What could change in the fight against medicine shortages in Europe?

By Charlotte Roffiaen, France Assos Santé

With the COVID-19 pandemic and the multiplication of antibiotic supply disruptions, the fight against medicine shortages has become one of the first priorities of the EU and its Member States. This is perfectly reflected in the “pharmaceutical package” presented by the European Commission on April 26th. In the draft regulation, almost 20 articles are devoted to managing shortages and strengthening the security of supply of pharmaceutical products to the EU, whereas the previous legislative framework contained only 2 very general articles on supply and notification obligations, without the very notion of a shortage being defined or taken into account.

Will this be enough to put an end to the explosion in the number of shortages observed in recent years? One can also wonder how these new rules, which will not be applicable for several years, will coexist with the legislative arsenal developed by the Member States to deal with this plague, especially when the national provisions are more protective of patients’ interests than the measures proposed by the European Commission.

The proposed regulation is undoubtedly a significant step forward compared to the current situation, and we can only congratulate DG SANTE for having adopted many of the proposals presented by EPHA and its member associations. Among the most significant measures are the following:

  • The early notification of market withdrawals (12 months) or shortages (6 months), which is applicable to all medicines commercialised within the EU.
  • The obligation to prepare a shortage prevention plan for all medicinal products placed on the market in the Member States.
  • The obligation to facilitate the transfer of a critical medicine to a third party when planning to withdraw the product from the market.
  • The adoption of a whole set of measures to consolidate the supply chain for critical medicines.
  • Strengthening the control and action capacities of the EMA and the European Commission to combat shortages.
  • The obligation for Member States to adopt effective and dissuasive sanctions to punish the infringements of the Regulation.

Nevertheless, the Commission’s proposal has certain limits, which France Assos Santé and its member associations will seek to overcome during the discussion before the European Parliament and the Council of the EU.

  • Shortages lasting for less than 2 weeks do not have to be notified, even though the absence of notification does not allow the actual duration of the shortage to be checked.
  • The obligation to publish shortages by the national and European medicine agencies is too limited; all medicine shortages should be made public as soon as they are notified.
  • It is impossible to monitor the effectiveness and the appropriateness of shortage prevention plans without a proactive transmission to the competent authorities and the possibility of access to these plans open to patient associations and healthcare professionals.
  • Finally, the regulation does not provide for any real obligation to constitute safety stocks of medicine. The possibility for the Commission to impose, via ad hoc decisions, contingency stock requirements of active pharmaceutical ingredients or finished products for a very limited list of medicines considered as critical at EU level is not sufficient.

Disclaimer: the opinions – including possible policy recommendations – expressed in the article are those of the author and do not necessarily represent the views or opinions of EPHA. The mere appearance of the articles on the EPHA website does not mean an endorsement by EPHA. 

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