WRITTEN QUESTION E-0491/01

by Daniel Hannan (PPE-DE) to the Commission

(22 February 2001)

Subject: Drug ban

The European Commission is supporting moves by the CPMP to ban two appetite suppressants, Diethylpropian and Phentermine.

These drugs are cheaper than recently-developed alternatives and therefore easier for lower-income families to afford. They have been successfully sold in the United States for decades without their safety having been challenged.

Why, therefore, has the Commission accepted an unpublished report from one doctor as sufficient grounds to support a ban? What level of peer review of this research has followed? What proof of side effects does the Commission hold as grounds for supporting a ban?

What is the Commission's estimate of the cost of obesity in the European Community, and does it believe that banning these drugs on apparently unsubstantiated research justifies these costs?

Answer given by Mr Liikanen on behalf of the Commission

(14 May 2001)

The Commission adopted on 9 March 2000 four decisions(1) obliging Member States to withdraw all national marketing authorisations for medicinal products containing anorectic substances. These decisions cover, among others, the substances Amfepramone and Phentermine, mentioned by the Honourable Member.

The Commission adopted these decisions on the basis of the procedure set up by chapter III of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(2). The decisions were adopted following the delivery of a scientific evaluation of the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA), in 1999, which recommended based on the latest scientific information available the withdrawal of the national marketing authorisations of these groups of medicinal products, because of their negative risk/benefit ratio.

The Commission proposed to follow the scientific opinion of the EMEA and prepared the draft decisions of withdrawal. These drafts were submitted to the Standing Committee on Medicinal Products for Human Use. The Member States gave a favourable opinion on these draft decisions.

Therefore, the Commission decisions obliging Member States to withdraw the national authorisation for these medicinal products were adopted on the basis of the need to protect the public health. Even though the Commission is concerned about obesity as a public health issue, it considers that the withdrawal of these medicinal products was only due to be substantiated on the basis of the scientific opinion given by the CPMP and no consideration or estimation of the cost of obesity was used as a basis for these decisions.

The Commission is currently addressing the issue of obesity by funding projects on a healthy diet and physical activity. This work has been undertaken under the current Health Promotion programme, and will be continued under the new Public Health programme. A Communication from the Commission to the Parliament and to the Council on an action plan on nutrition policy is currently in the pipeline, the main aim of which is to make the healthy dietary choice available, affordable and attractive for the people in the Community. This document is foreseen to be adopted by the Commission this summer.

The Commission is also preparing a Proposal for Council Recommendations on European dietary guidelines, where obesity will be addressed. This proposal is expected to be available in the third trimester of 2001.

(1) C(2000)452; C(2000)453; C(2000)608; C(2000)573.

(2) OJ L 147, 9.6.1975.