Patient safety

Medical Devices proposal: more than 1,000 amendments to be discussed

More than 1,000 amendments will be discussed today (29 May) during the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) meeting on the proposals for a Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation. An overview of key issues is provided below. On 3 and 12 April 2013, the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) published two draft reports amending the (...)

[eHealth week] eHealth innovation must be driven by full inclusion

13 May, Brussels -The motto of the 2013 eHealth week (13-15 May), which kicks off today, is ‘Delivering Innovative Healthcare and Well-being’. According to the European Commission, eHealth Week aims to encourage continuous investment in health IT in an effort to improve patient care and get a handle on rising medical costs. An integral part of this year’s eHealth Week is the High Level eHealth Conference, organised by the Irish Presidency and the European Commission. (...)

[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 (...)

The European Medicines Agency (EMA) publishes list of drugs under additional monitoring

As one of the deliverables of the pharmacovigilance legislation, that came into effect in July 2012, the European Medicines Agency (EMA) released an initial list of drugs subject to additional monitoring on 25 April 2013. Please click here to read the full EMA Press Release, which contains additional information. How to identify them? Medicines subject to additional monitoring will have to display an inverted back triangle in their package leaflet and in the information for healthcare (...)

EP resolution underlines the need for action on medicines access problem

On 18 April, the European Parliament (EP) voted on a Resolution on the impact of the financial and economic crisis on human rights. The resolution highlighted some of the global impacts of the crisis on the right to health. EPHA applauds the EP’s recognition of the multiple impacts of the crisis on ordinary people and the need to further champion public health across Europe. The Resolution states that "the rising price of medicines (by up to 30%) is having a negative impact on the (...)

[EPT] Medical devices - Regulation (recast) - Medical devices and in vitro diagnostic medical devices (17 April 2013)

Medical devices and in vitro diagnostic medical devices. The term “medical device” covers an extremely diverse range of healthcare instruments – from simple bandages and dressings to tongue depressors, medical thermometers and blood sugar meters to pacemakers and life-supporting products, as well as eHealth devices which communicate remotely. The medical devices industry constitutes a key sector for healthcare. It is one of the most dynamic sectors, improving and saving (...)

[European Network for Workplace Health Promotion] Guide to good practices on chronically ill employees

The European Network for Workplace Health Promotion (ENWHP) has released its European Guide to Good Practice on chronically ill employees. Chronic illness poses a major challenge for public health - it is the leading cause of mortality and morbidity in Europe, and has a major impact not only on the life expectancy but also in the years of good health lived. In addition, there is reasonable evidence that chronic disease affects earnings, the ability to work, job turnover and disability. (...)

[Save the Date] Third Flu Summit of the European Scientific Working Group on Influenza (ESI)

The third annual Flu Summit organised by EPHA member the European Scientific Working Group on Influenza will take place on 2 May 2013 in Brussels. It will be an opportunity to learn about and discuss with experts issues such as pandemic preparedness, new influenza target groups, and vaccination strategies. This year’s edition focuses on new developments and challenges in the influenza field, with special attention for discussions on safety and effectiveness of influenza vaccines. (...)

Medical Devices at EU Socialists & Democrats Workshop: an evolving debate

On 19 March 2013 a workshop on medical devices took place in the European Parliament to continue discussions over the legislative proposal presented by the European Commission in September 2012. The workshop was organised by the S&D Group (Group of the Progressive Alliance of Socialists and Democrats in the European Parliament) and was chaired by the Rapporteur for the Medical Devices report, Dagmar Roth-Behrendt MEP (Germany, S&D). The discussion over the two proposals on Medical (...)

EU Parliament votes to adopt Antimicrobial Resistance (AMR) measure as part of agricultural reform

The European Parliament voted on its plenary session on 13 March on the reform of the common agricultural policy (CAP). As part of this vote, amendments concerning Antimicrobial Resistance (AMR) were offered and adopted as part of the Parliament’s position for the second reading procedure. The relation between AMR and the Common Agricultural Policy (CAP) The adopted amendment 192 and 193 introduces a new Good Agricultural and Environmental Condition (GAEC) standard (containing a (...)