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Proposed EU Regulation on Data Protection suffers delays

July 2013

Joint Statement

Proposed legislation for protecting personal data in the European Union (EU) has been the subject of public dispute between the Members of European Parliament (MEPs) responsible for the legislative process. The Draft Report issued by MEP Jan Philipp Albrecht (Group of the Greens/European Free Alliance, Germany) on 16 January 2013 has stirred controversy and led to fundamental disagreements that are delaying the process of adopting the new legislation.

EURORDIS and EPI-RARE (the European Platform for Rare Disease Registries), along with MEP Marielle Gallo (European People’s Party, France), who is involved in the data protection discussions, are organising a Lunch-Debate on the topic of Data Protection and medical research, to take place at the European Parliament in Brussels on 26 September 2013.

The proposed legislation has raised serious concerns amongst the rare disease community that some of the measures introduced in the Draft Report would hinder research on rare diseases by creating further obstacles to the exchange and utilisation of already scarce data. In March 2013, EURORDIS issued a Joint Statement, supported by relevant scientific learned societies, medical groups and patient organisations in Europe as well as in Australia, Canada, New Zealand and the USA. The Joint Statement urges Members of the European Parliament to ensure that the proposed new legal framework for the protection of personal data does not obstruct medical research, and in particular research on rare diseases. The low prevalence characteristic of rare disorders makes the pooling of information and the optimal use of limited data critical. The Joint Statement calls for clarifying and strengthening specific provisions in order to establish a productive European health research framework while protecting personal data. EURORDIS followed up the Joint Statement with a Question and Answer document designed to help readers better understand the complex issues involved. 

The European Data Protection Directive of 1995 (Directive 95/46/EC) seeks to guarantee the free flow of personal data between EU Member States (internal market) while ensuring effective implementation of the fundamental right of individuals to the protection of their personal data. While the basic principles included in the 1995 Directive are as valid today as they were 18 years ago, the current rules need modernising to meet the new challenges brought by rapid technological developments in both communications and medicine. Furthermore, the current legal framework allows for fragmentation across the EU, due to the differences in the way each country applies the law at national level, leading to uneven protection for personal data depending on where one lives.

EURORDIS welcomes the proposal for a Regulation, which, being of higher level than a Directive would be directly and immediately applicable in the national legislative frameworks, and especially one that takes into account the many advances in technologies in the fields of communications, medicine and bioinformatics. However, EURORDIS wants to ensure that medical research will not be stalled by the introduction of disproportionate measures on data protection and would like to see specific provisions included in the new Regulation that enhance the collection and sharing of rare disease data, in order to better diagnose and treat rare diseases.

After discussions in the LIBE Committee (Civil Liberties, Justice and Home Affairs) in the European Parliament earlier this year, it is hoped that a vote will take place at the beginning of October 2013 on the basis of compromise amendments to be elaborated by the Rapporteur MEP Jan Philipp Albrecht in collaboration with the shadow rapporteurs. EURORDIS is in regular contact with the rapporteurs in order to voice the specific issues of people living with rare diseases while advocating for reasonable compromise amendments.

The European rare diseases community hopes this legislation can move forward in a manner that strikes the right balance between the protection of personal data and the protection of medical research in the EU.

Louise Taylor, Communications and Development Writer, EURORDIS