European Union policymakers have embraced the concept of “Open Strategic Autonomy” (OSA) in recent years as a response to key challenges, following an approach originally aimed at enhancing the EU’s ability to act independently. The political momentum around OSA has broadened beyond its original scope of energy and defence, including now trace, technology and even industries affecting health provision. The COVID-19 pandemic highlighted the vulnerabilities of global supply chains, prompting a political response that is steadily gaining support across the continent.

However, a crucial challenge has emerged as a result particularly for an innovative area such as healthcare: the need to strike a balance between building a more resilient system and increasing the EU’s competitiveness, avoiding the negative effects of protectionism.

The political priorities on resilience can heavily impact the future of healthcare provision and industry. We, public affairs professionals, have the opportunity to contribute and make this concept appropriate and relevant to ensure not only resilience, but also access to innovation and competitiveness in the years to come. To create the right environment, the key could lie in advocating for further access and innovation as the only way to ensure resilience and autonomy. How can we do this?

1. Recognise this is a multi-faceted challenge: Supply chains, Shortages, Innovation, and Access

The conversation around strategic autonomy in the area of healthcare has primarily revolved around addressing supply chain dependencies and preventing shortages of critical medical products. As part of these efforts, the European Commission has launched in 2024 the Critical Medicines Alliance, a coalition with all involved actors to identify solutions to prevent shortages and disruptions in the availability of essential medicines.

However, the challenge of EU’s Strategic Autonomy and resilience in this area cannot be resolved by only looking at supply chains and prevention of shortages. The European Union is not just grappling with foreign dependencies; it is also experiencing an alarming loss of leadership in healthcare innovation.

The lack of a global level playing field is undoubtedly harming the EU’s position towards other key regions such as the United States and Asia. However, this is no excuse to consider this challenge comprehensively. In fact, EU’s resilience in healthcare is also heavily affected by its regulatory environment, the promotion if innovation and, perhaps less intuitively, access policies in each Member State. As a result, companies are increasingly opting to develop and prioritise marketing their products in other regions, resulting in a slower access to innovative treatments and devices in the EU coupled with a decreased autonomy and resilience. The link between these challenges and their consequences to real patients’ access to innovation should be at the core of messaging.

2. Promote coordination as a response to the current incentives for local production

In response to these challenges, some EU member states have begun adopting policies aimed at boosting domestic production or expanding those where previous similar policies existed. Many governments are introducing preferential pricing and reimbursement (P&R) arrangements to incentivise local manufacturing.

While these policies can contribute to addressing the problem, they come with a potential risk of fragmentation. A competitive environment where Member States prioritise only domestic investments could lead to inefficiencies and, ultimately, undermine the very resilience the EU is striving to achieve.

For strategic autonomy in healthcare to succeed, a coordinated approach is needed. The European Commission must take the lead in promoting EU-wide incentives for local production, and Member States’ policies should always consider the EU as a single market, providing incentives to European actors and not only local ones. The industry can play a vital role in making the case for connecting these incentives across countries.

3. Bridging the gaps: defending and promoting EU competitiveness

Despite some efforts in key areas such as the Pharmaceutical Strategy and legislation, the Health Technology Assessment Regulation, the new Medical Devices Regulations, the Clinical Trials Regulation or the European Health Data Space, the EU seems to lack a comprehensive strategy to prioritise competitiveness in the healthcare sector.

Mario Draghi’s report on the Future of European Competitiveness launched on 9 September 2024 was clear: the pharmaceutical industry (adding to it the medical devices industry, even if only briefly mention in the report) is key to EU’s competitiveness, and innovation is its core. Resilience in innovation is, therefore, vital for EU’s future.

Yet, the current framework of Open Strategic Autonomy could hinder this if it becomes solely focused on reshoring and protectionism. If the EU’s approach to autonomy relies only on these at the expense of open trade and neglecting innovation and investment, the consequences could be devastating to its global competitiveness on the long run. While reshoring may seem like a short-term solution to supply chain vulnerabilities, it risks hampering innovation, raising costs, and isolating the EU from the broader global market.

This approach might also lead to a loss of regulatory leadership, which has long been one of the EU’s strengths. As the world’s largest single market, the EU holds significant influence over global regulatory standards, but this advantage will only be preserved if its regulatory framework remains stable, predictable, and conducive to investment.

To move forward, the EU must embrace a broader vision of Strategic Autonomy in Healthcare, one that prioritizes innovation, access, and regulatory stability alongside resilience. This requires not just addressing supply chain vulnerabilities, but also fostering an environment where scientific development can flourish, and companies feel confident investing in Europe’s true Single Market. Innovative developers should collaborate with policymakers to bring about the necessary changes in a comprehensive way.

Towards a European Health Union for more access and innovation?

Clearly, one potential solution lies in further EU coordination on healthcare policy. Beyond the current EU pharmaceutical legislation, there is a need for harmonized action to improve access to innovative therapies and medical devices across all Member States. But is the EU’s existing governance framework sufficient to achieve this level of coordination (one that has clearly shown its limits, even in moments of crises or even in negotiations of key files such as the HTA Regulation), or do we need more fundamental changes including a revision of the Treaties?

As the question of a Treaties revision is off the table in the short term (as concluded after the recent Conference on the Future of Europe), other instruments could be politically transformed to serve as intermediate but successful solutions.

The recent momentum for a European Health Union could be further expanded, perhaps even without a treaty change. A European Health Union not only based on protecting citizens but also on preserving an innovative and competitive environment could be the best framework for coordinated action among Member States. This initiative could be an opportunity for Member States to voluntarily seek for further legal harmonisation. While in the short term this might lead to a two-speed approach, with some countries moving ahead faster than others, the advances would ultimately be shared across the EU and benefit all patients.

Coordination in access and innovation policies across Member States also poses some challenges in access strategies. However, this could be the way to mitigate the negative risks stemming from an ill-conceived EU Strategic Autonomy. It is vital for public affairs in innovative healthcare industry to explore these strategies together with other functions, including market access, and define satisfactory positions that can hep drive EU’s innovative environment and resilience at the same time.