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Benefits and risks discussed at the EFPIA Patient Think Tank

The European Federation of Pharmaceutical Industries and Associations (EFPIA) Patients’ Think Tank convened on 1 July 2014 in Brussels.  A key item on the agenda was benefit-risk - This session started with a background presentation from Yann le Cam, Chief Executive Officer of EURORDIS.

The current regulatory framework defining risks and benefits is expensive and slow. The Innovative Medicines Initiative (IMI), Europe's largest public-private partnership is exploring a Call that would include benefit/ risk modelling.

“Patients have played an important role in shaping regulatory decisions and risk management plans in the past. We are not starting from a blank page and there is a clear need for patient engagement in this field. However patient advocates need information and support to be able to contribute their unique expertise to   these discussions. This is where the European Patients’ Academy, EUPATI, can play a role”, said EPF Executive Director Nicola Bedlington.

The European Medicines Agency’s analysis of patient input to protocol evaluation suggested that we have made significant contribution in more than 50% cases. Although the role of patients is accepted in principle, this evidence base is too thin to create a platform for good practice dissemination. It is therefore crucial to have additional studies that address the benefit of our involvement in decision-making and underpin its importance to regulators.

Also on the agenda of the Think Tank was the Patient Access Partnership (see previous article). Think Tank members highlighted that this topic is a complex issue that needs also to include psycho-social access barriers. The concrete metrics of inequality in driving EU action on cancer could be used as a model going forward.

On 16-17 October, EFPIA and the Pharmaceutical Research and Manufacturers of America (PhRMA) will host a healthcare summit in Brussels with representatives from patient organisations, co-organised by the EFPIA Patient Think Tank. 

For more information, please contact EPF Executive Director Nicola Bedlington at nicola.bedlington@eu-patient.eu.