In this article, we continue our study of the quality of medicines by following the value chain from the medicine producer to the consumer.

Medicines, as manufactured, marketed and consumed by all, require a chain of many successive actors.

There are two stages:

– The manufacturing stage: active ingredients by the chemical industry; inactive ingredients and packaging materials by other manufacturers; finished products by pharmaceutical companies.

– The distribution stage: wholesale importers, distributors, pharmacists, health services (hospitals, health centres) /etc. to the patient.

Active substances and finished products circulate from one country to another by import/export because in this field, as in many others today, almost no country carries out all the stages on its national soil.

The international market is characterised by countries that produce/export active substances (mainly China and India) and finished products (India, China, Korea, Philippines, Russia, etc.). These countries manufacture for their own domestic market and export to Africa in particular.

The often complex circuits between these actors make it difficult to trace products and, as a result, responsibilities are not always identifiable. The “international zone” (between the exporting and importing countries) is by definition beyond the reach of national regulations. The situation has been seriously complicated by the explosion in the sale of medicines on the Internet.

In African national markets, medicines that can be used, i.e. that have a national marketing authorisation, are officially available only from legally authorised structures:

– pharmaceutical wholesalers (central purchasing agencies, laboratory agents, dispatchers, etc.), who buy locally produced and/or imported medicines in bulk and resell them to pharmacies

– pharmacies (private pharmacies or pharmacies in hospitals, dispensaries, maternity wards), which are responsible for individual distribution to the patient (dispensation).

Legal and illegal ‘channels’:

However, the reality is quite different because in all countries, illegal channels coexist with the legal one.

– In industrialised countries, illegal channels are rare and generally limited to the development of illicit sales via the Internet.

– In low- and middle-income African countries, many illegal channels have been established in parallel to the legal channel, to the point of becoming the main distribution channel.

– Between these two extremes, all situations exist.

– The sale of products on the Internet has opened the door to the uncontrolled illegal marketing of adulterated or sub-standard medicines. The literature is full of examples of such medicines being sold illegally on the Internet and causing serious accidents to gullible or unwary customers.

Legal and illegal channels coexist, and the illegal channel is so commonplace that it is often referred to by the benign name of ‘informal’. All sorts of medicines, of all origins and of all dangerousness, are sold on the markets and by peddlers who go from village to village. The two circuits are far from watertight, and, in some countries, the legal circuit (wholesalers, pharmacies) offers few more guarantees than the illegal circuit.

Counterfeits circulate mainly, but not exclusively, within the illegal markets. They are mainly copies that imitate the products of major international laboratories or generic products.

These falsifications concern all types of medicines. They are not limited to comfort medicines but also concern vital medicines for acute or chronic diseases, such as anti-malarials, vaccines or anti-cancer drugs.

Substandards are rife in low- and middle-income African countries, which are poorly regulated and therefore very poor in international trade relations. Many very low-cost medicines are imported. They have often been manufactured specifically for developing countries, which often do not have the resources to evaluate these medicines and to ensure that the Marketing Authorisation (MA) issued is a guarantee of quality. Some pharmaceutical companies indeed manufacture the same kind of drugs but with a double standard: a high standard for the high-income country market and a lower standard for the low- and middle-income country market. One may question the legality of such practices, which amount to falsification.

Substandards affect both illegal channels and legal markets, in both the public and private sectors.

In the public sector (where “marketing” is done through national purchasing centres), the pressure imposed by buyers, particularly through the tendering system, often neglects the quality aspect in favour of low prices above all. This focus on price, combined with the evolution of drug production and marketing channels, has contributed to making the international drug market increasingly risky, especially for African countries, due to the constant presence of sub-standard medicines linked to this excessive competition, which ultimately benefits the less serious firms that are the most adept at understanding how the system works.

In the private sector, the cause of the existence of sub-standard medicines (whether imported by wholesalers or produced locally) also lies partly in a race to the bottom and the limited resources of regulatory authorities.

The fight against falsified and sub-standard products

In Belgium, the FAMHP, the Federal Agency for Medicines and Health Products, issues export authorisations for medicines produced in Belgium. For more than 10 years, no cases of export of substandard medicines have been identified, but it is important to remain vigilant.

The online sale of medicines and medical devices is regulated by a 2009 Royal Decree. According to this decree, authorised pharmaceutical pharmacies that are open to the public can sell medicines and certain medical devices online and send them via a courier service. It is forbidden to sell medicines online for which a medical prescription is required.

Are there manufacturers of falsified medicines on Belgian territory? It is possible, but they are flying under the radar so far. On the other hand, it is very likely that criminals operate from the EU to sell falsified medicines via the Internet all over the world, especially to African customers.

It is certain that falsified and substandard medicines from the Far East are transiting through major European ports; customs play an important role in controlling imports, but they have no role in controlling goods in transit. They say that it is up to the regulatory authorities in the countries of destination to do this job. Is this honest?

The EU issued a directive in 2011 and another in 2019 to combat drug-related crime. The 2019 directive will require pharmaceutical companies operating in the EU to put in place, at their own expense, a system to verify the medicines they produce.

At the initiative of the Council of Europe, the MEDICRIME Convention entered into force on 1 January 2016. It establishes a framework for national and international cooperation between competent health, police and customs authorities at both national and international levels, for the adoption of measures to prevent crime involving the private sector, and for the effective prosecution of offenders and the protection of victims and witnesses.

Christian Roberti

(to be continued)