June 18, 2009
Authorization of GMPs in Europe: A procedure made to measure for multinationals
Contrary to the United States who adopted the principle of equivalence in substance in order to favour the development of GMOs by avoiding all specific evaluation, the authorization procedure for trans-genetic plants in Europe seems, at first glance, to be more controlled. It is in fact very hypocritical since laudable principles (like evaluation of files on a case by case basis) are effectively cancelled by the way they are implemented (for example by entrusting the assembly of the files to the petitioner).
Directive 2001/18 which governs the use of GMPs in Europe is a political compromise between to contradictory preoccupations held by European authorities: the concern for guaranteeing free trade and that of preserving the environment and public health.
While this law accepts the principle of the dissemination of GMPs, it also brings strong constraints. It demands that ahead of authorization for dissemination the case must respond to numerous criteria. It also gives states the possibility of implementing a safeguard clause that allows them to provisionally ban the use of a variety authorized in the EU on their territory.
But it is in the application of these laws where the hypocrisy lies. First, entrusting the integrity of studies which are held in order to prove the innocuousness of a product to its producer is unacceptable. Secondly, not insisting upon a complete absence of conflicts of interests for members of the authority responsible for evaluating the files (the European Food Safety Authority) is a negation of the precautionary principle. Finally, relaxing the evaluation conditions of directive 2001/18 by passing regulations (rules 1829 and 1830/2003) is a way of overturning the democratic debate in order to favour multinationals.
Furthermore, and even if this debate largely overtakes that of GMOs, it is not possible to conceal the absence of consideration of the will of citizens or local collectivities in the modalities of decisions at the community level.
For all these reasons, the authorization procedure for GMPs in Europe needs to be thoroughly reviewed.
Guaranteeing an Independent Evaluation of All Files
This independent evaluation is only possible if the European Union is willing to give the necessary means. We can imagine an agency where the members will be recruited not just for their competencies but also for their independence from industry in general and the agro-chemical industry in particular. It could be called, for example, the BEA for Biotechnology Evaluation Agency. As its name indicates, this agency is responsible for evaluating the environmental and health effects of trans-genetic plants before cultivation or use in the food chain is authorized. It puts in place a serious protocol based on the annexes of directive 2001/18 and calculates an average cost for implementing it and drawing reliable conclusions. It then charges the petitioner this amount when they submit their case. In this way, the firm also has to be responsible for the cost of the evaluation rather than the community, and it will also be conducted with complete independence. The conclusions of the study is to form an opinion whose the purpose is to clarify public debate and policy-making.
Involve European Citizens in Decision-making
On June 25, 1998, in the Danish city of Aarhus, 39 states signed a convention on “access to information, public participation in decision-making and access to environmental justice.” In particular, the Aarhus Convention presumes a need to favour public participation in decision-making that will affect the environment. The implementation of this step is planned following an adjustment procedure where, “all options are open and effective public participation can take place” (Article 6, paragraph 4). The results of their participation need to be taken into consideration in the final decision (Article 6, paragraph 8). Directive 2003/4/CE on January 28, 2003 concerns public access to information on the environment officially seeks to make community legislation compatible with the Aarhus convention, which the European Union also signed. We will note that while this law only addresses the question of access to information, public participation is returned on each case.
One of the best ways of implementing the principles of the Aarhus convention would be to generalize citizens’ conferences. In this step, a group of citizens receives training on the scientific, ethical, social, political, and economic aspects of a problem over several days of seminars. In the second stage the group of citizens publicly debates with representatives of the political world, NGOs, experts, and economic stakeholders who they have asked to meet concerning questions of their choice. After this conference, citizens will give their input and recommendations in a public report.
All claims concerning a new GMP application (GMO-pesticide, medicinal GMO, …) need to be submitted to a European citizens’ conference, reuniting nationals of each member state. The European Institutions will organize this conference sincerely by including NGOs in an advisory board and by respecting the conclusions that are produced.
Reconsidering the safeguard clause
The safeguard clause allows a member state to question the validity of an authorization granted by the European Union to consume or cultivate GMOs. In order to do this the state needs to bring scientific proof of the risk to public health or the environment caused by this GMO. The foundations and implementation conditions of this safeguard clause need to be modified. From now on, the notion of risk needs to be expanded to economic risks for non-GMO networks. Next, it needs to integrate the eventual gaps in the evaluation procedure that bring them to doubt the absence of risk by reversing the burden of proof. The admissibility of the safeguard clause needs to be examined by a mixed commission composed of member states, independent specialists and NGO representatives. Finally, the activation of the safeguard clause by a state needs to bring the immediate suspension of the authorization granted by the European Union. This suspension then leads to the resumption of the evaluation procedure in order to examine the objections that have been formulated and determine if they are justified or not.
Putting a regional safeguard clause in place
Since the dissemination of GMOs does not have the same consequences across all local characteristics, a regional safeguard clause needs to be allowed. Following a regional citizens’ conference, a community can ban the cultivation of a GM variety authorized by the European Union in order to protect health and the environment or to preserve diversity among agrarian systems. The motivations of this ban are passed on to the member-states and European institutions for information purposes. The mixed commission called for in the preceding section examines the justification of this regional safeguard clause and, accordingly, begins the immediate suspension of the authorization authorized by the European Union or decided on new precautionary measures on all or part of the community territory.
- Create the BEA for Biotechnology Evaluation Agency. It will be:
- Independent from industry
- Responsible for the evaluation of health and environmental effects of trans-genetic plants before they are authorized for cultivation
- Responsible for implementing a serious protocol based on the annexes of directive 2001/18;
- Implement the principles of the Aarhus convention by generalizing citizens’ conferences;
- Submit all requests concerning new GMO applications to a European citizens’ conferences
- Put a mixed commission in place composed of member states, independent specialists, and NGO representatives which is responsible for examining the admissibility of the safeguard clause
- In the event of the activation of the safeguard clause by a state, begin an immediate suspension of the authorization granted by the European Union
- Allow for recourse to a regional safeguard clause following a regional citizens’ conference, given that the dissemination of GMOs does not have the same consequences across all communities.