Agriculture Reference
In-Depth Information
production. Perhaps even more significant, regulatory uncertainty that
translates into extended timeframes and higher regulatory costs can
be expected for authorizing pharmaceutical products from GM crops.
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Technology platforms that are similar to presently used contained pro-
duction systems - highly controlled and sterile environments for devel-
opment of cell lines and microbes - may therefore be facing lower regula-
tory hurdles - at least for the first wave of PMPs. This approach may also
be more attractive for the pharmaceutical industry, which seems to be
reluctant to adopt PMPs from open fields.
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Such production platforms
could work well for high value products that would not be needed in very
large amounts.
For PMPs such as insulin, certain antibodies, and vaccines that need
to be produced at larger scales, open field production in food crops may
still be considered as the only feasible approach. This may hold true for
those PMIs that require larger volumes at much lower overall costs, such
as those to be used for food supplements or feed additives that confer
health benefits (nutraceuticals), or for making bioplastics.
Another Scenariofor aPublic Debate
Previous discussion has illustrated the characteristics of molecular farm-
ing and its associated health, environmental, and economic risks, as com-
pared to first-generation GM crops. Increased activities in European
R&D and the proximity to the market stage of the first products of
plant molecular farming are now confronting EU regulators. Several
challenges are posed to regulators to allow for commercialization of
molecular farming in the EU, including contamination of the food and
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A. Sp ok &M. Klade, Molecular Farming. Novel Challenges for Risk Management and
Legislation (Office of Technology Assessment at the German Parliament 2005).
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A. Sp ok & S. Karner, Plant molecular farming. Opportunities and challenges. Techni-
cal Report Series, Joint Research Centre Institute for Prospective Technological Stud-
ies, EUR 23383 EN, DOI 10.2791/30861, European Communities 2008; available at
