WRITTEN QUESTION No. 3435/97 by Cristiana MUSCARDINI to the Commission. Drugs to treat Aids
Date: 1997-10-31
Institutions: European Parliament, MUSCARDINI
Subjects: AIDS, European organisation, application of EU law, marketing, marketing standard, medical research, medicinal product, pharmaceutical legislation, public health, testing













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91997E3435

WRITTEN QUESTION No. 3435/97 by Cristiana MUSCARDINI to the Commission. Drugs to treat Aids  


Official Journal C 158 , 25/05/1998 P. 0112 





WRITTEN QUESTION E-3435/97 by Cristiana Muscardini (NI) to the Commission (31 October 1997)Subject: Drugs to treat AidsConsiderable breakthroughs are being made in the research aimed at eradicating Aids, most recently by a Naples University researcher who has managed, along with a German team, to replicate the HIV virus capable of stimulating the formation of antibodies, the first step towards the solution to the vaccine problem. However, bureaucracy is contriving to obstruct the new-generation drugs because of the delay in giving the go-ahead to testing. As many as 40 000 applications awaiting authorization are presently gathering dust at the pharmaceutical testing office.Will the Commission draw up a Community Directive with a view to centralizing pharmaceutical testing of the new drugs for Aids by setting up a testing agency to coordinate the Member States' research systems?Will it issue a Directive to reduce the waiting time entailed in obtaining permission for testing?Answer given by Mr Bangemann on behalf of the Commission (16 December 1997)Drugs for the treatment of Aids have, from its first appearance, mostly been developed through international cooperation, in particular to ensure their effectiveness and safety. The clinical testing required sometimes involves hospitals located in a number of different Member States. Clinical testing is carried out in accordance with international guidelines adopted by a special forum known as the 'International conference on harmonisation' (ICH), which has been meeting since 1990. These guidelines lay down the conditions under which experiments with the future drugs must be carried out. To meet public health requirements, to ensure the free movement of pharmaceutical products and to complete the Community legislation on the marketing authorisation for medicinal products, the Commission recently drew up a draft Council Directive ((OJ C 306, 8.10.1997. )), which is currently being discussed. The draft directive lays down rules for clinical testing at Community level and essentially lays down the guidelines to be followed by the Member States and certain ethical considerations with deadlines for the performance of experiments. This draft Directive completes the Annex to Council Directive 75/318/EEC, as amended by Commission Directive 91/507/EEC ((OJ L 270, 26.9.1991. )), and lays down rules for the content and presentation of clinical results submitted in support of applications for marketing authorisation. Lastly, it should be pointed out that most drugs for Aids are, by their very nature, innovative and have been or are being authorised under the centralised Community procedure provided for in Regulation (EEC) 2309/93, which reduces the period for the granting of marketing authorisation to a maximum of 210 days.