HL Deb 17 July 2000 vol 615 cc652-6

7.41 p.m.

Lord McIntosh of Haringey rose to move, That the draft regulations laid before the House on 3rd July be approved [25th Report from the Joint Committee].

The draft legislation concerns the implementation of Articles 1 to 11 of European Directive 98/44/EC on the legal protection of biotechnological inventions into United Kingdom patent law. Biotechnology is a relatively new science and offers huge potential. For example, treatments for asthma, rheumatoid arthritis, diabetes, hepatitis B and some forms of cancer are already being improved through biotechnological solutions. Biotechnological changes to crops, so that they are able to withstand extremes of climate while reducing reliance on pesticides and herbicides, are highly significant developments and these may be merely the tip of an iceberg. If this sector is to develop its potential benefits for enhancing quality of life, the legal framework within which decisions are made to invest in research and to bring new products to market must encourage innovation and the taking of commercial risks. The patents system is an integral part of that framework.

While those examples and other developments of themselves must be good things, I am very much aware of the social and ethical concerns that surround this new technology and the need for a full understanding of the relationship between scientific research, ethics and the law. Scientific developments must be life enhancing and not dehumanising. The directive sought to address those issues as far as patent law can, and sought to get the balance right.

The directive has a long history. As far back as 1985, the Commission's White Paper on the completion of the internal market foreshadowed action on biotechnological patents. A first proposal for the harmonisation of patent laws in this field emerged in 1988 and the Council of Ministers was able to adopt a common position on a directive in 1994. However, the European Parliament voted against that text in 1995 and the proposal was not adopted.

The Commission produced a second proposal later that year. Following scrutiny by both Houses of Parliament, the UK Government joined a qualified majority in adopting the directive in December 1997. The directive entered into European law in July 1998 and member states have until 30th July to implement.

The texts of European national patents law are already closely aligned as all EU member states are party to the European Patent Convention, an intergovernmental agreement dating from 1973. However, differences in interpretation of these laws in respect of biotechnological inventions encouraged the European Commission to bring forward a proposal to reduce or eliminate variations which were cited by industry as causing uncertainties, and so reducing incentives to invest in costly research. Such a deterrent is unwelcome and the directive sought to address that.

Of course, patent rights are without prejudice to other bodies of law. Patents provide what might be called a negative right; that is, a right to prevent others from using a protected invention. They do not give rights to use an invention or to market products or services embodying a protected invention. Such use is determined, for instance, by regulations safeguarding human dignity, the environment, animal welfare and competition. Those are not affected.

The regulations create little change in United Kingdom law, which is the Patents Act 1977. They do not lead to anything becoming patentable which is not currently patentable under existing legislation, but introduce changes to limit access to patent rights in certain sensitive areas of technology. For example, patents will not be granted for reproductive cloning of human beings, for processes where the germ line genetic identity of human beings is modified and for certain processes in which human embryos are used.

In particular, it should be noted that under UK law at present, human genes as they exist in the cells in our bodies cannot be patented. The directive establishes that basic principle across Europe, rightly making clear that patents will be obtainable only for inventions for new technical solutions. The simple discovery that a gene sequence exists in nature, or the information contained in such a sequence, will not be able to be patented as it is not of itself an invention.

That is fully consistent with the joint statement made by the Prime Minister and President Clinton on the human genome. That stated that raw, fundamental information about the genetic make-up of the body should be freely available. The United Kingdom has very clear rules, reinforced by the directive and the draft legislation before us to ensure that basic gene sequence information will not be patented.

I should add that a regulatory impact assessment was signed by the Minister on 3rd July and has been placed in the Library of both Houses. It gives evidence of extensive public consultation earlier this year. A summary of the views expressed in the consultation and the information available from the consultation will be published in due course. The consultees will be advised of the debate in this House.

Moved, That the draft regulations laid before the House on 3rd July be approved [25th Report from the Joint Committee].—(Lord McIntosh of Haringey.)

Lord Mackay of Ardbrecknish

My Lords, I had little to say about this regulation until earlier this evening. I was simply going to make the point, not just in respect of this regulation but the others too, that, frankly, the Explanatory Notes are a misnomer. They are explanatory only if one understands the whole issue sufficiently to be able to follow the original statutory instrument. I have no doubt that the Minister will tell us that it has always been thus. Maybe it is time we thought about changing things and making the Explanatory Notes more of an explanatory note and less of a repeat of small parts of the statutory instrument.

However, the real point I want to make came to me in a fax I received from Mr Anthony Keeling of Elsoms Seeds. It is particularly about plants, not animals. I accept that much of the Minister's speech was about animals, especially, indeed, the human animal and the genes we all have.

If I may, I am going to do a version of what I might describe as a "Tam Dalyell"; that is, I am going to read out the letter. It is not a subject with which I am familiar. But the person who sent the letter has a point. Perhaps the principal point is this. The Minister mentioned that this statutory instrument was in adherence to a European directive. Have we gone any further than that European directive? In other words, have we gold-plated it in any way? Is there anything in this instrument which is a step further than the European directive? The reason I ask that will become clear in a minute.

Mr Keeling writes thus: I am writing to you urgently as I understand [that this] will be debated tonight in the House of Lords and because representations made by me and our trade society, The British Society of Plant Breeders, have been ignored in this draft Statutory Instrument. In particular, completely contrary to the intention of European legislators, the current draft specifically disadvantages smaller breeders who do not have a major in-house gene bank and do not have direct access to biotechnology patents. To be quite specific in section 7 of the draft SI 'patented biotechnological inventions: patent licences' it is now required that the applicant is the holder of Plant Breeders Rights in a plant variety and has another plant variety which is/was bred from that first variety but which cannot be exploited without infringing the patent concerned. For consumers, a strength of Plant Breeders Rights legislation is that competitors are completely free to use a breeder's protected variety to create new varieties. In fact small breeders, without a large historic background of their own varieties, use competitors varieties as the main source of their parent material. (This is amply proven by the declared parents in National List applications.) The draft SI, therefore, effectively disenfranchises smaller breeders from being able to use the compulsory licence provisions! The British Society of Plant Breeders has made the point to the government's civil servants that the vital aspect which should be covered by this Statutory Instrument is that the applicant ('the breeder') should be a potential holder of Plant Breeders Rights. To encourage competition and smaller breeding enterprises it is crucial that this change is incorporated into this legislation in line with the letter and the intent of the European Directive concerned. The whole point of the compulsory licence provisions was to enable breeders, such as us, to have some equity in this area. As this draft stands, quite the contrary, patent holders will readily be able to obtain a compulsory licence to enable them to register 'our' variety incorporating their patented construct whereas, as I have indicated above, the converse is almost impossible for us". I understand that when it comes to, say, winter wheat, the major player in this field is now Monsanto and that company owns around 80 per cent of the parents. Previously a small breeder could actually use those parents to breed their own variety. But under this statutory instrument they will not be able to do so. Mr Keeling's point is that that goes a lot further than the directive asks us to go. He suggests to me that this simply looks like protection for the market leader in any particular field.

I know that this is a complicated issue. As I do not pretend to understand it deeply, I do not expect the Minister to give me chapter and verse. If he is able to do so, I shall be extremely grateful and, as always, impressed by the noble Lord, Lord McIntosh of Haringey. But if he is not, I understand that he will write to me afterwards.

Lord Razzall

My Lords, I share the view of the noble Lord, Lord Mackay of Ardbrecknish, in his description of the documents given to us as being an explanatory memorandum. They use "explanatory" in the same way as we call fee-paying schools "public" when they are not.

However, a number of points have been raised by those who have concerns about this statutory instrument. I would welcome the Minister either answering tonight or writing to me through his officials. First, are we correct in assuming that under these regulations farmers are entirely safe using their own home-grown seed or can they do that only when it is clear that the sellers—that is, seed merchants or other sellers—agree to their using their harvest for seed? Or will farmers in future have to make entirely sure that they read the small print on the seed sacks in order to be safe in using their own home-grown seed?

Secondly, people have certain anxieties in relation to the human genome project and this statutory instrument. The great thing about the recent announcement on the successful completion of the human genome project was the fact that the information would be put into the public domain and not be associated particularly with private intellectual property rights. Are the regulations saying that, provided we can clearly identify the function of a sequence and that it has some industrial or medical application—for example, a breast cancer gene or a gene for muscular dystrophy—it can be patented? And does that mean that the consequence of these regulations is that private industry will run away with the profits from what has been widely advertised as being publicly-funded research?

Thirdly, touching again on a question raised by the noble Lord, Lord Mackay of Ardbrecknish—whether or not the regulations gold-plate the European position—how do the regulations fit in with the European patent position? I had understood that the European Parliament overturned the Commission's proposals to allow patenting of genome sequences. How do the regulations impact on that?

Lord McIntosh of Haringey

My Lords, I shall do my best to respond to the points being made, though some of them become a little bit recherché.

The most important point made by the noble Lord, Lord Mackay, was as to whether or not, as alleged by his correspondent, the regulations go further than the European directive. I can give him a categorical assurance that the regulations in fact copy precisely the terms of the directive. There is no gold-plating and no deviation from the directive's test.

I can confirm also that the British Society of Plant Breeders was consulted and expressed its views. As I have already said, in due course those views will be made public. But the fundamental point I have to make to the noble Lord, Lord Mackay, is that his point does not apply to Articles 1 to 11 of the directive, which is all that is being implemented by this order; it applies to Article 12, which is to be dealt with in the future by negative resolution rather than by this affirmative resolution. It will be dealt with under the Patents and Plant Variety Rights Compulsory Licensing Provisions 2000, which have not yet been laid, and discussions with plant breeders are ongoing. There is still an opportunity therefore for the correspondent of the noble Lord, Lord Mackay, to make his views known to officials of the Department of Trade and Industry and the Patent Office, to make sure that his point is fully considered. So nothing is lost by these regulations.

In relation to the point raised by the noble Lord, Lord Razzall, the European Parliament turned down an earlier version of the directive, but this version was approved by all the authorities from whom it needed approval. The regulations do not change the position of farmers and their home-grown seeds. There is a derogation from patent rights in any case for small farmers, and I guess that that will apply also to horticulturists.

As I believe I said in my opening remarks, the patenting of the genome sequence is not changed by this regulation; it is only an invention, not a discovery, which can be patented under patent law. As I understand it, what the noble Lord, Lord Razzall, was describing would fall into the category of a discovery rather than an invention. There is no proposal from the Commission for patenting the genome sequence. I hope that I have answered the points raised. I commend the regulations to the House.

On Question, Motion agreed to.