Position papers

Principles for Balanced Transparency of Regulatory Data in the European Union

Recent reviews of access to documents policies by EU regulatory agencies have confirmed a trend to greater openness to access requests, coupled with more extensive proactive data dissemination. This trend is based on considerations that enhanced transparency increases public confidence in the institutions.

The initiatives were prompted by requests from interested parties to gain access to detailed data on medicines, GMOs, chemicals and plant protection products and pressure to broaden public access rights to the data underpinning regulatory submissions or decision-making.

Innovative companies are required to submit very detailed data packages to EU authorities under various regulatory procedures. These packages routinely contain commercially confidential information (CCI; sometimes also referred to as confidential business information CBI), which is an important intangible component of a company’s valuable business assets. The possibility that CCI submitted to regulatory agencies may be disclosed to the public and thus available to unfair use can be a disincentive for innovation and investment in research and development - and can also detract from a more structured sharing of data between interested parties. This may result in lower competitiveness of the industry and can even jeopardize the survival of companies by providing competitors with an unfair competitive advantage.

An adequate level of protection of CCI requires a fair balance between competing interests. However, recent developments have shown that this balance is not sufficiently implemented in EU law and that protection of CCI is increasingly conceded in face of increasing demands for “total transparency”, at the expense of the competitiveness of EU companies and without proper evaluation of the merits of each case.

Industry actively supports balanced transparency and calls for a fair and predictable approach towards access to regulatory data, implementing the Access to Documents Regulation (1049/2001) and the Aarhus Regulation (1367/2006) in a manner that stimulates innovation and industry’s competitiveness.

According to the associations supporting this approach, including EuropaBio, any initiative or practice to increase transparency of regulatory data held by EU institutions, agencies and bodies should observe certain key principles: predictability, fairness, proportionality and coherence. Access the PDF below for an explanation of these principles.