The EU is to attempt later today to adopt a directive on genetic and biotechnological patents, which has been 10 years in gestation, despite renewed controversy last night over its contents within the European Parliament. The latest form of the directive presented by the European Commission has still not ensured adequate safeguards or accurately reflected the concerns of Parliament, according to opponents including Irish Green MEP Ms Nuala Ahern. It was ambiguous on the patenting of human genetic material, lacked specificity on the need to spell out patent use, would facilitate biopiracy in developed countries and lacked sufficient ethical safeguards, she claimed during a second reading debate.
A German socialist, Mr Willi Rothley, who was rapporteur on the legislation, said Europe needed "the legal certainty of biotechnological patenting for the next century". It was not a directive for European biotech industry and would ensure independent and national research was adequately protected.
He was supported by many MEPs who claimed it would protect research and make a clear distinction between discovery and invention and particularly between the role of a gene as a vector for heredity and its possible use as "a molecular machine" for other purposes.
Ms Ahern said a sustained campaign by lobbyists, financially supported by a multinational pharmaceutical company, had "misrepresented and misinformed MEPs" about the concerns of patients' organisations. Its main thrust was to suggest independent patients' groups supported the directive.
Fine Gael MEP Ms Mary Banotti alleged, however, that the European Campaign on Biotechnology Patents had claimed incorrectly that listed patient groups, including many from Ireland, were against the directive when she had established they were in favour of it. Labour MEP Ms Bernie Malone said she was conscious of "a huge level of opposition among development, environmental and religious groups in Ireland". In her view the draft legislation did not provide sufficient protection for farmers in developing countries. The Greens proposed a series of amendments with a view to strengthening requirements that patent holders show firm evidence of prior informed consent from patients where genetic sequences were the subject of research or applications.
They also insisted that patents should not cover a gene sequence itself. A different product or therapy incorporating or using knowledge of the same gene sequence should be covered by an entirely separate patent, and there should be no derivative patents.
The amendments are to be voted on later today.
