Third Standing Committee on Delegated Legislation
Thursday 20 July 2000
[Dr. Michael Clark in the Chair]
Draft Patents Regulations 2000
The Minister for Competition and Consumer Affairs (Dr. Kim Howells): I beg to move,
That the Committee has considered the draft Patents Regulations 2000.
It is a great privilege to serve on a Committee chaired by the only member of the Chairmen's Panel who owns some patents or, indeed, knows anything about them, Dr. Clark.
The regulations concern the implementation into United Kingdom patent law of articles 1 to 11 of European directive 98/44/EC on the legal protection of biotechnological inventions. Biotechnology is a relatively new science and offers huge potential: for example, as hon. Members may know, treatments for asthma, rheumatoid arthritis, diabetes, hepatitis B and some forms of cancer are already being improved through biotechnological solutions, and biotechnological changes to crops that enable them to withstand extremes of climate while reducing reliance on pesticides and herbicides are highly significant developments that may be merely the tip of an iceberg.
If the biotechnological sector is to deliver its potential benefits and enhance 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. Although the examples I have given and other developments must, of themselves, be good things, I am acutely aware of the social and ethical concerns that surround the new technology and of the need for full understanding of the relationship between scientific research, ethics and law. Scientific developments must be life enhancing, not dehumanising. The directive sought to address those issuesas far as patent law can do soand 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 the field emerged in 1998, and the Council of Ministers was able to adopt a common position on the 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 and, following scrutiny by both Houses, the United Kingdom 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 30 July to implement it.
The text of European national patents laws are already closely allied, as all EU member states are party to the European patent convention, an inter-governmental agreement dating from 1973. However, differences in interpretation of those laws in respect of biotechnological inventions encouraged the European Commission to make a proposal to reduce or eliminate variations that had been cited by industry as causing uncertainties and therefore reducing incentives to invest in costly research. Such a deterrent is unwelcome and the directive sought to address the problem. Of course, patent rights are without prejudice to other bodies of law: patents provide what might be called a negative rightthat 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 that embody 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 with specific regard to the Patents Act 1977. They do not lead to anything becoming patentable that is not patentable under existing legislation. However, they introduce changes to limit access to patent rights in sensitive areas of technology: for example, patents will not be granted for reproductive cloning of human beings, for processes in which the germ line genetic identity of human beings is modified, or for processes in which human embryos are used.
It should be noted in particular that, under current UK law, human genes as they exist in the cells in our bodies cannot be patented. The directive establishes that basic principle across Europe, rightly making it clear that patents will be obtainable only for inventions for new technical solutions. The simple discovery that a gene sequence exists in nature, or of the information contained in such a sequence, will not be patentable 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: it stated that raw, fundamental information about the genetic make-up of the body should be freely available. The United Kingdom has clear rules, reinforced by the directive and the draft legislation, to ensure that basic gene sequence information will not be patented.
Mrs. Angela Browning (Tiverton and Honiton): I am pleased to serve for the first time in a Committee under your chairmanship, Dr. Clark, especially given your specialist knowledge of the area. You will keep us all in order.
I am sure that the Minister has already marked me out as a consensus politician and he will already know that I want to be helpful in this matter, not least because industry needs a framework; however, I want to raise some concerns. For the record, I was the Minister who licensed the first genetically modified products in this country, so I am philosophically signed up to the advance of technology and science in this general area.
I will reiterate something that the Minister mentioned, namely the joint statement on 26 June concerning the human genome project made by the Prime Minister and the President of the United States. We all understand why they said they wanted access to sequence data to be unencumbered: we are hopeful that those data, now that they are universally available and while they continue to be made so, will lead to developments for which patents will almost certainly be required. Therefore, although I accept what the Minister has said, I hope that we can put patenting into context.
I draw the Minister's attention to the fact that the regulations focus on an EU solution when, in fact, the issue requires a global solution. The statutory instrument emanates from the EU directive, but we have recently seen a global new world patent law treaty drawn up under the auspices of the United Nations, to which the United Kingdom and the USA are signatories, although to date France is not. That point focuses attention on the way in which the EU directive has emerged and whether the Government should be attending more to the global dimension rather than the EU dimension. That is important not least because I read in the Government's regulatory impact assessment that, following a debate in the Dutch Parliament, the Netherlands has made reference to the European Court of Justice seeking to annul the directive; Italy has intervened in support of the Dutch, but France has opposed the Dutch action. The case is before the European Court. That should not delay implementation by other member states.
There are clear signals that there is not agreement in the EU. I want national Governments to use their authority to make their national position clear, because if progress can be made globallyespecially with a key agreement between the United States and the United Kingdomwe should be able to make progress. I hope that the Minister will not think that the matter has been addressed because the regulations have been laid: he must deal with the wider issues in a global context, not least because we want matters to proceed satisfactorily for inventors and scientists in this country. There is a clear difference between the United States, where patent ownership is based on the first to invent, and the United Kingdom, where it is based on the first to file. We need clarification. Almost inevitably there will be a dramatic race across a range of disciplines, such as the human genome project, for patent registration. I hope that the Government regard those considerations as a priority in their negotiations with the United States. The United Kingdom should not be impeded by disagreement among EU member states, because this is not solely an EU matter; it has a global dimension and UK companies and scientists need the stability of a reliable framework.
In respect of the regulations before us today, an editorial that appeared in the New Scientist expressed concern that
Many of the implications of this legislation regard what rights someone has on an inserted gene. If the technology is patented then it must be made available to public scrutiny. It can be fairly simple to produce a similar gene product with a different gene structure. Would a patent protect this kind of change? If a plant is grown with modified genes and patented would plants fertilised by pollen from modified plants be liable to patent protection and the owner of the hybrid plants liable to prosecution?
Those questions reflect scientists' worries about the regulations. I am aware that the subject matter does not make it easy to provide a rigid and clearly understood framework, but that necessary uncertainty has a downside because companies and scientists may spend a great deal of valuable time testing cases in court. That will impede, not only commercial progress, but the valuable results that we hope to gain from new and exciting scientific research. I hope that the Minister will reassure me about the way in which the regulations have been drafted. In particular, I should like to know what analysis his officials have made of minimising the need to test in the courts, because that is not a satisfactory way to legislate.
On page 6 of the regulations, paragraph 5(2)(b) of new schedule A1 refers to the use of such products by farmers and their liability. The principle of payment is established in lawI may have been the one who introduced it, so I have no intention of challenging it. As many more products are now available to farmers, has the Minister had a chance to consider the documentation and administrative costs and the process by which farmers are required to prove that they are ``a small farmer''? That could become very bureaucratic with use. A select and discrete range of options available to the farmer would be all right. However, in the light of the current broadening out, will the Ministerwhose Department, has responsibility for deregulation and removal of regulatory costs, although the main responsibility in this respect probably lies with MAFFassure us that he will consider the processes by which the definition of a small farmer is to be reached and the relevant payments made? Events are moving on. I do not see an exact cost apportioned in the impact assessment, but costs to small farmers could be reduced in this context.