06 Sep 2019
How life sciences regulation will save lives in 2025
Right now, life sciences regulation is like a sled pulled by a hundred cats: too many disparate parts going in different directions. It’s struggling to keep up with the ever-faster pace of change in medicine, science and technology - which means it’s struggling to protect patients’ safety.
However, a new report by the Deloitte Centre for Health Solutions shows that regulation in the life sciences industry is on the brink of a revolution. They predict that developing technologies will enable regulators and industry to work collaboratively to create the best, most innovative outcomes for patients.
They’ve made four optimistic predictions for 2025, designed to call industry leaders to action and make them come true. Here’s how regulators, industry and patients might behave after the regulation revolution.
Life sciences regulation in 2025
One regulatory world – Canada and the US have already harmonised their regulation, and regulators in South East Asia, Australia and APAC are moving to do the same. Regulation in 2025 could be nationally and internationally aligned, with regulators sharing data across the world and getting all the benefits of working collaboratively using co-regulation and self-regulation.
Win-win collaboration between industry and regulators – In 2025, regulators and the life sciences industry will be working closely together and sharing data in real time. Regulators will have an outcome-based approach that’s data-driven and segmented - and they’ll be able to automate whole chunks of their reporting. This is already happening - the FDA has launched a programme to assess software technologies for safety and effectiveness without hindering patient access, and the EMA has opened a portal where developers can consult simultaneously regulators and health technology assessment bodies.
Faster approvals and risk assessments with new data-driven approaches – New evidence frameworks will be created based on data collected outside clinical trials. The origin of data submissions could be verified using blockchain - the same technology that drives bitcoin. The FDA is already supporting innovations like these with its 2018 guidelines on modernising oncology trials and its use of bio markers.
A productivity revolution driven by tech – AI, natural language generation, robotic process automation, and other futuristic technologies will be an everyday part of clinical trials and streamline processes. This will free up regulators to focus on the tasks only humans can do - making decisions, taking action, and getting reviews and feedback done faster.
Can this really be done?
Short answer: yes. There are concrete steps regulators and industry can take to make this positive future a reality:
- Develop more effective and efficient processes and systems
- Acquire new skills and talent
- Learn to use new technologies more effectively
The regulators of 2025 will have a very different skillset and engagement strategies. Patients will be fully engaged in designing regulations.
Life science companies too will need to adjust their attitude to regulation to create a new, industry-wide collaborative culture. They’ll need to be truly patient-centric and step up to become full strategic business partners for the regulators instead of back-office enablers.
It’s going to take hard work, but the reward will be more lives saved and more quality of life for patients.
More importantly it is going to take great people to undertake these roles. And this is where we step in……..