|Implemented in this survey?|
In December 2007, the New Zealand Ministry of Health released its high-level ?Medicines New Zealand? Strategy and Action Plan. The Strategy aims to achieve improvements in medicines processes for community pharmaceuticals in three key areas: access, quality and rational use. Given that New Zealand operates a capped pharmaceutical spend, a corollary of the Strategy is to ensure greater transparency of decision-making about prioritisation and public funding of medicines.
In New Zealand, most medicines are publicly funded under a capped budget for community pharmaceutical spending. However, to date New Zealand has lacked an overarching cohesive strategy for regulating, obtaining and managing the use of medicines in the community. There are issues of transparency and decision-making about prioritisation of funding of medicines.
The release of the 'Medicines New Zealand' strategic framework and its action plan 'Actioning Medicines New Zealand' (Ministry of Health, 2007a; 2007b) are the culmination of an extensive review and consultation process (Ministry of Health, 2006).
The objectives of the Strategy and its Action Plan are to support the medicines system to deliver:
These in turn will be supported by:
Source: Actioning Medicines New Zealand. Wellington: Ministry of Health, 2007.
High-level framework to ensure equitable access to high quality medicines; that medicines are optimally used; and that decisions surrounding approval and funding are evidence based.
|Medienpräsenz||sehr gering||sehr hoch|
The health and disability support system in New Zealand is enshrined under the New Zealand Public Health and Disability Act (2000). The Ministry of Health sets national health policy and guidelines for the system. These are outlined in a range of national health and disability strategies which seek to improve the health of New Zealanders and to reduce health inequalities between population groups.
Medicines policy interacts with, and plays a role in achieving, outcomes of other policies. The New Zealand medicines system is made up of a range of agencies and stakeholders, each of which has various functions relating to the quality, safety and efficacy, access, and optimal use of medicines. This spread of responsibility can create tensions. It does, however, provide checks and balances necessary in a robust and accountable system.
One key tension is that since 1993, New Zealand has had a capped budget for publicly funded community pharmaceuticals introducing explicit rationing. The 21 District Health Boards (DHBs) which have responsibility for the health of their populations, together with Pharmac, a crown entity responsible for purchasing medicines, work together to recommend a budget for medicines to the Ministry of Health. Once that is set, Pharmac ultimately decides which pharmaceuticals will be publicly funded. Two committees that provide advice to Pharmac also play a role. The Pharmacology and Therapeutics Advisory Committee (PTAC) advises on effectiveness. The Consumer Advisory Committee advises on consumer issues. Medsafe - an unrelated organisation - assesses the safety of products.
|Implemented in this survey?|
To date New Zealand has lacked an overarching cohesive strategy for regulating, obtaining and managing the use of medicines in the community. Other recent strategies covering biotechnology and the safe and quality use of medicines also have a bearing on the development of the Medicines Strategy.
Work towards a medicines strategy began in 2005. Following consultation with the medicines sector and government, terms of reference were established in April 2006. In December 2006, the Ministry of Health released its consultation document: 'Towards a New Zealand Medicines Strategy'. This document described the structures and processes of the existing system and proposed objectives and principles to guide future policies, structures and systems. It also identified potential issues for improvement.
Consistent with the framework for a medicines strategy recommended by WHO, the focus of the framework was on:
The consultation document received a wide sector and public response. Arising out of that the Strategy 'Medicines New Zealand' and 'Actioning Medicines New Zealand' were released in December 2007.
While the Strategy and its Action Plan do not constitute a review of Pharmac, issues of transparency and decision-making about prioritisation of funding of medicines are to be addressed. These will provide for greater consultation and feedback processes, more transparency in budget setting, and independence of technical advice. More generally 'Medicines New Zealand' is intended to be a platform to build relationships and create a cohesive, effective and responsive medicines system.
The Ministry of Health had the leadership role, with the review being undertaken by the
Health and Disability Systems Strategy Directorate of the Ministry. Terms of reference were established following discussions with the medicines sector and the government. A consultation document was released. Also consultation meetings were held in major metropolitan areas.
The Ministry of Health received 92 written submissions from a range of stakeholder groups (eg DHBs, clinical providers, professional bodies, pharmaceutical providers and funders, scientific advisory groups and consumer groups).
Submissions overwhelmingly supported the development of a medicines strategy and there was broad consensus with the proposed medicines system outcomes. Most submitters felt that 'optimal use' offered the potential for real gains.
Access issues drew the greatest response. There was a call for greater transparency in medicines funding and prioritisation decisions by Pharmac, including the process for setting the level of the community Pharmaceuticals Budget. There were concerns about the independence of Pharmac's clinical advisory committee, PTAC, and its ability to provide free and frank clinically focused advice. Submitters also wanted increasing responsiveness and flexibility concerning decisions that affect small groups (eg those needing high costs medicines).
|Cabinet ministers||sehr unterstützend||stark dagegen|
|Ministry of Health||sehr unterstützend||stark dagegen|
|District Health Boards||sehr unterstützend||stark dagegen|
|Consumer groups||sehr unterstützend||stark dagegen|
|Moari and Pacific groups||sehr unterstützend||stark dagegen|
The Medicines Strategy does intend to address the regulatory framework in the Medicines Act 1981 and the Medicines (Standing Orders) Regulations 2002. It is possible that legislation will follow.
|Cabinet ministers||sehr groß||kein|
|Ministry of Health||sehr groß||kein|
|District Health Boards||sehr groß||kein|
|Consumer groups||sehr groß||kein|
|Moari and Pacific groups||sehr groß||kein|
The Ministry of Health has overall responsibility for implementation of this high level strategy. However, as the medicines system is made up of a range of agencies and stakeholders, each of which has various functions, in practice responsibility will be shared across many domains. A key aspect of the Strategy and its Action Plan is the development of stronger relationships between these. To ensure that the framework supports sound medicines processes over time, it is envisaged that the initiatives outlined in the Action Plan will change as needs arise.
The Ministry of Health will evaluate and review the effectiveness of the Strategy and will report in December 2008. The Ministry will hold a stakeholder forum every 2 years. This will give stakeholders the opportunity to contribute both to the implementation and to ongoing monitoring and evaluation of the Strategy.
It is too early to make any judgment about the expected outcome of the Strategy. Outcomes will depend on the process of implementation and available resources.
|Qualität||kaum Einfluss||starker Einfluss|
|Gerechtigkeit||System weniger gerecht||System gerechter|
|Kosteneffizienz||sehr gering||sehr hoch|