Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-10-22-Speech-2-043"
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"en.20021022.1.2-043"2
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". – Mr President, today's debate has been very instructive and shows the great commitment of many honourable Members of this House to these issues.
As regards the additional data protection on switching, we agree that this request is not unjustified. This could increase the availability of over-the-counter medicines. We can therefore accept Amendment No 92 in principle, but we still retain our right to look at the duration of that additional protection.
As far as the additional data protection for old products is concerned, this entails a proposal that could extend data protection far beyond ten years – up to 14 years, to be precise. That is why we cannot support Amendment No 40.
The third issue concerns improving information for patients. I feel a little uncomfortable with this debate because I am also against the proposal that many Members oppose, namely the American model. For instance, one Member said that in America the ten most used pharmaceuticals are the ones that are the most advertised. Among the five most advertised medicines at least, no one would have a right to take part in even the pilot project.
A pilot project does not mean direct advertising. It is only information validated by the competent authorities which can be given at the request of the patient or patients' organisations. It is right that people are against the American direct-to-consumer advertising. That is not what we are proposing.
We have a situation where abundant information is available on the web, which is not validated and makes the consumer extremely unsure, which concentrates on products which are not on the market and which confuses many citizens when they visit their doctors. Because we cannot stop it, we want to offer the possibility of access to information validated by clear guidelines, accepted by the Community and monitored, observed and controlled by the Medicines Evaluation agency. I understand that people are against the American system, but we have never proposed it. That is why we cannot support Amendment No 101 and others aiming at the same objective.
The fourth issue concerns relative effectiveness. Some amendments relate to relative effectiveness. They suggest that the added therapeutic value should be considered as a criterion for the authorisation of a medicinal product – alongside quality, safety and efficacy. The Commission agrees that the issue of relative effectiveness is of great importance because it can help the kind of innovation that brings important benefits to patients.
An authorisation depends on a positive benefit/risk ratio, on the quality, safety and efficacy of the medicine itself, on its own merit. Relative effectiveness is not a reason to deny access to the market.
The Commission can support the idea that relative effectiveness should be considered at EU level, and can accept in principle some related amendments, like Amendments Nos 4 and 100. The Commission cannot, however, accept amendments that establish relative effectiveness as a fourth hurdle for marketing authorisation.
The fifth group of amendments concerns legal status. The Commission proposes that the conditions of supply – over-the-counter or prescription-only – should be determined under the mutual recognition procedure. This would obviously lead to a harmonised EU legal status for all products authorised accordingly.
The Commission continues to believe that it is appropriate to include legal status in the mutual recognition procedure. But the Commission understands the concerns that this might lead to a situation where too many products are classified as prescription-only medicines because of a 'lowest common denominator' effect among the Member States.
A number of interesting issues have been raised. I want to tackle those raised by Members who are still here in the Chamber. It is unfortunate that often Members have disappeared when it is time for me to reply – I hope this is not an improper comment.
Finally, on the European Medicines Evaluation Agency, our proposal follows the lines which were provided for the European Food Safety Authority at the time of our proposal. Amendment No 16 aligns the EMEA Management Board with the model finally adopted for the Food Safety Authority, and the Commission can support this amendment.
Finally, let me just briefly reiterate that Parliament is provided in writing with a full list of the Commission’s positions on each of the amendments.
I will comment on six groups of amendments. Firstly, on the extension of the scope of the centralised procedure. Mrs Grossetête put the whole case very well. The whole idea behind this procedure is to guarantee that goods are delivered quickly, equitably and in the interest of all patients in Europe. If we do not have a centralised procedure by the time the ten new Member States join, there will be enormous inequality.
We take the comment on the SMEs very seriously and, for that reason, we are ready to seek concrete measures that would alleviate the burden on SMEs, for instance, a reduction in fees, direct scientific advice from the agency in London or administrative support.
The Commission is also convinced that extended scope for the centralised procedure for human and veterinary medicine would benefit European citizens and businesses alike. For that reason, the Commission cannot accept amendments which reduce the scope of the centralised procedure.
The second question is the balance between innovation and competition from generics. That is a very sensitive issue. I would be happy to discuss that in depth. In regard to the American system, as Mrs Corbey mentioned, we must remember that we cannot take just one point of comparison. In America, the drugs market is totally deregulated and there is direct consumer advertising. We are not proposing that. It is through data protection that we are trying to strike a balance. We are proposing something that the Commission refused to propose for years – namely the Bola system for generics which, of course, means more competition in the sector after the expiry of a patent and, at the same time, lower prices and lost revenue for those who originated the medicine. It is clearly better for the consumer. It is extremely important that we stick to that.
Secondly, at the same time, to counterbalance it, we want to propose a solution for exclusivity involving a ten-year period and, if there are indications needing to be researched into later, ten plus one.
I do not believe that European industries have been losing market share, that there are less innovative medicines and research in this field, and that this is in the interests of European patients. I just do not believe it. I am sure that we must try to accept that there are two or three public goods we can defend at the same time. Public health takes top priority but we must also support research innovation in Europe. If we do not support it we are going to be in permanent decline in all sectors. Research-intensive areas are those which create jobs, development and wealth and make it possible to assume our global responsibilities. So both are issues we must try to tackle at the same time. The balance is not always easy. We have done this after very careful consideration.
There are a few amendments seeking to change this and we will oppose them. For instance, Amendment No 34 wants to go further in favour of generics and weaken the position of innovation. To keep the balance, we cannot support it. On the other hand, Amendments Nos 40 and 92 call for additional data protection of three years in two situations. Firstly, when a new indication is developed for an old medicine, and secondly, when a company submits documentation for switching a product from prescription to non-prescription status. These amendments must be seen in the whole context of the data-protection scheme."@en1
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