A new approach for the benefit-risk assessment of non-prescription medicines

Objectives of the Conference

In the context of an ageing population and social security systems that are already under a lot of pressure, self-care is bound to play a much more significant role in the future and respond to patients’ growing aspiration to be empowered. However for this to happen, self-care should be given the latitude to fulfil its promises. The number of active pharmaceutical substances available to the public without a medical prescription has been growing quite slowly over the last years with a pace varying from one country to another. In addition, some well established ingredients have been scrutinised and some have even been withdrawn from the market or were reverted to prescription status.

There are concerns that this will lead to a reduction of consumer choice and, in the end, to fewer possibilities to practise responsible self-care. In the whole pharmaceutical sector considerable efforts are underway to come to a more coherent benefit-risk assessment. A benefit-risk modelling project was initiated by the European Medicines Agency and is expected to deliver concrete results in 2012. Complementing and building on these activities, the self-medication industry has on the global level commissioned important research aiming at reaching consensus on a more adequate benefit-risk assessment for non-prescription medicines.

The research is expected to be published in early 2012 and will be the basis for a wide range of discussions withall stakeholders interested in non-prescription medicines. The workshop in Copenhagen will provide a unique opportunity to discuss the results of this important research with the Heads of the EU Medicines’ Agencies and to look at new proposals for an adequate benefitrisk assessment of non-prescription medicines.  The workshop in Copenhagen, organised under the Danish EU Presidency, is the  5th AESGP conference held in conjunction with the Heads of EU Medicines Agencies.

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