Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-10-22-Speech-2-005"
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"en.20021022.1.2-005"2
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"Mr President, before briefly introducing the three Commission proposals, I would like to thank and congratulate the two rapporteurs, Mrs Müller and Mrs Grossetête, as well as the Committee on the Environment, Public Health and Consumer Policy for all the work and effort they have put into finalising these three reports.
The Commission believes that this is a balanced proposal. It takes account of the interests of the innovative European pharmaceutical industry, which is losing ground compared with the industry in the United States. It means fewer jobs and less research in Europe unless we do things differently. At the same time, it will facilitate the development of a competitive market in generics, and that means medicines at lower cost for European citizens.
Finally, I should like to say a few words about controlled access to information for patients. I knew this would be a difficult discussion, but, first of all, the Commission is not proposing an American type of direct advertising to patients. The discussions have concentrated to a large extent on the US model, but this is not our model.
The facts of the matter are that a lot of fragmented information is already available on the web, at least for English-speaking patients. This has two major drawbacks: firstly, it discriminates against non-English-speaking people and, secondly, it means that the information can be piecemeal and unreliable.
Our proposal is that European citizens should obtain information that has been validated by European regulatory authorities and that follows guidelines to be agreed between the Member States and the Commission. It is a prudent proposal. It is a European pilot project, and has nothing in common with the US model. The alternatives to what we have today are, on the one hand, the continuation of massive direct advising to patients via the web. We cannot change this situation by our legislation. The alternative is to enable patients to obtain sound information, validated by the competent European authorities, on medicines for a small number of diseases. I think that this second option increases both choice and security for European patients.
In conclusion, the Commission proposals aim to guarantee a high level of public health to European citizens, to increase, in a balanced way, the availability of innovative medicinal products and generic products and also to be ready for enlargement.
This is a challenging piece of legislation. I am looking forward to the debate in the House today and to continued cooperation with Parliament and the Council.
Let me start with the objectives of the proposals. There are three. First and foremost, to guarantee a high level of health protection for European citizens, and that is always the starting point. Secondly, to increase the availability of innovative medicinal products and, at the same time, favour competition with generic products, and, thirdly, to prepare for enlargement, which will very soon become a reality.
As far as the concrete proposals are concerned, I will concentrate on three of them. First, the need to reinforce the role of the European Medicines Evaluation Agency and the centralised procedure. Why? Because the objective is to make new innovative medicines available to all EU citizens, at the same time. This is a question of equality of all patients in Europe. Thus, the Commission has proposed that the centralised authorisation procedure for all medicines containing new active substances be made mandatory. This is the Community solution to the issue of innovation availability and I hope that this House will support it. Additionally, this would produce economies of scale, save resources and time and, finally, lead to improved regulatory efficiency.
The Commission wants, especially in the enlarged EU, to ensure that patients have quicker access to innovative medicines. The mutual recognition procedure has shown its limits. The evaluation process at the London agency takes an average of 180 days – clearly fewer than the maximum of 210 days provided for in the legislation.
The centralised procedure would also be positive for small and medium-sized enterprises. Let us take the example of biotechnology. SMEs are very active in this field, where centralised authorisation is already mandatory. Experience has not brought any major problems to light.
The benefits of a centralised procedure for SMEs are obvious in areas such as orphan drugs, where most of the marketing authorisations are granted to SMEs. This said, the Commission could, with a view to an overall solution, seek supporting measures for SMEs if there are particular obstacles, to help SMEs overcome them.
Secondly, we need to find the right balance between innovation and competition from generics. Why is this so important? To put it in a nutshell, we need innovative products for the benefit of patients and we need generics to help reduce the pressure on health care costs.
How then are these needs to be balanced? For innovative medicines, the Commission proposes a new data-protection period. For generics, entry to the market will be speeded up. How will this happen? First, the Commission proposes to harmonise the national data protection periods at 10 years across the board. This will provide a harmonised solution for Europe. The protection period will give the innovative pharmaceutical industry an opportunity to recover its R[amp] D investments. This will also allow for the smoother operation of the internal market. To reward further innovation and research in new products, the proposal provides for a possible extension of the protection period up to 11 years.
For generics, the Commission proposes to change a long-standing EU policy. We propose now, for the first time in EU legislation, that trials may begin on generics before the expiry of the patent or other form of intellectual property protection. This will speed up the marketing of generics on most of the national markets and will substantially help to increase competition."@en1
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