20 Apr 2022
Due to the advancement of medical sciences and demand for medicines and medical products, it is necessary to keep a check on the manufacturers and distributors for the sake of the citizens’ sound health. In the UAE, the Ministry of Health and Prevention (MOHAP) regulates all drug-related matters and issues licenses for marketing and advertising medicines and healthcare products. It issues guidelines for regulating the marketing of medicines and other medical devices to ensure observance of the highest ethical standards and other applicable rules of conduct. UAE has made legislations regarding pharmaceutical and healthcare products to restrict the advertising and marketing of medical products according to ethics and high standards. This article will discuss in detail the legislation and other relevant resolutions. Federal Law Number 15 of 1980 Governing Publications and Publishing (Publications Law) in its Article 83 states that advertisements on medicines or pharmaceutical products may be published after obtaining a special permit from the Ministry of Health and Prevention (MOHAP). It is prohibited to publish any advertisement regarding a medical product or medicines without complying with the stipulated requirements, and it will amount to an offense otherwise. The UAE Cabinet Resolution Number 7/2007 prohibits medical products’ advertisement without prior permission from the competent authority. Similarly, Ministerial Resolution Number 430 of 2007 Regulating Health Advertisements does not allow the marketing and advertisement of medical products without having permission from MOHAP.
For the advertisement of healthcare products, the advertising companies should adhere to the restrictions imposed by law to get permission legally to advertise any medical product. They should not deceive or misrepresent facts about any medicine or medical device to change the public’s views or convince them to purchase that product; it is illegal and prohibited, it should contain an authentic and balanced statement. It also states that the medical product advertisements shall not be licensed unless the product is approved according to the State rules and regulations in force. It should not harm the third party’s product and facilities. The advertisement must not contradict UAE customs and traditions nor Islamic principles. The MOHAP’s Drug Control Department governs the marketing and registration of medical devices. The medical device manufacturers need to register the device before presenting it for marketing. For the issuance of a license for advertisement for the medical devices, that must have been checked by the competent authority to ensure its safety for use, and the advertisement for its promotion is up to the standard set by the law. MOHAP by the Ministerial Decision Number 1412 of 2017 has issued a specific code of ethics for the advertisement and distribution of all medical products in the UAE. It also defines the nature and form of content to be presented in the advertisements and sets rules for medical professionals’ engagement in the marketing and promotion of medical products. UAE Cabinet Decision Number 21 of 2018, through this resolution, the Cabinet strives to encourage, protect, and support breastfeeding by advertising nutritional products and food-related to feeding infants. It is also trying to create awareness in public by showing the disadvantages of feeding infants with nutritional products instead of breastfeeding them. Electronic Media Regulation 2018 (EMR) these regulations set forth rules regarding marketing/advertisement of medical products through electronic media, including the internet, social media sites, and TV. Through these regulations, the National Media Council UAE requires approval from the competent authority before the advertisement of any medical or healthcare products. Besides this, the advertising company requires to obtain a license from the National Media Council to advertise the medical products on electric media, which should be in accordance with the said law. The MOHAP is the only competent authority in UAE to issue licenses for marketing, advertisement, and manufacturing, importation, use, and sale of medical products. Other than MOHAP, some emirates have authorities regulating health-related matters and implementing policies in their jurisdiction. Such as Dubai Health Authority (DHA) in Dubai and the Health Authority for Abu Dhabi (HAAD) in Abu Dhabi. These health authorities regulate and implement particular additional regulations regarding healthcare and medical products in these emirates following the Federal Laws for healthcare. The DHA has issued guidelines for social media advertisements regarding healthcare matters. The guidelines have set parameters for social media advertisements for managing the social media contents regarding medical advertisements.
The guidelines insist that the content of the medical products’ social media advertisements shall comply with the Federal laws and local laws for the public’s good and safety. The Dubai Health Authority does not allow the promotion of non-healthcare products as healthcare products. Market Authorisation Certificate is issued by the MOHAP for the medical/healthcare products to be advertised or promoted in the market; without obtaining this certificate, it is prohibited to advertise any medical product. It is issued to registered medical products. For obtaining the certificate for marketing or advertisement, an online application is made to the MOHAP. All the relevant documents, marketing authorization, content, product details, media platform, location, desired type of advertisement are electronically uploaded to the account created on the MOHAP website; it reviews the whole data and content and approves that particular advertisement in six months at least. Additionally, the DHA and HAAD can review the advertisement’s content before they are implemented in their emirates.
The Publications Law and NMC prohibit the advertisement of abortions, embryo freezing, products proven to be harmful to individuals, treatment or preventing cancer, STDs (sexually transmitted diseases), AIDS (Acquired Immune Deficiency Syndrome), hepatitis, mental and psychological disorders. MOHAP’s Pharmaceutical Licensing Committee is empowered to investigate any violations and take any necessary measures against liable parties. Fines can be imposed on the violators, and the offending or non-complying materials will be removed. Under Electronic Media Regulations, the National Media Council can impose 100,000 to 200,000 AED (UAE Dirhams) fines for publishing advertisements online and on social media without obtaining relevant authorizations from both MOHAP and the NMC. The Federal Law Number 8 of 2019 has merged various previous laws regarding the advertisement and marketing of medical and healthcare products in the UAE. However, many laws, including those mentioned above, still exist in the field and govern this matter.