The Case for an Algerian FDA in the Wake of Unethical TV Ads

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In the wake of a spate of television advertisements for dietary supplements claiming to offer solutions to the COVID-19 crisis, regular PharmaBoardroom contributor Yacine Sellam argues for the need for a more robust regulatory framework in Algeria and even the creation of a unified FDA-style regulator to counter this threat and better secure the health security of all Algerians.

 

While the eyes of the whole world are turned to innovative pharmaceutical companies in the hope that a safe and effective treatment or vaccine against COVID-19 can be developed, the current health situation has definitely constituted a real boon for the dietary supplements industry. There has been a notable push to better communicate the role of micronutrients in strengthening the body’s immunity with some observers noting that demand for dietary supplements has increased considerably as COVID-19 has spread.

 

Algeria is, of course, no exception to this global phenomenon. However, certain advertisements on national television channels have caused outrage among the informed public by purveying misleading health claims. Unfortunately, in order to better convince an audience that naturally relies on the word of physicians (the first bulwark against the COVID-19 pandemic), it has become common to call on health professionals from different medical specialties, who have clearly been tempted by money.

 

Several professional organizations in Algeria have recently struck out against unethical practices. For example, the Community Pharmacists National Syndicate (SNAPO) has denounced the illegal exercise and unfair competition of dietary supplements being sold outside pharmacies and the Medical Deontology Regional Council of Blida (50km south of Algiers) has threatened to crack down on health professionals who agree to lend their image to false advertisements for flagrant violation of the medical ethics code provisions.

 

But nothing and no one could have stopped this advertising machine. The audiovisual regulatory authority (ARAV), which is supposed to exercise control, by any appropriate means, over the subject, content and programming methods of advertising programs, in accordance with article 55 of Law 14-04 dated of February 24, 2014 relating to audiovisual activity, has not reacted (until three days after publication of this article in a local newspaper). The same is true for the four co-signatory departments of the Interministerial Decree dated of October 19, 2017, setting the terms applicable to nutritional labelling of foodstuffs (since it is this definition that dietary supplements meet), which are the ministries of health, trade, industry and agriculture.

 

In fact, it cannot be argued that there is a legal vacuum since Article 23 of the aforementioned decree provides that “the use of any health claim is subject to the prior agreement of the authorized health services, and this, in accordance with the laws and regulations in force”. The questioning is all the more legitimate since the non-prescription drugs, which can be dispensed freely by the pharmacist, are prohibited from being advertised to the public (in the same way as all drugs for human use in Algeria are), in accordance with article 240 of the Health Law 18-11 dated July 2, 2018, while the latter are safe, effective, and of known composition, duly controlled and approved by the authorized services of the Ministry of Health. In addition, products whose active substances are exclusively one or more plant substances or herbal preparations, fall under the definition of plant-based medicinal products, and the obligation of registration decision issuance prior to their marketing (articles 210 and 230 of Health Law 18-11, respectively).

 

Nevertheless, the dietary supplements in question here have not been subject to prior control to be exercised by the Ministry of Health services, and the flood of advertisements that accompanies them gleefully exploits the psychosis caused by COVID- 19, or sometimes the hope of offspring for couples suffering from fertility disorders, and not so long ago, that of patients suffering from chronic pathologies. Any sense of ethics was thus disregarded, in addition to violation of the legislation in force, including the provisions of Executive Decree 13-378 dated of November 9, 2013, setting the conditions and terms relating to consumer information, in particular its articles 36 and 56 (false allegation and advertisement).

 

Furthermore, the proposal for banning dietary supplements from import, recently raised by the Minister of Pharmaceutical Industry, is laudable given that many of these products are linked with important foreign currency transfers abroad, and that they could benefit local pharmaceutical manufacturers, whose factories operate only at 30-35 percent of their production capacity for drugs, and their margins are constantly pinched by the erosion of local currency value (drugs prices are administered and unchanged over time). In fact, thinking should be further broadened at a time when there is the advent of a National Health Security Agency (ANSS), whose contours are still unclear, while health security is also on the plate (foodstuffs, and by extension dietary supplements). This is also evidenced by a recent declaration of the Minister of Health, who has made imported food products one of his sector priorities, given that some of these products may be a risk factor for certain types of cancer in Algeria.

 

In addition, the reactivation of the National Agency for Pharmaceutical Products (ANPP) which remains cut off from the prerogatives inherent in the control of drugs for veterinary use, necessarily leads to a duplication of resources and efforts at the level of the Ministry of Agriculture that is in charge of it today. Given the fragmentation of institutional and regulatory framework surrounding food, drugs, dietary supplements, or even cosmetic and phytosanitary products, Algeria should take this opportunity to move towards a Food & Drug Administration model, by making its own the “too many agencies kills the agency” quote, and also drawing on successful experiences of the United States (US FDA created in 1906), China, South Korea, Argentina and, closer to home, Jordan, Saudi Arabia or Iran. While this may be wishful thinking, how beneficial it would be for the health security of Algerian citizens!

 

This article was originally published on July 5th 2020 in El Watan newspaper (in French)

https://www.elwatan.com/pages-hebdo/sante/de-la-COVID-19-des-complements-alimentaires-et-de-lopportunite-dune-agence-du-medicament-et-des-aliments-en-algerie-05-07-2020

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