EU directive does little to ease fears of clinical researchers
THE warning could not have been starker: “This single paragraph if implemented will doubtless result in the cessation of clinical research in Ireland.”
It concerned a draft version of a proposed EU directive, to be implemented this May, aimed at harmonising the laws governing clinical trials throughout Europe.
Such trials include studies of new treatments for cancer and other diseases. They are conducted by both academic researchers and pharmaceutical companies, and often in tandem.
Without them, thousands of lives would be cut unnecessarily short in this country, and millions throughout Europe.
Responsibility for licensing such trials in Ireland had been transferred from the Department of Health to the Irish Medicines Board (IMB) in the 1990s. For that reason, the IMB had a crucial role to play as the Department and its counterparts in the member states sought to finalise the EU Clinical Trials Directive in the late 1990s.
Negotiations on the directive first got under way in 1991. As work on the initial draft progressed, the IMB did not like what it was seeing, and made this clear to the Department. The dire warning outlined above came in a September, 1998, fax to the Department, released under the Freedom of Information Act, and concerned the constraints that would be placed on the voluntary committees at each research facility that ensured trials were ethical.
Work on a revised draft got under way, but this one made the IMB more uncomfortable. In a letter to the Department in June, 1999, it raised a string of concerns with the draft, saying: “It is no improvement on the first, in fact it is probably a step backward.” Documents from the Department reveal just how tortuous a process it was to finalise the directive.
Each draft is littered with footnotes detailing the objections various countries had to different sections of it. Despite this, a final draft was hammered out and agreed upon in December, 2000, being formally adopted by the European Council and Parliament in 2001.
In an email in December, 2000, the Department's chief pharmacist, Tom McGuinn, thanked the IMB for its “valuable help with this draft directive which in my experience (was) the most difficult that I have had to deal with”.
Speaking to this paper last Thursday, he said the IMB's concerns had been addressed. “The IMB raised a lot of concerns in the process of the negotiations, which was their duty to do so. We then raised those issues at the negotiations ... and we compromised.”
The IMB says it was satisfied with the final draft. “The IMB had concerns with all the various drafts that emanated since 1991, but were satisfied with the regulations that were finalised in 2000,” said a spokeswoman. “They're very comfortable with it, as it stands now.”
That would seem to be the case, judging by a submission the IMB made to the Department last November.
BECAUSE each member state has responsibility for transposing the EU directive into national law by May 1, the Department has to draw up specific Irish legislation to enact it here. It published its first version of this legislation last year and opened a consultation period, inviting submissions from interested parties.
It is now reviewing those submissions with a view to finalising the legislation ahead of the May deadline.
The IMB’s six-page submission outlined a long list of concerns, but these were mostly about perceived inconsistencies in the draft or areas that needed clarification. It contained none of the fearful language that so characterised the IMB's correspondence with the Department prior to the EU directive being adopted in 2001.
Curiously, however, while the IMB's fears have seemingly subsided, the fears of the researchers, whose trials the IMB sanctions, have grown. Any number of researchers in the non-commercial sector - at hospitals, universities and publicly-funded institutions - have warned of the effects the directive will have on their work. Their language is remarkably similar to that once used by the IMB.
For instance, the Health Research Board, a statutory body that funds and conducts medical research, said in December that the “implementation of (the) EU directive may jeopardise academic-led clinical trials”.
The Irish Clinical Oncology Research Group (ICORG), which counts every cancer doctor on the island as a member, has warned likewise.
Generally, researchers fear that the directive could increase the costs and levels of paperwork associated with such trials, and put intolerable legal burdens on individual researchers. They say the directive, though well-meaning, was aimed at placing greater responsibility on the pharmaceutical companies which run private trials of new drugs and neglected to take into account academic researchers.
Tom McGuinn says the Department “cannot depart from the directive” when it finalises the Irish legislation, but there are “certain areas where discretion is allowed to member states.”
Because of this, he says the Department is hoping to ensure a system amenable to academic researchers. Like the IMB, he is confident the envisaged threat to medical research - and the knock-on effect on people's lives - will not materialise. Nevertheless, it is hard to rectify the major differences of opinion between the Department and the IMB, on one hand, and the researchers on the other.
Members of ICORG, together with fellow researchers from across Europe, met on February 10 with senior officials from the European Commission's Research Directorate General (DG Research), whose mission it is to develop the EU's research policy.
“It was a positive meeting at which some suggestions of ways forward were raised,” says ICORG chief executive, Dr Brian Moulton. “DG Research shared (our) concern, and are looking at the formation of a working party in the very short term.”
If that happened, it would be a remarkable development. It would be an indication from the heart of the EU structure itself that its own directive could be dangerously flawed.
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