The message is clear: now is Europe’s moment to aim high, and to realize an ambitious vision for its’ strategic autonomy in health. The COVID-19 pandemic accelerated a rethink: on centering health in Europe’s priorities; and on the advancement of technological sovereignty in R&D and industrialization to improve health and create economic growth and jobs.
Europe’s research-based pharmaceutical industry employs 830,000 people and invests over €36 billion in R&D. The sector has a key role to play in ensuring Europe’s competitiveness in a context of fierce global competition.
With a strong R&D presence, investment creating new partnerships in research, and almost 40 production sites across Europe using the latest technologies, Sanofi is a major part of Europe’s pharmaceutical value chain.
Bringing science to patients
An important part of building Europe’s strategic autonomy is its ability to set the agenda in transforming science into reality for patients.
Europe’s excellent regulatory framework for medicine authorization plays a critical role. It helps Europe to compete with other key geographies in the fast-paced arena of scientific advances and game-changing data generation, including uses in AI and digital technologies. We’ve seen that the COVID-19 crisis prompted therapies reaching patients in record time, as well as vaccine development and registration in the EU, where rolling reviews and scientific dialogue have demonstrated their value.
An important part of building Europe’s strategic autonomy is its ability to set the agenda in transforming science into reality for patients.
Paul Hudson, Chief Executive Officer, Sanofi
Europe is going the extra mile with the recently-approved extended mandate of the European Medicines Agency (EMA), which equips the agency to address future crisis response and preparedness. The focus must be on ensuring a truly futureproof framework for medicine regulation, allowing fast and safe availability of life-saving treatments. For this, we need new incentives for highly-innovative therapies. We also need to formalize existing pathways for medicines, such as the EU PRIME scheme, ensure expedited assessment pathways, and build synergies with Health Technology Assessment bodies on clinical evidence requirements, enabling Europe to speak with one voice. These are key areas that will make a difference to medicine availability in Europe.
The answer to creating greater access to medicines will in turn come from a shared responsibility and investments between industry and public authorities in the EU member countries.
An integrated approach across research, innovation & industrialization
Europe aims to lead in strategic sectors and the twin green and digital transition. To succeed, a strong effort in managing the full value chains of key technologies is essential, balancing interdependencies and strong supply chains.
The example of mRNA is illustrative. The scale and timelines of development and production of COVID-19 vaccines based on mRNA technology might lead us to believe that the production systems for these biological molecules are well established in Europe. But this is not the case. The EU is falling behind the U.S. in mRNA R&D, with an ecosystem that is much less mature than other regions.
An IPCEI in Health, as announced in France, can anchor R&D, innovation, and industrial strength in the EU to generate cutting-edge pharmaceuticals and vaccines. Joint projects must establish capabilities for large-scale industrial projects that can encourage the rapid development and scale-up of innovative medical solutions, supporting patient needs across pharmaceuticals and vaccines. This will require input from a broad diversity of stakeholders to be successful.
Joint projects must establish capabilities for large-scale industrial projects that can encourage the rapid development and scale-up of innovative medical solutions, supporting patient needs across pharmaceuticals and vaccines. This will require input from a broad diversity of stakeholders to be successful.
Brendan O’Callaghan, EVP, Global Industrial Affairs, Sanofi
Clusters should be supported in areas such as oncology, where multidisciplinary exchanges between public and private entities in the field of research, biotechnology and pharmaceutical investments, medical technologies, data science, and artificial intelligence are essential. Building blocks have been created such as the Paris Saclay Cancer Cluster, bringing together key players in oncology innovation. This is unique to Europe — building the best scientific, human, and technological expertise to shape the future of personalized medicine and to accelerate the discovery of new customized cancer treatments.
Europe needs to equip itself with dedicated capacity, a long-term perspective, and governance to lead and fund at scale cutting-edge technologies in strategic sectors. With recent calls for a “European DARPA,” the time is certainly right to start working in that direction.
Research leadership governing EU health data
Another key driver for European sovereignty is data, which is central to the pharmaceutical value chain. It plays a critical role in understanding efficacy and safety aspects of new medicines and vaccines and is essential for attracting research. Data analysis of patients and ‘omics’ technologies will drive a new paradigm in treatment development, leading to personalized therapies that will improve patient care and significantly impact survival rates.
Progress in advancing a European Health Data Space can result in improved coordination for clinical trials at EU level, better patient care, and the optimization of resources through more accurate and faster decision-making. Access to data is an enabler to accelerate innovation in different areas of health care, for example in clinical trials. Public-private collaboration on data access, built on trust, is crucial for Europe to up its game in technological competitiveness, in terms of tech profiles, infrastructures framework, and culture.
The COVID-19 pandemic has put health at the center. It has shown that investments in health are a strategic priority, and that through new forms of cooperation between the public and private, Europe can seize the moment to generate and develop groundbreaking science, made in Europe.
Olivier Charmeil, EVP, General Medicines, Sanofi
Strategic autonomy means giving the European Union the tools to master key technologies and innovations and set its own priorities. But it cannot be realized without the right level of political ambition as set by the French Presidency of the Council of the EU, a degree of risk and investment sharing, a willingness to pool resources, and a joined-up implementation between national and European policies. The COVID-19 pandemic has put health at the center. It has shown that investments in health are a strategic priority, and that through new forms of cooperation between the public and private, Europe can seize the moment to generate and develop groundbreaking science, made in Europe.
About Sanofi
We are an innovative global health care company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Source: Politico