WRITTEN QUESTION E-0051/03

by Struan Stevenson (PPE-DE) to the Commission

(22 January 2003)

Subject: Prescribed drug abuse

In moving to stop over-the-counter sales of certain food supplements and herbal products, what research has the Commission conducted to prove any detrimental effect from such products, and are there copies of the information on which the decision was made, available for examination?

What funding has the Commission made available to biomedical research and development in human medicine within Europe?

What funding has the Commission made available for research into the long-term effects of prescribed psychiatric drugs on patients in medical services in Europe?

What is the diagnosed rate of the following conditions within the European Union: autistic spectrum disease, attention deficit disorder, attention deficit hyperactivity disorder, schizophrenia, dyslexia, dyspraxia, Down's syndrome?

What auditing system is in place to ensure that information supplied by pharmaceutical companies when registering new drugs is the full information and that adverse trial information is not withheld from patients and the licensing authorities?

Answer given by Mr Byrne on behalf of the Commission

(21 March 2003)

In June 2002 the Parliament and the Council adopted Directive 2002/46/EC of 10 June 2002, on food supplements(1). The Directive covers products marketed as foods and does not apply to OTC (over-the-counter) products. In any case the aim of the Directive is not to stop the sale of any food supplements but to ensure that when marketed, such products are safe and bear adequate labelling. This will allow consumers to make informed choices, suitable for their individual needs, from a wide range of safe products.

The Commission's proposal for a Directive on traditional herbal medicinal products(2) intends to ensure patients' access to traditionally used herbal medicines for which the information on traditional use allows the assumption of their safety and efficacy. It provides for a simplified registration of such products, which do not require medical prescription. So the range of available herbal medicines fulfilling the necessary criteria of quality, safety and efficacy is broadened and not limited.

There is a lot of information available on risks related to herbal medicinal products. Apart from scientific literature, which regularly deals with this issue, some information is also available on the medicines agencies web sites(3).

Under the 5th Framework Programme (1998-2002), a total of EUR 1,27 billion was committed to supporting health-related research activities.

The breakdown by programme area was as follows:

- Key action 1: Food, Nutrition and Health 110 million;

- Key action 2: Control of Infectious Diseases 267,8 million;

- Key action 3: Cell Factory health part 194,4 million;

- Key action 6: The Ageing Population and Disabilities 169,3 million;

- Generic Activities 449,8 million;

- Support for Research Infrastructures 82,2 million.

Under the 6th Framework Programme most of the health-related research is concentrated under the Priority Thematic Area Life Sciences, Genomics and Biotechnology for Health where EUR 2,255 billion is available over the period 2003 to 2006. Some funding probably around 40 million is also available for policy-related research in the health and linked areas. It is not possible at this stage to identify the likely biomedical research component since the programme is only just starting.

The public health programmes have not made available funding for research into the areas mentioned.

The Commission does not collect data concerning the prevalence of the conditions mentioned. The Community Public Health Programme 2003-2008 is intended to set in place a health monitoring system which will collect information on a series of health data.

Directive 2001/83/EC(4) lays down the obligation that the applicant provides in the application for a marketing authorisation for a medicinal product all information, which is relevant to the evaluation of the product, whether favourable or unfavourable. In particular, all relevant details shall be given of any incomplete or abandoned pharmacotoxicological or clinical test or trial. Where an applicant submits incomplete or falsified applications, the application has to be rejected. In addition, Member States have to establish the necessary mechanisms to ensure that these obligations are respected in practice.

(1) OJ L 183, 12.7.2002.

(2) OJ C 126 E, 28.5.2002.

(3) (see e.g. http://www.emea.eu.int/ for the European Medicines Evaluation Agency,http://heads.medagencies.org/ for links to the national agencies and http://www.fda.gov/ for the USA agency).

(4) Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 28.11.2001.