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Early Access Pathways in CEE
Benchmarking report
| Name: | "Early and Expanded Access Pathways in Ukraine, Poland, and the Baltic States" |
| Price: | free |
| File format: | .pdf (A4, album) |
| Period: | 2021-2023 |
| Pages: | 34 |
| Tables and figures: | 12 |
| Download: | Get the Report |
Introduction
This benchmarking report, "Early & Expanded Access Pathways in Ukraine, Poland, and the Baltic States," was developed on a pro-bono basis by the Eirhub team during Summer-Autumn 2023 and is available for free.
The work involved desk research and expert interviews with industry stakeholders: patient advocacy groups, law firms, Market Access managers of innovative pharmaceutical companies, and other industry experts.
The first section covers terminology, various methods for early access, disparities between access mechanisms, and their implementation in different countries.
In the second part, we examined early access to medicines in four Central and Eastern European countries: Poland, Ukraine, Latvia, Estonia, and Lithuania.
Finally, we consider the potential benefits of the early access concept to patients, patient organizations, and governments.
Report contents:
1. Access to medicines and early / expanded access concept globally
- Access to Medicines
- Expanded Access to Medicines
- Early Access Concept
- Ambiguity of Definitions
- EAPs & Clinical Trials
- Open-Label Extension (OLE) Studies
- Off-Label Use Concept
- Compassionate Use Basis
- Named-Patient Basis Access
2. Early Access Programs in the European Region
- Compassionate Use Programs (EU regulations)
- Named-Patient Programs (EU regulations)
3. Early & Expanded Access Mechanisms in Ukraine
- Early Access Pathway for Drugs Under CUPs in Ukraine
4. Expanded Access Pathways for Medicines in Poland
- Emergency Access to Drug Technologies (RDTL) Mechanism.
- Off-Label Use & Import of Unauthorized Drugs for Individual Needs.
5. Expanded & Early Access Options in the Baltic Region
6. Conclusions & Recommendations for Ukraine
- Benefits of Early & Expanded Access Programs for Ukraine.
- Recommendations for Stakeholders on Early Access Programs in Ukraine.
About Eirhub
About Eirhub
Eirhub is a professional consulting firm providing advisory services for Life Sciences industries stakeholders—Pharmaceuticals, MedTech, Digital Health, and Healthcare.
We support various industry stakeholders on market access topics, regulatory environment assessment, market analysis and intelligence, executive search, recruitment, and talent mapping.
Regions we cover CEE, Ukraine MENA, South Caucasus, and Central Asia.
Our Ukrainian roots inspire us to help rebuild Ukraine and its economy to bring new businesses and knowledge into our country.
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