EuropaBio Principles on Transparency in the European Union

23.01.2014

The biotechnology industry is keen to engage on the implementation of Regulation (EC) No.

1049/2001 and believes that any implementation must ensure the following:

- predictability for operators

- respect for the owner of the data

- respect of the international legal framework

- respect data protection of patient data

- protect international competitiveness of firms with European operations

 

Background

The European Medicine Agency (EMA) and the European Food Safety Authority (EFSA) recently took

initiatives to provide public access to documents provided to them by private companies as part of the regulatory approval for their products. The access by the public to documents "of" European Institutions is granted by the Treaty and implemented through Regulation (EC) No 1049/2001. The Regulation provides legal certainty regarding the transparency of the EU decision-making process, whilst recognizing the need to protect vital interests, including the protection of confidential

commercial information (CCI), personal data and other rights derived from intellectual property.

 

Article 4 of the Regulation states that "access to a document where disclosure would undermine the protection of commercial interests of a natural or legal person including intellectual property" should be refused unless there is an overriding public interest. The balance between transparency and the protection of these rights was put at risk through recent actions by authoritiesi.

 

As underlined in the Commission's EU 2020 Strategy, research, development and innovation (RDI) are essential for prosperity and growth in the EU. RDI investments depend on a solid regulatory framework including intellectual property (IP). Any undermining of IP by misinterpretation of transparency rules regarding data access will have an immediate effect on RDI in Europe to the detriment of the region's prosperity and its society.

 

Overarching principles

 

1. The biotechnology industry supports transparency initiatives, such as public access to

documents, provided measures are in place to minimise the possibility of misuse that could decrease trust in decision-making processes or in regulated products, or undermine industry's legitimate economic interests.

 

2. The industry also supports enhanced efforts by the EU institutions to further a better and broader

understanding of the procedures that already exist to ensure public access to relevant documents held by EU institutions.

 

3. Similarly to other industries, the biotechnology industry requires a predictable and stable

operating environment that includes an adequate legal and regulatory framework respecting the principles governing the protection of personal data, confidential business information and intellectual property.

 

4. The biotechnology industry is also concerned about the protection of patients' personal data,

especially in the case of rare diseases, where data de-identification could be problematic, given the extremely small number of individuals participating in the clinical studies.

 

5. The biotechnology sector is one of the world's most R&D intensive sectors. Data in regulatory

dossiers includes data of high commercial value and is the result of years of costly research and trials - whether in the healthcare, agricultural or industrial biotechnology sectors. The value of regulatory data is confirmed by the fact that in the case of pharmaceutical products, it is mainly competitors requesting public access to regulatory dossiers.ii Major OECD countries consider certain clinical trials data as confidential and believe that disclosure could cause competitive harm to originator study sponsors.

 

6. In most research and IP-intensive industries, undue disclosure of confidential business

information can cause severe economic impact by undermining the value of companies' research and business know-how.

 

7. This issue is particularly relevant for biotech SMEs, of which there are close to 2,000 in Europe,

and whose livelihood often lies in the one product they are filing an application for. Premature disclosure of their research, or threat thereof, could undermine their ability to operate, including their ability to obtain appropriate Intellectual Property protection for their developments and their ability to attract essential investment for survival and further development.

 

8. The biotechnology industry is concerned about the possible misuse or unfair commercial use of

information rendered public. Indeed, disclosure of data and information pertaining to applications or pending applications without adequately protecting confidential business information can allow other companies to reproduce the products in question possibly in areas where no stewardship or adequate IP protection exist.

 

9. Any release of data should not require applicants to produce additional material or reformat

materials beyond retraction of CBI or rendering personal data anonymous, as this could be very challenging especially for resource-constrained SMEs.

 

10. A disclosure of pseudonymous patient data (whose deployment options are explicitly mentioned

in the informed consent text) to third parties is in most cases not covered by the current wording of the informed consent forms and any further distribution to third parties is not mentioned in the informed consent. Therefore such disclosure would be a violation of the informed consent given by the patient. This would undermine the trust of study participants and may have a negative impact on their willingness to participate in future clinical trials. An additional transfer of data to third parties can only be changed prospectively by necessary adjustments to the informed consent forms used in clinical trials. This aspect should be respected in all discussions on transparency.

 

Proactive proposals

 

1. There is a need for a structured dialogue between EU authorities and regulated industries

regarding what data is released, when it is released and in what manner and format. Predictability, respect of the protection of confidential commercial information (CCI), intellectual property and personal data should be guiding principles within such a dialogue.

 

2. There is a need for public communication on how access to data is currently already being

granted and how it contributes to increased public confidence.

 

3. There is a need for a clear definition of the terminology "overriding public interest" stated in

Article 4 of Regulation (EC) No 1049/2001iiiin light of Court findings that transparency for the

principle of transparency is not legally viable.

 

4. There is a need for clarification concerning how the EU's transparency efforts are in line with

international legal requirements such as TRIPs.

 

5. EFSA and EMA could draw inspiration from other EU agencies, such as ECHA, which grants

applicants submitting dossiers for product approvals the opportunity to identify per section of the dossiers which materials are confidential commercial information and which are not.

 

i Publication on the EFSA website of the full submission for approval of a product, in downloadable format, without ciiompany consent.
i iDoshi P, Jefferson T (2012) The First 2 Years of the European Medicines Agency's Policy on Access to Documents: Secret
No Longer. JAMA, December 19, 2012. doi:10.1001/jamainternmed.2013.3838
iii C-514/07 P, Sweden v API (Association de la presse internationale) and Commission:"¼in principle, the overriding public interest - as referred to in the last line of Article 4(2) of Regulation No 1049/2001 - must be distinct from the principle of transparency¼"