威望 16 点
发表于 2015-7-17 08:06
個人精力有限，我只能把PHARMAC的一些背景從網上的文章http://www.sciencedirect.com/sci ... i/S0168851013002108 摘錄下來．個別段落如有進一步翻譯的需要，請告訴我，時間允許的話，我會盡力而為．
PHARMAC, New Zealand's Pharmaceutical Management Agency, was established in 1993 in response to rising prices for medicines . Initially established to subsidise community medicines, its role was recently expanded to cover hospital medicines, and it will soon take on purchasing of medical devices for hospitals as well .
PHARMAC differs from many other pharmaceutical pricing and reimbursement programs in that it combines many functions (management of the formulary, assessment of comparative effectiveness and cost effectiveness, reimbursement decisions, price negotiation, procurement, management of the budget, and payment functions) within one organisation, enabling a greater degree of control over expenditure than some other programs . PHARMAC is also different in that it is required to operate within a capped annual budget, and it has a legal obligation to secure “the best health outcomes that are reasonably achievable from pharmaceutical treatment and from within the amount of funding provided” .
PHARMAC has two advisory committees. The Pharmacology and Therapeutics Advisory Committee (PTAC), is an expert committee that considers the evidence against a set of decision criteria and makes recommendations as to whether new drugs should be added to the Pharmaceutical Schedule, and what priority they should be given . PTAC makes recommendations to PHARMAC; PHARMAC then considers cost-effectiveness and budgetary considerations and negotiates with suppliers. PHARMAC's decisions are also informed by a Consumer Advisory Committee .
PHARMAC's decision criteria
•The health needs of all eligible people within New Zealand;
•The particular health needs of Māori and Pacific peoples;
•The availability and suitability of existing medicines, therapeutic medical devices and related products and related things;
•The clinical benefits and risks of pharmaceuticals;
•The cost-effectiveness of meeting health needs by funding pharmaceuticals ，rather than using other publicly funded health and disability support services;
•The budgetary impact (in terms of the pharmaceutical budget and the government's overall health budget) of any changes to the Pharmaceutical schedule;
•The direct cost to health service users;
•The Government's priorities for health funding, as set out in any objectives notified by the Crown to PHARMAC, or in PHARMAC's Funding Agreement, or elsewhere; and
•Such other criteria as PHARMAC thinks fit. PHARMAC will carry out appropriate consultation when it intends to take any such ‘other criteria’ into account.
Source: PHARMAC (2012) Making Funding Decisions. Available from: http://www.pharmac.govt.nz/2011/09/16/04FUNDING_DECISIONS.pdf
PHARMAC is very effective in using market competition to drive down prices . A range of commercial purchasing strategies is employed to ensure value for money. These are shown in Box 2. Of particular significance are negotiation (primarily used for medicines under patent, for which there are no generic alternatives), tendering for sole subsidised supply (a key strategy for obtaining generics at low prices), therapeutic reference pricing (linking the price of medicines to existing medicines with similar therapeutic effects) and multi-product agreements, where price reductions on older medicines are negotiated by bundling them together with new products considered for subsidy .
PHARMAC's commercial purchasing strategies （採購策略）
•Alternative commercial proposals (ACPs)
•Requests for proposals (RFPs)
Source: PHARMAC (2013) Purchasing Medicines. Available from: http://www.pharmac.health.nz/cke ... -medicines-2013.pdf
PHARMAC's processes have ensured that New Zealand performs well on many measures of pharmaceutical expenditure when compared with most other OECD countries. In 2009, New Zealand's per capita expenditure for prescribed medicines was 237 USD PPP compared with 370 for Australia and 815 for the United States . In that year New Zealand also spent only 0.9% of GDP on pharmaceuticals in comparison with the OECD average of 1.5% . Within the OECD only Denmark, Luxembourg and Norway spent a lower proportion of GDP on pharmaceuticals, while the United States spent more than 2% .
Because of its effectiveness in negotiating prices for medicines, PHARMAC has long been in the sights of the pharmaceutical industry. The 2012 special 301 watch report of the United States Trade Representative cites US industry concerns over “unfair reimbursement policies” in several countries, and particularly the operation of PHARMAC:
“The industry continues to express concerns regarding, among other things, the lack of transparency, fairness, and predictability of the PHARMAC pricing and reimbursement regime, as well as the negative aspects of the overall climate for innovative medicines in New Zealand [13, p. 21]”.
In recent years, the US Government has sought more favourable market access for its pharmaceutical industry through bilateral and plurilateral trade agreements. The first attempt to modify another country's drug coverage program was made in the Australia–US Free Trade Agreement, which came into force in January 2005. However, although some process changes were made to the Australian Pharmaceutical Benefits Scheme (PBS), the core listing and pricing mechanisms of the program remained unchanged, and the US was unsuccessful in its pursuit of the industry's key offensive interests and . A second and far more successful attempt was made in 2007 as part of the negotiation of a bilateral free trade agreement with South Korea (KORUS), and led to much more substantial changes to the operation of various South Korean programs and .
More recently, the US pharmaceutical industry has sought to use negotiations for the Trans Pacific Partnership (TPPA) to constrain the operation of pharmaceutical coverage and reimbursement programs in several other countries. While among the negotiating countries to date only Australia and New Zealand have established national pharmaceutical coverage programs, the eventual provisions of the TPPA may well circumscribe the manner in which any future programs are developed in the other TPPA parties, and will extend to any countries that sign up to the TPPA in future  and .