17th October, 2001
Dr. Henry: 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' 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.
Dr. M. Hayes: I thank Senator Henry for sharing her time and support what she said. I do not intend to follow her into the underworld of genetics in which she is more expert than anyone else in the House. We should be grateful to her for calling our attention to this. It is part of a wider question about the patenting of medicine and the return that people get on their research. A side effect is to deprive people in poorer countries of the medicine they need so that countries like Argentina and South Africa had to break the rules.
It is serious for us because some of the best work on this subject is done in hospitals in Belfast and Dublin. The close link between research, clinical practice and analysis is the key to advances being made and to be made in cancer care. Although money is important, the threat to clinical practice and the possibilities for advance in Ireland and Europe are more serious in the long term. Other countries see the danger, and I suggest to the Minister of State that if the United Kingdom, France and other countries think it important for the interests of patients, health service and future research into cancer to contest this, then Ireland should join them. I support Senator Henry's plea and congratulate her on bringing it to our attention.
Dr. Moffatt: I thank the Senators for raising this matter on the Adjournment of the House and for giving me this opportunity on behalf of my colleague, the Minister for Health and Children, Deputy Martin, to set out the current position on the development of services in cancer genetics, both at European and national level.
Patenting of gene sequences has been possible in the United States for many years. However, a moratorium on gene patenting has until recently been in force in Europe. The EC Directive on the Legal Protection of Biotechnological Inventions (98/44/EC) was adopted by the European Parliament in July 1998 after more than a decade of negotiations between member states in the Council of Ministers, the European Commission and the European Parliament. The directive's purpose is to harmonise the member states' national patent laws concerning biotechnological inventions. It obliged all members states to ensure that by 30 July 2000 their national patent laws were consistent with the terms of the directive and Ireland implemented the necessary Statutory Instrument on 28 July 2000. The European Patent Office altered its implementing regulations in June 1999 to put the directive into effect, so that new applications for patents are now subject to the rules contained in it.
This directive does not substantially alter existing law which states that patents can only be obtained for advances which meet the three basic requirements for patentability, that is, they must be new, not obvious and have an industrial application. It requires that patents are not obtainable for genes or other body parts in their natural state. However, inventions concerning isolated genes which are identical to those found in nature are not prevented from obtaining patent rights. The interpretation of the directive is complex and has been the subject of court action at European level, but the interpretation being placed on the directive by biotechnology and pharmaceutical companies and by the European Patent Office is that genes are now patentable in the EU, as they must be isolated before they can be sequenced.
Shortly after the directive was passed, the Dutch government appealed to the European Court of Justice following a vote by the Parliament of the Netherlands against its adoption. The Netherlands' challenge was supported by Norway and Italy. The case was heard by the court on 13 February 2001, and on 9 October 2001, the court dismissed the application.
With regard to the case mentioned by the Senator, I understand that on 4 October last, the European Parliament adopted a resolution against EP0699754 B1, the patent granted to Myriad Genetics, Salt Lake City, USA, on the use of sequences from the BRCA1 (breast cancer) gene and decided to file their own opposition. The patent has also been the subject of opposition by interested parties in a number of member states.
Genetic research is a very exciting area with the potential to revolutionise medicine and health care. In the past ten years, there have been significant advances in our understanding of cancer genetics in particular. The chief medical officer of the Department of Health and Children has requested the national cancer forum to examine the issue of genetics and to report back on how the forum should develop and support services in cancer genetics in the country. In the course of its investigations, the forum will also consider all developments in this area at European and international level and advise on the most appropriate response. In this context, I will ask the forum to take account of the case referred to by the Senator during the course of its deliberations. It is a complex area and I take on board what was said here this evening.
Dr. Henry: I am disappointed in the reply. There is no sense of urgency. We are at the forefront of genetics, but Irish research workers will be disadvantaged and Irish patients will suffer. I hope that Senator Hayes will press the case in Belfast and urge that the more active United Kingdom approach is supported there where splendid work in this area is done.
The Seanad adjourned at 8.30 p.m. until 10.30 a.m. on Thursday, 18 October 2001.
