Viatris, Vaxxas, and AAHM challenge the status quo at manufacturing inquiry hearing

Pharma News: The House Standing Committee on Industry, Science, and Resources convened a public hearing in Brisbane yesterday to discuss the future of advanced manufacturing in Australia.

Key players from the pharma and biotech sectors included Viatris executives Sylvain Vigneault, Country Manager for Australia, and Robert Elliot, Head of Operations for Australian & New Zealand, in addition to Michael Junger, Senior Vice President of Advanced Technology of Vaxxas, and Professor Andrew Cuthbertson, Fellow of Australian Academy of Health and Medical Science (AAHM) and CSL Board member. Together, they presented valuable insights and recommendations to drive the growth of local manufacturing.

During the hearing, Sylvain Vigneault, the Country Manager for Australia at Viatris, proudly shared that the company already manufactures 35% of their commercialized products within Australia. However, he expressed concerns about the challenging policy environment that the Australian manufacturing sector faces and the need for collective efforts to improve the industry’s context.

One critical issue raised during the meeting was the hindrance in manufacturing certain products for export, despite their patents expiring in other countries. This limitation puts Australian manufacturing centres at a disadvantage compared to international competitors, resulting in substantial revenue losses and missed opportunities for knowledge transfer.

To address medicine supply challenges, Mr Vigneault proposed a strategic partnership and dialogue with Australian medicine manufacturers. He emphasised the importance of identifying crucial medications that should never be out of stock and exploring opportunities for local production.

“We believe that there should be discussions with the pertinent working group, including the Department of Industry and Manufacturers, to identify the products that should be locally produced and find ways to make it happen,” stated Mr Vigneault.

Regarding medication pricing, Mr Vigneault discussed the impact of the 2008 price disclosure process on manufacturing capabilities. He stressed the importance of sustainable pricing for critical drugs and called for a more holistic approach that goes beyond just focusing on price.

“We need to protect critical drugs from a price perspective and ensure a level playing field. We want to manufacture drugs that are not just for Australia but also for the global market,” he said.

One of the most important factors in ensuring Australia’s competitiveness in the global market for the supply of products is patent law. Mr Elliot emphasised that the current struggles with obtaining new products for Viatris’ plant in Carroll Park are a result of patent laws hindering local manufacturing capabilities.

“If we can’t manufacture it because of the patent laws in Australia, we don’t even get a seat at the table. First thing we want is to have a seat at the table with our manufacturing network to be able to put a hand up and say that we want that product in Australia,” commented Mr Elliot.

Skilled labour shortages and visa issues were also discussed during the hearing. The executives suggested streamlining the visa process for bringing in short-term experts to transfer knowledge and skills to the local workforce.

“We are prepared to invest and train new graduates and bring them up to speed. Strengthening our links with universities will also be crucial in addressing the skills shortage,” Mr Elliot added.

Furthermore, the hearing explored the critical role of advanced manufacturing in the medical device industry, where sterile and aseptic environments are of utmost importance. Mr Junger from Vaxxas emphasised the significance of automation in producing high-quality medical products and highlighted the need for seamless connectivity across manufacturing systems to meet future regulatory expectations.

The company has faced challenges in securing adequate funding and support in Australia for the development of its needle-free vaccine delivery system. The patch’s ability to also eliminate the need for extensive refrigeration and medical personnel could be a game-changer in fighting pandemics and saving lives worldwide.

The limited availability of local financial resources has hindered the nurturing and development of pioneering biotech and medtech startups within Australia. Consequently, numerous promising ventures have been forced to seek investment opportunities overseas, resulting in a potential loss of intellectual property and economic value.

To address workforce challenges, Vaxxas plans to collaborate with universities and foster educational programs focusing on biomedical and engineering degrees. This approach aims to establish a skilled pipeline and build a homegrown talent pool to support the company’s growth and enhance Australia’s advanced manufacturing sector.

Professor Andrew Cuthbertson, a distinguished Fellow of AAHM and board member of CSL, emphasised the need to focus on both research and development (R&D) and successful commercialisation.

“If research discoveries are developed and manufactured in Australia, or involving Australia, it is much more likely that the final product will be manufactured here as well,” said Professor Cuthbertson, highlighting the interconnected nature of R&D and domestic manufacturing.

To encourage investment, particularly for small and medium-sized companies engaged in R&D, Professor Cuthbertson advocated for a peer-reviewed grant system and a favourable tax environment.

“It’s not just about setting a specific tax rate, but ensuring our policy settings are competitive with other countries that have successfully attracted advanced manufacturing industries,” he added, citing Switzerland, Singapore, Ireland, and the UK as examples.

He also highlighted Australia’s capability to conduct high-quality clinical trials and stressed the need to expand and encourage these endeavours.

“The average success rate for National Health and Medical Research Council (NHMRC) grants is just 17%. Being able to fund more of those high-quality research grants to lead to the development of a candidate and ultimately lead to advanced manufacturing in Australia would be a good thing,” he said.

The public hearing represented a crucial step toward addressing the challenges faced by Australia’s manufacturing sector and exploring opportunities for growth and innovation. Collaborative efforts between industry players, policymakers, and academia are key to achieving a thriving advanced manufacturing landscape in Australia.

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