What Australia can learn from Europe’s HTA collaboration

25 March 2026

Australia is building stronger ties with Europe by fast-tracking an association with Horizon Europe, a move in the right direction although opportunities exist in the future for Australia and New Zealand to potentially benefit from Europe conducting joint health technology assessments (HTA) for innovative therapies and devices.

European access expert Elaine Julian was in Sydney earlier this month and spoke with MedNews about the European Union’s progression to conducting joint clinical assessments (JCAs) of new medicines, saying it could ultimately become the poster child for global cross-border HTA collaboration.

While Australia was an early adopter of HTA and is often seen as leading in the field, Julian said Australia could still potentially benefit from building closer HTA ties with Europe while New Zealand had potentially even more to gain given it is a smaller market.

Having worked in Australia for several years and with Roche in Germany, Julian now sits on the Secretariat of the European Access Academy (EAA) – a multi-stakeholder initiative aiming to facilitate and support the development of a joint European value framework for the assessment of innovative health technologies.

The European Commission, whose President Ursula von der Leyen is in Australia this week to announce a Free Trade Agreement between Europe and Australia, has led the way in bringing together the European states to make the EU more attractive for pharma companies to launch new medicines.

New HTA regulations came into effect in January 2025 enabling joint HTA for new medicines, and while only 12 JCAs have been conducted – less than half expected – Julian is optimistic these problems will be ironed out, arguing collaboration is the way forward.

The US Administration’s Most Favored Nation (MFN) policy is of great concern to Europe, which fears companies will not launch new medicines there if it threatens their US pricing. MFN has added additional pressure to get JCAs right.

“We have to make sure EU HTA doesn’t keep people from coming,” said Julian. “It’s been a discussion behind closed doors over the past months that companies were thinking about whether or not to launch in Europe, so as not to drag down their price in the US.

“We need to make sure our HTA system works smoothly because, if you have too many no-goes, European patients are going to miss out because the drugs are not going to come.”

While politicians in Europe and the UK are vocal about the threat of MFN, Australian politicians are saying little, even though MFN is likely to have a bigger impact on Australia than Europe, Australia being around one per cent of the global medicines market while Europe is a major market. The policy is driving countries to work together, the trade deal inked this week one example.

“All the health systems in Europe are under pressure financially so can’t go higher with prices to match what the company global head offices want,” said Julian. “It’s a near impossible situation at the moment.

“It’s nearly impossible to find a balance between having a health system that’s sustainable and having the drugs we need at the prices companies want for the US.”

One of the constraints of JCA is that pricing was removed, meaning only clinical datasets are aligned. The original goal was to reduce duplication for the benefit of HTA evaluators and companies, but companies are concerned final outcomes will leave individual countries wanting more country-specific data.

Julian said Australia was already “doing a pretty good job” in HTA, incorporating clinician and patient input, but faced similar constraints to the EU in terms of expert capacity. A shortage of HTA evaluators caused a significant issue in the lead-up to the March 2025 PBAC meeting, resolved by lassoing additional capacity and splitting the meeting in two.

“Overall, I think the Australian system overall is a bit more pragmatic, and it’s not as strict and bureaucratic as the European system,” said Julian. “That does open a little bit of leeway here and there to just be more flexible with innovation.”

Julian said while discussions had been held as to whether Australia could benefit from the EU JCA dossier, it was likely an HTA decision would be reached in Australia before the JCA report was ready, meaning it could slow down access.

“On the other hand, if you didn’t rely fully on the assessment and instead focused on all the capacities in ongoing discussions, maybe that would speed up time and could be a way to make it more efficient,” she said.

The global problem of companies trying to meet HTA requirements of multiple markets is driving the move towards greater collaboration, Australia in constant discussions with markets like the UK and Canada in a bid to find areas where they can reduce duplication, just as the EU is doing.

Julian admits HTA has become “a bureaucratic monster” that has forgotten its purpose in bringing medicines to patients and is instead overly focused on data, some dossiers in Germany running up to 30,000 pages while too often pharma is viewed as “the bad guys” when in reality, they may well be closer to patients and clinicians.

“Why not limit the dossier to what’s really needed and make it easier for everybody?” she said. “That also means clinicians and patients can understand it and don’t necessarily need an additional lay summary, which is something they have been fighting for. We should really try to make the whole thing a little bit leaner.”

While Europe has not yet proven if its 27 member states can work together on HTA, nor whether JCAs will work for industry, Julian says it is still the most promising global model for collaborative assessment.

“I do think this could be a very good precedent for a very complicated situation in everything. It doesn’t need to be restricted to health – it could be other things as well. It is about finding a way from all the different views coming together and building this up, which I think is great achievement.

“We need to go this way. Europe wants to be strong and it needs to be strong, to be unified. We need to make sure new drugs come to Europe, and nobody’s going to do separate processes for every country anymore – it’s just too complicated.

“We need to have a degree of pragmatism in how we deal with uncertainty, making sure patients get the best outcomes without being put at risk. Achieving that balance is probably the most difficult.”

As Australia builds stronger ties with Europe, it is likely Australia will look to the larger market for learnings on how to modernise its own HTA system through methodological exchange, data-sharing agreements, and early scientific advice mechanisms. In return, Europe will look to Australia in areas like broad PBS listings for immuno-oncology therapies to see how innovative concepts work in a much smaller, contained market.

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