The Observatory of transparency in drug policies alerted Tuesday to shortages. The government wants to be reassuring.
“It is unacceptable for such an important drug to be unavailable for even a week.” The Observatory of Transparency in Medicines Policies (OTMeds) alerted, in his latest report Tuesday, April 18, on shortages of misoprostol, an abortion pill used for a large majority of voluntary terminations of pregnancy (IVG) in France. However, the Minister of Health, François Braun, denied this observation, Wednesday on RMC. A situation that raises several questions to which franceinfo answers.
1 What pills are we talking about?
Medical abortion consists of taking two drugs in succession: mifepristone then, 36 to 48 hours later, misoprostol, necessary for the expulsion of the embryo. In France, two misoprostol-based specialties are authorized in medical abortions. Gymiso and MisoOne are marketed by the Nordic Pharma laboratory, whose capital belongs mainly to Americans.
2 Which regions are affected?
According to OTMeds, which had already sounded the alarm several weeks ago, several areas have been affected by shortages. Misoprostol has thus been or still is difficult, if not impossible to find, in Lille at the beginning of Aprilin Versailles (Yvelines), in Issy-les-Moulineaux (Hauts-de-Seine), he reported.
“We recently received new testimonials indicating that it is not available either in Occitania or in certain Parisian pharmacies”Pauline Londeix, co-founder of this observatory, said on Tuesday.
3 What are these difficulties due to?
The OTMeds gives several possible explanations. He first notes that “misoprostol is under patent, there are no generics or equivalent products”. Its production is very concentrated (in number of holders and production sites), which makes “the vulnerable supply chain”.
“A limited number of factories and operators expose the manufacturing and marketing of products even more to threats and pressure from anti-abortion groups”, adds the OTMeds. However, at the beginning of April, a federal judge in Texas withdrew the marketing authorization for mifepristone.
“If you have diverse sites, calls for boycotts or threats are possible, but you have more possibilities to resist”confirm with Release Jérôme Martin, co-founder of OTMeds. The latter evokes the risk of seeing “American capital” allocated to medicine “possibly lower”.
In a press releasethe High Council for Equality (HCE) also expressed concern on Tuesday that “the production of the two drugs used for medical abortions” either “in the hands of a single producer, the Nordic Pharma group, a substantial part of whose capital is American”.
The National Agency for the Safety of Medicines and Health Products (ANSM) confirmed on Tuesday that it had been informed at the end of 2022 by Nordic Pharma of manufacturing delays for Gymiso. “This delay led to a disruption in the coverage of Gymiso needs, estimated at 20%, which led to a postponement of use to MisoOne, to which was added a delay in the supply of raw materials for the latter. “she detailed.
4 Why this worrying situation?
In France, two thirds of abortions are medical, according to figures from the Ministry of Health (PDF). “Access to abortion risks being severely limited, seriously undermining women’s sexual and reproductive rights”, deplores the HCE. Beyond the shortage, the OTMeds is concerned that the search for a solution “diverts the time of caregivers and plunges into anguish those who need quick access”.
Asked about the subject, the Minister of Health however wanted to be reassuring on Wednesday, on RMC. Access to this drug is “possible everywhere”, assured François Braun. Emphasizing “a tension” more “no shortage”he specified that if it was not found in pharmacies, the centers which practice abortions have always had it available. “There are now three months of stock.”
“A shortage does not necessarily mean a total and definitive absence of a health product throughout the territory”replied l’OTMeds, “but can be: either its quota, or a de facto unavailability on a given territory”. “It is unacceptable for such an important drug to be unavailable for even a week. That’s what happened and still happens with this pill.”hammers the observatory.
5 What is being done to remedy this?
In this context of “forte tension”, the drug agency points out have set up a “contingentement” to better manage available stocks, with a ban on the sale and export of medicines by wholesalers abroad. This measure “must be applied and respected until normal availability of the medicinal product, allowing a continuous and appropriate supply of the national market“, states on its website the organization.
“These tensions are being resolved with the distribution of tens of thousands of boxes of Gymiso last week and MisoOne starting this week”, now assures the ANSM. In parallel, “in order to consolidate” supplies, “an import of the Italian MisoOne specialty is also in progress”.
Concerns about supply provoked strong reactions. Political figures such as Sandrine Rousseau (EELV) or Laurence Rossignol (PS) have asked the government to act urgently to “guarantee this right of women”. Last week, Family Planning was also moved by the situation, calling for measures “so that access to abortion is not restricted”.
In turn, the High Council for Equality asked the French government to “relocate” the manufacture of the abortion pill. He wants France “rapidly regains its sovereignty in the production of abortion pills”.
