eu-flag.jpg (3382 bytes) EUROPEAN COMMISSION
INDUSTRIAL AFFAIRS III: Consumer goods industries Pharmaceuticals and cosmetics
Brussels, 1/10/98
PD/EC D(98) data/pharmvig/medawar1

Ref:   Antidepressant drugs - new warning for inclusion in the SPC - your letter of 4th August 1998

Dear Mr Medawar,

I refer to your letter of 4th August 1998. I understand that you are concerned about the new warning about withdrawal reactions recommended for inclusion in the products SPC for the antidepressant fluoxetine. You are probably aware that this was adopted as a Commission decision on 9th June of this year. In your letter you ask about possible appeal mechanisms.

I am sending you a reprint of an article entitled "New EC procedures for authorisation of medicinal products" and would like to refer you to section on "Grounds for appeal" on page 28. In this article, I explain that, by virtue of the Treaty of Rome, except as described below, the Commission decision is not open to appeal, either by the marketing authorisation holder, the member states or a third party. Supervision of the acts of the Council and the Commission is governed by Article 173 of the treaty, which gives control to the Court of Justice. The only judicial remedies against the Commission decision in this instance would be those provided by the treaty: action for annulment, action against failure to act, and action for damages. However it is important to note that these actions may only be taken by the addressees of the decision and certain privileged petitioners. A private individual, natural or legal person may only take an action against a decision directed at another person if it concerns that person directly and individually. It is therefore unlikely that any, of these remedies are open to you.

However, the fact that there is no mechanism to appeal against the decision does not mean that the decision cannot be changed, for example, in the event of new pharmacovigilance data, new results from clinical studies etc. A referral to the CPMP to vary the marketing authorisation may be made by the Commission, a Member State, the applicant or the marketing authorisation holder either "in specific cases where the interests of the Community are involved" (Article 12 of Directive 75/319/EEC), or in other circumstances, by a Member State in accordance with Article 15a of the same Directive. However given that, in the case of fluoxetine, it is not so long since the issue was considered by the CPMP, it is difficult to see that this would be justified, unless there is substantial new information available, which was not considered by the CPMP on that previous occasion.

It is not clear from the correspondence between you and the EMEA, whether the CPMP was in a position to consider the concerns outlined in your paper before adopting its opinion in December 1997. I intend to clarify this. If the CPMP, on the basis of the scientific information provided, concludes that your concerns are justified, there are certainly mechanisms to amend the decision adopted.

Patrick Deboyser
c.c.: Professor R. Bass Head of Unit

Rue de la Loi 200, B-1049 Bruxelles, Belgium     Telephone: direct line (+32-2)296.15.29    Fax: 296 15.20 


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