At a pivotal moment when the European Union re-evaluates its dependence on external suppliers for essential medicines and pharmaceutical ingredients, the central message from the recent Medicines for Europe Annual Conference in Athens was clear: the off-patent medicines sector must be recognized not merely as a cost-containment tool for health systems but as a strategic asset vital for Europe’s economic resilience and health security.
A Crossroads for European Pharmaceutical Production
Europe stands at a critical juncture, facing a fundamental choice: to actively maintain its position as a pharmaceutical producer or to increasingly cede ground to imports. This stark assessment, voiced by political leaders and industry representatives at the Athens summit, underscores a broader shift in the EU health agenda, where discussions on strategic autonomy, supply security, and industrial competitiveness have taken center stage.
The off-patent medicines sector is a cornerstone of European healthcare, supplying approximately 70% of all medicines used across the continent. It supports a substantial workforce of around 190,000 highly skilled individuals and operates over 400 manufacturing sites throughout the EU. These figures alone highlight the sector’s significant contribution to both public health and economic stability.
Greece: A Model for Pharmaceutical Resilience?
For Greece, the implications of this debate are particularly profound. Over the past decade, the nation has emerged as a significant pharmaceutical manufacturing and research hub in southeastern Europe. With 51 manufacturing facilities, 31 research and development centers, and more than 15,000 direct jobs, the Greek pharmaceutical industry has become a dynamic force within the national economy.
Minister of State Akis Skertsos lauded the industry as “one of the most dynamic sectors of the Greek economy” and a “strategic pillar of Europe’s resilience and competitiveness.” He emphasized that strengthening Europe’s pharmaceutical production capacity is not just an economic imperative but a matter of strategic autonomy and security. Reliable access to critical medicines, he argued, is an essential component of a stronger and more resilient Europe. Skertsos also linked Greece’s ambitions in this sector to its upcoming Presidency of the Council of the European Union in 2027, signaling the country’s intent to actively shape Europe’s future health and industrial agenda.
Theodore Tryfon, President of the Panhellenic Union of Pharmaceutical Industries (PEF) and vice-president of Medicines for Europe, echoed these sentiments. He asserted that recent geopolitical upheavals have fundamentally altered the role of the off-patent medicines industry, stating, “Access to affordable medicines cannot be taken for granted – it must be actively secured.” Tryfon stressed that resilient supply chains are not optional but a strategic imperative, and a strong European manufacturing base is essential for autonomy and stability.
The Greek “Investment Clawback” Mechanism: A Blueprint for Success?
A significant portion of the conference was dedicated to Greece’s innovative approach to supporting domestic pharmaceutical production through public-private partnerships and targeted industrial policies. Health Minister Adonis Georgiadis highlighted the “investment clawback” mechanism, which allows pharmaceutical companies to offset mandatory clawback payments by investing in production facilities, research, and development.
According to Georgiadis, this scheme has already catalyzed over €1.5 billion in investments with less than €500 million in public financing. He projected that these investments are now maturing, and in the coming years, Greece will “practically double the size of our internal pharmaceutical industry.”
The minister also drew attention to Greece’s multi-winner procurement model, introduced during the financial crisis to combat medicine shortages caused by single-winner tenders. This revised system awards contracts to multiple suppliers, ensuring supply continuity while fostering competition. Georgiadis proudly declared that Greece is “a country with the least shortages of medicines throughout Europe,” suggesting that this model could offer valuable lessons for other member states as Brussels advances the implementation of the Critical Medicines Act.
Europe’s Competitiveness Challenge and Regulatory Hurdles
Steffen Saltofte, president of Medicines for Europe and CEO of Zentiva, articulated Europe’s fundamental choice: to be a consumer or a producer. He argued that the EU’s regulatory and pricing frameworks have lagged behind a rapidly changing global environment, while competitors like the United States, China, India, and Japan are moving more swiftly to attract pharmaceutical investment. Saltofte emphasized that without a foundational structure for off-patent medicines in Europe, it becomes challenging to continue serving patients effectively. He called for greater regulatory coherence, enhanced collaboration between member states, and reforms to outdated pricing systems.
Another significant concern raised by manufacturers was the impact of environmental legislation, particularly the Urban Wastewater Treatment Directive, on pharmaceutical production. While expressing support for Europe’s environmental objectives, speakers cautioned that implementation must be rooted in robust scientific evidence and carefully consider potential impacts on medicine availability and industrial competitiveness.
Saltofte criticized the scientific basis of certain elements of the current Urban Wastewater Treatment Directive, urging policymakers to engage in an “adult conversation on facts” before imposing additional costs on manufacturers. Georgiadis echoed these concerns, warning that environmental measures introduced without a comprehensive assessment of their industrial and healthcare implications could inadvertently undermine Europe’s strategic autonomy and health security goals. “If pharmaceutical production in Europe starts to decline, we will eventually face shortages,” he stressed, advocating for a balance between environmental objectives and the preservation of Europe’s industrial base.
Looking Towards Greece’s 2027 EU Council Presidency
The conference repeatedly circled back to the question of Europe’s long-term pharmaceutical strategy and the crucial role Greece could play during its EU Council Presidency in 2027. For both policymakers and industry leaders, the challenge extends beyond medicines alone, encompassing industrial policy, economic competitiveness, technological innovation, and Europe’s capacity to maintain strategic autonomy in an increasingly fragmented world.
Tryfon concluded by asserting that Europe possesses the necessary scientific expertise, industrial capacity, and talent to succeed, but requires greater alignment among governments, industry, patients, and European institutions. He summarized the situation succinctly: “Europe stands at a crossroads. If it seeks genuine strategic autonomy, resilient health systems and security of supply, it must invest in its own productive base.” The Athens summit served as a powerful call to action, urging Europe to make a decisive choice for its pharmaceutical future.
Source: https://www.euractiv.com/news/eus-off-patent-medicines-industry-calls-for-industrial-strategy-at-athens-summit/
