Agriculture Reference
In-Depth Information
GMO legislation and medicinal product legislation. Furthermore, PMP
companies are still facing uncertainties with regard to how drug reg-
ulators, who are used to dealing with contained production facilities
and strictly controlled and validated production processes, will deal with
open-field agricultural production environments that will be influenced
by weather, climate, soil, and pests. Finally, potential humanitarian ben-
efits to developing countries are frequently mentioned by manufacturers
and scientists, that is to say the availability and applicability of drugs
might be improved (e.g., for oral vaccines, storage conditions of PMP's
in kernels).
12
Until a few years ago, most activities have centered in the United
States and Canada, with far fewer activities in the EU. As this chapter
shows, the picture in the EU is changing and challenges for regulators
are looming.
In the first section of this chapter, the driving forces of the technol-
ogy are discussed. Then, in the second section, the present status of com-
mercialization and the most important aspects of the North American
public debate are reviewed. Third, evidence is presented that molecular
farming is about to gain a foothold in Europe. In the fourth section, it
is argued that specific hazards and risk dimensions are associated with
molecular farming. The subsequent sections identify policy challenges
for the EU and explore possible repercussions from very stringent rules
for open field cultivation to the innovation process. In the concluding
section, it is argued that policy development for molecular farming will
have to be pursued in a complex environment where unresolved prob-
lems with the first generation of such GM crops
13
are still prevalent. The
overall focus of the article is on PMPs but frequent reference is given to
PMIs.
12
J. K. Ma et al., Plant Derived Pharmaceuticals - the Road Forward, 10
Trends in Plant
Science
580-585 (2005).
13
First-generation GM crops comprise so-called output traits that are not aimed to
directly benefit the final consumer. This group comprises various types of tolerance
traits, mainly herbicide and insect tolerance.
