The Detail Of Law Relating To Modern Biotechnology

The ability of science to operate effectively within society is de- pendant on a number of factors. Science is totally reliant on the law for its regulation and control, while the boundaries in which science can operate are governed by legal constraints. These boundaries are strongly influenced by society which dictates acceptable levels of morals and ethics in which science can ope- rate. Economic factors must be considered as industry requires reward in order to recoup its research and development inve- stments and continue competing in a competitive and growing market place. Thus the law must reconcile the different tensions raised by science, economics, politics, society and the law itself. This paper looks how this may be achieved at the international, regional and national level.

How should law be used to regulate science? This question is currently the source of a fundamental and complex socio-legal debate. It is fundamental because of the increa- singly central role of science and technology in modem society, and because of the speed of progress in these areas. It is complex because the regulation of science presents many diverse challenges. Scientific technology invariably moves forward, making it difficult to create laws with lasting relevance. Scientific research and scientific advances often engage strongly held social values, making consensus on the objectives and forms of regulation difficult to obtain. In the face of such varied considerations, policy makers have struggled for years to design legislation to regulate existing technologies while trying to take into account the advent of new technologies. Terminology used in science is fluid, with meaning changing as new understandings develop or discoveries are made. Once a law has been enacted, the definitions upon which it is based are often fixed.

While many regard a new scientific advancement with optimism i.e. that it may have the potential to take the human race to new levels and have defended scientists' rights to research almost any area, others treat the advancement with caution or even consider the research a 'slippery slope' from which society may never recover. Scientists often hold the view that research should be unfettered; that society should not choose to control that which is done in the research laboratory. It is only the development of discoveries (whether commercial or otherwise) that need be controlled by society. This view is not generally shared by those not deeply involved with research endeavour. The decision as to whether to regulate scientific research is one which has to be considered carefully by legislators, in order to ensure that our understanding of the world around us is not qualified by political considerations. Regulation of development and, in particular, commercialisation of new products may well be necessary to ensure that the values of the society in which this development occurs are maintained.

What should regulation hope to achieve? It should aim to protect human health, ideally human dignity and human rights, and the environment. According to the Rio Declaration on Environment and Development (1992) 'Human beings are at the centre of concerns for sustainable development. They are entitled to a healthy and productive life in harmony with nature'. Regulations should also reflect public values in relation to such things as the use of animals, humans and embryos in research, and the sustainability of the environment and the society. It is not only those who are alive now that need or deserve protection from our actions. Regulation may increase public trust and thereby enable science to gain public support and a robust platform for scientists and industry to build upon.

There are three levels at which science may be regulated: international, regional and national. Regulation at the international level is perhaps the most desirable in some circumstances, because it removes some of the anomalies seen in regional and national legislation, yet the hardest to achieve. International regulation requires consensus from the majority of countries in order to make a multilateral agreement function. However, often the only way in which to reach a consensus is by a broad drafting in order to accommodate a wide range of perspectives resulting in an agreement which can be interpreted in many ways and frequently does not achieve its primary goal. There are few international agreements covering modem biotechnology. One area of biotechnology where there are international agreements is agro-biotechnology where protection of biological diversity is a primary goal that transcends national barriers. The Rio Declaration on Environment and Development (1992) required that: 'States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to exploit their own resources pursuant to their own environmental and developmental policies, and the respon- sibility to ensure that activities within their jurisdiction or control do not cause damage to the environment of other States or of areas beyond the limits of national jurisdiction. '

The Convention on Biological Diversity (CBD), addressed the need for countries to ensure that the use of modem biotechnology within their borders is achieved in a safe manner (Article 8(g)). The Cartagena Protocol to the CBD was agreed in 2000, after years of negotiation and argument, with many misgivings, but in an atmosphere which had changed from that which pertained at the time the negotiations started. Article 19(3) of the Convention on Biological Diversity (June 1992) had required parties to consider the possibility of a Protocol to the convention that addressed the use (and primarily transboundary movement) of living modified organisms that might have an adverse impact on biological diversity. Eight years later Europeans were no longer accepting modem biotechnology; products had disappeared from the shops, and there was distrust in many countries that was not observed in North America. Few, if any, products derived using modem biotechnology are now available in Europe (Genetically Modified Plants for Food Use and Human Health (2002). In North America, farmers adopted transgenic organisms with little opposition, and products derived from them have been in the shops for nearly 10 years. The Developing Countries had wanted far more in the Protocol than they were able to get, with many more safeguards. However, the producer countries fought hard to ensure that, insofar as it was possible, few if any controls were applied particularly to commodity goods. The size of the commodity market alone, they argued, made it difficult to contemplate a regime which required what amounted to 'visas' at country entry points.

Even though the final version of the Cartagena Protocol was a compromise made between many countries, the major producers of GMOs, the US, Argentina and Canada have yet to ratify the Protocol. The Protocol and Article 8(g) of the CBD are primarily concerned with adverse impacts that living modified organisms resulting from modem biotechnology may have on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

There is little international regulation in relation to human genetics and health, although the UNESCO Universal Declaration on the Human Genome and Human Rights, which was formulated in 1997, is a non-binding Declaration that has implications for the use of modem biotechnology in humans. The Declaration addresses the right to respect for individual's human dignity irrespective of their genetic characteristics. It asserts that the human genome, in its natural state shall not give rise to financial gains, and addresses the rights of individuals in relation to their genetic heritage. Article 11 requires that: 'Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted. States and competent international organizations are invited to co-operate in identifying such practices and in taking, at national or international level, the measures necessary to ensure that the principles set out in this Declaration are respected. '

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Although this Declaration does not constitute regulation, it (at the very least) permi- ts states to institute regulation to protect human dignity where it might be compromised through the use of modem biotechnology. The UN has been trying to reach agreement on a stance on cloning for more than 2 years, during which time the 191 member states were split between two resolutions. The frrst, put forth by Costa Rica, proposed a total ban on all forms and purposes of cloning. The second submitted by Belgium, recommended a ban on human reproductive cloning but left the decision about therapeutic cloning up to individual states. The parties are as far apart as ever and no consensus has been reached

The EU achieves regulation at the regional level primarily via Directives (that need to be implemented by member states) and Regulations. The regulatory system for the use of transgenic microorganisms in containment and for the release and marketing, traceability and labelling of genetically modified organisms are detailed and arguably, excessive. The use of animals is partially controlled; there is a protocol to the Treaty of Amsterdam on the protection and welfare of animals, and Directive 86/609 addresses the protection of animals used for experimental and other scientific purposes. However, there are few if any, Directives or Regulations that directly cover many areas of modem biotechnology where they directly involve humans, such as stem cells, cloning or gene therapy. At the Council of Europe's level, the Convention on Human Rights and Biomedicine, signed in Oviedo in 1997, in Article 18 establishes that it is up to each country to decide whether or not to authorise embryo research with surplus embryos. Each country is only obliged to respect two conditions: 'to ensure adequate protection of the embryo', (that is to say to adopt a legislation fixing the conditions and limits of such research); and to prohibit ''the creation of human embryos for research purposes'. The Convention is binding only for the States which have ratified it. In the EU to date nineteen countries have completed the procedure and some are in the process of doing so. The UK has not signed.

However, the EU requires that the Convention is respected, when undertaking research fmanced through European Commission funds. At the same level, the Charter on Fundamental rights of the European Union approved by the European Council in Nice (France) on 14 October, 2000, prohibits different kinds of practices possibly related to embryo re- search, namely 'eugenic practices, in particular those aiming at the selection of persons' and 'the reproductive cloning of human beings'. This Charter will form part of the new European Constitution (art 11-63). However, to date, only three EU member states have ratified the Convention.

GMOs appear to be one area where Directives and Regulations bring about a certain degree on harmony within the EU. Since the de facto moratorium on the commercialisation of GM crops in 1998, the EU has introduced a series of legislative measures which control GMOs from the laboratory to field trials to placing on the market to labelling and traceability. The three main pieces of legislation are: Directive 2001/18, on the deliberate release into the environment of GMOs, Regulation 1830/2003 concerning the traceability and labelling and Regulation 1829/2003 concerning genetically modified food and feed.

This legislation is generally viewed as being extremely comprehensive while others see it as over regulation. Every GMO is reviewed on a case-by-case (and step-by-step) basis. It must pass risk assessments of its impact on human health and the environment, food safety assessments whether for food or feed, labelling based on the origin of the GMO rather than the presence of any GM DNA or protein, traceability right through the food chain - from farm to fork, all aimed at allaying consumer fears and giving the consumer choice.

But why has so much legislation been introduced so quickly? The development of certain areas of modem biotechnology has huge economic implications. This is especially true of agro-biotechnology. The EU accounts for about 15% of the world's agricultural exports and about 20% of the imports bringing in millions of Euro. It may be argued that much of the legislation has been implemented in response to public concerns over GMOs and their purpose is to insure low risk to human health and the environment. Alternatively, it may be argued that the speed and breadth of the regulations are actually to encourage innovation and economic development. In other words to promote trade. Although each member country retains some responsibility for decisions in relation to GMO products, much of the oversight of the use of living modified organism has now been taken over by the European Food Safety Authority.

In technologies which have less of an obvious impact on trade with or between the EU and the rest of the world, the policy on regulation appears to be one which moves from a harmonised position to taking a pluralist approach. The lack of any EU regional legislation in many areas of modem biotechnology has resulted in very different national legislation within the EU member States. This is particularly evident in the area of therapeutic cloning and stem cell research. In the UK, for example, where stem cell research is both legal and encouraged, there is a good regulatory framework for embryo research governed by the Human Fertilisation and Embryology Act (1991). The HFE Act is administered by the Human Fertilisation and Embryology Authority (HFEA) which has issued licenses for research projects relating to human embryonic stem cells and allow therapeutic cloning to produce embryonic stem cells. In contrast, The Federal Embryo Protection Law (1990), in Germany, prohibits both the procurement of embryonic stem cells from human embryos and the creation of human embryos for research purposes. However, in June 2002 a new law on stem cells allows for the import and use of human embryonic stem cell lines under certain conditions. The German stem cell law evolves from the widely held belief that human life begins at the moment of conception. This taken in conjunction with the recognition of the embryo as having human dignity, a concept enshrined in the German constitution, has resulted in a reasonably conservative approach. So why allow for the import of and research on stem cells under certain conditions? This suggests a conflict between scientific freedom and the legislative prohibition of scientific research. The partial prohibition of stem cell research may be viewed as a way of not violating scientific freedom. Thus allowing for some re- search, but under very limited conditions. Alternatively, it may be that the potential beneficial therapeutic applications that may arise from stem cell research for individuals and society outweigh the strong ethical arguments justifying an outright ban.

Some countries, particularly the USA, frequently take the view that decisions that address concerns associated with the application of biotechnology, must be purely science based - this applies especially to agro-biotechnology. Science must be the base by which regulatory officials can assure and build upon credibility, remain current, and assure a rational basis for decision-making. In this way, science and the legal processes are inextricably linked for regulations that evaluate biological products. However, this approach is severely limited and will not operate successfully in Europe where citizens are much more questioning of new technology.

So what do regulations in biotechnology hope to achieve? The central purpose of regulations should be to ensure safety, limit the risk to human health and the environment and limit potential product risks, while being efficient and encouraging innovation and economic development. In addition, regulations need to reflect societal values which dictate acceptable levels of morals and ethics in which science can operate. Lack of tran- sparency and accountability, which can be facilitated through public engagement, will result in science being wiable to gain the trust of the public. GM crops in Europe being a case in point.

References

1. Report of the United Nations Conference on Environment and development (Rio de Janeiro, 3-14 June 1992). Annex I: Rio Declaration on Environment and Development; Principle 1.
2. The Royal Society (February 2002) Genetically Modified Plants for Food Use and human health - an update. Policy Document 4/02 ISBN 0 85403 576 1 paragraph 2.