The COVID-19 “Regulatory Road to Innovation”
Europe’s regulatory system is designed to ensure that new treatments for patients are high quality, safe and effective. It has helped to extend and improve the lives of millions of people across Europe and beyond. But to keep pace with developments in science and technology and to keep pace with regulatory innovations in other regions, Europe’s regulatory framework has to evolve. This has become increasingly evident in order to tackle the coronavirus.
The COVID-19 pandemic is unique in recent history and as a result, is placing unprecedented demands on global supply chains for healthcare products, clinical research and our regulatory infrastructure. In these exceptional circumstances, everyone involved in bringing new vaccines and treatments to patients needs to consider how collectively, we can simplify and accelerate procedures. Industry and regulators are currently in dialogue to secure;
- The uninterrupted supply of healthcare products to enable the continued treatment of patients;
- Clinical research into novel treatments and vaccines to address COVID-19;
- Adapted regulatory practice to ensure continued supply and development of high quality medicines needed to address all patient needs during the pandemic while maintaining the integrity of the regulatory system
- Continuity of vaccine supply and of vaccination programs to protect the most vulnerable populations and to avoid outbreaks of other infectious diseases which can put additional burden on health systems
- Preservation of ongoing clinical research, including protecting and maintaining supply of investigational medicinal products (IMPs) to trial participants
- Concerted, harmonised approaches to tackling difficulties as and when they occur, in order to protect the public and ensure we achieve the best possible outcomes for our patients.
The aim should be to simplify procedures, minimise non-value adding activities and accelerate delivery, in order to free resources for the regulators and the industry to focus on the most critical tasks.
Regulatory authorities in Europe have shown a great willingness to adapt their practices to mitigate the current crisis. For example, just a little over one week ago European Medicine’s Agency (EMA), European Commission and the European medicines regulatory network have developed and published a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients. While this is of course an important focus, EFPIA has called for adaptations to the regulatory framework to be applicable to all medicinal products so that all patients can continue to receive the medicines that they need.
To meet today’s and tomorrow’s challenges, all stakeholders in the healthcare system must identify opportunities within the current legislation to optimise translation of new science and technology into innovative health solutions.
Even before the COVID-19 outbreak, the EFPIA members reflected on how the EU regulatory framework can best leverage these new opportunities science is offering. Last year we embarked on our “Regulatory Road to Innovation”, which includes suggestions on what can be done within the current medicine’s legislation. Not surprisingly, its conclusions are particularly relevant in light of the current crisis even though the reflection was conducted way before the COVID-19 outbreak.
Encourage the use of new types of clinical trials to help new medicines get to patients fasterSince participant/patient travel to clinical trial sites will be limited during the COVID-19 crisis, EU regulators should encourage innovative approaches to evaluate new medical products, such as through master protocols, adaptive studies, and decentralized trial designs. Through a collaborative effort, sponsors (commercial and non-commercial), regulators and other stakeholders may be able to develop and coordinate an efficient clinical trial framework tailored to this outbreak, using novel approaches for data collection that are suited to the challenge of evaluating products in the setting of a public health emergency (where typical site based evaluation may not be feasible because of isolation protocols and stress on the healthcare system).
Allow greater use of data from real world use of treatment
As the current outbreak shows, data collected in medical practice would not only inform health systems and their resources, but also inform development of medicines. This data allows us to consider the real-life impact of our medicines in addition to the data collected during traditional clinical trials and can play an important role in tackling Covid-19. Real World Data (RWD) on Covid-19 patients and treatments is being collected across global health systems as we speak. We can learn a lot about its quality and accessibility and how it translates into evidence. On this basis, EU regulators would be able to develop and adopt guidance on RWD/RWE framework with clear principles for data quality and interoperability, access, analysis and regulatory acceptance. This will not only support development of medicines for COVID-19 but bring important lessons and best practice for sustainable use of data collected in various regions in future medicines development.
Allow ongoing dialogue and discussion about a medicine throughout development – dynamic regulatory assessmentTo ensure novel treatments and vaccines for Covid-19 are developed as quickly and as efficiently as possible, there is a need for continuous dialogue between developers, regulators and other stakeholders so that there is mutual awareness, and agreed analysis of the emerging data and a common understanding of what the data is showing. This approach to development should help reduce the uncertainties and optimize the application process. This would allow more rapid approval of medicines and faster access for patients to new treatments.
Clarify how combinations of medicines with other healthcare products are regulated1 in 4 medicines approved at an EU level includes a device component. Diagnostic tools and medicines are currently evaluated by separate authorities. Diagnostics play a key role in identifying those who are impacted by COVID-19. Although this can be the first, and a separate component before starting any treatment to alleviate the symptoms of the virus, in the long run, we should think about how the regulatory pathway for diagnostics and combination products which include a medical device and a medicine are streamlined as much as possible. For example, advances in personalised medicine require additional regulatory requirements, such as biomarker validation. Current biomarker qualification process lengthens already cumbersome procedures thus jeopardising access of patients to innovation. EMA should look into adopting an integrated EU pathway for the assessment of drug-device combinations and in vitro diagnostics.
In conclusion, it is clear that COVID-19 teaches us how to optimise research and development and how to streamline regulatory processes. Some of the elements on how to manage the pandemic crises should be evaluated and tested in the post-COVID era. The “new normal” in regulatory terms should include less complexity while ensuring the key elements of preserving quality, safety and efficacy of the medicines for patients who need them.