- 6 months ago
1 April 2026
A new analysis by GlobalData suggests the US Government’s Most Favoured Nation (MFN) pricing policy is already reshaping global launch behaviour, with significant declines in new product introductions across Europe – and it seems Australia is also impacted.
Using its price intelligence (POLI) database, GlobalData compared launches in the 10 months before and after the MFN announcement, made on 12 May 2025.
It noted an overall decline across Europe of 35 per cent in the 10 months following the introduction of International Reference Pricing (IRP) policy compared to the previous 10 months, but said it was slightly more pronounced when focusing on the countries included in US reference baskets.
For the six countries included in the GENEROUS basket (Denmark, France, Germany, Italy, Switzerland, and the UK), the fall was 37 per cent while for 14 of the 17 European countries in the GLOBE/GUARD group, the drop was 43 per cent.
“It is important to acknowledge that while other factors will have contributed to this drop (such as regulatory delays, pricing and reimbursement negotiations, or supply chain constraints), the trend seen is an early signal of the impact that the introduction of IRP in the US has had on European markets,” GlobalData states.
“Based on the MFN policy framework and reference baskets, the lowest-priced markets are used as a reference point for US pricing.
“Consequentially, there is a structural disincentive to launch early in countries where prices are significantly lower, and pharmaceutical companies may be deliberately delaying the launch of their products in certain European markets.
“Additionally, US biotech firms have reportedly become wary of entering into licensing agreements with European partners in case they might be accused of inadvertently triggering MFN provisions that could erode US pricing. Heightened uncertainty may therefore be responsible for the strategic delay observed across Europe.”
Australia not isolated from MFN impact
While launches in Australia and not directly comparable to Europe given companies may get regulatory approval and delay the launch until they get a PBS listing, analysis of new drug registrations in Australia may provide an early signal of the impact of MFN.
Australia is one of the three non-European countries included in the GLOBE/GUARD comparator baskets, hence guaranteed to be experiencing the same impact of the IRP policies as European countries.
MedNews’ analysis found 37 new drugs registered in the 10 months prior to the MFN policy being announced and 26 registered in the 10 months after – a fall of 30 per cent.
Given it takes 12 months for a new drug to be registered in Australia, it is likely the full impact of the policy will hit this year and with only five new products registered on the ARTG in the first quarter of 2026 compared with 20 in 2025, this suggests Australia could see a dramatic fall in access to new therapies in coming years.
The GlobalData analysis also highlights a sharp rise in European product withdrawals, with a 43 per cent increase in the number of brands for which at least one pack was removed from the market in the 10 months after MFN.
In the GENEROUS countries, withdrawals rose 10 per cent while in the GLOBE/GUARD markets they increased 40 per cent, the report citing Amgen’s withdrawal of Repatha from Denmark as an example.
Forty per cent of drugs in development globally are from the US followed by China with 20 per cent. Only 11 per cent of medicines are manufactured in Europe, meaning it is also looking to build ties with China.
Europe has also been inking Free Trade Agreements with countries like India, which has a large generic drug manufacturing industry, and Australia as it looks to shore up its medicines supply.
The GlobalData analysis comes as PhRMA, representing the US pharmaceutical industry, continues to lobby against the MFN policyas price setting.
A recent PhRMA post referred to a Magnolia Market Access analysis comparing US healthcare spending with comparable OECD countries and finding prescription drug spending accounted for 9.7 per cent of the per capita spending difference.
Taken together, the Magnolia spending analysis, the POLI launch and withdrawal data, and Australia’s own ARTG trend point to a converging story: MFN is beginning to reshape global pricing expectations, and companies are adjusting their strategies in anticipation of downward pressure on US prices.
Meanwhile, the Department of Health, Disability and Ageing says it is monitoring applications for medicines to be withdrawn from Australia for evidence MFN is impacting despite the real risk lying with access to new medicines.
Regardless, it is clear that companies are adjusting their launch strategies to balance the impact of the IRP measures, many saying there is now a ‘take it or leave it’ launch price that if Australia does not want to pay, then patients can expect to face even longer access delays.
©MedNews 2026