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Axis 1 - Introduction: « Knowing and understanding the medicines market from the Production source and Quality control point of view"

Speaker

Christophe PERRIN, pharmacist, consultant, experience in clinical trials, MEG supply chain management, quality management (Quality Assurance).

Summary

The pharmaceutical sector includes a number of actors, each playing a particular role and function.
In fact, there is often a distinction between the roles played in theory by pharmaceutical actors and reality on the ground.
For example:

  • The mandate of Drugs Regulatory Agencies is not carried out to the full by all agencies in countries with limited resources.
  • Even in the developed countries (Europe, North America...) the Drugs Regulatory Agencies do not carry out their mandates fully, especially regarding checks on products destined for export.
  • The donors often fix the rules of the game but do not have the technical resources or sufficient knowledge of the pharmaceutical market with respect to countries with limited resources.
  • The buyers often find that they are the sole guarantors of safety of MEG supply, even though they do not necessarily possess all the requisite skills. In addition, some international supply agencies are also subject to commercial constraints, which are not always compatible with the requirements of an optimal quality assurance policy.
  • The producers often offer multiple production standards, depending upon the final customer or destination.

We have in fact therefore a medicines market which is not fully regulated in which price is the moving factor and where ethical standards are completely absent or count for little.
Some measures for attempting to control the market in certain molecules (e.g., WHO/PG and WHO technical support) and to make it secure have been taken.  These measures however will only have a real effect if all the actors in the MEG supply chain act in accordance with their duties.