HC Deb 28 July 1997 vol 299 cc119-28

Motion made, and Question proposed, That this House do now adjourn.—[Mr. Robert Ainsworth.]

10.13 pm
Mr. Matthew Taylor (Truro and St. Austell)

On 15 July, the European Parliament discussed and approved the proposed EC directive for the legal protection of biotechnological inventions or gene patenting. That decision reversed the position of the European Parliament in 1995 and the Labour party's position at the time. It is likely to have far-reaching and uncertain consequences. For that reason, I am immensely grateful that the House has afforded me the opportunity to air the concerns of a great many people.

Since it was announced that I had been successful in the ballot for the debate, I have been contacted by many organisations and individuals, including my hon. Friend the Member for Lewes (Mr. Baker) and the hon. Member for Nottingham, South (Mr. Simpson), who hope to make some brief comments tonight. I know that we are not alone in our concerns. The Government's view on the issue appears to be confused. I welcome the Minister's presence tonight and I hope that he can clarify where the Government stand and how they will respond to the debate that is now emerging.

I have been told that several organisations, including the Women's Environmental Network and the Gaia Foundation wrote to the Minister in advance of the European Parliament vote requesting the Government's views. At least one—the Women's Environmental Network—was told that the British Government were awaiting the final text from the European Commission. As the Government's position was not made clear, it assumed that a position had not been taken in advance of seeing the final text of the directive.

Meanwhile, the Minister informed a scientific political adviser at Greenpeace that the Government intended to hold a public meeting for all interest groups once the text of the Commission's amended draft was known. Again, it appeared that the Labour Government were prepared to listen and consult before taking a final position.

I would like to congratulate the Minister on that approach, which I believe to be correct, but I cannot do so because, on the same day that that letter was written, another letter was winging its way across Europe to United Kingdom Members of the European Parliament. That letter, also from the Minister, was also about the forthcoming vote, but its message was rather different. It explained how important the new Government considered the directive to be for the future of the United Kingdom and European biotechnology industry and urged all Members of the European Parliament to vote for the directive.

I do not intend to be over critical as I wish to raise some important issues, but it is important that the Minister explains how those conflicting statements came to be made. More importantly, as I want to look forward rather than back, will the Minister outline the Government's current position on what is still an emerging discussion that has not reached its final conclusions? Is he for or against a fuller debate and if he is in favour should it not be before rather than after urging support for the directive in Europe?

Liberal Democrats are not opposed to new and appropriate technology. I have listened to the arguments of those in favour of the directive who have been as vocal as those who are against it. However, a recognition of the potential that genetic engineering offers must not lead us to set aside consideration of the possible pitfalls. Above all, we should not encourage faster development here—as the directive will do in practice—in order simply to protect the United Kingdom's competitive position at the cost of long-term risks.

The draft directive would allow human body parts, including DNA, genes and cells, to be patentable outside the human body even though they have an identical structure to their natural counterparts. The directive would also cover cloned animals and genetically engineered food.

Industry says that it needs the directive. It argues that every year the pharmaceutical industry produces new, innovative products that relieve suffering, create employment and reward investors who fund research. For that potential to be realised, those who invest in long-term, high-risk biotechnology research need to know that the possible fruits of their investment will be protected from copyists. Hence, the industry argued the need for patent protection for inventions involving molecules such as proteins, DNA, enzymes and antibodies, which are needed for the treatment and diagnosis of diseases. Without patents, it says, there will be little innovation and no cures.

According to the Minister, however, the draft directive does not render anything patentable that is not patentable under current UK law. If current laws are not adequate, why does the Minister support a new law that does nothing different? I fear that, on the contrary, the European directive will make a difference beyond simply European integration of the rules. That is why commercial concerns are eager to see it in place.

In contrast, organisations that are against such genetic patenting include the Clinical Genetic Society and the Human Genome Organisation—the international body that co-ordinates research into the sequences of the human genome. Opposition also comes from the Royal Society, which has said:

The Royal Society is strongly opposed to any attempts to patent genetic information that is unrelated to the function of use of relevant genes. Commercial pressures in this direction pose a grave threat to scientific research and a hindrance to its ultimate medical applications. The House of Commons Science and Technology Committee on human genetics concluded in its third report that there manifestly is no consensus on a Directive to harmonise patent law and we consider that the imposition of a Directive could be more harmful than the differences in the criteria for patentability in different countries under the current system. The Select Committee did not oppose any form of patenting. The hon. Member for Birmingham, Selly Oak (Dr. Jones) spoke to me earlier about the important concerns that the Committee raised about patenting material that is identified without any change, as distinct from the techniques used or the specific use to which it is to be put. If such patenting happens, I fear that there will be a constriction on the research available. That is the background to the concerns that have been raised.

Some patient groups are opposed to genetic patenting—though others are in favour of it—in spite of apparently being the clearest potential beneficiaries. The American patient umbrella group NORD—the National Organisation for Rare Disorders—has spoken out against patenting of genes, arguing that it will have a negative effect on research. Incidentally, that organisation supports the orphan drug law, which offers tax incentives, among other benefits, to companies involved in research and development. We are not talking about opposition to the principle of the uses to which such research can be put, but a real concern about further research or useful medical use being restricted because of the costs.

The European Union has already produced a draft proposal for a European Parliament and Council regulation on orphan medical products, which is due for discussion. However, the patent draft directive is being discussed without co-ordination.

Other reasons for the concerns of such disparate bodies are clear. Perhaps the most important is that there are many who believe that the directive will threaten future scientific and medical research. In the United States, where such patents already exist, the concerns that I have expressed have become a reality. The United States company, Biocyte, has a sweeping patent on the use of all human blood cells from the umbilical cord of a new-born. That is being disputed by US and European medical groups, because it threatens the free use of such cells for transplant and research.

The Minister should also bear in mind the experience of the Manchester Regional Genetics Centre, which received an unexpected bill from a Toronto-based company demanding a $5,000 licence fee, plus a royalty of $4 per test for every time the centre used a cystic fibrosis gene screening test on which the company had previously filed a patent application. The centre cannot afford that, and I fear that many others in the national health service will not be able to.

Dr. Lynne Jones (Birmingham, Selly Oak)

As the hon. Gentleman knows, Eurocord, the international organisation of cord blood banks, has challenged Biocyte's patent. Does that not highlight the fact that patents are being granted far too widely—the point made in the Select Committee report? Does the hon. Gentleman agree that if the proposals in the report were adopted, many of the concerns that he is raising could be addressed?

Mr. Taylor

I agree. I mentioned the report a moment ago for that reason. The Americans are patenting too much and too widely, but the European directive appears to be drawn equally widely in its potential application.

I shall not concentrate on those issues tonight, but I do not believe—as the Government argue—that patenting has no relation to the wider ethical, moral and environmental issues. There are real concerns about animal cruelty, the effect on biodiversity, the impact on farmers—particularly in developing countries—and our ability to control the after-effects of the technology. We are moving further into the commercial development and patenting sector than our ability to control the issues yet allows us. That is the imbalance about which I am concerned.

I suspect that the Minister will argue both that clear patenting laws are necessary to protect investment and innovation and that existing UK law already allows such protection. It is certainly true that some advances in biotechnology are already patentable. A body of case law regulations is already in place in national patent offices and the European patent office. The EPO is however an independent international organisation, granting European patents according to the European patent convention, which has been signed by European Union member states and several European states that are not in the EU.

There are provisions in the European patent convention that govern relations between national patent offices and the EPO in order to harmonise national and European laws while maintaining an important degree of subsidiarity. That system has been in place for more than 20 years, and during that time, case law has built up important nuances and precedents that I understand are not contained in the proposed directive. I wonder why it is felt that it is right to ignore that history and the slower evolution of matters rather than go for the big-bang approach of a single directive.

Moreover, in the past few weeks, the European Commission has announced the publication of its Green Paper on the creation of a Community patent. That paper should have preceded the proposed directive. It is a consultation document, open to public view and opinion, whereas, in contrast, the biotechnological patenting directive is a legislative document which will have direct effect on Community and national law. It seems that the cart is before the horse.

Mr. Alan Simpson (Nottingham, South)

Does the hon. Gentleman think that it would be helpful for the UK to make two specific submissions? First, perhaps there is a case for less rather than more patenting. Secondly, we ought to be exploring the notion of public goods. Where there has been a financial contribution to research schemes—direct or indirect—either by Governments, charities or voluntary participants, that should be translated into a public stakeholding in goods which cannot be patentable.

Mr. Taylor

I would certainly be interested to consider that, although I do not think that it would necessarily be simple. There are question marks over how far back the research goes for it to be considered that there had been public input. Nevertheless, the point is interesting. I shall turn later to how wide genetic patenting appears to go beyond anything in the past.

If the draft directive is adopted by the Commission, which institution does the Minister believe will have authorisation to grant patents—the EPO or the Commission? To which institution will national patent offices be finally responsible? Which institution will regulate and, in cases of contravention, prosecute?

It has been argued by some that the directive is necessary to clarify advances in genetic patenting. I fear that it is more likely to lead to confusion. There is confusion not only in the consequences of the directive but in its wording. The issue of human cloning, for example, has been left vague. It is true that the directive excludes procedures for human reproductive cloning and methods in which human embryos are used", but technically an embryo is a fertilised cell—a stage bypassed when the now infamous Dolly the sheep was cloned. The language used and the scope for restrictions are therefore demonstrably flawed.

Mr. Norman Baker (Lewes)

Does my hon. Friend share my concern that, just as it was said in the 1930s that where one begins by burning books one ends up by burning people, where one begins by experimenting and patenting parts of animals and plants one ends up by patenting parts of human bodies? Does he agree that the directive could have significant detrimental effects on animal welfare? Is he aware that the Minister sought to press Members of the European Parliament to widen the conditions under which animals could be patented beyond medical benefits to other benefits? Does he agree that it is better to go slow rather than fast in this area because significant matters are at issue? We need to be careful because once something is unleashed, it is difficult to recall it.

Mr. Taylor

My hon. Friend makes some important points. I certainly have concerns about animal welfare implications in some areas. I do not have time to dwell on those points in detail. It is a huge area and the debate is short.

The processes for production of human beings other than by cloning are not mentioned explicitly. The draft directive excludes methods for the artificial production of human embryos containing the same genetic information as another human being or dead person. That is unusual wording which leaves unanswered the question of the production of a human being with different genetic information with, for example, a slowed-down aging process.

The Roslin Institute, which cloned Dolly, has filed a patent application for the technique covering human cloning as well as the cloning of sheep. What is the Government's view on that application? To be fair to the Roslin Institute, it has claimed that that has been done to prevent others from producing a human clone with the technique. Nevertheless, the principle of patenting the technique raises some real concerns.

Biotechnology developments have outpaced our ability to oversee and regulate them. Genetically modified soya bean is in the food chain, and we have no ability to label or police it. Genetically modified organisms are entering the natural environment, from which they cannot be retrieved, and yet no one can be certain of the long-term effects. Plant and animal varieties are increasingly coming under the control of industrial conglomerates, as is scientific research.

The Minister's letter to British Members of the European Parliament argues that British industry would be hampered if the directive were not passed. However, European patents are valid only in European countries that are party to the European patent convention. Therefore, if a European company is not granted a European patent for a specific application, a US or Japanese firm will not be granted one either. If a European firm wishes to apply to the US patent office, it can do so. If a US patent is granted, the European firm is allowed exactly the same patent rights as a US or Japanese firm holding the same patent. I can, therefore, see no reason why the present patent-granting system should affect European industry's international or competitive position, or any reason to rush into taking decisions.

The key issue is whether genetic patents should be broader in scope than those in other fields and, crucially, whether someone who isolates and characterises natural material should be able to patent the material itself, rather than the method for doing so or the use to which it is put. The discoverer has not necessarily contributed anything to the material, merely identified and isolated it. If that principle had been applied to chemistry, the elements themselves would have been patented. Isolated elements are not inventions, although the technique used to remove the element may be inventive.

Patents should therefore only be granted on the inventive process developed to isolate the element or perhaps the use to which it is put. Otherwise, it would be possible for a biomedical company to control completely all future research and medical development that arose from the isolation of a specific gene. That would not foster research, but kill it. It would also make the possibility of genetic testing for disorders, such as heart disease or breast cancer, potentially prohibitively expensive—too expensive for our overstretched NHS. In those respects, the directive threatens the foundations of scientific research and medical action—the free access to material and the freedom to pursue promising lines of inquiry. That is my concern and the reason why I have brought the issue to the House.

10.32 pm
The Minister for Science, Energy and Industry (Mr. John Battle)

I thank the hon. Member for Truro and St. Austell (Mr. Taylor) for initiating this debate because it brings together important issues of scientific research, ethics and the implications for human beings and animals and the law. As the House knows, much of our law is based on property law and the amalgam of those issues is an important focus for debate. To some extent, the debate is helpfully premature. By that I mean that the debate has been sparked by the European Commission's proposal to harmonise patent law in Europe. That proposal will probably arrive before the House in some two to four years' time when, I hope, it will be fully debated under the affirmative resolution procedure.

The hon. Member is right to suggest that we get ahead of the debate. We debated the issue on 11 July at the instigation of my hon. Friend the Member for Norwich, North (Dr. Gibson), although I was sad that more hon. Members were not present. However, at the current rate of one debate a week, the subject will get a fair hearing over the next four years, which is right and proper.

Biotechnology is a relatively recent area of science and it is already providing us with steroids to treat asthma and rheumatoid arthritis, improved forms of insulin for diabetes, vaccines for hepatitis B, monoclonal antibodies for the treatment of cancer and diagnostic test kits for use in blood and food hygiene testing. I do not want to suggest that all biotechnology is bad; in all fairness, I do not think that the hon. Member for Truro and St. Austell suggested that that it was either. Others spoke on the understanding that the debate concerns scientific research, ethics and law rather than suggested that the whole lot should be thrown out. That is much appreciated.

Biotechnology is already driving some of the helpful, useful medicines of the future and could be the key to well-being and quality of life. Its contribution to the future may be enormous. It will offer the possibility of improved diagnosis and treatment for a range of conditions—some of which are apparently incurable at present—and that must be welcome. It will provide benefits not only for animal health but for animal feed, seeds and plants and it will improve the ability of crops to withstand extremes of climate while reducing the need for reliance on pesticides and herbicides. That in itself must be good. It will enable crops to be grown in drought-hit parts of the world and contribute to tackling world poverty and obtaining international food security.

We as parliamentarians should see our job as this: to do our best, in the ambiguous world of science, to ensure that scientific developments are life enhancing and not dehumanising. It is in that context that anxieties about patenting, in particular, are important. I appreciate the anxieties that new technology can create—for instance, worries about genetically modified foods, the prospect of cloning and the application of technologies to the very substance of life itself. We need to ensure that regulations safeguarding human health and dignity, the environment and animal welfare play a key role in creating and maintaining public confidence. I entirely accept the need for us to ensure that regulation keeps pace with scientific developments, to the best of our abilities, and I welcome the fact that our debates are ahead of decisions that may be made four years hence.

Although the patent system is long established and although the concept of registered invention is broadly understood, the system remains incredibly complex legally. It is worth running over a few of the ground rules within which the current United Kingdom system operates.

Patents encourage research by providing an opportunity to cover costs, but the system does not insist that the research takes place; nor does it influence the subject or direction of research. That must be for those involved in developing the technology to decide. It would be wrong to influence such decisions or to try to second guess the actions arising from them by somehow tailoring rights to specific technical subjects or directions. Patent rights are without prejudice to all other bodies of law. That means that, although a patent holder has the legal right to prevent anyone else from using an invention, that right gives him no authorisation to use or exploit it himself. Such use is entirely governed by other regulations dealing with such matters as human health and dignity. That puts the issue into a clear public legal context.

Patents give rights holders a monopoly for use of their inventions, but that lasts for a limited period. Patentees can be obliged to license their rights if it can be shown that monopolies are blocking the exploitation of other patents. It is important to note that the free use of a patented invention for experimental purposes is also allowed. When the rights cease, the invention passes into the public domain for all to use. When patents drop out of the system, inventions become generically available for anyone to work on.

In return for that kind of protection, details of the invention must be published in enough detail for the technically competent to be able to use it. The scope of that protection must be clearly stated for all to see—and to challenge if they wish. I stress that because the hon. Gentleman mentioned a particular case—the Biocyte case—to which my hon. Friend the Member for Birmingham, Selly Oak (Dr. Jones) also referred. That is a demonstration of the right to challenge. People should challenge, to find out what is the scope of the patenting cover and to try to compete with the original invention.

Dr. Lynne Jones

The Select Committee recommended that those who wished to challenge the patent should have the right to challenge it before it was considered by the relevant patenting organisation rather than have to wait until the patent had been granted and then challenge it in the courts, which would take many years. Will my hon. Friend look at that? The Committee wanted the Government to act.

Mr. Battle

Yes, I shall. I have only a few moments in which to reply and I feel constrained by the fact that this is not a full debate. We can consider that and I shall come to it in more detail in a moment.

We ought to remember that patents are available only for technical inventions. Rights cannot be obtained for finding something that freely occurs in nature, such as a gene sequence; nor can they be obtained for materials in their natural state. We should be absolutely clear that the human body and its elements in their natural state are not patentable. Moreover, treatments and diagnoses when performed on the human or animal body, including those using isolated genes, are not protectable. Plant and animal varieties also cannot be patented.

Furthermore, rights can be refused or revoked if it is found that using an invention would be immoral. As I said, given the promises of biotechnology for new treatments and cures, it seems that rather than providing patents on life, as some have suggested, one might see the system as providing patents for life.

Patents are obtained for new technical solutions to problems to the extent that an invention involves intervening in the genetic make-up, which in practice means that rights can encompass gene sequences, but only when separated from nature to the extent that the product of the invention is protectable. In other words, genes in their natural state cannot be patented, only new technical interventions. It is important to make that clear distinction.

As with any technology, those first in uncharted territory may be in a position to obtain patent rights that are broader than appear later to be justified once the area has been explored further. There has been concern that that may be happening in biotechnology—precisely the point that the hon. Gentleman raised. I must emphasise, however, that rights can always be challenged. That means that the judiciary should be ready to review the scope of the patentee's legal entitlement.

A recent case before the House of Lords—Biogen v. Medeva —has shown that monopolies can be cut back if they move into areas outside their legitimate scope. That case involved the ownership of a gene sequence relating, I think, to hepatitis B. As parts of that monopoly could not have been understood at the time, the court ruled against it. The courts can cut access to rights. Existing claims can be challenged and it is important to remember that.

I must say a few words about the European Commission's directive. It has a history—it was proposed as long ago as January last year. We managed to get the first opinion on the original proposal on 16 July. Some 70 amendments to the Commission's proposal were passed, including a suggestion from one Member of the European Parliament that an ethics committee should be created. We support that suggestion. We were asking the Commission to give us a proposal. That was the idea. There was nothing to discuss because the question had fallen into a void.

Essentially, the European Commission's proposal is a single market measure to extend or change the existing patent system in Britain. It is designed to enhance the operation of a single market in biotechnological products rather than to change the law in Britain.

The European Parliament's amendments were passed and we now need to study carefully the proposals that were put together from those amendments. We do not even have the final text of that document. When the proposals emerge, they will be put before us.

The European Commission is expected to amend its proposal in the light of the Parliament's opinion and to submit that to the Council of Ministers for adoption. Until the Commission's amended proposal emerges, it is not possible to determine the precise text that will be put before the Council of Ministers dealing with the internal market.

When the Council is able to reach a common position on the text, it will be sent back to the European Parliament, which will produce a second opinion. Only when the Council and Parliament have agreed will the directive be put forward for adoption in the member states. At that stage, we can discuss the statutory instrument in this Chamber and in Committee and there will be a full debate in the other place.

We are a long way from debating the detail. What we needed was a text to debate and that was the purpose of my letters, which were played off, one against another, rather unfairly.

The motion having been made after Ten o'clock, and the debate having continued for half an hour, MR. DEPUTY SPEAKER adjourned the House without Question put, pursuant to the Standing Order.

Adjourned at seventeen minutes to Eleven o'clock.