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FTA flags offshore processing of Aust blood s -

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Broadcast: 15/05/2006

FTA flags offshore processing of Aust blood supplies

Reporter: Mary Gearin

KERRY O'BRIEN, PRESENTER: In a world where everything seems to have been reduced to a commercial
transaction, it's remarkable to think that Australia's blood supplies still come from voluntary
donations. But that tradition could be about to change thanks to the free trade agreement signed
with the United States. At the instigation of international pharmaceutical companies, an inquiry is
examining whether Australian plasma should be processed overseas, breaking the monopoly currently
enjoyed by CSL. Despite assurances about safety procedures, the prospect of Australians being given
blood products processed in other countries has caused alarm, particularly at the Red Cross. The
fear there is that this could be the first step towards paying for blood. Mary Gearin reports.

MARY GEARIN, REPORTER: Like hundreds of thousands of others around the country, Marion Mitchell has
taken time out of her working day to give blood as a matter of community service. That's undermined
by her trust in Australia's system of collection and processing. But what if the plasma given at
this busy collection centre was sent offshore to be processed?

DONOR #1 I think the main concern would be the safety aspects of the plasma or the product that
comes back.

DONOR #2: There's all the transporting costs and fuel and everything like. That...

DONOR #3: If it's just about money, better off to have a process on board that's really working
well for us.

MARY GEARIN: Whether such concerns are sensibly cautious or parochial and alarmist depends on where
you stand in the tug of war for control of Australian plasma that's about to start. A letter
attached to the Australia United States free trade agreement promises a review that would threaten
the effective monopoly currently held by the multi-national Australian-based company CSL.

KIM BJOERNSTRUP, DEPUTY CHAIRMAN, OCTAPHARMA: I believe that if you see all over the world it's
never good with a monopoly in any situation.

would like to be able to say to our donors that their plasma is constantly under the supervision of
an Australian regulatory authority.

MARY GEARIN: The fuss is all about this - fractionation, the process where plasma is separated into
proteins and made into a range of essential products, vital for trauma patients, haemophiliacs and
an increasing range of conditions. Australia has always brought in a few foreign-made products CSL
can't make locally, but increasingly over the past four years the Government's imported more of the
most widely used plasma product intravenous immunoglobulin known as IVIG, because supply can't
totally meet demand.

PROFESSOR JAMES ISBITER: I think we've got to match up supply and demand in Australia as much as we
can using our own voluntary donated system.

MARY GEARIN: Professor James Isbister is chair of the Red Cross Blood Service Advisory Committee.
He says the main problem is that the Australian regulatory body, the Therapeutic Goods
Administration, can't control a process performed overseas.

PROFESSOR JAMES ISBISTER: If it goes offshore, we are much more dependent on other government's
regulatory agencies that may or may not be as strict as ours.

MARY GEARIN: No-one from CSL or the TGA would be interviewed for this story but the Federal Health
Department asserted in a statement that under the agreement Australia retains the right to
standards for ensuring the safety, quality and efficacy of its own plasma products. And one of the
frontrunners to challenge CSL's monopoly says it would expect nothing less than stringent
Australian supervision.

KIM BJOERNSTRUP: You have some very competent authorities in Australia like the TGA, and they would
not allow any blood product into your country unless it's been scrutinised, I can assure you of
that. We have been through that process with several products and they are at least as tough in
their judgment as renowned agencies like the FDA from the United States.

MARY GEARIN: Swiss-based Octapharma already supplies Australia with a brand of intravenous
immunoglobulin, but it's keen to process Australian plasma offshore. It has plants in Austria,
France, Sweden and Mexico. Speaking in London, the company's deputy chairman insists Octapharma
guards against cross-contamination just like CSL is required to do.

KIM BJOERNSTRUP: We can assure you 100 per cent that there will never be any mix of Australian
plasma with any other foreign sources of plasma and the reason we can say that with, I think we can
say that, we can prove that to you is that we have been running these projects with Norway for the
country of Norway for more than, I think we calculated something like 17 years now.

MARY GEARIN: The group representing leading international plasma processors has called on the Red
Cross to stop making "unfounded claims about the safety of their products" . Even if the Australian
plasma remains unsullied from other sources it may not come back in forms we recognise.

manufacturer who uses a different process, then the side effect profile for that product may
change. And patients who have previously used that product without any problems may have problems
in the future.

MARY GEARIN: Haematologist Dr Helen Savoia is on the Council of the Australian New Zealand Society
of Blood Transfusion. She says the society can see problems and advantages with overseas

DR HELEN SAVOIA: Competition might introduce new products to the Australian market.

MARY GEARIN: But Dr Helen Savoia is concerned about doctors needing to dole out new and unknown
products to patients.

DR HELEN SAVOIA: It's possible that some of the information might be treated by companies as
commercial in confidence and I think that would be concerning.

MARY GEARIN: Recently, the Red Cross launched what it says is its biggest blood drive yet,
emphasising the restrictions it places on Australian donors. You're one of the few Australians who
can give blood.

MARY GEARIN: Curiously there was no official comment from the Red Cross for this story, even though
it campaigned vigorously in the media before making a submission to the Government review. The Red
Cross submission hints at dark possibilities ahead that the Government could be heading towards a
totally commercial system, where foreign-sourced products flood the Australian market and
ultimately, to paying for blood donations. But that shouldn't alarm Australians according to
Octapharma it currently processes blood from paid donors.

KIM BJEORNSTRUP: According to what we see and the way the market is growing in Australia, I don't
think - I think it would be quite difficult with just non-remunerated donors to provide those
supplies to the patients.

PROFESSOR JAMES ISBITER: I'd be extremely surprised if the Australian community would ever accept
paid donation.

MARY GEARIN: The Health Department says in any case that topic is well outside the scope of the
review which is only about plasma fractionation. The heart of this issue may be health but the
review itself is linked to the free trade agenda. It'll be hard to separate the emotion from the
economics when the Government review concludes early next year.

(c) 2006 ABC