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23 September 2020
Over the past two years, the French administrative courts have witnessed several proceedings concerning the use of Baclofen for alcohol-related disorders.
In 2008 this treatment, which is a myorelaxant originally intended for severe spasticity, chronic brain or spine-derived pain, was said to have a beneficial effect on alcoholism.
As there was no marketing authorisation for such indication, a temporary recommendation for use was first adopted by the National Agency for Medicines and Health Products Safety (ANSM) in 2014, allowing Baclofen's use at a maximum daily dosage of 300mg. In July 2017 the ANSM modified the temporary recommendation for use and notably limited daily dosage to 80mg because of the risks associated with high intakes revealed by a 2017 study by the French National Health Insurance Fund, the ANSM and the National Institute of Health and Medical Research.
As many patients had been prescribed a higher dosage, the French Administrative Supreme Court was seized with a request to annul the ANSM's 2017 decision.
On 23 May 2018 the court rejected the claim to annul the 2017 decision,(1) noting that the ANSM's director had not committed a "manifest error of assessment" of the situation by considering that, in light of the state of the scientific evidence and available information, it was impossible to define general conditions of use for doses above 80mg per day. The court also highlighted that practitioners could still prescribe a higher dosage outside the scope of the temporary recommendation for use, if in specific cases it provided more benefits than risks in light, notably, of the severity of the consequence of the patient's alcoholism and the failure of other available treatments.(2)
Ethypharm submitted an application to the ANSM to obtain marketing authorisation for Baclocur as an indication for alcoholism. The ANSM established two scientific committees (the Temporary Specialised Scientific Committee (CSST) and the ad hoc joint commission, which included patient associations), both of which handed down unfavourable opinions on the marketing authorisation request.
Nevertheless, on 22 October 2018 the ANSM granted a marketing authorisation to Baclocur limited for 80mg per day for certain forms and ended the temporary recommendation for use when Baclocur would be put on the market for said indication.
These decisions led to several proceedings before the Administrative Supreme Court, notably by patient associations, on various grounds and with different requests, including:
All of these proceedings were triggered by the fact that the claimants challenged the efficiency of this drug with a dose lower than 80mg per day and aimed to ensure the appropriate formulation, prescription and reimbursement of Baclofen for higher doses.
All of these claims were rejected.(3)
However, in a 8 July 2019 ruling,(4) the Administrative Supreme Court considered that it lacked jurisdiction concerning the specific request to cancel the marketing authorisation granted to Baclocur and referred this question to the Cergy-Pontoise Lower Administrative Court.
Several claimants, including a patient association (Collectif Baclohelp), initiated an interim measure proceeding, notably, requesting the suspension of the ANSM decisions of 22 October 2018 granting Baclocur a marketing authorisation.
On 17 June 2020,(5) two days after Baclocur had been put on the market, the court ordered the suspension of the marketing authorisation.
The interim judge considered that the request's urgency was demonstrated by the fact that patients could face difficulties in being prescribed and delivered doses superior to 80mg per day.
The court also ruled that that there was a serious doubt regarding the legality of the ANSM's decisions because of the unfavourable opinions handed down by the two committees appointed by the ANSM. The court noted that the ad hoc joint commission had considered that the quality of file presented by the market authorisation holder was "insufficient" as it contained contradictory medical studies and, therefore, the file was "not robust enough".
The Cergy-Pontoise Lower Administrative Court also considered the fact that the National Authority for Health assessed that the drug's medical benefit was low in the indication and dosage of the marketing authorisation (80mg per day).
As a result, for the time being, the 2018 temporary recommendation for use is once again applicable and patients can still be prescribed Baclofen with a dosage of more than 80mg per day while awaiting for the ruling on the merit on the validity of the marketing authorisation. It remains to be seen whether the Cergy-Pontoise Lower Administrative Court will give the same weight to the fact that the ANSM has decided not to follow the scientific opinions of the committees that it appointed.
The Baclofen saga highlights the difficulty for a health authority to make decisions lacking a purely scientific basis which aim, at least partially, to satisfy third parties.
This paradoxical situation has led to the suspension of the ANSM decision – which aimed to find a compromise with patients' associations on drug availability while limiting the use of high dosages – but which resulted in the dissatisfaction of these associations.
For further information on this topic please contact Armand Aviges or Delphine Lapillonne at Altana by telephone (+33 0 1 79 97 93 00) or email (email@example.com or firstname.lastname@example.org). The Altana website can be accessed at www.altanalaw.com.
(2) Article L 5121-12-1 of the Public Health Code allows prescriptions in the absence of a temporary recommendation for use in the absence of therapeutic alternatives and where the prescriber considers that it is essential, in light of the established scientific knowledge, to use this medicinal product to improve or stabilise a patient's clinical condition.
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