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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 (...)
Access to Medicines
Pharmaceuticals and Medicines
Health Rights and Patients
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 (...)
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. (...)
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 (...)
The European Parliament’s ENVI Committee vote on the proposals for Regulations on Medical Devices and InVitro Medical Devices has been postponed for the second time. There are rising concerns by health stakeholders regarding the speed of the process, as ongoing delays undermine public trust in the EU’s ability to create legislation that will adequately protect patients.
On Wednesday 18 September, the ENVI committee postponed the vote on the Medical Devices Regulations for the (...)
One year after the release of its original position paper, EPHA has revised the document following member discussions about the evolving developments at EU level.
The updated EPHA Position on Medical Devices refers in particular to a number of points contained in the European Parliament reports produced by Rapporteurs Dagmar Roth-Behrendt (S&D, Germany) on medical devices and Peter Liese (S&D, Germany) on in vitro diagnostic medical devices and the subsequent debates over the most (...)
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 (...)
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 (...)
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 (...)
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