The European Commission has unveiled its 2012 Work Programme “Delivering European renewal”. The overarching priority is to foster a sustainable and job-rich economic recovery and to address the financial crisis. Clinical trials, medical devices, tobacco products, long term care, or child poverty are on the agenda.
In the general policy areas, the Commission announced that it will continue to mainstream the use of impact assessment as a standard part of the Commission’s work in 2012.
The Commission announced an extension of the minimum time for public consultations from 8 to 12 weeks, as EPHA has been requesting. (EPHA position on smart regulation)
This will help to ensure that Commission proposals are well grounded in the views of stakeholders, and that all have had an opportunity to give their opinions on the key public policy choices.
Health legislations and policies for 2012
– Health and safety : The Communication will build on the current strategy and build on the final evaluation of the current strategy,
– Package on innovation in health:
(1) Communication on the Promotion of innovation in medical devices for the benefit of patients, consumers and healthcare professionals aimed at improving the regulatory environment to foster innovation in medical devices in the light of new developments (such as ageing, ICT etc.).
(2) Medical devices Legislative The aim of the proposal is to ensure that the regulatory framework continues to promote innovation in the sector while guaranteeing patient safety.
(3) Clinical trials to foster clinical research and innovation in the pharmaceutical sector: The objective of the proposal for a revision on the Directive on clinical trials (2001/20/EC) is to strengthen knowledge and innovation in clinical research. Issues likely to be addressed are: reduction of administrative delays, overcoming divergent decisions throughout the EU and streamlining of reporting procedures.
– Revision of the Tobacco Products Directive concerning the manufacture, presentation and sale Legislative Recent developments in tobacco products will be addressed by an update of the Directive (2001/37/EC), to cover Internal Market issues and look at new products and labelling.
Specific legislations that are health relevant
– European Accessibility Act: improving accessibility of goods and services in the Internal Market for persons
with disabilities and elderly persons, based on a “design for all” approach.
– Communication on long-term care : the Communication will present policy orientations to respond to increasing need for long-term care provision.
– Child poverty: A Recommendation will support the EU and Member States’ efforts to tackle child poverty. It will set out common principles for effective policy intervention in the following key areas: support to families
(access to labour market for parents, income support), services (childcare, education, healthcare, housing, social services), participation in society.
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