12 November 2018 - Authored by: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).
This post was originally co-authored by Patricia Carmona Botana.