Kristina Nordlander, Vincenzo Salvatore and Pola Karolczyk, Sidley Austin
EU lawyers have increasingly had to balance industry’s right to confidentiality with the public’s right to know what substances are used in various products and emitted into our environment. In a recent plant protection products case involving information about the substance glyphosate, Stichting Greenpeace, the balance has tilted dramatically toward the presumption of public access. In this case, the General Court granted NGOs access to confidential and proprietary information on glyphosate. The Court’s reasoning dramatically increases the risk of publication of information on plant protection products, and sets a precedent that could apply to information on chemicals or even – by extension – data on medicines. Confidential documents in all these sectors may soon be the subject of multiple access requests originating from NGOs and industry competitors. We expect an appeal of the judgment in Stichting Greenpeace, likely involving many industry associations.
The Issue: Transparency versus Confidentiality
EU institutions, bodies and agencies should conduct their work as openly as possible. Indeed, this is required by the Treaty on the Functioning of the European Union, which identifies transparency as an overarching principle governing the activities of the Union and as a fundamental tool to promote good governance and ensure the participation of public society. The notion of transparency is twofold: it implies proactive dissemination of information that the EU institutions and bodies consider of general public interest, and reactive disclosure of documents in response to requests received from individual applicants.
However, when making information or documents publicly available, the EU institutions and bodies must also protect the confidentiality of commercially sensitive information provided by individuals or legal entities (for example in the context of seeking product approvals). This is required not only by EU law, but also by international trade rules.
This clash of interests is particularly evident in the framework of regulatory procedures concerning plant protection products, chemical substances, and medicinal products. In these procedures, applicants are required by law to submit proprietary information to EU regulatory authorities to trigger the scientific or technical assessment needed for marketing authorisation or approval. As they must file this information, companies should reasonably expect that this information will remain confidential.
A game-changer: the Stichting Greenpeace judgment
Transparency recently trumped confidentiality in Case T-545/11 Stichting Greenpeace Nederland and PAN Europe v European Commission. In this case involving confidential information about the plant protection product glyphosate, the General Court had to strike a balance between the expanded public access rules set by the Aarhus framework and exceptions under sector-specific legislation protecting confidential business information on the other. The Court’s judgment, delivered on 8 October 2013, came down on the side of a dramatically expanded right of public access. The General Court ordered the Commission to grant access to proprietary confidential information of a type that is typically protected from disclosure under the general Transparency Regulation and under the Plant Protection Products Regulation.
Environmental NGOs brought this case after the Commission refused to grant access to confidential information submitted in the approval process for the active substance glyphosate. Seeking to annul this refusal, the NGOs requested access to information on product composition, the identity and level of impurities and the manufacturing process. The General Court granted access on the grounds that the information was “information on emissions” to which the public can presume access.
Under the Aarhus Regulation, the public is presumed to have an interest in disclosure of information on emissions, even if it would impair the commercial interest (or IP rights) of a natural or legal person. The term “information on emissions” was previously understood as describing the very act of sending forth a chemical substance into the environment, and specifying the circumstances of such release (name of the substance, where and when it was released, and the amount of the release). This common-sense understanding was supported by the Implementation Guide for the Aarhus Convention, which limits the concept of emissions to releases originating from installations.
However, in Stichting Greenpeace, the General Court stretched the notion of “information on emissions” to include any information about the substance that relates “in a sufficiently direct manner to emissions into the environment”. The General Court’s reading of this term is surprisingly broad and clearly goes beyond what was initially intended by the Aarhus Regulation. As a result, information about glyphosate’s composition, substance identity, and the level of impurities qualified as information on emissions.
By the same token, any information about plant protection products relating directly to their impact on the environment could potentially be considered as information on emissions, thereby triggering the presumption of access in the Aarhus Regulation. The potential implications are wide-ranging.
Significantly, the General Court in Stichting Greenpeace granted public access to specification of impurities and information on the complete composition of a plant protection product, the very information defined as confidential in the Plant Protection Products Regulation. Article 63(2) of this regulation specifically provides that if the above information is disclosed, the disclosure is deemed to undermine the protection of commercial interests. Thus, the General Court’s ruling in Stichting Greenpeace broadens the Aarhus test while arguably depriving article 63(2) of its practical meaning.
Not only does the Stichting Greenpeace ruling threaten the loss of confidentiality for proprietary data in the EU, it also endangers confidentiality in other jurisdictions, including the United States. It is therefore interesting to contrast the ruling with the strong protection for trade secret, commercial, and financial information under US law, which clearly favours confidentiality for such proprietary data. Section 10 of the US Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides that applicants submitting data required for registration of a pesticide may clearly mark information as trade secret, commercial, or financial information and separately submit the marked data to the US Environmental Protection Agency (EPA). The EPA is prohibited from publicly releasing information that, in its judgment, contains or relates to trade secret, commercial, or financial information. If the EPA proposes to publicly release information that the submitter believes to be protected from disclosure, it must first notify the registrant or applicant of its intent to release such information.
Chemicals: another area of great concern
The potentially problematic impact of the Stichting Greenpeace judgment will not be limited to the sector of plant protection products. The EU courts are likely to apply an equally broad interpretation of the notion of “information on emissions” to other areas of substance regulation. This concerns, in particular, chemicals regulated under the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). If the General Court’s extremely broad interpretation of “information on emissions” is applied to chemicals, chemical companies will be placed in a double bind: the very registration of products in accordance with EU law will risk exposing their confidential business information or intellectual property rights.
Another pending case – ClientEarth and International Chemical Secretariat v ECHA – epitomises the type of chemicals dispute where Stichting Greenpeace may be used to argue for broader access to confidential business information. In this case, two NGOs claimed a right of access to information concerning 365 chemical substances, but ECHA, the competent agency under REACH, refused to grant it. The NGOs then challenged ECHA’s decision before the General Court.
The NGOs had requested information about the names of manufacturers and importers, as well as their contact details, the precise tonnage of the substances manufactured or placed on the market, and (if this information was unavailable) the total tonnage band. ECHA considered that the information about the names of the registrants was valuable market information and that its disclosure would make the market more transparent. It also concluded that granting access to information about the precise tonnage could undermine the commercial interests of registrants by disclosing the market shares of the companies to competitors. Finally, ECHA did not possess information on tonnage band and thus could not make it available to the applicants.
In their action before the Court, the NGOs referred to their general right of access under the Transparency Regulation, but also to the wider right of access to environmental information under the Aarhus Regulation. Specifically, the NGOs argued that all the information they had requested could potentially relate to the chemicals’ impact on the environment, while the information on precise tonnage should be considered as information on emissions.
The judgment in Stichting Greenpeace has substantially reinforced these arguments by offering a new interpretation of the concept of “information on emissions”. The NGO applicants may now be able to successfully argue that the information on precise tonnage relates “in a sufficiently direct manner to emissions into the environment,” because for each chemical concerned the information allows a determination of the amount of active substance released into the environment. As a result, the Court may order ECHA to disclose the information requested.
Another chapter: Medicinal Products
Although medicinal products may fall outside the scope of the Aarhus rules, the developments discussed above are likely to further support those pushing for increased transparency in the area of quality, safety and efficacy of pharmaceutical products. In this sector too, the types of information to which the public can presume access is being broadened, paralleling the broadening of the Aarhus “emissions” test.
Until recently, the European Medicines Agency (EMA) generally refused to grant access to documents contained in the “dossiers” submitted with marketing authorisation applications for medicinal products, arguing that the contents of the dossier were confidential and could not be disclosed unless the public interest would outweigh the interests of the marketing authorisation holder. However, to meet the growing demand for public information, as of 2005 public assessment reports were published to provide a defined set of data about the product after authorisation.
In 2010 the European Ombudsman recommended broader disclosure. In response, the EMA reversed its position and announced a new policy pursuant to which certain types of documents containing clinical and non-clinical data from the marketing authorisation dossier could be released following authorisation of the product. In the next three years, the EMA released over 1.9 million pages of clinical trial data in response to access requests. In November 2012, the EMA announced plans for a new policy to release clinical data proactively. These plans triggered an intense debate, inter alia because the data released in Europe could be used in support of generic marketing authorisation applications in certain third countries. The new policy has not been finalised yet.
The 2010 policy was recently challenged by pharmaceutical companies before the EU courts in an attempt to prevent the agency from granting access to documents related to specific clinical trials. The cases are closely watched by industry, for several reasons. First, the EMA itself recognised that the documents in question contained information normally classified as secret, and the cases on the merits will show whether, as EMA alleged, it would be “unreasonable” not to disclose information regarding safety and efficacy of an authorised medicinal product. Second, the General Court is likely to discuss whether maintaining secrecy is warranted if disclosure causes a loss of patentability. Third, the cases may shed light on the interaction between EU rules and the provision set out in article 39.3 of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).
TRIPS article 39.3 mandates that WTO members, including the EU, must protect undisclosed test and other data whose origination involves a considerable effort and whose submission is required by governments as a condition for approving the marketing of pharmaceutical or agricultural chemical products that use new chemical entities. Protection against “unfair commercial use” is one type of protection mandated by that article.
Neither the WTO Appellate Body nor a dispute settlement panel has interpreted TRIPS article 39.3.
The Stichting Greenpeace ruling changes the game for regulatory data protection in the EU. It puts a number of sectors in a double bind, and potentially puts EU regulations in conflict both with US legislation and with WTO law, although this has not yet been tested in court. Companies should closely watch the expected appeal in Stichting Greenpeace. They should also monitor other data access cases to see if a broad and potentially problematic precedent has indeed been set.