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Published March 31, 2023 / Public health

Strengthening the legal framework in the fight against fake medicines

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London, 31 March 2023 - From its launch in January 2020, the Lomé Initiative against Falsified and Substandard Medicines (FSM) set two major conditions for success:

- Strengthen and harmonise legislation to combat trafficking FSM.

- Sign and ratify international agreements, notably the Council of Europe's Medicrime Convention, the UNODC's Palermo Convention against Transnational Organized Crime, and the treaty establishing the African Medicines Agency (AMA).

Jean-Louis Bruguière, former anti-terrorism judge and Advisory Board Member of the Brazzaville Foundation, oversees the legal component of the Lomé Initiative. Photo taken at the Lomé Summit on 18 January 2020, © Togolese Presidency.

Between 2020 and 2021, the Brazzaville Foundation conducted a legislative audit with pro bono support from the law firm Allen & Overy. This exercise demonstrated the weakness of the criminal law component of pharmaceutical regulation in Africa. Indeed, while most legislation recognises the offences and crimes committed by sellers of FSM, it does not recognise the criminal characterisation of acts committed by traffickers who sow death by feeding informal distribution networks. In some regions, these cross-border criminal networks are linked to terrorism. For Jean-Louis Bruguière, former anti-terrorism judge and Advisory Board Member of the Brazzaville Foundation, who oversees the legal aspects of the Lomé Initiative: "It has been proven that penalties are not dissuasive and are often evaded. It is therefore necessary to put in place powerful and dissuasive repression mechanisms".

 

Watch his speech at the Lomé Summit on 18 January 2020

 

Nevertheless, the African Union has a model pharmaceutical law that is in force in more than twenty countries. Developed by AUDA-NEPAD, this text, adapted at the national level, allows the establishment of regulatory authorities and the entire arsenal of pharmacovigilance to provide quality medicines to African patients. Regulatory work carried out, for example, by the WAEMU is moving in the same direction. However, as long as the repressive aspect of trafficking is not framed by a strengthened penal framework legislation to incriminate traffickers and corrupting agents, it will not be sufficient. The ongoing launch of the pilot project in Togo will allow for experimentation in this regard.

 

For this reason, the Brazzaville Foundation is intensifying its work on the legal and regulatory framework by inviting all the stakeholders identified on this subject to work together at technical seminars to be organised by the end of 2023. In coordination with WHO, a toolbox will also be made available, bringing together all existing mechanisms.