Europe must support innovation to strengthen future health systems.

Resilience encompasses all challenges

COVID-19 has been a rude awakening to the need for EU member states to consider – singly and collaboratively – how to make their health systems more resilient.

Resilience has been defined by some based on the ability to withstand and respond to health shocks such as COVID-19 while maintaining routine functions. The COVID-19 pandemic has certainly underscored the need to better prepare health systems to manage both the direct impact pandemics, and to avoid the collateral damage caused by the disruption to critical health services for other diseases.

Beyond COVID-19 we believe that resilience must encompass the health system’s capacity to manage all types of public health challenges – including the rising pressure from age-related chronic diseases (See Introduction), antimicrobial resistance, and the health threats posed by environmental risks and climate change. We must concertedly strengthen our health systems against all these long-term stresses, as well as unpredictable shocks.

Empowering the future health workforce

POWERing up health systems – focusing on people-centricity, outcomes, efficiency and the workforce – will inherently strengthen them.

Why? Because healthier people are critical to build more resilient societies. The far higher rates of severe disease and death from COVID-19 in people with underlying conditions should once and for all teach us the societal value of investing smartly in better disease prevention and management throughout life.

In addition:

• Strengthened, digitally enabled public health systems will be better prepared to identify and address acute threats
• Optimised primary, community and home care services will help protect hospital capacity for people who need it – particularly during pandemic
• Building health literacy and patient empowerment will help combat disinformation that can undermine public health responses, as shown during the COVID-19 pandemic, and better enable patients to manage their own conditions.

The POWER priorities therefore align with many expert recommendations on improving health system resilience post COVID-19.

 

The COVID-19 pandemic has tested Europe’s medicine supply chains as never before, dramatically increasing demand of certain critical products while ad-hoc and unilateral measures by Member States threatened supply processes during the first phase of the pandemic.

Medicines supply chains are complex, international, long-term enterprises involving many stakeholders. The average medicine has around 350 components whose supply must be carefully co-ordinated and timed to provide a finished product; the whole process typically takes around 2 years. For biological products, including vaccines, the process of production and distribution can be even more complicated.

For the most part, Europe’s research-based pharmaceutical industry actively rose to the challenge posed by COVID-19 and maintained continuous supplies of medicines. Pandemic preparedness plans were triggered late 2019 allowing manufacturers to enhance both manufacturing and supply capacity. In addition, diversification of supply channels, demand forecasting, and in some cases close cooperation with health authorities and EU-level coordination of national measures (e.g. large orders for stockpiling purposes), were key elements of our collective response to the pandemic.

Pharmaceutical companies are constantly investing in strengthening their supply systems, for example using digital technologies (predictive analytics and artificial intelligence) to improve demand forecasting, agile supply chains and industry workforce support. These endeavours will need co-operation with, and support from, the EU and Member States to help overcome bureaucratic obstacles and ensure success. However, there is significant room for improvement, necessitating collaborative EU-wide action.

Ensuring medicines supplies: rising to the challenge

Strength through European unity

Since diseases know no borders, EU Member States need to work together to strengthen their health systems and public health capacities. This should aim not only for all to be better prepared against cross-border threats, but toward equal access to healthcare and comparable health outcomes for patients.

The EU also needs 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 the allocation of supplies based on actual patient needs at Member State level, both in normal times and during emergencies.

Specific measures that would help strengthen supply chains and build resilience to future shocks include:

• Greater cooperation and transparency between EU agencies (especially the European Medicines Agency and European Centre for Disease Prevention and Control), national authorities, industry and other supply chain actors to provide better real-time data for demand forecasting and monitoring, and a common definition and reporting framework for shortages
• A solidarity-based allocation mechanism, with political backing from Member States and EU institutions to be triggered in case supplies are temporarily limited by external shocks and may not cover demand for medicines, as well as a joint understanding and visibility regarding the demand signals (either via patient need, or stockpiling, or economic demand by operators)
• The establishment of the proposed Health Emergency Preparedness and Response Authority (HERA) dedicated to improving Europe’s capacity and readiness to respond to cross-border health threats and emergencies
• Regulatory harmonisation among relevant authorities to help make medicines distribution more agile
• Practical measures to reduce the logistical and administrative burden of medicines supply, such as flexible labelling requirements.

Clinical trials are an essential step in bringing new treatments and vaccines to patients.

The COVID-19 pandemic has caused thousands of trials to be suspended or stopped globally. At the same time, the pandemic mobilised an unprecedented, collaborative research and development effort that has delivered regulator-approved COVID-19 vaccines and treatments of enormous value to society in record time.

All partners in the EU innovation environment must take this opportunity to urgently reflect on how we can optimise clinical trials to better serve patients and health systems.

These learnings may include:

• adaptations to improve resilience, e.g. through tele-health and remote monitoring to reduce the need for some clinic visits
• novel trial approaches, including ‘adaptive’ designs that can be updated as data accumulates, platform trials that allow multiple interventions to be tested simultaneously, and the wider use of real-world data to complement data from clinical trials
• frameworks that facilitate public-private collaboration
• harmonised EU-wide legislation that facilitates clinical trials with advanced therapy medicinal products consisting of or containing genetically modified organisms (GMO) 
• streamlining regulatory approval processes.

Optimising clinical trials

Industry: partnering for more resilient health systems

EFPIA is an active advocate and partner in strengthening the resilience of EU health systems. We fully support the goals of the European Commission on preparedness against cross-border threats and will work with all parties in the coming years to support their work in this crucial area, including via the Structured dialogue on security of medicines supply convened by the Commission.

In May 2021, an EFPIA-commissioned report assessed the impact of the COVID-19 pandemic on cancer care, integrating contributions from numerous stakeholder organisations and industry partners. This report made six specific recommendations to European health systems to help them recover optimally from the COVID-19 disruption, while adapting to be able to absorb future shocks more effectively.

• Clear the cancer backlog now, using innovative practices which emerged during the pandemic
• Maintain the proven agility of R&D and marketing authorisation processes
• Continue the intensified European collaboration in clinical assessment to use scarce HTA resources more efficiently after the pandemic
• Continue the adoption of digital health to increase remote care and use healthcare resources more efficiently after the pandemic
• Maintain and build adaptive surge capacity to be ready for future disruptions to cancer care
• Safeguard cancer budgets as a critical enabler for improving continuity, efficiency, and sustainability of cancer care.

EFPIA will continue to work collaboratively with all partners on other relevant initiatives with respect to broader aspects of improving health systems resilience, including on access to innovation to address unmet medical needs, and tackling the health system impacts of demographic ageing, antimicrobial resistance and climate change.

EFPIA is the founding member of the European Medicines Verification System, data from which could provide additional intelligence regarding the quantities supplied by manufacturers on the various markets as well as the quantities of medicines dispensed to patients at national level.

Individual EFPIA members are also working on specific programmes. For example, AstraZeneca has co-initiated the Partnership for Health System Sustainability and Resilience (PHSSR) together with the London School of Economics and the World Economic Forum, based on a shared commitment to improving population health through and beyond the COVID-19 pandemic. From new models of care, to innovative financing mechanisms and breakthrough technologies, the PHSSR aims to make change happen, by identifying transferrable solutions with the greatest potential, and supporting their adoption to deliver better health and better care for all. In March 2021, the initiative published interim findings and recommendations with respect to governance, financing, workforce, medicines and technology, and health service delivery, together with a series of country level and disease area-specific reports.

EFPIA members are also collaborating with research hospitals, regulators and patient organisations in IMI projects supporting health system resilience, such as:

In the EU Patient-Centric Clinical Trial Platforms (EU-PEARL) project, leading research hospitals, regulators, patient advocates and industry are working together to help shape the future of clinical trials. Specifically, this project aims to support a wider use of patient-centric ‘platform’ trials, which allow novel techniques and treatments developed by multiple companies and organizations to be tested efficiently to help address unmet needs. Patients and carers are integrally involved to ensure their perspectives are consistently incorporated in trial designs and outcome measures.

The Trials@Home Consortium, which aims to help move trials from the traditional clinic setting to the participant’s immediate surroundings. These so-called Remote Decentralised Clinical Trials (RDCTs) use new digital innovations and enable participants to visit a clinical trial centre less frequently, if at all. This will help larger, more diverse and remote populations to participate in clinical trials. These trials are expected to be faster and more efficient to run, and to provide results that are more representative of the real world because the data are collected in the daily context of participants’ lives.