Fractionation Agreement

The national split agreement for Australia will begin on 1 January 2018 and will last a total of nine years until 31 December 2026, subject to satisfactory performance against the most important measures and a satisfactory conclusion of a review on the basis of certain criteria, which is expected to be completed in the fifth year. The new agreement replaces a long-term agreement between the National Blood Authority and CSL Behring, which expires on December 31, 2017. CSL Behring announced today that it has signed an agreement with the National Blood Authority, which represents all Australian governments, to continue to provide the Community with a first-rate and safe supply of plasma-derived therapies produced in Australia. Plasmadean medicinal products (PMDPs) are an essential part of the modern therapeutic armamentarium. They differ from most other drugs in several respects, notably by the uniqueness of the raw material used in their manufacture. Human plasma has been split into PDMP over the past 75 years, and manufacturing profitability currently requires harvesting as many products as possible and tailored to clinical needs from each litre. PMPs can be purchased on the open market by various commercial and not-for-profit manufacturers (NPPs). They can also be manufactured under a contract (CM) from plasma, supplied by public bodies and assimilated as a product of blood transfusion services. Customers for CM strive to make full use of donated plasma, which maximizes donor donation after the standard transfusion components are harvested. Many of these countries are also trying to make their national clinical needs self-sufficient in PDMP and are trying to gain strategic independence from the vagaries of the open commercial market. The growing business demands in the PMDP sector create a tense relationship with ethical aspirations that are difficult to resolve.

In particular, the need to harvest as much protein as possible can produce supernumerary products with national needs, which requires an ethical paradigm for the optimal supply of these products. In addition, traditional relationships between blood services and national splitting agencies can be put under pressure because of the competition processes that underlie these transactions and are now subject to international free trade standards. The blood services that handle the supply of hospital transfusion components are separated from the good manufacturing pharmaceutical culture (GMP) used for plasma production for CM, while the production of such plasma by extraction from total blood donations diverts attention from a special raw material for CM onto a by-product of the donation process. We review the CM area, assess current tensions within the sector and make proposals for the strategic positioning of governments and other clients to ensure optimal results for all stakeholders. “The National Fractionation Agreement for Australia provides the health care system with access to safe care in high-quality plasma therapies for the duration of its nine-year period,” she said. Under the new agreement, CSL Behring will continue to provide a comprehensive portfolio of life-saving plasma products at its Broadmeadows Advanced Production Plant in Victoria. “CSL Behring welcomes the opportunity to continue our long-standing commitment to plasma-derived therapies to treat people in Australia suffering from serious diseases such as immune system diseases, blood clotting disorders or serious injuries,” said Loretta Croker, Executive Director of CSL Behring Australia and New Zealand.

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