Global demand for new vaccines, medicines and gene-based treatments is at an unprecedented level. Companies have to be given clear protections by way of patent if they are to invest many millions of pounds required to respond to those needs. If for that reason alone, the controversial biotechnology inventions directive which has been adopted by the European Parliament this week, is due some welcome.
The directive, which was thrown out by MEPs in 1995, largely on ethical grounds, was accepted by a three-to-one majority amid protests within and outside the parliament by the Green group, which claimed it was a sell-out to multinational industry. Those expressing concerns yet accepting the need for the directive, have not been helped by ambiguous language which is open to the interpretation that human gene sequences are "primary patentable commodities outside the human body". While companies have to specify what therapeutic use a gene sequence may be put to before obtaining a patent, many fear they may make sweeping, catch-all claims with a view to tying-up royalties on all possible future uses. This cannot be allowed happen.
The directive permits patents on human, plant and animal genes and royalties on medical or agricultural applications. But the European Commission has largely addressed concerns that surfaced in 1995. There will be a monitoring ethics committee; animal welfare safeguards and farmer protections. A gene sequence may only be patented where there is a specific application outside of the human body.
EU patent regimes relating to biotechnology are in a mess. This has inhibited research and opened the door to the US and Japan to exploit further one of the world's most rapidly developing technologies. Moreover, the need for certainty and controls in the face of awesome scientific advances is underlined by the recent announcement by a US multinational that it will decode the entire human genome by 2001, courtesy of a new robotic gene sequencer, and sell the information to scientific institutions and drug companies.
Irish MEPs were edgy as they gathered in Strasbourg for the vote. There were allegations that the directive would facilitate indiscriminate use of human embryos. It was paraded as "a patent on life" by opponents concentrated among the Greens. It was enough to prompt two Fianna Fail MEPs - Mr Pat "The Cope" Gallagher and Mr Liam Hyland - to issue statements saying the directive must be watertight on human cloning. It does not purport to address that complex issue, though the directive explicitly rules out patenting of processes using embryos for commercial or industrial use. Tension was heightened further on Tuesday when Fianna Fail MEP, Mr Mark Killilea, intervened during the vote to complain of the intimidating presence of lobbyists against the directive at the door of the chamber.
In reality, the most intensive lobbying came from the biotechnology industry. Some claim it was more menacing and less obvious but unrelenting ever since the directive was thrown out three years ago. Eurosceptics who believe the parliament is a powerless talking shop, should note the many millions of pounds spent by the industry trying to get the directive adopted - not to mention that spent by tobacco and publishing interests trying to head off the directive prohibiting tobacco advertising.