Ministers van Volksgezondheid bespreken EU-tabaksregels(en)

Proposals include size of warnings on packets, misleading labelling and the banning of additives which disguise tobacco flavour.

Dr.James Reilly, Minister for Health of Ireland will tomorrow (Friday 21st June 2013) chair a meeting of EU Health Ministers, where discussions will focus on a revision of the EU tobacco directive, legislative proposals on medical devices and clinical trials. The meeting will be held in Luxembourg as part of the 2-day EPSCO (Employment, Social Policy, Health and Consumer Affairs) Council.

The main item of business is to seek agreement on a general approach on the revision of the EU tobacco directive, including proposals in relation to warning size on packets, misleading labelling and the banning of additives which disguise tobacco flavour. Agreement would represent a major success for the Irish presidency.

The Council will also be updated on progress in relation to the negotiation of new legislation governing medical devices and legislation to update the regulation of clinical trials on medicines. The Proposals for legislation on medical devices (hip, heart valve, breast implants etc) will seek to strengthen the conformity assessments which are carried out before a medical device may be placed on the market. The legislation, when agreed, will also include a central European database and devices being fitted with a unique identifier, to ensure full traceability.

The number of clinical trials conducted in the EU fell by 25% between 2007 and 2011 as the cost of trials and administrative burdens increased significantly, stifling growth and innovation in this sector and reducing citizens’ access to new medicines and medical advancements. The new proposal for legislation on clinical trials seeks to reverse those losses by strengthening knowledge and innovation in clinical research, reducing administrative delays, overcoming divergent decisions throughout the EU by having a uniform application of common rules, while ensuring a high level of protection for clinical trial participants.

The Council will also be updated on cross border threats to health - an issue on which the Irish Presidency reached political agreement with the European parliament. This is an important health development which aims to better prepare and protect EU citizens against possible future pandemics. It allows the EU, for the first time, to issue pandemic warnings and provides for the joint procurement of vaccines - a timely issue considering the ongoing spread of the novel coronavirus (MERS-CoV) .

EPSCO comprises employment, social protection, consumer protection, health, and equal opportunities ministers. The meeting begins on Thursday with employment and social policy issues and continues Friday with Health matters.