Access to orphan drugs: A comprehensive review of legislations, regulations and policies in 35 countries

Keyphrases

• Orphan Drugs 100%
• Rare Diseases 22%
• Orphan Drug Designation 22%
• Market Exclusivity 22%
• Marketing Authorization 22%
• Orphan Drug Policy 22%
• Patient Demographics 11%
• China 11%
• India 11%
• Reimbursement Mechanisms 11%
• Pricing Policy 11%
• Absence of Evidence 11%
• Health Technology Assessment 11%
• High Prices 11%
• Assessment Criteria 11%
• Negative Impact 11%
• Cost-effectiveness 11%
• Large Country 11%
• National Legislation 11%
• Peer-reviewed Articles 11%
• Current Regulation 11%
• Policy Instruments 11%
• Patient Access 11%
• Reimbursement 11%
• Population Size 11%
• Drug Legislation 11%
• Orphan Medicines 11%
• Regulation Instruments 11%
• Marketing Incentives 11%
• Critical Difference 11%
• Traditional Health 11%
• Marketing Pricing 11%
• Tax Credits 11%

Pharmacology, Toxicology and Pharmaceutical Science

• Orphan Drug 100%
• Rare Disease 15%