By requiring consent for most uses of individuals’ information, including age, location and health conditions, and limiting the situations in which these data can be used, European legislators will stifle progress in medicine and food security, they say.
In an open letter to the European Commission earlier this month (12 September), board members of the UK Collaborative on Development Sciences (UKCDS) — a group of government departments and research funders — urge policymakers to reverse plans to modify European Union (EU) Data Protection Regulation adopted by the European Parliament on 12 March.
“We must restore the original text because if we cannot work with these data we will end up stuck in the mud.”
Edvard Beem, Netherlands Organisation for Health Research and Development
“If implemented, these amendments would have a devastating impact on research targeted at poverty alleviation and the wellbeing of populations in developing countries,” they write.
“We urge the commission to continue to take a strong position on research to ensure that the parliament’s amendments are rejected … so that important collaborative research in health and the social sciences with developing countries can continue,” the letter says.
The commission has confirmed receipt of the letter but has not yet issued a response.
The original draft of the regulation, first tabled in 2012, gave health and scientific research a privileged position to use personal data without individuals’ consent — providing strict privacy safeguards were applied.
But the new amendments significantly restrict the conditions under which researchers can apply these exceptions, particularly for health data — with the waiver of consent only possible for projects deemed to be of the “highest public interest” and for those that “cannot possibly be carried out otherwise”.
The rules would not apply to developing countries, but as much of the data collected in these nations are stored and analysed in the EU, they would put collaborative projects and major investments from governments and aid organisations in jeopardy, the letter says.
This could impede the development of drugs, vaccines and diagnostics for diseases such as tuberculosis, malaria and AIDS, as well as projects on food and water security and on gender and equality that use personal information for research and policy applications, it says.
Efforts to monitor progress towards the forthcoming Sustainable Development Goals, which will require data on indicators, may also be hit by the proposed rules, says UKCDS director Andrée Carter.
While their actions may be “well meaning”, policymakers risk doing great harm by introducing legislation that scientists widely see as “superfluous”, she tells SciDev.Net.
“The view is that research ethics frameworks are sufficiently robust to protect individuals,” she says.
Edvard Beem, co-director of the Netherlands Organisation for Health Research and Development — one of 101 organisations to sign a separate statement calling for the amendments to be scrapped — says the proposals threaten the future of healthcare.
“There is no compromise here,” he says. “We must restore the original text because if we cannot work with these data we will end up stuck in the mud.”
> Link to the EU Data Protection Regulation
> Link to UKCDS open letter
> Link to the statement signed by 101 organisations