By Karen Taylor, Director, Centre for Health Solutions
Following our 2014 and 2017 Life Science and Health Care Predictions reports, ‘A bold future?’ and ‘The future awakens’, this week we launched our third predictions report, A bold future for Life Sciences Regulation: Predictions 2025. This year’s report presents an unashamedly optimistic view on what Life Sciences regulation might look like in 2025 if both life science companies and regulators were to work more collaboratively, embrace disruptive technologies, and acquire new skills and talent. We argue that this would improve not only the productivity of the regulators and industry but also provide patients with access to the latest medical innovation much sooner. We also imagine through a series of ‘portraits’ how a regulator, company and patient might behave in 2025. This week’s blog provides an overview of the four predictions presented in our future of regulation report and examples of the evidence today that enable us to predict a bold future for life sciences regulation in 2025.
Our four predictions for 2025
1. Regulators are globally aligned and coordinated
In 2025, regulation has been aligned at both a national and international level, with regulators around the world benefiting from more collaborative approaches such as co-regulation, self-regulation and international co-ordination. This approach has encouraged innovation while protecting consumers from potential fraud or safety concerns. As life sciences companies have continued to expand into multiple jurisdictions, increasing the number of multinational trials, regulators have acknowledged the benefits of regulatory convergence in speeding up the process of getting products to market around the world. The EMA is of course, already a model in collaboration between EU member countries. Other examples of regulatory convergence happening today include:
- since 2011, the Canada-United States Regulatory Co-operation Council has been streamlining regulation in both countries through the sharing of inspection schedules and using the Common Electronic Submission Gateway as a platform for the life science industry to send information to both the US FDA and Health Canada at the same time.
- founded in 2014, APACMed brings together local industry associations, multinational, pan-Asian and local corporations, and innovative start-up companies to address the specific challenges of a heterogeneous health care landscape in Asia Pacific.
2. Regulatory relationships are based on a ‘win-win’ approach
In 2025, regulators, patients and industry work closely together, sharing ‘real-time’ data to enable faster review and feedback. Regulators have created a digital platform for more ‘self-regulation’ moving the management of risk closer to those affected by it. Regulation is outcome-based, data-driven and segmented, using advanced analytics to detect new patterns and trends, to ensure that products are safe, effective and personalised. Industry has responded by creating its own regulatory pathways, while also acquiring the skills and talent needed to improve its collaboration and negotiations with regulators. Examples currently occurring include:
- in July 2017, the EMA introduced a single gateway for parallel consultations between the EMA, the European Network for Health Technology Assessment (EUnetHTA) and health technology assessment (HTA) bodies. The aim is to help developers generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies.
- in July 2017, the US FDA’s Precertification programme is a regulatory framework which assesses the safety and effectiveness of software technologies without inhibiting patient access to these technologies. The ultimate goal is for industry to lead the charge and ‘self-regulate’ the technologies that they are looking to bring to market. Nine companies have been selected to be on the programme, with the end goal that ‘Pre-certified’ companies should be able to enter the market faster.
3. Regulators successfully balance rapid assessment of innovation with real-time regulation
In 2025, regulators now expect real-world evidence (RWE) to support decisions for approving new drug applications (NDAs), label expansions and revisions. The increasing reliance on data collected outside the controlled environment of clinical trials has led to the creation of new evidence frameworks and the development of new skillsets and capabilities within regulatory bodies. RWE has allowed industry to address evidence gaps, resolving a number of issues that had previously proved difficult to address in randomised control trials (RCTS) and post-launch surveillance. This, together with significant advances in biological data and computing power, has resulted in the regulatory approval of treatments for numerous rare diseases and conditions that had previous proved elusive, like dementia. An examples of this happening today is:
- in June 2018, the FDA announced the introduction of new scientific domains into the development and review process. These domains include the widespread use of modelling and simulation, greater use of RWE in the pre- and post-market setting, and the adoption of better tools for assessing real-time safety information after products are approved. The initiative also aims to engage sponsors, disease specialists, academic researchers and other regulatory agencies earlier in the development process.
4. A technology-enabled approach is driving the productivity and quality of regulation
Regulators and industry have both adopted next generation technologies to automate processes and help improve the speed and quality of regulatory oversight. Technology is enabling regulators to process the copious amounts of data from disparate sources to make better decisions and take regulatory action where there is a perceived issue with product safety or efficacy. Regulators and industry are working together more closely together, sharing ‘real-time’ data, enabling faster review and feedback on clinical trials. Examples today include:
- in July 2018, the FDA’s Center for Devices and Radiological Health has initiated a challenge for companies to develop new medical devices for managing pain, in order to tackle the opioid epidemic in the US. Selected developers will engage more frequently with the Agency throughout development and evaluation of their product, and the product will receive breakthrough device designation if it meets the necessary criteria.
- Intel Corp. has partnered with a number of life sciences companies to use blockchain to track and trace where drugs are falling out of the supply chain. Intel is also looking to use blockchain to tackle the opioid epidemic, by identifying when a patient takes out multiple prescriptions from various physicians. The system would work by pharmacies registering the issuing of a medication into a blockchain database once the prescription has been sold.
A bold future for life sciences regulation
Today’s regulatory environment is changing rapidly. This poses significant challenges for life sciences regulators who are striving to maintain a balance between fostering innovation, protecting patients and encouraging innovation.
Although we recognise that our four predictions are an optimistic view of what the life sciences regulatory landscape might look like in 2025, we contend that the vision it presents, while ambitious, is achievable. However, this will require regulators and industry to embrace the following three key enablers:
- wide-scale adoption of new digital and cognitive technologies.
- recruitment and retention of new skills and talent.
- streamlined and agile regulatory systems and processes.
These enablers are critical for realising each of our predictions, and the speed of adoption will inevitably impact the pace of transformation.