by ecancer reporter Janet Fricker

Proposals for an amendment to the European Privacy Legislation are sounding alarm bells across the European cancer research community. Concerns centre on a proposal by the Committee on Civil Liberties, Justice, and Home Affairs (LIBE), a standing committee of the European Parliament, to remove article 83 from the legislation.

The article, which made an exception to the principle of consent for data being processed for “historical, statistical and scientific purposes”, had been felt to “safe guard” the future of registry research and biobanks using residual tissue.

“It’s imperative that the original text is restored for the sake of the advancement of translational research in Europe,” said Peter Riegman, the leader of work package 10 biobanking in the Eurocan Platform project, which aims to improve infrastructure for European translational cancer research.

Riegman, who was tipped off about the significance of the LIBE proposals by Evert-Ben van Veen, from MedLaw consult in the Netherlands, now wants to bring the import of the amendments to the attention of the wider European research community.

“Without the article it will no longer be possible to use historical data and samples in future studies,” he said.

The proposed amendments, he added, could also lead to broad consent being replaced by specific consent, which would require researchers to re-contact donors for each possible new use of the tissue.

The right to privacy is a highly developed area of European law, with all member states of the European Union (EU) signatories of the European Convention on Human Rights (ECHR).

The European Commission’s proposal for a General Data Protection Regulation, unveiled in January 2012 and currently under consideration, represents the most significant global development in data protection law since the EU Data Protection Directive. The new regulation has been considered necessary to take into account new developments like globalization and technological developments like social networks and cloud computing.

According to the European Commission personal data is any information relating to an individual, whether it relates to his or her private, professional or public life. It covers everything from a name, a photo, an email address, bank details, posts on social networking websites, medical information, or a computer’s IP address. It is also of significance that a regulation, unlike a directive, it is directly applicable in all EU member states without the need for national implementing legislation.

“We’re smart people and might be able to find a way around the problems created by LIBE. But the bottom line is that this will make the research process much more expensive, and could compromise the validity of our outcomes and our long term ability to operate,” said Riegman. Rare cancers, he added, will be particularly affected since such data will always be considered indirectly identifiable.

“There’s a real danger that biobanks could start to fail like the financial banks. Millions and millions of pounds have already gone into funding these projects and the tragedy is that the wrong wording in the privacy legislation could be responsible for destroying all this innovation. The result in future is likely to be a great deal of unnecessary mortality and morbidity among patients.”

The amendments by LIBE, he added, would also hinder long term big population studies that are looking to identify genomic associations for conditions such as diabetes and dementia. Other issues include the fact that if scientists find that there is something that is not in accordance with the original diagnosis, it will be impossible to trace the individual patient if full anonymisation has taken place.

Commenting on the proposals, The European Alliance for Personalised Medicine (EAPM), wrote in a press statement, “The present and future health of Europe’s citizens is at stake. To attain the right balance, EAPM calls on the European institutions to ensure that all stakeholders are engaged in the search for solutions – and in particular, representatives of patients and citizens. That is the way to achieve the objective of establishing a fully coherent, transparent, harmonious and robust framework with a high level of protection for all data processing activities inside the EU and beyond.”

All biomedical researchers, said Riegman, need to realize the devastating impact of these proposals and start lobbying their MEPs for reinstatement of the paragraph.