News & Events / New EU Biocidal Products Regulation Introduces Important Changes for Biocide Data Protection in Europe
New EU Biocidal Products Regulation Introduces Important Changes for Biocide Data Protection in Europe
Beveridge & Diamond, P.C., June 15, 2012
Last month, the Council of the European Union formally adopted the EU’s new Biocidal Products Regulation (“BPR”) – which is set to replace the EU’s existing Directive 98/8/EC (the “Biocidal Products Directive,” or “BPD”). The BPR is set to be published in the EU’s Official Journal in the coming weeks and will be effective in all Member States 20 days after publication. Among the many changes, the BPR establishes a new data protection framework for biocidal products that will have significant impacts on biocide manufacturers and distributors in European markets. These new provisions will go into effect on September 1, 2013.
In the EU, pesticides are regulated by two separate legal frameworks: (1) all “plant protection products” are set under the provisions of the Plant Protection Products Regulation (EC) No. 1107/2009 (formerly Council Directive 91/414/EEC) and (2) all “biocidal products, including antimicrobials, material preservatives, and disinfectants, as well as many non-plant protection insecticides and rodenticides, are regulated under the provisions of the existing BPD and, beginning next year, the new BPR. By contrast, under U.S. law, the term “pesticide” is defined broadly to include a wide range of substances –including many agrochemicals, insecticides, rodenticides, antimicrobial products, and genetically modified plant-produced protectants – all of which are subject to the pesticide registration requirements of a single statute, the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”).
The new changes introduced by the BPR include new procedures for biocidal product authorizations, specific requirements for articles that have been treated with or incorporate a biocidal product (known as “treated articles”), and new labeling requirements for biocidal products. We focus below on the BPR’s new data protection requirements, in the context of a comparison with equivalent provisions of FIFRA. The basic protections made available for studies submitted to support biocidal active substances and products under the BPR appear in many respects more limited than the data protections that U.S. pesticide registrants are accustomed to under FIFRA. Moreover, the untested nature of many of these requirements may pose challenges for both EU authorities and the regulated community alike, as data compensation disputes – including disagreements over the level of effort used to resolve such disputes -- are examined and decided in the future by any number of national courts in the EU.
For more information about the BPR or the regulation of biocidal products in the United States or European Union in general, please contact: Kathy Szmuszkovicz at Beveridge & Diamond, P.C. (firstname.lastname@example.org or 202-789-6037), Elizabeth Richardson at Beveridge & Diamond, P.C. (email@example.com or 202-789-6066), or Alan Sachs, Independent Consultant Attorney (firstname.lastname@example.org or 410-230-1345).
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A. New Data Protection and Data Sharing Requirements Under the BPR
The BPR provides for varying periods of “data protection” during which data that have been previously submitted to EU authorities in support of the approval of new biocidal active ingredients or products may not be used by those authorities “for the benefit of” a subsequent application without the express written authorization of the data owner. BPR, at Art. 59, 60. These data protection periods – which range from five to 15 years depending on the specific circumstances surrounding the active substance or biocidal product that the new data are intended to support – are all triggered by the date of first approval of the relevant active substance, biocidal product, or use. BPR, at Art. 60.
Unlike FIFRA, however, the BPR does not clearly set out an “exclusive use” period during which follow-on applicants are expressly prohibited from unauthorized reliance on data previously submitted in support of products containing new active ingredients (or pertaining to the registration of a new uses of an existing active ingredient). See FIFRA Sec. 3(c)(1)(F)(i). To the contrary, and as described below, the BPR imposes an overall data compensation negotiation mandate, and further requires that EU authorities allow follow-on applicants to rely on previously submitted vertebrate studies -- regardless of whether or not those studies support a new biocide or use, or whether the parties have in fact been able to reach a data compensation agreement. Even with respect to non-vertebrate studies, the BPR is unclear when or even if a data owner will be able to withdraw from the required negotiations and decline to provide a follow-on company with permission to rely on its data.
B. Mandatory Data Sharing for Vertebrate Studies
The BPR expressly prohibits follow-on applicants from duplicating previously submitted studies involving vertebrate animals – even if those data are still subject to an applicable protection period. Instead, the follow-on applicant must ask EU authorities to determine whether such studies have already been submitted in the EU; if so, the authorities must provide the applicant with the original data owner’s contact information. The applicant is then required to request from the data owner “all the scientific and technical data related to the tests and studies concerned as well as the right to refer to these data when submitting applications” under the BPR. BPR, at Art. 62(1), (2).
Once the follow-on applicant makes such a request to the data owner, the follow-on applicant and the data owner are together required to “make every effort to reach an agreement on the sharing of the results of the tests or studies requested by the prospective applicant” or, alternatively, submit the matter to an arbitration body and commit to accept the arbitration order. BPR, at Art. 63(1). Unlike the requirement for mandatory arbitration provided under FIFRA Section 3(c)(1)(F)(iii), however, the option to submit to arbitration under the BPR appears to be voluntary; on its face, the BPR does not require parties that fail to reach an agreement -- after having made “every effort” to do so – to subsequently submit to a data compensation arbitration. Rather, the arbitration option appears to be provided as an alternative to data compensation negotiations altogether. That said, the BPR does not define the term “every effort” – an almost certain source of dispute between data submitters and follow-on applicants. This issue will likely be put before EU Member State authorities and national courts, who may be asked to determine the sincerity of each party’s data compensation positions against the inexact standard of “every effort.”
If the parties do reach an agreement or obtain an arbitration order, the data owner has the option of either making all of the scientific and technical data related to the vertebrate studies available to the follow-on applicant, or giving the follow-on applicant “permission to refer” to the data owner’s vertebrate studies. BPR, at Art. 63(2). However, if there is still no agreement at least one month after the follow-on applicant first receives the data owner’s contact information, the follow-on applicant must inform EU authorities. BPR, at Art. 63(3). The authorities are then required to give the follow-on applicant “permission to refer” to the requested vertebrate studies, provided that the applicant “demonstrates that every effort has been made to reach an agreement and the prospective applicant has paid the data owner a share of the costs incurred.” It is not at all clear how an applicant can actually make this demonstration, particularly if after the passage of only one month, nor how such an assertion might be challenged by the data submitter. In any event, while the data owner cannot refuse to accept the payment that must be offered by the applicant, such acceptance is considered to be “without prejudice” to the data owner’s right to have the “proportionate share of the cost” determined by a national court. BPR, at Art. 63(3).
C. Requirements for Sharing Non-Vertebrate Studies
The BPR requirements for sharing non-vertebrate studies raise similar questions. The BPR permits, but does not require, applicants to ask EU authorities whether such tests or studies have previously been submitted, and similarly permits, but does not require, applicants to subsequently request the studies (and the right to refer to them) from the data owner. In other words, with respect to non-vertebrate studies only, follow-on applicants are given the option (as under FIFRA) to either generate their own data or cite to previously submitted data.
Once such a request for data reliance is made, however, the applicant and the data owner are once again charged with making “every effort to reach an agreement on the sharing of the results of the tests or studies,” or submitting the matter to an arbitration body – raising the same questions noted above concerning how the parties’ negotiation positions will be judged by authorities seeking to determine whether “every effort” has in fact been made. BPR, at Art. 63(1). Even though EU authorities are not required to provide a follow-on company with permission to refer to previously submitted non-vertebrate studies, use of the same “every effort” standard suggests that a data submitter’s decision to withdraw from negotiations and not to share all of its protected data – including non-vertebrate studies – may be subject to close examination and even challenge by EU authorities.
D. Key Differences in Data Protection
In summary, there are a number of key distinctions between the data protection requirements for biocide data contained in the BPR and FIFRA, including:
· Data protection and compensability under the BPR are not triggered by a study’s submission date, as under FIFRA Section 3(c)(1)(F)(iii), but by the date of first approval of an active substance, product, or new use.
· Unlike FIFRA Section 3(c)(1)(F)(i), the BPR does not provide for any express “exclusive use” period in connection with data submitted to support a new product or use. Instead, the BPR specifically prohibits the duplication of vertebrate studies and requires EU authorities to permit follow-on applicants to rely on such previously submitted data, as long as “every effort” has been made to reach a data compensation agreement. There is no similar prohibition against the duplication of any pesticide studies under FIFRA, and follow-on applicants may always choose to independently generate and submit their own data rather than cite to previously submitted studies.
· The BPR’s requirement that parties also make “every effort” to reach an agreement with respect to the sharing of non-vertebrate studies renders uncertain the degree of actual autonomy that data submitters will hold even when data sharing is not entirely “mandatory.” No similar standard exists under FIFRA. When data sharing is required under FIFRA Section 3(c)(1)(F)(iii), for example, the parties do not need to demonstrate that any specific level of effort has been made to reach a data compensation agreement. Instead, if the parties have not reached an agreement 90 days after the follow-on applicant provides the data submitter with the required offer to pay, either party may initiate binding arbitration.
· While binding arbitration may be selected under the BPR as an alternative to data compensation negotiations, there is no mandatory arbitration requirement as found under FIFRA Section 3(c)(1)(F)(iii). Instead, unresolved data compensation disputes will be determined by EU national courts.