Nancy Rothwell

April 2, 2004

UK scholars must look to partnerships to tackle European legislation that might have a detrimental effect on science

Most academics are probably quite law-abiding citizens. We may be seduced occasionally by the savings of cash payments to a plumber, exceed speed limits or even park illegally, but in general we recognise that UK law is there to protect us. Yet the academic community is becoming increasingly agitated by new legislation that promises to impose additional, and sometimes unreasonable, restrictions on our research.

The fine details of the UK legal system are probably beyond the understanding or interest of most academics, although the system is generally considered reasonable and fair. But we seem to have been hit by a raft of recent and pending legislation - much of it originating in European law.

Recent European legislation has included employment conditions for contract researchers. No one in British academia apparently saw this coming until it was effective in Europe and about to be implemented in the UK. The higher education establishment was taken by surprise and reacted with great confusion and a diversity of views and legal opinions; in the end, a "let's see what happens" attitude seems to have prevailed.

In fact, this is a law that has fundamental benefits at its core. Its aim is to prevent the abuse of short-term workers who form the mainstay of much research in the UK but who have had a raw deal. The result has been an inevitable loss of talent from academia. It would have been better to have had time to plan how to deal with the new law, but in the end we will probably manage, and some significant benefits for career management and the training of contract researchers will ensue.

Other legislation seems less beneficial. New laws on clinical trials, passed in Europe and very soon to be considered in the UK, are causing concern. Yet again, the legislation has a good moral grounding, namely the protection of patients who enter clinical studies, and is addressed mainly at trials that are funded and managed by the commercial sector. So, on the face of it, it is possibly a good law. But the impact on publicly funded trials (which are greater in number in the UK than in other European countries) is potentially devastating.

The requirements for formal sponsors, the associated costs and the complex reporting structures could prevent most publicly funded trials. We are now at the 11th hour on this (with implementation just a month away), but the clinical research community and the funders are working hard to find a solution that will not be detrimental.

There is more to come in the future. The chemicals testing bill is progressing in Europe - with major implications for the costs of research and the use of animals for testing often routine and seemingly safe chemicals. European legislation on the use of animals in research is now in the early stages - although here the research community is more actively involved.

So do we stand back and watch it happen, or should we all become legal experts ready to campaign against any irrational or damaging future legislation? Neither option is viable. We do not know which pieces of legislation might have a serious impact on UK research, but academia does not have the time, expertise or inclination to take on expert analysis or lobbying. One potential solution lies in partnerships between interested parties that may be able to secure the funding and expertise necessary to deal with new legislation. Universities UK is an obvious representative body, since it oversees our higher education institutions. However, the diversity of universities in the UK means that it may be difficult to reach consensus. An example of such partnership (albeit rather late) is the alliance of medical research funders and the Academy of Medical Sciences, which is lobbying hard on the clinical trials legislation.

But what about the future? Such partnerships need to look to upcoming legislation to consider its impact and argue the case early and effectively where necessary. A group of biomedical researchers, together with the Biosciences Federation, is now considering engaging experts in European law and "horizon scanning" for future legislation (or amendments to existing laws that can also have a serious impact). This needs to be more widespread and include collaboration with the commercial sector, which is rather more effective in spotting and acting effectively to modify legislation.

As academics, we often accept the law unquestioningly, which is fine when it comes to criminal law or even speeding fines and parking tickets. But when the law, however well meaning, has a serious impact on research - and in some cases specifically on UK competitiveness - we need to be better informed and sufficiently well prepared.

Nancy Rothwell is Medical Research Council research professor at the School of Biological Sciences, Manchester University.

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