Multinational regulatory & HTA opportunities across Australia, Canada and the United Kingdom

Multinational regulatory & HTA opportunities across Australia, Canada and the United Kingdom

Multinational regulatory & HTA opportunities across Australia, Canada and the United Kingdom

Multinational regulatory & HTA opportunities across Australia, Canada and the United Kingdom

How biopharma innovators can benefit from the ACCESS Consortium and CAN/UK/AUS collaboration in HTA

Multinational regulatory & HTA opportunities across Australia, Canada and the United Kingdom


Multinational regulatory & HTA opportunities across Australia, Canada and the United Kingdom

Multinational regulatory & HTA opportunities across Australia, Canada and the United Kingdom

What’s happening now, across the regulatory and HTA systems of these countries?

Pharmaceutical regulatory authorities in Australia, Canada, Singapore, Switzerland formed the ACSS Consortium in 2007. The UK announced in October 2020 that the MHRA had joined the consortium, renamed ACCESS Consortium, and that they would begin work-sharing from January 2021 on assessing the benefit-risk of innovative pharmaceuticals. In late 2022, the health technology assessment (HTA) agencies in three of those countries – Australia, Canada and the UK – also announced that they would collaborate on the value assessment of innovative pharmaceuticals. Taken together, these two initiatives could create a horizontally-integrated regulatory and HTA process in three wealthy marketsi, creating an opportunity for integrated regulatory and access strategy, more efficient evidence generation and faster time-to-market for biopharma innovators targeting these three markets.

Australia, Canada & the UK are already work-sharing on regulatory assessments

The ACCESS Consortium represents an example of the emergence of reliance as an important concept in the 21st Century regulatory environment.  Reliance ranges from: the implementation of common standards e.g., ICH Guidelines; through work-sharing agreements; joint reviews e.g., African Vaccine Regulatory Forum (AVAREF); centralised reviews e.g., EU Centralised Approval; to Mutual Recognition of decisions made by another agency e.g., EU Decentralised/Mutual Recognition procedures.  WHO published documents on Good Regulatory Practices (GRP) and Good Reliance Procedures (GReP) as Annexes 10 and 11 to WHO Technical Report 1033[ii]

The ACCESS Consortium has developed work-sharing procedures for generic medicines, biosimilar and new active substances.  The New Active Substance Work-sharing Initiative (NASWSI)[iii] has approved more than 20 new medicines in Australia since the scheme was established in 2018[iv].  In 2022, the first two new medicines have been approved in all five member countries (asciminib and faricimab).  Faricimab, a treatment for progressive eye diseases, was approved in the UK and other consortium members between May and August 2022, based on their work-sharing agreement.  It is interesting to note that CHMP issued a positive opinion in July 2022 with EU approval in September 2022, while FDA approved it on January 28th, 2022.  The use of three regulatory procedures, two involving reliance, thereby resulted in the approval of a novel therapeutic in thirty-five countries of over 800 million people over a 10-month period.  These approvals would also support further approvals in many other countries that also apply reliance procedures based on medicines approved by these regulatory agencies.

Under the NASWSI procedure an applicant may request a joint review for a new chemical entity or new biological entity, if simultaneous submission is planned in at least two of the ACCESS members.  The applicant should submit an expression of interest (EoI) at least 3 months before the planned submission and should seek technical pre-submission meetings with the selected agencies under their national procedures.  If agreed, the agencies will decide on the work sharing approach and the agency taking the lead on the clinical assessment will coordinate the logistical pre-submission meeting.  The work-sharing phase is expected to have a total maximum time of 255 days, including clock stops, so is comparable with the EU review period.  The national approval is a separate phase and will depend on any additional national requirements. In the example of faricimab three agencies issued approval within 2-3 weeks and the latest approval came within 3 months of the first approval in the UK.  According to the information published by Swissmedic[v] the review was distributed between the agencies: Drug substance (Singapore); Drug Product (Switzerland); Non-clinical (Australia) and Clinical (Canada/UK).

This work-sharing approach has benefits for the regulatory agencies involved by allowing greater efficiency and the opportunity to share knowledge across the network.  It may also avoid delays in marketing authorisation applications in the five member countries, by reducing the uncertainties and to some extent the workload for the applicant, as a result of the consolidated review and questions from regulatory agencies.  The resulting benefit is earlier access for patients in these five countries, than might be the case without this initiative.

Australia, Canada & the UK have announced their intent to work together on value assessment as well

In late 2022, the health technology assessment (HTA) agencies in Australia[vi], Canada[vii] and the UK[viii] announced that they would collaborate on the value assessment of innovative pharmaceuticals. Announcing five areas of potential collaboration (including COVID-19, HTA methods and AI technologies), this article focuses on two: “Collaborating With Regulators” and “Work-Sharing and Efficiency Gains”.

The first of these clearly connects to the ACCESS Consortium described above, building on global best practice for bio-pharma innovators in aligning regulatory and access strategy, as well as licensing and value evidence generation, for:

  • Consistent messaging to decision-makers
  • Efficient data generation
  • Low lag times between marketing authorisation and reimbursement/access.

High-performing companies are well accustomed to joint regulatory/HTA scientific advice and evidence generation in, for example, an EU context. This leverages existing processes managed by the EMA and EUnetHTA, as well as preparing for the forthcoming EU HTA Regulation[ix], to achieve such benefits. Using similar practices to achieve these gains across Australia, Canada and the UK seems an obvious opportunity to explore.

Similarly, the Work-Sharing and Efficiency Gains objective of this freshly-announced multi-national HTA collaboration (which does include Scotland and Wales[x] as well as England) has precedents to leverage. In particular, the Beneluxa[xi] and FINOSE[xii] multi-national HTA collaborations have paved the way in work-sharing on the value assessment of gene therapies, rare disease products and oncology treatments. The gains to participating agencies include resource efficiencies and the promise of earlier launch as companies size up the combined market value of such collaborations. The attractiveness to industry is also efficiency – one dossier instead of three or five – and further, as these processes bed in, the promise of greater speed to market, with aligned decisions across multiple markets at once.

Early experience with these collaborations has not been without bumps in the road, of course. Nevertheless, lessons can be learned and a CAN/UK/AUS collaboration on HTA could improve on industry’s experience with Beneluxa to date, through the advantages of shared language, methodological similarity within the “cost-effectiveness market” archetype and similar GDP/healthcare spend per capita suggesting a similar willingness/ability to pay informing the value assessment.

  • Australian Government Department of Health and Aged Care
  • Canadian Agency for Drugs and Technologies in Health (CADTH)
  • National Institute for Health and Care Excellence (NICE)
  • Healthcare Improvement Scotland
  • Health Technology Wales
  • All Wales Therapeutics and Toxicology Centre.

Biopharma innovators can benefit from integrating regulatory & HTA strategy – and evidence generation planning – for three markets in one

Between them, Australia, Canada and the UK create a healthcare market worth over $700bn[xiii] – larger than that of Japan. A typical global pharmaceutical company currently plans and manages regulatory strategy; price, access, reimbursement and HTA strategy; and market-specific evidence generation completely separately for these three markets – perhaps fragmented across Americas, Europe and Asia-Pac processes and governance – whereas Japan typically merits its own focused strategy and evidence generation planning.

The increasing complexity of medicines development, the demand to demonstrate value of new therapeutic options, an environment of limited resources for assessment, and the desire for increased health equity provide substantial challenges for national assessment agencies. The concept of reliance and in particular work-sharing provides national authorities with opportunities to address these challenges while maintaining decision-making responsibility.  We anticipate that these approaches will place increased expectations on developers and manufacturers to explore the opportunities to broaden the early introduction of important new therapeutics.

The regulatory and HTA convergence described above creates the opportunity for a global biopharma innovator to treat Australia, Canada and the UK as one market, with potential benefits for:

  •  Strategic alignment
  •  Evidence generation efficiency
  • Speed to market.

Whether you are a global major with regulatory and value & access strategy teams in house and need objective expert support to flex processes and governance to seize this new opportunity to boost ROI; or whether you are a younger biotech looking for external expertise to help you move as far and as fast as you can in getting your latest medical innovation to patients, AESARA and Highbury would be delighted to help.

Contact us to explore what these multi-national opportunities mean for you.

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[i] GDP per capita: Australia: $ 59,934; Canada: $ 52,051; UK: 47,334. accessed 19 Oct 2022

[ii] WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fifty-fifth report. Geneva: World Health Organization; 2021 (WHO Technical Report Series, No. 1033). Licence: CC BY-NC-SA 3.0 IGO. (

[iii] Operational Procedures (OP) Access Consortium New Active Substance Work-sharing Initiative (NASWSI)










[xiii] Healthcare spend per capita from OECD (2022): Health spending (indicator). doi: 10.1787/8643de7e-en (Accessed on 19 October 2022), analysed in conjunction with open source country population data.



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