Plasma Derived Medicinal Products (PMDPs) is an essential part of the modern therapeutic arsenal. They differ from most other drugs in several ways, including the uniqueness of the raw material used for their manufacture. Human plasma has been fractionated into PDMP over the past 75 years, and the profitability of production currently requires that each liter be harvested as many products as possible and reflect clinical needs. PDMPs can be purchased on the open market by the various commercial and non-profit producers (NFPs). They can also be manufactured for account (CM) from plasma supplied by governments and other similar authorities as a blood transfusion service product. CM`s customers strive to take full advantage of donated plasma and thus maximize donor donation after the collection of standard transfusion components. Many of these countries are also seeking to make their national clinical needs self-sufficient in PDMPs by trying to gain strategic independence from the goats of the open commercial market. The growing business imperatives operating in the PMDP sector are creating tension with such ethical aspirations that are not easy to resolve. In particular, the need to harvest as much protein as possible can produce products that exceed national needs, which requires an ethical paradigm for the optimal supply of these products. In addition, the traditional relationship between blood transfusion services and national fractionation agencies may come under pressure due to the competitive processes that underpin such transactions that are now subject to international free trade standards. Blood services related to the supply of hospital transfusion components are separated from the GMP (Good Manufacturing Practices) pharmaceutical culture necessary for the production of plasma for CM, while the production of such plasma by extraction from whole blood donations directs the attention of a dedicated raw material for CM to a by-product of the donation process. We review the CM domain, assess the current tensions within the sector and propose proposals for the strategic positioning of governments and other clients to achieve optimal results for all relevant stakeholders.
The national splitting agreement for Australia will start on 1 January 2018 and will have a total duration of nine years until 31 December 2026, subject to satisfactory performance for the important measures and the satisfactory conclusion of a review based on defined criteria, to be completed in the fifth year. The new agreement replaces an existing long-term agreement between the National Blood Authority and CSL Behring, which expires on December 31, 2017. . .