On 17 June 2020 the Cergy-Pontoise Lower Administrative Court ordered the suspension of the marketing authorisation for Baclocur (a Baclofene-based drug) on request of the Collectif Baclohelp patient association (for further details please see "Suspension of decision granting Baclocur market authorisation when decision is based on compromise rather than scientific knowledge").
The request was motivated by the fact that the National Agency for Medicines and Health Products Safety's (ANSM's) decision granting the marketing authorisation for alcoholism was limited to 80mg per day while some patients were originally treated with higher doses (lower doses being, in some cases, deemed inefficient).(1)
The judge considered that the request's urgency had been demonstrated by the fact that:
- patients could face difficulties in being prescribed and delivered doses of more than 80mg per day; and
- there was a serious doubt regarding the ANSM's decision in light of the content of opinions handed down by two scientific committee that the ANSM had appointed.
The ANSM and the marketing authorisation holder decided to appeal the 17 June 2020 ruling before the French Administrative Supreme Court.(2)
In a 25 November 2020 ruling,(3) contrary to the Cergy-Pontoise Lower Administrative Court, the French Administrative Supreme Court found that the conditions necessary for the suspension of an administrative decision (urgency and serious doubt as to the decision's legality) had not been met.(4)
On the question of urgency, the court considered that the Cergy-Pontoise Lower Administrative Court had committed an error of law in finding that the marketing authorisation prevented patients from being prescribed Baclofene at a higher dosage than 80mg per day.
It stated that pursuant to Article L 5121-12-1 of the Public Health Code, Baclocur could still be prescribed outside the scope of the marketing authorisation when the prescriber considered such prescription to be essential, in light of the established scientific knowledge, to improve or stabilise a patient's clinical condition. As a result, ending the temporary recommendation for use did not modify the conditions under which Baclofene could be prescribed and be reimbursed by the National Health Insurance Fund.
Concerning the second condition, Collectif Baclohelp claimed that the marketing authorisation infringed:
- the principle of equality between Baclofene and competing drugs;
- the principle of equality between patients;
- the principle of equal access to medical care; and
- the principle of res judicata in light of a 23 May 2018 French Administrative Supreme Court ruling.(5)
However, with further explanation, the court ruled that none of the arguments that the Collectif Baclohelp had raised were sufficient to demonstrate that there was a serious doubt regarding the legality of the ANSM's decision.
As Baclocur's suspension has been lifted, it can once again be commercialised. However, as the 25 November 2020 ruling concerns an interim measure, it remains to be seen whether decisions on the merits will lead to the same result, especially in light of the discussions concerning the state of scientific knowledge, notably within the committees which the ANSM had appointed on the subject.
Endnotes
(1) French National Agency for Medicine and Health Products Safety.
(2) The marketing authorisation holder also seized the Cergy-Pontoise Lower Administrative Court of a summary proceeding requesting the end of the suspension granted by the same court on 17 June 2020. This request was denied by an order dated 30 July 2020.
(3) French Administrative Supreme Court, 25 November 2020, 441409.
(4) Article L 521-1 f of the French Administrative Justice Code.
(5) The court had rejected a request to annul the ANSM's decision to modify the Baclofene recommendation for use limiting prescription to 80mg per day and notably stated that prescribers could still prescribe a higher dosage under certain conditions.
