Françoise Grossetête (PPE-DE), rapporteur. – (FR) Madam President, Commissioner, ladies and gentlemen, I should like to thank all my colleagues for their contribution to this text and for their efforts to find a solution. I am also grateful to the Council and to the Austrian Presidency, which have taken note of the views of Parliament and given priority to the regulation of medicinal products for paediatric use. Finally, Commissioner, I should like to thank your staff for their technical input and recommendations. I was extremely pleased to work with them. Thanks to everyone’s efforts, we shall be able to approve on second reading a regulation of vital importance for health in Europe. We were unanimous as to the goal, and our discussions enabled us to reach agreement on the operational aspects of this regulation.

It seems inconceivable that, in 2006, our children do not have treatment tailored to their needs. However, this is the situation we have. Today, numerous medicinal products administered to children have not been developed specifically for them. Frequently, products used for the youngest children are the same as those prescribed for adults, with only the dose reduced – and with consequences that are sometimes catastrophic. A child’s metabolism is different from that of an adult. Children therefore need specific pharmaceutical forms, not only for better tolerance but also for greater effectiveness and safety.

This European Regulation creates all the conditions for the development of paediatric medicines, notably by supporting innovation and research and by creating incentives for pharmaceutical laboratories, while at the same time requiring them to develop a paediatric form for every new drug and to make it available in all Member States.

On a large number of points, the Council had already followed Parliament’s recommendations at first reading. I am thinking particularly of the system of incentives which extends by six months the Protection Certificate for all new paediatric indications. The Council had also accepted on first reading Parliament's request to avoid additional clinical trials being carried out on children where not absolutely necessary. On the eve of the second reading, only a few differences of opinion remained. A common position had to be found on technical details.

We therefore reached an agreement between the three institutions, largely through application of the 'better regulation' principle. I am thinking in particular of the question of the independence of members of the Paediatric Committee and the issue of pharmacovigilance. Earlier legislation already included robust measures on these points. It is therefore more appropriate to refer to that legislation rather than create an accumulation of rules. This agreement was also helped by the Commission's response to our demands concerning the use of potentially dangerous substances in the outer covering of the medicinal product. We welcome the official declaration submitted to us and now, of course, await concrete results.

There is one further point to which I should like to draw the Commission’s attention, namely the question of the period of time between the issue of a marketing authorisation and the availability of the medicinal product to patients. A directive exists on transparency, which establishes the deadlines for setting the price and for the reimbursement for medicines. The timing differences between Member States are too great. This is a situation which has negative consequences for patients. I have discussed this point with colleagues in all parliamentary groups and we should like to ask you what can be done to reduce these disparities.

Finally, the Commission’s initial proposal states that all requests for an extension of the Supplementary Protection Certificate resulting from a new paediatric indication must be lodged no later than two years prior to expiry of the certificate. I support that approach, but, above all, we must be pragmatic. By adopting this measure as it stands, we would stand the risk of depriving ourselves of medicinal products which, when this law entered into force, happened to be in this two-year period. Under the terms of this article, it would be impossible to conduct research in order to develop a paediatric indication.

The transitional clause we are proposing, with the agreement of a majority of my colleagues, is intended to remedy this undesired effect. We are therefore requesting that, for five years, any application for an extension of the Supplementary Protection Certificate as a result of a new paediatric indication may be lodged no later than six months before expiry of the certificate. After this period, the Commission’s initial proposal will apply. We should be grateful for your agreement on this point.

To conclude, this text provides the opportunity to match words with actions in supporting European research; that is what we shall do tomorrow. A great debate is currently in progress to find the best way of promoting Europe to our fellow citizens. Europeans are not interested in grandiose rhetoric – they expect action. This regulation on paediatric medication is a concrete response to that expectation. This text is a good example of the added value of Europe in everyday life, as no Member State acting on its own would be able to promote such a policy on behalf of all children.