De pandemie heeft ons duidelijk gemaakt hoe belangrijk een goede gezondheidszorg op Europees is, zegt Moll. ‘Dit soort grensoverschrijdende ziekteverwerkers kunnen alleen maar gezamenlijk worden aangepakt.’ Daarbij heeft de geneesmiddelensector haar rol gepakt, door samen met de Europese Commissie en de EMA te werken aan het opzetten van klinische studies naar vaccins en behandelingen, maar ook in het voorkomen van toeleveringsproblemen van medicijnen.
Moll: ‘De pandemie heeft ons ook geleerd dat innovatie cruciaal is om deze uitdagingen en gezondheidsproblemen aan te pakken. Daarnaast hebben we gemerkt dat afstemming van regelgeving en samenwerking over vraag en aanbod van geneesmiddelen noodzakelijk is om er voor te zorgen dat patiënten overal toegang hebben tot behandelingen.’
Maar Moll is ook bezorgd. ‘Door afnemende investeringen is het aantal behandelingen afkomstig uit Europa, de afgelopen 25 jaar sterk afgenomen.’ Ze roept op om Europa aantrekkelijker te maken voor biomedisch onderzoek. ‘Daarvoor is een infrastructuur die onderzoek stimuleert en een goede bescherming van intellectueel eigendom absolute noodzaak.’ Namens de sector belooft ze zich te blijven inzetten voor innovaties én betere toegang tot behandelingen voor patiënten.
Lees hierna het integrale interview met Nathalie Moll, in het Engels. Of download hier het artikel.
The COVID-19 pandemic has been going on for almost two years. How has COVID changed the role of the EU and the European Commission in the field of healthcare? What steps have been taken which would have been unthinkable two years ago?
'The pandemic has certainly elevated the importance of healthcare at the EU level, underlining the need for a united response to global health threats.
The early phase of the pandemic tested Europe’s medicine supply chains as never before, dramatically increasing demand of certain critical products while ad-hoc and unilateral measures by some Member States threatened supply processes during the first phase.
The industry worked closely with the European Commission and the EMA during this period to understand and anticipate disruptions and ensure that the Commission had the right information to take decisions on new guidance and regulations. This meant that we were collectively able to ensure continuous supply of critical medicines as well as continued clinical research despite the disruptions caused by COVID thanks to this close and timely collaboration.
These experiences also led the Commission to propose a strengthening of the EU preparedness system, including the EMA and ECDC. And the pharmaceutical industry welcomes the European Commission’s commitment to build the foundations of a stronger European Health Union in which 27 countries work together to “detect, prepare and respond collectively”, as Ursula von der Leyen, European Commission President, has put it.
The EU would need reinforced capabilities to monitor national and regional healthcare demands and capacities in order to better inform the supply of essential medicines, medical equipment and other healthcare resources to better coordinate allocation of supplies based on actual patient needs at Member State level, both in normal times and during emergencies.
As we are moving into the next phase in the fight against COVID-19, we also need to start reflecting on what this crisis has taught us so far together, about the state of European health systems and European health collaboration in a broader sense, and what could be done better or differently in the future.
COVID-19 forced health systems across Europe to accelerate the implementation of innovations which mitigate the negative impact on patients and achieved equal or better outcomes from fewer resources. Learning from these experiences is crucial to recover from the COVID-19 pandemic as soon as possible and make healthcare systems more resilient to future disruptions and sustainability challenges.'
What lessons can we draw from these past two years?
'The pandemic has underlined the importance of medical innovation in addressing global health treats and our existing health challenges. It also showed a stark and inextricable link between our health and our economic well-being.
When on 30 January 2020 the World Health Organisation declared that the World was facing a Public Health Emergency of International Concern, there were no licensed therapies to treat patients and no vaccines to protect citizens. To face this imminent threat, new ways of working emerged, and we hope that they can be sustained in the future:
• Unprecedented collaboration efforts: Collaboration was key and a feature of the industry response to the pandemic. Multiple research initiatives were established in record time, working with academic groups, start-ups and vaccine manufacturers working to find and test preventative tools.
• Simplify and accelerate: Vaccine development typically takes several years of research and development and clinical trials. But the sheer scale of this global pandemic meant an urgent need for solutions. Working with the regulators we found ways to run parts of the development process in parallel without ever compromising on safety.
• Uninterrupted supply: Discovering and developing safe and effective vaccines against COVID-19 was just the first chapter in the recovery story. This global pandemic required and continues to require a global response. It has meant expanding existing manufacturing capacity and creating over 300 production and supply deals around the world to ensure we could manufacture the billions of doses required to protect people worldwide. Since the COVID-19 pandemic was declared, production has increased to 9.3 billion (October 2021), increasing by over 1.2 billion per month. At this rate, by December 2021 that figure will rise to around 12 billion doses.
• Preservation of ongoing clinical trials: the pandemic impacted the many thousands of patients across the EU that take part in over 4000 clinical trials for new medicines across many therapy areas. Working closely with the European Medicines Agency, companies and regulators found innovative ways together to support the continuity of clinical trials, critical to trial participants and future advances in patient care.
We learnt that regulatory harmonisation, flexible labelling requirements, transparency and cooperation on demand data and supporting global supply chains are recipes to help ensure that patients in Europe get the medicines they need.
Our recent report The Impact of COVID-19 on Patient Access to Cancer Care in Europe also highlighted some of lessons learned over the pandemic. For example, the COVID-19 pandemic and related vaccine development have clearly shown joint clinical assessments is possible. Moving forward, continuing the intensified European collaboration in clinical assessment to use scarce HTA resources more efficiently will be key. COVID-19 has also accelerated a shift towards digital healthcare. There is now considerable interest in and momentum behind making the transition to digital delivery of healthcare organic and sustainable, to increase remote care and use healthcare resources more efficiently after the pandemic.'
The European Commission has been working on a large revision of the pharmaceutical legislation. Ideally, what ambition would be at the core of this revision?
'The evaluation of the EU pharmaceutical legislation is a once in a generation opportunity to help realise a vision of a healthier future for Europe. A future based on prevention, innovation that addresses unmet medical need, access to new treatments, better outcomes for patients in a more resilient and prosperous Europe. Realising this vision means working with all stakeholders to develop collaborative solutions to access and availability issues as well as creating the right regulatory and incentives frameworks to facilitate the discovery and development of the next generation of treatments and vaccines to improve the health of European citizens and drive Europe’s economic growth.
Today, 47% of global new treatments are of US origin compared to just 25% emanating from Europe (2014-2018). This represents a complete reversal of the situation just 25 years ago.
Reversing the 25-year trend of life science investment being relocated away from Europe means that any new policy framework has to be equally, if not more, competitive than other offerings around the world. To foster a flourishing research-based industry in Europe will also require an IP framework that continues to protect investment in medical research in the EU and globally, a research infrastructure that helps deliver the next generation of health innovation, a regulatory framework that is stable, fast, effective and globally competitive and faster, more equitable access to innovative treatments for patients across Europe.'
What role can the pharmaceutical industry play to reach this ambition?
'In our response to the Commission’s public consultation on the review of the general pharmaceutical legislation, EFPIA has outlined a series of proposals designed to deliver a step change in faster, more equitable access to medicines for patients and ensure that Europe can be at the forefront of the development of the next generation of diagnostics, treatments and vaccines. Only by addressing these two elements in unison can we realise a shared vision of a healthier future for Europe. A future based on innovation that can address unmet medical needs, increased access to new treatments, better outcomes for patients in a more resilient and prosperous Europe.'
Part of the proposals would be a revision of the OMP Regulation. How does the call to limit incentives for the development of orphan medicines relate to the large unmet medical need in rare diseases? And what would the impact be of limiting incentives?
'It is about understanding how innovation happens. You start by incentivizing broad research and as new avenues of research open up, these can be applied to different conditions - when breakthroughs happen, new treatments follow. Narrowing incentives just doesn’t fit with the reality of scientific discovery and development and could end up doing much more harm than good.
The stability and predictability of the existing European incentives’ framework has enabled our industry to invest in research and development, and to deliver new medicines to patients, healthcare systems and society. To attract investments in Europe as a true research and innovation hub, it is important that these new incentives are predictable and do not change late in development.
In fact, the Regulation on Orphan Medicinal Products introduced in 2000 by the European
Commission has been a successful, progressing care in many overlooked conditions and the innovative pharmaceutical industry investigates areas of unmet need to develop treatment options for patients living with rare disease.
There is always room for improvement. The lack of therapeutic options in some areas is a consequence of existing scientific, regulatory and economic barriers to development and which are further compounded by uncertainties relating to pricing & reimbursement. Addressing these challenges means really understanding how and where innovation to meet unmet need happens. That is the basis for developing framework at EU and Member State level that allows meaningful partnerships towards the shared goal of reducing unmet needs and to address the barriers to innovation, access and availability and aspects on affordability in a holistic approach, not in silos.'
What can EU Member States, and the Netherlands in particular, do to support innovation and a strong life sciences sector in Europe?
'EU Member States develop life science strategies to deliver economic growth, develop their research and development eco-system including supporting their SME and academic sectors as well as positively impact the health of their citizens.
Whatever the level of ambition, the success of Member State life sciences strategies is inextricably linked to the EU policy environment. Many of the primary drivers of medical innovation such as the regulatory framework, incentives for research and development and intellectual property are an EU competence.
The implementation of the current EU Pharmaceutical and Industrial Strategies will color the innovation potential for Member States and the success of their life science strategies. It’s therefore critical that Member States actively engage in the ongoing discussions and decisions in the implementation of the pharmaceutical strategy to make sure that whatever decisions are taken in terms of future European policy frameworks and legislation, these enhance the EU life science’s ambitions and enable the realisation of their life science strategy.'
Is there anything else you would like to bring to the attention of our readers?
'The COVID-19 pandemic has shown that only science-based and high-risk research embedded in a strong life science industry ecosystem can bring the lasting solutions to health challenges. The first aim of the Commission initiative should be to regain EU global leadership as a home for R&D and a cutting-edge industry to secure high-quality and sustainable care for patients and citizens.'
