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General Data Protection Regulation - how to reconcile ethical and business concerns?

An event organised by the CEPS on 13 May 2015 provided an update of the status quo of the General Data Protection Regulation (GDPR) and presented issues under discussion during the Trilogue negotiations. Although the principal focus lay on stimulating dialogue between regulators and SMEs/start-ups, the debate also touched upon some health-related issues such as the development of eHealth as part of the Digital Single Market, and it brought up ethical questions related to the potential uses (...)

Health technology assessments and innovation in health

European Ministers of Health also adopted conclusions on innovation for the benefit of patients at a Council meeting on 1 December 2014. Ministers are calling on national governments and the European Commission to cooperate more closely on the ’life cycle approach’ for new innovative medicines and move ahead with the implementation of health technology assessment. The Council conclusions highlight the importance of early dialogue between technology developers, regulatory, (...)

[Open letter to President-elect Juncker] Are we to understand that the portfolios for medical devices and health technologies will not remain with the Health Commissioner?

Further to our Joint Letter of 16 September 2014 (1) , we are contacting you again to express our gratitude for your decision (2) to move the competence for medicines and pharmaceutical products back into the hands of the European Commissioner for Health. We firmly believe that this directorate is best placed to ensure a good balance between economic and public health objectives while promoting ‘smart, sustainable and inclusive’ growth for Europe. 28 October 2014, Brussels (...)

[Open letter] To Heads of State and Government of the European Union Member States on Pharmaceutical Policy in the Public Interest

Brussels, 2 October 2014 - We are writing to support Member States who have already expressed their concerns on the decision of European Commission President Elect Jean-Claude Juncker to move the competence for medicinal products and health technologies from the Commissioner in charge of Health to the Commissioner in charge of Internal Market and Industry within the new Commission. We would like to ask for your full support to have that decision reversed. Dear Head of States, Dear Prime (...)

[Press Release] European Parliament takes leap towards patient safety

Brussels, 3 April 2014 – EPHA welcomes the majority of the measures adopted yesterday by the European Parliament as part of the revision of the EU Medical Devices Directive (MDD) and the In Vitro Diagnostic Medical Devices (IVD) Directive. After a year and a half of proposals (1) and in-depth discussions, it is time to rebuild the trust of patients around Europe. “As the protection of patient safety is a paramount objective, the European Parliament has today taken a (...)

eHealth: Building trust = access for everybody + demonstrated value in reducing health inequalities

On 14 January, MEPs voted on a resolution in support of the eHealth Action Plan (eHAP) 2012-2020, with the aim of improving healthcare for the benefit of patients, giving them more control of their care and bringing down healthcare costs through ICT: innovative and user-friendly eHealth and mHealth tools. While the benefits of ICT have been widely reported, what about the link between eHealth and health inequalities? Vice-President and Commissioner for the Digital Agenda, Neelie Kroes (...)

[European Commission report] Personalised Medicine

The European Commission has recently published a Staff Working Document (SWD) exploring the potential of Personalised Medicine, reporting on recent developments in the EU legislation, as well as looking at the factors affecting the uptake of personalised medicine in healthcare systems. Personalised Medicine is now more close to be effective to patients, which means that treatments can be designed taking into account a specific patient group and hence able to tackle the problem with the (...)

Potential ban of HIV self-testing kits caused a stir prior to IVD Medical Devices vote

Prior to the European Parliament vote on In Vitro Diagnostic Medical Devices, concerns have been voiced surrounding Amendment 40 and the potential ban of self-testing kits, such as those for HIV and other sexually transmitted infections (STIs) as this would reduce vital additional testing opportunities for people. In September 2012, the European Commission launched a renewed legislative package for medical devices and In Vitro diagnostic medical devices. The procedure is now approaching (...)

[Medical Devices and In Vitro Diagnostic Medical Devices] European Parliament vote: Win-win for patients and industry?

On 22 October, the European Parliament (EP) voted in plenary on one of the most discussed pieces of legislation in recent months, the proposals for Regulations on Medical Devices and In Vitro Diagnostic (IVD) Medical Devices. The newly-approved rules will bring more transparency during the entire process. Some provisions were rejected, such as the centralised pre-market authorisation system (PMA) and the provision stating that certain devices may only be supplied upon medical prescription. (...)

Medical Devices: European Parliament’s ENVI Committee vote

On 25 September the European Parliaments’ Committee for the Environment and Public Health (ENVI) approved stricter rules on medical devices in order to protect the patients. 27 September, 2013 - Stricter rules on medical devices such as a new pre-market approval system, more transparency and better traceability were voted on ENVI Committee last 25 September. Clear rules were introduced by Members of the European Parliament (MEPs) to boost public access to clinical data, create a new (...)