EU PHARMA FORUM

Discussion on Pharmaceutical Regulations and Data Protection in the EU

Petak, 7. veljače 2025.
Mozaik event centar, Zagreb

EU Pharma Forum središnja je platforma za analizu stvarnih učinaka prve velike europske reforme zakonodavstva o lijekovima nakon 20 godina; mjesto koje okuplja ključne dionike iz zdravstvenog sektora s ciljem konstruktivne rasprave i razmjene iskustava i stavova o novim izazovima i prilikama koje reforme donose te budućim smjerovima razvoja zdravstvenih politika u Europi, pa tako i u Hrvatskoj.

EU Pharma Forum 2025. – započinje li nova era europskog zdravstva?

EU Pharma Forum mjesto je okupljanja relevantnih dionika iz sektora zdravstva – od donositelja odluka i regulatornih tijela do udruga pacijenata i farmaceutske industrije. Forum pruža jedinstvenu priliku za raspravu o budućnosti europskog zdravstvenog sustava u kontekstu najnovijih zakonskih inicijativa, poput “pharma paketa”, koji će se odraziti na regulaciju tržišta lijekova, pristup pacijenata lijekovima, inovacije u farmaceutskom sektoru, kao i na održivost zdravstvenih sustava u EU.

Ciljevi EU Pharma Foruma:

Pružiti platformu za ključne dionike

Forum služi kao središnje mjesto za prepoznavanje i tematiziranje izazova i prilika unutar promjena farmaceutskog područja EU-a koje dolaze s izmjenama zakonodavstva u okviru „farmaceutskog paketa”, stvarajući prostor za zajedničku, konstruktivnu raspravu.

Poticati suradnju i inovacije

Forum služi kao središnje mjesto za prepoznavanje i tematiziranje izazova i prilika unutar promjena farmaceutskog područja EU-a koje dolaze s izmjenama zakonodavstva u okviru „farmaceutskog paketa”, stvarajući prostor za zajedničku, konstruktivnu raspravu.

Raspravljati o ključnim pitanjima budućnosti hrvatskog i europskog zdravstva

Forum se bavi temama kao što su pristup lijekovima, borba protiv antimikrobne rezistencije, održivost farmaceutske industrije i ubrzanje pristupa novim terapijama, adresirajući ključne izazove i smjernice razvoja sektora.

Zašto sudjelovati u EU Pharma Forumu?

Forum je prilika za dublje razumijevanje zakonskih i regulatornih promjena na europskoj razini, koje će imati direktan utjecaj na hrvatsko (i slovensko) zdravstvo.

Forum je mjesto za razmjenu ideja o jačanju zdravstvenih sustava u EU-u, postizanju ravnoteže između istraživanja i pristupačnosti, te osiguravanju jednakog pristupa lijekovima i zdravstvenoj skrbi.

Forum okuplja ključne dionike iz zdravstvenog sektora, stvarajući jedinstvenu priliku za umrežavanje i dijalog na visokom nivou.

Ne propustite priliku biti dio ovog važnog događaja!

Pridružite nam se na EU Pharma Forumu 2025. kako bismo otvorili prostor za konstruktivnu raspravu, razmjenu stavova i mišljenja, te zajednički razmatrali izazove i prilike u zdravstvenom sektoru!

Agenda

EU PHARMA FORUM

Discussion on Pharmaceutical Regulations and Data Protection in the EU

7. veljače 2025.
Mozaik event centar, ZAGREB

Opening Remarks                                

09:00 – 09:15 h (15 minutes)

Welcome and introduction of participants
Overview of agenda topics

Moderator TBD

Session 1: The future of the European Health Union

09:15 – 09:35 h (20 minutes)

Single European market for medicines

Representative of the EC 

09:35 – 09:45 h (20 minutes)

Croatian position on the EU Pharma Package

How is the new pharma package going to impact Croatian patients?

Representative of the working group of the Ministry of Health of the Republic of Croatia

09:45 – 09:55 h (20 minutes)

Slovenian position on the EU Pharma Package

How is the new pharma package going to impact Slovenian patients?

Representative of the working group of the Ministry of Health of the Republic of Slovenia

Session 2: Regulatory Data Protection and Proposal for a new incentives framework

09:55 – 10:05 h (10 minutes)

Discussion on the EU’s proposal to shorten regulatory data protection and orphan market exclusivity baseline for innovative pharmaceuticals

Implications & analysis

10:05 – 10:45 h (40 minutes)

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

Representatives of innovative and generic pharmaceutical industry; institutional representatives from Croatia and Slovenia and the EU

10:45 – 11:00 h (15 minutes) COFFEE BREAK

Session 3: The Role of Legislation on Investment for Innovation

11:00 – 11:10 h (10 minutes)

Overview of mandatory of drugs in all 27 EU member states

Mandatory drug launchacross the EU member states

Impact on member states, particularly regarding orphan drugs

Obligation to launch orphan drugs process

Member states’ concerns about imposed regulations

How to build on past legislations to incentivize more innovation?

What are the most important EU legislations pending adoption and what recommendations participants must make sure these incentivise innovation and attract investments.

What are the legislations ahead and how can these be leveraged?

 

11:10 – 11:50 h (40 minutes)

Panel discussion: “Challenges and Opportunities in Registering Pediatric and Orphan Drugs Across the Europe”

Representative of innovative pharmaceutical industry; institutional representatives from Croatia and Slovenia and the EU

Session 4: Clinical Trials in the EU & Innovative Therapies for Smaller Markets

11:50 – 12:05 h (15 minutes)

Examination of the need for innovative therapies in smaller markets

Critique of current reforms and their failure to achieve this goal

Overview of the regulatory impact on clinical trials

Discussion on how increased costs might deter innovative research

 

12:05 – 12:45 h (40 minutes)

Panel discussion: “How Regulatory Changes Impact Innovation: Are We on the Right Track?”

Representative of innovative pharmaceutical industry; institutional representatives from Croatia and Slovenia and the EU

12:45 – 13:45 h (60 minutes) LUNCH BREAK

Session 5: The Role of Generic and Biosimilar Medicines in Enhancing Access

13:45 – 13:55 h (10 minutes)

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

 
13:55 – 14:35 h (40 minutes)

Panel discussion: Are generics going to lower the price of medicines in the EU and ensure new drugs are more accessible?

Representative of innovative and generic pharmaceutical industry; institutional representatives Croatia and Slovenia and the EU

Session 6: Challenges in pharma supply chain

14:35 – 14:55 h (20 minutes)

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

Session 7: Closing Remarks and Q&A

14:55 – 15:15 h (15 minutes)

Summary of key points discussed

Next steps and action items

Q&A session

15:15 – 16:30 h After Work Networking – Coffee break

Agenda

TimeDurationTopicSpeaker
Opening Remarks
09:00 – 09:15 15 minutesWelcome and introduction of participants

Overview of agenda topics
Moderator TBD
Session 1: The future of the European Health Union
09:15 – 09:3520 minutesSingle European market for medicines
Representative of the EC
09:35 – 09:4520 minutesCroatian position on the EU Pharma Package
How is the new pharma package going to impact Croatian patients?
Representative of the working group of the Ministry of Health of the Republic of Croatia
09:45 – 09:5520 minutesSlovenian position on the EU Pharma Package
How is the new pharma package going to impact Slovenian patients?
Representative of the working group of the Ministry of Health of the Republic of Slovenia
Session 2: Regulatory Data Protection and Proposal for a new incentives framework
09:55 – 10:0510 minutesDiscussion on the EU’s proposal to shorten regulatory data protection and orphan market exclusivity baseline for innovative pharmaceuticals

Implications & analysis
10:05 – 10:4540 minutesPanel discussion: “Ensuring the availability of medicines while supporting the competitiveness of the EU’s pharmaceutical industry” Representatives of innovative and generic pharmaceutical industry; institutional representatives from Croatia and Slovenia and the EU
10:05 – 10:4515 minutesCOFFEE BREAK
Session 3: The Role of Legislation on Investment for Innovation
11:00 – 11:10 10 minutesOverview of mandatory of drugs in all 27 EU member states
Mandatory drug launchacross the EU member states
Impact on member states, particularly regarding orphan drugs
Obligation to launch orphan drugs process
Member states’ concerns about imposed regulations
How to build on past legislations to incentivize more innovation?
What are the most important EU legislations pending adoption and what recommendations participants must make sure these incentivise innovation and attract investments.
What are the legislations ahead and how can these be leveraged?
11:10 – 11:50 40 minutesPanel discussion: “Challenges and Opportunities in Registering Pediatric and Orphan Drugs Across the Europe” Representative of innovative pharmaceutical industry; institutional representatives from Croatia and Slovenia and the EU
Session 4: Clinical Trials in the EU & Innovative Therapies for Smaller Markets
11:50 – 12:05 15 minutesExamination of the need for innovative therapies in smaller markets
Critique of current reforms and their failure to achieve this goal
Overview of the regulatory impact on clinical trials
Discussion on how increased costs might deter innovative research
12:05 – 12:45 40 minutesPanel discussion: “How Regulatory Changes Impact Innovation: Are We on the Right Track?”Representative of innovative pharmaceutical industry; institutional representatives from Croatia and Slovenia and the EU
12:45 – 13:45 60 minutesLUNCH BREAK
Session 5: The Role of Generic and Biosimilar Medicines in Enhancing Access
13:45 – 13:5510 minutesAnalysis 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
13:55 – 14:35 40 minutesPanel discussion: Are generics going to lower the price of medicines in the EU and ensure new drugs are more accessible?Representative of innovative and generic pharmaceutical industry; institutional representatives Croatia and Slovenia and the EU
Session 6: Challenges in pharma supply chain
14:35 – 14:55 20 minutesCan 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
Session 7: Closing Remarks and Q&A
14:55 – 15:15 15 minutesSummary of key points discussed
Next steps and action items
Q&A session
15:15 – 16:30 45 minutesAfter Work Networking – Coffee break

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