To strengthen the US-EU dialogue on biotechnology.

Transcription

1 EUROPEAN COMMISSION Brussels, BIOTECHNOLOGY IN BILATERAL AND MULTILATERAL FORA Modern" biotechnology can be distinguished from older existing biotechnology techniques which also use the characteristics of living organisms, such as yeasts for the production of beer or wine. Generally modern biotechnology makes systematic use of scientific insights, thereby applying modern techniques (available since the end of the 1970 s), such as DNA recombination, in order to overcome natural barriers to recombination between different species of organisms. Plants, animals and microorganisms can now be genetically modified in such a way as to produce new substances or express particular traits. Plants can be modified to express particular characteristics such as tolerance to herbicides, which may enable their growth with reduced herbicide costs or with increased yields. BILATERAL FORA Biotechnology issues are discussed bilaterally with the US, Canada and Japan. 1. EU-US 1.1 In the framework of the Transatlantic Economic Partnership (TEP), a group on biotechnology was established between the Commission and the US Administration (TEP-Biotech Group) with the following tasks: To monitor the progress of the dialogue on the various technical issues carried out in existing groups with a view to reduce any unnecessary barrier to trade. To increase and enhance scientific and regulatory cooperation and information exchange and promote transparency and information of consumers. To promote a pilot project in order to compare the molecular genetic characterization data requirements under our respective environmental review processes. To strengthen the US-EU dialogue on biotechnology.

2 The TEP-Biotech Group held three meetings in 1999 and one meeting in 2000 (on 11 February, 18 June, 13/14 December 1999 and an audio conference on 26 April 1999 and on 26 May 2000). These meetings were conducted in a constructive atmosphere, despite well-known differences of basic approach on biotechnology issues. There has been an agreement to exchange various elements of information, such as monitoring data on the environmental aspects of the use of particular genetically modified crops and updates of the policy process concerning labelling and product approvals. There were early warnings of several product approval applications and an explanation of the process regarding the adoption of a proposal for an amended directive concerning the deliberate release of GMOs into the environment. At its meeting of 18 June 1999, the group agreed on the terms of reference for the simultaneous applications pilot project which will be conducted as a priority. The first phase of this project, the comparison of the molecular data requirements, was launched at a workshop on 19/21 October During the last TEP-biotech meeting, the US side has been informed that the Commission had received feedback from 6 Member States on the Molecular Characterisation Data requirements, relevant for product approval under respective regulatory systems. These comments of Member States together with 4 additional received after the last TEP-biotech meeting were compiled and the overview of EU/US differences concerning these requirements were discussed with Member States during a meeting held in Brussels on 10 February The result of the discussions will be sent to the US side. The importance of scientific co-operation with regard to developing state-of-the-art testing and sampling methodology was stressed during a TEP biotech meeting in Washington DC on 26 May USDA Grain Inspection, Packers and Stockyards Administration (GIPSA) and the Community's Joint Research Centre (JRC) are about to formalise working contacts in this area. Certification of GMOs based on mutually acknowledged testing and sampling methods could help to avoid unnecessary trade problems. However, the Commission has made it clear that the EU is not in a position to guarantee market access to the EU of possible future certified shipments of GMOs without retaining the possibility of further verification, in particular in respect to possible comixing with non-eu approved varieties. 1.2 In October 1999 Presidents Prodi and Clinton agreed that dialogue on biotechnology between the EU and the US should be enhanced on a broad range of issues. At the December 1999 EU-US Summit a twin-track approach was endorsed, involving high level dialogue between Administrations in the New Transatlantic Agenda Senior Level Group, and with input from civil society via an independent panel of experts: the Consultative Forum. The Senior Level Group (biotech) last met on 29 March 2000 to take stock on a number of issues of concern to both sides: such as product approval process, labelling rules, and the ECJ ruling on Novartis GM maize; and to finalise the details for the launch of the Consultative Forum. The precise mandate and proposed members of the Forum were finalised and endorsed at the May 2000 EU-US Summit. Since then the co-chairs have been appointed (Professor Lubbers and Professor Garza) and preparatory work has begun. The first full meeting of the Forum is likely to be in September. The Forum is due to report to the December 2000 EU-US Summit. The next meeting of the SLG (biotech) is also scheduled for September (exact date to be confirmed). The EU and US Administration have identified the pursuit of this dialogue on a wide range of issues relating to modern biotechnology as a priority for the second half of In addition to the TEP- Biotechnology Group, which is an overarching group, there 2

3 are the following EU-US technical groups: The EU-US Task Force on Biotechnology and the EU-US Agri-food Biotech Group on the Commercialisation of Agricultural Crops and Foodstuffs derived from modern biotechnology. - The EU-US Task Force on Biotechnology Research This Group has its 10th anniversary in October this year and has met annually to exchange information on research activities. Workshops on numerous topics have been held and particular attention has been paid to Biosafety research relating to GMOs and their growth in the environment. Several International Symposia have been organised on this topic. Under the new scientific collaboration agreement with the US, the group is now moving to a phase of collaboration giving emphasis to biosafety research and risk assessment. - The EU-US Agri-food Biotech Group-on the Commercialisation of Agricultural Crops and Foodstuffs derived from modern biotechnology Since the establishment of the Group, in 1996, there have been three meetings of the Group. At the 3rd meeting, which took place on 17 June 1999, the Group focused mainly on regulatory and technical aspects which may have an impact on the commercialisation of biotechnology-derived plants and food products, namely the implementation of the Novel Foods Regulation, the provisions for commercialisation of genetically modified plant varieties and labelling. The Group has agreed that apart from technical aspects of regulations, in its future discussions it will also consider economic and industrial aspects of biotechnology. Industry representatives from both sides can participate in the discussions of the Group on selected issues. 1.4 The Transatlantic Dialogues (non-governmental) Under the auspices of the New Transatlantic Agenda people to people chapter, the Commission has supported the establishment of several non-governmental transatlantic dialogues. These dialogues set their own agendas. Currently three of the dialogues: the Transatlantic Business Dialogue, the Transatlantic Consumer Dialogue and the Transatlantic Environment Dialogue are taking an active interest in biotechnology, and have made a number of specific joint recommendations to the US Government and to the EU authorities. These three Dialogues were invited to nominate an expert to participate in the Consultative Forum. 3

4 2. The EU-Japan Biotechnology Policy Working Group This group does not actively consider trade issues. The group includes Commission and EuropaBio representatives on the EU side, and MITI and the Japanese Biotechnology Industry Association representatives on the Japanese side. It meets every 9 to 12 months. Peripheral meetings usually take place with MAFF and the Ministry for Health and Welfare. The focus is on exchange of information on how to develop a modern biotech industry in our respective countries. Public policies and ideas are presented and explained, and industry presents its view of developments. The Commission and MITI produce an agreed document of economic indicators of relevance to the industry. There is also a presentation and discussion on research programmes in the biotech fields. During the last years discussion has been mainly concentrated on the regulatory systems on both sides. These are however of an explanatory character. 3. EU-Canada The Canada-Europe Round Table for Business (non-governmental dialogue) has recently discussed agri-food biotech issues and has adopted recommendations addressed to both Governments. A similar project as the Pilot Project in the framework of the TEP-biotech group (see under paragraph on EU-US) has started with Canada. The first round of discussions on the molecular data requirements for product approvals was held in Ottawa on November Ten delegates from six Member States participated in these discussions. A draft summary report on that meeting was prepared by Canada sent for comments to Member States in February Comments will be discussed and forwarded for discussion to the Canadian side. MULTILATERAL FORA Biotechnology has been most actively discussed in the context of the negotiations concerning a Biosafety Protocol on the transboundary movement of Living Modified Organisms (LMOs) under the Convention on Biological Diversity, in various Groups in the OECD and in the framework of the Codex Alimentarius. Biotechnology issues are also under consideration in more recent fora, e.g. the International Conference on Harmonisation (ICH) and a working group of experts under the World Intellectual Property Organisation (WIPO). 1. Biosafety Protocol In November 1995, the Parties to the Convention on Biodiversity (CBD) agreed to start a negotiation process to develop a protocol on biosafety, in the field of the safe transfer, handling and use of living modified organisms (LMOs) 1 covering transboundary movement of any LMO that may have "an adverse effect... on biological diversity. After six preparatory meetings, a 1 These are basically seeds, but not the products derived thereof 4

5 negotiating effort to conclude a Protocol failed in Cartagena, in February In a final negotiation session in Montreal from January 2000, a Protocol on Biosafety has been adopted by the extra ordinary Conference of the Parties of the CBD. The Community and 14 Member States subsequently signed the Protocol in May An intergovernmental process on the necessary procedures for the Protocol has been set up. France will host the first meeting of this Committee in December The Protocol provides a minimal legal framework for transboundary movements of LMOs for which there were no international rules in place so far. This Protocol is particularly in the interest of developing countries which, in most cases, have not yet developed a national framework to cover the handling and safe use of LMOs, and do not have the capacity to deal with the risk assessment of such organisms. In recognising the very specificity of LMOs and of potential associated risks, it will also provide greater legitimacy to the EU legislative framework. Other essential characteristics of the Protocol are: The Protocol establishes an Advance Informed Agreement (AIA) procedure for Living Modified Organisms (LMOs), which will be released into the environment, and establishes an alternative procedure for LMO commodities which builds on a system of advance warning about possible imports through an international information sharing mechanism, the Biosafety Clearing House, as well as capacity building for developing countries. The decision-making procedure for imports is science-based and allows the use of the precautionary principle. The Protocol refers to the precautionary principle in the preamble, in the objectives and, for the first time in an environmental agreement, in the operative articles of the text (relating to decisions on imports of LMOs). The Protocol contains a provision stating that LMOs for food, feed or processing have to be accompanied by documentation that clearly identifies shipments as "may contain" LMOs and as not intended for introduction into the environment. The provision further states that detailed requirements, including specification of their identity and any unique identification, be decided no later than two years after the Protocol s entry into force. The EU was successful in its insistence on the deletion of any `savings clause' in the Protocol (which would make, according to the EU s assessment, the Protocol subordinate to WTO agreements). Instead agreement was reached on preambular language, containing three elements; firstly, mutual supportiveness, secondly that the Protocol shall not be interpreted as implying a change in other international agreements and, thirdly, a paragraph stating that the second element is not intended to create sub-ordination of the Protocol. The Protocol will, in addition to establishing an AIA for LMOs intended for direct introduction into the environment, in the first instance help developing countries without satisfactory domestic legislation to take decisions on imports on LMO commodities based on the precautionary principle in order to protect their biodiversity. The Protocol should through establishing a link between environment, trade and development and by providing legitimacy for the precautionary principle in international law have an important impact in the longer perspective. 2. OECD 5

6 The OECD contributed extensively to the debate on biotechnology over the last two decades. Different working groups have produced, in particular, comparative studies related to scientific, regulatory and patenting frameworks within the OECD members and have developed `consensus documents for use during the regulatory assessment of a particular product (biology of certain crop plants and selected traits), as well as technical and economic studies about the impact of biotechnology. The OECD is also responsible for some international standards in which biotechnology is an issue. This is the case in particular for the `OECD Schemes for the varietal certification of seed moving in international trade, as well as the `OECD Scheme for the control of forest reproductive material moving in international trade These schemes are legally binding for their members, notwithstanding some opting out provisions. EC directives dealing with these matters are closely related to these schemes, which are under revision. The inclusion of provisions relating to the identification and labelling of GMOs has been raised by the EC in the context of these two schemes but a solution has not been found so far, due to resistance from the US side. The recent approval of the Biosafety Protocol could ease the coming negotiation in that respect. Most recently, OECD has prepared a report for G8 on biotechnology and other aspects of food safety. This report covers five elements: A consultation with civil society held in November 1999 A Conference on food safety aspects of biotechnology in February 2000, A report from the Working Group for the Harmonisation of Regulatory Oversight in Biotechnology, on the environmental aspects, A report from the Task Force for the Safety of Novel Foods and Feed, on the food safety aspects A report from a specially created ad hoc group on other (ie non-biotech) aspects of food safety. The report from the ad hoc group consists of Compendia on National Food Safety systems and activities and on International Food Safety systems, and an Executive Summary Report. All groups have fulfilled their mandate from G8. The debate on follow up action has centred on Continuation of the mandate of the ad hoc food safety group Setting up an independent international panel on biotechnology. A second conference, this time on environmental aspects of biotechnology. OECD, supported by the EU, was willing to continue with these initiatives, but there was some resistance from non-eu members. The OECD Ministers, on 26/27 June, concluded that there should be a second OECD conference on biotechnology. OECD was also invited to continue to carry out economic analyses and to play an active role in the international discussions on food safety, particularly involving civil society, and sharing the results with developing countries. The debate then moved to the G8 summit in Okinawa (21/23 July). The Final Communique supports the conclusions of the OECD Ministers. However, unable to agree on the umbrella for the international panel (UN or OECD) theg8 Ministers stated simply that 6

7 they will explore the way to integrate the best scientific knowledge into the global process of consensus building on biotechnology and other aspects of food safety. They also supported the efforts of the Codex General Principles Committee to achieve greater global consensus on how precaution should be applied to food safety where available scienetific evidence is incomplete or contradictory a key point for the Community. 3. CODEX alimentarius 3.1 Codex Committee on Food Labelling (CCFL) This Committee is working on recommendations for the labelling of foods obtained through modern biotechnology. Two texts constitute the basis of discussions: Section 2 (definitions), and Section 5 (rules for labelling). The Commission participates in a drafting group which is part of a wider ad hoc Working Group, both chaired by Canada. The CCFL decided on most of the definitions at its last session in May 2000 but, given the diversity of opinions among Member countries, decided to mandate the Working Group to continue its deliberations and combine the different options discussed in the text and at the CCFL meeting. The Working Group has to prepare a revised version for circulation and consideration by the next session in May Ad Hoc Task Force on Foods Derived from Biotechnology The Task Force was established at the 23 rd Session in 1999 with the following terms of reference To elaborate standards, guidelines or other principles, as appropriate, for foods derived from biotechnology; To coordinate and closely collaborate, as necessary, with appropriate Codex Committees within their mandate as related to foods derived from biotechnology; and To take full account of existing work carried out by national authorities, FAO, WHO, other international organisations and other relevant international fora. The Task Force shall complete its work within four years. The Task Force should submit a preliminary report to the Codex Commission in 2001, a mid-term report, where appropriate, to the Executive Committee in 2002, and a full report in The first meeting in the Task Force was held in Japan on March 2000 and it was agreed to establish a Working Group with a mandate to develop general principles for the risk analysis and guidance for the risk assessment of foods derived from biotechnology. Furthermore, the Working Group would review discussion papers on traceability and familiarity, if available. The Working group met for the first time beginning of July and will meet again in October 2000 to prepare the documents for the next session of the Task Force in March

8 4. The World Intellectual Property Organisation (WIPO) The World Intellectual Property Organisation (WIPO) has convened a Working Group of experts in the field of biotechnology and intellectual property rights. At its first meeting on 8-9 November 1999, the Working Group agreed to undertake a number of projects in the first half of the year A final report will be prepared and submitted to WIPO by the end of June Nine different topics for further study are to be examined in the context of the Working Group, e.g. in relation to the protection of genetic resources and traditional knowledge. In this respect, the Working Group is aiming at: examining practices related to the protection of biotechnology inventions under patent and plant variety protection systems of WIPO Member States, reviewing application of certain legal standards in an early stage and certain other biotechnology inventions under patents, examining legal regimes and university/government practices related to the use of patents to create technology-based collaboration with the private sector and to evaluate the relative success of different models for technology transfer, assessing modalities for technology commercialisation involving biological resources, and prepare studies that may facilitate discussions related to collaboration agreements for conducting R&D of naturally occurring biological materials, evaluating issues related to the establishment of a multilateral system for the deposit and use of machine-readable nucleotide and amino acid sequence information, and evaluating means for recording ownership interest in inventions arising out of privatepublic collaborative research and similar projects. The Commission supports these initiatives. 5. The International Conference on Harmonisation (ICH) The International Conference on Harmonisation was set up in 1990 to expedite the global development and availability of new medicines without sacrificing safeguards on quality, safety and efficacy. It is an informal forum which allows dialogue between regulatory authorities and the pharmaceutical industry from the EU, US and Japan in order to identify and reduce the differences in technical requirements for medicinal products development and to identify areas where modifications in technical requirements or greater mutual acceptance of research and development procedures could lead to a more economical use of human, animal and material resources, without compromising safety. As of October 1999, over 40 harmonised guidelines, standards or recommendations had 8

9 reached the point of implementation in the three regions. A further 10 projects are in process. Some new specific proposals are under consideration including biotechnology and other new technologies. 9