Local view for "http://purl.org/linkedpolitics/eu/plenary/2006-05-31-Speech-3-166"
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".
Madam President, ladies and gentlemen, I would, first of all, like to thank Mrs Grossetête, the rapporteur for the Committee on the Environment, Public Health and Food Safety, and to congratulate her on her report. I also want to thank the members of the committee for supporting this proposal. I would also like to emphasise the committed work of the Austrian Presidency in connection with this matter.
The Commission believes that a further thorough scientific analysis of these issues is necessary, before we decide on possible measures. The Commission therefore plans to ask the European Agency for the Evaluation of Medicinal Products for an opinion on the use of such substances as auxiliary agents in medicinal products for human use. This opinion will be forwarded to the European Parliament and to the Council. Within six months of the delivery of the opinion, the Commission shall inform the European Parliament and the Council about the measures that it plans to put in place.
I have given a declaration to this effect to the Secretariat of the European Parliament so that the wording can be published and made accessible to all Members.
By way of conclusion, allow me to stress that this regulation is a good example of better lawmaking, one that does equal justice to the aims of safeguarding public health and promoting innovation. This is one of the Commission’s first legislative proposals that is based on a detailed impact assessment.
The proposal will improve health protection for our children and it will simultaneously promote innovation and competitiveness in the European medicinal products industry. I am grateful for your support of this proposal.
Thanks to the constructive cooperation between the three institutions we now have the opportunity to bring this legislative procedure to a close. We must be reticent about making new laws, but this proposal is necessary. In the European Union today, more than half of the medicinal products given to children have never been tested for this usage. The reason for this is that paediatric medicinal products frequently only have a tiny share of the market and clinical testing can be very expensive.
In practice this means that a doctor who prescribes a medicinal product for a child does not always know if it works at all or whether it could have any side effects. With the new Regulation this problem will be solved in the interests of children. It creates incentives for first-class research in this field and promotes the development and licensing of high-quality, effective medicines for children.
I would like to emphasise two items which were raised in this Parliament’s discussion. Firstly, the influence of the so-called Transparency Directive and, secondly, the treatment of substances that are carcinogenic, mutagenic or toxic to reproduction.
The European Parliament was quite right to point out the significance of the Transparency Directive. I agree with you wholeheartedly that the decisions of national authorities on the price of paediatric medicinal products and on the reimbursement of costs in connection with these must not lead to the availability of these products being delayed. Decisions about pricing policies and reimbursement of costs are the responsibilities of the Member States. However, the Commission cannot accept any deviation from the procedural rules laid down in the Transparency Directive.
We have therefore intensified our efforts to scrutinise more thoroughly the proper execution of the Directive in all Member States and to ensure that it is more effectively enforced. Furthermore, I have established the Pharmaceutical Forum together with my colleague Mr Kyprianou. Working in partnership with Member States and concerned groups, this framework is intended to provide solutions to urgent questions relating to the medicinal products sector, including among other things aspects of price and reimbursement.
The European Parliament has also raised the important question of substances that are carcinogenic, mutagenic or toxic to reproduction. I share your judgment that we must be extremely careful in dealing with such dangerous substances in all areas. Nevertheless I believe that the amendments – which, together with this Regulation, aim at prohibiting the use of such substances as auxiliary agents in medicinal products in general – are problematic for two reasons.
Firstly: the regulation on paediatric medicinal products can only regulate the auxiliary agents in medicines for children. However, the rules governing auxiliary agents should be identical for all medicinal products.
Secondly, we cannot rule out the possibility that – precisely for certain important medicinal products – such auxiliary agents are indispensable."@en1
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