French Senate issues recommendations to tackle pharmaceutical supply disruptions

Eveline Van Keymeulen

In October 2018, the French Senate published a report on supply disruptions of medicinal products and vaccines. The report provides recommendations to combat the causes of such disruptions, which have increased by 30% since 2016, and to secure sufficient stock. In particular, the report proposes to:

  • Set up tax exemptions for companies investing in French manufacturing sites for essential medicines or active substances.
  • Introduce a public programme for the manufacture and distribution of discontinued or disrupted essential medicines.
  • Publish the history of supply disruption of pharmaceutical companies on the National Agency for Medicines and Health Products Safety (ANSM) website, as well as companies’ plans on managing supply disruptions.
  • Impose fines on companies that have not notified or implemented their management plans on supply disruptions or that do not have adequate stock of essential medicines.
  • Entrust the ANSM with assessing conditions for the distribution of medicines between wholesalers and distributors.
  • Set up a national platform that provides information on the supply disruption status of products. The platform would be fed with data provided by the ANSM, companies, distributors, pharmacies and other stakeholders.
  • Create a national unit for managing, preventing and solving supply disruptions, placed at the Prime Minister’s cabinet.
  • Allow pharmacists to suggest substitutes for specialty products that are in supply disruption.
  • Review the mechanism of hospital tenders and fix a maximum price threshold in procurement procedures.
  • Activate the pooled procurement of essential vaccines and certain medicinal products by member states.
  • Introduce a specific status for certain old medicines (inspired by the orphan drugs framework) and include incentives to maintain their commercialisation in the EU.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, October 2018 Issue (Thomson Reuters).

 

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