Background:
Population based cancer registration linked to additional data sources is essential in cancer control. Quality and efficiency of therapy and services as well as risk factors for preventing cancers can be assessed. Results are based on linked individual data, aggregated in the analysis and reporting. The current proposal for a regulation on data protection in the EU may seriously affect unbiased population based, clinical and translational cancer research. Everybody wants the benefits of biomedical research, but debate and distrust on maintenance of confidentiality and individual privacy prevail. Existing codes of conduct in research are challenged, as the complex nature of research where individual data for millions of people are aggregated and analysed is not acknowledged.
Aim:
To advocate for changes in the proposed regulation by based on previous research results visualising what will be impossible to do in the future.
Strategy:
The critical clauses in the regulation were identified, and studies on survival, treatment, long term follow-up after environmental or workplace exposures, introduction of wireless technologies etc. were collected and transcribed into short and clear summaries. New legal text was proposed where needed and all relevant MEP’s and Commission were provided the developed material with personal letters. Networks in research, cancer leagues and other stakeholders were involved to raise awareness. Meetings were held with decision makers and officials.
Policy Process:
It was accepted that individual consent, does not work for register based research, and technical procedures e.g. pseudonymisation does not solve the problem. Unfortunately the European Parliament voted to negotiate with the Commission and Council on a text impeding research. Networks across Europe are activated to influence this negotiation to avoid a serious setback for health research and health.
Outcomes:
Continuous advocacy efforts are needed from all stakeholders to avoid a major setback for health in the future.