- Email: [email protected]
Regulatory policy: Europe on the starting blocks
Regulatory policy: Europe on the starting blocks Guest editorial Brian Ager Senior Advisory Group on Biotechnology, Brussels, Belgium Current Opinion in Biotechnology 1992, 3:218-219 The creation of a single European market in 1992 is mainly an economic exercise b y the 12 m e m b e r states of the European Community (EC), aimed primarily at harmonizing internal regulatory structures to create the world's largest single market of s o m e 340 million people. Most of the necessary legislation has been adopted, and, in broad terms, the whole project is well on track. In the run-up to the creation of the single market, biotechnology has received special attention. Not surprisingly, there have b e e n both positive and negative developments. To consider first the positive aspects, in April 1991 the European Commission p r o d u c e d a biotechnology policy document. Promoting the Competitive Environment for the Industrial Activities Based on Biotechnology Within the Community w a s launched b y the Industry and Single Market Commissioner, Vice-President Martin Bangemann. At the time he said that the Community must take a strategic view of biotechnology. The policy document states that biotechnology is a key factor in the economic d e v e l o p m e n t of the Community and will play a significant role in facing the major challenges of food, health, environment and population growth. Responsibility for competitiveness rests with Industry and will d e p e n d on strategies of individual firms but the Community as a w h o l e must ensure a framework to satisfy public concerns and also to encourage industrial developments. The policy document clearly places the topic on the economic agenda of the EC. It states that "The achievement of the internal market for biotechnology will mainly d e p e n d u p o n the application of two tools: the legal framework and the use of standards. The Commission will: ensure a coherent regulatory approach; ensure existing legislation is kept u n d e r review to reflect rapid d e v e l o p m e n t s and technical and scientific progress; put in place a single assessment and notification procedure for product authorization; prepare a clear and precise mandate for biotechnology standards and codes of practice; in assessing products, apply the three traditional criteria (of safety, quality and efficacy) based
on scientific evaluation. Socio-economic aspects need to be considered in a different way. It is not the intention to have another assessment in addition to the three criteria". Since their launch in April 1991, the policy proposals have received the seal of approval from the Council of Ministers w h o represent the governments of the Member States - - the ultimate political authority in the EC Institutions. The proposals have therefore b e c o m e Community policy. Approval of the policy d o c u m e n t was a key event, because in the scheme of government and EC operation, the establishment of a policy sets the direction and limits of regulation. It aims to give a predictable climate in which academia and industry can operate, even though the precise detail is not laid down. Finally it should provide a reference document to policy makers, interest groups and the general public throughout the Community. So there is n o w a policy platform in place on which it is possible to work together to achieve European competitiveness. The next step has to be the translation of policy into action. In this, the Commission is benefitting from the creation last year of the Biotechnology Coordination Committee. This group is chaired by the Commission's Secretary General and pulls together all the relevant services of the Commission at a senior level for the task of policy coordination. There have b e e n positive developments in applying the policy document. For example, a major EC and EFTA (European Free Trade Association) p r o g r a m m e on standards is being put together with the full support of the Co'rnmission and the EC's m e m b e r states. The transsectoral nature of biotechnology means that it is important to establish c o m m o n standards to reinforce good practice in academia and industry. The w o r k will also c o m p l e m e n t the Community's legislative activity and will collectively involve industry, g o v e r n m e n t officials, scientists and other groups. The p r o g r a m m e will be supported by an EC mandate giving both political and financial support. The objectives of the p r o g r a m m e are twofold: to strengthen the competitiveness of industrial activities based on biotechnology in the European Commu-
Abbreviation
EC--EuropeanCommunity. 218
© Current Biology Ltd ISSN 0958-1669
Regulatory policy Ager 219 nity and, b y defining technical specifications, codes, methods, etc., to provide the technical c o m p l e m e n t to, and support for, the legislation. These standards for biotechnology will cover operations with 'traditional' organisms and microorganisms, as well as with genetically modified organisms, and areas subject to legislation, as well as those that are not regulated. In effect it is a consensus initiative by the practitioners of biotechnology, defining good and safe practice and is clearly in the interests of researchers, producers and consumers. The p r o g r a m m e will cover six broad areas. First, in laboratories for research, d e v e l o p m e n t and analysis the p r o g r a m m e will provide codes of good practice for laboratory operations, defining the equipment needed according to the degree of hazard, methods for handling, testing and inactivation of waste, and so on. Second, guidelines will be drawn up to cover large-scale processes and production, including plant design, process design and operating procedures for large-scale fermentation and extraction processes. Third, the programme with set standard testing procedures and performance criteria for various pieces of equipment. The fourth area covered will be modified organisms for use in the environment, including methods for their detection and identification. The fifth part of the p r o g r a m m e involves examination of the various lists of plants and animal pathogens and of hosts and vectors, to support classification w o r k at the Community level. Finally, the p r o g r a m m e will detail the methods required for the implementation of quality control procedures. The EC policy d o c u m e n t is essentially forward-looking and w e can expect m o r e positive developments to come. But w e should also p a y attention to what has h a p p e n e d in the past.
ing products on the basis of the technology used to manufacture them is a real recipe for errors of judgement on product safety. This point is well recognized and increasingly put into practice by Europe's major trading competitors - - the USA and Japan. It is important to 'get it right' from both the scientific and the safety point of view. For regulatory purposes the focus must be on product characteristics and intended use and not on the process by which the product was derived. To quote from the recent US White House policy on regulation: "products develo p e d through biotechnology processes do not p e r se pose risks to h u m a n health and the environment". This approach is being w o v e n into the public policy fabric of the USA and Japan. This product approach to regulation is recognized b y last year's Community policy paper, and so we have reason to h o p e for a clarified and more scientific direction in Europe. But, unfortunately, the system w e are labouring under in Europe was developed before the Community policy was developed and approved. The EC Directives, which were supposed to be implemented b y October 31st 1991 are only in force in one country, Denmark. Other m e m b e r countries are having difficulty in implementing them, and some are questioning the wisdom of adopting them at all. Until the Directives have been implemented in all Member States, they cannot operate at the Community level. Does it matter if we in Europe have a different approach from the rest of the world and one that is out of step both scientifically and with respect to policy? Indeed it does - - it matters throughout the chain from research innovation to the market place. The danger is that if w e b e c o m e out of step world-wide, w e will lose investment, manufacturing and jobs, and will end up being merely a consumer and not a producer.
Back in the mid 1980s the Commission had b e g u n to draft Directives to regulate key aspects of biotechnology. These are c o m m o n l y k n o w n as the Contained Use and Deliberate Release Directives. They give the Commission the p o w e r to supervise the regulation, not only of research, but also of products. These directives are applied w h e r e the n e w techniques of biotechnology have b e e n used. In other words, the process used to manufacture a product determines its system of approval.
Europe has traditional strengths in terms of its life science research base and industries. Provided that we can together successfully implement the Community policies that have n o w b e e n set, we stand a good chance of maintaining these strengths while delivering m a x i m u m benefits to the consumer in terms of products and services. The m a p has b e e n drawn but there is still some w a y to travel.
Of course, the best method of regulation is b y a system that evaluates all products in the same manner, irrespective of h o w they have b e e n made. Apart from anything else, those w h o have the responsibility of evaluating such products will have garnered the best experience to judge their safety. Classifying and judg-
B Ager, Senior Advisory Group on Biotechnology, 4 Avenue E Van Nieuwenhuyse, B-1160 Brussels, Belgium.
on scientific evaluation. Socio-economic aspects need to be considered in a different way. It is not the intention to have another assessment in addition to the three criteria". Since their launch in April 1991, the policy proposals have received the seal of approval from the Council of Ministers w h o represent the governments of the Member States - - the ultimate political authority in the EC Institutions. The proposals have therefore b e c o m e Community policy. Approval of the policy d o c u m e n t was a key event, because in the scheme of government and EC operation, the establishment of a policy sets the direction and limits of regulation. It aims to give a predictable climate in which academia and industry can operate, even though the precise detail is not laid down. Finally it should provide a reference document to policy makers, interest groups and the general public throughout the Community. So there is n o w a policy platform in place on which it is possible to work together to achieve European competitiveness. The next step has to be the translation of policy into action. In this, the Commission is benefitting from the creation last year of the Biotechnology Coordination Committee. This group is chaired by the Commission's Secretary General and pulls together all the relevant services of the Commission at a senior level for the task of policy coordination. There have b e e n positive developments in applying the policy document. For example, a major EC and EFTA (European Free Trade Association) p r o g r a m m e on standards is being put together with the full support of the Co'rnmission and the EC's m e m b e r states. The transsectoral nature of biotechnology means that it is important to establish c o m m o n standards to reinforce good practice in academia and industry. The w o r k will also c o m p l e m e n t the Community's legislative activity and will collectively involve industry, g o v e r n m e n t officials, scientists and other groups. The p r o g r a m m e will be supported by an EC mandate giving both political and financial support. The objectives of the p r o g r a m m e are twofold: to strengthen the competitiveness of industrial activities based on biotechnology in the European Commu-
Abbreviation
EC--EuropeanCommunity. 218
© Current Biology Ltd ISSN 0958-1669
Regulatory policy Ager 219 nity and, b y defining technical specifications, codes, methods, etc., to provide the technical c o m p l e m e n t to, and support for, the legislation. These standards for biotechnology will cover operations with 'traditional' organisms and microorganisms, as well as with genetically modified organisms, and areas subject to legislation, as well as those that are not regulated. In effect it is a consensus initiative by the practitioners of biotechnology, defining good and safe practice and is clearly in the interests of researchers, producers and consumers. The p r o g r a m m e will cover six broad areas. First, in laboratories for research, d e v e l o p m e n t and analysis the p r o g r a m m e will provide codes of good practice for laboratory operations, defining the equipment needed according to the degree of hazard, methods for handling, testing and inactivation of waste, and so on. Second, guidelines will be drawn up to cover large-scale processes and production, including plant design, process design and operating procedures for large-scale fermentation and extraction processes. Third, the programme with set standard testing procedures and performance criteria for various pieces of equipment. The fourth area covered will be modified organisms for use in the environment, including methods for their detection and identification. The fifth part of the p r o g r a m m e involves examination of the various lists of plants and animal pathogens and of hosts and vectors, to support classification w o r k at the Community level. Finally, the p r o g r a m m e will detail the methods required for the implementation of quality control procedures. The EC policy d o c u m e n t is essentially forward-looking and w e can expect m o r e positive developments to come. But w e should also p a y attention to what has h a p p e n e d in the past.
ing products on the basis of the technology used to manufacture them is a real recipe for errors of judgement on product safety. This point is well recognized and increasingly put into practice by Europe's major trading competitors - - the USA and Japan. It is important to 'get it right' from both the scientific and the safety point of view. For regulatory purposes the focus must be on product characteristics and intended use and not on the process by which the product was derived. To quote from the recent US White House policy on regulation: "products develo p e d through biotechnology processes do not p e r se pose risks to h u m a n health and the environment". This approach is being w o v e n into the public policy fabric of the USA and Japan. This product approach to regulation is recognized b y last year's Community policy paper, and so we have reason to h o p e for a clarified and more scientific direction in Europe. But, unfortunately, the system w e are labouring under in Europe was developed before the Community policy was developed and approved. The EC Directives, which were supposed to be implemented b y October 31st 1991 are only in force in one country, Denmark. Other m e m b e r countries are having difficulty in implementing them, and some are questioning the wisdom of adopting them at all. Until the Directives have been implemented in all Member States, they cannot operate at the Community level. Does it matter if we in Europe have a different approach from the rest of the world and one that is out of step both scientifically and with respect to policy? Indeed it does - - it matters throughout the chain from research innovation to the market place. The danger is that if w e b e c o m e out of step world-wide, w e will lose investment, manufacturing and jobs, and will end up being merely a consumer and not a producer.
Back in the mid 1980s the Commission had b e g u n to draft Directives to regulate key aspects of biotechnology. These are c o m m o n l y k n o w n as the Contained Use and Deliberate Release Directives. They give the Commission the p o w e r to supervise the regulation, not only of research, but also of products. These directives are applied w h e r e the n e w techniques of biotechnology have b e e n used. In other words, the process used to manufacture a product determines its system of approval.
Europe has traditional strengths in terms of its life science research base and industries. Provided that we can together successfully implement the Community policies that have n o w b e e n set, we stand a good chance of maintaining these strengths while delivering m a x i m u m benefits to the consumer in terms of products and services. The m a p has b e e n drawn but there is still some w a y to travel.
Of course, the best method of regulation is b y a system that evaluates all products in the same manner, irrespective of h o w they have b e e n made. Apart from anything else, those w h o have the responsibility of evaluating such products will have garnered the best experience to judge their safety. Classifying and judg-
B Ager, Senior Advisory Group on Biotechnology, 4 Avenue E Van Nieuwenhuyse, B-1160 Brussels, Belgium.