European health ministers will meet on Tuesday in Luxemburg to decide on a range of proposals from the Commission. It is quite a wide range of issues from rare diseases over patient safety including the prevention and control of healthcare associated infections to the so called “pharmaceutical package”.
The most controversial part of the ‘pharmaceutical package’ seems to be patient information. Most people I talked to assumed that the proposal is politically dead since lots of EU Member States don’t like it. The main reason the increased possibility for pharma companies to inform patients about their products. Other countries such as Sweden and Denmark have serious issues with the proposal due to their constitutional rights on freedom of speech as the proposal would demand a system where governments censor companies’ information. As a Swede I must say I find the proposal quite restrictive and don’t really understand what it is in the current Swedish system that the Commission thinks needs to be limited. On this topic, there was quite good presentation held by Per Manell, at conference organized by the European Commission and EPF, "The Pharmaceutical Forum – Delivering for Patients" about the Swedish pharma industry web site for information on pharmaceutical products. The presentation can be found here.
Another issue to be discussed is the Commission communication on organ donation. The proposal went through the European Parliament this spring and is not very controversial. I therefore find it a bit surprising to see that some Member Stateswant to specifically exclude organ donations from the proposal on patient rights at cross border care! The full proposal for patients is highly controversial starting from the first ECJ case in 1995, continued via the proposed service directive where MEPs excluded medical services in the end in 2006 until today when the Commission first postponed several times and then most recently with the PSE group in the parliament trying to obstruct a decision in the Parliament.
Given how long this issue has been discussed, it´s a surprise to find, in the material put forward by the Council to the EU Member States, the phrase: “Due to the lack of time, the WP did not examine this revised compromise in detail”....
One should have expected that after a compromise on the patients rights Directive was found in the European Parliament, the Council’s decision on the issue should be easier, but that is obviously not the case: First of all, a large number of EU Member States are still very much the whole idea of patients receiving treatment abroad.
Secondly, when one looks at the details one notices that they want to further strengthen the rights of national administrations to forbid travel for treatments Member States want to increase the obligation to seek “prior authorization (or rather “prior refusal”) and even to exclude certain treatments. Since the assessment is that the proposal as it stand right now in the council is not supported by the ECJ case law one of the issues to discuss on Tuesday is how to “tackle the legal uncertainty for patients and its negative impacts on providing cross-border healthcare that may arise? (e.g. by means of adopting new legislative proposals on the excluded types of healthcare?)” Very important question indeed!
Thirdly, quite a lot of Member States wish to exclude private providers from the scope of the Directive. Now there is not really any legal ground for this policy so the sitting Czech presidency wants to find a compromise where they Member States have the right to exclude providers only if it is on the basis of quality (i.e. exclude unsafe and low quality private providers). Would it be worthwhile to try to work with a solution enabling a system excluding those providers who do not meet some quality and safety standards? The answer is clearly Yes. That is fine. Obviously it is not so easy for some of the more dogmatic EU Member States (which prefer to keep healthcare only for public providers).
The second question raised by the Czech Presidency is what mechanism for other co-operations between EU Member States should be put in place. The MS have decided they do want more cooperation in other matters (eg e-health, health technology assessments, quality) – not that easy since they of course know very well that every new formal European co-operation is a step closer to a single European healthcare system. It is slow, it is painful but it is where we heading – the governments are already in agreement on the vision and basic values that should be guiding our healthcare systems. Now we are on to practicalities, starting with allowing patients freedom to seek care in the various countries and continuing with co-operation on general issues.
If you want any of the background material you would have to send me an email.