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August 2015

© Data Saves Lives Campaign, Genetic Alliance UK

EPF’S ACTIVE ROLE ON EU KEY LEGISLATION THAT IMPACT PATIENTS

In 2015, EPF advocated a patients’ perspective on various EU legislative dossiers. These included recommendations on the Medical Devices Regulation, to ensure patients have access to safe quality devices, and actions to ensure the final Data Protection Regulation reaches the right balance for patients and for research.

Data protection regulation: Uncertainties on patients’ rights

The Council adopted a partial general approach on the draft general Data Protection Regulation on 15 June 2015. This legislation can have important consequences for health research that is vital for EU patients. The Council has taken into account the view that some exemptions are needed from the obligation to always ask patients for their specific consent for health research. EPF advocated for this alongside non-profit research and public health NGOs in the “Data Saves Lives” Campaign. Without such provisions, key research projects could be hampered. However, EPF also noted that other provisions proposed by the Council leave many uncertainties on patients’ rights as regard access to their data, information and transparency.

In November, the European Data in Health Research Alliance, which brings together academic, patient and research organisations from across Europe, launched a petition to call on EU decision makers to strike the right balance between protecting privacy rights and allowing use of personal health data to continue for health research purposes. EPF also endorsed the common statement led by the Wellcome Trust for the final negotiations of the legislation.

EPF recommendations on the Medical Devices Regulation

In June 2015, the Council reached a partial agreement on medical devices. EPF noted in its statement that while the Council is proposing some key steps forwards on transparency, important gaps remain for patient safety. In addition, the Council did not commit to any progress on involving patients in the governance for medical devices. In October EPF adopted detailed recommendations for the trilogue process between the European Parliament and the Council to encourage decision makers to tackle the remaining gaps and take a more patient centred approach in the final legislation. EPF had been active in advocating for medical devices since 2008.

These two legislations may have an important impact on European patients; therefore in 2016 EPF will continue to advocate a patient perspective on these dossiers and will inform patients’ organisations on the outcome of the discussions.

Contact: EPF Policy Officer, Laurene Souchet at laurene.souchet@eu-patient.e