Snelle Europese toelatingsprocedure voor levensreddende medicijnen bij epidemieën (en)

The European Commission has decided to speed up the authorisation of newly developed drugs for life-threatening diseases under strict conditions.

Under current rules, it takes 10 years from the discovery of a new medicine to its introduction on the market. This might be too long for patients suffering from life threatening diseases. New medicines are also needed at short notice to respond to emergencies like bioterrorist attacks or an influenza pandemic. In order to ensure that new treatments reach patients faster, the European Commission has decided to speed up the authorisation of newly developed drugs for life-threatening diseases under strict conditions.

These new Commission rules will maintain high safety standards, while allowing patients with unmet medical needs to receive new treatments earlier during product development. The new rules will allow medicines to enter the EU market using a so-called `Conditional Marketing Authorisation' which will be valid for one year and which legally binds companies to complete studies to confirm the medicine's safety and effectiveness.

Commission Vice-President Günter Verheugen i responsible for enterprise and industry policy said: "Our initiative can make a real difference for patients suffering from life threatening diseases for which no treatment exists. The new authorisation procedure can only be used under strict conditions so that safety is not endangered."

Prior to a medicine being authorised it has to undergo extensive studies to ensure that it is safe, of high quality and effective. Sometimes patients have such serious diseases for which no treatments are available that it is necessary to grant marketing authorisations on the basis of less complete data than is normally the case, thereby getting medicines to patients quicker. There are many serious or fatal diseases which today do not have effective treatments: if an effective treatment can reach the market a year or two earlier then this can save lives and reduce suffering. These new `conditional marketing authorisations' will only be granted if, in the judgement of the expert committee which advises the Commission on medicines, the benefits of the medicine outweigh its risks and, furthermore, the benefits to public health of the immediate availability of the medicine outweigh the risk inherent in the fact that additional data are still required.

Medicines eligible for Conditional Marketing Authorisations are medicines for seriously debilitating diseases or life-threatening diseases, medicines for use in emergency situations as well as medicines for rare diseases (so-called orphan medicines). Under careful controls public health protection will be maintained by ensuring that further studies are completed, submitted, assessed and acted upon, to confirm the medicine's favorable benefit risk profile. They also ensure that the medicine is very closely scrutinised by the regulators once on the market.

This regulation will also stimulate innovation in pharmaceuticals by allowing return on investment earlier during product development and before the total cost of product development has been expended. This reduces the upfront costs of product development and by allowing earlier return on investment, reduces the costs of capital and hence total development costs.

The Commission has been working intensively with the Member States, the European Medicines Agency (EMEA) and the World Health Organisation to ensure preparedness for any possible future influenza pandemic. Conditional marketing authorisations will add an additional tool to the measures in place to authorise medicines, including vaccines rapidly in the event of an influenza pandemic.

Background

Article 14 (7) of Regulation (EC) No 726/2004 directs the Commission to adopt a regulation on the provisions for granting Conditional Marketing Authorisations for applications submitted via the centralised (Community) procedure.

More information:

On the regulation of medicines in the EU in general and specifically to access the regulation on Conditional Marketing Authorisations:

http://pharmacos.eudra.org/F2/home.html

On influenza and pandemic preparedness:

http://europa.eu.int/comm/health/ph_threats/com/Influenza/influenza_en.htm