Appendix C Blood sectors

C1 Australian blood sector

Standing Committee on Health and Australian Health Ministers’ Advisory Council

The Standing Committee on Health (SCoH) is responsible for the oversight and management of the Australian blood sector. The committee’s responsibilities include national policy and financial decisions in relation to the supply of blood and blood products, and the determination of which products and services can be bought with public funds. SCoH oversees the implementation of the National Blood Agreement (described below), and is supported in its roles by the Australian Health Ministers’ Advisory Council (AHMAC).

Clinical, Technical and Ethical Principal Committee

The Clinical, Technical and Ethical Principal Committee (CTEPC) was established in 2006 to consider and provide advice to the AHMAC on a range of issues. Areas covered include:

• clinical, technical and medico-ethical developments that are likely to affect more than one jurisdiction
• options for ongoing coordination of the clinical and technical services that are managed on a national basis
• the appropriateness, effectiveness and safety of clinical and technical developments
• any policy implications arising from the issues considered by the committee
• the impact of clinical and technical developments on the delivery and management of health care and other services
• the impact of clinical and technical developments outside the health-care sector.

Jurisdictional Blood Committee

All Australian governments are represented on the JBC, which was established by the National Blood Agreement in 2003. The committee:

• is the conduit between governments and the NBA
• represents the Australian state and territory governments' position on:
  • – blood policy, demand, supply planning and product distribution
  • – funding
  • – evidence-based approaches to emerging products, services and technologies
• overseas the NBA's role in blood supply contacting.

The committee is the primary body responsible for providing advice and support on these matters to the SCoH through the CTEPC (of which it has been a subcommittee since September 2006) and the AHMAC.

National Blood Authority

The NBA was established in 2003 as an Australian Government agency within the health and ageing portfolio. It is responsible for ensuring the adequate, safe, secure and affordable supply of blood and blood products. The role of the NBA is outlined in the National Blood Authority Act 2003 and the National Blood Agreement.

Part 5 of the National Blood Agreement requires the development and implementation of specific safety and quality strategies, including development, implementation and review of evidence-based national clinical practice guidelines for blood, blood products and blood-related services. The aim is to encourage best practice in the management and use of such products and services.

Therapeutic Goods Administration

The TGA is the regulator for blood and blood products in Australia. The TGA is responsible for:

• regulating the sector in terms of the safety and quality of blood and blood products under the Therapeutic Goods Act 1989
• auditing good manufacturing practice
• issuing product recalls
• modifying safety standards
• issuing directives such as donor deferral.

Australian Red Cross Blood Service

The Australian Red Cross Blood Service was established as a national organisation in 1996. It is responsible for collecting, processing and distributing blood and blood components sourced from voluntary donors in Australia. The Australian Red Cross Blood Service works alongside Australian regulators, government departments, and commercial and professional organisations, and with international bodies, to constantly review and improve the safety and provision of blood and blood components in Australia. The Australian Red Cross Blood Service also has significant transfusion medicine expertise and clinical involvement.

C2 New Zealand blood sector

Ministry of Health

The New Zealand Minister of Health is the government owner of the New Zealand Blood Service (NZBS). The Minister appoints the NZBS Board and approves the Statement of Intent and Output Agreement.

The Ministry of Health monitors the performance of the NZBS, and works closely with the organisation in setting the overall strategic direction for the provision of blood and blood products in New Zealand.

Medsafe

Medsafe is the regulator for blood and blood products in New Zealand. Medsafe is responsible for:

• regulating the sector in terms of the safety and quality of blood and blood products under the Medicines Act 1981 and Medicines Regulations 1984
• auditing and licensing blood centres in accordance with good manufacturing practice
• issuing product recalls
• approving changes to the NZBS Collection and Manufacturing Standards.

New Zealand Blood Service

The NZBS is a Crown Entity established under the New Zealand Public Health and Disability Act 2000. Its legislated purpose and core activity is the safe, timely, high-quality and efficient provision of blood and blood products to clinicians for the people of New Zealand. It also provides related services, including matching of patients and donors before organ or tissue transplantation, and provision of tissue banking (skin, bone and stem cell services).

The NZBS Board is appointed by, and responsible to, the Minister of Health, and performs strategic and governance functions in accordance with the Act.

The NZBS works closely with regulators, the Ministry of Health and international agencies to monitor international developments in the field of transfusion medicine, to develop national policies and to implement them as appropriate in the New Zealand setting.

In addition to its role in collecting, processing and distribution of blood and blood products, the NZBS is actively involved in the provision of blood banking and clinical services within New Zealand’s major hospitals.