European Standing Committee B
Tuesday 25 November 1997
[Mrs. Gwyneth Dunwoody in the Chair]
Biotechnological Inventions
10.30 am
The Minister for Science, Energy and Industry (Mr. John Battle): In introducing this consideration of the proposals before us, I want to spell out that the document concerns the European Commission's proposal for establishing a clear framework for the legal protection of biotechnological inventions through the harmonisation of certain aspects of national patent law. The Commission's attempt in Europe to achieve that has a long history. As far back as 1995 the Commission published a White Paper on the completion of the internal market, which foresaw action on biotechnological patents. A first proposal emerged in 1988 and the Council of Ministers was able to adopt a common position on the directive back in 1994.
On Second Reading, the European Parliament sought to introduce amendments which were found to be unacceptable to the Council. Although a joint text was agreed during the conciliation process, the European Parliament voted against that text and the proposal was not adopted.
The Commission has now embarked on a fresh attempt to harmonise national patent laws to pull them together. A second proposal emerged at the beginning of 1996 and the European Parliament voted in July this year to introduce a further 70 amendments to the Commission's text. The document before us today is the Commission's revised proposal, which incorporates almost all the amendments that Parliament sought at the time. There is already substantial harmonisation between the national patent laws of member states of the European Union. All the members of the European patent organisation--[Interruption.]
The Chairman: Order. The Speaker has made it clear that no one should carry electronic toys during House of Commons proceedings and I fully support that view.
Mr. Battle: I assure you, Mrs. Dunwoody, that I am not carrying any electronic toys, as far as I am aware. I apologise for the interruption.
All members of the European Union are members of the European Patent Organisation and its central patent-granting authority, the European Patent Office, is based in Munich. By making a single application to the European Patent Office, applicants for patents may obtain rights in several or all member states. However, patents may be obtained without using the European route by making separate applications to the national authorities and, in any event, one granted, all rights are subject to national patent laws.
To put the system into effect, national laws of member states were closely aligned with the European patent convention 1978. Although the text of member states' national laws is closely aligned, there are differences of interpretation between member states and between them and the European Patent Office. That confusion must be sorted out. The differences are causing uncertainties which may act as a deterrent not only to scientific research and development, but to industries using that scientific research and development. If they cannot patent properly, they do not know where they are and the confusion may block developments. That deterrent is unwelcome.
I emphasise that biotechnology is a new science with huge potential. The treatment of asthma, rheumatoid arthritis, diabetes, hepatitis B and some forms of cancer is already being tackled through biotechnological solutions. Biotechnological changes to crops to enable them to withstand extremes of climate, while reducing reliance on pesticides and herbicides, are already highly significant developments. I am tempted to say that they may be the tip of the iceberg in the potential of technology to deliver change.
To enable the biotechnology sector to deliver its potential benefits to enhance the quality of life on our planet, 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 risk.
The patent system is absolutely essential: it is an integral part of that framework. Although the examples that I have given and other potential developments must be beneficial, I am aware that there is a sense of awe around the technology--a sense of threat, and a worry about where it may lead. It is surrounded by social and ethical anxieties. We need a fuller understanding of the relationship between scientific research, ethics and law. Scientific developments must be life enhancing and not dehumanising.
The European Parliament rejected the Commssion's first attempt to introduce this harmonising directive because it felt that the proposal did not deal properly with ethical issues. The document is intended to incorporate almost all the Parliament's views, and to get the balance right between patent law and ethical anxieties in so far as patent law can deal with such issues.
All patent rights are without prejudice to other bodies of law: the patent law has to be perfected, but that does not diminish the need for other laws to act as a counter and as a check on inventions. Patents provide a negative right: a limited 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. That use is determined by regulations that consider and safeguard human dignity, the environment and animal welfare. Those regulations must keep pace with technology.
The proposal will have little effect on United Kingdom patent law--the Patents Act 1977. The proposal will not lead to anything becoming patentable that is not currently patentable under existing legislation. Changes will be required, however, to limit access to patent rights in some sensitive areas of technology. Patents will not be granted for genetically modified animals if such genetic modification causes suffering without substantial medical benefit; for reproductive cloning of human beings; for processes in which the germ line genetic identity of human beings is modified; or for some processes in which human embryos are used.
The proposal is intended to clarify what is patentable. It confirms that discoveries may not necessarily be regarded as patentable inventions. It is designed to harmonise practice in Europe to create a single market in biotechnology, which is vital to enable those who research into the area to know where they stand within the European Union.
The Chairman: Order. We now have until 11.30 am to question the Minister. Provided that questions are brief and to the point, we shall succeed in fitting in many of them.
Mrs. Gillan: I thank the Minister for his opening statement. I appreciate the Clerk's efforts to remedy the late deposit of papers for our scrutiny.
I raised that matter with the Minister at the Committee's previous sitting. Can he explain, therefore, why the specific request of the Select Committee on European Legislation that the Minister provide a report on the 17 October meeting of interested parties was not complied with until after 7 pm yesterday? Does the Minister appreciate that the Select Committee did not ask lightly for that report? Was not his Department in serious dereliction of its duty in producing the documents at 7.15 pm? Has he any explanation for that, apart from carelessness or lack of attention to detail? How does he expect the Chairman, members of the Committee or other hon. Members to absorb such a quantity of material in that time?
Mr. Battle: I apologise unreservedly to you, Mrs. Dunwoody, and to the Committee. Documents ought to be available in proper time so that members of the Committee can read them and contribute to their scrutiny. These documents did arrive late, including my own copy. I can say only that the four documents that we will scrutinise today--the initial proposed directive, the Department's explanatory memorandum, the revised proposal and the supplementary memorandum--were sent out on 18 November by my Department's parliamentary branch to you, Mrs. Dunwoody, and the Vote Office, and to all members of the Committee on 20 November.
It was brought to my attention by officials yesterday evening that the Select Committee on European Legislation had asked for a report of the public consultation meeting held to discuss the proposed directive. The documents provided are transcripts of the 17 October meeting and a compilation of the written evidence submitted then. Committee documents should, of course, be available to us, but those that we are to scrutinise were available.
The other material is supplementary, and I can hint that some of it was available as some of the written material was sent out to hon. Members. That is no excuse, as every member of the Committee should have received the documents.
I can only apologise and emphasise that I do not believe that the late delivery will substantially change our consideration of the documents before us. Those documents are detailed and include a lot of background evidence, particularly the first of them. We are considering the second version of an original document and there has been some change. The consultation did not take place in a vacuum as there have been conversations on this matter across Europe since 1988. I hope that the fact that the documents were not available will not substantially alter our ability to scrutinise the relevant documents.
I have asked my Permanent Secretary to find out why the documents were not available on time and an inquiry will take place. I apologise unreservedly to the hon. Lady, to you, Mrs. Dunwoody, and to the rest of the Committee.
Mrs. Gillan: I appreciate that generous apology. However, papers considered vital by the European Select Committee were not available in time. I do not intend to go into the detail of the transcripts. As the Minister has rightly said, they are not a report of the meeting, but it is on the record that many of those who attended the public meeting were not satisfied with how it was conducted. The documents do not contain a list of those who attended, but are a verbatim transcript from tape and include blanks and asterisks where the tape missed things. I have read the transcript since I received it at half-past eight last night. I am not entirely convinced that the Minister has had the opportunity to scrutinise what was said at the public meeting and I hope that he will read the transcript because if I were him, I would be unhappy with some of its comments.
First, it would seem that the Minister, through no fault of his own but perhaps the fault of his Department, has not provided papers for this morning's meeting on a timely basis.
Secondly, why did the Minister ignore the Select Committee's request for the matter to be debated on the Floor of the House? When members of the Select Committee scrutinised the documentation, they considered the matter to be of such importance as to deserve a wider debate. That request has been totally ignored by the Minister, who instead prefers to conduct what he describes as a ``low-key'' approach to a matter that the Select Committee considered to be of
``considerable legal and political importance.''
This is not a trivial subject but a matter of public interest, so I ask the Minister why it was decided that the debate should be held in Committee and not on the Floor of the House where a wider group of hon. Members could participate?
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