Science and TechnologyWritten evidence submitted by the Agricultural Biotechnology Council (abc)

The views expressed in this submission are those of abc—the umbrella organisation for the agricultural biotechnology industry in the UK. abc, comprising of six member companies, works with the food chain and research community to invest in a broad range of crop technologies—including conventional and advanced breeding techniques, such as GM. These are designed to promote the sustainable intensification of agriculture by tackling challenges such as pests, diseases and changing climatic conditions, whilst reducing water usage, greenhouse gas emissions and other inputs. The companies are BASF, Bayer, Dow, Monsanto, Pioneer (DuPont) and Syngenta.

Executive Summary

1. The UK has a strong pedigree in agricultural research and the capacity to find solutions to the pressing food production challenges facing both the developed and the developing world.

2. Europe is being left behind by other economic powerhouses across the world when it comes to the commercialisation of new and innovative agricultural technologies, including GM and other advanced seed technologies.

3. abc believes that significant barriers exist to the commercialisation of agricultural research in the UK which could be alleviated through stronger governmental and policy maker support.

4. Many scientists and professionals from the EU find better employment in more technology-friendly environments in other parts of the world due to the difficulties in the commercialisation of certain agricultural technologies. Although research in this area started in Europe, the lack of opportunity for research and practical applications means that intellectual capital is increasingly at risk.

5. Attracting investment into the agricultural sector requires confidence and positive signals from Government. abc believes that the UK Government should speak out on the challenges set out in the Foresight Report across all departments, and offer public support to the role of agricultural technology research and innovation in increasing agricultural production in a sustainable way.

6. Agricultural biotechnology should be incorporated into economic planning policy, and included alongside medical and industrial biotechnology in future bio-economy strategy documents.

7. Introduction

7.1 The role of agricultural biotechnology

7.1.1 Scientists around the world, including in the UK, are developing agronomic systems and technologies that combat pests and disease, allowing crops to respond to a changing climate and ensuring that fewer inputs are needed to preserve resources whilst increasing agricultural productivity.

7.1.2 A range of integrated agricultural innovations, including biotechnology, are required to meet the global challenge of food security. UK political backing is required to enable new technologies to deliver significant economic benefits and new breakthroughs for farmers.

7.2. The agricultural biotechnology chain from research to commercialisation

7.2.1 The development of agricultural technology from basic research through to the cultivation of new crops involves a number of stages. Similar to other R&D chains, this process involves:

initial laboratory research to develop new crop traits (eg disease-resistance);

further applied research to test the trait’s commercial viability, including field trials (ie successfully growing a crop with the disease-resistant trait outside of the lab);

submission for technical assessment and approval for cultivation by regulating authorities, including crop co-existence (ie food safety, how close it can be grown to other crops etc); and

commercial seed sale and cultivation of the crop.

7.2.2 There is a further stage of utilisation when the crops enter the food and feed chain, for example as feed for cattle.

7.3. Strengths and weaknesses in the UK chain

7.3.1 There are at least twenty universities and institutes in the UK engaged in pure and/or applied research in agricultural biotechnology.

7.3.2 The UK has a particular strength at the early discovery stage of R&D, a vital stage of the agricultural technology development cycle. Investment from public sources in UK (such as the BBSRC which spends around £470 million on biotechnology and biological sciences), is relatively high compared to the EU.1

7.3.3 The UK has successfully developed clusters of research expertise with biotech firms found in Oxford, Cambridge and Dundee, many of which are spin-offs from university research departments. This reflects the success that has been achieved in other sectors, such as healthcare technologies, where the UK has achieved significant SME growth and has attracted investment from leading multinationals on the back of its scientific reputation.

7.3.4 Biotech multinationals and research institutes in the US, Brazil and China, are benefitting from the UK’s intellectual investment. Due to the imposed limitations of the agricultural technology industry in the UK (see 1.4), many of our brightest graduates from highly respected universities, and those working in specialist research institutes, perceive their futures as being better served outside of the country.

7.3.5 Research from the Rothamsted Institute found that the UK is losing its expertise in applied sciences, with those employed in applied R&D work increasingly getting older and fewer in number. There have been three significant closures of public research institutes associated with agriculture in the past decade. The closures of Long Ashton Research Station in 2003, Silsoe Research Institute in 2006 and the Hannah Research Institute in 2007, have all contributed to a decline in our public agricultural research base.

7.4. Why are there weaknesses? Key issues addressed in abc’s submission

7.4.1 In the EU, decision-making on the import and cultivation of biotech crops is regulated at a European level.

7.4.2 Developers of biotech crops, such as abc’s members, submit biotech crop applications to the European Food Standards Agency (EFSA), which then makes a science-based, independent recommendation for approval or rejection to the European Commission.

7.4.3 However, the process for approving GM traits for cultivation by EU farmers has been beset by delays and political interference over the past 14 years. Only two products from over 25 waiting for assessment have been approved for cultivation in the European Union throughout this time, despite a state-of-the-art rigorous safety process.2

7.4.4 Innovators, and those who bring innovations to the market, rely on a political and regulatory environment in which innovation is fostered and promoted, and where science is at the heart of decision-making. This unpredictable regulatory regime limits the sector’s potential in the UK by limiting its appeal to private investors.

7.4.5 This creates a significant barrier to universities and publicly funded research institutes wishing to find private funding to eg launch spin-out SMEs to commercialise their innovations.

7.4.6 Despite significant attempts to improve matters, including the formation of Knowledge Transfer Networks and Technology Strategy Boards, the Government has been reticent to talk up the sector. This sends a confused message to would-be investors and acts as a disincentive to progress in this area.

8. What are the difficulties of funding the commercialisation of research, and how can they be overcome?

8.1 Europe is being left behind by economic powerhouses across the world when it comes to investment in agricultural technologies, including GM and other advanced seed technologies.

8.2 Public spending on agronomic research in the UK is around £400m per year—with the Coalition Government committed to maintaining this in cash terms until the end of the current Parliament (May 2015). This supports a viable and vibrant research base, yet the UK is missing out on the potential benefits of commercialising some innovations due to EU-level reluctance to pursue science-based decision making.

8.3 A co-ordinated approach by governments from across Europe, public research institutes, and the private sector is required to realise the economic value from R&D in the sector. This will ensure that Europe, and specifically the UK, benefits from its growth potential in a similar way to the gains that have been made in healthcare biotechnologies and other science based sectors.

9. Are there specific science and engineering sectors where it is particularly difficult to commercialise research? Are there common difficulties and common solutions across sectors?

9.1 For the abc response to the first part of this question, please see point 2 (above).

9.2 abc’s submission relates specifically to the agricultural technology sector, and other organisations may be better placed to judge how this compares with other sectors.

9.3 However, it has been suggested that approvals processes in the pharmaceutical and industrial biotechnology sectors demonstrate how functioning, science-based policy and regulation can enable research to meet its economic and growth potential.

10. What, if any, examples are there of UK-based research having to be transferred outside the UK for commercialisation? Why did this occur?

10.1 The transfer overseas of UK-based research discoveries in agricultural biotechnology for commercialisation is not, in itself, a negative process. With adequate safeguards in place for the protection of intellectual property, UK agricultural research institutes can still benefit from the royalties received from the commercialised product.

10.1.1 Some of the innovations which they are researching, eg bananas, may also not be appropriate for cultivation in the UK, and therefore transfer outside the UK for final development and commercialisation may be more appropriate.

10.2 EU regulations on the cultivation of GM crops have directly impacted on the research and development of agricultural biotechnology innovations in the UK, and have acted as a disincentive for companies to develop crops optimised for European use:

10.2.1Field trials of GM crops are allowable in the UK, in accordance with strict regulation, and approval for such trials for research and development purposes are considered at national level by Defra (for proposed releases in England, or by the relevant authorities in Wales, Scotland or Northern Ireland).3

10.2.2However, the process for approving GM traits for cultivation by EU farmers has been beset by delays and political interference over the past 14 years. Only two products from over 25 waiting for assessment have been approved for cultivation in the European Union throughout this time, despite a rigorous safety process.

10.2.3Many other products have waited for years for approval or otherwise due to political interference in what should be a science based assessment process. This effective ban on cultivation of GM crops may also act as a disincentive to field trials. Put simply, investors may not wish to invest millions of pounds in the commercialisation of a trait in the UK if there is no hope of also growing it in the UK.

If the crop is only allowed to be grown outside the EU, eg in Brazil or the US, it can make more sense to commercialize the crop in that country, tailoring its development to local climatic and topographic conditions.

10.2.4It would subsequently make financial and logistical sense to process the finished crops in that country, manufacturing products which can then be sold back into the EU.

The licensing of UK innovations and IP to international partners for development and commercialisation can generate revenue for UK research institutes. However, the obvious drawback of commercialisation outside of the UK is the significant knock-on impact on the competitiveness of UK agriculture; with UK farmers unable to access innovative traits which may have first been developed here.

10.3. Some recent examples of this include:

10.3.1 Partnerships and research links between Rothamsted Research and the agri-business and research arm of the Brazilian Government, Embrapa.4

This is a fantastic example of the UK’s world-leading knowledge base in plant genomics and agricultural biotechnology, and of international collaboration to tackle the challenges raised in the Foresight Report.

But it also highlights the value which Brazil places on research into wheat disease, with a regulatory regime under which GM solutions are much more likely to receive science-based assessment and approval.

10.3.2 The commercialisation of GM technology from the John Innes Centre in Norfolk which enhances the root systems of plants.5

The technology was developed by Dr Liam Dolan and his colleagues at the John Innes Centre in Norwich. The team cloned and characterised genes which may play vital roles in anchorage, water use and nutrient uptake in plants. The technology has already been shown to be effective in enhancing root systems in transgenic plants of major crops around the world.

Dow AgroSciences has now licensed the technology for commercialisation from the JIC via PBL, a company which develops innovative technologies from public and private sources worldwide and turns ideas into patented, scientifically validated and licensable technologies.

Dow AgroSciences now hope to develop and commercialise the trait in different crops, enhancing their ability to survive stress, increase nutrient utilisation, and provide yield stability in challenging years or in parts of the world where there are less than favourable growing conditions.

11. What evidence is there that Government and Technology Strategy Board initiatives to date have improved the commercialisation of research?

11.1 abc does not have the evidence to be able to reliably answer this question directly, but the member companies are involved in the TSB and other initiatives, and therefore can provide further evidence individually if required.

12. What impact will the Government’s innovation, research and growth strategies have on bridging the “valley of death”?

12.1 If the Government continues to avoid addressing the issues facing agricultural biotechnology, the answer must be “not very much impact”.

12.2 The failure of the Government to include agricultural biotechnology alongside medical and industrial biotechnology in the recent Office for Life Sciences Life Sciences Strategy document highlights this problem.6

12.3 The UK is currently a world leader in agricultural research, renowned for its science base and unrivalled farming knowledge, which together help develop and apply new technologies in innovative ways. The UK has a particular strength at the early discovery stage of R&D, a vital stage of the agricultural technology development cycle.

12.4 Public policy in the UK is also increasingly recognising the need to capture the benefits inherent in the development of agricultural technology, as demonstrated by the Foresight Report.7

12.5. Investment from public sources in UK (such as the BBSRC which spends around £470 million on biotechnology and biological sciences), is relatively high compared to the EU. But the wider EU regulatory environment creates a chilling effect on greater private sector investment in the sector, particularly in commercialising innovations (see point 4).

12.6 However, abc believes that the UK Government could act to reverse this trend through stronger governmental and policy maker support and continued UK leadership on agricultural technology in Europe. This would send a positive message and encourage further private sector investment in agricultural biotechnology. For further details, please see point 7.

13. Should the UK seek to encourage more private equity investment (including venture capital and angel investment) into science and engineering sectors and if so, how can this be achieved?

13.1 The agricultural technology sector already attracts significant levels of investment around the world from private equity investors (including venture capitalists) and from R&D investment by existing companies. This investment is driven by a global biotech seed market worth $10.6 billion in 2009.8

13.1.1The average cost of achieving approval for a GMO in Europe has been estimated at €7–10 million per event. These costs mainly accrue from the large number of studies which the applicant companies have to present to EFSA. The financial investment required to develop a crop from innovation to the point of submission to EFRA can be much higher.9 This often puts commercialisation beyond the budget of public research institutes; hence partnerships and investment from the private sector are crucial.

13.2 However, investment in the development of agricultural technologies by the private sector is dependent upon industry confidence in the stability of, and returns offered by, the market. The current inconsistent operation of a science-based approvals process in the EU for agricultural biotechnology does not incentivise the private sector to invest in commercialisation of traits in the UK over other countries, as illustrated in point 5.

13.3 To improve this situation, the UK Government needs to start taking the technology seriously and devoting the same energy to promoting it as is currently given to the other biosciences. The Government’s recent public recognition of the potential of agricultural biotechnology is welcome, and it should now:

13.3.1Continue to press the European Commission to ensure that the system for approvals is properly implemented and based on scientific assessment

13.3.2Speak out on the challenges set out in the Foresight Report across government, and offer public support to the role of agricultural technology research and innovation in increasing agricultural production in a sustainable way. Particularly via the inclusion of agricultural biotechnology alongside medical and industrial biotechnology in future bio-economy strategy documents.

13.3.3Design a public policy framework that favours the development of new technologies, including biotechnologies, in cooperation with EU partners and other countries.

13.3.4Support Intellectual Property rights to encourage and protect innovation.

14. What other types of investment or support should the Government develop?

14.1 Recent public statements by Ministers in Defra on the potential of agricultural biotechnology have been extremely welcome, and contribute to one of the key conditions on which growth and investment in the sector is dependent—industry confidence in a science-based and stable regulatory environment (as highlighted in point 8).

14.2. There are a number of tangible actions which would further bolster this confidence, and allow industry to start planning for further growth and investment in the UK:

14.2.1BIS and HM Treasury should incorporate agricultural technology, including biotechnology, into its economic policy planning. In particular, abc would like to see the potential of agricultural biotechnology recognised alongside medical and industrial biotechnology in BIS’s future strategies for UK Life Sciences.

14.2.2Defra should broaden the remit of current working groups on Foresight to encompass the economic benefits of agricultural technology to the wider economy, as well as increasing agricultural production in a sustainable way.

14.2.3The UK Government should ensure a continuation and expansion of funding for crop research by public sector and academic institutions.

14.2.4Continued UK Government support for Intellectual Property rights to safeguard revenues generated from commercialisation overseas of innovations developed in the UK.

February 2012

1 www.bbsrc.ac.uk/organisation/spending/spending-index.aspx

2 Approvals of GMOs in the European Union, EuropaBio, October 2011,
www.europabio.org/sites/default/files/position/approval_of_gmos_in_the_european_union.pdf

3 www.defra.gov.uk/environment/quality/gm/

4 www.rothamsted.ac.uk/PressReleases.php?PRID=94

5 http://www.pbltechnology.com/documents/News%20Documents/DAS%20PBL%20News%20Release%
2000.244%2002.11.10%20.pdf

6 www.bis.gov.uk/assets/biscore/innovation/docs/s/11-1429-strategy-for-uk-life-sciences.pdf

7 www.bis.gov.uk/foresight/our-work/projects/published-projects/global-food-and-farming-futures

8 Pocket guideto GM crops and policies, EuropaBio, 2001
www.europabio.org/sites/default/files/position/pocket_guide_gmcrops_policy.pdf

9 GM crops: Reaping the benefits, but not in Europe - Socio-economic impacts of agricultural biotechnology www.europabio.org/agricultural/positions/gm-crops-reaping-benefits-not-europe-socio-
economic-impacts-agricultural-0

Prepared 11th March 2013