Protection of Human Genetic Sequence

– in the House of Commons at 3:31 pm on 8th March 2000.

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Photo of Mr Richard Allan Mr Richard Allan Shadow Spokesperson (Business, Innovation and Skills), Shadow Spokesperson (Education and Employment) 3:31 pm, 8th March 2000

I beg to move,

That leave be given to bring in a Bill to give protection to the human genetic sequence; to prevent the patenting of human genes; and for connected purposes. There is a great deal of debate about science, including genetics, in the media at present, which makes the Bill somewhat topical. That topicality has been reinforced by the submissions that I have received since proposing to introduce it. I thank all those who have supplied me with background information to prepare for the debate, including the BioIndustry Association, which made its arguments on behalf of the industry. Although it may disagree with some of the points that I want to make, I appreciate it putting its case to me.

In 1996, the Parliamentary Office of Science and Technology produced a useful report entitled "Patents, Research and Technology", which kept ahead of the debate at that time—I recommend it to hon. Members—and the hon. Member for Lewisham, Deptford (Joan Ruddock) has tabled the very good early-day motion 298 on the subject. I agree with its sentiments entirely. However, some of the media debate can be disturbing in respect of the assumptions being made, especially about the public understanding of public policy issues in science and genetics in particular.

It is clear that the public contribution to the debate often lags behind the discussions in scientific and sometimes even political circles. That leaves many members of the public with the real worry that deals have already been done, which in turn leads to wider opposition and the polarisation of views. That was very clear in the debate about genetically modified organisms. My concern is that the gene patenting debate may represent a real risk of significant future public anger if we do not have a more comprehensive discussion now. That is part of my motivation for introducing the Bill to the House today.

Some of those who talk about science policy seem to think that only those with the relevant qualifications can understand and that ordinary people should be left out of the debate. Such a position is offensive in a democracy, as we shall all have to live with the results of decisions taken in science public policy. It also seriously underestimates most people's interest in, and understanding of, those issues. That attitude is more likely to generate an anti-science mood as people respond negatively to what they perceive to be scientific and technological arrogance.

The citizens of this country—men, women and children—are perfectly able to participate in the debate and will do so. We need to look for ways to improve public participation and to involve them better, rather than seek to restrict decisions to committees of experts. Some coverage does not help by referring to absurd examples that owe more to science fiction than science fact. For example, the debate about genetic patenting has been expressed in terms of private companies owning the biological material that is inside all of us so that, somehow, we would have to pay royalties to produce new cells containing those genes. That is no more the real issue than that the human cloning debate should be about brainless automata being created to donate their organs to the rest of us, although, when one listens to the questions in Prime Minister's Question Time, one wonders whether the Government already have the job of creating automata in hand.

The heart of the debate is about how to create the greatest benefit for the greatest number of people from the incredible potential that is now being realised by our ability to decode the human genetic sequence. Patent law is difficult to grasp, and the uncertainties will keep lawyers happy and well fed for many years to come. It is based on certain key principles that we established through legislation and through our international agreements, especially at European Union level, but increasingly at international level.

The most relevant legislation is the 1998 EU directive on the legal protection of biotechnological inventions, article 5 of which states: The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. It goes on to say: An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. Hence the work created for lawyers in this area. The directive leaves major room for debate about what should constitute a patentable invention. There is some uncertainty about whether sequences can be patented, or only their specific applications.

The view of Myriad Genetics is that it can patent the genes, which is why it has attempted to secure patents on the breast cancer susceptibility genes BRCA and BRCA2. That has caused much of the current debate. Other companies are similarly seeking exclusive rights on particular genes through the EU patenting process. Their argument is that the only way to keep research going is by generating income from the results. I would argue that the rewards can instead come from the proper patenting of specific applications of the technology without granting patents on the genes themselves.

The analogy of a mousetrap patent has been used. It is better for a company to secure a patent on a mousetrap design than on the process of killing a mouse. However, I would argue that the patenting of human genes is equivalent to securing a patent on dead mice, rather than on a mousetrap. If that patent were secured, the dead mouse patent holder could seek royalties from anyone else who invents other methods for killing mice. It is that exclusivity over the material rather than the applications that is the major source of concern.

There will be some serious implications if we allow such an environment to develop. What will the costs be to the health service if the costs for genetic testing have to include royalties to the holder of the patent for that gene? What will be the effects on public research if the incentive to develop novel applications is tempered by the knowledge that those applications cannot go to market or be used for the public good in the public domain without negotiating with, and making payment to, the gene patent holder?

There are real ethical considerations. Although I do not subscribe to the notion that this will lead to the ownership of bits of our cells, there are nevertheless genuine concerns about where the commercial exploitability of such material should begin and end.

In September last year, the Government sent out signals that they were looking to defend the public interest on this issue. It was reported that the Prime Minister was holding discussions with United States President Bill Clinton. When I recently asked the Prime Minister a question in the House, I was a little surprised to hear him say that no negotiations were taking place. I find it difficult to square that response with the report in The Guardian of 20th September 1999 entitled "Blair and Clinton push to stop gene patents". The report states: Tony Blair and Bill Clinton are negotiating an Anglo-American agreement to protect the 100,000 genes that control the human body. … The extraordinary deal—initiated by Mr. Blair—aims to prevent entrepreneurs profiting from gene patents and to ensure that the benefits of research are freely available. Reports of discussions have been released under US freedom of information legislation, but the Government have gone strangely quiet since then.

There is an urgent need for a debate about our approach to the use of human genetic information. This urgency is reinforced by Tuesday's report in The Guardian, headed "Protocol on gene research is at risk as firm demands exclusive rights". Dr. John Sulston, the well-respected director of the Sanger Centre—one of the leading research institutes in the world and a proud British institution—has said of the US company Celera:

The emerging truth is absolutely extraordinary. They really intend to establish a complete monopoly … on the human genome for … at least five years. Dr. Sulston says: People ought to know about it. I think that people are becoming aware of it, and that that awareness is growing daily. I believe that the Government can no longer refrain from making their view clear, and that they should, on an urgent basis, make progress with the negotiations begun so admirably in, I believe, September 1999—although that is now denied by the Prime Minister. I urge the House to demonstrate that it, too, takes the issue seriously by supporting the Bill.

Question put and agreed to.

Bill ordered to be brought in by Mr. Richard Allan, Dr. Ian Gibson, Mr. David Heath, Dr. Brian Iddon, Jackie Ballard, Mr. Norman Baker and Dr. Jenny Tonge.