Agriculture Reference
In-Depth Information
not necessarily needed to be grown, transported, and processed in more
than one member-state. In all likelihood, such seeds and plants will also
not be traded on the market. Cultivation or processing of such plants
might even be conducted in-house or by contractors under supervision
of the manufacturer. Given the U.S. experience, companies may want
to stay under strict regulatory oversight during the commercial produc-
tion stage, which is not foreseen in the present EU regulatory regime
(see e.g., www.bio.org/healthcare/pmp/factsheet4.asp).
Part C authorization procedures would be more proportionate for the
increased rigor of their risk assessment and their demand for mandatory
monitoring, but in the complex EU environment there may be continued
unpredictability regarding eventual authorization decisions. National-
level Part B procedures would be more straightforward but would not
be considered sufficient in terms of risk assessment and monitoring, and
perhaps not as acceptable if there is a chance that possible contamination
might affect commercialization of food and feed products for other EU
member-states.
One could therefore argue that the characteristics of PMPs require a
separate authorization track in the EU. However, given the sensitivity of
the issue, it is difficult to envisage such a procedure becoming established
at any national level without the involvement of the EU or national
authorities. EU regulators might also reconsider the Part B track in case
of field trials of pharm crops. In contrast to GM crops for food and feed
use, pharm crops are to be cultivated for long periods of up to fourteen
years and are likely to be grown in larger areas to collect data and pro-
duce sufficient amounts of substances necessary for testing in the course
of their authorization as biopharmaceuticals.
Fourth, a related issue could emerge from the fact that EU-based
companies tend to conduct their field trials in part outside of the EU,
such as in Chile, the United States, and elsewhere - supposedly because
of the more difficult regulatory environment and the less favorable public
perception in the EU, but also because this makes it possible to get more
