MEP Interest Group on Brain, Mind and Pain

1. MEP Interest Group on Brain, Mind and Pain Aims to: Encourage research into and access to innovative treatments, promote prevention and self-management approaches, decrease stigma and work together to improve quality of life for people living with these disabling conditions. • Support patient-led campaigns to educate, eradicate stigma and raise awareness of neurological and chronic pain disorders • Support research into the development of innovative prevention and treatment options within a regulatory framework which facilitates equitable access to affordable therapies • Strengthen patient involvement in this research, and in policy-setting and decision-making • Implement relevant European social legislation to ensure appropriate support for people living with neurological and chronic pain disorders

2. Our Book of Evidence: The Challenges • For most brain, mind and pain disorders there is no cure, and for many we do not know the exact cause. • Only 8% of CNS drug candidates succeed (compared to 15% in other disease areas). • CNS drugs take longer to develop: late-stage clinical development takes one third longer than for other categories. • Diseases amongst most complex and least understood in medicine. • Analysis of research funding from 2005 revealed that the total spent on brain research in Europe was approximately €4.1 billion, of which 21% was public funding (government and charitable foundations). • For comparison, the US spent €12.5 billion on brain research, 42% of which was publicly funded. • European public funding was equivalent to just 0.2% of the cost of brain diseases per year (and industry funding a further 0.8%).

3. Our Book of Evidence: The Opportunities • Potential to make European trial design and regulation work more in the interests of patients and more attractive to pharmaceutical companies and medical device manufacturers. • Major opportunity for progressing research and accelerating clinical trials is the development of large pan-European disease registries. • Commission’s Expert Group on Safe and Timely Access to Medicines and the European Medicines Agency’s adaptive pathways approach, both aim to expedite access to new treatments in disorders with high unmet need. • Greater scope to incorporate patients’ views in the review and ethical approval processes, encourage patient participation in clinical trials, and ensure patients can access high quality information before and after clinical trials.

4. Patient-Public Involvement: Our Role The ‘Healthy Brain Healthy Europe’ conference led by the Irish EU Presidency in 2013 recommended the promotion of: “The role of patients in all stages of research and evidence-based healthcare… Patients need to be actively involved in the planning of research approaches, the execution of services and the maintenance of standards of healthcare.”

5. Patient-Public Involvement: Why most important in brain, mind and pain [BMP] disorders? • Most impactful symptoms and disease progress often cannot be directly measured: must be assessed using questionnaires or interviews with patients • Clinical scales against which outcomes can be measured are, therefore, limited. • For many disorders, regulators now require evidence that a drug/device changes the patient’s real-world functioning as well as improving symptoms. • In BMP conditions, where external markers of disease progress are often absent, this is a positive step which re-orientates drug development towards the most patient-relevant outcomes. • Secondary symptoms often more burdensome than primary/Multi-Morbidity

6. Aim of Today - To explore why we should involve patients in research - To assess how this can be done - To discuss how European Institutions can encourage and support this involvement