Data protection laws must not block vital healthcare research
Sascha Marschang, Policy Manager for Health Systems, European Public Health Alliance (EPHA) argues that proposed restrictions on using health data could prevent many hugely beneficial studies being conducted in Europe.
New regulations aimed at protecting people from having their personal data misused is progressing towards becoming law in the European Union. This is good news – but we are very concerned that the new rules might make much existing and future health research impossible to conduct in Europe.
The General Data Protection Regulation (GDPR) is currently draft legislation aimed at updating and harmonising rules around the use of personal data across Europe. The new laws have been tabled because of the great explosion of data being created through electronic records in all walks of life, with the aim of stopping this data being used or exchanged without an individual’s consent.
In creating a new European law, the European Commission, European Parliament and Council of Ministers all have a say in amending and passing legislation. However amendments made by the European Parliament to the draft legislation last year could make important health research extremely difficult, and possibly unlawful. That’s why we at EPHA are part of a new coalition of organisations called the European Data in Health Research Alliance (EDHRA).
The Alliance brings together academic, patient and research organisations from across Europe, including Cancer Research UK, the European Respiratory Society, the European Genetic Alliances’ Network, EPHA of course, and many more. As a group, we want to ensure that the new regulation allows hugely beneficial health research to take place without the need for specific consent from individuals when personal data is used.
In December, the alliance launched a new campaign – ‘Data Saves Lives‘ to highlight the huge benefits of using medical data for research in Europe. A great deal of studies rely on ‘broad consent’ – individuals giving consent for their data to be used in a wide range of studies, with researchers not necessarily specifying what the studies will be. In addition, in some studies, obtaining consent from individuals is not practical; existing rules allow data to be used without consent in these cases.
If the European Parliament position were to be implemented, research conducted without consent would face severe new restrictions.
“This threatens a huge amount of very valuable ongoing research, and could severely limit Europe’s ability to participate in the so-called ‘big data’ revolution within healthcare”
This threatens a huge amount of very valuable ongoing research, and could severely limit Europe’s ability to participate in the so-called ‘big data’ revolution within healthcare. One example of an existing study that might be blocked in future is a European-wide study of prostate cancer (part of the Collaborative Oncological Gene-environment Study).This major collaborative study has built the largest data set ever used in cancer research to investigate inherited risk factors for cancer.
Thanks to the results of this study, we now know much more about how likely a person is to develop prostate cancer from their genetic make-up, which could improve the chances of detecting and preventing this disease.
This is an example of a study in which participants provided broad consent for the use of their pseudonymous genetic data. But the European Parliament amendments would only allow pseudonymous data to be used without specific consent on rare occasions, with researchers having to prove that studies couldn’t “possibly be carried out otherwise” and that they were in “high public interest”. These conditions are vague and difficult to prove in practice.
The alternative of using fully anonymous data is not feasible, as the study involves linking data about people from different data sets. All this means that major studies like this might never get off the ground because of overly-strict regulations.
The principal challenge is to balance a high level of privacy protection with the needs of public health. This includes recognising that substantial benefits can be derived from processing patient data for health research, such as developing more effective diagnoses and evaluation of treatments, taking into account not only disease-specific but also gender and age-relevant aspects and the needs of vulnerable groups.
Accessing patient health data also facilitates the recruitment of research subjects and enables the setting-up of databases and biobanks for future research where the purpose cannot be predicted today. This is necessary because tomorrow’s possibilities are determined by technological progress. For example, ‘Big Data’ offers hitherto unforeseen option in terms of storing and processing vast amounts of information. Combined, this will support evidence-based and inclusive policymaking in the public interest.
Gaining consent to use data
When it comes to health research, consent is a key issue, and researchers respect that robust safeguards must be in place to avoid abuse of personal health data. It is important to recall that vital precautionary measures, including approval by independent ethics committees and pseudonymisation, already exist and they have served well to protect the rights and the privacy of patients.
However, there are many instances when it is either impractical or even impossible to obtain specific and explicit consent for every study undertaken. This includes research that includes participants across different member states; they can be hard to track down years after the original study, which, in turn, delays research outcomes. There are also cases when the very act of seeking consent could introduce bias, and hence render any results less worthwhile or inaccurate.
“Survivors and their next-of-kin pointed out that having to provide multiple consents for different studies can be emotionally draining and thus this could even have an unintended negative effect”
The effects of seeking consent on the quality of life of parents and families of children living with cancer were discussed at a recent event in the European Parliament hosted by MEP Glenis Willmott (S&D, UK). Survivors and their next-of-kin pointed out that having to provide multiple consents for different studies can be emotionally draining and thus this could even have an unintended negative effect. This is because refusing consent might become preferable to being reminded of an overwhelming disease like childhood cancer time and again. Moreover, MEP Willmott expressed concern that the Parliament’s GDPR amendments could have a negative effect on the transparency provisions that have been achieved in the new Clinical Trials Regulation adopted in April 2014.
A more balanced approach
The good news is that the Council of Ministers released its position on the proposed regulation, which was more in line with the original proposal put forward by the European Commission.
This development is encouraging, as it would maintain the balanced approach that recognised the need for exemptions relating to the use of personal data in research. Otherwise, following the logic of the European Parliament, research using identifiable data could not go ahead at all, and even the use of pseudonymised data would be cumbersome as member states would be subject to stringent justification procedures. As noted on the EDHRA website, ‘anonymous, pseudonymous and identifiable data are all invaluable in different ways, and their use in research is vital for public health’.
The existence of different ‘data protection traditions’ across Europe is complicating negotiations. Some member states are generally more accustomed to data sharing. For instance in Nordic and Baltic countries, data sharing goes hand-in-hand with the development of patient registries and expanding eGovernment and eHealth sectors, but in other member states, data protection remains a thorny issue, as the level of trust among patient-users is low for a variety of reasons, including cultural and historical.
The current Latvian Presidency is hoping to advance these discussions, and bring the different viewpoints across the EU towards consensus. The European Parliament has now made some concessions to recognising the special requirements of health research, but we believe these are still not enough.
One example of this is that the Parliament has now recognised the significance of broad consent – but the wording of the amendment is too narrow to cover the broad consent used in many studies. It is also now recognising that it is not always possible to gain consent, but we’re concerned that this exemption is still too narrowly defined.
We are urging Members of the European Parliament to make their concerns about research heard before negotiations between the Parliament, European Commission and Council of Ministers enter their final phase. European institutions need to work together to find a compromise for research, or face losing these hugely beneficial tools for improving public health.
About the author:
Sascha Marschang joined the European Public Health Alliance (EPHA) in 2009, where he holds the position of Policy Manager for Health Systems. Apart from issues related to the European health workforce, his policy portfolio also includes eHealth and medical devices, pharmaceutical policy, health threats, as well as other developments impacting on health system.
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