Combating falsified medicines in East and Central Africa with the MEDISAFE Project
The falsification of medicines poses a serious threat to public health, with risks of the treatment proving ineffective or even deadly for patients. This problem is particularly acute in developing countries. The issues concerning the quality of medicines are compounded by a lack of consensus on the definitions, a lack of reliable and scalable technology, the weakness of regulatory authorities at the national and regional level, and shortcomings in regulations and the control of the manufacture, mainly in China and India.
To address this threat, the European Union’s MEDISAFE project, implemented by Expertise France, aims to fight against falsified medicines in 11 East and Central African countries. It is based on a consortium of three partners and an integrated strategy, aligned with WHO recommendations. Its objectives include the prevention, detection and response to the falsification of medicines, with measures to ensure the quality, security and legality of the medicines distributed. This project is part of a “Team Europe Initiative” on manufacturing and access to vaccines, medicines and health technologies in Africa (TEI MAV+).
In six years, tangible progress and positive results
The project has contributed to improving the proficiency of professionals in the legal, law enforcement and pharmaceutical sectors, strengthening existing policies, and promoting national and regional cooperation. Six years on, the project has achieved 96% of its initial objectives.
To address the urgent need of helping countries to strengthen their legal frameworks, the consortium has produced five key documents:
- Supply Chain Security, produced with the collaboration of 11 pharmaceutical experts and drug regulatory authorities in the target countries, as well as the World Health Organization.
- The Reference Manual on legislation on substandard and falsified medical products, prepared in collaboration with the African Union (AU) and the New Partnership for Development-African Union Development Agency.
- Standard Operating Procedures (SOP) on law reinforcement, sector and council for Interpol.
- Outline of 11 National Action Plans with recommendations on law enforcement, pharmaceutical products, and awareness-raising in each country.
- Communication strategy on the fight against falsified and substandard medical products.
Furthermore, more than 270 institutions in 11 Central and East African countries have benefited from awareness-raising on the prevention and fight against falsified and substandard medical products. A pool of 22 national experts has also been created at regional level concerning the pharmaceutical and legal aspect, and more than 15 international experts have been mobilised in various fields of action.
Lessons learned on the ground: gender mainstreaming and use of communication systems
According to the surveys conducted in various countries, women are more likely to find themselves faced with falsified medical products in street pharmacies. But according to INTERPOL, men are more exposed to counterfeit drugs when they buy certain medical products, especially products for sexual problems.
In conclusion, while the initial training primarily targets women, men should clearly also be included in these workshops.
There are communication systems between the various sectors, but they are often not sufficiently used. Communication on counterfeit drugs between the police, customs and pharmaceutical regulatory bodies is often ineffective.
While the project had initially planned to focus its efforts on regional communication channels, it became clear that additional support and training was necessary at national level.
In short, it is crucial to test the assumptions and adjust the plans according to the lessons learned on the ground.
The European Union plans to develop a second phase of the project. The aim is to continue the work in some of the 11 initial target countries, while extending its operations to West Africa in 2025 using the same successful model.
For further information, consult the MEDISAFE website and the project sheet.