Estimating the impact of political hostage-takers

Date: 09/10/1997

By Ian S. Forrester QC

THE European Parliament used to be an unpredictable nuisance which lawyers preferred to avoid.

Things have changed. Legal technology can no longer ignore political concerns, even if these are not always well articulated. A good illustration proving this proposition is the yet unresolved furore over the patenting of biotechnological inventions.

Patents reward inventors. The inventor receives a legal monopoly which lasts for 20 years. The inventor must disclose the invention to the world. Others can exploit it once the patent expires. Thus patents encourage the development of technology and enrich the world of innovation by revealing technology which will one day be exploited.

What if an inventor requested a patent for a letter-bomb? It would be refused because the invention would be morally abhorrent. But what about a biologically engineered bacterium which ate the filthy residue in oil tankers? The European Patent Office decided years ago, as did the Japanese and US patent offices, that patents on lower life-forms should be available provided that the other criteria for patentability (inventive step, commercial applicability, and so on) were satisfied.

Controversy arose when it became implicit that higher life-forms would thus be patentable: for example, a tomato plant. The US, Japan and EU member states accepted that inventions would emerge which fulfilled the criteria for patenting but which would be plants or animals.

The European pharmaceutical industry, a world leader, was keen to achieve the same level of legal (and therefore financial) security, to motivate the pursuit of research, as its counterparts in the US and Japan. However, there were a number of largely technical discrepancies between the member states in how they approached the patenting of biotechnological inventions.

For example, patents are normally 'disclosed' in writing. How can competitors get proper disclosure of a bio-invention other than by access to the biogenetic material developed by the inventor? What about balance of proof in this instance?

More fundamentally, in the law of some member states there was uncertainty as to whether biological material and higher organisms could be patented, since conventionally living material had arisen naturally (and therefore could not be patented).

These doubts were to be reconciled in a proposed directive, drafted in the 1980s as a highly technical piece of Euro-legislation eliminating uncertainties and discrepancies in national law for the benefit of the biotech industries of Europe.

But the text adopted by the Commission in 1988 as a proposal to the Council of Ministers became the focus of a vast debate on various subjects with little to do with patent law.

Those opposed to medical experimentation on animals, worried about mad scientists 'cloning human beings', uneasy about the rights of embryos (endowed with souls), supporters of the interests of third-world farmers, some anti-science groups and numerous ethically sensitive bodies all had their say.

The result was that instead of discussing the realities of what the biotechnology industry was doing and how European patent law should be adapted to encourage it, the debate in the European Parliament was a non-converging clash of agendas.

An unlikely coalition of Greens, animal rights proponents, religious bodies, Socialists and Conservative Christian Democrats emerged, sceptical about the risk of scientific abuses. The industry experts underestimated the sincerity of the ethical concerns of the critics, at times regarding them as eccentric, ill-informed activists.

Even more extraordinary, once the criticisms had been addressed by the conciliation procedure the Parliament voted down, on 1 May 1995, the text which its (initially sceptical) rapporteur favoured.

The approach of supporters then evolved. The proposal was withdrawn and a fresh version put forward by the Commission. A more effective dialogue was joined. Patients' groups asserted their interest in seeing the emergence of a cure for diseases like cystic fibrosis or Alzheimer's.

Ethical problems presented by biotechnology were addressed frontally through the creation of expert groups to advise on how to regulate unacceptable forms of scientific endeavour, rather than whether it was wise to patent today's morally acceptable inventions for fear that abhorrent ones might be patented tomorrow.

The Commission's new proposal has attracted broader endorsement although, in practical terms, it is not very different from its predecessor. The institution has accepted more than 60 of the Parliament's amendments and adoption of the measure now looks likely, though opposition may yet jeopardise the outcome.

The debate has been particularly delicate in Germany, where ethical and moral issues are more politically sensitive than in, say, the UK, where such matters are not often the focus of partisan political dispute.

What do we learn from the controversy? That drafters cannot ignore politically relevant factors even if they are technically irrelevant. Economic industrial expertise may not be enough if political sensitivities are not considered. The Parliament cannot be ignored and will not be; and political hostage-takers can have a huge impact.

This article reflects the personal views of the author.