The COVID-19 pandemic has caused a seismic shift in our approach to healthcare. On the one hand, the vulnerability of Europe’s healthcare systems has been seriously exposed, leaving policymakers to reflect on how we can do better in the face of future healthcare threats. At the same time, it’s also shown us what’s possible when it comes to discovering new medicines and vaccines and bringing them to patients in a way that would have seemed unimaginable pre-pandemic. Through collaboration amongst the pharmaceutical industry, scientists and policymakers, vaccines were not only developed in less than one year (vaccine development usually takes 10-15 years), but they were also approved and rolled out at an unprecedented speed. But what does this mean for access to innovative medicines for European patients in the future?
European patients currently wait longer to access and generally have less access to innovative medicines than the US and Japan. Europe presents a challenging launch environment for innovative medicines because the European Medicines Agency (EMA) takes more time to approve medicines than its global equivalents. In 2017, the EMA took an average of 423 days to approve a medicine, whilst the Food and Drug Administration (FDA), the EMA’s equivalent in the US, only needed 243 days. The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan also outpaced the EU with only 304 days. This is because of the EMA’s famously slow and rigid approval processes.
Figure 1 Average number of days taken for approval in 2019.
This directly impacts how patients access much needed innovations. Alzheimer’s disease (AD) patients in the US, for example, currently have access to the first new AD treatment in over 20 years, whilst European patients still don’t. In 2021, its conditional FDA approval raised the hopes of the European AD patient community, anticipating the EMA might follow suit. It rejected it. What’s interesting is that whilst both agencies had a fierce debate over its efficacy, the FDA made the decision that the potential benefits outweighed the unknowns and granted conditional approval. This allowed patients to access the medicine and satisfied the hopes of the AD community state-side, without compromising on patient safety.
The reason why the FDA and PMDA approve medicines more quickly than the EMA is because they have highly efficient and innovative approval processes. The SAKIGAKE designation system (Japan) and Accelerated Approval (US) grant medicines ‘conditional approval’ based on preliminary evidence, that can give an indication of treatment effect but is not yet a solid demonstration of the medicine’s efficacy. Once conditionally approved, medicine developers commit to providing regular real-world evidence on the medicine’s efficacy, a process that is much easier and more time-efficient than just using closed clinical trials. Employing this extent of flexibility gives innovative medicines the chance to unfold and prove their benefit whilst ensuring quality and safety at the same time.
The EMA has introduced similar pathways and has gone some way to becoming more flexible and to speed up access to innovative medicines. But these efforts have been criticised as being less ambitious. PRIME, an EMA regulatory pathway for medicines covering unmet medical needs, fosters early dialogues with medicine developers to clarify which data is needed, enabling a quicker approval process. But the EMA’s stagnant approval times don’t speak for this process. Strict eligibility criteria to enter PRIME in the first place seems to hinder its efficacy and utilisation that would speed up average approval times. Between 2016 and 2019, only 25% of total applications were approved and, believe it or not, 72% were rejected.
In its quest to fill the regulatory gap, the EMA also launched a pilot project called Adaptive Pathways, which ran from 2014 to 2016. This initiative was a European version of the US and Japanese innovative approval processes mentioned earlier: making use of preliminary evidence to approve a medicine conditionally and supporting the decision by the collection of real-world evidence after launch. Although the project was highly efficient in bringing innovation to the patient as acknowledged by the EMA itself, 6 years later, a follow-up from this project is yet to be seen.
But the reality of this whole situation is that it doesn’t need to be this way, the EMA can speed up, and we’ve been the beneficiaries. During COVID-19, the EMA accelerated vaccine approval times from the usual 210 active days to 150. Early dialogue between the EMA and medicine developers, a rolling review of the vaccines during their development, and conditional market authorisation all made it possible. Should we now expect a future where swift access to innovative medicines, whilst keeping safety and quality standards high, is the new norm rather than an exception? The Healthcare Practice at FleishmanHillard is closely following the long-lasting impact of COVID-19 on approval and access to innovative medicines in Europe and improving access to medicines for all in Europe is a personal motivator for our team.
Looking ahead at the healthcare policy landscape for the rest of 2022, we’re also following multiple legislative initiatives that will impact both approval and access to innovative medicines. This includes the newly adopted Health Technology Assessment (HTA) Regulation which should remove duplicative HTA processes in Europe and speed up access. Currently, even after a medicine’s approval European patients wait an extra 500 days to actually access it through their local doctor or pharmacist. Additionally, the upcoming revision of the pharmaceutical legislation, focusing, in some part, on restoring Europe’s reputation as a global leader for pharmaceutical innovation and competitiveness, will provide an opportunity for engaging and marking our standpoint: every patient should have access to the best treatment possible, no matter where or who they are.