Regulatory Requirements

New Draft Law in France: MAHs to pay up to 3 million € in Penalties for Drug shortages

The Adents Team Written by The Adents Team
06-May-2019

The French Senate has recently proposed a law to fight against pharmaceutical and vaccine shortages in France. This is in response to the growing issue of pharmacies and hospitals running out of stock of critical medications. This situation received a tremendous amount of media coverage which lead French Authorities to tackle this issue.

The parliamentary working group has written a series of propositions made up of 13 articles which range from creating Strategic working group, setting up shared traceability platform to giving huge financial penalties to the pharma companies who will not comply with the requirements.

Let’s highlight the most interesting articles of this Senate proposed law:

  • Article #2 aims to make public the shortage of management plans elaborated by the Manufacturers for pharmaceuticals that provide high therapeutic value
  • Article #3 recommends to build a global traceability platform gathering data from MAH’s, Wholesalers / Distributors, Hospitals and Pharmacists to bring more visibility to the pharmaceutical supply chain to identify the bottlenecks, and to know more precisely when the shortage will end and to help improve production forecasts
  • Articles #4 and 5 commission the ANSM (Agence nationale de sécurité du médicament et des produits de santé) to give financial penalties to the MAH’s who do not adhere to the laws to fight against drug shortages or prevent Wholesalers and Distributors from complying with their public service obligations.
    These penalties can reach 150 000€ for a person and 30% of the annual sales revenue with a maximum of 3 million € for a company which will fail with complying towards its obligation to fight against shortages.
  • Article #6 opens up the possibility for the MAH to discuss price level of its medicines with the ANSM if recurring drug shortages are strongly linked with high costs of production (and a lack of profitability for the manufacturers)
  • Article #8 authorizes the reselling of products between pharmacies for some exceptional cases
  • Article #10 provides tax incentives to the MAH’s opening new facilities within the French territory to produce medicines considered as strategic.

The fight against pharmaceutical shortages in hospitals and pharmacies has become a central issue for the French Health Authorities and now the Senate.

Adents is strongly aligned with the vision of setting up a shared IT platform providing transparency and visibility at the different steps of the pharmaceutical supply chain to market stakeholders. 

End-to-end traceability from manufacturers to the point of dispensation will be a real asset to reduce the risks of drug shortages and provide better quality healthcare service to patients.

The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.

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