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The role of European legislation in investment in innovation (10 min)

Adriana Funderáková Beňová - , Innovative Pharmaceutical Association Slovakia ·

Europe has the potential to become a leader in the research and development of new medicines, but geopolitical changes require a rethink of healthcare approaches. Policymakers have a choice: continue in the same vein, caring for an increasing number of people. At the same time, budgets stagnate or even decline, or rethink how healthcare is organized and how budgets are allocated. This means taking a more strategic approach to investments that will improve patient health, strengthen healthcare sustainability, and deliver long-term economic growth and security. Adequate intellectual property protection is key to the sustainability of drug development and investment in the EU. The proposed legislative changes in this area may weaken the innovative pharmaceutical industry and widen the gap in competitiveness and availability of medicines, including in Slovakia. It is essential to thoroughly assess these changes and their impact on the healthcare sector.

Innovation in healthcare is not only about artificial intelligence and digital hospitals, but also about new medicines. Their path to European patients, however, is getting longer and more complicated. What does this mean for Slovakia and what changes are being prepared in Brussels?

Why Europe is losing ground

The share of clinical trials in Europe has fallen by roughly six percentage points over the past decade, and investments are shifting to more predictable environments, especially the United States. The reasons include weaker intellectual property protection and a fragmented market: in the United States, a decision applies to the entire market at once, whereas in the EU reimbursement decisions are made in 27 countries. The draft so-called European pharma package also envisages shortening regulatory data protection by two years, which increases investor uncertainty. The pharmaceutical sector is simultaneously facing additional regulations, such as chemical legislation and the directive on the treatment of urban wastewater.

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Adriana Funderáková Beňová

Innovative Pharmaceutical Association Slovakia and Bayer
PharmDr. Adriána Funderáková Beňová is a pharmaceutical executive with over 18 years of experience. She currently serves as Head of Public Affairs at Bayer, where she develops impactful strategies to enhance Bayer’s reputation and operational flexibility across Czech, Slovakia, Slovenia, and Croatia. Her efforts align with the company’s global p…

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