During the panel discussion ‘Drug safety and competitiveness of the pharmaceutical industry in the new geopolitical reality’, held in the Rzeczpospolita Lounge at the 34th Economic Forum in Karpacz, participants discussed how to reconcile innovation with accessibility, the role of the state with market mechanisms, and national sovereignty with both the functioning of the global market and European solidarity.

Adam Jarubas, a Member of the European Parliament (MEP) and Chair of the Committee on Public Health (SANT), opened the discussion by highlighting the intensive and unprecedented legislative work being undertaken at the EU level to address these challenges.

‘First and foremost, we have the biggest reform of the medicines market in 20 years on the table: the pharmaceutical package. The Polish Presidency has been successful in adopting the position of the Member States, negotiating the shape of this reform between EU countries’, said Jarubas, emphasising that this key achievement paves the way for tripartite negotiations with the European Parliament and the Commission.

Adam Jarubas noted the ambitious plan to complete these negotiations by the end of the year, while also pointing out two other key legal acts integral to the package. ‘The missing link in this package, this constitution for medicines, is the act on critical medicines’, he said. He added that EU Health Commissioner Olivér Várhelyi had honoured a commitment from his appointment hearings by presenting the document. Work on it is now underway in the European Parliament with rapporteur Tomislav Sokol, with the ambition of adopting a negotiating mandate by the year's end.

The third pillar will be the announced act on biotechnology, essential in an era of dynamic development in biological medicines. ‘We want to introduce efficient and effective regulations that will guide new preparations from the invention stage through to implementation and production’, the MEP explained. ‘We hope that these three regulations combined will give Europe’s pharmaceutical sector a strong boost and create a balance between its innovative and generic components, whose importance cannot be ignored’, he added.

Increase in domestic production needed

‘I am glad that awareness of the threat posed by drug insecurity has been recognised in Europe and Poland’, stated Barbara Misiewicz-Jagielak, Director for Public Relations at Polpharma. She noted that a list of critical medicines, essential for saving the lives and health of Europeans, has been drawn up, and expressed hope that mechanisms will one day be implemented to make Europe genuinely independent of medicines and active substances supplied from Asia.

‘These medicines and the active substances they contain – APIs – should be produced in Europe’, emphasised Barbara Misiewicz-Jagielak. ‘During the Polish Presidency, the government argued for a special budget to increase the production of medicines and APIs in Europe. However, I feel there is a lack of coordination between countries on production projects, which is necessary to avoid a situation where we all choose the same medicines. It is better to draw up lists now detailing which products individual countries can and want to produce. I would, however, appeal for us to rely primarily on ourselves and make efforts to produce as many of the most important medicines as possible in Poland. Borders were closed to medicines during the pandemic, and this could happen again’.

Dr Monika Raulinajtys-Grzybek of the SGH for Health think tank contributed a strategic – military, economic, and research-based – perspective to the discussion by referring to two reports. The first concerned drug safety in the context of a potential armed conflict. ‘Just as the pandemic made us aware of epidemiological threats, recent geopolitical events force us to ask whether we are ready for war’, she said.

In this context, she highlighted critical issues such as access to energy, medical and logistical personnel, and securing the production and transport of medicines. Noting that ‘capital does not like unrest, capital does not like war’, she argued that it is therefore the state's task to stabilise the economy and create incentives through industrial policy.

The second report, which analysed supply chains for cardiac drugs, reached more pessimistic conclusions. It found that while some production occurs in Poland, China and India dominate the global supply of active substances, with Spain being the key producer within Europe. ‘The key question is how to strengthen the entire supply chain, starting with what we can do at home’, emphasised Monika Raulinajtys-Grzybek.

The growing gap between Europe and the US

Wiktor Janicki, President of AstraZeneca Pharma Poland, also addressed the link between drug safety and competitiveness. ‘These two issues are closely related, as are innovation and generics. The entire pharmaceutical market cannot function without these two pillars’, he emphasised.

He drew attention to the rapidly growing investment gap between the European Union and the United States. ‘In 2002, R&D expenditure was €2 billion lower, and by 2022, it was €25 billion lower. This gap is widening dramatically’, warned Wiktor Janicki. He believes regulatory initiatives such as the Biotech Act are necessary to prepare Europe for emerging treatments like cell and gene therapies.

Wiktor Janicki pointed out that competitiveness is determined not only by EU funds but, more importantly, by solid foundations: stable and predictable laws, better cooperation between science and business, access to anonymised medical data, and effective intellectual property protection. ‘The industry already invests 20-25% of its revenue in research and development, but our future is determined not by money alone, but by the stability of the investment environment’, said the AstraZeneca Pharma Poland CEO, adding that intellectual property rights are ‘crucial from the perspective of long-term investments’.

Janusz Cieszyński, MP and former deputy health minister, also addressed the topic of competitiveness, albeit with considerable scepticism.

‘Ambitions are best measured by the budget. And today, these expenditures are very low’, he noted, arguing that with limited resources, Poland cannot pursue all its strategic goals simultaneously. ‘I don’t see that we have a strategy in Poland to improve drug safety or any specific, large-scale measures in place’, he added.

As an example, he cited the state-owned company Tarchomin, which is struggling with serious liquidity problems and a PLN 100 million deficit, while also sharply criticising symbolic actions that end in ribbon-cutting ceremonies without producing lasting results.

In terms of geopolitics, Janusz Cieszyński cited American strategic documents that predict a potential conflict with China over Taiwan as early as 2027. ‘This would be a very difficult moment for Poland’, he emphasised.

He argued that as a US ally in NATO, Poland would have to accept painful sacrifices in its economic relations with China. He also noted that preparations for such a scenario, while often secret, are necessary not only for medicines but for other technologies as well.

Europe needs change

Iwona Pająk, Director of Public Affairs at Novartis Poland, highlighted the key conditions for building the European pharmaceutical sector's competitiveness while also drawing attention to an alarming investment gap. ‘Europe’s share of global clinical trials has fallen from 44% in 2009 to 21% in 2024, far behind the US (35%) and China (30%)’, she said.

‘Firstly, it is necessary to increase spending on healthcare, both in Poland and across Europe’, she emphasised, adding that developing R&D investment incentives and supporting strong industrial ecosystems are also essential to ensure Europe remains a competitive place for breakthrough discoveries.

She considered investments in prevention and the better use of digital tools and artificial intelligence to be equally important, and also pointed to the need for a fundamental change in thinking: to treat healthcare not only as a human right but also as a strategic resource and a pillar of economic development.

Iwona Pająk emphasised the direct link between the geopolitical situation and the sector's competitiveness, arguing that it is essential for Europe to prioritise policies that reward health innovation and support long-term growth in biopharmaceutical research.

‘What exactly is competitiveness? Can Europe really call itself competitive?’ posed Justin Gandy, managing director of MSD Poland. ‘If we treat it as a competition, Europe would lose. The gap has become enormous’, he said.

He argued that the ‘Old Continent’ should focus on its strengths: specialists, knowledge, and existing infrastructure. While the pharmaceutical industry plans for the long term, Gandy pointed out that Europe too often focuses on short-term costs instead of the long-term benefits of investment. ‘If we focus only on costs, we are acting short-sightedly. And that means a lack of continuity’, emphasised the managing director of MSD Poland.

He considered it necessary to build broad public-private partnerships and foster joint action across the European Union, instead of competition between its 27 member states. ‘Drug availability is a priority that requires joint action by the private sector and public institutions’, said Justin Gandy.

Financial challenges

Referring to the new EU financial perspective for 2028-2034, Adam Jarubas highlighted a significant change in the budget architecture: the merger of 14 sectoral funds into a single European Competitiveness Fund. ‘Four windows will be created, one of which will cover health and biotechnology, while the others will cover digitalisation, defence, decarbonisation, and economic competitiveness’, he explained.

From a health perspective, he noted that the lack of a separate programme like the current EU4Health is worrying. This programme, the largest of its kind for 2021-2027 with a budget Jarubas described as ‘only’ €5.3 billion, also had ‘a dedicated funding path’.

The MEP emphasised that since the EU budget accounts for only about 1% of the Community's GDP, the burden of financing healthcare still rests with Member States. However, he noted that a well-conducted European policy can stimulate significant cooperation and research, as exemplified by the European Reference Networks for rare diseases. He added that as much as one-fifth of the new budget will be allocated to repaying the loan from the Next Generation EU recovery fund, further limiting the scope for new priorities.

Justin Gandy stated that research, development, and innovation must be a pillar of the new EU financial perspective, alongside modernising how clinical trials are conducted and attracting investment to this area. He stressed that the health sciences sector in Europe generates around €1.5 trillion annually and employs 29 million people. ‘In this context, allocating $10 billion by 2030 is a significant step in the right direction’, he said.

However, Gandy noted that success requires cooperation and realistic prioritisation. ‘If the right people don't sit down at the table, if we don't define a common goal, we will try to solve everything at once, and as a result, we will not solve any of the current challenges’, he warned.

This is also the purpose of the Hack4Health initiative, which aims to prepare recommendations for public health as a key factor in economic development and national security. These recommendations include proposed systemic changes to healthcare financing—such as altering the paradigm for calculating programmed expenditure based on GDP from two years prior (t-2) – in favour of proactive planning over ad hoc responses to current needs.

Justin Gandy emphasised that, from the EU's perspective, it is crucial to invest steadily in research and innovation, modernise clinical trials, and use existing experience and investments to benchmark and drive further competitiveness.