Zeneca welcomes the opportunity to provide evidence to the committee.

ZENECA

  1. Zeneca is a world leader in bioscience with its business and research headquarters based in the UK. The company invents, develops, manufactures and markets products to improve human health, nutrition and quality of life around the world. The company employs 32,100 people, of which over 7,000 are scientists, working in three separate businesses; Pharmaceuticals, Agrochemicals and Specialties. Over 94 per cent of Zeneca sales are outside the UK.

  2. Zeneca Agrochemicals is the international business that develops chemical and gene based products for the agricultural sector; and were the first company to successfully launch in the UK a food (tomato puree) produced from genetically modified (GM) fruit. The business had a turnover in 1997 of £1,613 million. Zeneca's agrochemical business is the third largest in the world. In addition, Zeneca is co-owner of Advanta, the world's fifth largest seed company with its headquarters in The Netherlands.

  3. Innovative research, coupled with effective product development and marketing skills, is the foundation for Zeneca's present and future success in agriculture and food. Zeneca Agrochemicals has 1,200 people directly involved in research and development, and this year is investing £140 million in this activity. To achieve the critical mass necessary for productive research most of the investment is based in the UK.

ZENECA'S RESEARCH STRATEGY

  4. Zeneca's research strategy is based on the philosophy of Integrated Crop Management (ICM)—the use of the appropriate combinations of agronomic, chemical and genetic techniques, to optimise food production and crop quality. ICM is an approach that enables the farmer to conserve and enhance the environment, whilst producing safe and wholesome food economically. In farming, like in other business enterprises, commercial success is dependent upon making the best economic use of available resources. Getting the balance right is the fundamental tenet of this agricultural philosophy.

  5. Biotechnology plays a major role in Zeneca's research programmes. For example, biotechnology is critical to the invention and evaluation of new generations of superior chemicals, new crop varieties resistant to pests and diseases, and plants with desirable traits such as enhanced yield and nutritional characteristics.

  6. We believe that biotechnology has the potential to have a profound and beneficial impact on agriculture and the environment. Biotechnology will contribute to the development of sustainable agricultural systems in developed and less developed economies and hence increase agricultural productivity to help meet the challenge resulting from the projected population increase. The underlying science supporting biotechnology is describing the genetic basis of all aspects of plant growth, metabolism and development. Plant genome descriptions will give a full catalogue of useful genes and allow focused efforts to catalogue and conserve biodiversity at the gene and species level. Genetic improvement through knowledge-based breeding or through genetic modification will be enhanced by these genome programmes.

  7. The first products developed through use of genetic modification are ones where single gene traits are providing major effects in crop protection (herbicide selectivity, resistance to insect attack or quality changes). As the technology develops, then more complex gene combinations will result which give improved effects. Integration of chemical and genetic effects to provide crop protection solutions is an area where we see great opportunities, particularly in the control of fungal and insect attack. On the same timescale, the knowledge of the fundamental makeup of plants and their pests and diseases will allow the more rapid identification of superior (cost effective with even lower environmental impact) chemicals for crop protection. The end uses of crops are enormously varied. Biotechnology will allow in the future the better tailoring of the raw material attributes of the crop to the specific desired end use, be this for optimum animal or human nutrition, or the production of specific feedstocks for industrial processes on a renewable basis.

INFLUENCE OF REGULATION—THE UK EXPERIENCE

  8. The UK was a pioneer in the development and implementation of regulations which cover biotechnology; this is generally considered one of the reasons for the success of biotechnology in UK academia and industry. Zeneca feels that it played its part in the development of the regulatory strategy. These regulations were science based, carefully thought out and implemented. They have been respected and copied around the world. Zeneca was generally very impressed with the manner in which both the environmental and food regulations were applied in the UK. However, at the European level despite very positive statements on the importance of biotechnology for European competitiveness and funding of research, the regulatory situation is a cause for considerable concern.

INFLUENCE OF REGULATION—THE PRESENT SITUATION

  9. To be successful Zeneca has to plan its research at least 10-20 years ahead. This is because of the long invention and development times in agriculture, due partly to the need to evaluate the products under different agronomic conditions and partly the time needed to gain regulatory approval. For example, we are just now launching Amistar one of a new generation of fungicides. Amistar is based on a natural product and has taken seven years to go from discovery to the market (the average period for an agrochemical is 8-10 years). We are however, already evaluating strategies for using biotechnology to control leaf disease in bananas and potatoes. The first field trials of the genetically modified banana plants will take place this year, but it will be another six years before we can offer disease resistant plants to the farmer as part of an ICM package. Regulatory uncertainty is a major issue in research planning.

  10. The regulatory problems we face today are indecision and a lack of leadership at the European level. This is having a negative impact upon our business both directly and also indirectly via the damage it is doing to consumer perception. The main problems which affect our business are discussed below.

  11. Failure to develop the European regulations at the same pace as the technology has progressed. For example, the UK has had novel food regulatory guidelines for many years. It was the existence of these well respected guidelines which enabled us to launch the GM tomato puree in 1996. However, it was only last year that the European Novel Food Regulation became law, yet it was obvious for many years that such a regulation would be needed. We believe that discussions on this regulation started at the European level in 1990. At the time of preparing this evidence there are still no clear European Union labelling guidelines for genetically modified foods. The industry has had to develop its own voluntary guidelines without any consistent guidance from governments; the resulting confusion leading to a lack of consumer confidence. Meanwhile the USA has in place a regulatory process which is widely respected by both industry and consumer.

  12. Potential conflicts between different regulations. The European regulation defining organic products (2092/91) was carefully framed to "increase credibility with consumers" and to "ensure fair competition between producers". The regulation, which covers imports, as well as crops grown within the EU requires that "95 per cent of the ingredients" are obtained in accordance with conditions laid out in the regulation. In June this year the European Council of Ministers will vote on amendments to this regulation which states that "in organic production, genetically modified organisms, parts thereof and products derived therefrom must not be used in products labelled as from organic production". If this is interpreted as 100 per cent exclusion of any pollen from a genetically modified crop then this badly framed amendment will damage both the credibility of the organic label and the viability of European agriculture.

  13. A lack of transparency, not only for the applicant but also for the consumer, in decision making. As a company we welcome any attempt to increase transparency.

  14. The scientific base of the regulations is being diluted by political compromises. Society handles uncertainty by using the principles of risk assessment and then giving this advice to our elected representatives and leaders for a decision. The questions on biotechnology asked by the European and American regulators are very similar, which is not surprising since they are based on a scientific approach to risk assessment. To ask the regulator to provide a political, commercial, sociological or ethical decision is both a misuse and abuse of the scientific risk assessment approach.

  15. The sound bite approach to risk assessment. In our view it is as wrong to state that all applications of biotechnology are safe, as it is wrong to state that all applications are dangerous. An important component of risk assessment is the case by case approach. The universal genetically modified crop plant does not exist. Each species and inserted trait must be dealt with independently. For example, the likelihood of outcrossing from varieties of tomato, maize, sugar beet and oil seed rape are totally different and must be evaluated differently. Similarly, the hazards of particular traits that may be inserted must be evaluated independently. It is scientifically dishonest and misleading to decision makers and the public to argue that the risks posed by crop plants with totally different agronomy and ecology are the same.

  16. A conflation of different issues. Genetically modified crops have become the lightning rod for a debate on many other issues, such as agricultural reform, WTO and biodiversity. Genetically modified crops are usually only a small component of these discussions, but become the focus for the debate because that debate is not being held, or perceived as being held, elsewhere.

  17. International trade. As at the European level, the regulatory implications of the transfer of GM seeds and plants between countries (and hence international trade) has been apparent for some time. The committees advising the Dutch and UK governments on the release of GMOs in late 1994 proposed guidelines to cover this issue. They in time evolved to become the UNEP "International Technical Guidelines for Safety in Biotechnology". We are now debating the BioSafety Treaty under the Rio Convention (which has not been ratified by the USA). Unhelpful trade disputes are the inevitable consequence of these different regulatory processes.

CONSEQUENCES

  18. Direct cost and delay is the first result of this lack of regulatory leadership. There is a no clear regulatory route map for either academia or industry to follow. In preparing the case for a development decision on a product, the time and cost taken to achieve regulatory approval is one of the most critical factors. It is simply not possible to define this time and cost for a product entering the European Regulatory System. The time taken for the regulatory approval of genetically modified tomatoes indicated this issue. These regulatory applications are essentially for the same product.

Type of application	Submission date	Approval date
USA to grow and process	February 1995	June 1995
USA human consumption	September 1994	April 1995
UK human consumption	August 1994	January 1995
Canada human consumption	December 1995	June 1996
Mexico to grow and consume	June 1996	September 1996
EU to grow and process	November 1996	still no decision
EU human consumption	March 1998

  In the absence of an appropriate EU regulation it was only possible to launch the product in the UK which has a long history of regulatory guidelines for novel food. After receiving the regulatory approvals the product went on sale in Safeway and J Sainsbury stores on 5 February 1996. The cans of puree are sold next to the regular product which is produced from fruit grown in Italy. The transgenic tomatoes were grown in California. There is still no regulatory approval to grow and process these tomato plants in Europe.

  19. Effect on innovation and UK competivity. The lack of predictability means that some of our most senior staff have to devote their time to steering the company through this state of regulatory chaos. Small companies, universities and research institutes do not usually have these skills available and therefore tend to concentrate on less contentious, though arguably less innovative, areas. In addition, potential investors are naturally concerned about uncertainty in product development. In our experience there is in the EU, compared with the USA, a dearth of entrepreneurial SMEs in the agricultural and food areas. One reason for this we would suggest is the regulatory system.

  20. Public acceptance. The confused regulatory system does nothing to build the trust of the consumer in the regulatory system, those who administer the regulatory process, or the underlying political system. Without the political leadership to develop and defend the regulatory system, the way is open for the present spate of totally unjustified claims about safety to be made. The success of the genetically modified tomato puree sold in the UK stores of Safeway and Sainsbury was, we believe, partly because of benefits for the consumer, regulatory approval from HMG, the provision of information and clear (voluntary) labelling. The success shows that the European consumer will accept these biotechnological products provided they are treated with respect.

29 May 1998