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France Presents Plan To Tackle Medicine Shortages and Adds Sense of Urgency to European Discussions

  • 09/07/2019
  • Articles

Agnès Buzyn, the French Minister for Solidarity and Health, presented on 8 July 2019 a four-year plan to tackle medicine shortages in France (see, annex). The plan is the latest move in what is gradually becoming a wave of new rules and policy initiatives across Europe to fight the lack of availability of specific medicines. The plan reflects a four-pronged approach that includes the following measures:

 

 

  1. Increased transparency and enhanced channels of communication between all stakeholders, including individual patients and patient organisations 
  1. New strategies for preventing, mitigating and managing medicine shortages 
  • Power for community pharmacists, subject to conditions, to substitute out-of-stock medicines of major therapeutical importance (“médicaments d’intérêt thérapeutique majeur “ – “MITM”);
  • Focus on antibiotics that run an out-of-stock risk;
  • Further development of management plans for out-of-stock medicines (“plans de gestion des pénuries” – “PGP”) and creation of enhanced management plans for medicines that have already faced supply problems (“PGP renforcé”);
  • Specific measures targeting hospitals and wholesaler-distributors.
  1. Reinforced national coordination and increased European cooperation 
  • Increased powers for regulator (“Agence nationale de sécurité du médicament et des produits de santé – “ANSM”) to tackle supply quota systems (“contingentements”) and to import substitute medicines, including competing products;
  • Powers for specific public institutions to stock and distribute MITMs;
  • Pursuit of European rules, including definitions of key concepts such as medicine shortage and medicines of major therapeutical importance;
  • Advocacy in Europe of European or French production of key pharmaceutical ingredients and medicines;
  • Increased focus on joint procurement of essential vaccines;
  • Exchange of information between Member States on medicines hit by shortages.
  1. Modified institutional architecture 
  • The new plan will be implemented and steered by a “Comité de pilotage” (“COPIL”) and supported by a task force composed of representatives of the various competent ministries. ANSM will also be given a more prominent role.     

The French plan is certain to be met with close attention in France and abroad as it plays into the often expressed and at times overstated fears of supply disruption of medicines. Following repeated similar statements by other policy makers and interested parties (see e.g., Van Bael & Bellis Life Sciences Newsflash of 28 June 2019), the plan is certain to catapult this issue on the list of top health priorities of the incoming European Commission.

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