Healthcare system reform
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Scenario wherein the healthcare system is more integrated, shorter lines between pharma, medicine, insurance companies
Developments in time
2010-2015
At the end of first decade of new millennium, innovation in the healthcare system is primarily dominated by multinational companies. Regulators had generally seen their role as being limited to that of framing regulations to deal with potential safety and efficacy issues, and ensuring compliance with these regulations. Around 2010 after the 2008 financial crisis, instead of seeing themselves as passive responders to events, regulators began to see their role in a much more proactive way. In line with “new governance” agendas and linked to globalisation initiatives, discussions began to take place within regulatory bodies about their role in stimulating changes in the processes and outcomes of health care innovation. The challenge addressed was to ensure the continued safety, quality and efficacy of new drugs but to do this within a system that was responsive to the new challenges being presented by life science innovation. There was a profound shift in the perceived nature of the problem of the failure rate of new drugs in Phase 2 and particularly Phase 3 clinical trials. This had been seen as a failure of industry innovation models but began to be seen more as a mismatch between: - the nature of new biotechnology innovations; - the nature of the companies that could best exploit these innovations; - public and patient expectations of new drugs and treatments; and - regulatory systems that were designed around 20th century models of drug development. The new regulatory approach that began to emerge required creative and constructive thinking from senior managers, regulators and analysts in life science and ICT industries, along with an enthusiasm for collaboration across non-traditional boundaries.