On June 13, the French Government released a list of 450 medicines considered “essential” to meet patient priority needs and which require specific measures to ensure their availability. Medicines were selected according to shortage criticality combining frequency of use and severity in case of shortage. The current list is available here but is not set in stone. It is intended to be enriched and updated according to changes in the French population’s needs and the actual risks of shortages.
Specific work will be undertaken to better guarantee the availability of these “essential” medicines: reinforced monitoring of supply capacities, analysis of prescription practices and purchasing trends, corrective action to ensure that needs are met as well as relocation operations for certain medicines.
A core-list of 50 essential medicines whose dependency to non-EU imports is considered undeniable has also been drawn up. The French President announced that the production of half of these medicines will be relocated or significantly increased within the next five years and that 8 new relocation projects will be funded by the French State, representing a total investment of over 160 million euros as part of the France 2030 Plan
The “essential” medicines list was eagerly awaited and regarded as an important step in the battle to combat medicine disruptions and shortages. However, there are already strong criticisms from certain experts. The content of the list, drawn up following consultation with medical learned societies, is considered inaccurate with some redundancies: some of the truly “essential” medicines are not listed whereas some of the ones listed are in fact never prescribed. This list is also seen by some actors as only an additional list to the existing ones, such as the list of the so-called medicines of major therapeutic interest which is already subject to specific regulatory requirements such as minimum-security stocks. Furthermore, in a region where 40% of the medicines are manufactured outside of the EU, combatting medicine shortage requires concertation at EU level more than ever. In this respect, the Government has confirmed that this list will be joint to the one to be established at EU level.
Emmanuel Macron also said that the inclusion of a medicine on this list will lead to the setup of a specific surveillance system of its availability and will require its manufacturer to comply with a number of specific regulatory obligations, any breach of which may be sanctioned by the French Agency for the Safety of Medicines. These obligations are as yet unknown, but the government has already indicated that manufacturers will be required to hold a minimum of 4 months’ stock. If security stocks’ requirements help combatting medicine shortages, here again coordination at EU level is crucial as local security stocks may be counterproductive and jeopardise the fight against shortages across the region.
The French President also mentioned the need to take the French relocation ambition to the EU level referring specifically to the EU Pharma Package to help strengthening our common resilience throughout the region. Interestingly enough, he declared that Europeans must remain consistent when it comes to intellectual property making sure not to threaten it as it would weaken EU attractiveness. Is that also an allusion to the many criticisms of the proposed reduction of the regulatory data protection?
Finally, the French President also insisted on the fact that France is prepared to pay the “right price for certain medicines when this is the imperative condition for ensuring French production”. This is probably referring to the inter-ministerial task force launched last January by the Prime Minister to analyse and make proposals on improving the mechanisms for regulating and financing healthcare products. The task force’s report was expected before summer, but to date nothing has been published yet… A source close to the French Government has indicated that the task force has been granted an extension, and that the report will have to be submitted by early July for it to be taken into account in the Social Security Financing Bill for 2024. To be continued…!