French medicines agency announces action against "short-liner" wholesale distributors
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On 6 May 2019, the French National Agency of Medicine and Health Products Safety (ANSM), facing the challenges of stock shortages and the risks of introducing falsified medicines into circulation, published an announcement on action against "short-liner" wholesale distributors. Wholesale distributors, holding authorisations granted by the ANSM, carry out the purchase, sale, storage and distribution of medicinal products in France. The Public Health Code imposes public service obligations on those operators, which "short-liners" are not respecting, an omission they were condemned for in 2018.
"Short-liners" develop their businesses without complying with some or all of their obligations, in particular to have an adequate stock of medicines, which requires adequate storage capacities and the ability to deliver to pharmacies within 24 hours. These obligations entail a significant cost in the operation of wholesale distributors but are essential for the appropriate and continuous supply to patients in France.
The ANSM stresses the fact that the issue concerns essential supplies and goes beyond the question of equity between the players in this market since it can:
- Facilitate the introduction of falsified medicines into the legal distribution chain.
- Complicate traceability.
- Lead to a drying-up of the market because some short-liners buy medicines at lower cost in France and sell them in other European countries.
In addition to the administrative consequences and financial sanctions (five injunctions and fines totalling EUR500,000 were issued in 2018), the ANSM, in conjunction with the Regional Health Agency, will use a number of actions such as an increased vigilance on the quality and completeness of the application submitted to obtain a wholesale distributor licence and the systematisation of an on-site inspection during the year following the actual opening, in the course of which the implementation of the commitments made at the time of the application will be verified.
This article was co-authored by Alexis Vaujany.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, May 2019 Issue (Thomson Reuters).