GTC Biotherapeutics (fka GTCB)

[Lewis R Goudy]

A good overview of the Aussie picture illustrating
the ubiquitous paranoia about nations "sharing
bodily fluids" :) nb somewhat dated

Safety debate colours blood product trade
Quality control fears are shaping a battle for control of Australia's blood products market, reports Sean Parnell
08jul06
HAEMATOLOGIST Andrew Boyd knows how successful blood products can be in treating blood disorders. But
the products derived from blood and plasma are now being used to treat a much broader range of medical
conditions.
With demand on the rise, the value of products like intravenous immunoglobulin (IVIg) – a plasma derivative
used largely to combat inflammatory or autoimmune diseases – is obvious in both a medical and financial
sense.
"The government has quite strict guidelines about how it can be used because it is a fairly expensive therapy,"
professor Boyd says of IVIg, which he administers to oncology patients at the Royal Brisbane Hospital.
"You need permission to use it and the Red Cross hands it out quite sparingly."
Not surprisingly, blood and plasma has become big business. While Australia makes up only 2 per cent of the
world market, the seemingly insatiable appetite for IVIg – demand in Australia alone has grown 220 per cent in
the past 10 years – has health officials debating how best to deliver such treatments well into the future.
But the debate, while well-intentioned, has also served to reveal controversial policy decisions, cause friction
between the major players, and, some say, threaten public confidence in the system.
Australia has long had a policy of self-sufficiency in blood and plasma, due to, and because of, the nation's
admirable safety and quality record. Under a system established by federal, state and territory governments, the
Australian Red Cross Blood Service collects blood and plasma from unpaid donors under the direction of the
National Blood Authority and the oversight of the Therapeutic Goods Administration.
That plasma is sent to Australian biopharmaceutical giant CSL Limited for fractionation – the process of
separating proteins for use in a dozen different products – and the Red Cross distributes the end blood and
plasma products free of charge.
However, the system is changing.
The NBA is so concerned the Red Cross and CSL might fail to keep up with demand for plasma it last year
began actively importing products – sourced from overseas donors and subject to offshore fractionation – well
beyond the emergency caveats to the self-sufficiency policy.
Only five years ago a review by Ninian Stephen warned "the importation of foreign-sourced plasma is not
recommended as a strategy for meeting Australia's plasma product shortfalls".
But that was 2000, when domestic demand for IVIg was only 852,998 grams. By 2004 it was 1,344,798 grams –
an increase of 58 per cent. The last meeting of Australia's health ministers agreed to increase funding for the
Red Cross to collect a record 329 tonnes of plasma this financial year. But they also agreed 18 per cent of IVIg
should be imported, thereby reducing reliance on CSL.
Page 2 of 3
"Patient needs must come first," a federal health department spokeswoman says of the decision to import IVIg,
making clear that CSL has never made some of the niche plasma products.
"If the supply of domestic blood and plasma products cannot meet patient needs then safe products will be
imported."
Yet the Red Cross – the collector and distributor in the supply chain, and not normally an outspoken critic of
public policy – is not as confident these imports are safe.
In April, Red Cross Blood Service national operations manager Pip Hetzel told The Australian she was
concerned offshore fractionation plants might not meet the same standards as those set by the TGA for CSL.
What's more, the plasma used in imported products often came from paid donors with higher risks and was not
subject to the same tests, interviews and exclusions as Red Cross donors (something the organisation
promotes in its current advertising campaign).
At the same time, the Red Cross sent a letter to all donors, this time taking aim at the Howard Government's
decision to review CSL's monopoly on Australian plasma fractionation services.
Under a side letter to the Free Trade Agreement with the US, the commonwealth is obliged to recommend to the
states and territories that CSL faces competition from overseas companies such as US-based Baxter and
Swiss-based Octapharma when its contract ends in 2009.
The commonwealth has initiated an independent review to ensure the states' decision is informed. The $3
million review is headed by Philip Flood, somewhat fittingly, a former diplomat and spy agency chief.
Flood and his colleagues have already received 45 submissions and expressions of interest. The review
secretariat toured fractionation plants for Baxter, Octapharma, LFB and BPL in Europe last month, and this
month will visit Baxter and Telecris facilities in the US.
Given the intensity of the battle for control of the Australian blood market, the fractionation industry body, the
Plasma Protein Therapeutics Association (PPTA), wasted no time in responding to the Red Cross concerns
about the safety of imported products, accusing the organisation of embarking on a scare campaign.
While the PPTA, like the federal health department, trades differing research and policy statements with the Red
Cross on that issue, Octapharma, a PPTA member, has taken a markedly different stance.
So keen is Octapharma for a greater stake in the Australian market it has altered how it sources plasma from
Europe and the US.
"As part of our commitment to building ongoing relationships with Red Cross organisations, and to appease the
current emotional concerns raised around non-remunerated donors, Octapharma have therefore made the
decision to only use non-remunerated donors for our products in Australia," group vice-president Frederic
Marguerre wrote in a letter to the Red Cross last month.
The move is unlikely to influence the Red Cross, as it would prefer Octapharma be shut out of the Australian
market altogether. The Red Cross opposes offshore fractionation of Australian plasma and wants more funding
to collect enough plasma from unpaid local donors to restore the self-sufficiency policy.
Not surprisingly CSL, which performs offshore plasma fractionation for New Zealand, Hong Kong, Malaysia and
Singapore but still has spare capacity at its Melbourne plant, wants to extend its coverage of the Australian
market.
"With improved long-term planning for plasma collections, involving modest and achievable annual increments,
Australia could be 100 per cent self-sufficient in IVIg," its submission to the review states.
Page 3 of 3
According to CSL, 80 per cent of the developed world markets are largely self-sufficient, and the largest single
market, the US, is fully self-sufficient.
Several commonwealth departments have made submissions to the review, although they may never be made
public. And the states are already taking a stand, with Victoria, Queensland and South Australia opposed to
offshore fractionation. Queensland Health, in its submission, says the review should really be looking at the
domestic shortfall of plasma.
In a letter to Flood, Victorian Premier Steve Bracks says his government is committed to "maximising the supply
of Australian plasma and using non-Australian plasma as a last resort".
Bracks says tinkering with the policy of self-sufficiency could damage public trust in Australia's blood supply.
Importing more products would also increase our reliance on other countries, possibly without the same
safeguards and definitely without the ability to enforce Australian criminal sanctions.
Boyd – and other doctors like him – doesn't realise how increased demand for plasma products has caused the
realms of politics, health and big business to collide in such a fashion. But nor does he need to. Boyd just wants
to know plasma products like IVIg will continue to be available as a treatment and adjunct to other treatments.
"It (IVIg) is often extraordinarily effective, and I'd have to say we probably don't understand completely why it is
so effective," he says.
Flood is not due to deliver a report until next year. At this stage, even though the review has the services of a
Melbourne PR firm and allows federal health department to do the talking on the issue, there are no indications
what the report will say.
The Red Cross will continue to lead the debate. As Hetzel says, the evolution of the self-sufficiency policy
"raises questions concerning the safety and quality of the plasma products, costs, Australian capability, national
security and – of fundamental importance to us – the impact on our Australian donors and, ultimately, their
willingness to continue to donate".
A federal health department spokeswoman – pointing out that the Red Cross struggles to meet its plasma
collection targets – says the review is not looking at plasma imports, but rather how to ensure an open
fractionation market is safe and efficient.
Health ministers have taken the opportunity to order an "efficiency and effectiveness" review of the Red Cross
Blood Service. The action was initiated at their April meeting, when the ministers also agreed upon the 18 per
cent IVIg imports figure – two decisions not recorded in the official communique, so sensitive are the issues at
present.
With the states lining up to defeat the commonwealth's bid to open up the plasma fractionation market, the result
of the review may already be known. But the review, by its very existence, is fostering a broader public debate
of blood policies, an exercise with a far less certain outcome.

http://www.intrafusion.cc/Documents/Safety%20debate%20colours%20blood%20product%20trade.pdf

One could argue that globalization of plasma products would
increase the perceived risks in the highest value markets
and thus enhance GTC's comparative advantage re safety.