The report is available in English with a French summary - KCE

106 Plasma KCE Reports 120
Table 44: The Plasma Products Agreement between CSL-Ltd and the
Australian National Blood Authority
Heading Content
Section A: Interpretation and Term Definitions, rules of interpretation
Section B: Relationship Management Relationship between the parties, Contacts and notices,
Management meetings and reviews, Public Affairs
Management, Variations to the Deed, CSL contracts with
other Nat. Blood Suppliers
Section C: Products / Services Obligations Provision of products (quantity; notice obligations, etc..)
Exclusive right to fractionate plasma, Reporting obligations,
Obligations under Therapeutic Goods Act, CSL general
obligations (as a manufacturer and where CSL is not a
manufacturer)
Product compliance and return,
Performance requirements for goods and services
Section D: Payment Obligations Payments by the NBA, Invoicing obligations, Recovery of
money by the NBA,
Section E: Ownership Issues Possession of products, Intellectual property, Moral rights
Section F: Protection of Information Confidentiality, Data security, Privacy, Conf. of Interest
Section G: Treatment of Risks Risk Manag. Warranties, Indemnities, Undertakings,
Insurance, Supply continuity plans & options
Section H: Other Requirements of CSL Records, Access to information & Premises, Audit.
Section I: Termination and Disputes Termin. for default, for change of policy, Handover
obligations, Dispute Resolution,
Section J: Miscellaneous Assignment (by CSL, by NBA), Execution of separate
documents.
CSL Limited is also in charge of maintaining the National Reserve of plasma products for
the NBA, under a contractual arrangement separate to the PPA.
4.2.2.2 In France
French Approach of self-sufficiency
In France, there is no official and legal definition of “self-sufficiency” as such. However, a
general approach of this concept could be defined as the turnover of LFB (national
fractionator enjoying the monopoly of EFS plasma fractionation) compared to the total
turnover of fractionators operating in France. One must bear in mind that the plasma
product market is subject to competition. LFB must therefore compete with other firms
(Baxter, Octapharma, etc…).
Considering this approach, it must be outlined that LFB meets 75% of the needs of the
French market. However, it must be underlined that LFB corporate objective is to be in
the position to fulfil 100% of these needs in 2011 (specific investments have been
planned accordingly).
Another important point is the very last update of the French regulation framework. In
Summer 2009, the new French Law on Health Care organization (Loi Hôpital Patients
Santé et Territoire – Loi HPST) officially stated that fulfilling the French patients’ needs
must be LFB’s priority (in return of its monopoly of EFS plasma fractionation).
Supply of blood and plasma-derived products: the French monitoring system
Following the shortage of Factor VIII in France in 2000-2001 (and consequential
problems for haemophilia patients), the French Department of Health decided to set up
a long-term monitoring system -National Steering Committee- to address this specific
kind of problems. The latter has been organized since 2001 (by means of a Department
of Health’s Circular dated 28 June 2001) under the leadership of the AFSSAPS Agence
Française de Sécurité Sanitaire des Produits de Santé– French Agency for the Safety of
Health Products.
Following the meetings of these groups, and depending on the likelihood of shortage of
plasma derivatives, national official recommendations – including priority orders - can be
officially set out and published by the AFSSAPS and to rationalize the use of these
products accordingly (eg: Fibrinogene-derived products in December 2008 and the
following months).