21st September 2001
The patenting of human genes is of ethical significance for all of us and not only doctors and scientists working in the field. It is of major financial significance to all the biotechnology companies with investment in this field and many of those companies have projects in Ireland. Despite these facts there has been no public debate on the issue and, indeed, little within the scientific community although the issue has an impact on medical practice and research here.
As a representative of the Enterprise and Small Business Committee of the Oireachtas which examines issues regarding patenting, I attended a meeting in Brussels in early July and discovered there has been much more discussion on the issue within the other EU states and in the applicant countries. Being a University Senator has many advantages, not least the fact that one is bound to have a constituent who is an expert in any required field. In this case I must thank Dr. David Barton, Chief Scientist of the National Centre for Medical Genetics at Our Lady's Hospital in Crumlin for supplying me with up to date information.
The patenting of genes and gene sequences has long been possible in the United States of America. Members of the American Society of Human Genetics (ASHG) which is the primary professional organisation for human genetics in North America representing nearly 7,000 researchers, physicians, academics, laboratory practice professionals, genetic counsellors, nurses and others in the field, have expressed serious concerns in recent years over the patenting of genetic information and the implications it has for the delivery of genetic health care services. They are particularly opposed to the patenting of DNA sequences, the so called expressed sequence tags (ESTs) which have no demonstrated utility. In a letter sent to the Patents Office in Washington on March 22 last year they quote the words of President Clinton "to realise the full promise, raw fundamental data on the human genome including the human DNA sequence and its variations should be made freely available to scientists everywhere", spoken in London on March 14. The ASHG recommended that the patent's office "raise the bar" for patent eligibility of nucleic acid sequences to ensure that utility was shown and that a "predicted" utility should not be a factor in considering eligibility for acquiring a patent. They also opposed any possibility of allowing a claim on a short sequence or EST to be expanded into a claim on the full sequence of a gene. They have many more concerns as well which can be found on www.faseb.org/genetics/ashg/policy/pol-39.htm
Seeing that the Supreme Court in the United States of America has said that anything under the sun could be patented it is very interesting to see a scientific body so concerned that patenting may do more harm than good.
After more than ten years of negotiating the EU produced a directive in 1998 for the legal protection of biotechnological inventions. The Directive does not substantially alter existing law which states that patents can only be obtained for advances which meet the three basic requirements of patentability, that is they must be new, not obvious and have an industrial application. Mary Harney, the Minister for Enterprise, Trade and Employment brought in a Statutory Instrument here in July this year as she was obliged to do under the Directive.
Meanwhile, back in Brussels I found that many involved in the field of genetics are as concerned about the patenting of human genes and bits of genes as their American Colleagues. Many felt that gene sequences are discoveries, not inventions. Frequently those who discover the genes have been building on the work of others, some of whom will have been supported by charities involving those who suffer from an inherited condition. It would be dreadful if these people were denied any benefits because the gene had been patented.
David Barton pointed out to me that Professor Peter Daly of St. James Hospital had amongst his patients a large Irish family with breast cancer who were important in the mapping of the second breast cancer susceptibility gene BRCA2. Myriad Diagnostics in Salt Lake City have had the patent for the gene for years and charge $1,800 per test. So Irish patients in that family would be obliged to pay large sums for the test despite their important contribution to it.
Huge money will be made in the development of such tests. Myriad is, however, being challenged in the French Courts. The Institut Curie in Paris, one of the world's best known cancer research centres is challenging two gene patents granted by the European patent office to Myriad Genetics. The Institut is supported by 17 other hospitals or research centres and, tacitly, the French Government. Myriad admits their test is not 100% reliable. The French say they can produce a more reliable test for one third the price. As Jean Mattei, MP and leading French Geneticist put it: "Under the guise of providing legal protection for biotechnology discoveries we are preventing possibly vital research and therapeutic advances being made by anyone other than the patent holder".
In Ireland only sex is considered an ethical issue but maybe we could make an exception regarding the patenting of human genes.
Senator Mary Henry, MD
