Health security strategy: strengthening Europe’s pharma industry base
By Olivier Charmeil, Executive Vice President, General Medicines, Sanofi
A resilient and dynamic ecosystem for healthcare innovation is key to strengthening the European Union. A comprehensive strategy brings patient well-being, economic value, and social cohesion.
The COVID-19 pandemic, now officially over, accentuated the European Union’s dependence on third countries, particularly China, for pharmaceutical products. It also highlighted the fragility of supply chains in the face of massive disruption that has led to medicine shortages.
Europe’s industrial response to COVID-19 is of vital concern to all Europeans. We only have to look westwards and eastwards to see countries and regions who are out of the starting blocks and well down the track: The US has forged ahead with its ‘Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States’1, China has unveiled its ‘Dual Circulation Strategy’2 with its stress on state-led growth and self-reliance while India has homed in on its ‘Self-reliant India’3 initiative.
But, what about Europe?
While Europe’s long-delayed revision of its pharmaceutical legislation4 is finally out, its approach towards pharmaceutical supply chains fails to address the critical situation in which the EU finds itself: losing ground in the biopharmaceutical sector.
EU leaders call for a Critical Medicines Act
EU leaders are acutely aware of this as shown by their recent invitation to “continue and accelerate work on the proposed reform of the pharmaceutical legislation, including as regards access to medicines and an innovative and competitive pharmaceutical sector”5. The same goes for the 21 Member States who have supported the Belgian initiative on “Improving the security of medicines supply in Europe”6.
This comes in the footsteps of the European Chips Act and the Critical Raw Materials Act. Like these, this initiative would support European production of essential medicines, vaccines, active pharmaceutical ingredients, and intermediate ingredients for which the EU is entirely dependent on one country or a handful of manufacturers. To dovetail with existing initiatives, it should be complementary to the ongoing review of the pharmaceutical legislation, albeit proceeding at a quicker pace.
This call, in favour of greater European sovereignty in health, is a welcome step. But we believe that a full-bodied European mission must go beyond cutting-edge – green and digital – production of critical medicines towards a real strategy to strengthen Europe’s health security and open strategic autonomy7.
A European Act to strengthen Europe’s health security
Europe will undoubtedly face other pandemics, but it will also have to deal with an increasingly uncertain geopolitical order threatening the stability of its supply chains and perhaps on a grander scale than we’ve seen before
Addressing this will require innovative research, new technologies, and best-in-class manufacturing to walk hand-in-hand, providing the EU with a competitive advantage at global level.
How to achieve such a synergy? By building on Europe’s approach to a clean-energy circular economy, a holistic industrial, innovation and investment strategy encompassing a broad portfolio of policies from digitization and decarbonization to health and trade as well as global health partnerships.
Only by adopting this all-encompassing approach will Europe be able to improve the efficiency of its research and development processes while strengthening its supply chains and reinforcing its position as a leader on key technological platforms and in spearheading innovations.
This would be the embodiment of Sanofi’s philosophy. We are an innovative global healthcare 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 centre of our ambitions.
Advancing the (re)industrialization of Europe
The first step towards health security and sovereignty will be to restore the European Union’s competitiveness at global level by:
1. Facilitating public private collaboration in R&D and advanced manufacturing capacity.
2. Fostering capacity building through HERA (Health Emergency Preparedness and Response Authority) and the recently announced Strategic Technologies for Europe Platform8.
3. Speeding up the regulatory process to ease the uptake of innovative technologies in manufacturing and R&D.
It is reassuring to see that this ambition is also in the mind of Ursula von der Leyen, President of the European Commission, who just re-confirmed her wish to “improve the EU’s capacity to manufacture innovation at scale”9 while driving investments into Europe. This support for innovative industry should also apply to vaccines: as demonstrated by COVID-19, innovative vaccines will be at the forefront of public health responses to future pandemics.
Decarbonising the health ecosystem
At a time when climate change is rightly on everyone’s mind, industrial policy needs to support the greening of the manufacturing process. Responsible for 5% of global emissions, the health ecosystem should figure strongly within Europe’s climate goals and circular economy, with the Net Zero Industry Act10 serving as a blueprint for action.
Starting at product level, measures should range from the first stages of development to advance low-carbon value chains in health by inter alia supporting the generalisation of digital clinical trials, regulatory flexibility and solutions: at Sanofi, our objective is to save 330 tons of plastic per year and achieve carbon neutrality by 2030 for all our products including vaccines.
Combined with the development, and implementation, of EU-wide targets for cutting emissions along the entire patient care pathway, this will pave the way for increased investment in mitigating the environmental impact of healthcare systems.
Building today’s resilience to safeguard tomorrow’s European open strategic autonomy
Beyond the industrial and green components, EU strategy will require a global perspective under the European Global Health Strategy around three main areas:
1. The resilience of supply chains.
2. Crisis response and pandemic preparedness as in the WHO Pandemic Accord negotiations.
3. Global partnerships and trade policy.
As a trusted global actor, the European Union should make full use of international fora (such as the WHO, WTO, United Nations, G7, and G20) to defend such a strategy and reassure its partners that it eschews protectionism and will foster open strategic autonomy by diversifying European supply chains.
In addition, the HERA should be strengthened to prepare for future health emergencies in cooperation with other national and international agencies. This would allow the EU to take the lead in managing priority areas for drawing up medical countermeasures at global level (via target pathogens and technologies).
This renewed focus on health security as a global issue could then translate into bilateral partnerships built on stronger ties when it comes to the manufacturing and supply of pharmaceuticals and vaccines.
Conclusion
The current global context has given the European Union a new impetus to support its strategic industries, first and foremost the pharmaceutical industry.
By proposing a European Act to strengthen Europe’s health security, it would be positioning itself in favour of competitiveness and innovation, while sending out a clear message to foreign investors keen to invest in attractive, stable, and progressive territories.
Crucial for the industry, the European act will ultimately benefit European patients: at a time when shortages are increasing and making life more difficult for patients, we must propose solutions to guarantee them rapid access to vital treatments.
The appeal of the Member States must be heard by the new European Commission which will take office at the end of 2024. At the same time, it will be vital to put into practice the European Council’s ambition to make health a strategic priority for the next five years11.
The time has finally come to close the gap between Europe and its Chinese and American counterparts or lose out definitively in the competitiveness stakes.
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1 Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs
4 EU pharmaceutical legislation
5 European Council meeting (29 and 30 June 2023)
6 Improving the security of medicines supply in Europe
7 The future of EU’s Open Strategic Autonomy: Ensuring citizens’ well-being
8 Strategic Technologies for Europe Platform
9 Statement by President von der Leyen
11 Letter from President Michel on the next Strategicn Agenda
