Non-Food Agriculture Core Group
23 August 2004
Note
Attendees: David Buckeridge, Dave Carmichael, Rosie Hails, Laura McMahon, Patrick Erwin and Emma Knox
Guest Speakers:
Professor Julian Ma, Guy’s Hospital
Dr Philip Wright, The Association of the British Pharmaceutical Industry
1. David Buckeridge began by updating the guest speakers on the progress of the Commission’s non-food agriculture workstream. He made the following points:
· The project was focusing on three particular areas in which to explore the subject of non-food agriculture: biofuels, biopharmaceuticals and biomaterials/bioplastics.
· Within each of these areas a case study would be identified which would be used for carrying out a detailed regulatory analysis, exploring the policy drivers in the area and to explore public perception of non-food uses of crops.
· At the last full Commission meeting in Aberdeen the Commission had agreed on a case study for the biofuels area: short rotation coppice willow and poplar.
· At this meeting the core group would like to identify a case study for the biopharmaceuticals area with assistance from the guest speakers.
· A case study for the bioplastics area would be identified at the Commission’s next full meeting at the end of September in York.
2. David Buckeridge then invited the two guest speakers, Julian Ma of Guy’s Hospital, London and Philip Wright of The Association of British Pharmaceutical Industry to offer their views.
3. Julian Ma made the following points in introduction:
· 75% of the world’s population depended on plants for treating illnesses.
· Infectious diseases were still a significant cause of death globally, predominantly in the developing world where access to vaccines was limited.
· Immunisation was the most cost effective resistance to diseases however they were not significantly distributed in the developing world.
· Vaccines had a high social value but low economic value for the companies producing them. This was because companies were under pressure to produce vaccines at marginal costs and therefore they make little profit which could be put back into research and development.
· There was great potential for producing vaccines in plants due to their cellular ability to put together very complex proteins. A vaccine against tooth decay had set the precedent for producing monoclonal antibodies in plants.
· One of the biggest advantages of producing vaccines in plants was the scale at which they could be produced. Production of vaccines at agriculture scale was limited only by the amount of land available. However, profitability depended on the yield that it was possible to get from the crop.
· All pharmaceuticals produced in plants would have to under go the same stringent safety test as other pharmaceuticals, including human and animal testing.
4. Philip Wright argued that it was much easier to get a vaccine into a person in chemical form and that the vast majority of vaccines were not taken orally, as vaccines produced from pharmacrops would be.
5. Philip discussed the concept of drugability which he argued was key to the pharmaceutical industry when producing new pharmaceuticals. Drugability was the ability to get the compound into the patient, at the dosage required, in a form that the patient was willing and able to take it in. Small compounds tended to be used for pharmaceuticals because they had good drugability and they were easy to get around the body of the patient.
6. Philip Wright’s view was that pharmaceuticals produced in plants would only be used in niches and specialist areas, e.g. arthirits, or where for a sub-set of individuals the conventional drug was ineffective. This was because small compounds were easier for patients to take in most cases.
7. Julian disagreed and thought that there was great potential for the use of vaccines produced in plants particularly for the developing world due to the scale of the vaccines that they needed. However, Philip argued that the biggest problem surrounding medicines in the third world was actually getting them to the patients rather than developing the medicines themselves. He stated that producing the necessary pharmaceuticals for the developing world was not the answer to their problems, what they needed was a healthcare structure.
8. It was said that pharmaceutical products produced in plants were likely to be used for “designer drugs” for longevity rather than fatal diseases as there was a higher demand for these drugs due to them being taken with frequency. However, these drugs were controversial because some people believed that because they did not treat conventional diseases and illnesses public money should not be spent on developing them.
9. Philip Wright argued that in developing controversial pharmaceuticals such as Viagra, it was the patients who this affects that should be asked their opinions on these, because one’s perceptions changed significantly when one was a patient.
10. Julian commented that large companies were not investing in the production of vaccines in plants because the appropriate regulatory framework was not yet in place. For Julian, the critical issue was to get the first product commercialised so that companies could see how the regulatory process would work and therefore be more likely to invest in the technology.
11. Philip argued that companies would be disinclined to produce vaccines in plants due to the issue of intellectual property (IP). In order to produce pharmaceuticals in plants one had to use transgenics and therefore any products produced in plants would have to go through additional regulations to those conventionally produced pharmaceuticals went through. Consequently the time in which the company had to recover its research and development (R&D) costs and to make a profit was shorter given the short lengths of patents.
12. Philip concluded that large companies did not invest their money in producing pharmaceuticals in plants because there were other routes that were quicker and more likely to be successful.
13. An additional issue would be that in some cases this technology would be used in crops that were food crops, therefore it was necessary to be able to ensure that it could not enter the food chain or be consumed by mistake.
14. Julian suggested some possible solutions that had been identified:
In potatoes:
· using clonal propagation so that the product looks different to edible versions
· producing varieties where cooking the potato deactivates the proteins
· using male sterile plants to prevent cross-pollination
In tomatoes:
· using seedless varieties
· using the colourless line for identity preservation
· Physical containment of the crop in greenhouses (however, this would work against the major advantage of producing pharmaceuticals in plants – large scale production).
· Geographical containment of the crop in an isolated area, e.g. a canyon.
15. Julian made the following suggestions for case studies in order of feasibility:
· Rabies post-exposure prophylaxis
If a person has been exposed to rabies they need to be given the rabies vaccine, which takes 10-14 days to work, and be injected with antibodies around the bite in order to survive. In the UK if a person was susceptible to rabies, e.g. a bat tenderer, they were given a rabies vaccine.
In developed countries a human-derived antibody was used for post-exposure treatment of rabies, however in developing countries a horse-derived one was used and stocks of this were running low. Developing countries require anti-rabies antibodies to replace this.
The World Health Organisation (WHO) put out a tender for production of monoclonal antibodies to replace the depleting stocks of the horse-derived antibodies, however no companies responded. Therefore the WHO approached Julian and a colleague and asked if they would carry out research into the production of an alternative in plants.
· Hepatitis B vaccine
This was the first vaccine produced by recombinant biotechnology in yeast. Greater quantities of this were required for use by developing countries.
A disadvantage to doing this case study was that the cost of this vaccine had come down considerably recently and therefore there may no longer have been the demand for it to be developed in plants. However, there was still a possible issue of it needing to be produced on a larger scale, which its production in plants could solve.
· HIV protein microbicides
As there would be no vaccine for HIV in the foreseeable future, a female-controlled alternative to the prevention of viral transmission could be through the use of topical HIV microbicides.
Julian was working on a five-year programme to put HIV antibodies into a plant and then take that product all the way through the regulatory trail.
Producing HIV antibodies in maize would be advantageous because maize can be produced all year round and there was good knowledge of the genetics of maize.
16. Julian Ma explained that it was unlikely pharmacrops would be grown in the UK due to a lack of space and that most crops grow better (and were therefore more productive) elsewhere. However, it was pointed out that the initial development could be done in the UK.
17. Finally, both speakers agreed that nutraceuticals should be treated differently to pharmaceuticals because they go through different regulatory processes and recommended that the core group reflect this in their scoping paper.
18. David Buckeridge thanked Julian and Philip for giving up their time and sharing their views with the core group. Julian and Philip left at this point.
19. The core group agreed that of the case studies discussed they preferred the suggestion of producing an HIV microbicide in maize. Whilst it was unlikely that this would be grown in the UK, the UK science base might carry out the scientific development. In addition, it would be a good example for testing the UK regulatory structure and interesting for the public engagement work.
20. David Buckeridge agreed to find out whether maize could set seed in the UK.
21. It was agreed that the Commission could definitely work with the Eden project on the TV programme if this took off. The idea preferred by the Core Group for a programme was one looking at how the Common Agricultural Policy (CAP) would change the British landscape, although this was not so directly relevant to the non-food agriculture workstream.
22. We could also usefully work with the Eden project on some of the public engagement aspects of the non-food agriculture workstream such as the wall chart.
23. Secretariat to draft a thank you note to the Eden Project.
24. Richard Reisz of TV6, a television production company, was in the process of putting the programme proposal to the BBC.
25. Secretariat to email core group members with suggested dates for future core group meetings.
26. Secretariat to send draft background papers to core group in advance of sending round to all Commissioners as a paper for the September Commission meeting.
