December 15, 2017
By Emilia Korkea-aho and Päivi Leino
In November 2017, after a great deal of political maneuvering, the EU Member States decided to extend authorization for glyphosate, the world’s best-selling herbicide, for a period of five years. Eighteen Member States voted in favour of the extension, nine voted against and one abstained. The decision came following a lengthy and combative process, which focused on the question of whether glyphosate is carcinogenic, something that the World Health Organization declared in 2015 as probable. The public debate surrounding the decision has been exceptional, resulting in a ‘Ban Glyphosate’ European Citizens’ Initiative and a pending Court case relating to the publicity of the scientific reports regarding the use of glyphosate and its effects on humans.
The pending Court case involves a request by four Green Members of the European Parliament addressed to the European Food Safety Agency, which after lengthy correspondence agreed to disclose parts of the reports but refused to hand out their most sensitive parts, including the summaries of scientific findings. The correspondence can be found in full on the AskThe EU – website under “Is glyphosate safe? We have the right to know!”. The debate illustrates how the role of agencies has been gradually changing in the EU. While their creation was initially justified by reference to the need to delegate technical issues to bodies operating largely outside politics, it seems that many agencies (such as the European Chemicals Agency (ECHA), the European Food Safety Agency (EFSA), and the European Medicines Agency (EMA)) today deal with issues that are politically “hot stuff”.
A tension between confidentiality and transparency has become particularly evident in the framework of regulatory procedures concerning chemical substances, food, and medicinal products. In these procedures, applicants must provide EU agencies with commercially sensitive information to trigger the scientific and technical evaluation needed for marketing authorization or approval, and legally, these companies “own” the data that they provide. In the case of glyphosate, EFSA refused four MEPS access to the scientific studies on the grounds that the information is commercially sensitive. While the rules on public access to documents should certainly not allow competitors to access the business secrets of others, they exist to safeguard a key function of democratic society: enabling broad and enlightened debate about issues that concern society at large. That the possible health risks caused by glyphosate belong to these matters is something that few would disagree on.
In recent Agency practice, a new “ownership” paradigm seems to have evolved with the potential to develop into a novel kind of originator control. Originator control, which has been used in the context of sharing information with other governments or international organizations, makes re-dissemination of information conditional on the originator’s approval, and is unknown to EU public access legislation, which requires consultation procedures for third party documents. Disclosure decisions must be taken in appreciation of the potential harm caused to commercial interests, including intellectual property rights, which is to be weighed against public interest in disclosure.
Copyright and public access regulation are a poor match, with disparate and competing policy objectives that are not easily balanced or reconciled. Many agencies have in practice relied on companies to propose and justify redactions and non-disclosure decisions. Agency disclosure decisions have also been accompanied by a statement intended to limit the subsequent use of information by the applicant. It is clear that when an application for access is based on Regulation 1049/2001, there should be no legal grounds for limiting its re-use. However, when agencies disclose information with the disclaimer that the use of released documents may lead to copyright infringement, they shift the legal risk and liability to the applicant; a risk that should be with the public authority deciding on public access.
Current legislation and case law provide limited guidance in helping to settle the balance. According to rumours, the European Commission is now planning to adopt a legislative proposal that would force pesticide companies to make public all scientific studies on the safety of their products in an attempt to eliminate claims that industry holds too much influence over authorizations. At best, the proposal would enable independent assessment of the way in which agencies evaluate scientific studies. It would, however, offer limited guidance for the new situation in which agencies increasingly find themselves. The fact that EU agencies deal with issues that are politically “hot stuff” also means that they engage directly with the general public, and it remains to be seen whether this new role of agencies is foreseen in the proposal.
This blog post is based on findings from Emilia Korkea-aho and Päivi Leino, ‘Who owns the information held by EU agencies?: Weed killers, commercially sensitive information and transparent and participatory governance, 54(4) Common Market Law Review (2017) 1059-1092.
Päivi Leino is Professor at UEF Law School
Author : TARN
Emilia Korkea-aho is Academy Research Fellow and Docent in EU law at the University of Helsinki