THE Society of Hospital Pharmacists of Australia (SHPA) has broadly supported proposed adjustments to the Therapeutic Goods Administration's (TGA's) Orphan Drug Program in its submission to the TGA consultation.
The consultation document proposes relaxing the "rare disease threshold" to make drugs that are otherwise unviable to market available to as many as 12,000 Australians as opposed to the present 2,000.
Medicines Australia urged a longer exclusivity period than the "arbitrary" 3-6 months for orphan designation to incentivise innovating manufacturers, while the Generic and Biosimilar Medicines Association submission rejects incentivising innovators, proposing instead an alternative funding model where the cost of evaluating orphan drugs is covered by the industry sector that brings the products to market and not shared by the generic and biosimilar sector.
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