MFN ripple effects linked to medicine launch decline: New analysis

A new analysis has documented a steep fall in new medicine launches in the 12 months following the US Administration’s Most Favoured Nation (MFN) executive order, adding pressure to the ongoing debate over the delays in the Health Technology Assessment (HTA) Review implementation.

Researchers examined pharmaceutical launches using an updated GlobalData extract, comparing product launches across two matched 12-month periods from May 2024–2025 and May 2025–2026 across three cohorts.

New medicine launches declined across all reference cohorts. In the 19-country GLOBE/GUARD basket, which includes Australia, launches declined by 30%, while across 11 EU member states the reduction was steeper at 38%. In contrast, US launches fell 11% over the same period.

The divergence is more pronounced when orphan designation is considered. In the reference cohorts, orphan-designated launches were more resilient than non-orphan launches. In the 19-country cohort, orphan drugs declined 22% versus a 32% decline for non-orphan products, while in the 11 EU cohort, orphan launches fell 10% compared with a 46% decline in non-orphan launches.

In the US, however, the pattern reverses. Non-orphan launches were flat over the analysis period, while orphan-designated launches declined 27%. Analysts argue this inversion is consistent with reference-pricing spillover dynamics, where manufacturers maintain launches in the US while deprioritising or delaying launches in markets that contribute to international price referencing frameworks underpinning US benchmarks.

Despite these significant signals, and compounding reports of Pharmaceutical Benefits Scheme (PBS) negotiation withdrawals alongside the removal of previously reimbursed medicines from access pathways, Federal Health Minister Mark Butler has defended the PBS, saying, “In Australia, we only fund new medicines when the evidence shows they genuinely work and offer good value for taxpayers.”

As negotiations on the Strategic Agreement between the government and Medicines Australia commence this month, the sector is now under renewed pressure over whether it can force through implementation of the HTA Review recommendations in a way that aligns domestic pricing with US MFN pricing expectations.

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