❓ A parliamentary question regarding the safety and availability of recombinant Factor VIII and IX for haemophilia patients, compared to plasma-derived products, focusing on the risk of blood-borne viruses and the implementation of recommendations for safer alternatives.
AnsweredQoN 1872Legislative Council
QuestionView source ↗
The Australian Health Ministers Advisory Council established the Factor VIII and Factor IX Working Party in 1998. When that Working Party finally tabled its report in April 2003 amongst other improvements for the treatment of haemophilia in Australia, it recommended the supply of safer recombinant or genetically engineered Factor VIII and Factor IX instead of plasma-derived clotting factors, in line with international best practice. The Australian Health Ministers’ Conference of July 31 2003 considered the Working Party proposal had ‘merit’, yet there has still been no commitment to this -
(1) Do you acknowledge that haemophilia patients, who are forced to use plasma derived clotting factors for their treatment (up to 3 infusions of plasma-derived Factor VIII or Factor IX per week) are exposed to an increased risk of blood borne viruses and agents such as variant CJD (mad cow disease) for which there are no blood tests available?
(2) Are you aware that when a test for hepatitis C was introduced in Australia in 1990, 85 per cent of haemophilia patients tested positive for hepatitis C that had been contracted from the use of hepatitis C contaminated factor VIII and factor IX treatments?
(3) Do you acknowledge that haemophilia patients are still at risk because they must use plasma-derived products?
(4) Is the Government exposed to liability in the event of a virus or agent slipping through the blood supply when an alternative safer product can be offered?
(5) What will you do to progress the Stephen Review Factor VIII and Factor IX Working Party recommendations?
(6) Will you provide the comparative costs of plasma derived and recombinant factor VIII and IX products?
(1) Do you acknowledge that haemophilia patients, who are forced to use plasma derived clotting factors for their treatment (up to 3 infusions of plasma-derived Factor VIII or Factor IX per week) are exposed to an increased risk of blood borne viruses and agents such as variant CJD (mad cow disease) for which there are no blood tests available?
(2) Are you aware that when a test for hepatitis C was introduced in Australia in 1990, 85 per cent of haemophilia patients tested positive for hepatitis C that had been contracted from the use of hepatitis C contaminated factor VIII and factor IX treatments?
(3) Do you acknowledge that haemophilia patients are still at risk because they must use plasma-derived products?
(4) Is the Government exposed to liability in the event of a virus or agent slipping through the blood supply when an alternative safer product can be offered?
(5) What will you do to progress the Stephen Review Factor VIII and Factor IX Working Party recommendations?
(6) Will you provide the comparative costs of plasma derived and recombinant factor VIII and IX products?
AnswerView source ↗
Answered
4 May 2004
Responded by
Parliamentary Secretary representing the Minister for Health
Response time
35 days
1. Yes, although it should be noted that since the introduction of viral inactivation and new blood donor selection criteria 12 years ago, there has not been a case of disease transmission by a plasma derived clotting factor detected in Australia. 2. Many people with haemophilia who used blood-derived products prior to 1990 were infected with Hepatitis C. In all, around 40% of people with haemophilia tested positive for Hepatitis C. Of these around 10% cleared the virus spontaneously. Many have been treated with good effect, and with current treatment regimens, 1 in 3 are being freed from infection. 3. Yes. The risk derives from the fact that no blood product can be guaranteed to be free of currently unidentified disease or disease for which no screening test is available. Testing and screening procedures mitigate the risks. 4. Yes. However, this risk is not confined to those being treated with plasma derived products for Haemophilia. 5. All Health Ministers, the National Blood Authority and States’ Department of Health officials have been working to implement the recommendations of the Factor VIII and IX Working Party Report, including the recommendations concerning access to Recombinant Products. Important in this planning is the sufficiency and sustainability of supply which must be achieved Australia wide. Ministers are expecting to have access to all the information required to make a decision this year. 6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
2. Many people with haemophilia who used blood-derived products prior to 1990 were infected with Hepatitis C. In all, around 40% of people with haemophilia tested positive for Hepatitis C. Of these around 10% cleared the virus spontaneously. Many have been treated with good effect, and with current treatment regimens, 1 in 3 are being freed from infection. 3. Yes. The risk derives from the fact that no blood product can be guaranteed to be free of currently unidentified disease or disease for which no screening test is available. Testing and screening procedures mitigate the risks. 4. Yes. However, this risk is not confined to those being treated with plasma derived products for Haemophilia. 5. All Health Ministers, the National Blood Authority and States’ Department of Health officials have been working to implement the recommendations of the Factor VIII and IX Working Party Report, including the recommendations concerning access to Recombinant Products. Important in this planning is the sufficiency and sustainability of supply which must be achieved Australia wide. Ministers are expecting to have access to all the information required to make a decision this year. 6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
3. Yes. The risk derives from the fact that no blood product can be guaranteed to be free of currently unidentified disease or disease for which no screening test is available. Testing and screening procedures mitigate the risks. 4. Yes. However, this risk is not confined to those being treated with plasma derived products for Haemophilia. 5. All Health Ministers, the National Blood Authority and States’ Department of Health officials have been working to implement the recommendations of the Factor VIII and IX Working Party Report, including the recommendations concerning access to Recombinant Products. Important in this planning is the sufficiency and sustainability of supply which must be achieved Australia wide. Ministers are expecting to have access to all the information required to make a decision this year. 6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
4. Yes. However, this risk is not confined to those being treated with plasma derived products for Haemophilia. 5. All Health Ministers, the National Blood Authority and States’ Department of Health officials have been working to implement the recommendations of the Factor VIII and IX Working Party Report, including the recommendations concerning access to Recombinant Products. Important in this planning is the sufficiency and sustainability of supply which must be achieved Australia wide. Ministers are expecting to have access to all the information required to make a decision this year. 6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
5. All Health Ministers, the National Blood Authority and States’ Department of Health officials have been working to implement the recommendations of the Factor VIII and IX Working Party Report, including the recommendations concerning access to Recombinant Products. Important in this planning is the sufficiency and sustainability of supply which must be achieved Australia wide. Ministers are expecting to have access to all the information required to make a decision this year. 6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
2. Many people with haemophilia who used blood-derived products prior to 1990 were infected with Hepatitis C. In all, around 40% of people with haemophilia tested positive for Hepatitis C. Of these around 10% cleared the virus spontaneously. Many have been treated with good effect, and with current treatment regimens, 1 in 3 are being freed from infection. 3. Yes. The risk derives from the fact that no blood product can be guaranteed to be free of currently unidentified disease or disease for which no screening test is available. Testing and screening procedures mitigate the risks. 4. Yes. However, this risk is not confined to those being treated with plasma derived products for Haemophilia. 5. All Health Ministers, the National Blood Authority and States’ Department of Health officials have been working to implement the recommendations of the Factor VIII and IX Working Party Report, including the recommendations concerning access to Recombinant Products. Important in this planning is the sufficiency and sustainability of supply which must be achieved Australia wide. Ministers are expecting to have access to all the information required to make a decision this year. 6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
3. Yes. The risk derives from the fact that no blood product can be guaranteed to be free of currently unidentified disease or disease for which no screening test is available. Testing and screening procedures mitigate the risks. 4. Yes. However, this risk is not confined to those being treated with plasma derived products for Haemophilia. 5. All Health Ministers, the National Blood Authority and States’ Department of Health officials have been working to implement the recommendations of the Factor VIII and IX Working Party Report, including the recommendations concerning access to Recombinant Products. Important in this planning is the sufficiency and sustainability of supply which must be achieved Australia wide. Ministers are expecting to have access to all the information required to make a decision this year. 6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
4. Yes. However, this risk is not confined to those being treated with plasma derived products for Haemophilia. 5. All Health Ministers, the National Blood Authority and States’ Department of Health officials have been working to implement the recommendations of the Factor VIII and IX Working Party Report, including the recommendations concerning access to Recombinant Products. Important in this planning is the sufficiency and sustainability of supply which must be achieved Australia wide. Ministers are expecting to have access to all the information required to make a decision this year. 6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
5. All Health Ministers, the National Blood Authority and States’ Department of Health officials have been working to implement the recommendations of the Factor VIII and IX Working Party Report, including the recommendations concerning access to Recombinant Products. Important in this planning is the sufficiency and sustainability of supply which must be achieved Australia wide. Ministers are expecting to have access to all the information required to make a decision this year. 6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
6. No. The contracts for the processing and supply of both plasma derived and recombinant blood products are held by the National Blood Authority and are ‘commercial in confidence’.
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