Good afternoon
Most interesting article stumbled across in the AFR that may well interest CSL advocates:
The pressure tactics that turned CSL from ‘minnow’ to powerhouse
John Kehoe Economics editor
Jan 3, 2025 – 5.00am
Updated: Jan 23, 2025 – 5.07pm.
American trade negotiators tried to break local biotech CSL’s control of the Australian blood plasma market, in a move that chairman Brian McNamee says helped spur the company to transform into a global powerhouse.
Newly released Howard government cabinet documents from 20 years ago reveal the pressure the United States placed on Australia to open up CSL’s exclusive contract with the federal government and Red Cross for plasma fractionation services.
Plasma fractionation is the collection of blood plasma from donors and the extraction of proteins into different life-saving products that are critical for people who have immune deficiencies, haemophilia and other serious conditions such as burns.
Today, the global plasma fractionation industry reaps about $US35 billion ($56 billion) annually with Australia’s CSL controlling almost 30 per cent of the world market and tussling with European and Japanese companies for dominance.
But some 20 years ago, when John Howard’s government and George W. Bush’s administration were negotiating a free-trade agreement, American giant Baxter was a dominant global player and seeking to disrupt CSL in Australia
A cabinet minute dated December 15, 2003, said: “Australian negotiators would continue to resist requests by the United States of America for early commitment by the Australian government to an early termination of the five-year contract being negotiated between the National Blood Authority and
CSL Limited for the supply of blood products and blood fractionation services.”
To appease the Americans when the Australia-United States Free Trade Agreement was signed, trade minister Mark Vaile
wrote a side letter in May 2004 to US trade representative Robert Zoellick committing to the CSL contract finishing no later than the end of 2009 and to review with the states the single-sourcing arrangement.
Mr Zoellick responded: “The United States expects that Australia will undertake any future arrangements for blood fractionation services through tender processes.”
Details of the pressure Australia came under from the Americans on CSL have not previously been reported.
The Americans lobbied hard on behalf of the multinational company Baxter, which at the time controlled about 30 per cent of the global market for blood plasma fractionation, compared to less than 1 per cent for CSL. “CSL was just a minnow at the time,” Dr McNamee said in an interview with
The Australian Financial Review.
‘The making of the company’
“It was a catalyst to drive us to break out internationally. In one sense it was the making of the company because it showed us we couldn’t just rely on the local market and we would globalise our business with best-in-class products. “There is nothing like a competitor to spur you on.”
Trade negotiations occurred between March 2003 and May 2004 when the final deal was signed by the Howard government and the Bush administration.
CSL announced in December 2003 that it was buying Pennsylvania-headquartered Aventis Behring for $965 million to position itself as a world leader in plasma therapeutics. It merged Aventis Behring with Swiss plasma company, ZLB Bioplasma, formerly owned by the Swiss Red Cross, which CSL acquired in 2000. By 2006, CSL began building a modern production plant for immunoglobulins in Bern, Switzerland.
In 2022, CSL opened the largest plasma fractionation manufacturing plant in the southern hemisphere in Broadmeadows, Victoria.
“You need scale, innovation and a global footprint to compete,” Dr McNamee said.
Today, CSL provides lifesaving products to patients in more than 100 countries and employs 32,000 people.
Its revenue was $US14.8 billion last financial year,
making it one of the world’s largest biotechs, a far cry from its minnow days when the US came after its dominant position in the Australian market.
Top-three company
CSL is now Australia’s third largest publicly listed company behind Commonwealth Bank of Australia and BHP, and its market capitalisation is about $135 billion.
Commonwealth Serum Laboratories was established in 1916 by the federal government, before being listed as CSL on the Australian Securities Exchange in 1994.
Former Australian trade official Pru Gordon, who was involved in implementing the free trade agreement, said: “The US wanted access to CSL’s monopoly contract for the fractionation of blood services.
“Australia said no but committed to doing a review.” The US also pushed to end the Australian government’s discount bulk purchase of drugs from US pharmaceutical companies for the Pharmaceutical Benefits Scheme.
But Mr Howard and Mr Vaile rejected this and told the Americans it was a “no go” zone because it would lead to higher prescription drug prices for patients under the PBS.
Australia’s Therapeutic Goods Administration had followed a single supplier policy for the provision of blood and blood products, under an arrangement with CSL and the National Blood Authority, which partnered with the Red Cross to manage the supply of blood collection, services and products in Australia.
Overseas-sourced plasma products were required to demonstrate a clinical superiority over domestically sourced and manufactured products before they would be considered for approval in the Australian market.
Flood inquiry backs CSL
A review led by former bureaucrat Philip Flood in 2006 advised the government to maintain the existing arrangements and recommended against the introduction of foreign outsourcing of domestic plasma fractionation services.
A 248-page report submitted to then-health minister Tony Abbott said Australia had an enviable system for the provision of safe, high-quality blood and plasma products, with local voluntary donors playing a vital role.
“There are potentially major risks associated with the offshore fractionation of Australian plasma,” the Flood report noted.
“The close oversight of CSL Bioplasma in its capacity as Australia’s national fractionator, and of the ARCBS [Australian Red Cross Blood Service] as the agency charged with collecting blood and plasma nationwide – together with the longstanding commitment by both organisations to health care in Australia, and the exceptional generosity of Australia’s many voluntary blood and plasma donors – are the factors that combine to create the unique, world-class system that today governs the supply of plasma products to the Australian community.”
At the expanded plant opened two years ago in Melbourne, the high-capacity facility includes 198 stainless-steel tanks used to process nine million plasma equivalent litres per year, up from about 200,000 litres when CSL was publicly listed in 1994.
The facility manufactures biotherapies that treat rare and life-threatening conditions including immunodeficiencies, neurological disorders, shock and burns.
The Broadmeadows plant processes domestic plasma from Australia collected by the Red Cross, which is not allowed to be mixed with foreign plasma or sent offshore. The plant also processes domestic donor plasma for New Zealand, Taiwan, Hong Kong and Malaysia, which is collected and returned to those countries.
The Broadmeadows facility also makes commercial products sold globally which are manufactured from plasma sourced globally through CSL Plasma, one of the world’s largest collectors of human plasma.
“It’s a very rigorous and strict contract and it serves the Australian market well,” Dr McNamee said.