Pharma boss: EU’s open strategic autonomy needs a European health security act

A comprehensive strategy to build a European health security framework with a broad perspective for action should be at the heart of any efforts regarding EU’s Open Strategic Autonomy from the view of health, Olivier Charmeil, executive vice president of General Medicines of Sanofi told Euractiv in an interview.

As Ministers of Health meet on 30 November in Brussels with the Open Strategic Autonomy in the field of health at the top of the agenda, talks are expected to focus on medicine shortages and resilient supply chains, the EU’s competitiveness, and pharmaceutical strategy.

Growing challenges

As Charmeil pointed out, among the European dependencies already identified is the lack of local access to Active Pharmaceutical Ingredients (APIs) and precursors critical to producing essential medicines.

“Despite de-risking, our dependence in China for the APIs of many critical medicines poses a tangible threat to our common health security”, he said.

Other vulnerabilities (e.g., supply chain challenges and R&D disparities) require a focused and comprehensive approach, as he says, underlining the need for strategic measures to strengthen R&D investment in green active ingredients and key precursors while fostering the sustainability of pharmaceutical production.

Moreover, for Charmeil, urgent and decisive investments are needed to close the gap between European Research & Development (R&D) investments in new pharmaceutical products and advanced therapies compared to competitors in China and the US, respectively, representing 3 and 1.3 times as many clinical trials as the EU.

Critical medicines are just the tip of the iceberg

Commenting on the recent Communication on addressing medicine shortages, Charmeiltalked about a positive first step, mainly dealing with existing vulnerabilities, especially regarding demand-side measures.

Beyond that, more sustainable forms of procurement that could integrate local requirements are essential, along with structural measures to further integrate international partnerships and instruments to foster investments in the EU’s industrial infrastructure.

For Charmeil, “regulation is not a one-stop solution for everything; we all have a role to play in addressing shortages and other dependencies”, he said, adding that Sanofi is ready to play its part and will seek to bring a tangible contribution to the planned Alliance on Critical Medicines.

“Critical medicines are just the tip of the iceberg in terms of our dependencies, while the risks to European competitiveness remain underwater”, he noted.

“Let’s face it, Europe is experiencing a steady and silent decline in this area while other countries outside of Europe are boosting their innovation capacities in biopharmaceuticals”, he said.

Using the example of R&D, he explained that of the total investments made in the US, Europe, China and Japan, only 31% are made in Europe – compared to 41% in 2001.

“At the same time, the emergence of new dependencies, on top of existing ones for certain essential medicines, is not a pipe dream. It is vital that Europe not only looks at today’s situation but promotes innovations as they are critical for developing the medicines of the future”, he said, adding that this concerns health security at a time of significant geopolitical change and intense competition from other countries to attract pharma-related investment.

Three pillars of a Health Security Act

For Sanofi’s officials, today’s ministerial discussion is an opportunity to call on the European Commission to present a comprehensive strategy to build Europe’s health security and broaden its perspective for action.

“We believe in approaches that draw from what we see with the Chips Act or the Critical Raw Materials towards a Health Security Act combining industrial, innovation and investment strategies, based on three pillars: Securing Europe’s health resilience, securing the European way of life through decarbonisation of the health ecosystem, and securing health innovation at the core of Europe’s competitiveness”, he says.

Resilience doesn’t end at supply chains for Sanofi but expands to “building a more impactful and resourced HERA around global partnerships and a trade strategy aligned with Europe’s economic security strategy”.

Regarding a trade strategy that all member states can get behind, Charmeil is convinced that, even though it will “undoubtedly be a bumpy ride”,… “the general interest will prevail once again”. “The EU’s credibility and independence in the face of future pandemics are at stake”.

As for green sustainability, Charmeil stressed the need for a clear decarbonisation strategy for Europe.

“This process can be part of Europe’s global competitive advantage in biopharmaceuticals, with national healthcare systems being a key driver for change”, he added, emphasising that this goes beyond the EU.

“At Sanofi, we hope the work of COP28 to reduce emissions and waste in the healthcare sector will bear fruits. By assessing the greenhouse gas emissions of national healthcare systems, the EU could act upstream, designing an industrial strategy in favour of decarbonisation, and downstream, streamlining prevention to decarbonise the patient care pathway”.

Fostering innovation clusters

“We need to develop an integrated ecosystem for innovation, through research to industrialisation to support cutting-edge science delivery in Europe”, Charmeil said.

According to him, one good option to foster innovation for competitiveness “is to look at fostering innovation clusters”.

“By using the Strategic Technologies for Europe platform to enable technologies that improve research efficiency, the EU can accelerate biopharmaceutical innovation while developing advanced manufacturing and clinical trials. This will ensure that upstream value is matched by good and predictable downstream policy and procurement”, he noted.

“The European Union proves that the continent can achieve great things if it’s moving together and united. Time is of the essence, and it’s crucial to keep the momentum of Open Strategic Autonomy alive,” he concluded.

(Vasiliki Angouridi | Euractiv.com)