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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 (...)
Also about: Health Rights and Patients , Research , Health Inequalities , public health , health system , data protection

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 (...)
Also about: Pharmaceuticals and Medicines , Health Rights and Patients , Transparency , EMA

[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 (...)
Also about: Access to Medicines , Pharmaceuticals and Medicines , Health Rights and Patients , Research , Patient safety , health literacy , Health Inequalities , medical devices , Innovation , pharmacovigilance , health system

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 (...)
Also about: Air Quality and Air Pollution , Chronic Diseases , Transparency , food safety , WHO , Cross Border Healthcare Directive , medical devices , Tobacco Products Directive (TPD)

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 (...)
Also about: Health professionals , Research , Health Inequalities , medical devices , vulnerable groups , women health

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 (...)
Also about: Pharmaceuticals and Medicines , Health Rights and Patients , Health professionals , Research , Healthcare services , Transparency , Health Inequalities , public health , patient rights , pharmacovigilance , health system

[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 (...)
Also about: Research , health system , data protection

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 (...)
Also about: tobacco and smoking , Cross Border Healthcare Directive , eHealth , medical devices , public health programme

[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 (...)
Also about: Ageing and Older People , Access to Medicines , Pharmaceuticals and Medicines , Health professionals , Research , Health Inequalities , public health , Innovation , health system , health economics , women health

Clinical Trials: European Commission revamps the EU rules

The European Commission has published its draft proposal to revise the Clinical Trial Directive. According to the European Commission, the main aim of the revised proposal is to simplify the rules for conducting clinical trials in Europe, while maintaining the highest standards of patient safety. Once adopted, the proposed Regulation will replace the 2001 ’Clinical Trials Directive’. The objective is to ensure that Clinical Trials rules are identical throughout the EU. The (...)
Also about: Pharmaceuticals and Medicines , Research , Patient safety , patient rights , Innovation