Eurobrief 05
May 2008
For further information on any of these news items, please contact: nwhile@bma.org.uk
Contents
European Working Time Directive: agreement possible?
Consultation: updating the medical devices directives
European Commission 2009 health priorities
MEPs support ban on certain food additives
Implementation of the Tobacco Advertising Directive
Recognition of Professional Qualifications: non-implementation
Innovative Medicines Initiative: funding grants available
New code of conduct for EU lobbyists
Protecting health from climate change: new publication
European Working Time Directive: agreement possible?
The UK Government has reached an agreement to grant equal treatment to workers employed via temporary work agencies. This now clears the way for a long delayed EU directive on the issue. Under the new rules, after 12 weeks in any given job, agency workers will be entitled to equal treatment to permanent workers'. Following this development, the Slovenian EU Presidency has decided to add EWTD/Temporary Agency Workers onto the agenda for the next meeting of EU employment ministers which will take place on 9-10 June. This means that member states will once more debate the issue of the UK opt-out and the definition of inactive on-call time at the workplace. If agreement is not reached in June, the incoming French EU Presidency is expected to put forward proposals on the issue over the coming six months. The BMA has written to the UK Government to re-state its concerns over on-call time.
Consultation: updating the medical devices directives
The European Commission has launched a stakeholder consultation with the aim of revising the legal framework for medical devices in Europe. The existing directives have been in place since the 1990s and cover medical devices, implantable medical devices and blood derivatives. The Commission wants to update and simplify the rules in response to a number of new challenges such as the increase in new and emerging technologies, increasing global competitiveness and the variations in national implementation of the rules.
The Commission is seeking the views of stakeholders on a number of issues, including:
- Should cosmetic implants and the like (tattoo needles etc.) be regulated at the EU level and be classed as medical devices?
- How can we avoid different levels of assessment being applied in the EU by the 80 notified bodies that are responsible for assessing the safety of new medical devices?
- How do we better ensure that when an adverse incident happens there is swift coordinated action across the EU to protect patients?
- Should the role of the European Medicines Agency be extended to cover the approval of high risk devices such as coronary stents, pacemakers and HIV test kits?
- How can we make sure that medical devices that are imported into the EU from third countries are of the same safety standards as those made in the EU?
The consultation document can be read in full at the website below:
http://ec.europa.eu/enterprise/medical_devices/recast_docs_2008/Public_consultation_en.pdf
Please forward any comments to the Brussels Office by 16 June 2008.
European Commission 2009 health priorities
The European Commissioner for health attended the European Parliament’s public health committee this month to outline the Commission’s 2009 priorities in the field of health. She mentioned a number of proposals that are due to be released over the coming 12 months, including:
- Green Paper on the European health workforce
- Communication on rare diseases
- Directive on the quality and safety of organ donation
- Communication on cancer containing a new EU strategy to combat the disease
- 2010-2014 strategy for combating HIV/AIDS
- Communication to support member states in tackling health inequalities
- Recommendation on mental health
- New health and safety package
In addition to this, the Commission will release proposals on food labelling. These will stipulate the printed information that must be included on food labels including nutritional information and information on allergens. These proposals will cover ‘mixed alcoholic drinks’ (such as alcopops) and food that is sold loose, in restaurants and through caterers. The Commission also aims to clarify the country of origin rules which are currently causing consternation in the UK where some products are imported to the UK, re-packaged and labelled as being UK produce.
MEPs support ban on certain food additives
The European Parliament’s environment committee has voted to support the Commission in its aim to ban certain food colouring agents that are linked to hyperactivity in children. The proposal establishes a common authorisation procedure for regulating food additives and flavourings. Final adoption is foreseen for July with the new rules taking effect from 2010.
Implementation of the Tobacco Advertising Directive
The European Commission has published a report on the implementation of the 2003 Tobacco Advertising Directive which covers print media, radio, internet and sponsorship of events while involve several Member States, such as the Olympic games and Formula One races. The report concludes that all member states have transposed the directive into national law and that enforcement of the ban is generally well respected. The report can be read at:
http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/com_20080520_en.pdf
Recognition of Professional Qualifications: non-implementation
The European Commission has sent a ‘reasoned opinion’ to nine member states who have failed to transpose the EU Directive on the Recognition of Professional Qualifications into national law. The directive facilitates the recognition of professional qualifications in a range of disciplines (including medicine) across Europe. The UK implemented the directive in October 2007.
Innovative Medicines Initiatives: funding grants available
The Innovative Medicines Initiative (IMI) is a public-private partnership between the European Commission and members of the pharmaceutical industry which aims to remove bottlenecks in the drug development process by supporting innovative research projects. To this end, grants of €123 million will be available in 2008 to the most promising research projects in the areas of brain disorders, metabolic and inflammatory diseases. In future years, IMI will also cover cancer and infectious diseases. The deadline for submissions is 15 July and further information can be found on the IMI website:
http://imi.europa.eu/calls-01_en.html
New code of conduct for EU lobbyists
The European Commission has adopted a code of conduct which regulates the behaviour of EU lobbyists and acts as a forerunner to the voluntary register for lobbyists which will be launched next month. The code calls on those lobbying the Commission to abide by a number of standards relating to the way they represent their members and the way they deal with European Commission officials. The BMA intends to sign the register thus continuing its commitment to transparency when dealing with Commission staff. The code of conduct can be read here:
http://ec.europa.eu/transparency/docs/323_en.pdf
Protecting health from climate change: new publication
The World Health Organisation European Office has published a new report on climate change and health. The report covers issues such as emerging diseases, adverse weather events, health inequalities and workforce adaptation. It can be read at:
http://www.epha.org/IMG/pdf/Protecting_Health.pdf