Euro Brief 20
November 16-30 No.20/2003
- Success for doctors in EU Committee vote
- MEPs increase protection rights of pharmaceuticals
- Set-back for EU-funded embryonic stem cell research
The European Parliament's Legal Affairs finally voted on the Commission's proposal for a Directive on the mutual recognition of professional qualifications across the EU after months of uncertainty.
The medical profession appear to have scored a positive result in ensuring that the number of medical specialties being automatically recognised are increased from 17 proposed by the Commission to the 52 currently recognised in the Doctors Directive.
Doctors have also secured better protection for patients with amendments to maintain a strict regime for the regulation of migrant doctors in a host state being passed in the committee on 17th November.
The BMA has been campaigning to safeguard Doctors' rights to automatic recognition, subject to high training standards, while at the same time rejecting any relaxation of regulatory procedures in the interest of patient safety.
The Committee also voted to keep a clear separation between general recognition systems and sectoral regimes such as that for Doctors and pharmacists which seems to have prompted some committee members who were determined to amalgamate the two regimes to vote AGAINST the Report as amended.
The vote to adopt the Report - as amended - was very tight and the Shadow Rapporteur, German Socialist Mrs Gebhardt warned the Committee that she and her Group would be putting forward amendments to "simplify" the legislation at Full Parliament in December. This would again run the risk of having Doctors being subjected to the same recognition procedures as other professions.
Nevertheless, European healthcare professions have welcomed the Committee decision. Particularly, there was relief that the committee decided to maintain a clear separation between the General System and the sectoral systems of recognition. Provisions to ensure professional input is guaranteed in any consultation mechanism were also passed.
Some 14 out of 16 joint amendments of health professionals covered by the sectoral directive were accepted.
At one point there were over 400 amendments.
The Plenary vote (First Reading) has been set for 17th December
MEPs increase protection rights for pharmaceuticals
In a blow to the growing generics medicines industry, the European Parliament's Health and Environment Committee voted to extend data protection for patented drugs to 11 years.
This increases further the length of protection since the Pharmaceutical Review had its First Parliamentary Reading last year when MEPs voted for 8 years protection.
Data protection currently varies between six and ten years throughout the EU. However in some accession countries which are due to join the EU in May, much cheaper generic copies can enter the market after only 3 years data protection - as is the case in Poland.
Industry argues that it needs data protection to remain competitive and keep investing in new research.
However the closeness of the committee vote on 26 November means that large pharmaceutical companies have a struggle to find qualified majority for these amendments when they are considered again at Second Reading in Full Parliament in mid-December.
Set-back for EU-funded embryonic stem cell research
Five EU Governments have blocked moves to allow EU funding for embryonic stem cell research despite the European Parliament vote to abandon any cut-off date and permit funding in any country where it is legal.
Germany, Italy, Portugal, Austria and Luxembourg object to tax-payers money being used for embryonic stem cell research.
It is up to each EU member state to decide on the ethics of such research but there has been a moratorium for the last year on EU funding under the 6th Framework Programme which the Commission is trying to lift by introducing new guidelines. It appears that the Competitiveness Council may try to resolve the situation on 3 December.
Secret EU Ministers Meeting Make Changes to Treaty Health Powers
EU Foreign Ministers met in secret on 28-29 to finalise arrangements for a new EU Constitution which the Italian Presidency want to have ready by the end of the year.
Some significant agreements were reached under the chairmanship of Franco Frattini, Italian Minister for Foreign Affairs
Each of the 25 EU countries are to have their own Commissioner with equal voting rights. However Spain and Poland are adamant that the EU should stick to the Council Voting system agreed in Nice in December 2000. This deal disproportionately favours Spain and Poland with a generous number of votes – 27 each to Germany’s 29 despite having to combine their population to match that of Germany.
This remains the biggest sticking point with all other member states wanting a double majority system to replace the weighted votes. This would require 60% of the EU’s population to be represented by collective council votes before it could be regarded as a “majority”. The UK want to kick this issue into the long grass, arguing that they should return to the issue nearer 2009 when the Nice deal runs out. If this issue can be resolved by 13th December when it is the Prime Ministers turn to negotiate in Brussels, there is every chance a Constitution will be ready before Christmas, contrary to all expectations.
Other deals reached so far include defence co-operation based on a joint proposal submitted by the UK, France and Germany
The Presidency document highlights the fact there are changes to a number of articles including Article 179 on public health. Again, observers believed that this would be a long shot. The wrangling over thorny institutional issues meant it was unlikely the InterGovernmental Conference would have time to un-pick policy areas in the Treaty agreed on during the 18 month European Convention. The BMA has been campaigning to re-open the question at the IGC because of a last minute deal done in the Convention to weaken EU health powers compared to the EU’s more commercial / internal market competences. The UK Government reserved the right to re-open the Health Article; although given London’s particular wish-list, it was more probable the question would be brought to the table by some other member state.
Although the strong calls from many Member States to include ' health protection ' as an EU objective in Article I-3 do not appear to have been taken into consideration, Page 26 introduces a new article called 'the Social Clause”, which includes “protection of human health.”
A new point has been added to Paragraph 1 of Art III-179 (the new Health Article in the Treaty)
b) monitoring, early warning and combating accidental or intentional serious threats to health when they may have a European dimension.
Also a new point has been added to Paragraph 4 of Article III-179, which sets out in which areas the EU may introduce legislation;
(c) measures setting high standards of quality and safety for health products and devices for medical use.