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'Growing' medicines in plants requires new regulations
Date:2/19/2013

f 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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Contact: Zoe Dunford
zoe.dunford@jic.ac.uk
44-077-681-64185
Norwich BioScience Institutes
Source:Eurekalert

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