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21 April 1993
Doc. 6816
1403-20/4/93-2-E
OPINION
on European biotechnology1
(Rapporteur: Mr Albert PROBST,
Germany, CDU/CSU)
I. Introduction
1. Biotechnology is the exploitation of biological processes for commercial benefit. Its roots are in beer, wine, cheese and bread production, and in classical plant and animal breeding. At its simplest it is traditional agriculture, which depends upon the selection and marketing of improved strains of animals and varieties of plants. At its most complex it is the synthesis of genes and the production of novel organisms for vaccine production or the synthesis of complex organic compounds. The inter-relatedness of the "old" and "new" technologies needs to be stressed. The only real difference is that the new technologies allow us to things we were doing before more quickly and more efficiently, and in some circumstances to solve problems which previously were very difficult to tackle. This is why so many scientists find it difficult to understand public concerns about recent developments. For example, it is hard from a purely scientific point of view to understand why it is perfectly acceptable to utilise strains of yeast for beer making that are derived from years of selecting mutants of the yeast that have arisen at random and which are modified in unknown ways, while it is totally unacceptable to use a yeast which has one change of known nature obtained by molecular techniques. More will be said about this problem later because of its importance to industry and the need to ensure that the present opening-up of public opinion is encouraged.
II. The underpinning science
2. For most of the period that the basic science underpinning advances in biotechnology has been developed European laboratories have been in the forefront of the related academic research. As a result there are many well qualified scientists available to develop the technology commercially. Indeed, it is likely that most university undergraduates in life sciences within Europe are familiar with the concepts and techniques of molecular genetics, and a large proportion are potentially able to develop their skills if employment in the relevant industries is available and sufficiently attractive. For example, it is not uncommon for undergraduate students in United Kingdom universities to conduct gene cloning experiments because the procedures used are well established and reasonably straightforward. The biggest challenge is seldom that of making recombinant organisms, but is to identify genes or sequences of DNA that regulate gene activity which can be manipulated to produce something useful.
3. Possibly the main area of concern for the development of biotechnology is in the basic understanding of how organisms function. Much of what needs to be done to improve the quality of farm produce requires that the way that plants or animals function is modified in a subtle manner to reduce the production of unwanted products and increase that of more useful products. A good example is the modification of oilseed rape to produce oils that are more useful to industry than those which this crop produces at present. To be able to do this one needs to know how different plant species make different types of oil and then to modify the mechanism in a good crop plant, such as oilseed rape, so that it can produce oils which otherwise are obtained from plants which are much less easy to cultivate. Unfortunately, funding for research on such topics has been limited and the work has been judged to be "too hard" and "not glamorous" by many able scientists who have concentrated in developing molecular genetic techniques. While the latter still need further development, there is no doubt that basic studies in biochemistry and physiology need to be expanded to provide the information required for the next generation of genetically engineered organisms. There is little need to worry about the development of molecular genetic techniques because these will come from medical research, and in particular "high profile" projects such as those to combat Aids and cancers. In Europe we have the opportunity to compete very successfully with the rest of the world if we can overcome this restraint because the same problem of under-supporting basic sciences is impeding our major competitors.
4. While discussing the underpinning sciences it is important to remember that biotechnology also involves engineering to enable biochemical processes to function in the production of useful compounds, such as antibiotics and enzymes. We are fortunate in Europe in having very strong pharmaceutical industries and excellent people capable of conducting basic research in biochemical engineering. These are particularly important areas to support if we wish to retain and expand one of our most important areas of industry. In this respect it is to be hoped that improved support will become available for basic research in biochemical engineering.
III. Background to legislation
5. The long established areas of biotechnology, such as plant breeding, and the production of pharmaceuticals and vaccines, have a well recognised range of regulations and known procedures for bringing products to market. In many areas, such as with pesticides, there are European Community regulations which have helped to facilitate marketing and have reduced the difficulties which would otherwise be inherent in controlling the production and use of products in twelve independent states. It would be very valuable for the development of Europe as a whole if such harmonised regulations could be adopted by all countries in the region. There is no doubt that we need regulations to ensure that new products and processes are safe, and that consumers are aware that their safety and that of the environment has been taken into consideration. The value of the European Parliament and Commission as bodies which can draft, discuss and approve directives to harmonise relevant legislation needs to be more widely recognised. If their role was better understood, their processes more transparent and more consultative there might be less opportunity for criticism and delay in implementing the directives which have resulted from discussions on the harmonisation of legislation. It would be very valuable if the Parliamentary Assembly of the Council of Europe were to take a more active role in the harmonisation of regulations across all twenty-seven member states.
6. A particular concern about the development of regulations for biotechnology has been the apparent disproportionate influence of "green" thinking in the drafting and parliamentary processes involved in the development of EC Directives; even though Green Party representation in member parliaments is very small. For those involved in genetic manipulation there has also been uncertainty about the quality of debate within the European Commission. It is inevitable that virtually all human endeavour, particularly that involving food and industrial production, will be to the detriment of the environment. Indeed, in overpopulated countries in the Third World it is conceivable that no natural environments will remain in areas capable of growing crops, as is the position in most of Europe. The quite legitimate concerns of DG XI (Directorate General for the Environment) concerning potential environmental harm would be much better articulated through the monitoring of compliance with regulations in a watchdog role, rather than having an important role in the production and running of regulatory procedures.
7. I am concerned that biotechnology may not be able to flourish in Europe because the regulatory framework is biased with controls being imposed by those whose principal role is to consider the environment. For any industry to flourish there is a need for an active and informed dialogue; preferably between equals. We must learn how to do this for biotechnology.
8. As a result of education and an active press in Europe people are aware of risks associated with their place of work and travel. The result is that for new technologies there is an understandable demand that they be risk-free. Because nothing is risk-free there is an immediate problem that new technologies are perceived to be harmful, even though they may replace existing technologies that people accept, but which are intrinsically more harmful, such as coal mining. For biological systems it is very difficult to predict anything with certainty, and thus a need to demonstrate that conjectural harm will not occur is a serious limitation to the development of biotechnology. A fertile imagination will always be able to dream-up a risk because it is not trammelled by the need to provide evidence for the assertion, while for the defender there is the constant need to produce sufficient data. In many areas of industry risk can be assessed fairly accurately, particularly when the strength of materials or other measurable parameters are involved. This seldom applies in biotechnology because of the complexity of living systems. For example, because biologists have very little knowledge at the biochemical level of what makes some plants weeds, and others not, they are usually unable to predict whether an introduced species from another country will become a weed. Thus when it comes to defending the release of a genetically engineered plant they will also be unable to predict the result with absolute certainty, even though it will generally be selected by the plant breeder for similarity to the parent which is likely to be well known. Fortunately in the past agriculture was allowed to develop without the need to demonstrate in advance that introduced crops, or selected lines of existing crops, could not give rise to a range of conjectural hazards.
9. It is to be expected that the general public will feel uneasy about a technology which is so manifestly unable to respond to requests for certainty in risk assessments; but it is also unacceptable that biological advances should be held back because of unreasonable demands for assurance. We have to find a way in which the exploitation of biotechnology can occur in an environment similar to that which enabled us to develop vaccines and other potentially very dangerous but socially desirable products, with the public being aware of the inevitable link between risks and benefits which appears so lacking in much of present thinking.
10. Some of the industries involved in developing biotechnology have been unhelpful in developing a climate of public opinion about a technology which can be highly emotive and can produce organisms which for the first time are truly designed by humans. In this respect it is a great pity that the use of this technology to develop vaccines and other life-saving products has received so little attention, whereas the development of herbicide resistant crops is widely publicised. There seems to be a major problem in Europe that industrial development leading to increased profits for industry is considered by many opinion makers to be intrinsically wrong. I believe that this arises from the present situation where most people are well fed and have almost unlimited access to consumer goods, and do not have any concept of economics. How the significant proportions of the populace in most European countries would survive without the income they derive from the government, and hence taxes on industry and income, needs to be made clear. it really is time that there was a major effort to educate the public about the benefits that arise from well regulated industrial development and the absolute necessity to continuously develop new products and procedures for making them. If this debate is not pursued with sufficient vigour we will surely start to stagnate and could easily drift to the sort of industrial and agricultural malaise that has almost destroyed living standards in much of eastern Europe. We need to ask more often what right we have to deprive future generations of the benefits of new technologies, while we enjoy those of our ancestors.
IV. Plant sciences
11. This is perhaps one area in which there is the greatest potential for well recognised public benefit from biotechnology. We all depend upon plants for food and throughout the world food production is a major political problem. The very desirable position in Europe where food is not limiting is surely only a temporary situation and is certainly one that does not, and probably cannot, exist throughout much of the rest of the world. Our concerns about excessive food production appear to be almost obscene when viewed from much of the developing world which is rapidly destroying natural environments in its attempt to feed ever increasing populations. We must learn to look ahead for more than the next few years in planning agricultural developments, both because of the need to consider that people in other countries are also humans and will need food aid and because there is a need to improve our existing crops.
12. One of the most exciting benefits that can be gained from gene manipulation is the ability to make crop plants resistant to pests through alterations which make the plants themselves intrinsically resistant to the pests. For example potato blight is a very serious disease, but is not a disease that most other plants suffer from. Modification of potatoes to make them more like these other crops would have an enormous impact on potato yields throughout the world and would reduce the need for chemical pesticides because they would no longer be needed for this disease. Similar alterations to other crops could result in the virtual elimination of the use of pesticides in agriculture for the control of diseases and pests. It is very difficult to predict when this might occur, but it is likely that this might be achieved by the middle of the next century. On the route to this desirable objective we now have insecticidal genes functioning in cotton, tobacco, tomato and corn plants, and hope soon to see the introduction of genes which will protect plants from being attacked by fungi. The full and rapid exploitation of all forms of research to produce plants which can survive the ravages of disease and insect attack will be needed if we are to be able to feed the expanding world population.
13. Present developments to make crops resistant to insects by adding genes for chemicals that the plant will then produce in its leaves are interesting and will soon lead to commercial varieties, such as cotton resistant to a particular insect pest which may be in commercial use within the next two years. Cotton is the most commercially advanced of the new insect resistant crops. What we are witnessing now are the first fruits of a new technology which are as comparable to future resistant crops as were the early hot air balloons to the present generation of aeroplanes. Work on plants to make them resistant to virus diseases is progressing well and promises to provide plants in the next decade which will be much less susceptible to these very important causes of yield loss.
V. Animal sciences
14. The use of animals for food, fibres and for social purposes is a very important and emotive aspect of life in wealthy countries. While most people are happy to eat meat and have pets, there is an increasing lobby for "animal rights". This affects the consumption of animal-based products, which is a problem for some of Europe's poorest farmers, and also impinges on health care research because animal experimentation is a particularly unpopular form of exploitation. In the absence of effective campaigning against the animal rights lobby there is every reason to believe that this issue will become more of a problem in the future.
15. Developments in biotechnology involving animals promise to become a major area of conflict with the public in the future because so much of what will be done will be to increase the exploitation of animals. Examples of things that are being considered at present are the production of pharmaceutical compounds in milk, modifying food conversion properties of animals so that they produce more useful meat from the same amount of feed, and modifying wool production by sheep so that it falls out and they do not need to be sheered.
16. Major strides are being made in the area of animal health, even to the extent of using a genetically-engineered rabies vaccine to protect wild animals and limit, or stop, the spread of the disease in Europe. It is possible that further developments in animal vaccines will virtually eliminate the major diseases of farm and domestic animals. It will be interesting to see whether the alleviation of suffering that this will bring about will receive the recognition due to it, or whether the opponents to the use of animals will prevail.
17. One of the more spectacular successes of work with animals has been the development of transgenic fish with greatly increased growth rates. Such fish have the potential to increase enormously the productivity of fish farming, but are of concern because the environmental consequences of the release of such fish to rivers or the sea are difficult to predict. The recognition that there might be a problem, and the work being done to determine possible consequences, are indications that the present regulatory framework is working well to protect the interests of the public and the environment.
VI. Microbiology
18. For many people the role of micro-organisms in anything other than disease is not well understood, even though alcoholic drinks and bread making have traditionally depended upon them. The range of fermentations that are exploited for the production of foods, such as tea, chocolate, salami, and cheeses is enormous. Surprisingly, for products which are consumed by humans, we often have an incomplete knowledge of the microbiology of many of these processes. A particularly good example being chocolate production, where improved methods using defined cultures of microbes do not match the quality of cocoa beans fermented naturally with microbes present in the environment.
19. Gene manipulation techniques are relatively well developed for many species of micro-organisms and allow the production of strains that have modified procedures for producing required products, or have totally new metabolic activities. Such organisms are being utilised in fermentation processes in Japan for beer, soy sauce and other food products as well as for pure chemicals. There is much interest in Europe, and considerable financial support from the European Commission, in developing lactic acid bacteria for the production of cheese and other fermented milk products. Obvious targets are to make the bacteria resistant to antibiotics which sometimes are present in milk and to modify the range of acids and other products produced to improve flavours and reduce the amount of unpleasant and often toxic products that are produced at present. It is going to be very interesting to see how such organisms will be marketed. Will it be on the basis that existing selected organisms are not particularly desirable? Or will it be possible to market the foods solely on the basis that they taste better?
20. The use of micro-organisms to produce vitamins, amino acids, antibiotics and other important molecules by the pharmaceutical industry is widespread and often involves microbes which have been genetically manipulated. Regrettably, from a European point of view, much of this technology has been developed in Japan which has a very strong biochemical engineering industry. There is no reason why Europe should not become a major centre for this technology, which is one that can very quickly translate academic research into high value commercial products, other than a perception that it may be difficult to obtain regulatory approval. A particularly exciting development for the future is the use of micro-organisms, or enzymes derived from them, that are immobilised in columns through which organic molecules are passed for biochemical processing. In this way it is possible to make compounds that cannot be produced chemically or be derived from plants or animals in sufficient quantity and purity. Chemical transformations of this nature have enormous potential for converting relatively low value agricultural products into ones which are not only higher in value but which are also in demand. The linking of this technology with the production of plants that produce particular chemicals which can be upgraded in this way offers an attractive prospect for developing totally new crops for European agriculture.
21. There are two main problems that need to be addressed for the continued exploitation of microbes. The first is to develop a better understanding of the basic biochemistry of important metabolic pathways for useful products, so that it is possible to isolate appropriate genes and modify them as required. The second is to improve our ability to culture micro-organisms on a large scale with appropriate procedures for extracting the desired products from the culture medium. There is considerable, internationally-recognised, talent in Europe for studies of this nature.
VII. Ethical aspects
22. There is no doubt that most people are made anxious by change, especially when they feel that they have no ability to influence it. One of the problems for biotechnology is that it is closely associated with genetic engineering, which is a difficult concept for most people to understand and is one that appears very threatening. Part of the reason for this is that the scientists themselves called for a moratorium in the early 1970s because they felt that there were risks that should be evaluated, and that they did not want to be responsible for developing a new technology which might cause harm because risks were not assessed in advance. Most developed countries responded to the moratorium by establishing committees to determine risks and ensure that research was conducted under conditions of containment that would not allow the release of the engineered organisms so that they could harm the general public or the people working with them. Almost by default, and for the best of reasons, an exciting and generally very safe technology was treated in the same way as is work with dangerous pathogens, and became associated with pathogens and harm to humans.. We now know from experience that the risks associated with this type of work are very small for most types of experiment. Indeed, most genetically engineered organisms are as safe as the parent organism and some are safer. Perhaps the biggest challenge in introducing the use of such engineered organisms as foods, or in other ways in which the public are exposed, is to be able to convince people that the original very cautious approach was incorrect. We need to make it clear that we erred very heavily on the side of caution because we wanted to ensure that safety was paramount. Unfortunately, because the public are much more used to regulations following disasters, this will be difficult to achieve because most people will be unaware that it was the academics who pressed for regulation, not governments responding to a call for legislation following a disaster.
VIII. Conclusions
23. The genetic manipulation of animals, including humans, is an area of biotechnology that causes many people great concern for ethical and humanitarian reasons. It is important that these concerns are discussed freely, recognising that many different points of view must be reconciled if this technology is to expand as it should to provide important benefits for society. To do this effectively it will be important to develop a dialogue between research workers and animal welfare groups to discuss issues as they arise, rather than after they have had an opportunity to cause concern.
24. We should be aware that Europe has large and successful industries which are very active in this very important area of technology. They are very concerned that the regulatory position and associated public attitudes in Europe allow them to develop further and ensure that we retain a place in the forefront of the biological revolution. Throughout this brief report it was constantly referred to public concerns and perceptions. This is because many scientists are worried that biotechnology in Europe will not develop as it might because the debate has been too biased towards the concerns of opinion-formers.
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Reporting committee: Committee on Agriculture (Doc. 6780).
Committee for opinion: Committee on Science and Technology.
Reference to committee: Doc. 6321 and Reference No. 1702 of 22 November 1990.
Draft opinion approved on 16 April 1993.
Secretaries to the committee: Mr Perin and Ms Meunier.
This opinion is based on a study prepared by a consultant expert to the Parliamentary Assembly, Professor John E. Beringer, School of Biological Sciences, University of Bristol, United Kingdom.