The political landscape in Brussels has undergone many changes over the past seven months: the new European Parliament started its activities last September, a new Commission just in office, and the much-debated Lisbon Treaty finally ratified by all Member States. This background sets the framework for a number of changes of relevance to the sector of homeopathic and anthroposophic medicinal products.

The Lisbon Treaty

The Treaty of Lisbon  finally came into force on 1 December setting the new EU-level political context. Its key objectives are to make the EU more democratic and more efficient.

One of the Treaty’s novelties is the appointment of a permanent Council President and a High Representative. Belgian Prime Minister Herman van Rompuy and UK Current Trade Commissioner Catherine Ashton have now been selected for these roles. Mrs Ashton is also Commissioner for external relations and one of the Vice Presidents of the European Commission. Council President van Rompuy, who will serve a term of two and a half years, represents the 27 Member States on the international scene, together with High Representative Ashton. He will also chair the meetings of the Heads of State (the ‘European Summits’). The current system of rotating EU Presidencies will continue.

‘Lisbon’ also extends the power of the European Parliament, by broadening the range of policy areas where co-decision with the Council of Ministers applies.

In addition, it brings change in terms of health. First, the Article outlining the health competence of the EU has been revised. The EU public health policy objectives remain - improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to human health - but actions to fight against the major health scourges are now included - monitoring, early warning of, and combating of cross-border health threats. In addition, the European Charter of Fundamental Rights is now legally binding (except in Poland and the UK). This contains a number of Rights that may be important for health decision-making. Thirdly, a new Article 11 introduces the ‘citizens’ initiative’ , which allows for the direct involvement of civil society in EU policy making.

Under the citizens’ initiative (ECI), one million Europeans can call on the European Commission to bring forward legislative proposals in a given area. Any such petition requires the signatures of one million citizens, who must be nationals of a ‘significant’ number of Member States. The precise conditions for such initiatives are still being defined. The Spanish Presidency is hopeful that the regulation can be adopted in July and that the ECI will be operational in early 2011.

The new European Parliament (2009–2014)

After the June elections, resulting in an overall victory for the political centre-right across the EU, the European Parliament  formed its political groups, elected its President and Vice-Presidents, and decided the number and responsibilities of the Parliamentary Committees. (See also ‘The new Parliament takes shape’, September 2009 )

Since September, the new Parliament’s attention has been focussed on the Swedish EU Presidency’s programme and the debate on the reappointment of José Manuel Barroso as European Commission President. It has also continued its deliberations on a number of policy dossiers relevant to homeopathic and anthroposophic medicinal products, including the ‘pharma package’ (see ‘The Pharma Package and its implications for homeopathic and anthroposophic medicinal products’  March 2009 and article below ). The reappointment of Mr Barroso as President of the European Commission was approved in September, and in January the Parliament took on the task of formally ‘hearing’ the various Commissioners-designate.

The new Commission

President Barroso announced the proposed candidates, portfolios and responsibilities for the new College of Commissioners  at the end of November. It consists of one Commissioner for each Member State - as required by the Lisbon Treaty - including the President. There are 7 Vice-Presidents and the new Commissioners have their backgrounds in different political families, more specifically the centre-right (13), liberal and (8) and the centre-left (6).

Some new portfolios (e.g. climate action, fundamental rights) have been added, and some of the existing ones reconfigured, most specifically pharmaceuticals has been moved from Directorate General Industry and Enterprise to the Directorate General for Health and Consumers (DG SANCO).

The new Commission, which will be in office until 31 October 2014, will be guided in its work by a set of political guidelines, proposed by Mr Barroso to the European Parliament last September, highlighting the need for EU leadership, and shaping globalisation on the basis of its values and interests. Priorities for tackling these challenges are currently being defined in a ten year framework to deliver a vision for the EU in 2020.

Parliament hears Health Commissioner John Dalli

Before being formally appointed, the new Commission had to be approved by the European Parliament. All Commissioners-designate were submitted to individual hearings before the Parliamentary committees dealing with their specific issues.

Mr John Dalli , a former Finance and Health and Social Affairs Minister from Malta with an impressive track record in politics and industry, will take on the role of Commissioner for Health, Consumer Affairs and Food Safety. Apart from health policy, Mr Dalli will also be responsible for pharmaceutical policy.

During his hearing on 14 January, Mr Dalli underlined his intention of putting patients and consumers at the core of policy development, and of ensuring the effective integration of pharmaceutical initiatives into the health portfolio. He indicated that he will focus on health determinants, healthy lifestyles and health information and education. His answers to the MEPs’s questions were well received, in particular his repeated commitment to ‘put patients and consumers first’. Rather than prioritising illnesses, he proposes to tackle horizontal issues such as obesity, alcoholism, drug and tobacco-related problems first, as it will prove to be ‘much more productive and effective to focus on educating people about a healthier lifestyle than on focusing on research on one particular disease’. He also promised to revise the Commission’s position on the pharmaceutical package, specifically the proposed Directive on Information to Patients, that is currently blocked in Council.  As part of the review of this proposal, he intends to make a clearer distinction in the proposal between information and advertisement, which is one of the main issues for many Member States.

In recognition of the shift of responsibility for the pharmaceutical industry to DG SANCO, Mr Dalli outlined his intention to ensure a stronger public health dimension within pharmaceutical policies, while not forgetting the need for a strong and competitive industry.

The vote of consent on the new Commission as a whole took place at a European  Parliament Plenary session on 9 February. The Parliament agreed to the appointment of the new Commission within the context of a revised working arrangement between the European Parliament and the Commission for the next legislative term, agreed in the form of a Parliament Resolution. The new Commission gained the support of 70% of voting MEPs.

New Commission takes office

The new European Commission formally took office on 10 February Commission. President Barroso has already indicated that he intends to improve the internal organisation and cooperation between the team of Commissioners. In an internal note , he outlines his plans to set up groups of Commissioners to work on specific subjects for a given period. Each group should bring together the ‘most competent Commissioners with a view to developing a specific political initiative’. The groups will not be permanent and should provide defined results or deliverables within a specific timeframe.  Barroso’s note also refers to the need to perform impact studies for all major new proposals (as requested by the European Parliament). A special Committee will be set up to ensure this happens. Impact assessments should include the initiatives’ policy objectives, economic, social and environmental consequences as well as issues such as fundamental rights and the effects on SMEs. Barroso has also indicated that he would like to hold internal ‘orientation debates’ to discuss ‘sensitive moral and political issues’.

Spanish Presidency health priorities

The Spanish EU Presidency has set out four main priorities for public health:

 ·         Health inequalities: Spain will organise an expert conference in April ahead of the informal Health Council on 22–23 April.

·         Organ donation: Spain would like to reach a political agreement on the proposed Directive on organ donation at the June Health Council.

·         Chronic diseases: the Presidency will organise two expert conferences on this issue: one will focus on e-health and the other on patient safety related to infectious, cardiovascular and chronic mental health illness.

·         Pharma package: Spain is aiming for first reading agreement on the counterfeit and pharmacovigilance parts of the package. Not much progress is expected on the proposed Directive on information to patients, which is blocked in Council, unless the Commission takes active steps to change the proposal.

Little progress is expected on the cross border health care Directive since Spain was actively opposing the last compromise text from the Swedish EU Presidency. Legislation in this area is not expected until 2011 at the earliest.

Conclusions

The many changes in the political landscape will require action on the part of ECHAMP. Links and partnerships will need to be built with new MEPs and Commission officials; renewed efforts will be required to advocate our messages and issues. A new five-year term of office stretches ahead of us, offering many opportunities for effective advocacy and change. ECHAMP’s campaign to convince decision makers of the need for a review of the current pharmaceutical legislation, to better reflect the specific nature of our industry and our medicinal products, was set in motion some 18 months ago, with the publication of a ‘Better Regulation’ document, and since then activities have taken place in the European Parliament and with the relevant Commission departments (including extensive contact programmes and a welcome letter to the new Health Commissioner). It will be continued with renewed vigour and ECHAMP News will provide regular updates on these initiatives.  With patients’ and doctors’ organisations currently working with MEPs to create a Complementary and Alternative Medicine (CAM) Interest Group in the European Parliament, as well as ECHAMP’s many planned outreach initiatives, it is hoped these efforts will lead to such a review during the Commission’s and Parliament’s current term of office.

Christine Marking
ECHAMP Public Affairs Consultant