I have agreed to share time with Senator Hayes. I am delighted this Minister is here tonight because I know he will have an understanding of the matter I put forward.
The issue of human gene patenting is of the greatest importance to women with breast or ovarian cancer in Ireland and to research here into the genetic basis of cancer. Test kits are permitted to be made solely by the company which holds the patent even though it may not be the most suitable test, nor the least expensive.
Patenting of gene sequences has been possible in the United States of America for many years. In June 1998, after ten years of discussion, the European Parliament and Council adopted a directive for the legal protection of biotechnological inventions and all EU countries enacted laws to comply with it. The directive does not substantially alter existing patent laws which state that patents can only be obtained for advances which meet the three basic requirements of patentability – they must be new, not obvious and must have an industrial application.
The directive makes clear certain processes cannot be patented on the grounds that their commercial exploitation would be contrary to morality, for example, the cloning of human beings or the commercial use of human embryos. The directive requires that patents are not obtainable for genes or other body parts in their natural state but inventions concerning isolated genes which are identical to those found in nature are not prevented from obtaining patent rights, but they must satisfy the three conditions for patentability.
The directive is being interpreted by biotechnology and pharmaceutical companies and by the European Patent Office as allowing genes to be patented as they must be isolated before they can be sequenced. Many scientists, both in research and health care, object to this, feeling it to be contrary to the principles of natural justice and a distortion of the purpose of patent law – genes were there before the researchers.
Matters have come to a head with an EU patent, EP 0699754B1, being granted to Myriad Genetics, Salt Lake City, USA, on the use of sequences from the BRCA1 gene, a most important gene in the diagnosis of hereditary breast and ovarian cancer. The patent enables Myriad Genetics to demand that a major part of the genetic tests for European women with an enhanced risk of hereditary breast and ovarian cancer be done in Salt Lake City. Some of the most important work in this area was done here in Dublin, in St. James's Hospital.
Geneticists object to extracting these analyses from the European health care systems where genetic tests are performed on a non-profit basis and in close collaboration with the clinicians involved in treating the patients. Also, it will deprive European laboratories of the possibility of implementing improved technologies, which is an important part of molecular genetics world-wide. This is most important for us with our burgeoning biotechnology industry. The Myriad method is sensitive for the detection of subtle gene sequence changes but not suitable for the detection of large deletions which are a common feature in BRCA 1 genes in Europe. In the Netherlands, for example, it is suspected that it will not be suitable for about 25% of cases.
Opposition to the granting of the EU patent to Myriad has been lodged in the EU Patent Office by the French and Swiss governments and the genetic societies of the Netherlands, Belgium, the United Kingdom, Germany and Denmark. On 4 October the European Parliament adopted a resolution against EP0699754b1 and decided to file its opposition, that is, against its own directive. Ireland should immediately join this opposition. Genetic testing is carried out here in a comprehensive medical genetics centre, where the skills of scientists and clinicians are combined and reinforced, which is what is best, and testing is provided free of charge.
Breast cancer is a common condition in Ireland. The cost to the country will be enormous if all tests have to be done in Salt Lake City, from £150,000 to £300,000 per annum, and the tests may not be those which are needed most. Counselling of patients cannot be guaranteed if all the tests are sent abroad.
There is a growing awareness that clinical medicine and research in genetics will not benefit from granting exclusive rights for testing to one commercial company. The differences between health care in the United States and Europe should be recognised and Ireland should join the opposition to the granting of this patent at once.