Falsified and sub-standard medicines: danger of death, unusual in the industrialized countries, commonplace in the developing countries

Jacques Pinel was and still is a totemic figure at the medical charity, Médecins Sans Frontières (MSF – Doctors Without Borders).

A pharmacist with a few years of experience in voluntary service overseas in Africa and Asia, Jacques joined MSF in 1979 to work in a refugee camp in Thailand where the charity, still in its infancy, was trying to meet the medical needs of tens of thousands of Cambodian refugees.

Beginning with organizing the camp's pharmacy, Jacques very quickly turned his attention to all the logistics necessary so that the medical team could focus on care-giving, thereby inventing, then developing what would become MSF logistics (medical and non-medical).

From that moment on, he never ceased to think about and share new ideas, launching new projects, creating networks, bringing in potential partners and passing on his experience, always with the goal of improving the aid conveyed to people in need.

Jacques died in 2015, his mind still filled with projects for MSF and its partners.

 

Starting in the 1990s, Jacques devoted himself more particularly to the issues involving medicines, e.g. the issues of access to medicines required for fighting AIDS, malaria and tuberculosis and the quality of medicines on the international market.

He was the originator of MSF's Campaign for Access to Essential Medicines in 1999 and initiated a series of projects aimed at helping humanitarian organizations and international agencies ensure the quality of their supply.

Throughout his career he witnessed the evolution and growing complexity of the world's medicines markets with the rising risks for the people of developing countries.

Extremely worried about the dangers presented by falsified and poor-quality medicines for these peoples and always believing in the huge importance of education, Jacques spent his later years drafting a document for laymen about these issues.

When he passed away in August, 2015, Jacques had not yet finished his paper.

Jacques' close co-workers and companions (Jean-Michel Caudron, Cécile Macé, Corinne Pouget, Raffaella Ravinetto, Brigitte Renchon, Jean Rigal, Benedetta Schiavetti and Daniel Vandenbergh) therefore decided to finish this document in Jacques' spirit so as to make it available to as many people as possible. The outcome of this process is presented here.

 

The first chapter is devoted to explaining a few basic notions for a better understanding of the topic of medicines, their quality and their legal and regulatory environment.

The second chapter explains how a medicine can be of poor quality and the distinction to be made between falsified (counterfeit or frankly "fake" medicines) and "sub-standard" medicines.

The third chapter examines how the upheavals in the way the world is politically organized and the evolution of the international market have affected the quality of medicines available to the world.

And finally, chapter four explains what measures must be taken to improve the situation for the most deprived countries and the essential role played by the World Health Organization (WHO) with its Prequalification Programme.

 

Jacques was a fervent supporter of this WHO Prequalification Programme.

He hoped that the responsibility of the Prequalification Programme –initially targeting the antiretrovirals, TB-medicines and the artemisinin-combined therapies–would be widened to include all the medicines on the WHO Model List of Essential Medicines. But he understood perfectly well that this development would be complicated and certainly not attainable in the short-term.

While waiting for this development, one solution for him consisted in improving access to objective and cross-checked information about manufacturers, particularly manufacturers of generics, and pooling resources and means to collect such information as much as possible (between NGOs and international organizations, between governments, etc.).

 

We hope that this document will represent an enriching reading and/or a valuable pedagogic tool for most of you.

 

Jean-Michel Caudron, Cécile Macé, Corinne Pouget, Raffaella Ravinetto, Brigitte Renchon, Jean Rigal, Benedetta Schiavetti et Daniel Vandenbergh