A continental FDA for Acfta

Usually, we reserve the writings of this blog for the activities of the agri-food sector. For the purpose of this article, we join to our interest the Moroccan pharmaceutical sector, which we know, and African on which we have echoes. The reason is that we collaborated and / or worked with this sector for many years first in Lausanne (Switzerland) as an Assistant at the Faculty of Medicine, then in Basel (Switzerland), as a junior researcher in one of the largest multinationals, and here in Casablanca as a Scientific and Administrative Attaché to one of the local groups. Now, there is the fact that the local press reports, in recent times, that the Moroccan pharmaceutical sector is in great depression and accumulates for a while blunders like stockouts, the lack of essential drugs for patients and other failures we have not seen in the last thirty-five years. Elsewhere in Africa, the international press speaks of cases of mediocre drugs (substandard), generics of antibiotics in particular, prescribed to patients and, instead of curing; the products have precipitated the death of patients (see below). At the time of the entry into force of the Acfta (African Continental Free Trade Area), the subject has attracted our attention for this reflection which is meant to be educational without too much focus on the names neither of the drugs decried nor on pharmaceutical laboratories incriminated nor on the names of implicated officials of the private or the public.

With regard to Morocco, the active encouragement of metropolitan France, at the turn of independence, for the birth of a local productive sector of medicines may seem enigmatic at first glance. In fact, the pharmaceutical industry, more than most industries, is a highly capitalistic profession that depends on a dynamic Research / Development activity. At the time we are talking about, only the Faculty of Science of Rabat was relatively operational (could import some laboratory rats for example). Moreover, apart from alcohol and sugar, where the demand of the sector could partly be satisfied by local production, all other needs (raw materials, consumables, equipment, materials, know-how, etc.) had to be imported from metropolitan France. Indeed, considering that the colonizer had taken care to lock by regulations and standards (some are still in force), the activity of the national health sector in his favor, it was more than recommended to import the supplies listed of the metropolis. And, to the extent that France is not known to produce on its soil a good part of the articles mentioned (which it itself imports from elsewhere), the purchase of these tools for the Moroccan market from intermediaries French made them particularly expensive. As a result, drug prices in Morocco were relatively much more expensive to patients compared to their costs elsewhere in the world. But, French partners have found the opportunity to draw copiously from the pockets of Moroccan manufacturers and paying nothing to the local administration. It is probable that metropolitan France acted in other countries of French-speaking Africa in the same way it did in Morocco.

Now, if the health risks can concern both foodstuffs and pharmaceuticals, the potential dangers are not of the same degree on the health of the consumer or patient. In this perspective, the management of the threats in question must be adapted to the type of risk conveyed by the taking of a food on one side and, on the other, the possible consequences of a prescription drug (see below). For example, in the case of a foodborne infection, the chances are high that a few hours, or a few days, after eating a meal, symptoms (common to food-borne illnesses) such as fever, vomiting, headaches and others come out as warning signs of more serious health problems to come. This can, in a way, help for taking the lead and seeking appropriate medical care. In the case of a falsified medicine, the effect can be much more pernicious because you have to take into consideration the “placebo effect”. This means that at the idea of receiving a prescribed medicine, patients may, temporarily, feel better even if the product is faked. Under these conditions, if the drug administered is fraudulent and its deleterious effect is revealed only much later (carcinogenic and other products), the patient may have the feeling (placebo effect) of momentary healing when in fact disastrous effects, under the action of the defective drug, incubate in his body without his knowledge to emerge at a time when it will be too late to remedy the problem. For this reason, the quality and rigor of drug control is more pressing here than in many other areas of activity.

In this respect, the available data suggest that some generic drug manufacturers, mainly in China and India, define the Quality / Control criteria according to the country in which they intend to export the pharmaceutical product. The least careful manufacture (reduction of the content of active ingredient for example) and the laxest control (Falsified Analysis Bulletins) are reserved for products destined for our African countries. Apparently, these mafia-type professionals are well informed of the seriousness (or permissiveness) of the quality control system of the country of their interest so to not take risk “inconsiderate” for their business. This explains in particular the recurring under dosage results that are found in antibiotics imported into Africa and which seriously damages (disaster of bacterial resistance) the health of our fellow citizens.  At the same time, this observation correlates with the lack of rigor of institutional quality control in many of our African countries, which is regularly criticized by non-governmental organizations. It is important to emphasize that these same generic drug manufacturers carry out correct manufacturing operations and rigorous and unfailing controls on the batches of products that they send, for example, for American market which is considered the most severe in the world for verification of the quality of pharmaceuticals. Major global pharmaceutical companies regularly confirm that the passing of the FDA quality control tests significantly improves the chances of successful commercialization of a drug in the international market.

But not all countries can afford Quality control structures equivalent to those of FDA. For example, the information made public after the Benfluorex-Mediator disaster in France showed that besides the high cost of setting up pharmaceuticals control structures in France, those laboratories are far from easy to manage. Nevertheless, the result of the disaster of the aforementioned pharmaceutical, with hundreds (even thousands) of deaths and more still to come, remains unforgivable for families victims of the catastrophe. It is also deduced that if the management of such pharmaceutical control structures is considered expensive and complex for a large country like France, the effort might be far beyond the possibilities of an individual African country. At the same time, to dispense with the control of local or imported pharmaceuticals is not an option either. Otherwise, our African countries may become places for recycling poor products (substandard) or even simply outdated.

In the past, European countries have resorted to FDA assistance to help them rebuild their control structures destroyed in the last major war. One idea would be for our future leaders of Acfta to open a dialogue with FDA (US Federal Agency for Food and Drug Control) with the wish to benefit from same kind of assistance the European have been given before. There is no reason to believe the FDA would refuse them a service it has given to another continent in the past.