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 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.
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.
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.
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.
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!
EU PHARMA FORUM
7. veljače 2025.
Mozaik event centar, ZAGREB
Welcome and introduction of participants
Overview of agenda topics
Single European market for medicines
How is the new pharma package going to impact Croatian patients?
How is the new pharma package going to impact Slovenian patients?
Discussion on the EU’s proposal to shorten regulatory data protection and orphan market exclusivity baseline for innovative pharmaceuticals
Implications & analysis
Panel discussion: “Ensuring the availability of medicines while supporting the competitiveness of the EU’s pharmaceutical industry”
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?
Panel discussion: “Challenges and Opportunities in Registering Pediatric and Orphan Drugs Across the Europe”
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
Panel discussion: “How Regulatory Changes Impact Innovation: Are We on the Right Track?”
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
Panel discussion: Are generics going to lower the price of medicines in the EU and ensure new drugs are more accessible?
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
Summary of key points discussed
Next steps and action items
Q&A session
Time | Duration | Topic | Speaker |
---|---|---|---|
Opening Remarks | |||
09:00 – 09:15 | 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 | 20 minutes | Single European market for medicines | Representative of the EC |
09:35 – 09:45 | 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 | 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 | 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 | 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 |
10:05 – 10:45 | 15 minutes | COFFEE BREAK | |
Session 3: The Role of Legislation on Investment for Innovation | |||
11:00 – 11:10 | 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 | 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 | 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 | 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 | 60 minutes | LUNCH BREAK | |
Session 5: The Role of Generic and Biosimilar Medicines in Enhancing Access | |||
13:45 – 13:55 | 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 | 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 | 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 | 15 minutes | Summary of key points discussed Next steps and action items Q&A session | – |
15:15 – 16:30 | 45 minutes | After Work Networking – Coffee break | |
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