Moving beyond the existing regulatory paradigm
How can the regulatory system adapt to encourage the
development of innovative new medicines and technologies that deliver real value to patients in an increasingly cost-sensitive environment?
These were the challenges that an invited group of leading regulatory thought leaders, academics and patient advocates explored at the TOPRA Summit on 26 May 2016 in London.
Sophisticated new technologies and scientific tools offer faster, more effective drug development at a time when there are more promising new molecules in the pipeline than ever before. On the downside a challenging economic climate and increasing demand from an ageing population are focusing payers of healthcare on cost.
Patients and consumers are increasingly driving the healthcare agenda insisting that their voices are heard at all stages of medicines development so that endpoints, outcomes and quality of life reflect their needs.
Against this challenging backdrop, attendees debated issues across the medicines regulation spectrum agreeing that there is now an opportunity for some ‘blue-sky thinking’. The issues raised and how they could be tackled in order to re-design the drug approval process, facilitate collaboration, and improve communication and competences are outlined in our discussion paper.