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Vice-President of the European Commission responsible for Enterprise and
Ladies and Gentlemen, I would like to welcome you to the first meeting of the Pharmaceutical Forum.
This Forum builds on the old G10 Medicines process. The G10 highlighted the importance of the pharmaceutical industry to achieving our public health goals. This was an important step.
Today, we go further than recommendations developed by a limited high level advisory group. The particular characteristic of the Forum is that it brings together all Member States, the European Parliament and a broad range of stakeholders.
We do this because important G10 issues remain unsolved on which the only way forward is close cooperation of all those around the table today. Information to patients, price and reimbursement as well as added therapeutic value are areas, where isolated action by any of us is doomed to fail.
And let me be very frank: We cannot afford to fail. The industry is facing a number of serious challenges, matched only by those facing public health. The time has passed that Europe was the pharmacy of the world. True, our industry still has an inherent strength. But we are losing competitive ground to the United States and, increasingly, to China, India, Singapore and others. There are many worrying signals. Let me mention just two:
We need to respond to these challenges and I hope that today's discussion will pave the way for solutions. Our ambition must be equal to the challenges. What we need today is a clear political commitment from all around the table to fully support the Forum. And we should be impatient to achieve rapid and concrete progress in the months to come. Otherwise, Ladies and Gentlemen, there is a high risk that this Forum will fail – to the detriment of our patients, our industry and our health care systems.
Information to Patients
The first topic, on which our citizens expect us to deliver, is information to patients.
The current situation is unsatisfactory, and in my view even unacceptable. If you can speak English and use a computer, you already have as much information on pharmaceuticals as you could possibly want. What you get however are often Internet sites of dubious quality or even sources from outside the EU offering promotional material rather than information. If by contrast you don't speak English and cannot use a computer, the information available to you is very limited.
In our efforts to improve the information on pharmaceuticals as well as on diseases in general, we have to bear in mind some key aspects:
To address these aspects, the legal framework from the early 1990s is not fully appropriate any more. On medicines, advertising to the public is only permitted for self-medication medicines and completely prohibited for prescription medicines. For those medicines, even information is highly restricted. Information on diseases by contrast is much less regulated.
I regret that in 2004 the Commission's last attempt to modernise the legislation failed. But I am the first to admit that mistakes have been made.
The Commission is now called upon to present a report to the Council and the European Parliament next year. This is an excellent chance to put forward a new framework for information to patients. The report will take account of the discussions in the Forum. And we will also consult the public before the end of the year to ensure that everyone has an opportunity to contribute.
A potential source of information is the industry which has the knowledge, skills and resources to provide, at least, basic information. National and European regulatory authorities already depend on the industry to provide information for leaflets, labels and national databases. There is no reason why we should not build on this.
I strongly believe that industry should have the right to produce non-promotional information for patients about their own medicines and diseases and to publish it. This information should comply with strictly defined rules. It could be provided on a self-regulatory basis but subject to a robust system of control and quality assurance without creating a big bureaucracy.
Pricing and Reimbursement
Let me now turn to pricing and reimbursement.
The starting point of our reflections must be to discuss the fundamental objective of our pricing and reimbursement policies. Do they aim exclusively at cost-containing of the health care budget? If so, there is not much for us to discuss. In my view however, the ambition of our price and reimbursement policies must be to provide optimal service to our patients. Good policies give patients equitable access to the treatment they need and take into account the innovation and added value of medicines.
Do not get me wrong. The objective is not to spend more, but to spend more intelligently. Pricing and Reimbursement systems have to allocate our limited resources effectively and free them up to pay for the much-needed innovation of tomorrow. What is needed is a long-term approach, rather than short-term budget fixes.
To get there, we do not need new legislation from Brussels. The way forward is very simple: We need to learn from each other how to do better. Not more and not less.
Five main themes have emerged from the preparatory discussion and have to be addressed in the Forum:
I expect the working group on pricing to deliver a toolbox of concrete measures and options which can be picked up by Member States when addressing all these challenges. I look forward to a first proposal at the next meeting of this Forum.
Ladies and gentlemen there is much to discuss. We have a Progress Report which summarises the work of the Working Groups to date and points to issues that have yet to be tackled. It should form the basis of our discussion today. I hope that we will be able to agree to adopt the Report at the end of the meeting so that the working parties can start on the substantive work.