27.Insect-borne infectious diseases are a significant source of mortality across the world. Malaria is a disease caused by parasites that are transmitted to people through the bites of infected female mosquitoes. According to the most recent World Health Organisation (WHO) estimates, released in September 2015, there have been 214 million cases of malaria in 2015 and 438,000 deaths.20 The WHO asserts that about 3.2 billion people, nearly half of the world’s population, are at risk from malaria. Sub-Saharan Africa is particularly affected; in 2015, the region was home to 89% of malaria cases and 91% of malaria deaths.
28.Malaria is both preventable and curable, and increased efforts have seen significant reductions in malaria incidence (the rate of new cases) and deaths. Between 2000 and 2015, the WHO reports, malaria incidence fell by 37% globally and malaria death rates fell by 60% among all age groups, and by 65% among children under five.21 Vector control (in other words, controlling infected mosquitoes) is the principal means of preventing and reducing malaria transmission. Vector control, such as the use of insecticide-treated mosquito nets and indoor residual spraying, can be effective in a range of circumstances.
29.The world’s fastest growing insect-borne disease is dengue. The WHO reports that the global incidence of dengue has grown dramatically in recent decades and about half of the world’s population is now at risk.22 Dengue can be found in tropical and sub-tropical climates across the world, mainly in urban and semi-urban areas. The possibility of an outbreak of dengue, however, now exists in Europe and local transmission of dengue was reported for the first time in France and Croatia in 2010.
30.This mosquito-borne viral infection causes a flu-like illness and can develop into a potentially lethal complication named severe dengue. Severe dengue, the WHO reports, affects most Asian and Latin American countries and has become a leading cause of hospitalization and death among children in these countries.23 The actual numbers of dengue cases are underreported, and cases are often misclassified. A recent study estimated there to be 390 million dengue infections per year.24 As there are no vaccines for this virus, dengue prevention and control depends on effective vector control measures, such as managing environments so that mosquitoes are prevented from getting to egg-laying habitats.
31.Evidence from Research Councils UK (RCUK), on behalf of the Biotechnology and Biological Sciences Research Council (BBSRC), the Medical Research Council (MRC) and the Natural Environment Research Council (NERC), provided examples (though not an exhaustive list) of human diseases to which GM insect technology could be applied, including, but extending beyond, dengue and malaria (Box 1):
Box 1: Diseases to which GM insect technology could be applied25
Chikungunya: Chikungunya has been identified in over 60 countries in Asia, Africa, Europe and the Americas. The two mosquito species transmitting this disease can also transmit other mosquito-borne viruses, including dengue fever. Around 1.8 million cases of this viral disease were reported between 2005 and 2007. There is no specific antiviral drug treatment and no commercial vaccine. West Nile Fever: Birds are the reservoir hosts of West Nile Fever (WNF) virus. In Europe, Africa, Middle East and Asia, mortality in birds associated with WNF infection is rare, but WNF is highly pathogenic for birds in the Americas. WNF virus is transmitted to people and other mammals mainly through mosquito bites as a zoonosis. The virus can cause severe disease and death in horses, but equine vaccines are available. No vaccine is available currently for humans. Chagas (American trypanosomiasis): Vector-borne transmission occurs in the Americas. The insect vector is a triatomine bug that carries the parasite Trypanosoma cruzi which causes the disease. About 6 million to 7 million people are estimated to be infected worldwide, mostly in Latin America. Vector control is the most useful method to prevent Chagas disease in Latin America. |
Source: Written evidence from the Biotechnology and Biological Sciences Research Council (BBSRC), the Medical Research Council (MRC) and the Natural Environment Research Council (NERC) (GMI0017). The Research Councils’ submission also noted additional diseases to which GM insect technology could be applied: African trypanosomiasis (sleeping sickness), Japanese encephalitis, Leishmaniasis, Lymphatic filariasis and Yellow fever.
32.The Research Councils provided a commentary on how the range of insect disease vectors has changed over recent decades on account of factors such as climate change and globalisation, and that consequently some non-endemic diseases now pose a threat to Europe. They told us that:
“there are currently five invasive Aedes mosquito species known to be established in Europe, of which two species [were] implicated in the recent outbreaks of chikungunya and dengue fever in Europe; laboratory and field observations indicate that they have the potential to also transmit other pathogens of public health importance.”26
33.We heard considerable enthusiasm for, and optimism about, the potential of GM insect technologies. The British Ecological Society (BES) stated:
“The potential benefits that GM insect control could bring are obvious. This is especially significant in the case of malaria, where parasites are becoming resistant to drug treatments and mosquitoes are becoming resistant to pesticides, and for dengue where no licensed vaccine or dedicated therapy exists, and prevention and control solely depends on effective vector control measures.”27
34.The Wellcome Trust told us that: “Genetically Modified Insects (GMIs) potentially offer a more targeted and less environmentally harmful approach to insect-borne disease control than non-GM techniques and insecticides.”28 Importantly, the Wellcome Trust stressed that GM insects would play a complementary role alongside existing practices:
“It is important to note that the most effective way to control vector-borne diseases is through a combination of approaches (e.g., for malaria, a vaccine when available, plus vector control, bed nets and anti-malarials). We envisage GM insects will play a complementary role alongside existing Integrated Pest Management (IPM) programmes and we encourage this approach.”29
35.Target Malaria, a not-for-profit research consortium, explained the distinct advantages that GM insects could bring to disease control, whilst acknowledging that the use of modified mosquitoes would not be a ‘silver bullet’, and would be complementary to existing malaria control methods. They stated that modified mosquito technology could provide: “long-lasting effectiveness without the intensity and frequency of application required by current methods … particularly valuable in remote and difficult to access places”, and that it could improve access as “the intervention spreads naturally through wild mosquito populations and benefits all communities and individuals, regardless of wealth, education, or access to services and without direct cost to them.”30
36.In addition, Target Malaria argued that it should be “cost-effective and easily deployable”, not needing “extensive facilities, labour or equipment”, and, furthermore, “it would not require investment in human behaviour change because people do not need to change the way they work, live or sleep to obtain the protection provided by modified mosquitoes.”31 Target Malaria catalogued further benefits of the technology: “It limits harm to non-target species in the environment because it directly targets only the species of mosquitoes responsible for transmitting malaria, without affecting other species or the environment.”32
37.The Pirbright Institute set out conditions under which the use of GM mosquitoes would be most beneficial. The Pirbright Institute suggested that they would be most suitable for use where all the conditions below were met:
38.While the evidence we received was often very positive about the role that GM insect technologies could play, we were also made aware of the complexity involved in tackling insect-borne diseases. The differing epidemiology of diseases means that the application of GM insects may be more appropriate in some circumstances than others. GM insect technologies, for example, may be more applicable for the control of dengue than malaria. While mosquitoes which transmit malaria bite between dusk and dawn, mosquitoes transmitting dengue are day-flying. Insecticide treated mosquito bed nets, which can prevent malaria transmission, are therefore not effective against dengue.
39.Chris Whitty, Professor of Public and International Health, London School of Hygiene & Tropical Medicine, and former Chief Scientific Adviser, Department for International Development, expressed caution about the role that GM insect technologies could perform:
“For the sterile male technique equivalent technologies, it is possible but at the moment it is looking relatively niche. That may improve. For the replacement technologies, I have to say it is pretty speculative. The question is whether you are starting from a public health impact point of view or from a science point of view. From a public health impact point of view, this is a footnote on a footnote at this point in time. That does not mean it will necessarily remain that way.”34
40.Professor Whitty argued that GM insect technologies may be of more efficacy in controlling dengue rather than malaria:
“When we come to dengue and the Aedes-transmitting mosquitoes, the opportunities for GM technologies are greater, but for malaria, my own view—and I think this is a pretty middle-of-the-road view—is that, even potentially, the opportunity for these technologies is small.”35
41.Professor Whitty’s notes of caution—he described GM insects as “a relatively niche product” that we “may find uses for in due course”36—must be taken seriously. He also told us that GM insects were only one example of a number of new technologies under development in order to combat insect-vectored disease. He added:
“the possibility that this technology [GM insect] might become useful at some later stage strikes me as entirely plausible. For that reason, I am certainly not against investing in it, but what I would not want to do, to go back to a previous question, is take money away from, let us say, investing in getting new insecticides into this technology on the basis that these are somehow comparable. That does not strike me as realistic.”37
42.We endorse Professor Whitty’s view that investment should not be re-directed from the development of new insecticides to GM insect technologies, and we acknowledge that the complexities of disease control, not least the plethora of local circumstances, are manifold. Moreover, we agree that GM insect technologies are currently in their infancy.
43.We are, nevertheless, persuaded of the potential of GM insects as part of a complementary approach to pest and vector control management. The sheer disease burden means that all avenues should be explored, and the positive outcome from Oxitec’s dengue fever field trials should be capitalised on. This potential must be explored; it would be a mistake not to pursue GM insect technologies for a range of potential applications.
44.The Food and Agriculture Organisation of the United Nations (FAO) estimates that by 2050 the world’s population will increase by more than a third to over 9 billion people. If this proves correct, it would raise enormous challenges for global food security; world food production will be required to increase by 70% to feed this larger, more urban and richer population.38
45.Agricultural losses due to insect damage are large. For example, insect pests cause an average annual loss of 7.7% in production in Brazil, a reduction of approximately 25 million tons of food, fibre and biofuels, bringing annual economic losses of around US$ 17.7 billion.39 We were told repeatedly that the range of potential applications of GM insects for crop pest and animal disease control is vast. As Rothamsted Research told us:
“The possible applications of GM insects across the world is enormous as in theory any insect causing nuisance, damage or vectoring disease to livestock and any insect damaging crops either directly or indirectly (via transmission of plant pathogens) could be controlled this way.”40
46.George Freeman MP, Parliamentary Under Secretary of State for Life Sciences at the Department for Business, Innovation and Skills and the Department of Health, told us that: “globally we see a huge opportunity.”41
47.The submission received from RCUK provided a useful list of threats to livestock (Box 2):
Box 2: Some current, global threats to livestock (including aquaculture) and horses
Key threats:
Other potential threats (in no particular priority order)
|
Source: Written evidence from the Biotechnology and Biological Sciences Research Council (BBSRC), the Medical Research Council (MRC) and the Natural Environment Research Council (NERC) (GMI0017)
48.In terms of which of these diseases might be considered particularly important targets, the Agriculture and Horticulture Development Board (AHDB) told us that:
“For livestock an important target would be the control of a range of Culicoides species which vector bluetongue and Schmallenberg virus infecting livestock in the UK and throughout Europe. Other potential targets related to livestock would be flies in buildings and also blowflies in sheep where in field trapping has been tried in the past.”42
49.As for agricultural pests and insect-borne crop diseases which can be found across the world, the Research Councils provided an extensive list, which included three particular pests which were highlighted repeatedly during our inquiry:
“Diamondback moth: the biggest global pest of brassica crops and one of the world’s significant agricultural pests, costing farmers billions of dollars every year.
Mediterranean fruit fly: now spreading worldwide, a pest of fruit crops.
Spotted Wing Drosophila (SWD): this is a major threat to soft fruit, stone fruit, tomatoes, vines and other crops and could cause serious losses if not controlled. SWD originated in Asia and has been identified in the UK since September 2012.”43
50.The AHDB sought to quantify the potential economic benefit from the use of GM insects:
“The benefits to the UK accruing from the use of GM insects are potentially very large. To give an example it is estimated that the potential losses from spotted wing drosophila in the fruit industry (strawberries, raspberries, blueberries, blackberries, cherries, blackcurrants etc.) are between £80–120 million pounds per year at current levels of production and given current trends in production could rise to £135–235 million in 5 years. Whilst these losses are not realised because of existing control operations these compromise the use of biological control for other pests in fruit systems and can result in the need for repeat releases of biocontrols resulting in an additional cost of thousands of pounds sterling per hectare.”44
51.The British Ecological Society (BES) highlighted the advantages of GM insect control in comparison to the use of insecticides:
“GM insect control presents numerous benefits when compared with the use of broad spectrum insecticides; it does not rely on the release of toxic chemicals into the environment, and works well against targets that are difficult to find, and/or difficult to reach by conventional practices. These insects are unlikely to yield direct off-target effects however there may be some indirect impacts on wild populations and communities.”45
52.In terms of the extent to which the potential highlighted above may be realisable, Oxitec Ltd. asserted that they had:
“demonstrated solutions for a number of these pests including the olive fly … the Mediterranean fruit fly which is considered the world’s most damaging fruit pest, and Drosophila suzukii (spotted wing drosophila) which is now affecting soft fruit growers in the UK. This pest was inadvertently introduced to Europe in 2009 and now threatens a £1.8 billion UK industry including strawberries and raspberries …
… Multiple agricultural applications for pest suppression approaches using the same core technology are ready for field evaluation, and regulatory approvals for field trials have been secured (USA—Diamondback Moth, Pink Bollworm; Brazil—Medfly).”46
In summary, a range of GM technologies for the control of agricultural pests is in development and either in or approaching field trials.
53.GM insects clearly have the potential to provide an alternative tool for the control of insect crop pests and vectors of livestock diseases. Current technological solutions for the control of pink bollworm (a major pest of cotton), Mediterranean fruit fly and diamondback moth are currently under different stages of development and have the potential to be a novel tool to be integrated into the control of many agricultural pests. It is, of course, uncertain whether, and to what extent, this potential may be realised. We are persuaded that as the potential ‘prize’ is so great, and the challenge of food security so profound, every effort must be made to realise benefits in this area.
54.GM insects may also play a future role in tackling invasive species. The suppression of such populations could bring conservation benefits. The British Ecological Society (BES) told us of the potential of GM insects to play a role in wildlife conservation, for instance, in “the control of avian malaria (Plasmodium relictum) which continues to threaten multiple native species in Hawaii after the introduction of mosquitos in the early 19th century.”47
55.Professor Luke Alphey, Head of Arthropod Genetics Group, The Pirbright Institute, noted the problem of invasive species:
“Invasive species are a huge problem for conservation and biodiversity in any number of different places and some of those are insects, so what about controlling those? Those might be the same technologies as we are talking about here, but for a conservation biology target rather than a human health target.”48
56.We envisage that there could be future potential for the application of GM insect technologies beyond infectious disease control and reduction of agricultural pests.
57.Against the background of the many potential applications highlighted above, we sought information on the research and development underpinning this sector in the UK and the prospects for commercialisation of GM insect technologies. Sources of funding for GM insect research in the UK involve a mixture of public, charitable and private investment: including RCUK studentships and research grants; Innovate UK49 grants; Wellcome Trust and Gates Foundation funding; and private investment from Oxitec Ltd.
58.RCUK, over a five-year period ending in 2014/15, have invested approximately £50 million in GM insect research.50 An important distinction, however, must be drawn within this between two different kinds of GM insect research. The first relates to the use of GM insects as a research tool in laboratories in order to increase fundamental scientific understanding of genetics, cellular development and other aspects. Such model organisms would never be deliberately released into the environment; that is not the purpose of the research. The second is GM insect research of the type considered by this inquiry, that is modification of insects that, upon release, could have public health or agricultural pest management applications. A smaller proportion of funding has been invested in the latter, approximately £3.9 million from BBSRC and MRC together.
59.GM insects have not been a targeted funding priority for RCUK. Dr Paul Burrows, Executive Director, BBSRC, explained that funding has come from what is called ‘responsive mode’ sources whereby researchers apply for money. On the number of such applications received, he stated:
“The fact is, at the moment, we are not seeing many of those [responsive mode funding applications], and that is why the spend is relatively small.”51
60.Dr Burrows told us that a specific RCUK strategic initiative to drive research into GM insect technologies would be unlikely. He suggested, however, that a broader initiative could be possible:
“it would be framed in a much broader sense of alternative control mechanisms for agricultural diseases or something, so it would keep the options open. There is no reason why, technically, we should not prioritise this type of research in the future, along with all the other priorities that we have and our future budgets, if it was considered to be a priority.”52
61.Innovate UK funding in the broad biocontrol area has been approximately £3.2 million to date; approximately £1 million of this relates to the GM insects research of the type considered by this inquiry, which has been received by Oxitec Ltd.53
62.Professor Luke Alphey, Head of Arthropod Genetics Group, The Pirbright Institute, highlighted the support of Innovate UK as crucial in the development of fledgling businesses:
“Although it is very small scale, the support of Innovate UK … for small companies is very valuable, and R&D tax credits are very helpful. For those relatively early stages, there is a good economic environment, albeit perhaps a little at risk at the moment.”54
63.GM insect research in the private sector in the UK is dominated by Oxitec Ltd., a British biotechnology company, and the only company in the world producing and distributing GM insects.55 Oxitec was (August 2015) recently acquired by Intrexon Corporation, an NYSE-listed public company with operations in North America and Europe. Oxitec’s primary operations, including its research and development facilities, continue to be based in the UK. Ian Meikle, Head of Agriculture and Food, Innovate UK, perceived this as a good example of inward investment rather than a development which should necessarily cause concern.56
64.The BioIndustry Association (BIA), reflecting on the acquisition of Oxitec, also saw the acquisition as a positive development:
“Successful business deals like Oxitec’s will send a positive signal: a) to other companies, encouraging them to invest and grow in the UK and potentially to list on the public markets; and b) to the investment community, stimulating additional interest in UK biotechnology from specialist and cross-over investors.”57
65.The UK is currently a world-leader in the field of GM insects. Professor Tim Dafforn, Chief Scientific Adviser at the Department for Business, Innovation and Skills, told us:
“scientifically we lead or are close to leading in insect molecular biology, which covers both of these [areas]: the fundamental and what Oxitec do. You have to remember that we have one company that leads; it is the only company in the world as well. It leads not just the UK; it leads the world.”58
66.The National Institutes of Bioscience provided a helpful analysis of the commercial prospects for GM insect deployment (Box 3):
Box 3: Prospects for commercial GM insect deployment
As developer: design and development of GM insects and GM insect based control methods represent an emerging, knowledge-intensive and potentially high-value industry. Total value is hard to estimate, but it could potentially address a number of multi-billion-dollar problems in agriculture and public health around the world. Could the UK become a leader in this industry? What are the potential sources of comparative advantage, if any, for the UK, as a developer of GM insect technology? Current position: The UK has a clear lead in the commercial development of GM insect technology through Oxitec … The UK also has a number of leading academic research groups active in this area, including those led by Luke Alphey (The Pirbright Institute) and Austin Burt and Andrea Crisanti (both Imperial College), world-leading developers of GM insects, respectively focusing on self-limiting and self-sustaining methods. More generally, the UK has a strong bioscience sector in universities, research institutes and small and large companies. However, there is competition in the US and elsewhere, notably China where there has been considerable recent investment in this area. Furthermore, the current regulatory—and perhaps political—situation makes it hard to test GM insects in the UK. This has a knock-on effect on potential markets as there is an expectation that a developer would first test a product “at home”. Developers that can do this will have an advantage over those that cannot. Market: as noted above, the domestic market for this technology is limited. This precludes a common route for small companies of starting with a local market then expanding. If the government were to encourage the development of GM insect technology for those specific, otherwise intractable problems for which it seems appropriate, this would catalyse and underpin the development of an export industry which would likely otherwise struggle to gain traction. |
Source: Written evidence from the National Institutes of Bioscience (GMI0012)
67.In a similar vein, Innovate UK suggested that the UK could benefit economically from new GM insect technologies but warned that a restrictive regulatory environment could have an impact on this:
“The UK has the capability in the underpinning science and technology to benefit economically whether that deployment is within the UK, EU or elsewhere. However, where deployment is only possible in overseas markets, the UK risks losing its world-leading talent.”59
68.Ian Meikle, Head of Agriculture and Food, Innovate UK, alluded to opportunities for Innovate UK to invest further in GM insect research:
“going from a responsive mode to being targeted, that is something where we would look for the results of this inquiry, certainly in the Innovate UK space, and we always work in partnership with the research councils. If the results of this inquiry are positive, we could certainly do something that was more targeted to draw through more.”60
69.It will, of course, be vitally important to ensure that the excellence of the science base, and the UK’s world-leading research groups and institutes in this field, continue to be supported appropriately.
70.We conclude that the excellence of the science base, investment in infrastructure and the skills pipeline must at least be preserved, and preferably enhanced, in order to maintain the UK’s position as a world-leader in GM insect technology development. In this regard, we welcome the Chancellor’s announcement in the recent Spending Review that the resource budget for science will be protected in real terms for this Parliament.
71.We also welcome the announcement, as part of the Spending Review, of the new £1 billion Ross Fund61 which will be used to support the global fight against malaria and other infectious diseases. The Ross Fund will provide an opportunity for further research and development into products for fighting infectious diseases. This will benefit low to middle income countries which bear the greatest burden of infectious diseases.
72.On account of the potential that GM insects offer, both economically and in terms of public health, we conclude that there is a strong case for Innovate UK to invest further in this area to promote commercialisation of UK-based GM insect research. We therefore recommend that Innovate UK, in partnership with the Research Councils, considers providing targeted funding in order to develop the commercial deployment of GM insect technologies (see also paragraph 147).
73.It is important to note that only population suppression strategies, not population replacement strategies, have been taken towards commercialisation so far. Population replacement strategies may not be able to be commercialised as the desired outcome can be achieved by a single or limited number of releases.
74.We were dismayed to be told by Professor Luke Alphey that it was the EU regulatory environment, and European views on GM, which were holding back the development of GM insect technologies:
“The fact is it is impossible to sell this technology in Europe at the moment. Field trials, perhaps, but there seems to me no possibility of getting commercial registration in a reasonable time, or even having any idea how much time or money it would take. That is probably the biggest negative factor …
… it is the view of GM in Europe which has this chilling effect on the investor community as well, because they think, ‘You will never be able to do that’, or, ‘It will take too long or be too expensive,’”62
75.As articulated above by Professor Alphey, and alluded to by others in previous paragraphs, we were told, time and again, that the principal and overwhelming barrier to the fulfilment of commercial potential, at least for population suppression strategies, was the EU regulatory regime, and it is to this issue, which we now turn. As George Freeman MP, Parliamentary Under Secretary of State for Life Sciences at the Department for Business, Innovation and Skills and the Department of Health, put it to us:
“Unless we are also a good economy for using innovation, putting it to work and testing it in the field, we are in danger of being simply a good place to do research but the commercialisation will go elsewhere. That argument writ large confronts the EU on an even bigger scale.”63
20 World Health Organisation, Malaria Factsheet No. 94 (reviewed October 2015): http://www.who.int/mediacentre/factsheets/fs094/en/ [accessed 9 December 2015] All information in this paragraph is derived from this source.
21 Ibid.
22 World Health Organisation, Dengue and severe dengue Factsheet No. 117 (updated May 2015): http://www.who.int/mediacentre/factsheets/fs117/en/ [accessed 9 December 2015] All information in this paragraph is derived from this source.
23 Ibid.
24 Samir Bhatt et al, ‘The global distribution and burden of dengue’, Nature, vol. 496 (2013), pp 504–07: http://www.nature.com/nature/journal/v496/n7446/full/nature12060.html. The article states that: “Using cartographic approaches, we estimate there to be 390 million (95% credible interval 284–528) dengue infections per year, of which 96 million (67–136) manifest apparently (any level of disease severity).”
25 Dengue and malaria are included in the list provided by the Research Councils, but are not reproduced here. See previous paragraphs.
29 Ibid.
31 Ibid.
32 Ibid.
36 Ibid.
38 Food and Agriculture Organisation of the United Nations, How to feed the world in 2050 (2009): http://www.fao.org/fileadmin/templates/wsfs/docs/expert_paper/How_to_Feed_the_World_in_2050.pdf [accessed 9 December 2015]. We note that population control is clearly an aspect of this debate; it was not, however, the focus of our inquiry, so discussion of it is omitted from the paragraphs that follow.
39 Charles. M. Oliveira et al, ‘Crop losses and the economic impact of insect pests on Brazilian agriculture’, Crop Protection, vol. 56, (2014), pp 50–54: http://www.sciencedirect.com/science/article/pii/S026121941300269X [accessed 11 December 2015]
43 Written evidence from the Biotechnology and Biological Sciences Research Council (BBSRC), the Medical Research Council (MRC) and the Natural Environment Research Council (NERC) (GMI0017)
49 Formerly the Technology Strategy Board (TSB); an executive non-departmental public body charged with progressing science and technology innovations in order to grow the UK economy.
50 For a detailed breakdown of BBSRC, MRC and NERC spending on research related to GM insects from 2010/11–2014/15 please see their written evidence (GMI0017).
61 Named after Sir Ronald Ross, the first ever British Nobel Laureate who was recognised for his discovery that mosquitoes transmit malaria.