Controls over clinical trials are hindering the effectiveness of the British-based pharmaceutical industry, according to the Association of Clinical Research for the Pharmaceutical Industry (ACRPI).
At a recent conference, members of the association heard Merck Sharp & Dohme's medical director (Dr John Young) say that bureaucracy was hindering clinical trials. He said that delays caused by a two-tier ethics committee approval process, coupled with a third step at some National Health Service trusts was a major issue.
"These factors are deterring fast-track multinational companies from undertaking clinical research in the United Kingdom," he said.
Commenting on a proposed European Community clinical trials directive, Dr Young added: "If this piece of legislation is adopted in its current form it could have a major impact on the pharmaceutical industry in Britain as it dictates the way in which companies apply for clinical trials authorisation."
The ACRPI believes that the proposed directive means that research in Europe will be unable to compete with the United States or Canada, where timescales are shorter, or with Eastern Europe, where costs are lower.
The proposed EC directive Dr Young referred to is intended to harmonise laws on the conduct of clinical trials in EC countries and to ensure adherence to international standards of good clinical practice (GCP).
If accepted it will sets standards that ethics committees must take into account before approving trials and require organisations running clinical trials to register them with national authorities. National inspectorates will have to be established to check that GCP is followed.
Details of the European proposal can be found on the internet at europa.eu.int/scadplus/leg/en/lvb/l21165.htm.