Towards a New Zealand Medicines Strategy?
A comprehensive and detailed submission on Hon Peter Dunne’s Medicines Strategy has been lodged with the Ministry of Health by the combined research based pharmaceutical industry.
“The industry sees this review as a unique opportunity to reform patients' access to and procurement of medicines processes. |
“To this end, our suggestions are pragmatic and workable,” Dr Pippa MacKay, the chair of the Researched Medicines Industry Association said.
“We have worked up a set of comprehensive proposals that will work for patients, clinicians and the taxpayers alike. They are affordable, prescribe clear processes and accountabilities and cover the spectrum of the sector; from registration of medicines to prescribing them.
“Of course we understand Vote Health is not a bottomless pit and that rationing of resources is inevitable. However, we also firmly believe that patients and taxpayers should expect this rationing process should be transparent, equitable and accountable,” Pippa MacKay suggested.
Download our submission
New Zealand’s “low and slow” uptake of cancer drugs |
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| Table shows per capita cancer drug sales (€) in 2005 distributed after ‘vintage’. Source: Annals of Oncology, April 2007. Jonsson and Wilking, Stockholm School of Economics and Karolinska Institute, Sweden. The table is a representarive sample only of the 22 study countries. |
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Reform of evaluation and reimbursement processes
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The industry’s submission said there are no current reliable indicators to help the government or the public understand current access to pharmaceuticals, especially when compared with other countries.
“The reality is that the government is unable to articulate the rationing logic and the degree of rationing of medicines in New Zealand. Conversely, the public does not have any clear basis on which to hold the Government or PHARMAC or DHBs accountable for their rationing choices,” Dr MacKay explained.
“Moreover, what data is available suggests that the level of access to medicines in New Zealand is considerably poorer than the government’s consultation paper appears to indicate.”
The industry submission identifies four underlying institutional problems with the current access to medicines policies |
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The bundling of clinical assessment and procurement decisions |
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Poor quality of process |
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Lack of clear accountabilities |
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The bundling of commercial and public policy responsibilities |
The industry’s proposed reforms include the establishment of performance indicators, or metrics. These are important not only for keeping the public reliably informed, but also for holding PHARMAC accountable for meeting its objective to deliver the best health outcomes for the defined budget. |
The reforms have four key principles. |
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Separation of cost effectiveness decisions from funding decisions.
“We need an independent process for a first pass cost effectiveness review, which would identify the pharmaceuticals that should be considered for funding – that is the pharmaceuticals that provide value for money, and that the community needs.
“The key output of this process would be a list of products that New Zealand residents should have access to; a List of Need,” Dr MacKay suggested. |
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Separation of medical or scientific decisions from funding and procurement.
“Under the current system effectively the same organisation is responsible for undertaking an objective assessment of whether a medicine is efficacious and cost effective, and then wheeling and dealing to get the best possible price for it. These decisions should be made without being tainted by inappropriate incentives and within a transparent process.” |
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Reliable metrics and reporting requirements.
“To perform well, our improved model for pharmaceutical reimbursement needs to be based on a well developed set of metrics to assist in independently verifying and monitoring drug access and the performance of the reimbursement scheme. These metrics might include international comparisons and comparisons of approved and funded pharmaceuticals.” |
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Improved decision-making process.
“Each step in the decision making process should be performed by a different organisation to ensure transparency and credibility in the overall funding decision making process i.e. registration, evaluation, selection and procurement, dispensing and monitoring” she said. |
Case studies
A series of 25 often startling case studies are included in the industry submission.
Dr MacKay said that these very clearly show the lack of transparency, unrealistic delays, redefinition of application of registered medicines and even ongoing failure to communicate with individual companies by failing to respond for months, and in some cases, years!
Individual companies have long been reticent to “complain” about the lack of transparency, dubious dealings, and failure to communicate by PHARMAC over negotiations regarding funding of medicines.
There has been a natural fear of retribution. However, the industry decided that if a number of case studies could be published at the same time from a range of companies, that the potential for a tall poppy to be cut down to size would be reduced.
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Internationally Embarrassing |
“The uptake is low and slow for many drugs in New Zealand” according to a report published in the Annals of Oncology this month by the internationally respected Karolinksa Institute.
“This is a matter for national shame and embarrassment and is yet another confirmation that access to medicines in New Zealand is severely restricted,” said the Researched Medicines Industry Association (RMI) chair, Dr Pippa MacKay.
The report is an update and extension of research published in 2005, which had originally compared access to oncology medicines in EU countries. This report now includes a range of countries, including New Zealand.
“It is nothing short of damning but should be a positive shot in the arm for the potential outcome of Hon Peter Dunne’s New Zealand Medicines Strategy,” Dr MacKay commented.
“It tells the world exactly what the Access to Medicines Coalition, other patient groups, clinicians and the pharmaceutical industry have been telling Government for years:
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Public investment in medicines is extremely low in comparison with other countries, and |
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The appraisal processes for safety, efficacy and funding of medicines take far too long, again when compared other comparable countries. |
"While Pharmac takes comfort from the UK also being near the bottom of the list, many will see this as an accurate picture of the NHS," she said. |
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| What did others say in their submissions? |
The RMI’s views on reforms to the assessment and funding of medicines are shared by other stakeholders.
Access to Medicines Coalition
“We believe the current system is fundamentally flawed. Although we understand there are limits to what can be provided in our health system and that priorities need to be set, we believe the current system does not adequately address the needs of New Zealand or New Zealanders.
“The lack of funding for potentially life-saving medicines is an example that everyone is familiar with. Many patient groups have been very distressed by the fact that budget management has been almost the sole criteria guiding these decisions to date.”
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“The Cancer Society of New Zealand submits that the consultation document will do nothing to improve the lot of cancer patients in New Zealand. It will certainly not provide the modern pharmaceuticals we see in other parts of the developed world in a timely and appropriate fashion.
“Indeed the basic flaw in the document is that it presumes that the existing processes, systems and structures for the provision of pharmaceuticals to New Zealanders are adequate, and that they actually support the quality, access and optimal use of medicines.
“We submit that this is simply untrue.”
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| NZBio |
“Of most concern to NZBio members is that the Medicines Strategy takes no account of the economic benefits of research and development activity that come from a positive relationship between the pharmaceutical industry and the Government. Internationally the pharmaceutical industry is a major contributor to developing world class research infrastructure, building capacity and fostering biomedical innovation. We believe that this omission significantly undervalues the potential impact of the Government’s Medicines Strategy on its economic transformation agenda." |
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NZ Medical Association
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The (consultation) document leads with the premise that “NZ already has good systems and structures in place to support the quality, access and optimal use of medicines”. The implication from this is that the status quo does not need to be reviewed and that New Zealand can build on existing policies and structures.
“We do not accept that this assumption is correct. We note with concern the growing gap between the availability of therapeutic products available in other western countries and New Zealand, which results from the inadequacy of the pharmaceutical budget. This in turn means that access to therapeutic medicines in New Zealand by our residents is increasingly compromised. And while this may be simply because New Zealand does not have the funding of other countries, the purchasing process is not sufficiently transparent for us to be certain of this.” |
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