French Competition Authority issues unfavourable opinion on draft decrees regulating online sales of medicines
30 April 2016
On 26 April 2016, the French Competition Authority (FCA) issued an unfavourable opinion on the new draft decrees regulating the online sales of non-prescription medicines. The draft decrees follow the Council of State's March 2015 annulment of the 2013 Decree on good dispensing practices for the online sale of medicines. In contrast with the 2013 Decree, the drafts separately regulate:
- Good dispensing practices for the online sale of medicines.
- Technical regulations applicable to websites selling medicines.
The FCA, reiterating its support for a wider use of online sales, concludes that the envisaged good practices and technical regulations unduly discriminate in favour of brick-and-mortar pharmacies. Not only do the drafts contain restrictive provisions that the FCA had previously criticised in its opinions on the 2013 Decree (for example, quantitative limits on dispensing, required PDF formatting for package leaflets, storage in proximity of the pharmacy), but furthermore, they introduce additional constraints that are highly dissuasive for internet pharmacists, such as the implementation of a quality management system and far-reaching requirements in terms of pharmaceutical analysis.
In order to address these concerns, the FCA has issued a number of recommendations, for instance, issuing a good dispensing practices quality manual (foreseen by the 2013 Decree) as opposed to the much stricter quality management system proposed by the new Decrees and permitting the storage and handling of online orders in a close yet separate location from the pharmacy.
The French National Pharmacists Council shares the overall view of the FCA, and specifically supports its recommendation to issue good dispensing practices for brick-and-mortar pharmacies as well.