EU PHARMA FORUM

Be part of an important discussion about the new EU regulation for the innovative and generic pharmaceutical industry!

April 15, 2025 Hotel International

Miramarska cesta 24, Zagreb – Hall Market I
Agenda

Find out how the future of the European pharmaceutical sector will be defined!

Join us at EU Pharma Forum 2025 to create space for constructive discussions, exchange views and opinions, and explore challenges and opportunities in the healthcare sector together!

ABOUT THE CONFERENCE

The EU Pharma Forum is a leading event that provides an in-depth analysis of the impact of the first major reform of European pharmaceutical legislation. Through dialogue and the exchange of expert perspectives, we discuss the strategic implications of the reform, define challenges, and explore opportunities for the pharmaceutical industry in Croatia and Europe.

EU Pharma Forum 2025.

EU Pharma Forum 2025. participants

It is crucial to regulate processes so that medicines, once available on the EU market, become available to Croatian patients as quickly as possible and at an affordable price, with the Pharma Package enabling fairer access even in smaller countries like Croatia. At the same time, we must clearly define which medicines are considered critical and determine the level of EU reserves needed to prevent shortages, especially in times of crisis.
Irena Hrstić
Ministrica zdravstva Republike Hrvatske
A balanced regulatory framework is needed—one that supports both innovative and generic manufacturers equally; streamlining procedures must not compromise the quality and safety of therapies.
Tomislav Sokol
Zastupnik u Europskom parlamentu
Market withdrawals are often driven by unsustainably low prices and administrative burdens; a more stable pricing policy is needed.
Ana Gongola
HUP UPL / Sandoz / Lek
Generic and biosimilar medicines are the foundation of healthcare system sustainability and expanding access to therapies while controlling costs.
Adrian van den Hoven
Medicines for Europe
Legislation must adapt to new market developments; increased investment and stronger incentives for innovation are needed
Mislav Vučić
JGL / HUP UPL
The reform should strengthen the rights of patients and payers and ensure transparency and value for money across the entire chain.
Yannis Natsis
ESIP
Fragmentation of the EU market and differences in national rules lead to unequal access to medicines; greater alignment is required.
Ivan Bumber
Pfizer
The focus on innovation must remain in the EU for the Union to stay—and become—stronger; we need to recognize our strengths and build partnerships.
Claus Runge
Bayer
Shortening and simplifying procedures will accelerate access to therapies without compromising safety.
Nikolina Dizdar Čehulić
HUP Pliva
A well-functioning Internal Market is essential to unlock the full potential of savings for national healthcare systems delivered by parallel trade. It is equally important to prevent and remove unnecessary and disproportionate import/export restrictions that distort the market and can reduce the availability of medicines.
Margriet Keijzer
Secretary General, Affordable Medicines Europe
Protecting regulatory data is essential to safeguard sustainable investment in innovation and to consistently deliver new therapies to patients.
Roberta Savli
EFPIA
This conference is strategically important, and it is necessary to bring industry, institutions, and decision-makers together at the same table more frequently so that processes move faster and the adopted documents include all stakeholders and address the challenges they face from patients and the healthcare system to the pharmaceutical industry and legislation.
Siniša Tomić
Ravnatelj HALMED-a

Goals of the EU Pharma Forum

Providing a Platform for Key Stakeholders

Serving as a central hub for identifying challenges and opportunities within the EU pharmaceutical sector arising from legislative changes under the "Pharma Package."

Encouraging Collaboration and Innovation

Fostering cooperation among all relevant healthcare system stakeholders to develop high-quality solutions and address challenges for the benefit of all EU citizens.

Addressing Key Challenges

Ensuring availability for medicine combating antimicrobial resistance, enhancing the sustainability of the industry, and accelerating access to new therapies, especially for rare diseases.

Why Participate?

The forum brings together key players in the healthcare system, enabling networking and dialogue at the highest levels.
The forum provides an understanding of regulatory changes at the European level that will impact all healthcare systems.
The forum facilitates the exchange of ideas to achieve a balance between innovation and the accessibility of new therapies.

Don’t miss the opportunity to be part of this important event!

By participating, you become part of an important discussion, ensure your voice is heard, and actively contribute to shaping policies that will define the pharmaceutical industry in the coming years.
More info on the EU pharmaceutical legislation reform

AGENDA

Welcome and introductions of the Event   

08:30 – 09:00

Registration

09:00 – 09:05

Welcome and introduction of the Event

Antonija Mandić, moderator

09:05 – 09:10

Opening Remarks

  • Welcome and introduction of participants
  • Overview of the event and topics

Ana Soldo, President of Croatian Chamber of Pharmacists

Session 1 – The future of the European Health Union

09:10 – 09:20

Single European market for medicines

  • Reform of EU Pharmaceutical Legislation: How will the Pharma Package impact the European and Croatian healthcare systems and patients?

Keynote speaker: Tomislav Sokol, Member of the European Parliament

09:20 – 09:25

Croatian perspective on the EU Pharma Package

  • HALMED’s role in the context of the new pharmaceutical regulatory framework

Keynote speaker: Siniša Tomić, Head of Agency for Medicinal Products and Medical Devices of Croatia, HALMED

09:25 – 09:30

Aspirations of EU legislative initiatives on medicines

  • JAZMP’s role in the context of the new pharmaceutical regulatory framework

Keynote speaker: Momir Radulović, Executive Director of Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, JAZMP

09:30 – 09:40

Impact of the reform on regulatory data protection

  • Incentive system for the protection of regulatory data

Keynote speaker: Goranka Marušić Kontent, Advisor for European Affairs in Agency for Medicinal Products and Medical Devices, HALMED

Session 2 – Regulatory Data Protection and Proposal for a new incentive’s framework

09:40 – 09:50

Regulatory Data Protection and Proposal for a new incentive’s framework

Keynote speaker: Roberta Savli, Executive Director of Public Affairs, EFPIA 

09:50 – 10:30

Panel discussion: “Ensuring the availability of medicines while supporting the competitiveness of the EU’s pharmaceutical industry”

  • Discussion on the EU’s proposal to shorten regulatory data protection and orphan market exclusivity baseline for innovative pharmaceuticals
  • Will the incentive package be sufficiently attractive for the innovative industry?
  • Will the reform ensure improved access to innovative medicines for all EU member states?
  • Can the new legislation bring back research and development of new medicines to the EU?
  • Implications & analysis

Panel participants: 

  • Roberta Savli, Executive Director of Public Affairs, EFPIA
  • Ana Soldo, President of Croatian Chamber of Pharmacists 
  • Tomislav Sokol, Member of EU Parliament
  • Goranka Marušić Kontent, Advisor for European Affairs, HALMED
  • Yordan Aleksandrov, Senior Manager EU Government Affairs, Pfizer
  • Adrian van den Hoven, General Director of Medicines for Europe
10:30 – 10:45 COFFEE BREAK

Session 3 – The Role of Legislations on Investment for Innovation

10:45 – 10:55

The Role of Legislations on Investment for Innovation – Introduction into discussion

Keynote speaker: dr. Claus Runge, Chief Health Equity Officer SVP, Global Head of Public Affairs, Sustainability & Int. Engagement, Bayer

10:55 – 11:35

Panel discussion: “Challenges and opportunities in drugs availability”

  • Access and affordability of drugs across all 27 Member states
  • What approaches can be taken to make the EU a more appealing destination for investment in innovation?
  • What are some examples from EU countries that have successfully accelerated patient access to innovative products?
  • What strategies can the EU implement to strengthen its economic resilience against current geopolitical shocks?

Panel participants:

  • Ana Soldo, President of Croatian Chamber of Pharmacists
  • Claus Runge, Chief Health Equity Officer SVP, Global Head of Public Affairs, Sustainability & Int. Engagement, Bayer
  • Tea Strbad, Assistant for medical affairs in Croatian Health Insurance Fund, HZZO
  • Nikolina Dizdar – Čehulić, Chief Financial Officer, Pliva/Teva
  • Mislav Vučić, Chief Executive Officer, Jadran-Galenic Laboratory, Croatian Employers’ Association – Pharmaceutical Industry Association, HUP

Session 4 – The Role of Generic and Biosimilar Medicines in Enhancing Access

11:35 – 11:45

The Role of Generic and Biosimilar Medicines in Enhancing Access – Introduction into discussion

Keynote speaker: Adrian van den Hoven, Director General Medicines for Europe

11:45 – 12:25

Panel discussion: Will the EU pharmaceutical legislation reform lower the price of the medicines in the EU and ensure new drugs are more accessible?

  • Analysis of the patent expiration gap and generic availability
  • Discussion on improving access to medications
  • Bridging the gap: Ensuring equitable access to medicines across the EU
  • The Role of Generic and Biosimilar Medicines in Enhancing Access

Panel participants: 

  • Roberta Savli, Executive Director of Public Affairs, EFPIA
  • Adrian van den Hoven, Director General for Medicines for Europe
  • Ana Gongola, Croatian Employers’ Association – Pharmaceutical Industry Association, HUP. Member of the Management Board of Sandoz Croatia, and Director of Commercial Operations, Lek Slovenia
  • Eva Šintić, Acting Head of Department for Utilisation and Prices of Medicines, HALMED
  • Jelena Matuzović, Head of Medicine Service in Croatian Health Insurance Fund, HZZO
12:25 – 13:05  LUNCH BREAK

Session 5 – Financial aspect of the reform

13:05 – 13:15

Impact of the Pharma Package on healthcare financing

Keynote speaker: Yannis Natsis, Director of the European Social Insurance Platform, ESIP

13:15 – 13:55

Panel discussion: How will the EU legislative reform impact healthcare financing and the health market supply chain?

  • How will the reform affect healthcare system financing? Will services become more expensive?
  • Who will bear the financial burden of a potential price increase?
  • Impact of the Pharma Package on the health care market supply chain
  • Medicine shortages

Panel participants:

  • Jorge Batista, Senior Professional Affairs Advisor of the European Community Pharmacists (PGEU)
  • Yannis Natsis, Director of the European Social Insurance Platform, ESIP
  • Tea Strbad, Assistant for medical affairs in Croatian Health Insurance Fund, HZZO
  • Ana Soldo, President of Croatian Chamber of Pharmacists
  • Ivan Bumber, Policy & Public Affairs Lead ASB-HUB, Easter Europe, Pfizer

Session 6 – Challenges in health market supply chain

13:55 – 14:05

Challenges in health market supply chain – Introduction into session

Keynote speaker: Margriet Keijzer, Secretary General of Affordable Medicines Europe

14:05 – 14:45

Panel discussion: The EU response to the health market supply chain

  • Can the EU respond to all challenges in the potential new health crisis
  • Resilience and cohesion of the EU health market
  • Towards a unified future: Strengthening health systems in Europe
  • Role of health insurance in the formation of a single European health market in the medicines’ availability

Panel participants:

  • Ana Kontek, Head of Department for Availability of Medicines, HALMED
  • Diana Percač, President of Association of Wholesale Trade of Pharmaceutical and Orthopedic Products, Trade Department, Croatian Chamber of Economy
  • Yannis Natsis, Director of the Europen Social Insurance Platform, ESIP
  • Margriet Keijzer, Secretary General of Affordable Medicines Europe 
  • Tea Strbad, Assistant for medical affairs in Croatian Health Insurance Fund, HZZO

Session 7 – Closing Remarks and Q&A

14:45 – 15:00

Closing remarks: Ana Soldo, President of Croatian Chamber of Pharmacists

  • Summary of key points discussed
  • Next steps and action items
  • Q&A session
 

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