine by health professionals” such statements need to verified and corroborated with an independent study proving the accuracy of the statement. Hence, during the review of the advertising or even through a third party challenge/complaint, the Ministry of Health may request proof of such independent studies establishing the veracity of the statements contained in the advertising.
The Regulation also provides that certain medical advertising is prohibited based solely of the content matter, hence it is prohibited to advertise medical products and services relating to the following:
In conclusion, when deciding on advertisement related to the medical field, a greater degree of care and attention is required. Given the intended demographic, the legislator has implemented the set of regulations so as to avoid preying of the weak and desperate who may be more susceptible to the language, promises and results made in the medical advertising.