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[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 (...)
18/11/2013

[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 (...)
08/07/2013

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 (...)
08/07/2013

[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 (...)
30/04/2013

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 (...)
25/04/2013

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 (...)
25/04/2013

[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 (...)
22/02/2013

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 (...)
17/02/2013

Roundtable on Clinical Trials


Hosted by the European Policy Centre (EPC), this EPC’s Coalition for Health, Ethics and Society (CHES) roundtable on the revision of the Clinical Trials legislation provided an opportunity for EPHA to present its Position on the policy dossier and exchange views with stakeholders including representatives of the European Commission, industry and an NGO representing older people. The roundtable was kicked off by Stefano Soro, Head of unit for Medicinal Products – quality, safety (...)
04/02/2013

[Revised EPHA position] Clinical Trials


EPHA has revised its position on clinical trials following the European Commission’s release of a legislative proposal for a regulation over the summer. While the key elements remain the same, the updated version emphasises the need for clinical trials to go ahead so that different population groups can benefit from life-saving treatments, while underlining that patient safety must remain at the centre of the process, and not compromised by less rigid assessment procedures. The (...)
29/11/2012