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WORKING WITH NATIONAL REGULATORS AND HEALTH AUTHORITIES What to expect and what to hope for ALBERT FARRUGIA SENIOR DIRECTOR GLOBAL ACCESS PLASMA PROTEIN THERAPEUTICS ASSOCIATION International Patient Organization for Primary Immunedeficiencies Congress, Hertogenbosch, the Netherlands October 2008
Australian Treasury projections Effect of age group on health spending
Australian Treasury projections Spending on health
Australian Treasury projections Spending on health – sectorial breakdown
What are the priorities of government officials?
3 Deliver better population health outcomes (without
affecting 1 & 2)
awareness of mood in marginal electorates
understanding of swinging voters’ core values
knowledge of market research mechanisms
Precautionism is becoming a dominant policy feature
“… In the event of a future threat to the blood supply, the FDA should encourage small, low-risk solutions to large, difficult problems...” IOM Report 1995
“… If harm can occur, it should be assumed that it will occur. If there are no measures that will entirely prevent the harm, measures that may only partially prevent transmission should be taken…“ Krever Commission 1996
General properties leading to quality and safety may be reflected in standards of the pharmacopoeia.
But range of approaches to the manufacture results in significant differences between products.
This necessitates thorough evaluation for the potential effect of the process on the factors of interest and the impurities in the products.
Regulation of plasma derivatives
Regulation by the NRA … assuring quality, safety & efficacy
Establishing/maintaining a system of licensing & control
Dossier review and PAI
facility and product registration
inspection and enforcement
Providing standards and guidelines
Requiring that licence holders adopt and maintain appropriate quality systems
Providing competent, consistent, arrangements for post-marketing surveillance of products
NRA involvement in batch testing & release(?)
“ The core of the voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interest and is recommended by either a consortium of consumer-oriented organizations or other interested persons.”