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EU Policy Update

In policy news this month, the Commission publishes its 2013 Work Programme, EMA releases its opinion on medical packaging wording, updates on EU structural funding are provided at the European Health Forum Gastein and more. 

 

European Commission Work Programme for 2013 published

On the 23rd of October, the European Commission published its Work Programme for 2013. The programme outlines how the Commission will work on a day-to-day basis to bring about its main aim of returningEurope to sustainable growth.  It summarises the objectives for the Union in several key areas and outlines how it will tackle these by taking forward key initiatives and implementing legislation.

Though health is not mentioned as a key target area itself, the strategy underlines the health sector’s economic potential and the need for Europe to invest in it. Research is recognised as essential and public-private funding partnerships for research into pharmaceuticals is envisaged. Air quality is also going to be tackled, with assessments of current pollution levels and a revision of current air quality legislation planned. More information  Press release

 

European Medicines Agency opinion on required changes to product information

Following a European Medicines Agency (EMA) public consultation in July on the required changes to product information stemming from the new pharmacovigilance legislation, it has issued comments and approval of the wording it believes should be used on medicinal packaging. The new legislation requires information to be added to the summary of medicinal product characteristics and to package leaflets, including a black symbol for medicines that are under additional monitoring for safety issues and a statement encouraging people to report suspected side effects to their national reporting system. The EMA public consultation aimed to present these proposals to stakeholders, and to ascertain their opinions as to the best location for the black symbol and wording of the standardised text. The EMA Working Group on Quality Review of Documents (QRD) issued its opinion in a document released earlier this month, with additional comments appearing in blue. The Pharmacovigilance Risk Assessment Committee (PRAC), responsible for assessing and monitoring safety issues for human medicines, will be endorsing these statements during its next meeting on 29-31 October.  EMA document

 

Update on EU structural funding from the European Health Forum Gastein

 

The European Health Forum Gastein took place this year from the 3rd to the 6th of October in Austria. The forum is an annual health policy event that provides a platform for discussion for various stakeholders in the field of public health and health care, gathering approximately 600 participants per year. This year, one of the important issues discussed was structural funds and how European Member States can use them for health purposes. John F. Ryan, Director of Public Health at the European Commission’s DG SANCO (Health and Consumers) underlined that Member States may make a request to which certain restrictions apply. Structural funds may be used to improve the situation of hospitals, for medical equipment, educating healthcare professionals, launching prevention campaigns (e.g. national programmes; spirometry campaigns etc.) and creating sustainable patient organisations, etc. During the 2012 EFA AGM the EFA office gave a presentation on EU structural funding possibilities for members, which can be viewed here. If you would like further information or assistance with this, please contact Roberta.savli@efanet.org

 

New EMA report on its interaction with patients and consumers published 

The European Medicines Agency (EMA) has published its fifth report on its interaction with patients and consumers and the organisations that represent them. The report includes a comparison with previous years and highlights steps for future action. It details how interaction has been enhanced throughout 2011, for example through the inclusion of patients in the scientific advisory group (SAG) meetings and increased patient and consumer review of EMA documents. Among other things, the report says that during 2012 the new pharmacovigilance legislation will provide increased opportunities for interaction and collaboration between EMA and European patients and consumers. EFA is working with the EMA and welcomes the interaction.  More information on the EMA Patient and Consumer Working Party

 

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