Scientists say amending an EU directive on GMOs could help stimulate innovation in making vaccines, cheaper pharmaceuticals and organic plastics using plants.
In a paper to be published in Current Pharmaceutical Design, six scientists from the US and Europe compare risk assessment and regulation between the two continents. They will run a web chat on the subject with Sense About Science from 12-1 on Wednesday 20th February.
In the EU, plant-made pharmaceuticals have to be authorised in the same way as GM agricultural crops. In theory, agricultural crops can be grown by any farmer in the EU once approved. But for crops producing pharmaceuticals this would never actually happen. Drug companies would likely license farmers to grow these crops under controlled, defined and confined conditions.
"We need tight regulations enforced by continuous oversight to encourage investment, while maintaining trust," said Dr Penny Sparrow from the John Innes Centre.
"This will be of high importance, especially in Europe, where the issues surrounding the cultivation of GM agricultural crops remains a contentious concern."
"Plant-made pharmaceuticals challenge two sets of existing EU regulations and to make progress in this area we need to make sure they are applied sensibly to allow pharmaceuticals to be produced in plants."
Advantages of using plants to produce therapeutic proteins include the ability to produce large quantities quickly and cheaply, the absence of human pathogens, the stability of the proteins and the ease with which raw material can be stored as seed. This could be of huge benefit in developing countries where problems with storage can render vaccines useless.
If seed could be transported to local production and extraction facilities, the technology could also help boost local economies. The technology is also known as "plant molecular farming".
Just one farm growing 16,000 acres of safflower could meet the world's total demand for insulin. But potential cost savings are eliminated under current regulations, set up for GM agricultural crops not pharmaceuticals.
The average cost for having GMOs approved in Europe is estimated at €7-10 million per event, compared to $1-2 million in the US. This helps keep Europe behind in exploiting the potential of these technologies.
"Openness and transparency are needed to develop new regulations that work for the public and for investors," said Sparrow.
"Regulations need to be harmonised across the world, in order to keep advances and competition on a level playing field."
They propose amendments to EU Directive 2001/18 to allow pharmaceutical products from GM plants to be commercialised without needing authorisation to enter the human food or animal feed chain. Instead, the scientists say they should be grown under clearly defined and enforced conditions to keep the food and animal feed chain 'contamination free'.
As each GM plant moves from the laboratory to scaled-up production in a greenhouse or field, additional oversight is needed to consider issues with environmental release and the ultimate use by humans. Measures can include those adopted in the US, such as limited acreage, confinement, fallow zones and only supplying seed to farmers specifically contracted to grow PMPs.
Dr Sparrow was involved in a collaboration with EU partners to road test the challenges faced by potential investors. They chose the first plant-derived anti-HIV monoclonal antibody to be tested in humans. It was isolated, purified and formulated as a topical saline solution. One result of the project was preparing a regulatory pathway that others could follow to take a product into clinical trials. Another was establishing good manufacturing practices for biologically active proteins expressed in transgenic plants.
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To participate in the web chat
Questions for the live #plantsci Q&A with the authors can be sent via email to email@example.com, via Twitter using #plantsci or via the Sense About Science Facebook page.
Risk assessment and regulation of molecular farming - a comparison between Europe and US.
Notes to editors
About the John Innes Centre
The John Innes Centre, www.jic.ac.uk, is a world-leading research centre based on the Norwich Research Park www.nrp.org.uk. The JIC's mission is to generate knowledge of plants and microbes through innovative research, to train scientists for the future, and to apply its knowledge to benefit agriculture, human health and well-being, and the environment. JIC delivers world class bioscience outcomes leading to wealth and job creation, and generating high returns for the UK economy. JIC is one of eight institutes that receive strategic funding from the Biotechnology and Biological Sciences Research Council.
Live Q&A: Wed 20th Feb, 12-1pm
Plants can be modified to 'grow' medicines. For example, insulin can be 'grown' in a GM safflower plant, which would be cheaper and more efficient than current methods. These plant-made pharmaceuticals are never likely to enter the food-chain but they fall under the same EU regulations as GM crops that are grown as food. The EU GM regulatory system is lengthy and costly, making the cheaper plant-made alternative production method prohibitively expensive. In a soon to be published paper, a comparison between the US and EU regulations surrounding plant-made pharmaceuticals is made and the authors discuss whether EU regulation hinders progress and investment into these new technologies. Sense About Science will be running a live #plantsci Q&A with the authors on Wednesday 20th February from 12-1pm UK time. You can start sending questions, concerns and ideas now, on any aspect of this, for the authors to respond to.
Questions can be sent via email to firstname.lastname@example.org, via Twitter using #plantsci or via the Sense About Science Facebook page.
#GM plants to 'grow' medicine - Live #plantsci Q&A from @senseaboutsci, Wed 20th Feb, 12-1pm http://ow.