The ‘Information to patients’ strand of the so-called pharmaceutical package, which aims to offer citizens better information on medicines and protect them against falsified products, has been stalled in Council due to objections from the member states to the European Commission’s December 2008 proposal. A draft report on the issue is now expected to be released in December. Swedish MEP Christofer Fjellner (EPP), the Parliament’s patient information rapporteur says the current stalemate is “utterly unacceptable”.

What is your take on the current situation?

The Commission has finally presented something on an issue where we all know there are problems. Therefore the ‘do nothing’ approach is utterly unacceptable. Member states are acting like ostriches, burying their heads in the sand. Instead of sitting doing and debating the issues on which they do not agree with the Commission, they choose to do nothing. I call on them to at least come back to the negotiating table and give it a chance.

How would you evaluate the current proposal?

I think the proposal provides a good basis, it is a good attempt, to say the least. Overall, it is a controversial area, because many member states believe that they have the perfect system and secondly I think there is a notion that more information will drive up health care costs in the member sates. People would be more empowered and would want to have access to the best and latest pharmaceuticals. Some doctors have also raised concerns; they are afraid that patients would put pressure on doctors to give them specific medicines. I understand those arguments, but I think that they eventually will prove to be wrong because I think well-informed patients can decrease health care costs.

Can you give a summary of your report?

The Commission’s proposal risks having negative commercial side effects when it comes to advertisements for prescribed medicines. I would say, let’s rule out that risk because nobody wants that, including the pharmaceutical industry, so we should not be afraid of this. We should get a ban on advertisement in place but on the other hand we should improve the amount of information made available to patients. If the member states think that the proposal does not meet this expectation, they should tell me how to do it then. I understand that they are afraid of the costs of the enforcement of the legislation; eg the ex-ante checking of the medicine information by health authorities. But as long as they haven’t discussed this, it is going to be very difficult to fix the problem. There are other possibilities as well, such as self-regulatory systems.

I also want to find an agreement on what information the package leaflets should be allowed to provide. In this respect, practices vary widely across the Union. And I would like to change the whole objective of the proposed directive and follow this line down, to put it more into a ‘health and patient’ perspective (the proposal was drafted by DG Enterprise and Industry, a fact that has been criticised by many).

For now, the type and scope of information you get depends to a great extent on which member state you reside in or which languages you speak, or whether you have access to the internet. This creates health inequalities. The legislation we draft should oblige industry to disseminate information in a way we think is suitable and then have a discussion with the Council, which in turn should stop ignoring the issue.

Background

On 9 June, during a Health Council meeting in Luxembourg, it became clear that over 20 member states do not see the proposal to amend the regulation provided to the “general public” on prescription medicines as a “solid base for negotiations”. As a result, the proposal is left untouched by the Swedish EU Presidency, which nevertheless is continuing work on the other parts of the package. The overall package consists of three thematic and five legislative proposals; besides “improving information to patients,” the Commission’s proposals seek to strengthen pharmacovigilance and take up the battle against counterfeit medicines (see Europolitics3656).

According to the member states, the proposal on ‘Information to patients’ makes no distinction between ‘information’ and ‘advertising’. They believe that the proposed monitoring mechanisms are too costly and would create unneeded administrative burdens. They also argue that information about prescription-only medicines should come from “competent health authorities” and not directly from the pharmaceutical industry.