Amendment to Social Security Financing Bill seeks to provide clear legal basis for French medical cannabis pilot programme
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On 10 October 2019, French Deputy Olivier Veran introduced an amendment to the 2020 Social Security Financing Bill, in order to provide a clear legal basis for the medical cannabis pilot programme that was endorsed by the French National Agency for Medicines and Health Products Safety (ANSM) in July. The amendment is strictly speaking not necessary for the implementation of such programme but allegedly seeks to ensure that the pilot programme is adequately financed and can be launched as foreseen.
By way of reminder, in July the ANSM endorsed a medical cannabis pilot programme (see our earlier blog post: "Big day for legal cannabis in France: ANSM endorses medical cannabis pilot and launch of cannabis Parliamentary Mission") per the recommendations of the French specialised scientific committee (CSST) on cannabis which were published on 28 June (see our earlier blog post: “French cannabis committee unveils recommendations for medical cannabis pilot programme"). The first phase of the pilot programme has started in July and consists of the set-up of the programme by the end of the year.
The amendment in essence confirms the main principles suggested by the CSST and endorsed by the ANSM, but provides a legal basis therefore. The draft Article currently reads as follows (free translation):
"I. – On an experimental basis, for a period of two years, the State may authorise the medical use of cannabis in the form of products meeting pharmaceutical standards, in certain indications or clinical situations that are resistant to indicated and accessible treatments.
II. – The conditions for implementing the experiment are defined by regulation. They specify, in particular, the conditions of care, the number of patients concerned, the methods of importation and supply, prescription and dispensing by hospital and dispensary pharmacies, as well as the conditions for information and follow-up of patients and training of health care professionals.
III. – Within six months before the end of the experiment, the Government sends a report to the Parliament on the medical use of cannabis for patients, their follow-up, the organisation of the prescription and dispensing circuit, as well as the expenses incurred. This report examines, in particular, the relevance of expanding the use of medical cannabis at the end of the experiment and, where appropriate, how it is covered by the health insurance."
According to the Explanatory Memorandum, the amendment provides a legislative framework for the pilot programme (i.e., the experiment), which will make it possible to respond to the immediate need of patients who are not helped by available treatments. The Memorandum repeats the objectives of the pilot programme, i.e., it will assess the relevance of the prescribing and dispensing system in real situations, the adherence of health care professionals and patients to these conditions, and will provide the first French benefit-risk data in the main indications used. It further confirms that the pilot programme could involve about 3,000 patients and that the experimental framework will also make it possible to finance the costs associated with the medical use of cannabis, including the cost of purchasing the products, the creation of a patient monitoring register and its scientific use - the details of which will be defined by the ANSM - as well as that of the training of health care professionals and pharmacists who may respectively prescribe or deliver cannabis.
The amendment, which was proposed last week, will first be discussed in a parliamentary commission and subsequently be debated during a public session next week before possibly being adopted.
If you are interested in a broader overview of EU and national developments with respect to cannabis regulations, please have a look at our latest Cannabis Legal & Regulatory Updates here.
This article was co-authored by Alexis Vaujany.