Elisabeth Barlow, Innogen Communications and Policy Officer
For new technologies, policy makers are facing demands to devise and adapt regulatory systems before there is evidence on the nature of future products and processes, potential markets, or the benefits and risks to different stakeholders. They are facing a major challenge in meeting these demands without unnecessarily inhibiting innovation. This session brought together some of the leading voices in this area to discuss methods for improving the success rate of delivering life science products and processes that are both societally useful and commercially viable.
Based on a perspective from patients and families with rare diseases, Alastair Kent (Genetic Alliance UK) kicked off the session with a clear account of what a new regulatory framework could look like. Traditional regulatory decisions have been based on the licensing of small molecules for the benefit of large populations, ultimately delivering blockbuster drugs to millions while not being overly beneficial to patients and families with rare diseases.
Therefore, a new framework for regulating is needed – one in which regulation follows biology, not one that tries to make biology obey the law. In order to bring about this framework, Alastair explained a series of steps are required, including: collapsing the phases; testing using real world data; using patients as a resource; and utilising social media to spread to word and gather data.
Innogen’s Scientific Advisor, Joyce Tait, followed with a discussion on upstream and downstream regulation, in particular the need to balance top-down regulation of products and processes with bottom-up engagement and dialogue with stakeholders while maintaining a democratically governable system.
As Joyce explained, there is a need for smart, adaptive governance of innovative technology with both upstream and downstream components, including: regulation that can be modified in line with changes in risk assessment; recognising regulation’s role in constraining and enabling innovation; balancing the risks and benefits to people and the environment; balancing the interests and values of ALL relevant stakeholders; and being explicit about political influences on policy decisions.
Moving on from Joyce’s discussion, Ed Godber (GlaxoSmithKline) took the session to a more economic level. As he explained, fundamental changes on the demand and supply side for life science innovation are leaving the current system of regulation and public sector investment exposed. Ultimately, the rules that applied well to the era of blockbuster drugs and now having a distortive effect, and we are paying a penalty for not having a more adaptive, localised and collaborative model of regulation.
As a result, cultural productivity is critical to the life science model, including: patient accountability beyond consumer health; personalised outcomes vs personalised medicine; rule transparency in regulation; and remission from flare-ups in industry ways.
Alessandro Rosiello (Innogen Edinburgh) continued in the economic vein and concluded with a consideration of the effect of various factors on drug development performance, including R&D funds allocation across therapeutic areas and the proportion of biological molecules in the drug development portfolio. Ultimately, the empirical data from these factors has shown that a correlation exists between performance variables and the per-capita growth of biopharmaceutical firms’ revenues – an analysis that will hopefully be widely applicable across sectors.