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General Data Protection Regulation - EPHA progress report calls for health research exemption in trilogue negotiations

The General Data Protection Reform (GDPR) entered into the trilogue phase in June with the aim of concluding discussions at the end of 2015 or soon thereafter. A new EPHA progress report describes the challenges of the GDPR experienced so far and confirms the crucial role of data for health research and science purposes. In 2012, following the release of the European Commission’s proposal for a draft regulation (setting out a general EU framework for data protection) and a draft (...)

European Medicines Agency - Draft Proposal on Transparency Addendum

In a recent public consultation, the European Medicines Agency (EMA) solicited stakeholders’ views about its draft proposal for a transparency addendum pertaining to the content of the EU portal and database that will be set up for the implementation of the Clinical Trial Regulation No 536/2014. The express aim of the latter is to provide more information on clinical trials and their result in Europe. The consultation on the ’Draft proposal for an addendum, on transparency, to (...)

[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 (...)

[EPHA briefing] The Lithuanian EU presidency Health Priorities

On 1 July Lithuania took over the last full EU Council of Ministers Presidency before the European elections of 2014. The Lithuanian Presidency will focus its efforts in restoring EU’s economy credibility, attaining economic growth and better employment opportunities and reinforcing the EU as a model of openness and security, building on the cooperation with its Trio partners. The Lithuanian Priorities for health Presentation - Health Priorities of the Lithuanian EU Presidency (...)

Health priorities of the Lithuanian Presidency of the EU Council

The Lithuanian Presidency, which will be the last full EU Council presidency before the European elections of 2014, will focus its efforts in attaining a credible, growing and open Europe, building on the cooperation with its Trio partners. Lithuania will focus its efforts in the following health issues. The Lithuanian Priorities for health Advancing legislative initiatives Revision of the Tobacco Products Directive (high priority) Lithuania has confirmed its commitment to continue (...)

[EPT] Clinical Trials – new Regulation - Proposal for the Clinical Trials Regulation (CTD) - (updated on 30 April 2013)

Clinical trials Clinical trials are “Investigations in humans intended to discover or verify the effects of one or more investigational medicinal products (IMPs)”. Trials conducted in the European Union (EU) are currently governed by Directive 2001/20/EC (the Clinical Trials Directive, CTD) but these guidelines have been implemented differently across member states, thereby failing to reduce red tape and increasing costs. Consequently, in July 2012, the Commission published its (...)

Public consultation on Declaration of Helsinki on medical research involving human subjects

A two-month public consultation (15 April to 15 June 2013) on the World Medical Association’s Declaration of Helsinki on medical research involving human subjects has been launched by the World Medical Association. A revised version of the Declaration is available on the WMA website. This consultation is of particular interest in the context of the ongoing revision of the Clinical Trials legislation. Please click here for detailed information on the consultation process The (...)

Clinical trials: Exploring the limits of transparency

Glenis Willmott MEP (S&D, UK) took the initiative to bring together experts to discuss the extent to which more transparency could be workable in non-commercial clinical trials. The debate, which took place in the European Parliament on 10 April, served to present the key arguments for and against increased transparency in the context of administrative and data reporting requirements for academic researchers and patient safety. EPHA’s Position on Clinical Trials urges political (...)

[Special Summary] EU General Data Protection Regulation and Health Research

On 17 December 2012, the European Parliament’s Committee on Civil Liberties, Justice and Home Affairs (LIBE) released its draft report on the European Commission’s proposal for a regulation on the processing and free movement of personal data. The proposal and the amendments offered in the draft report have implications for a number of elements of health, inlcuding health research. This article takes a closer look at the potential effects of the new legislation for research (...)

Ireland’s Presidency Health Priorities presented

Ireland, in collaboration with its TRIO partners - Lithuania and Greece - has made a commitment to use its resources to prioritise solid progress on a number of key legislative dossiers in health and calls on member states to work together, sharing ideas, information and best practice. The Irish Presidency Programme, whose cornerstone is progressing the legislative agenda, contains a series of health priorities: on 23 January 2013 the Irish Minister of Health, James Reilly, presented them (...)