PERTH, Australia – In the aftermath of the COVID-19 pandemic, Australia is shoring up its national supply of medical products and making it a national priority to drive economic recovery and ensure future resilience.

The objective of the government’s modern manufacturing strategy is to build scale and capture income in high-value areas of manufacturing where Australia either has established competitive strength or emerging priorities. The aim is to help Australian drug and device companies to scale up, build resilience, compete internationally and create jobs.

The road map was developed by industry task forces that identified and set a future vision for priority areas with clear goals mapped out over the next two, five and 10 years. The medical road map includes medical devices, high value-add medicines, cutting-edge treatments, digitally integrated products and platforms and animal health. Cutting-edge treatments include regenerative medicines, genomics and mRNA vaccines.

Key actions to support this vision and drive scale in manufacturing include:

  • Creating better pathways for companies to translate their ideas into commercial products in Australia. This includes co‑investments in facilities that allow companies to undertake first production runs and prototyping;
  • Assisting manufacturers with a globally competitive product to integrate into local and international supply chains; and
  • Developing vibrant manufacturing ecosystems that support commercialization and expand manufacturing output.

The AU$1.3 billion (US$987.5 million) initiative will run over four years and will stimulate business investment in the manufacturing sector by addressing barriers to scale and competitiveness for Australian manufacturers.

The Australian government will strategically invest in projects that help manufacturers to scale up and create jobs, with investment targeted at supporting projects within the national manufacturing priorities.

“Quality medical products are at the center of a healthy society. They can also be the centerpiece of a dynamic economy based on translating smart ideas into globally competitive manufactured products,” the roadmap says.

“The pandemic has heightened the awareness of supply chain risk,” MTPConnect CEO Dan Grant told BioWorld. MTPConnect conducted skills gap analyses during the COVID-19 pandemic, which pointed to the potential for the medical technology sector and manufacturing sector as a potential pivot point to “develop the capabilities needed to support resilience efforts.”

“During the early stages of COVID, we saw a large number of manufacturers put their hand up to help support Australia’s efforts to secure or manufacture medical products. Many of these companies were unaware of the regulator and quality management systems required in this highly regulated space,” Grant said.

MTPConnect has deployed funding to increase the sector’s understanding of quality management systems and protocols, he said, noting that the group helped identify a number of key trends that are impacting the need for and the development of medical products in Australia and globally.

Digital revolution key focus

“Central to these trends is the digital revolution. Digital heath, digitally enabled devices, and the ability to access and analyze health data irrespective of disease area is an increased focus,” Grant said. “Leading on from that is the emergence of precision health care and personalized medicine, integrated care models and, importantly, consumer control.

“Smart devices that inform the patient, the clinician or care provider, or change to directly interact with the patient to provide the required intervention at the correct time are becoming increasingly more important,” Grant said.

Clinical trials are of particular importance to medical products. The process of running clinical trials is estimated to be worth $1 billion to the Australian economy annually. This can also benefit manufacturing as an intermediate step to large‑scale production of medical products. Final production is often “anchored” to the location where the late stages of clinical development occur.

Cutting‑edge treatments such as stem cell technologies have the power to change lives, and commercializing those products in Australia would provide early access to potentially lifesaving treatments to Australian patients.

“Drawing strength from our cutting‑edge research capabilities, Australia has the potential to accelerate medical product commercialization in regenerative medicine (RM), genomics and mRNA vaccines,” the roadmap says. The global RM market is estimated to be worth AU$120 billion by 2035. While Australia has been at the forefront of RM research, including conducting some of the world’s first human stem cell trials, there are opportunities to further commercialize that research.

During the COVID‑19 pandemic, Australian researchers have collaborated with industry to build capability in the development of mRNA vaccines, which are at the forefront of global medicine. As mRNA molecules are simpler to produce than proteins and can be manufactured by chemical synthesis, mRNA vaccines are quicker to be redesigned, scaled‑up and mass produced.

“That we have been able to develop at least three viable COVID-19 vaccines in under a year is unprecedented in human history and represents some of the most significant innovation ever seen in drug development,” said Chris Nave, managing director of Brandon Capital and CEO of the Brandon Capital-managed Medical Research Commercialization Fund (MRCF).

“When confronted with the most significant global health threat in over 100 years, the scientific community, governments and drug developers united and responded in record time. Safety standards have not been compromised and it clearly demonstrates that we can remove unnecessary bureaucracy from the drug development system when we have the will to do so,” Nave said.

“This is a vital lesson when we look at other major diseases which are responsible for killing significantly more people globally than COVID-19. To date, 2.4 million people have died from COVID-19. To put this into perspective, cancer is responsible for an estimated 9.5 million deaths annually, equating to one in every six deaths, while cardiovascular diseases are the number one cause of death,” he said.

Government co‑investments with industry could attract new and expanded manufacturing facilities in Australia and could help companies to build new manufacturing facilities for their products in Australia and to support existing businesses to onshore manufacturing they are currently sourcing internationally. In addition, it could attract new businesses with new capabilities.

Investment options include grants to offset capital investment costs in new or expanded facilities, or to develop plug-and-play facilities to attract international manufacturers to base themselves in Australia. Co‑investment could also support businesses to access supply chains and international markets.

Potential projects include infrastructure investments that enhance the export capability of multiple manufacturers through sharing the cost of packaging, storage and distribution. For example, establishing cold rooms near airports could streamline logistics and cut costs when exporting internationally.