CSL Limited T +61 3 9389 1911
45 Poplar Road F +61 3 9389 1434
Parkville [Link]
Victoria, Australia 3052
CSL Statement: ABC Four Corners screening of Blood
Business
For over 100 years, CSL has been driven by a promise to improve the quality of
life for people with rare and serious diseases. Our company and its near 20,000
employees are passionate about the health of our plasma donors and the safety
and quality of the therapies that we make for patients at our manufacturing
facilities around the world.
CSL shares the concerns of the Plasma Protein Therapeutics Association
(PPTA) - the international trade association that represents manufacturers of
plasma products and recombinant analog therapies - about the inaccurate and
disturbing claims made in the documentary Blood Business. The film contains
significant misinformation about regulations in relation to plasma donation, the
motivations of plasma donors, the safety of plasma purification and the costs
associated with production of life-saving medicines.
These false statements are both irresponsible and disrespectful to millions of
plasma donors, the hundreds of thousands of employees involved in the
production of life-saving therapies, and importantly, countless patients whose
lives depend on these medicines.
CSL Limited, 1 August 2017
- ends -
Background information:
About plasma products and the process of making them
CSL (through its subsidiary businesses, CSL Behring and CSL Plasma), is a
global leader in the plasma products industry. Around the world, CSL employs
nearly 20,000 people who work to deliver life-saving medicines, some of which
are manufactured from human plasma. Plasma products are made through a
process of separating and purifying the proteins that occur naturally in plasma,
and are used to produce a range of products - medicines for the treatment of
rare or serious conditions such as disorders of the immune system,
haemophilia, shock and trauma.
The collection of plasma and the subsequent manufacture of plasma products is
highly regulated, sophisticated and complex, involving advanced technologies to
assure safety and quality for the donors and the patients who greatly benefit
from these products. In a number of life-threatening conditions, plasma products
are the only option for effective treatment.
The film Blood Business has been systematically discredited by the Plasma
Protein Therapeutics Association (PPTA) the international organisation
representing the plasma industry. The PPTA has expressed strong concern
about false and misleading statements made in the film that could cause
unnecessary anxiety in patients and plasma donors. The PPTA cites its primary
concerns about the documentary being:
The inaccurate characterization of plasma donors in the United States;
the inaccurate depiction of the safety of compensated source plasma
in the U.S., the safety of the finished therapy and the lack of
differentiation between blood and source plasma used for further
manufacture.
Safety - Prior to donation, plasma donors are carefully screened and tested for
infectious diseases. Plasma products undergo rigorous safety controls and
inspections throughout every step of the manufacturing process from the
collection of plasma to the final packaging of the finished product, ensuring
plasma products are of the highest quality and safety.
Safety of the final product is assured through the four pillars of safety which act
in concert to prevent transmission of infection to the recipient. The four pillars of
donor selection, testing, pathogen inactivation and pharmacovigilance
have prevented clinically significant infectious disease transmission to recipients
of these products.
2
Tens of millions of plasma donations are collected each year (in 2016 in the
United States alone, the PPTA recorded 38,296,234 plasma collections1). Since
1994, CSL Behring has not had a confirmed transmission of an infectious agent
associated with its plasma products2. Our manufacturing methods have also
been demonstrated to be effective against emerging infections or viruses that
could be transmitted by blood. It is a record of which we are proud. Safety is not
taken for granted and CSL continues its research and vigilance to ensure that
this record of making safe, high-quality products for patients is maintained.
Compensation - In some states in the US, and some countries in Europe,
individuals who donate plasma are permitted to be compensated for the
significant amount of time it takes to donate (~1 1.5 hours) and for their
commitment to the donation process. Commercially sourced plasma from the
US currently supplies over half3 of the worlds plasma requirements - without
this compensation model, the producers of plasma products would not be able
to secure enough plasma to produce these products in sufficiently large
volumes to allow the treatment of individuals coping with life-threatening
diseases. As an example, it can take as many as 130 donations to deliver a
single treatment for a person with a primary immunodeficiency. For a patient
with haemophilia, around 1200 donations are needed to cover a years
treatment and in many cases, patients remain on these treatments their entire
lives.
Donors - Plasma donors are valued individuals who are contributing to the
production of life-saving treatments. Many are repeat donors who make a
commitment to longer term donation because they recognise the life-saving
benefits of plasma products. Some even have a loved one or friend with a rare
disease that is treated with plasma product. It is regrettable that the film does
not reflect this more accurately.
In Australia, the Commonwealth Government acting through Australias
National Blood Authority contracts the Australian Red Cross Blood Service to
collect donations of both whole blood (from which the plasma is extracted) and
plasma itself, on-shore in Australia. The Commonwealth Government, acting
through Australias National Blood Authority, contracts CSL Behring under the
CSL Australian Fractionation Agreement to manufacture 15 plasma products
from these plasma donations for use in Australia. The collection of donations
[Link]
07_-_2016.pdf
2
[Link]
3
UBS Global Research (UBS Evidence Lab), Global Plasma Pharmaceuticals, 9 June
2017
3
and manufacture of plasma products is highly regulated and subject to strict
quality controls.
CSL publishes detail about the products it supplies in Australia in its annual
report. The National Blood Authority also publishes detail about the plasma
products it procures for supply in Australia in its Annual Report.
CSL takes inaccurate and misleading claims about the industry very seriously.
We are transparent about our business processes and welcome unbiased
scrutiny of our practices. To this end, our annual Corporate Responsibility report
details our commitment to operating responsibly, how we ensure the safety and
quality of our therapies and our support for communities around the world.
CSL is committed to delivering safe, effective, reliable therapies to the many
patients worldwide who depend on our products. In doing so, we are committed
to upholding the highest ethical standards and contributing to the economic,
social and environmental well-being of our communities-of-interest. We believe
that behaving responsibly is critical to the sustainability of our company. We are
proud of our achievements and contribution to people with rare and serious
disease and to our shareholders, and stand by our reputation for ethical
practices, safety and quality.
Further information:
PPTA: [Link]
Statements on Blood Business documentary
[Link]
ppta-statement-on-the-documentary-das-geschaeft-mit-dem-blut
[Link]
ment_Response_to_ARTE_FINAL.pdf
CSL Limited
On plasma safety
[Link]
[Link]
4
Responses to questions from Four Corners
CSL Limited pay for donations overseas. Does that blood and
plasma get used in transfusions or in pharmaceutical products for
Australian patients? If so, please detail.
Australias supply of blood and plasma products is managed by
Australias National Blood Authority (NBA). The National Blood Authority
publishes detail about the plasma products it procures for supply in
Australia in its Annual Report.
Why did CSL Limited choose to set up operations in Cleveland?
CSL has 167 plasma collection centres across the United States.
CSLs operation in Cleveland was acquired as a part of CSLs acquisition
of ZLB Plasma from Nabi in 2001. The centre has an exemplary record
and follows the same Food and Drug Administration / European
Medicines Agency (EU) regulations followed by all of CSL Plasmas
plasma collection centres. This includes the same training methods,
Standard Operating Procedures, electronic donor management system
and passing audits by external regulators.
What is CSL Limiteds response to criticisms that operations like
CSLs exploit people living in poverty?
CSL Plasma works with plasma donors from many socio-economic
groups. All people who attend our centres in the US, Germany and
Hungary to make a plasma donations are treated as valued participants
in the process of providing safe and effective plasma products to
patients in need, although some will not qualify to be donors. There is no
discrimination or exploitation involved our donors donate voluntarily.
The socio-demographic background of CSL Plasma donors in the US is
very diverse. Based on self-reported survey data (1/1/2016
12/31/2016), approximately 47% of donors described themselves as
working full-time with the remaining non-fulltime and unemployed having
26% respectively. Of the donors who completed the survey,
approximately 11% describe themselves as students. In addition, 99% of
the donors who completed the survey stated they would donate
again. Overall, the trend supports that the majority of donors are fully
employed and donate to help improve the lives of patients in need of life
saving therapies.
5
What is CSL Limiteds approach to the number of donations that a
person should make? How do you monitor it?
CSL Plasma adheres to donation limits defined by applicable
regulations. We use both medical examinations and laboratory tests to
monitor the health of our donors. This process is monitored through our
electronic Donor Management System and underpinned by our Quality
Assurance processes. In addition, the plasma collection industry has
processes in place (such as the Cross Donation Check System (CDCS))
that ensure a donor does not donate more frequently than is allowed
under the applicable regulations.
What are the procedures and policies that CSL Limited has in place
to ensure that blood and plasma donated at CSL run donation
centres are safe?
CSL Plasma collects plasma donations. It does not collect blood
donations. To optimise the safety of the plasma products we
manufacture from these plasma donations, CSL relies on the four pillars
of safety:
1. Donor screening (questionnaires and medical evaluation) to ensure
health
2. Testing of all donations utilising advanced testing technologies (both
individually and once pooled together at the start of the
manufacturing process) for pathogens that could be contained in
plasma
3. Dedicated and specific pathogen reduction steps validated steps
included in the manufacturing process solely to destroy or remove
pathogens that could be contained in plasma during manufacturing
4. And pharmacovigilance (investigation of all reported adverse
events).
We also have a laboratory-based research program that monitors all
emergent infectious threats. These activities are managed by our Quality
Assurance Program.
In terms of safety for donors, we monitor the results of laboratory tests
run (haematocrit and plasma proteins) and perform regular medical
evaluations. We also investigate all adverse events that occur
associated with donation, and take corrective action as needed.
Does CSL Limited think that rules or policy should be reviewed in
Australia to allow donors to be paid to make donations of blood
and plasma?
6
This question would be best directed to Australias National Blood
Authority.