Lobbying efforts turn around good ship Europe on biotechnology patent law

AT TIMES, it appears, the European Parliament behaves like a giant battleship whose momentum through the sea takes five or 10 miles to brake. Sometimes, it is like a whimsical, impetuous child at the mercy of every gust of public opinion.

So it was two years ago, when a brilliantly-timed, hysterical campaign by Green peace scuppered a directive on the patenting of biotechnological products, and, most controversially, of human genes. Suddenly the majority of members found they might be drifting into the lobbies behind a potentially explosive proposition of which they were only dimly aware. Discretion being the better part of valour, they voted no.

The Irish contingent did so too, some admitting complete ignorance of the issue, and one that "it is too complicated for MEPs to be asked to make a decision". For most, it appeared, it was enough - for opponents to talk of mad scientists playing God or of the vested interests of the deeply-distrusted drug companies to rally - the troops.

Two years later, a new directive, whose content is substantially the same, is before the Parliament. This time, however, it seems likely to pass and, indeed, to receive the backing of a majority of Irish MEPs. The turnaround is a tribute to the effectiveness of the "pro" lobby, largely the scientific community and the drugs industry, and most notably its success in enlisting the support of patients' organisations to its cause.

At stake is the conflict between the need to guarantee, through patent, a reward to researchers.for the products of their inventiveness, and a sense of unease at the idea of granting people rights to parts of the human body.

Proponents of the directive point out, however, that it specifically excludes the possibility of individual parts of the human or animal body being patented or the patenting of "germline" therapies in which changes are implanted in the genetic make-up to affect succeeding generations.

Crucially, they argue, patent law draws a distinction between an invention - patentable - and discovery, which is not. It is not possible to patent one of the moons of Jupiter, but one can patent the means by which it is discovered, for example, a new telescope. Similarly at the micro level, it must be possible to patent the technique for isolation of a particular gene but not the gene itself.

The German Socialist, Mr Willi Rothley, who has written the Parliament's report, argues simply that "patents are a morally neutral means of promoting technology." Why should a cancer drug be patentable, he asks, if it comes from a test tube, but not if has been produced genetically from the udder of a cow or a goat?

"Those who reject the industrial exploitation of life should not make the patent office the guardian of ethics," Mr Rothley argues. "The patent office also has to protect anti-tank mines if there are grounds for anticipating that they be of use for defensive purposes. Only inventions which are manifestly contrary to morality - for example, banned biological weapons - do not enjoy patent protection."

Politicians must determine elsewhere whether mines or medical techniques are ethical, he argues.

Ms Nuala Ahern, the Green MEP for Leinster, is sceptical and feels that it is crucial that the human body and its elements are not commercialised even though inventions which make use of this knowledge can be patented.

"It is very important that methods of treatment developed for serious genetic diseases are available to those who are suffering without an exorbitant licence fee which is accrued as the end of a long line of scientific development to which there have been many different inputs."

She argues that patient organisations have been "misled".

But Mr Alan Kent, president of the European Alliance of Genetic Support Groups, told MEPs at a recent hearing: "For many years families have been struggling to raise funds for research into genetic diseases. Now we have cracked the human genetic code, and have begun to understand the scientific basis of genetic diseases. Families want to see the benefits for themselves and their children. The encouragement given by the directive to industry and investors is crucial."

Mr Kent represents support groups including muscular dystrophy, cystic fibrosis, breast cancer, and Huntington's chorea.

Mr Pat Cox (Ind, Munster) agrees. "If one of my children suffered from an illness that scientists could cure, I would want my legislators to do everything possible to facilitate them while respecting the essential ethics of life itself."

He is one of several Irish MEPs who admit to having changed their views. Ms Bernie Malone (Labour, Dublin) is another - she has been lobbied in favour by her union, MSF, which represents scientists and scientific workers.

Mr Brian Crowley (FF, Munster), who brought the Legal Affairs Committee to meet scientists in the Schering-Plough plant in Cork, says the arguments of patients' groups have been decisive for him and he expects the Fianna Fail group will back Mr Rothley.

With most of the ethical arguments substantially answered MEPs are now also being swayed by the economic case. Mr Rothley points to the dramatic difference between the scale of research in Europe and the US. In the US 1308 firms have invested £4.7 billion in biotechnological R&D in the EU, 584 firms have spent only £0.4 billion.