Press release

EP vote should mean more medicine development for children

Public health - 01-06-2006 - 18:02
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Incentives for drug firms to develop child medicine

It will be easier for pharmaceutical firms to develop infant medicines after the Parliament vote today, aimed at ending the current situation, under which most children take small doses of medication developed for adults, which may not correspond to their metabolism and can even be harmful. Drug companies which develop effective and safe tests for paediatric medicine will receive a six-month patent extension. Only those firms meeting strict standards will be allowed to market infant medicine.

"This regulation which is in favour of paediatric medication is a concrete response to various expectations. This text shows how much Europe influences day-to-day life. A single Member State alone does not have the means to promote such a policy in favour of all children", the rapporteur Françoise GROSSETÊTE (EPP-ED, FR).
The law will cover medications currently in development and not yet authorised, authorised medications covered by patents as well as authorised products that are not covered by intellectual property rights. Pharmaceutical firms will have to present a "paediatric investigation plan" (a research and development programme aiming at guaranteeing the necessary data for those who require paediatric treatment). Two obstacles are therefore avoided: the lack of information concerning the dosage - which increases the risk of side-effects and even death - and ineffective treatment due to a reduced dose.
Parliament was keen to enforce the "Paediatric Committee" members' independence, a scientific committee which works at the heart of the European Medicines Agency. Parliament specified that its members should not "have financial or other interests in the pharmaceutical industry which could affect their impartiality, should undertake to act in the public interest and in an independent manner, and should make an annual declaration of their financial interests" and that their opinions will be made public.
Between two and three years after entering into force the "Paediatric Committee" will draw up an inventory of therapeutic benefits in order to determine research priorities.
Where the development of medicines for children could hamper the development of medicines for adults, MEPs in the committee wish to allow "justified derogations" from the requirement, proposed by the Commission, for firms to present the results of paediatric studies at the same time as human pharmaco-kinetic studies in adults.
To avoid being dependent on decisions by national authorities concerning the setting of prices for medicines or their inclusion in national health insurance schemes, products for which paediatric data is supposed to be submitted but which have received marketing authorisation in all Member States will be granted a 6-month extension of the Supplementary Protection Certificate. 
Parliament approved a transitional clause which states that, for five years after the regulation enters into force, "the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry" of a Supplementary Protection Certificate.
A special logo will be affixed on medication boxes which benefit from a paediatric guideline. Based on a recommendation by the Paediatric Committee the European Commission has one year to choose a symbol.
Entry into force 1 January 2007.
REF.: 20060530IPR08575