Brussels, 05/06/2009 (Agence Europe) - Health ministers from the 27 member states of the European Union will meet in Luxembourg on Tuesday 9 June for their main formal meeting of the six-month Czech Presidency. The adoption of two recommendations excepted, the meeting is unlikely to produce anything concrete. It will, however, provide the opportunity to take stock of progress on the directive on cross-border healthcare prepared by the Commission in July 2008 and on the three legislative proposals in the pharmaceuticals package that was presented on 10 December of last year. The Czech Presidency has decided to devote the morning to the adoption of the two recommendations and to a debate on cross-border healthcare. The new A/H1N1 virus, or so-called “swine flu”, and the measures taken to develop a vaccine before the onset of the next outbreak of seasonal flu will be discussed over lunch. The afternoon will be given over to the pharmaceuticals package.
Rare diseases. The Council is expected to adopt a recommendation calling on member states to put in place national plans covering diagnosis, treatment and care by 2013. The text also underlines the need for further work to identify and describe these still poorly documented illnesses (it is estimated that there are between 5,000 and 8,000 rare diseases affecting fewer than 5 people per 10,000) and stresses the importance of the Orphanet database. It recommends better coordination of research. Member states are asked to identify centres of excellence and to encourage them to take part in European reference networks. The text highlights, too, the importance of telemedicine, of a multi-disciplinary approach, of sharing best practice on diagnosis, medical care and social support measures, and also what remains to be done on the training of healthcare staff. It calls on member states to consult patients' organisations. The Commission will report on the implementation of this recommendation and the measures to be taken to improve the lives of patients suffering from rare diseases before the end of 2013.
In adopting this text, the Council has taken no account of calls made by the European Parliament when it passed the Trakatellis report in Strasbourg on 23 April. Parliament, which had only to be consulted, recommended, by a large majority (390 votes in favour): - structural aid for the Orphanet database; - the involvement of patients' organisations in the drafting of national plans; - presentation by the Commission of implementing measures on the centres of excellence networks, the collection of epidemiological data, patient mobility, etc, as early as 2012.
Patient Safety. Following a public debate, ministers will adopt a recommendation on patient safety which recommends putting in place strategies to prevent and control healthcare-associated infections. The text sets out various measures, such as setting up or enhancing warning systems, hygiene measures, disease prevention and vaccination, staff training and information to patients.
The Sartori report in the European Parliament in Strasbourg on 23 April called for a 20% reduction in the number of people every year who suffer unwanted effects after healthcare. Commissioner Androulla Vassiliou, however, felt that this objective would be difficult to apply given the wide differences between the situations in the various member states.
Cross-border Care. On Tuesday, ministers, working from a questionnaire prepared by the Czech Presidency, will hold a further debate on the draft directive on patients' rights in cross-border healthcare. Observers all agree that the Council working group has made fine progression on this text during these last six months, even though it has not given consideration to the 122 amendments adopted by the European Parliament in first reading (Bowis report) on 23 April (see EUROPE 9888). On this controversial issue, member states are seeking to retain their responsibility for the organisation of health systems, when the Parliament is seeking to promote easier and fairer access by patients to quality healthcare irrespective of where this care is provided. For this, the Parliament tried to provide close regulation on the prior authorisation recommended by the Commission for hospital care and to propose options so that the mechanism for pre-payment of charges and reimbursement does not discriminate against less well-off patients.
As things stand, member states are in agreement over the introduction of a prior authorisation system for hospital and specialist care. Some, in particular Portugal, Spain, Italy and Ireland, also want to exclude private, non national health providers from the scope of the directive (they are seeking to avoid repaying for care by their own providers, this repayment not being provided for at national level).
The member states also want to exclude long-term care (but are unable to define the term) and transplants from the directive's scope (given the shortage of transplant organs, they want to preserve the existing transplant cooperation structures like the Eurotransplant network linking up the transplant centres in six countries - Belgium, Austria, Germany, the Netherlands, Luxembourg and Slovenia).
The member states tend to favour the idea of mutual recognition of prescriptions. Most member states want to revise chapter 4 of the draft directive on the cooperation modalities among member states in reference networks, assessment of technology and online healthcare. Due to fears of the repercussions on the organisation of their healthcare systems, they are challenging the idea of the Commission being able to adopt implementation measures using the comitology procedure. The member states want a strict sharing of responsibility for providing information to patients. Countries of whose healthcare system the patients are members (the home country) would be responsible for informing the patient about authorisation and reimbursements procedures, and the countries where the healthcare is supplied would be responsible for providing information about the healthcare providers, treatments and compensation for adverse incidents.
The European Commission has expressed serious doubts about the compromise reached thus far by the member states. It is particularly concerned about measures to extend the scope of prior authorisation, to exclude some healthcare providers, and to water down quality and safety objectives and cooperation among the member states.
Pharma package. The debate in the afternoon about the pharma package will take place (for the second time) in the absence of Commissioner Gunter Verheugen, who will have delegated responsibility for defending the five proposals to Androulla Vassiliou (three directives and two regulations on tackling counterfeiting, pharmaceutical vigilance and patient information). The Council has already worked a lot on counterfeiting and pharmaceutical vigilance but has not got very far on the supply of information to patients by pharmaceutical laboratories. The entire package will have to wait for the setting up of new committees at the European Parliament before it can be examined by MEPs in detail in the autumn.
The member states are happy with the European Commission's desire to take measures to combat counterfeit medicines but the initial discussions shed light on the weaknesses of the European Commission's initial draft when it comes to sales over the internet. Without any reliable online sales figures and information about the type of products bought, but it is certain that the internet is significant in the sale of false medicines. The European Commission's draft legislation does not cover online sales. Six Council work groups have been working on the issue and the member states have been looking at how to improve matters, including monitoring raw materials (often imported from outside the EU) used in the manufacture of medicines that are a potential source of danger in terms of product quality. As usual, countries are divided over the traceability and safety measures for pharma products between countries favouring parallel trade (or even brokering systems) and countries favouring monopolies for the sale of medicines (see EUROPE 9801).
On pharmaceutical vigilance, member states seek greater efficiency but face problems in defining the role and membership of the committee to be set up at the European Medicines Agency to deal with the issue. Some member states are concerned about how information collected from patients and doctors is treated. Along with issues arising from the complex nature of the work (there are no less than 17,000 reports every year assessing medicines in the EU), leaks about certain products could have a negative impact on public trust in the medicine. Almost all member states do not want to allow laboratories to supply information direct to patients. The strongest opposition comes from Finland and Luxembourg, both of which oppose the new EU legislation. Sweden, Denmark and Germany have raised constitutional problems - their constitutions ban them from issuing regulations on information. The United Kingdom is more open to the issue. Belgium and Estonia are the countries that are most in favour of such information, with strict rules as set out in the European Commission's proposal. (O.J./transl.fl)