With this article, the author wants to indicate the value of putting back the theme in the agenda of AEFJN as a top priority for the network. Why re-open this issue? Because the issue of the quality of medicines and their accessibility in dispensaries, hospitals and pharmacies is a crucial question that causes major suffering for millions of Africans.
Trade in medicine is a business that represents a huge, booming market and where the lack of regulation at all levels, notably at the level of the pharmaceutical industry, the financial markets, and the states of the world, including the EU, opens the door to deep economic injustices and serious criminal activities at the expense of African populations.
Therefore, this theme will concern both the organization of states to ensure the quality of medicines and the international economic market and relations that directly influence the price of medicines and their availability.
In this first article, we will focus on the issue of the quality of medicines threatened by falsified or substandard medicines.
A falsified or counterfeit medicine or a fake medicine is a product that is deliberately or fraudulently misleading as to its identity, composition or source; it lacks what characterises any quality medicine: traceability and transparency. Fraud occurs either at the time of manufacture and/or distribution. Falsified medicines can be found in both formal and informal/illicit channels (markets, shops, street vendors and increasingly on the Internet). The aim of falsifiers is to make money without worrying about the consequences for the health of consumers. Falsified medicines are always outside the control of the National Regulatory Authorities (NRAs). The consequences for patients are: poisoning, intoxication, lack of efficacy with aggravation of the disease or death, drug resistance… The importance of falsified medicines in poorly regulated African countries can amount to 40% of the medicines put on sale. Falsification is a matter for the judicial authorities.
A medicine is said to be substandard or of inferior quality when defects have appeared unintentionally or through negligence during manufacture and/or distribution. It may be over- or under-dosed, unstable, not bio-available when taken by the patient, contaminated, not sterile, degraded or mislabelled. These medicines have been ‘controlled’ by the NRA and have been wrongly granted an export permit or a Marketing Authorisation (MA) and therefore have a label of quality in the eyes of patients. The fault lies most often with the manufacturer, but it can also be the poor storage conditions and the responsibility of drug suppliers, pharmacists and health personnel; the question of negligence raises the question of whether it was deliberate or not.
The dangerousness of sub-standard medicines for patients partly overlaps with that of falsified products; sub-standard medicines are often less effective and induce resistance as is the case with antimalarials. The number of sub-standard medicines legally placed on the market is estimated to be between 10 and 20% of medicines with a marketing authorisation; in fact, the weaker the NRA (due to lack of qualified personnel, equipment, corruption…), the more sub-standard medicines will fall through the cracks. Combating the phenomenon of sub-standard medicines is the responsibility of the NRA and the Ministry of Health.
(to be continued)