Expert appointed to resolve drug test directive problems

Clinical trials: The Department of Health has appointed a senior bioethics expert to try to resolve delays that have slowed the number of trials on potentially life-saving drugs being approved.

The expert was appointed before Christmas to examine difficulties that arose following the implementation of the EU Clinical Trials Directive on May 1st, last year.

According to the Irish Medicines Board, which approves clinical trials, of the 162 trials approved last year, only 49 were approved in the eight months after the directive came into force on May 1st.

Concern at the delays led the Irish Pharmaceutical Healthcare Association (IPHA) to write to the Department in November seeking a solution.

An IPHA spokeswoman said that if the delays were not resolved, pharmaceutical companies would start to exclude Ireland from their research plans.

"Most large trials are run in a number of countries simultaneously. If the problems here persist, we believe clinical research will start to migrate out of Ireland.

"If the Government's aim is to try to embed the pharmaceutical industry here and try to move Ireland up the value chain and away from manufacturing plants, there has to be research and clinical trials here."

Tom McGuinn, chief pharmacist with the Department, said part of the problem was hospitals were reacting very cautiously to the new rules.

"Under the new directive their only discretion with clinical trials is to permit it or not permit it. They can't examine it through their own ethics committee as they used to do.

"We have undertaken a project to find out what are the problems, people's concerns and misconceptions. The directive does require a fair bit of formality and a significant amount of administration [for researchers]. It also involves an increased workload for existing ethics committees."

The requirements in the new directive have prompted the Irish Clinical Oncology Research Group (ICORG) to become one of the first independent research bodies in Europe to gain insurance allowing them to sponsor research trials.

Dr Brian Moulton, ICORG chief executive, said that because the directive no longer allowed pharmaceutical companies to give grants to independent researchers, ICORG had taken out insurance to allow these studies continue.

"An expert group in Britain has agreed to help us with insurance which means we can now take the role of sponsor for researchers. As far as I know, we will be first group in the country to do this and one of the first in Europe.

"This is not just an Irish issue, this is an EU issue, although we have particular problems here. The directive places huge administrative demands on independent researchers.

"For cancer research, independent studies are important, representing almost 50 per cent of all those under way. The benefit of independent research is we're not looking for a marketing success. Pharmaceuticals are thinking of the bigger markets when they do research, whereas independents look at smaller niche areas."

The Irish Patients' Association also met Department officials last April to express their concern at the impact of the new directive.

Stephen McMahon, chairman of the association, said "delays caused by the directive threaten the availability of the most up-to-date drugs for Irish patients".

"If Ireland becomes an unattractive place for clinical trials then Irish patients are looking at having to wait an extra five or 10 years before these trial drugs are on the market coupled with a gradual loss of research expertise.

"Many of our patients want and need the opportunity to be involved in a trial."