June 26, 2017

June 26, 2017

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European Food Safety Authority (EFSA) Grants Public Access to Data through Scientific “Data Warehouse”

The European Food Safety Authority (EFSA) is launching an ambitious project of public access to data that it collects and holds through the launch of a scientific “data warehouse.” EFSA announced this initiative on March 2, 2015, with the aim to create an “open science organisation” and increase public access to data that it holds. The ultimate goal is to enhance scientific progress by allowing the use of data by third parties for other purposes.

Data concerned are collected by EFSA or its network of agencies in EU Member States as well as submitted by data providers. According to EFSA, the data that will become publicly available include a large volume of scientific information on:

  • zoonotic diseases;

  • antimicrobial resistance;

  • foodborne outbreaks;

  • pesticide residues;

  • chemical contaminants in food and feed;

  • food consumption and consumer exposure to risks related to food consumption; and

  • chemical hazards.

EFSA plans to develop the project over the course of the next three to four years. Access to the data warehouse will become gradually available to stakeholders starting in 2015. The data warehouse will offer its content through web reporting tools, including tables, reports, graphs, maps and dashboards.

In order to enable initiation of the project, EFSA has proposed access rules to the data warehouse, which should apply to the project in 2015 and 2016 and may be revised subsequently if necessary. According to the access rules, different categories of users would have different access rights to data stored in the data warehouse:

  • EFSA staff and nominated staff of the European Commission have access to all data needed to carry out their duties, at the lowest level of aggregation;

  • Members of the EFSA Scientific Committee and Scientific Panels as well as their Working Groups have access to all data of scientific importance relevant to their specific mandate at the lowest level of aggregation and only for the time needed to complete their mandate;

  • Data providers have full access to data provided by their own organisation;

  • Stakeholders, including the general public (i.e., any user of EFSA’s website), have access to data through pre-defined queries prepared by EFSA, at a level of aggregation decided by EFSA in agreement with data providers and/or data owners and the European Commission;

  • Some data collections may become accessible under more specific rules, e.g., the Chemical Hazard Database or ad hoc data collections.

It is important to note that the access rules to the data warehouse apply without prejudice to EU legislation. They do not interfere with transparency rules applicable to EFSA, most notably Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents and Regulation (EC) No 1367/2006 on the Application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies.

Another important aspect of the access rules is that they guarantee the protection of commercially sensitive data and personal data in the context of public access to the data warehouse. The rules acknowledge that the data warehouse may contain commercially sensitive raw data as well as data protected by intellectual property rights, such as chemical contaminant information from private companies. The rules impose a responsibility on EFSA to guarantee that such information will not be publicly disclosed through the data warehouse. They also foresee a responsibility for EFSA to ensure that such data will be aggregated “in full respect of existing commercial interests and/or intellectual property rights.”

The data warehouse may also contain personal data in the sense of Article 2(a) of Regulation (EC) No 45/2001 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data. EFSA will bear the obligation to aggregate and filter such personal data to ensure anonymisation before granting public access to the relevant datasets.

© 2017 Covington & Burling LLP

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About this Author

Angeliki Valsamidou, Medical Devices Attorney, Covington Law Firm
Associate

Angeliki Valsamidou is an associate in the firm’s Brussels office. Ms. Valsamidou’s practice focuses on European regulatory law regarding pharmaceuticals, medical devices and other health products, food, cosmetics and consumer products. She advises on a variety of issues, including approval procedures, clinical trials, pricing and reimbursement, promotion, pharmacovigilance, orphan drugs, and biological and biosimilar medicines. Ms. Valsamidou also advises clients on policy and legislative projects, regulatory compliance. and competition and trade-related issues in the pharmaceutical...

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