Conference Presentation, Panel
What Does Brexit Mean for Health Care and Medical Research?
Milken InstituteAisling Burnand, Pierre Meulien, Isabelle Moulon, Margaret Anderson, Annalisa Jenkins
- The biomedical research ecosystem is projected to undergo a "real revolution" driven by the convergence of deeper biological insights and new technologies, specifically leveraging adeno-associated viruses to deliver human genes to hepatocytes for curing rare liver disorders, haemophilia, and metabolic conditions.
- Capital and risk equity are expected to continue flowing into the sector, facilitating unprecedented global collaboration and an externalization of innovation from big pharma as internal capacities shrink, with a prediction that 17% of new market medicines will originate from academia supported by political willingness in Europe.
- A strategic shift is anticipated where the industry moves from prioritizing scientific outcomes to focusing on patient and carer outcomes to satisfy regulators and payers, with efforts to bring Health Technology Assessment (HTA) bodies on board early to shorten time-to-access and integrate regulatory requirements during drug development.
- The sector foresees a reframing of research to place patients at the heart of the process, involving them early in discussions rather than as an afterthought, with expectations that the FDA and EMA will continue to require patient voices in decision-making to balance benefits and risks.
- Significant advancements in data utilization are expected, including the integration of "big data" and "real-world data" from healthcare systems, the joining of 60 million UK patient records, and the inclusion of imaging, ICT, and med-tech companies in initiatives like the Innovative Medicines Initiative (IMI) to accelerate innovation.
- Specific financial and structural plans include the UK government's articulation of an additional £2 billion for research, the growth of venture philanthropy models like the Dementia Discovery Fund from £2 million to at least $100 million, and the development of fiscal incentives to promote collaboration across public and private sectors.
- The UK research community expects to thrive if government and ecosystem collaboration aligns on plans for the "next couple of years" to secure a good future over the "next 10 years," while maintaining the Ludwig Institute and Oxford University partnership as a model for preserving financial capital and human capital.
- Despite political changes, the ecosystem is expected to remain collaborative, with over 800 employees in London continuing to regulate medicines and therapeutics in Europe, and the IMI maintaining "business as usual" to encourage continued UK participation in programs.
- Collaboration is expected to advance faster in certain European countries than others, with efforts to evolve Brexit into a "mechanical way" to change systems rather than a cultural block, ensuring that strides in rare disease research and orphan drug legislation are not undone.
- Patient advocacy groups and charities are expected to reshape research strategies by providing scientific excellence and community connections to help investors fund more effectively, while also being encouraged to ensure they are innovative enough and connected to broad networks.
- Concerns remain regarding the lack of a collective agreement on the "science of patient input," which could make it difficult for companies, organizations, and regulators to adhere to new standards, and the healthcare system is described as slow and challenging due to post-austerity funding constraints.
- Future progress relies on the "pre-competitive" engagement of senior leaders and the alignment of goals to build efficiency, with the expectation that the regulatory environment must "build the plane as we fly it" due to the continued pace of innovation, though optimism exists that "some amazing progress" will be evident within one year.