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Axis 3 - « Regulation of the Pharmaceutical Sector »


Introduction: « Regulation of the Pharmaceutical Sector »


Jean-Denis MALLET, inspecting pharmacist, GMP auditor, Director of Regulatory Compliance Europe at SNC Lavalin Pharma, formerly Head of Department of Pharmaceutical Inspection at AFSSAPS; formerly QA Manager at CICR.


Medicines are a product like others.  It is our profession to insist upon this.
Regulation is essentially based upon manufacturing authorisation (producers) and on marketing authorisation (for the whole supply chain, upstream from production).
Counterfeit medicines in Europe arrive largely via parallel markets (highly permeable to counterfeiting)  There is a need for political will to regulate.
Policy on medicines rests on 4 fundamental bases:

  • Social Politic
  • Scientific Politic
  • Financial Politic
  • Industrial Politic

A prerequisite: good governance...


Magali BABALEY, pharmacist, technical specialist at WHO (Geneva), Procurement Management Unit, Team for Access to Medicines and Rational Utilisation (MAR), Department of Essential Medicines and Pharmaceutical Policies (EMP).
Presentation given on behalf of Guitelle BAGHDADI, head of the Good Governance Axis in the Department for Essential Medicines and Pharmaceutical Policies (EMP), WHO Geneva.

General scheme of the Presentation

Presentation of the WHO programme on good governance for medicines.

The majority of modern societies, whatever their level of wealth, currently find themselves confronted with corruption.  The impact of corruption on the pharmaceutical sector is that much greater in that, contrary to ethics, it has a direct effect on public health.  At the pharmaceutical level, the fight against corruption is all the more difficult in that it can occur at all levels of the medicines supply chain, from production to promotion and the placing of the medicine on the market.
In this context the WHO decided in 2004 to launch its the global Good Governance for Medicines Program.  Begun initially in 4 countries, the program was widely developed so that currently it has been implanted in 26 countries.
The main goal of the program is to limit corruption in the pharmaceutical sector by applying transparent administrative procedures and by supporting ethical practices.

Essential questions on which the presentation is based
  • What can the usefulness of such a program be?
  • How to participate in its operation?