Expert insight

Traffic in Counterfeit Medicines Must be Curbed through International Cooperation and Regulatory Harmonization

16 April 2015
  • Marc Gentilini

For all the advances it has produced, globalisation also has its downsides. One such example, the counterfeiting of medical products, represents a major threat to our societies, in particular the poorest ones.

The data is rare and difficult to verify with certainty. According to the World Health Organisation (WHO), about 15% of medicines in the world are counterfeit, and in certain regions, this rate may easily exceed 60%! This scourge primarily affects the most disadvantaged regions, because of their impoverished populations and failing government institutions.

While these populations are already severely affected by transmissible and non-transmissible pandemics, producers and traffickers of fake medications are committing a two-fold crime: cheating patients out of their hope of being treated with quality medicine, and endangering the lives of those taking medicine that at best will have no effect, and at worst will be toxic or even fatal.

Mobilisation of all parties is essential in the face of this insidious menace, which evades the vigilance of the various links in the medicinal product chain and serves the financial interests of highly organised criminal groups.

First and foremost, this will require greater accountability on the part of political decision-makers who have shown little engagement, as well as greater risk awareness on the part of populations who know little about this new form of criminality. All links in the health chain must be mobilised to take part in an unrelenting battle. This means mobilisation of the authorities, doctors, healthcare professionals, pharmacists, manufacturers, civil society and all citizens concerned.

In 2006, the Conférence Internationale des Ordres de Pharmaciens Francophones [International Conference of Chambers of Francophone Pharmacists] made a first declaration in Beirut (Lebanon), directed at pharmacists as well as public authorities and patients. These pharmacists highlighted the paradox of investing in the development of medicinal products beneficial to health when the distribution systems are not sufficiently controlled and are increasingly in the hands of organised crime.

The Cotonou Declaration, issued on 12 October 2009 by French President Jacques Chirac in the presence of numerous heads of state and government, notably African (Africa being the continent the most harmed by counterfeit medicines), introduced the political dimension necessary to win this fight. The objective was to rally political decision-makers to fight this menace and urge them to provide more help to the public health community.

This political advocacy is not intended to replace the health community but to involve political decision-makers in combating this traffic, which is doing more and more harm to their populations.

Since then, several “booster shots” have been given, such as the Declaration of Niamey, signed in November 2013 by five African First Ladies (Burkina Faso, Central African Republic, Guinea, Mali, Niger) who commit to continue this political advocacy with the heads of state and government. This month marked the launch of the international awareness campaign Fight The Fakes, which now brings together over 25 partners (representatives of healthcare professionals, product development partnership, foundations, financing institutions, wholesalers, mobile application, coalitions for consumer protection and the generic and R&D pharmaceutical industry). This campaign constitutes a concrete example of shared awareness.

Another critical need is reinforced international cooperation among states and expanded regulations harmonisation. Impunity in the face of the near absence of coercive and penal measures in certain regions, along with the disconcerting profitability of this traffic, makes it more and more attractive for certain criminal groups. A response is urgently needed in order to fill the legal vacuums taken advantage of by criminals.

In 2011, during a conference in Moscow, the Medicrime Convention of the Council of Europe was opened to the signature of all states. This convention protects public health by criminalizing and sanctioning the production, traffic and sale of counterfeit medicines, while ensuring cooperation among states to tackle this scourge.

The Medicrime Convention is the first international legal instrument available to every state as it is open to signature and ratification by all states – members or not of the Council of Europe. If offers an opportunity to establish international cooperation, which has been sorely lacking in the fight against counterfeiting of medicine, and currently counts 23 signatory states, including 3 that are not members of the Council of Europe (Guinea, Israel, Morocco). Only one more signatory state must ratify in order to bring the convention into force, which will certainly renew mobilisation.

Regional initiatives are also essential, because they involve responsible parties, elected officials and individuals closer to the reality in the field. Like the European Union, which armed itself with a directive on these lines in 2011, the African states should also invest in harmonising their regulations.

In Africa, authorities and professionals are expressing increasing interest in being better informed on the regulations and initiatives that may be transposed into their health systems.

In this framework, the DIA (Drug Information Association), the Fondation Chirac and the IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) are working together to organise a workshop on 29 April 2015 in Dakar with the theme “Integrated Approach against Counterfeit Medicines.” This event will bring together regulatory affairs professionals, representatives of health authorities and other professionals involved in combating counterfeit medicinal products.

The discussions will deal with the current regulatory landscape in Africa, the initiatives and measures capable of strengthening the integrity and inviolability of the distribution chains, and will end with exploration of possibilities for inter- and intra-state cooperation.

This reflection and approach should create a more widespread and intense awareness in support of a general mobilisation against the counterfeit medicines targeting the most impoverished. Do you want to be a part of this fight? Join us on 29 April 2015!


  • Marc Gentilini