Regulatory speed & agility

Over recent months industry and regulators everywhere have become animated with a sense of urgency as the era of Artificial Intelligence (AI) breaks through into the public consciousness with the advent of large language models.

With the flood of data advancing and generating at unprecedented speed, regulation is what stands between the best of AI’s potential on the one hand and the safeguarding of society from its potential imagined harms on the other.

AI also holds a lot of promise in R&D and healthcare system efficiency. As with AI, timeliness and urgency are also relevant with the regulation of medicines on their path from the laboratory to patients in clinical care: Speed and agility matters. It is implied also in the founding vision of the WHO (1948) in which regard for health as a human right puts an obligation on nation states to ensure access to timely, acceptable, and affordable health care.

Whatever stake we hold in the complex map of a healthcare system, be it as patients, families, startups, industry, regulators, or payors, we share the same goal. We work to bring innovative diagnostics, medicines, and healthcare solutions that address patient needs to communities and society at a pace that is dynamic and efficient. Because patients with unmanaged or terminal diseases do not have the luxury of time. Similarly, innovators are also time bound, with a fiduciary duty to deliver returns to owners while securing the funding to reinvest in the next wave of scientific progress and innovation.

Yet, while speed and agility matter, we must also ensure the effectiveness, safety, and quality of healthcare innovations. All steps of the development process, and indeed beyond, are highly regulated. To this end, in Europe, the European Medicines Agency (EMA) fulfills its mission through clear mechanisms that support developers right along the lifecycle of a medicine or therapeutic advancement, from preclinical phases to post market oversight of the product in clinical practice.

Dialogue tools such as scientific advice, protocol input, parallel scientific advice with Health Technology Assessment bodies (such that the totality of evidence requirements can be agreed upon early on), all support efficient processes. Such mechanisms are essential for innovators to address the regulatory uncertainty that is inherent in the development of healthcare innovations: A Regulatory environment that rapidly creates certainty on the acceptability of data and study designs reduces R&D attrition and costly failure rates. Such regulatory input helps clarification and overall ecosystem efficiency. Regulation of medicines has in this way a material impact on the vitality of the innovation environment and its competitive standing globally.

Timelines are a lead indicator of regulatory speed and agility. And regulatory speed and agility  are at the heart of what enables innovations to emerge from R&D, enter into clinical practice, and help patients. Over the past several years EU timelines on the delivery of novel medicines to patients are lagging compared to most other major agencies, despite clearly defined pathways and dialogue mechanisms.

The reasons for delays are multifactorial, e.g. products combining drugs and devices, first-of-a-kind products for which the regulatory pathway is as yet unclear, or differing assessments of data requirements. Furthermore, in Europe, regulatory decisions are stratified across EU and Member State levels, a governance reality, which adds further process to timelines.

Major regulatory authorities are constantly developing and enhancing their regulatory tools to best guide innovators. As the development of medicines is global, an EU framework that works with speed and agility is essential to Europe’s contribution to international initiatives, its influence on global regulatory trends, and to ensuring the EU sustains pole position / on the first wave grid in filing considerations.

All major agencies have for example expedited strategies to shorten the development and review timelines of the most promising innovative products towards unmet medical needs. The however EMA does not take full advantage of its own tools in this regard. Its ratio of expedited to standard review pathways stands at a low level of 10% relative to 71% at the FDA. 

The slowing regulatory pace, combined with the complexity of the EU system, has led to a decrease in the attractiveness of the European location for clinical trials with fewer trials now conducted in the region than in the past.  This erosion trend in clinical trials risks the significant advances made in healthcare in general, and most recently, the urgency with which health system actors were collaboratively able to resolve the COVID crisis in particular. 

The draft EU General Pharma Legislation reflects the disquiet with these timeline disparities, and makes robust commitments to address them, which we welcome at Roche.  The trimming of EMA assessment times from 210 days to 180, and the European Commission’s authorisation time from 67 days to 46 are a real step forward when the proposals are implemented as drafted. Likewise welcome are the simplifying of the EMA committee structure, and streamlining of expertise based decision making.

If we cast an eye to the future, the plethora of innovations coming out of industry pipelines in the coming years will diversify and complexify to a greater degree than ever. The value emerging from the convergence of digital and biological revolutions of the past couple of decades is advancing also in healthcare. And the range of product formats entering regulatory assessment will be demanding. 

Twenty five (25): This is the number of technological trends in healthcare that the EMA identified in partnership with the World Health Organization (WHO) and the European Commission’s Joint Research Centre’s (DG JRC) in an horizon scanning exercise in 2022. The trends provide the EU regulator’s perspective on what it considers to be the innovations to come and for which they themselves need to prepare.

Several of the trends are aligned to work in progress at Roche across our innovation engines, including the Internet of Medical Things (IoMT) and Artificial Intelligence (AI), each with potential applications across all of R&D and the patient’s journey with their condition, from diagnostics to post-treatment checks; digitalisation and telemedicine, with potential to facilitate data exchange and analysis, to complement traditional clinical trials; computational omics profiling, to help unravel the multiple determinants of a disease, and personalized medicine, shifting from “one size fits all approach” to addressing genomic changes at the molecular level, and for which new regulatory approaches are needed.

Europe already faces complexity with the implementation of the In Vitro Diagnostics Regulation as it relates to medicines in clinical trials, which affects R&D and ultimately patient access to solutions. Future and more complex integrated healthcare solutions, drawing on several frameworks (including new ones such as AI, Substance of Human Origin), will face further complexity at interfaces.  

Each component of an integrated solution may fall under a different regulatory definition, framework or procedure with oversight by different public and private bodies. Developers must navigate a fragmented and overly complex system when developing and seeking regulatory review for these products. To harness the potential of integrated solutions and to keep pace with the rapid advancement of science and technology, it is crucial EMA plays a leading role in orchestrating modern, streamlined regulatory approaches and procedures with all relevant authorities, bodies and stakeholders necessary in order to deliver these innovations to patients more quickly.

Bridging the innovation regulation gap

Regulation and innovation are in dynamic interplay: Regulation impacts innovation and advances in science and technology inform regulation. We also welcome the EC General Pharmaceutical Legislation’s introduction of a sandbox mechanism to test the innovations of tomorrow, those that have not yet surfaced or are as yet, only formative.

This will help futureproof the EU operating environment and foster innovation. However, to enable the full potential of the sandbox approach for integrated solutions, it needs to expand beyond pharmaceuticals towards devices and in-vitro diagnostics as well. Regulatory science, methodologies, practices and decision-making cannot be set in stone, and need to always have room to evolve and absorb what comes next, underpinned by rigorous evidence within a clarifying framework.

While speed and agility is essential, having the right resource is crucial. As we proceed with the consultation and formalisation phases of the legislation, it is imperative that the commitments that will improve regulatory speed and agility are upheld. The commitments must be funded and expanded so that the EMA can deliver on its mission also in future, with the breadth and depth of skills required and when necessary, new capabilities acquired, to do so.

As we look to the future of healthcare, the need for specialised resources to assess the growing momentum of differentiated products becomes imperative. Scientific advice, e.g. joint consultations, also in the preclinical phase, can help. But the EU General Pharmaceutical Legislation’s phased review path falls short of rolling /dynamic reviews, and this is a missed opportunity to pave the way to the practices of the future, including leverage of the EU’s own digital transformation strategy.

The innovation regulation gap was never starker than across the digital transformation of the past 20 years and training of AI on healthcare challenges will only increase demands. We invite dialogue as the means to address assymetrical information issues (innovator-regulator having unequal knowhow) to enable decisions on an informed basis. Fit-for-purpose resourcing is needed for each of today and tomorrow’s healthcare product flow, and the urgency is as tangible as the pace of change is breathtaking.

Attention to regulation is increasing across sectors and regions. Regulators and policymakers are also innovators and developments such as the ILAP in the UK, the European Health Data Space in the EU are being followed with interest, as are Project ORBIS led by the FDA.  Regulatory reliance also continues to gain traction, informally during COVID, but also across more formalised work sharing groupings, such as the ACCESS consortium and as an early pilot of the African Medicines Agency. The global trend, also with resource optimisation in mind, is towards working together.  For mature markets regulation is increasingly viewed as a marker of fair market economy policies and conditioner of economic vitality. 

In conclusion, in meeting the needs of patients and society for high quality, safe and effective medicines, regulation must be balanced with optimising the operating environment to stimulate, foster, and value innovation. Predictable, yet agile frameworks that can absorb new product formats and combinations allow for long term investment, reducing uncertainty. 

The EU review of the General Pharmaceutical Legislation is a once in a generation opportunity.  The decisions made in the coming months and years, including on the role of EMA, and separately its increasingly specialist resource requirements, will have lasting implications for patients, for health systems, for society, and also for the dynamism of the biopharma industry in Europe, for decades to come.


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