Please note: this interview has been translated from Dutch to English

Regulatory innovation is crucial for pandemic preparedness. Indeed, it is vital to have medicines and vaccines available as quickly as possible without compromising on (knowledge about) safety and effectiveness. Since the COVID-19 pandemic, governments have been working at both national and European levels to better prepare for future pandemics. One aspect of the Dutch efforts is the ZonMw programme on legal pandemic preparedness. In 2022, this programme initiated four studies into regulatory innovation. Laurien Rook, policy officer at the Ministry of Health, Welfare and Sport (VWS), and Marlous Kooijman from FAST discuss the outcomes.

“We are currently translating the lessons from the COVID-19 pandemic into future strategies,” says Rook. “Within the pandemic preparedness policy programme, we focus on prevention, early detection, and of course, effective response to a pandemic. In such cases, it is essential that effective vaccines and drugs become available as soon as possible. Regulatory processes are an essential part of this.”

Kooijman adds: “At FAST, we aim to contribute to pandemic preparedness. Regulatory innovation is a crucial topic for us, regardless of whether a pandemic is ongoing or in the so-called ‘cold’ phase. We want to ensure that regulations and assessments align well with innovations in therapy development.”

Four themes

The recently finalized reports cover four topics from which significant regulatory challenges arise: drug rediscovery, pharmacovigilance, remote monitoring, and advanced therapy medicines. VWS commissioned the subprogramme, and FAST was involved in its setup and execution.

Drug rediscovery (repurposing) involves researching and repurposing existing drugs for new applications, such as against a new pathogen. The report suggests solutions to existing barriers for academic researchers and companies. A key recommendation for research into repurposed drugs during a pandemic is the need for more international coordination. Rook explains: “This aligns with our efforts to establish a network of clinical platform studies within Europe, where medicines can be quickly researched.”

Pharmacovigilance, monitoring adverse effects of a drug or vaccine, requires extra attention during a pandemic. Kooijman says: “When a large number of people receive a new vaccine or drug and there is considerable concern about safety, there is also a surge in data traffic to pharmacovigilance organisations like Lareb. How do you manage this, how can you analyse the data more efficiently, and how do you inform everyone about the results and combat misinformation?” The subreport indicates that, in addition to the spontaneous reporting system, other data sources such as healthcare data and social media could be more effectively utilised.

Remote monitoring is an important source of data in modern therapy development. Measuring drug effects remotely reduces the risk of infection during a pandemic, as participants do not need to visit the research centre as frequently. The subreport highlights that much remains to be explored to effectively utilise this new technology during a pandemic.

Advanced therapy medicines, such as gene and cell therapies, present a growing challenge for regulatory agencies. Kooijman notes: “The therapies of the future require a different regulatory framework than those of today. Advanced technologies often have different mechanisms of action, risks, and quality requirements. All these aspects must be appropriately considered.” Given that highly innovative treatments can be crucial during a pandemic, it is advantageous that regulatory and other bottlenecks in the development of such technologies, including advanced therapy medicines, have been identified along with potential solutions.

National and international efforts

The final report of the sub-assignments outlines four overarching recommendations to strengthen the Netherlands’ regulatory pandemic preparedness:

1. Improve understanding of the regulatory system, procedures, and requirements. FAST is working on this by making information accessible through the guidance function.
2. Strengthen multidisciplinary knowledge collaboration within the regulatory field. Marlous adds: “For both pandemic preparedness and other FAST objectives, it is important that the Dutch innovation ecosystem operates even more smoothly. We are jointly exploring how to better connect relevant parties.” At the national level, the Regulatory Science Network Netherlands (RSNN) contributes to this.
3. Shape regulatory adaptation based on pandemic scenario planning. Rook comments: “We are working on several scenarios to help us think about potential future pandemics in a broader sense.”
4. Achieve harmonised data collection and improved access to data for regulatory purposes. In addition to the aforementioned efforts regarding clinical platform studies, ZonMw and VWS’s policies on FAIR (Findable, Accessible, Interoperable, and Reusable) data are also relevant.

Pandemic preparedness and regulatory innovation will continue to demand attention in the coming years. The collaboration between VWS and FAST on this subprogramme provides a solid foundation. Rook concludes: “It is very accessible. If I have a question, I can pick up the phone and find people who understand the question and often know the answer. For both pandemic preparedness and other FAST objectives, it is crucial that the Dutch innovation ecosystem becomes even more efficient.

In the field of regulatory innovation, the Netherlands plays a leading role within Europe. Regulatory innovation involves interdisciplinary and multistakeholder research and development. In the Netherlands, interdisciplinary research is encouraged, high-level scientific research into regulatory innovation has been ongoing for years, and there is a high willingness to collaborate among various stakeholder groups. The RSNN, where stakeholders from industry, academia, and regulatory bodies work together on regulatory innovation, plays a key role. The reports from the ZonMw programme provide essential building blocks on all these themes. Kooijman concludes: “For FAST, it is crucial that regulatory innovation is prioritised as it is a key condition for bringing innovative therapies to patients more quickly. We are working with involved parties on various initiatives to follow up on the recommendations from the thematic reports.”