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[Editorial] The balancing act of orphan drug pricing

In the past year, the high price tag of orphan drugs has come under severe scrutiny. Global industry players have used incentive schemes such as the USA’s Orphan Drug Act (which offers a 50% tax rebate to help cover research and development costs and 7 years of marketing exclusivity from approval), and the EU Regulation on orphan medicinal products (which offers exclusive access to market for 10 years when approved) to drive up profits in the sector. Health-care systems, under increasing pressure from under-resourcing, ageing populations, and high-price biomedical advances, can be tempted to reduce costly orphan drug programmes to balance their budgets.