Going the Extra Mile to Turn Science into Reality for Patients in Europe

The pandemic proved that necessity truly is the mother of invention and furthermore demonstrated the critical need to ensure a resilient and robust European Health Union.

Europe is reliant on ensuring it has in place a globally competitive research and industrial ecosystem if it is to realize its strategic autonomy in health. Delivering on this ambition, requires bold measures that support accelerated scientific and medical innovation, as well as the ability to rapidly scale-up manufacturing and supply of medicines across the pharmaceutical value chain, while establishing leadership in critical areas, such as innovative biologics-based production capacity.

1. Equipping Europe with a bold European research, innovation and industrial strategy for health

The US BARDA (Biomedical Advanced Research and Development Authority) set up 15 years ago allowed the pharmaceutical industry to gather unique expertise and knowledge through the various projects initiated and funded by the agency.

The creation of the EU’s HERA – Health Emergency preparedness and Response Authority is a clear illustration, building on a strong political willingness to make a similar concept a reality in Europe.

Its work programme rightly reflects that close partnerships are needed to ensure that research, development, manufacturing, and supply chains are directed to the strategic objectives of the EU and its member states in normal times, but capable of being rapidly ramped up as soon as a crisis arrives. With its comprehensive mandate and associated budget recently approved of 6-billion-euro to accompany these missions over a six-year period coming from various EU programmes (such as Horizon Europe, EU4Health), this sends a strong signal on the need to respond collectively, through public and private partnerships, to anticipate and address future health threats. The setting up of new industrial partnerships and the creation of a Joint Industrial Cooperation Forum are other welcome elements, which need to be complemented with pragmatic and results-oriented ways of working.

While HERA’s structure is promising, 2022 will be pivotal for operationalizing the authority’s mandate setting up a clear governance and implementing the different streams – such as ever-warm facilities for vaccines and therapeutics production, advanced R&D and the provision of medical counter measures.

Likewise, the ongoing discussions on Important Projects of Common European Interest (IPCEI) represent a promising path forward to allow for greater collaboration, teaming up so we can act today to address tomorrow’s challenges in health.

This approach ensures an integrated vision for the health industry sector with upstream, downstream and end-to-end supply chain capacities being established to respond to a rapidly growing demand in healthcare.

An analysis of strategic dependencies and of available capacities in Europe, is in this respect essential, but needs to then be followed by the right policy framework to foster both innovation as well as production and sharing investments from public and private partners to create strong R&D and manufacturing capabilities for the future.

We’re pleased to see the Manifesto Towards a Health IPCEI launched by the French Presidency to the EU signed by sixteen member states, marking strong support of an IPCEI for health.

2. Bringing transformative therapies to patients

With a strong R&D presence, investments creating new partnerships in research and almost 40 production sites across Europe, we at Sanofi are a major part of Europe’s pharmaceutical value chain. We’re building on a world-class pipeline which is accompanied by a transformed and modernized industrial network. We’re not only building the capacity to deliver our science of tomorrow but we’re also playing our part to respond to societal concerns such as equipping our systems to be prepared to respond to future health threats.

We have made significant investments in France to increase our capacity for vaccines research and production and contribute to future pandemic risks. We’re creating an Evolutive Vaccines Facilities (EVF), as a new production site concept and a research center in France which will be dedicated to vaccines.

EVF is a new type of factory designed around a central unit, housing several fully digital production modules that make it possible to produce three to four vaccines simultaneously and based on different technologic platforms (including classical Biologics approaches, or mRNA), versus only one in current industrial sites. This modularity will make it possible to prioritize the production of a specific vaccine in a timely manner based on public health issues.

This contributes to Europe’s growth and technological competitiveness and will support the region’s future autonomy in health. The ambition to build European-owned strategic autonomy, to become more resilient in facing healthcare, economic and technological challenges is essential, especially in our times of recovery.

3. Transforming our industrial network to embrace the digital and green transition

Looking at our own journey of digital transformation, we are realizing a twin goal. We’re of course looking at accelerating our performance and efficiency in our industrial network but doing so is also the key enabler to serve a collective agenda with our goal to be carbon neutral by 2030 and to have net-zero carbon emissions by 2050.

In this context, we’re continuing to execute a significant investment plan to digitalize our factories, across 15 sites in Europe which represents more than 300M€ in five years to improve all aspects of manufacturing and supply operations ranging from yield, productivity, quality, flows and including direct connectivity with both suppliers and customers alike, to build a true value stream, across the entire pharmaceutical eco-system. Our ambitions, furthermore, includes our sites’ comprehensive plan to improve their footprint and impact on levels of energy, water and waste.

For example, our manufacturing site in Sisteron (France) is a clear illustration of our commitment to build such a sustainable future. We created a fully automated and digitalized chemistry unit to accelerate the launch of new, specialized small chemical molecules for potentially life-changing oncology and specialty medicines. This unit is also an integral part of our ambition to reduce our environmental footprint and shift towards green pharmaceutical chemistry, through improved waste management and air recycling allowing 40% reduction of the site’s electricity’s consumption.

Another compelling example is the development of a launch unit for the industrialization of small molecules in the field of rare, autoimmune and oncology in Scoppito (Italy). In this world center of excellence, we use the most advanced digital technologies and apply energy consumption targets aimed at zero emissions.

We are and will continue to play our part on the transition to a healthy planet, but we must continue to work hand in hand with our public counterparts. To build on the momentum, there is a need to develop common regulations on environmental footprint to accompany the green transition, maintaining market attractiveness for instance through sustainable procurement models including relevant criteria for pharmaceuticals, or vaccines produced with high environmental standards.

And we also need to reflect on this green transition in the IPCEI in health by incorporating innovative bioproduction, greening production technologies and processes into its scope.

I believe Europe can make a difference and has the means to take a leading global role in this important policy area for the future autonomy of the Union.

Europe also has everything it takes to become a world-class life science hub. We saw that the first initiatives taken to respond to the pandemic go in the right direction. But we need to think beyond that.

Benchmarking ourselves with other sectors is always inspiring. The European Chips Act is worth looking at as it recently proposed a compelling case of a bold and comprehensive approach. It combines a mix of public funding for research, industrial innovation, industrial production capacity and supply chain-focused actions, with the specific regulation and international partnerships. The recipe for success is there with clear short and mid-term roadmap and well-defined KPIs shared across the EU and its member states. We hope other key sectors, including health, can be looked at through a similar lens.