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The legalization of medical cannabis in France: insurance and black market paradox
The legalization of medical cannabis in France implies that an upstream economic reflection on the entire sector is carried out, particularly on the price and the terms of reimbursement of the product. Failing this, patients may prefer to self-medicate and continue to purchase cannabis via the black market.
Self-medication linked to a lack of satisfactory health insurance coverage
A petition is circulating in Santa Clara County, California, challenging the fact that, in this Covid19 era, only patients with a prescription can obtain cannabis[1]. The sale of cannabis has been legal in California since 2016. The Adult Use of Marijuana Act[2] permits the possession, use, and cultivation of cannabis by persons over 21 years of age. The Medical and Adult Use of Cannabis Regulation and Safety Act[3] has made it possible to sell and distribute cannabis to adults in state-approved retailers.
However, since the entry into force of these laws, a significant number of patients have - according to the petition - stopped applying for the renewal of their prescriptions. Medical visits have their price and involve patients taking time off work to visit their doctor. By allowing recreational use of cannabis by adults, the law has made self-medication possible: 80% of the clients of the state-approved retailers would be patients without a prescription.
If Californian patients decide to stop using their doctors, it may be because they believe - rightly or wrongly - that they can manage their medication. But it is also - and for sure - because many of them are uninsured or underinsured.
In the US, about 12%[4] of the population has no health insurance. This part of the population tends to use medicine only when absolutely forced to do so, since they have to meet their medical costs themselves. However, having health coverage does not mean that health care costs are covered or properly covered in the United States: the specific condition the patient has may not be covered by his or her insurance; the deductible he or she has to pay before reaching the amount triggering coverage by his or her insurance may be too high for him or her; and finally, the proportion of the price of the drugs he or she has to pay for (which may be a fixed amount or a percentage) may dissuade him or her from buying them, even if they have been prescribed.
As a result, part of the American population will tend to resort to self-medication. In the case of medical cannabis, this phenomenon is exacerbated by the fact that equivalent products[5] are available over the counter for recreational use.
What can be deduced from this in the context of a reflection on the legalization of medical cannabis in France? Mainly, that any legalization of the medical use of cannabis must imperatively be accompanied by a broad coverage of the product by the French health insurance[6].
In France, the National Agency for Medicines and Health Products Safety (the ANSM, the French FDA) is planning[7] to set up an experiment on cannabis in real conditions. This is not a clinical trial[8]. It is an experiment aimed to test the implementation of the prescription and dispensing of medical cannabis as a "new public policy". The purpose of this experiment is not to evaluate the effectiveness of cannabis in the treatment of diseases. As explained by the ANSM, its experts considered that the scientific literature and the actual use of cannabis in some other countries showed that cannabis could be effective. The aim of the experimentation of cannabis for medical use will thus be to assess "the feasibility of the circuit for making cannabis available to patients, i.e., prescription by doctors, dispensing by pharmacists, the supply of products, patient monitoring, etc.".
Patients benefiting from the experiment will not have to pay anything during the experiment. Thereafter, coverage of patients will likely depend on the conditions for which cannabis may be prescribed. If these conditions are the same as those for which therapeutic cannabis will be experimented, patients suffering from these conditions will, in principle, be fully covered[9]. If these conditions also comprise other conditions than those for which it will be tested, patients whose costs are not fully covered by the French social security could be entitled to be prescribed cannabis. The question of the rate of reimbursement will then arise for these patients (and their health insurance).
However, the approach taken to consider the introduction of cannabis into the therapeutic arsenal is unprecedented and does not seem to follow the usual French process of setting the rate of drug reimbursement or seems for the time being to be challenging to reconcile with it.
An innovative process and many outstanding issues
As a general rule, a laboratory that wants to market a new drug in France applies for a marketing authorization (MA), which it can obtain after, among other things, conducting a clinical trial, i.e., testing the product to find out its effects, mechanism of action and side effects[10]. If the laboratory wishes to have its drug reimbursed, it then turns to the High Authority of Health (HAS), which evaluates the Rendered Medical Service (SMR) of the product to set the reimbursement rate[11]. When it is dispensed in pharmacies, the drug is reimbursed by the French social security according to the set rate (and the rest depends on the patient's health insurance, if he has one). In the case of hospitalization, the cost of medicines is included in the hospital flat-rate.
In the case of medical cannabis, it is not at all clear at the moment whether this "classic" procedure will be applicable. Indeed, how can the "collective" non-clinical experimentation procedure conducted by the ANSM be reconciled with the classic evaluations carried out on individual drug files?
Will medical cannabis and its different pharmaceutical forms ipso facto benefit from a marketing authorization if they comply with certain specifications decided by the ANSM, such as a medicinal plant or a magistral preparation? Or will they then have to undergo clinical studies, submit marketing authorization applications (and if so, what type?), even if this means that the new drug will not be introduced until several years from now? The answers to these questions depend on the legal status that will be chosen for medical cannabis.
There is little doubt that, if authorized in France, medical cannabis will be a drug in the legal and regulatory senses of the term. However, this status includes various categories, none of which seem to be appropriate for the product, and more specifically, for the different pharmaceutical forms under consideration for this medicine[12].
Therefore, the little information currently available on the (possible) future status of medical cannabis constitutes a major difficulty for the economic players in the sector. Without visibility, investment projects are done based on totally uncertain projections.
Competition with the black market
Canada legalized recreational cannabis in October 2018, with mixed results. After one year, 60-70% of cannabis purchases were still illegal[13]. Why was this? Because the price of legal cannabis is too high. The average price per gram of legal cannabis in 2019 was CAN$ 10.23, compared to CAN$ 5.59 on the black market.
In France, it is known that many patients currently obtain cannabis via the black market. Patient associations explained this at length during the hearings conducted by both the ANSM and the parliamentary mission on cannabis use.
Whether cannabis is medical or non-medical, the question of the price at which it can be sold, once legalized, depends on the value that the patient-consumer gives it. The price he is likely to pay (for the non-reimbursed portion in the case of therapeutic cannabis) for the product depends on the benefit he thinks he will derive from it, whether in terms of tranquility, guarantees, quality or any other specificity of the product. In the absence of an appropriate final cost for him, the patient-consumer will continue to obtain the product from illegal channels, as do consumers in the countries that legalized the product earlier.
This is also true at the other end of the value chain. The financial health of the sector and the quality of the products depends on the adequacy of the price that the various players in the cannabis industry will be able to obtain. If the financial burdens on producers or distributors are too high compared to the price they get from the sale of their products, the availability of the products may, of course, be compromised.
However, any investment must be anticipated. Here again, clear information is essential so that companies wishing to supply the French market can assess the adequacy of their investments with the expected return on the project. Thus, in parallel with the medical reflections on the safety of the dispensation of medical cannabis, some information should be given (or possibilities disclosed) so that the sector can prepare itself. If the governmental projects are at a standstill because of the Covid, the current period can also be an opportunity for all decision-makers to make progress on certain critical issues together with the actors of the (future) sector, and to prepare as much as possible for the post-confinement period.
[1] https://www.change.org/p/urgent-stop-santa-clara-county-from-rolling-back-prop-64-and-denying-safe-access-to-legal-cannabis-during-the-shutdown
[4] https://www.liberation.fr/planete/2018/02/04/les-etats-unis-une-superpuissance-au-systeme-de-sante-impuissant_1627429
[5] Or perceived as such
[6] The French experiment project to test medical cannabis in real-life situations carried out by the ANSM provides for cannabis to be prescribed by specially trained doctors only and to be dispensed by pharmacists who have also received training, so the question of self-medication would not arise outside the illegal circuit.
[7] Or was planning, before the Covic19 outbreak. Currently, the ANSM project is at a standstill, as is the parliamentary mission on cannabis use.
https://www.newsweed.fr/reformes-francaises-cannabis-arret/?mc_cid=2f76db13db&mc_eid=77842f806b
[8] https://www.ansm.sante.fr/Dossiers/Cannabis-a-usage-medical/Questions-reponses-sur-le-cannabis-a-usage-medical/(offset)/4
[9] because they suffer from a “long term affection”, which is fully covered by the French health insurance
[10] The purpose of clinical trials on medicinal products is to establish or verify certain pharmacokinetic (modalities of absorption, distribution, metabolism, etc. of the medicinal product), pharmacodynamic (e.g., mechanism of action of the medicinal product) and therapeutic (efficacy and tolerance) data for a new medicinal product or a new way of using a known treatment. https://www.ansm.sante.fr/afssaps/Activites/Essais-cliniques/Qu-est-ce-qu-un-essai-clinique/(offset)/4
[11] It then negotiates the manufacturer's sales price with the Economic Committee for Health Products (Comité Economique des Produits de Santé or CEPS) based on the Improvement of the Rendered Medical Service level (Amélioration du Service Médical Rendu or ASMR), also set by the HAS. In the event of disagreement between the MA holder and the CEPS, the CEPS may set this price unilaterally. The price for sale to the public corresponds to this manufacturer's price to which are added the wholesalers and pharmacies’ margins.
[12] This point will be addressed in a subsequent article.
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