The European Society for Medical Oncology (ESMO), a pan-European body representing European oncologists, has warned that retrospective clinical cancer research could be outlawed in Europe if the European Parliament's legislative proposals on data protection are not overturned.

A position paper, which it published Friday, maintains that the text adopted in recent months by the parliament could require researchers to seek patient consent every time new research is carried out on previously donated tissues or with previously released data. That would make research on tissues stored in biobanks or on data stored in cancer registries impracticable, while building up population-based disease registries would become impossible.

Nine other cancer organizations, including the European Organization for Research and Treatment of Cancer, the European, Middle Eastern & African Society for Biopreservation and Biobanking, and the European Cancer Patient Coalition, have endorsed the paper, and several others are reviewing it at present.

ESMO's comments echo those made back in January by the UK-based research charity the Wellcome Trust and a broad coalition of noncommercial research organizations and academic research institutes, who objected to a series of amendments to the European Commission's original draft legislation, which were proposed by the Civil Liberties, Justice and Home Affairs (LIBE) Committee of the European Parliament. Their intervention has fallen on deaf ears, however, as the European Parliament passed those amendments in March.

The Wellcome Trust continues to mobilize opinion on the issue as well. "It is essential that the Parliament's amendments are opposed and that the final text includes a proportionate mechanism for protecting privacy, while enabling health and scientific research to continue, in line with the Commission's draft," the organization stated to BioWorld Today. "As the process continues, the Wellcome Trust and our partners will continue to work with all three institutions to seek an outcome that enables society to continue to benefit from health research."

ESMO, which is based in Lugano, Switzerland, identified two amendments adopted by the European Parliament: Amendment 191 to Article 81 and Amendment 194 to Article 83, both of which explicitly deal with the issue of patient consent. The London-based Wellcome Trust and its partners take a similar view.

The original draft regulation included a requirement for specific and explicit consent for the use and storage of personal data, but provided an exemption for research, subject to defined ethical and governance safeguards. The Parliament's amendment significantly reduces the scope of that exemption and would prohibit the use of personal data in research without specific consent. Moreover, the consent requirement fails to take account of the protections arising from ethical oversight and patient confidentiality norms.

"This would put at risk significant European investments in genetics, cohort studies, biobanks, disease registries and the use of routinely collected data, and associated progress towards understanding society, health and disease that delivers real patient benefit," the Wellcome Trust and more than 100 other organizations stated in an updated position paper published this month.

As is generally the case, it will take several months of wrangling in Brussels and in other European capitals, before a final regulation is agreed among the European Parliament, the commission and national governments, working through the Council of Ministers. It is expected to be in place by 2015 at the latest.

PROPOSED CONSENT REVISION

Medical data are just one element in a much bigger picture. "The problem is this regulation applies to everything," Paolo Casali, author of the ESMO paper, told BioWorld Today. "It's difficult to talk about Google and to talk about a biobank at the same time – unfortunately, the regulation applies to everything."

The European Union's current rules on data protection date back to 1995, when Internet use was a tiny fraction of what it is today. The main thrust of the current reform process is to better inform European citizens of their data protection rights and to give them better control over the use of their personal data in online settings. The new legislation, called the General Data Protection Regulation, is also intended to benefit businesses, by putting in place a uniform, pan-European framework. Interpretation of the existing rules, according to the European Commission, has varied from country to country, creating a regulatory patchwork that imposes an unnecessary compliance burden. The new rules will also reduce reporting obligations in individual countries for international organizations.

At present, EU member states handle the issue of consent for retrospective research in various ways. In Denmark, patients need to explicitly opt out from future research. "There's a presumed consent but you can opt out," said Casali, who is based at Italy's National Cancer Institute (Istituto Nazionale Tumori) in Milan. "The UK has always been more in favor of a no-consent policy in retrospective research," he added. Italy has been more restrictive historically, but it is loosening its position of late, to take account of situations where it is not feasible to obtain consent.

ESMO is calling for a one-time consent provision, which would require explicit consent, but which would not require any further patient interaction. "One-time consent is feasible and protects the principle that the patient must agree that his data or tissue can be used for research," Casali said. It would also be in line with the EU's new Clinical Trial Regulation, which it adopted on April 16, and which will take effect from May 28, 2016. "The Clinical Trial regulation already foresees a one-time consent, which allows the use of the data for research which is not the primary purpose of the trial," he said. The organization is also seeking a derogation from the legislation for public disease registries, which, by definition, need to include data on all patients in order to be comprehensive and accurate.

Steering the data protection regulation through the legislative process is one of the priorities of the Italian presidency of the EU, which began its six-month term at the start of the month. Lobbying of national governments is already under way. "Many governments fully share our concerns," Casali said.