European healthcare stands at a pivotal moment. The pandemic may feel a lifetime ago, but we are yet to fully define the ‘post-COVID’ era – and what happens next will shape healthcare across the region for decades to come.
Many lessons were learned that we should hold onto. Healthcare collaboration within countries and across Europe was unprecedented. We went on the journey together to bring vaccines and treatments to patients – leading to a far greater appreciation of the effort this takes and why good health and timely access to innovation matters so much for society to thrive.
As European decision-makers and stakeholders, including industry, engage in talks following the publication of the European Commission’s (EC) proposed ‘Pharmaceutical Package’, we must remember the quality and resilience of our future healthcare depends on this continued collaboration.
At the heart of this partnership is a unified objective – to put the needs of patients first, just as during the pandemic. Across pharma, health systems, patient groups and clinicians, we all want to see more timely and equitable access to affordable medicines. Our destination is the same, but we have different perspectives on the route that will take us there – and we must listen and learn from one another if we are to deliver for patients.
From our point of view at Pfizer, the proposals contain several welcome improvements. These include streamlining and future-proofing the European Union (EU) regulatory system, the introduction of electronic product information, an EU-level ‘pull’ incentive to stimulate Research and Development (R&D) investment against antimicrobial resistance (AMR), the proposal for a rolling review of data, and regulatory sandboxes to test innovative ideas and processes.
These proposals show we can learn from our shared experience during the COVID-19 pandemic. We are encouraged by the potential to improve collaboration between manufacturers and regulators, speed up regulatory processes to bring innovation to patients sooner, incentivise R&D in a key area of unmet medical need such as AMR, empower patients through greater access to treatment information and respond to patients’ needs more directly.
However, the draft legislation also presents real, practical challenges to achieving the change we want to see for patients. We are all aware that the pandemic, the war in Ukraine and rising inflation have increased inequalities in access to innovative medicines across the EU, exacerbating Member States’ budgetary issues and increasing the focus on healthcare resilience. These issues are all crucial but need to be addressed in a coherent, comprehensive way between the EU and at a Member State level.
Improving access to innovative medicines, for example, is at the very heart of our industry’s purpose. The recently published 2022 Patient WAIT Indicator Survey shows that across Europe we can witness a tenfold variation in the time to access new medicines.1
We can all agree that this is unacceptable and we need to work together to address it with urgency. We are fully supportive of policies that enable our medicines and vaccines to reach every last patient faster, no matter where they live. This is a shared responsibility between industry and governments and, exactly as with the COVID pandemic, it will take the power of collaboration to make it happen.
With these inequities in mind, in April 2022 Pfizer and other EFPIA (European Federation of Pharmaceutical Industries and Associations) member companies launched a commitment to file pricing and reimbursement applications in all 27 EU Member States as soon as possible and within two years from receiving a marketing authorisation, provided that local systems allow it.2 We expect this commitment alone to contribute to improved medicines’ availability and accelerated time to access for European patients.
Our industry is serious about taking responsibility to improve access in areas within our control. But to make the greatest difference for patients, we believe European governments can raise the bar too. As shown in a recent study highlighted by EFPIA, the root causes of access delays and unavailability of innovative medicines are found in national healthcare and reimbursement systems, not in EU legislation.3 This is our deepest concern with the EC ‘Pharmaceutical Package’: the pursuit of legitimate, shared goals (access, affordability, availability) but with the wrong tools (EU regulatory and intellectual property incentives) will not be effective and may have undesired consequences.
As they stand, the reforms proposed run the risk of jeopardising, rather than enabling, the industry’s efforts to deliver medical innovations across the region. In effect, the reforms could negatively influence companies’ R&D decisions by proposing increased obligations and requirements on what, when and how we study, develop, launch and supply our products across a range of areas, together with a weaker, more complex and unpredictable incentives framework.
Notably, reducing the baseline duration of regulatory data protection (RDP) or orphan market exclusivity (OME) and linking its recovery to factors outside of a company’s control – especially ‘launching’ in all EU markets, with all the uncertainty around how ‘launch’ will be interpreted and implemented – will not help address current access inequalities across EU countries. Beyond access variation, we also need a system which promotes a proportional and risk-based approach to supply resilience. Medicine shortages are complex issues which require better use of demand data and ongoing dialogue between manufacturers and authorities to address.
On innovation incentives, the narrow, centralised definition of Unmet Medical Need (UMN) in the legislation presents a further challenge. From an ethical standpoint, the primary driver of medical innovation should be the patient perspective: how to improve outcomes, reduce side effects, and/or the burden on their caregivers. To encourage more R&D where currently no treatment option is available, more innovation is needed, not less.
Let’s also remember this is taking place while Europe’s global competitiveness as an R&D investment destination is already declining vis-à-vis the USA and Asia. Over the last 25 years, treatments emanating from Europe have dropped by 30%.4 During that same time, US over EU spend on R&D has increased by $23B. Europe’s share of total incoming R&D investment among the US, China and Japan has dropped by from 41% to 31%. In the meantime, China shares of international R&D investment grew from 1% to 8%.5 As for clinical trials, activity is steadily declining with a drop of 6.3% in 2020 versus the previous decade.5
At a time when investment is moving away from Europe, we must tackle the challenge head on and work to reverse the trend. Our shared goal should be to create a system that is fit for the future of Europe, and that meets the needs of European patients now and in preparation for the years ahead.
We must not let the post-Covid political weather overshadow the long-term goal of realistically advancing patient access to innovative medicines. Nor should it hinder our mutual goal to strengthen Europe’s global competitiveness and attractiveness for R&D investment.
There is much work to be done – and EU policymakers can get this right if these concerns are heard. Given the European Parliament elections in May 2024, it is unclear whether the new legislation may be adopted before 2025, with a further 18-month period before it will apply. The opportunity to create a resilient, sustainable healthcare system is here, now. We must achieve equity of access and focus on a broader approach from prevention to treatment. Few of us feel comfortable imagining it – but we must also safeguard against future pandemics, the threat of antimicrobial resistance, and the predicted health impacts of climate change. We’ve seen with COVID how events can turn ‘under control’ patients to ‘highly vulnerable’ – many of whom represent historically underserved communities that society owes a debt to – and we must prepare realistically for what may be just around the corner.
In summary, we must work together today to create a European health system that is fit for tomorrow. The opportunity is ours to seize, now.
4 EU Competitiveness: Mind the gap between rhetoric and reality (efpia.eu)
5 Why Europe must future-proof its pharma legislation (efpia.eu)