The life sciences industry operates in an increasingly complex regulatory landscape. Over the past few years, the industry has seen a proliferation of regulatory changes, with a plethora of new regulations due to come into force over the next few years.
At the same time, regulators face the challenge of continuing to protect patients and enhance public health, while fostering innovation by responding quickly and effectively to the exponential pace of change in medicine, science and technology.
Deloitte’s Centre for Health Solutions and Centre of Regulatory Excellence for Life Sciences have published numerous reports on these challenges, with insights drawn from primary research, literature reviews and our experience working with relevant stakeholders across our global network. This new report draws on our combined expertise and insights to take a novel view of the Future of Regulation in 2025.
In this report we imagine a new paradigm, where life sciences companies and regulators work collaboratively, stable and predictable regulations are seen as an enabler rather than a barrier, and disruptive technologies and new generation treatments are used more effectively to improve outcomes for patients. While there is of course a range of alternative scenarios, including a world where there is little collaboration and an antagonistic, restrictive and punitive approach to regulation, the evidence available today suggests that the more positive and optimistic outlook is what regulators and industry are striving to achieve.
However, achieving this more positive vision of the future and delivering better outcomes for patients will require regulators and the industry to: develop more efficient and effective systems and processes; acquire new skills and talent; and deploy new generation technologies more effectively. Indeed, the skill set and engagement strategies of regulators will look quite different from today, and life science companies will need to re-programme their regulation mind-set to create a new, more collaborative environment that drives a culture change across the industry. This is a future in which patients are fully engaged in designing regulations, companies are truly patient-centric and the regulatory function of each life science company has moved from being a back-office enabler to a strategic business partner.
Today, our industry finds itself facing a regulatory gap, where regulators struggle to keep pace with technological and other innovations. Drawing on our combined expertise in working with regulators and the regulatory functions across industries, we have developed four bold and optimistic predictions of what regulation in the life sciences industry might look like in 2025. Each prediction, brought to life by imagining how regulators, industry and patients might behave in this new world, is underpinned by trends, events and examples in 2018 that, if adopted more widely, paint a picture of a regulatory system that is very different from today.
We hope this report stimulates rich dialogue and prompts a move to action.
Deloitte Centre for Health Solutions
Centre for Regulatory Excellence