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03 February 2023

Developing a reference manual on substandard and falsified medical products legislation

Action plan
Réunion du groupe d'experts visant à élaborer un manuel de référence sur la législation relative aux médicaments et produits de santé falsifiés et de qualité inférieure

Work package no.2: Promotion of the adoption of comprehensive and harmonized legislation and regulations which criminalize the production, storage, transportation and sale substandard and falsified medical products.


The first seminar to develop the reference manual on substandard and falsified medical products legislation was held in the Seychelles on 30 January to 3 February 2023. The seminar brought together national legal experts and international experts to elaborate the structure and contents of the document and exchange experiences and practices from their different countries.

The reference manual on legislation relating to substandard and falsified medical products has been in progress since December 2022. It will help the 11 MEDISAFE project partner countries to strengthen their legislative frameworks to combat these products. The seminar in the Seychelles was the first regional meeting to be held on this topic.

National legal experts from Burundi, the Democratic Republic of the Congo, Ethiopia, Ghana, Kenya, Malawi, Rwanda, Tanzania, Seychelles and Uganda were in attendance. They were joined by Anita Sands, WHO expert, Babatunde Jayeola, Coordinator of the WHO AFRO regional office, Riikka Putonnen, head of the international programme to combat organized crime at UNODC, Anthony Bakenga Kapeta, legal officer at AUDA-NEPAD, and Dr. Jane Mashingia, representative of the East African Community.

The opening ceremony was attended by Seychelles Minister of Health, Ms. Peggy Vidot, who was guest of honor, and the event received extensive media coverage. Dr Rex Mpasange, WHO representative in the Seychelles and senior officials from the Ministry of Health were also present. In her speech, the Minister expressed her satisfaction that the Seychelles is one of the MEDISAFE partner countries and noted that her country was actively participating. She stressed the importance of combining efforts to strengthen national and regional capacity, both around health regulation and criminal justice. “I applaud the MEDISAFE project’s efforts and plans to combat the production, trafficking and use of substandard and falsified medicines and medical products and organized crime. It is clear that countries need a strong legal framework to address these multiple challenges. I fully support the development of a reference manual on substandard and falsified medical products legislation, which will not only serve the 11 MEDISAFE partner countries, but the African Union as a whole.” The Minister also thanked the European Union and Expertise France for their support and acknowledged the broader collaboration within the African Union and the United Nations, as well as the role of the World Health Organization as an unwavering partner.

The programme continued with presentations by international experts on pharmaceutical regulation and on the UNODC guide on best legislative practices. Several working groups were then formed. Legal experts reviewed the draft outline of the manual together, agreed on its structure and content and identified missing topics. Many discussions also took place during the seminar. In particular, experts were able to share information and examples of legal provisions from their national legislation for inclusion in the reference manual.

After five days of intense and fruitful discussions, a first draft of the reference manual was developed and approved by consensus by the experts. It will now be consolidated by the international legal expert. The draft will serve as a framework for the preparation of the final version. It is planned that the reference manual will be further discussed and finalized at the second expert group meeting, which will be held in Mombasa, Kenya, in May 2023.

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