The European Parliament (Strasbourg) has adopted a mixed bag of new amendments to directive 90/220/EEC, which is the framework for the safe environmental release and marketing of genetically modified organisms (GMOs). The amendments stand both to nurture and further constrain the GMO product market in Europe.
Although there were more than 20 new amendments and many additions made, "The big one [amendment 5] is the time limit on approvals," states Willy de Greef, head of regulatory affairs at Novartis Seeds (Basel). He explains that regulators approve a particular event (meaning a crop produced from a GMO), as opposed to a particular plant variety. "Then, we begin breeding programs to create different varieties adapted to different environments," he says. "If the approval is for 10 years, and 5 [of those] are dedicated to creating varieties, this is a severe constraint." After 7 years, a company will become hesitant to invest in further development," he says.
Other directive amendments define the need to identify the genetic alteration, routine registration and logging procedures, and such precautionary measures as a ban on GMOs that contain genes expressing antibiotic resistance (amendment 90), or that pose an "unacceptable risk" to biodiversity (amendment 91).
"One thing we applaud is the reference to setting up a centralized procedure 'assessment' agency [amendment 96]," says de Greef. Amendment 96 states that the long-term goal of the European Union (EU; Brussels) should be to create a centralized procedure at the European Community level along the same lines as those guidelines used for the licensing of medicinal products. The amendment goes as far as to suggest that the European Environment Agency in Copenhagen conduct a study on the possibility of centralized monitoring of the release of GMOs.
"What makes Europe attractive is the existence of the common market and a common standard that applies across the member states. Having one door to enter into the process will be a very significant improvement," says de Greef. Tom McDermott, spokesperson for Monsanto (Brussels) concurs: "We welcome any changes that would make the system work better." Under the current system, companies can go through the lengthy process of applying from country to country or choosing a rapporteur country to present their application to the EU member states.
Monsanto, Novartis, and other companies seeking approval of GMOs for the European market have grown to expect the unexpected while wading through EU bureaucracy. And the climate surrounding biotechnology, especially agricultural biotechnology, has been erratic. Public suspicion and nongovernment organizations lobbying against GMOs have prompted some legislators to tiptoe around the issue. For example, during the EU scientific committee's February vote on Monsanto's two varieties of genetically modified cotton, several nations abstained, making it impossible for Monsanto to obtain the necessary weighted majority of favorable votes to gain approval. Monsanto must now wait until June at the earliest before its cotton proposal is put in front of the EU council of ministers for a decision.
"The [approval] process is very unpredictable, takes a long time, and can be very cumbersome," comments McDermott, "and there is a political element and other considerations that contrast with how the regulatory process is handled in other parts of the world". de Greef also acknowledges that the EU needs to build more transparency into how regulations are set up and that the continent needs regulatory institutions that are as highly regarded as the US FDA or USDA.
Despite the complexities, the mood at both Novartis and Monsanto is optimistic. "Clearly there are fractions in the [EU] parliament that are anti-biotech, namely the Greens, but nobody else is really opposed," says de Greef. "What is needed is a good understanding of where biotech would fit in for sustainable agriculture, and we have a long way to go in communicating it. We must improve the dialogue with society, and that will take about 5–10 years. We are in for the long term."
The amended directive now moves to the European Council of ministers for a vote. Their redraft is then reconsidered by parliament before incorporation into the national law of EU countries.