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Time to address the medicine policy vacuum

Over the years, Medsafe and Pharmac have been allowed to become de facto policy agencies, but Covid-19 has highlighted the vital need for the Ministry of Health and the Government to take control of medicine strategy and decision-making, says Peter Dunne

Almost daily now we are hearing of the apparent imminence of a vaccine being approved in one country or another to deal with the Covid-19 virus and so allow the world to resume a degree of normality. Whether it be in Russia, China, the United States or Britain, political leaders are increasingly quick and keen to claim that their scientists are on the verge of producing the vaccine the world is so desperately seeking.

While much of this can be dismissed as posturing and chicanery from politicians trying to recover some of their own list reputations, the prospect of a vaccine becoming available raises significant issues about ensuring public safety, equality of access between nations, and general affordability.

National structures and policies governing the acquiring and supply of medicines to national populations are also coming under fresh scrutiny to ensure that when a reliable and safe vaccine is available, people will be able to get access to it.

In New Zealand, the national Medicines Policy, Medicines New Zealand, developed as part of UnitedFuture’s confidence and supply agreement with the Helen Clark-led government has been the overarching framework governing the regulation, procurement, management and use of medicines which has been followed by successive governments since it was first put in place in 2007.

Its primary objectives have been to ensure that medicines available here are safe, of high quality, and are effective; and, that New Zealanders have access to the medicines they need, regardless of their individual ability to pay, and within the government funding provided. All remain factors relevant to the potential availability of Covid-19 vaccines.

To give effect to those original ambitions, governments took a number of specific initiatives between 2007 and 2015. These included the establishment of the New Zealand Formulary to provide healthcare professionals with independent, clinically validated medicines information and guidance on best practice, so enabling healthcare professionals to select safe and effective medicines for individual patients. This was accompanied by moves to enhance and improve pharmacological vigilance activity, and changes to prescribing rules. There were also a number of specific actions taken around the pharmacy workforce and associated services.

After 2015, the focus shifted to changes needed within the wider health system and general community. Making the most of every point of care and empowering individuals and families/whanau to manage their own medicines and health, and a focus on the optimal use of medicines in older people and those with long term conditions have been key objectives since that time.

Overall, there have been substantial improvements in New Zealand’s medicines environment since the introduction of the Medicines New Zealand policy in 2007. Since then, well over 400 new medicines have been funded; over half a million more New Zealanders are today getting access to the medicines they need than was the case in 2007; and Pharmac, the Government’s medicines procurement agency, has seen its budget increased by more than 60 percent to just over $1.045 billion in 2020/21.

Now, the current iteration of the Medicines New Zealand Policy is coming to an end, and it is time to review progress and consider what needs to be done next. While much has been achieved since 2007, some significant fresh new challenges have emerged that require focusing upon over the next five years and beyond.

Data which has been gathered by the local pharmaceutical sector’s industry group (confusingly also called Medicines New Zealand) suggest that New Zealand has started to lag comparable countries in a number of key areas with regards to medicines policy. Critical amongst these is the overall level of funding dedicated to medicines (the significant increases in funding levels by successive governments over the last decade or so notwithstanding); and the time taken to fund new medicines once they have received clinical approval.

With the likelihood of Covid-19 vaccines availability looming, the possibility of this already difficult situation getting out of control is very real, although it will have been alleviated to some extent, at least for the medium term, by the Government’s recent decision to set aside (so far unspecified) millions of dollars for funding such vaccines, over and above any funding Pharmac might set aside for such purposes.

There are two critical areas future medicines policy needs to address.

The most important is that although the Medicines Policy has been the overarching framework since 2007, its focus has been understandably an operational one.

While Medsafe is the Government’s medicines regulatory agency, and Pharmac is the procurement agency, there is no medicines policy group within the Ministry of Health providing overall strategic advice to the Minister of Health on medicines issues. As a result, Medsafe and Pharmac have been allowed to become de facto policy agencies. While this undoubtedly suits governments as it means they can shunt aside all difficult questions about medicines to either Medsafe or Pharmac without becoming involved themselves at all, which is by and large what they have been doing over the last 30 years, it does not serve the public interest well.

Consequently, critical strategic decisions about the medicines to be available in New Zealand are being made on the basis of whether they meet the regulatory requirements and are deemed worthy of funding, rather than whether they are best placed to meet the needs of New Zealanders.

... it simply cannot be left to Pharmac as the purchasing agency or Medsafe as the regulator to decide what range of medicines New Zealanders should be allowed access to, nor is it fair to the expertise of both to do so

What is currently missing is agreement on the range of medicines the New Zealand population might reasonably expect to have access to and how these should be funded. The level of funding for Pharmac to support new medicines is determined more on the basis of what the Government thinks it can afford at any given time, than what might actually be needed.

That is where the Ministry of Health needs to step up and take a more active role, alongside the clinical experts and the pharmaceutical industry, and community advocates to prepare a plan accordingly to inform both future government funding decisions and Pharmac’s procurement strategy.

The Covid-19 experience has highlighted that requirement most strongly. While the Government has been prudent in setting aside the additional funding it is likely to require for vaccines, it was very much an ad hoc decision brought on by circumstances.

With many new medicines constantly becoming available to treat many other important health conditions, it simply cannot be left to Pharmac as the purchasing agency or Medsafe as the regulator to decide what range of medicines New Zealanders should be allowed access to, nor is it fair to the expertise of both to do so. Nor should it be left to patient groups to have to lobby the Government to get relevant medicines funded for what often might be comparatively small groups of affected patients.

The second important area exemplifies the difficulty Pharmac faces in the current policy vacuum. Its independent Pharmacology and Therapeutics Advisory Committee (PITAC) advises on pharmacological and therapeutics grounds whether a medicine should be supported, but it is not its role to make budget decisions about when a medicine is to be purchased. That is Pharmac’s role, as and when its budget permits. Often that means there can be a very long time-lag between a medicine receiving a favourable PITAC recommendation and a Pharmac funding decision being made.

The current policy vacuum leaves Pharmac having to juggle those decisions as best it can, without any definite sense, other than its estimate of public, sector group, and industry opinion, of the priority to be accorded to a particular medicine. Again, an overall government policy setting about health and medicine priorities would be of assistance here and would help provide more certainty than is currently the case.

These will be all be concerns for the next Minister of Health to consider as future medicines policy is finalised. It is to be hoped that in doing so, the Minister takes the opportunity to build on the progress made under the current national medicines strategy, and moves forward to the next phase of establishing a coherent and accountable medicines policy framework within which the ever important questions of access, affordability and efficacy can continue to be addressed.  
 

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