Skills Australia – Essential industry survey: biopharmaceutical and medical technology manufacturing industry (lodged by Tijan Ventures & BioMelbourne Network)

Posted to web – 31 March 2020

Lodged by Tijan Ventures & BioMelbourne Network

27 March 2020

Julie Stratford
Industry Engagement Manager
Skills Impact

By Email

Dear Julie,

Essential industry survey: biopharmaceutical and medical technology manufacturing industry

The Australian Government Department of Education, Skills and Employment, via Skills Impact, has requested perspectives on essential industries and critical occupations in sectors anticipated to experience specific supply shortages in the short to medium term as a result of COVID-19 impacts.

1. Has your industry been advised that it is an essential industry by the Government, and do formal exemptions from some or all restrictions apply

2. Does your industry believe that it is essential, and what is the reason for this, taking into account key industries and critical occupations in sectors which are anticipated to experience specific supply shortages in the short-medium term, and:

i) are essential to ensure the preservation of life in the event of increased COVID-19 impacts,
ii) deliver products/services essential to the preservation of life
iii) deliver products/services essential to ensure the effective operation of society

3. Are there specific job roles which may be:

* More essential than other roles within the industry
** More likely to be subject to shortages as a result of this crisis

This response relates to the biopharmaceutical and medical technology manufacturing industry and related sectors and has been prepared by

• Tim Oldham, CEO and Managing Director, AdAlta Ltd, Executive Leader Tijan Ventures and director BioMelbourne Network. Tim has has over twenty years international experience in the pharmaceutical and medical technologies industry, including senior leadership positions at Mayne Pharma and Hospira (now part of Pfizer).

• Lusia Guthrie, Chair of BioMelbourne Network, NED 4Dx Limited. Lusia has 40 years very broad experience in the pharma-biotech sector.

In the time available, the views in this response are our own and not necessarily the views of any organisation with which we are affiliated, however they are believed to be broadly representative of the views of the BioMelbourne Network Board. BioMelbourne Network (BMN) is an industry-led membership association for organisations engaged in biotechnology, medical technology and health innovation in the state of Victoria. Our role is to foster links between companies, research organisations, financial markets and government, creating an environment for greater collaboration and prosperity.

1. Has your industry been advised that it is an essential industry by the Government, and do formal exemptions from some or all restrictions apply

BMN has not been advised that our industry is essential, however we assume that our industry is critical because we have been approached by Victorian government for advice in relation to the sourcing of materials, design specifications, manufacturing capability and key industry contacts in relation to the rapid implementation of local production and supply of personal protective equipment (hand sanitisers and P2 masks) and hospital equipment (ventilators, medical isolation units) in response to the corona virus crisis.

In general, the definition of an essential industry is not clear (for example in stage 1 of lock down the only industries defined as non-essential were those listed including cafes, gyms, etc). There does not appear to be a definition and there does not appear to be a mechanism to determine if an industry, or a specific business within that industry is essential or not, is essential or can be
designated or become essential.

2. Does your industry (pharmaceutical manufacturing industry) believe that it is essential, and what is the reason for this

Australia has a diverse range of pharmaceutical manufacturing capabilities and facilities. These range from small molecule drugs to large molecule biologics and from oral to injectable and inhaled formats. There are also capabilities in diagnostic test kit manufacture, disinfectants and antiseptics. Some of these facilities will already manufacture products essential to either the preservation of life generally or in specific case of a COVID-19 outbreak. Importantly, many will be able to be repurposed to make such pharmaceutical products or test kits. The relevant products range from
critical care medicines such as anaesthetics, pain medications, blood products, antibiotics and antivirals, iv fluids, bulk hospital grade disinfectants and diagnostic test kits. The closely allied medical device industry can also support manufacture of eg ventilator masks.

A far from exhaustive list of relevant biopharmaceutical manufacturing companies include:

• Patheon Brisbane, Luina Bio Brisbane and Pfizer Adelaide (biological drug contract manufacturing);
• Pfizer Melbourne, GSK Melbourne, Aspen Melbourne, Baxter Sydney (making or capable of making injectable and oral pain, anaesthesia, anti-infective medicines and iv fluids);
• IDT Australia Melbourne, Palla Pharma Tasmania and Tasmanian Alkaloids Tasmania (active pharmaceutical ingredients);
• CSL Melbourne (influenza vaccines, blood products, therapeutic antibodies, vaccine adjuvants, fill-finish capabilities for bulk biologics), 4Dx Limited (lung diagnostics and scanners).

A broader definition of our category includes healthcare companies that manufacture:

• A range of allied products such as antiseptics, sanitisers, soaps, disinfectants that are used in homes, hospitals and premises across the country eg Perrigo/Orion Perth (chlorhexidine and alcohol based disinfectants);
• Products to maintain health include vitamins and supplements that are required by large sectors of the population e.g. calcium and vitamin D for osteoporosis.

Critical allied categories are:

• distributors and shippers of reagents (eg COVID-19 testing reagents) and raw materials and active ingredients, many of which are manufactured off-shore. Skills in procuring and importing these materials are not easily replicated
• Critical suppliers of components: manufacturers of packing (bottles, caps, labels etc) and manufacturers of masks, protective suits, aprons and gloves – among others.
• Terminal sterilisation of a range of products and equipment eg Steritech Melbourne.
• Accredited testing laboratories.

Still other manufacturing companies that may not be considered immediately essential can be repurposed to make masks, gowns, etc. Medical device manufacturing and engineering firms can assist with manufacturing (including 3D printing) of whole devices and spare parts. Design engineering firms are key (Invetech, Leica, Grey Innovation, Planet Innovation, Design+Industry, Outerspace) in medical device development and production (diagnostic technologies, hospital equipment and supplies etc).

In addition, many of our biotechnology companies and institutions are developing drugs or therapeutic goods that may assist in treatment of COVID-19 or management of symptoms or have capabilities that can be deployed in the fight against COVID-19. Some of these can be deployed directly on the front line, others such as my own company, AdAlta are developing medicines and diagnostics that will be important in the treatment of side effects and consequences of COVID-19 such as lung fibrosis. They also have skill sets that can be deployed on the front line for example members of my team are volunteering in response to the Australian Society of Microbiologists who have called for laboratory scientists with skills necessary to assist with increased COVID-19 testing.

An illustrative list of the companies in the sector, many of whom can contribute significantly or in supporting roles, may be found in the BMN Member Directory.

And critically, the TGA plays a role in fast tracking the release of products in response to emergency, and PBAC and MSAC processes are critical to ensure funding mechanisms are adapted to respond to the crisis eg the introduction of GP consultation fees to teleconsultations.

3. Are there specific job roles which may be:
* More essential than other roles within the industry
** More likely to be subject to shortages as a result of this crisis

Medicines and equipment shortages are going to (have already) become chronic at least in certain categories as nations develop stockpiles, supplier workforces are impacted and supply chains collapse. Manufacturing, quality, regulatory and logistics is arguably more important than other roles and many of these can only be performed on site, increasing the risk of exposure and workforce reduction through illness.

It is impossible to say that one set of roles in our industry is more important than other. The development of new diagnostics tests and treatments involves an entire supply chain of technology/product development, validation, scale-up, material sourcing and procurement, manufacture (production, testing, packing) and distribution. Personnel at every skill level and across several industries are deeply engaged in the sector.

However, when tough decisions need to be made, perhaps a hierarchy of importance could be developed along the lines of:

• Organisations directly manufacturing medicines, diagnostics, equipment, services and supplies critical to COVID-19 treatment, hospital operations and management or essential to general population health and sanitation (there is a WHO essential medicines list) and organisations supporting their supply chain
• Research teams working on COVID-19 treatments or prevention that could be available within 12-24 months
• Organisations willing to commit to repurposing for any of the above
• Organisations manufacturing or researching products that will assist in management of side effects and consequences

There needs to be simple mechanism for obtaining a determination of essential; and a clear set of guidelines to enable self-regulation of applications (since everyone will attempt to make the case that they should be able to continue operations).

An additional factor that needs to be considered as part of recovery is the impact of capital markets on enterprises across the pharmaceutical manufacturing and development sector. Particularly smaller SMEs active in developing essential therapeutic goods may struggle to survive, not because of poor science but purely because capital markets freeze. While this is true of many SMEs across the economy, this particular sector can be part of future pandemic preparedness, either through the products developed and services delivered or the skills being developed that can be deployed in pandemic situations. They cannot be allowed to fail and mechanisms to support them should be included as part of recovery efforts.

The COVID-19 crisis has highlighted the need for a database of capabilities, capacities related to the development of pharma and biotech products and therapies that includes the entire supply chain, and a whole of  government/industry approach to mobilising in different scenarios. The Department of Defence Medical Countermeasures team has commenced this work, however it appears not to be sufficiently broad in scope or scenarios to provide holistic leadership in this scenario. There is a case for greater co-ordination, engagement and scenario planning to best harness the capabilities of the industry in times such as this, but that is a challenge for recovery phase.

Thank you for the opportunity to comment. BioMelbourne Network is willing to engage further with government to connect and coordinate companies and people with necessary skills.

Tim Oldham, PhD
Executive Leader, Tijan Ventures




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