Medicines NZ - world-class medicines system for NZ
Medicines NZ - a world-class medicines system for New Zealand
The new medicines strategy is launched
Associate Health Minister Peter Dunne today unveiled Medicines New Zealand - a bold new strategy to guide the future access to, and use of, prescription medicines by all New Zealanders.
"The medicines environment has changed significantly over the years," he said.
"New products offer expanded treatment options, New Zealanders are increasingly taking more responsibility for their own health and there is a growing awareness of the risks of inappropriate medicines use.
"These are heartening trends, but we must continue to ensure that the medicines system can respond to change," he said.
"Under the confidence and supply agreement between UnitedFuture and Labour after the last election, it was agreed that a new strategic direction be set for medicines policy in New Zealand that would take account of these changes.
"Medicines New Zealand sets out the high-level framework that will ensure medicines are safe and of good quality, that people have access to medicines, that medicines are used to their optimum, and that decisions surrounding their approval and funding are evidence based.
"Medicines New Zealand is supported by a second document I'm releasing today, Actioning Medicines New Zealand, which is a dynamic action plan that will change over time as more is done to implement the strategies identified in the strategy framework."
Mr Dunne said "This is a bold and far-reaching strategy, based on engagement and transparency.
"Initiatives already identified include more effective use of the skills of the health sector workforce so that, for example, we will make better use of the skills and experience of our pharmacists.
"We also want to provide consumers with greater involvement in decisions about new medicines, provide more user-friendly web access to information about medicines, and get more transparency into the decision-making processes that involve the whole medicines system.
"Medicines New Zealand is the result of extensive consultation over the past year, including meetings held nationwide as well as almost a hundred detailed written submissions from consumers, health practitioners, industry and key stakeholders in the medicines sector.
"Medicines New Zealand represents a fresh approach to medicines policy in New Zealand, which should be welcomed by health practitioners, consumers and patients and the pharmaceutical industry as a positive step forward in ensuring that New Zealanders can get access to the medicines they need.
"It is important that all stakeholders continue to contribute, achieve and aspire to building a world-class medicines system for New Zealand that will ensure the best outcomes from medicines in this changing world," Mr Dunne said.
Medicines New Zealand: Questions and Answers
1.Why do we need a medicines strategy?
The medicines environment is changing. New products offer expanded treatment options with some medicines now replacing invasive procedures. We need a medicines system that can adapt to change, is responsive to the needs of New Zealanders and is affordable for New Zealand. To do this we need a medicines system that is united by a clear strategic direction.
Medicines New Zealand is the result of the 2005 confidence and supply agreement between the Labour-led Government and the United Future Party and articulates the outcomes we want from our medicines system.
2.How did the Ministry consult?
In December 2006 the Ministry released a discussion document, Towards a New Zealand Medicines Strategy. This described how the medicines system in New Zealand works, identified areas of possible improvement and proposed a new strategic direction. The Ministry received 92 written submissions. In addition, general consultation meetings were held in Auckland, Wellington, Christchurch and Dunedin in May 2007. Consultation meetings were also held with Maori and Pacific stakeholder groups.
3.What were the main themes to come out of the consultation process?
Submissions overwhelmingly supported the development of a medicines strategy for New Zealand and there was broad consensus with the proposed medicines system outcomes. These outcomes seek to provide New Zealanders with access to safe, quality and effective medicines within the funding available; and to ensure that the use of medicines results in optimal health outcomes. In particular submitters felt that optimal use was an area in which real gains can be made for the health of New Zealanders.
Access issues drew the greatest response from submitters. There was a call for greater transparency in medicines funding and prioritisation decisions, including the process for setting the level of the community pharmaceuticals budget. Submitters wanted to ensure that the Pharmacology and Therapeutics Advisory Committee (PTAC) was able to provide free and frank clinically-focused advice to Pharmac. Submitters also wanted increased responsiveness and flexibility to meet the needs of individuals or small groups of people, while still recognising the wider population needs.
4.What are the key initiatives in Actioning Medicines New Zealand?
Actioning Medicines New Zealand is the action
plan that begins to give effect to Medicines New Zealand. It
is not an exhaustive list of actions and will grow and
change over time. Key activities include:
.a series of initiatives to provide greater transparency in decision-making processes and to support people to identify opportunities to have input into, and find their way around, the medicines system
.activities to reduce health inequalities, including more effective use of the skills of the health sector work force
.continuing plans to build enhanced pharmacovigilance practices
.developing a national programme to reduce medication errors.
5.How can I have more say about which medicines will be funded and how will I know why a decision was made?
We know stakeholders want more consumer involvement and greater transparency in the funding process. Transparency has been included as a guiding principle underpinning Medicines New Zealand and responds to feedback from submitters during the consultation process.
Medicines New Zealand is already responding to the call for greater transparency. Pharmac has now held its first stakeholder forum and these will become a regular occurrence. Moving forward stakeholders, including consumers, will be encouraged to provide their views and have input into Pharmac's decision-making processes. Help will be made available to assist people to have input and this will then be considered as part of the application process. Publishing summaries of medicines funding decisions, moving toward a principles-based approach to the setting of the community pharmaceuticals budget and creating more user-friendly web access around the medicines system will also provide greater transparency.
6.Will there be more flexibility for the medicines system to meet my needs?
Some people can find changing the brand of their medicine difficult. Pharmac is currently working on a strategy that will allow those with significant clinical need, to remain on their existing brand of medicine. Actioning Medicines New Zealand has also signalled a review of the exceptional circumstances funding scheme.
7.Will Medicines New Zealand mean greater access to high cost and innovative new medicines?
Medicines New Zealand will not directly result in increased access to high cost or innovative new medicines. Rather it aims to address system issues that may have this outcome, for example the budget setting process. The role of the strategy is to build systems to support good decision-making and effective use of medicines. This includes taking account of and reflecting community values.
When assessing whether to fund new medicines, a number of factors must be taken into account such as whether the medicine is the best way to treat the condition and whether it is clinically and cost-effective. High cost medicines (including some innovative new medicines) need to be compared to and balanced against other health priorities, including other medicines recognising that resources are finite.
8.Will there be more money for medicines?
Medicines New Zealand is not directly proposing an increase in the community pharmaceutical budget, however, the Ministry of Health and DHBs are working together to develop ways to better prioritise health spending. This will assist DHBs to make decisions on the level of funding allocated to spending on pharmaceuticals. Any increase in pharmaceutical expenditure needs to be balanced against investment in other service priorities.
No one has yet come up with a way to determine the optimal amount to spend on pharmaceuticals relative to other health spending. Improving processes to make prioritisation decisions between pharmaceuticals and other health spending is an issue that is being grappled with internationally. Work is underway across the health sector in New Zealand and overseas, to refine the processes which determine how health funds are spent.
International comparisons on pharmaceutical spending are difficult because of the cumulative effect of variations in the price paid for individual pharmaceuticals, choices about which pharmaceuticals are funded; who can access subsidised pharmaceuticals and different country's purchasing regimes. Similarly, it is often difficult to compare the range of medicines available between countries, primarily because the populations of these countries will vary in their health needs, and therefore in their need for specific medicines. That said, Medicines New Zealand and Actioning Medicines New Zealand signal a need to examine the process New Zealand uses to set the community pharmaceuticals budget.
9.What does this mean for Pharmac - is it changing at all?
Pharmac's structure and accountability arrangements attracted considerable comment during the consultation process on Towards a New Zealand Medicine Strategy. Fundamental structural reform was outside the medicines strategy's Terms of Reference, however, the Ministry of Health reviewed Pharmac's structure and accountability arrangements as part of the development of Medicines New Zealand. The review found that the existing Crown Entity (Crown agent model) provides strong accountability to the Minister of Health, and therefore Parliament and the New Zealand public. It also provides Pharmac with the appropriate level of independence to undertake its day-to-day functions. This independence coupled with strong accountability arrangements ensures that the decision-making process is robust and has satisfied government that the appropriate structure is in place.
Actioning Medicines New Zealand contains a number of initiatives aimed at improving the understanding of how Pharmac works and providing greater opportunities for stakeholders, including the public, to contribute information and perspectives to Pharmac's decisions.
10.What does this mean for the Pharmacology and Therapeutics Advisory Committee (PTAC) - is it changing at all?
PTAC is a committee of clinicians nominated by professional medical bodies, whose primary purpose is to provide free and frank advice to Pharmac. They consider clinical evidence and risks and benefits related to funding applications. This includes consideration of Pharmac's nine decision-making criteria, before making recommendations to the Pharmac Board.
Pharmac requires expert clinical advice to inform its decision-making and PTAC provides this. No structural change to PTAC is being recommended, however, the feedback from submitters has prompted a number of initiatives to ensure that PTAC is able to provide the free and frank advice required. This includes a review of the PTAC appointment protocol and PTAC's operational guidelines and improving transparency around funding decisions by publishing public summaries of decisions on medicines funding applications. Interested stakeholders will also be able to access the advice that PTAC provides to Pharmac.
11.Are New Zealanders getting access to the medicines they need?
Currently, the Pharmaceutical Schedule lists over 2000 pharmaceuticals and related products which are publicly subsidised for New Zealanders. The schedule is organised by therapeutic groups and Pharmac aims to provide access to a subsidised treatment for each therapeutic sub-group.
In the community, access to medicines, health practitioners and services is supported through the Primary Health Care Strategy. Reduced prescription costs for New Zealanders enrolled in a primary healthcare organisation (PHO) and lowered fees to see primary care health practitioners makes access to medicines more affordable for individuals. However, some people are not accessing the medicines they need or are not getting the best health outcomes from them. This is particularly an issue for Maori, Pacific, disabled and low-income people. Medicines New Zealand aims to promote an environment where consumers will be able to take a more active role in making decisions about medicines and managing their healthcare together with their health practitioner. Consumers and health practitioners will also have timely access and accurate information and education about medicines.
12.Will plans for the Australia, New Zealand Therapeutic Products Authority (ANZTPA) be reconsidered?
Ensuring that the medicines taken by New Zealanders are safe and of high quality is a key outcome sought by Medicines New Zealand. ANZTPA was proposed to replace Medsafe in New Zealand (and the Therapeutic Goods Administration in Australia) and regulate all therapeutic products and address known inadequacies in the current regime. Work on this initiative was postponed in July 2007, however the need to ensure a sustainable regulatory capacity for New Zealand remains a priority and this is signalled in Medicines New Zealand and Actioning Medicines New Zealand.
The Government is considering the next steps following the postponement of ANZTPA and will announce them in due course. In addition to capacity and timeliness concerns in respect of prescription medicines, the Government is conscious that the status quo of a largely unregulated market for medical devices and complementary medicines cannot remain.