Bid to tighten research rules

Date: 06/03/1997

By Rory Watson

THE European Parliament is expected to support moves next week to tighten up existing EU safety standards for research into deadly diseases such as the Aids and Embola viruses.

The changes, which have already been endorsed by the Parliament's environment committee, are designed to update rules agreed almost eight years ago on the contained use of genetically-modified micro-organisms (GMMs), which are important elements in biotechnological progress.

Greek Christian Democrat MEP Antonios Trakatellis, a biochemistry professor, has been a leading light in the campaign to ensure that safety requirements keep pace with the growth in GMM research.

“GMMs are an excellent biotechnological tool and we are in a fast-expanding area in which more and more laboratories are becoming involved. That will increase the danger that something will happen and, as we have found with the BSE crisis and the collapse in the beef market, just one incident is enough to give the industry a bad name,” he explained.

Trakatellis insists that the measures being considered are not intended to be a burden on universities, laboratories and companies searching for useful substances such as human insulin. But he maintains that suitable safety standards must be put in place.

When the full Parliament examines the draft legislation next Wednesday (12 March) it will almost certainly support Trakatellis' efforts to establish a clear system for assessing the risks to human health involved in the different experiments, and the precautions to be taken.

His report divides these into four categories and, he believes, considerably tightens up the Commission's earlier draft.

Trakatellis' proposals are designed to ensure that the general public is guaranteed the same level of protection as that enjoyed by biotechnology workers, and to help the industry by removing any doubt about the category to which a particular GMM belongs and the precautions required.

But to date, the Greek MEP has only won the support of Green members for an even tougher classification which would include an assessment of the environmental risks at stake.

MEPs do believe, however, that a stronger onus should be placed on contained research environments, such as specially insulated laboratories, to prevent - rather than limit as the Commission had originally proposed - any contact between GMMs, the general population and the environment.

“If you say 'limit', you imply that some GMMs will get out anyway. But I would be very much opposed to any release of Aids or tetanus,” said Trakatellis.

The rapporteur was, however, unable to convince his colleagues on the environment committee that his concerns over the insurance arrangements to be applied were valid as they approved a text which would force all users to provide “a certificate of liability insurance of sufficient value to compensate all persons likely to be harmed by a failure of containment and control measures”.

While fully behind the concept, Trakatellis fears this wording could allow insurance companies to dictate terms to research laboratories and increase their costs unnecessarily.

But in contrast to Trakatellis' overall efforts to make the future rules as precise as possible, other members of the environmental committee complained that he was trying to rewrite the draft legislation, not amend it. “What he was proposing was excessively detailed and bureaucratic. We are politicians, not technicians. There is too much of a temptation to try and detail how the whole of the Union is going to behave,” explained British Socialist MEP David Bowe.

“We know the directive will be amended as technical progress is made. The question is how we keep an eye on the technical committee doing that and I think we have got that arrangement right,” he added.

The extent to which the Parliament will be able to influence the final shape of the new controls will also become clear within the next few weeks.

Trakatellis is pressing for the measures to be agreed under the Union's co-decision legislative procedures, which would strengthen the impact of any changes agreed by MEPs.

“To me, it is obvious we are talking about eventual industrial application of

the research. Therefore there has to be harmonisation and the same standards across the Union and so there should be co-decision,” explained the Greek MEP.