Medicines strategy

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

Abstract

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.

Purpose of health policy or idea

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:

• Quality safe and effective medicines;
• Equitable and affordable access;
• Optimal use of medicines resulting in optimal health outcomes.

These in turn will be supported by:

• Cross-sector collaboration and stakeholder engagement: The Ministry of Health will bring together agencies engaged in different aspects of the supply chain to encourage a more collaboarative and cohesive approach.
• Structures and systems that work well: Implementation of a nationally co-ordinated decision-making, funding and procurement programme for vaccines.
• System capability - financial resources, workforce, infrastructure, knowledge and information: Examples include the review of the out-dated (1981) regulatory framework and development of a user-friendly and linked websites across the medicines systems.

Source: Actioning Medicines New Zealand. Wellington: Ministry of Health, 2007.

Main points

Main objectives

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.

Innovationsgrad	traditionell		innovativ
Kontroversität	unumstritten		kontrovers
Strukturelle Wirkung	marginal		fundamental
Medienpräsenz	sehr gering		sehr hoch
Übertragbarkeit	sehr systemabhängig		systemneutral

Political and economic background

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.

Purpose and process analysis

Current Process Stages

	Idee	Pilotprojekt	Strategiepapier	Gesetzgebung	Umsetzung	Evaluation	Veränderung/Richtungswechsel
Implemented in this survey?

Origins of health policy idea

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:

• Quality, safety, efficacy
• Equitable and affordable access
• Optimal use - improving health outcomes by improving the way medicines are used.

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. 

Initiators of idea/main actors

• Regierung

• Kostenträger

• Patienten, Verbraucher: Support some aspects but also many concerns

Stakeholder positions

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).

Actors and positions

Regierung
Cabinet ministers	sehr unterstützend		stark dagegen
Ministry of Health	sehr unterstützend		stark dagegen
Kostenträger
District Health Boards	sehr unterstützend		stark dagegen
Patienten, Verbraucher
Consumer groups	sehr unterstützend		stark dagegen
Moari and Pacific groups	sehr unterstützend		stark dagegen

Influences in policy making and legislation

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.

Actors and influence

Regierung
Cabinet ministers	sehr groß		kein
Ministry of Health	sehr groß		kein
Kostenträger
District Health Boards	sehr groß		kein
Patienten, Verbraucher
Consumer groups	sehr groß		kein
Moari and Pacific groups	sehr groß		kein

Positions and Influences at a glance

Adoption and implementation

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.

Monitoring and evaluation

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.

Expected outcome

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.

Impact of this policy

Qualität	kaum Einfluss		starker Einfluss
Gerechtigkeit	System weniger gerecht		System gerechter
Kosteneffizienz	sehr gering		sehr hoch

References

Sources of Information

• Associate Minister of Health. Towards a New Zealand Medicines Strategy: Consultation Document. Wellington: Ministry of Health, 2006. www.moh.govt.nz/moh.nsf/pagesmh/5633?Open
• Ministry of Health. Summary of Submissions on Towards a New Zealand Medicine Strategy. Wellington: Ministry of Health, December 2007. www.moh.govt.nz/moh.nsf/indexmh/towards-nz-medicine-strategy-summary-submissions
• Associate Minister of Health, Minister of Health. Medicines New Zealand. Contributing to Good Health Outcomes for All New Zealanders. Wellington: Ministry of Health, 2007. www.moh.govt.nz/moh.nsf/indexmh/medicines-nz
• Associate Minister of Health, Minister of Health. Actioning Medicines New Zealand. Wellington: Ministry of Health, 2007. www.moh.govt.nz/moh.nsf/indexmh/actioning-medicines-nz

Author/s and/or contributors to this survey

Lisa Walton

Empfohlene Zitierweise für diesen Online-Artikel:

Lisa Walton. "Medicines strategy". Health Policy Monitor, April 2008. Available at http://www.hpm.org/survey/nz/a11/3