Insights & news

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.


Key contacts

Related practice areas

Related insights

Sign up for updates
    • 04/06/2020
    • Articles

    Europe - Four-Country Inclusive Vaccine Alliance In Quest for Covid-19 Vaccine

    In a letter to Parliament and a press release (see, attachments), the Dutch Minister for Public Health, Wellbeing and Sports, Hugo de Jonge, revealed on 3 June 2020 an initiative of Italy, France, Germany and The Netherlands to work together to secure a Covid-19 vaccine for “the European Union and other countries”.   According to the Minister, the “Inclusive Vaccine Alliance” (IVA) is in talks with several pharmaceutical companies regarding promising ventures and in the process hopes to establish a European manufacturing base for the vaccine. The IVA’s ultimate goal is to create a medicine that is “accessible, available and affordable”.   Other countries will be given the opportunity to join the IVA which is also in contact with the European Commission.

    Read more
    • 03/06/2020
    • Articles

    European Commission Publishes Roadmap Towards Pharmaceutical Strategy for Europe

    The European Commission (the Commission) published on 2 June 2020 its roadmap towards a Pharmaceutical Strategy for Europe (PSE) which it plans to publish in the fourth quarter of 2020 (see, attachment). The roadmap defines the steps which the Commission will take prior to adopting the PSE and the data which it will assemble to inform its PSE. While the Commission will consult a range of stakeholders, it has already announced a public consultation which will run until 7 July 2020.

    Read more
    • 02/06/2020
    • Articles

    Italian Competition Authority Approves Scheme for Distribution of Surgical Masks

    On 1 June 2020, the Italian competition authority (“L’Autorità Garante della Concorrenza e del Mercato”) authorised a scheme that would allow disposable surgical masks to be distributed and sold in pharmacies and health product retail outlets (see, attached press release). It did so at the request of the two principal Italian associations of pharmaceutical wholesalers. Under the scheme, the wholesalers and associations of pharmacists and health product retailers acquire the masks in a joint procurement procedure. The masks are then allocated among the wholesalers at a uniform price per unit that was agreed upon with the suppliers. The scheme will last until 30 June 2020. The competition authority approved the scheme because it solves an urgent and wide-ranging health problem and is limited in time. It thus applied for the first time the principles of its guidance of 22 April 2020 regarding cooperation agreements designed to ensure the distribution of scarce essential goods and services, including health products and food. The competition authority’s approach is in line with the views expressed by the European Commission and competition authorities around Europe to address the problems resulting from the Covid-19 pandemic (see e.g., Van Bael & Bellis Life Sciences News Alert of 9 April 2020 and of 26 May 2020). Not coincidentally, the competition authority indicates that it obtained counsel from the European Commission.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *