Dear Ministry of Health,

Please consider that this OIA request is urgent and so concerns the processes for applicants as the law and secondary legislation currently stands. It appears that approvals for nutrients on Pharmac have stalled. The stalled process adversely effects socially disadvantaged young people, including Māori. There is evidence that these groups can benefit from access to broad-spectrum multinutrients that wealthier groups can privately access. It is unclear what the barriers to approval on Pharmac may be, but the stalling may be via Medsafe and changed regulatory approval processes as a medicine.

This OIA would be sent to Medsafe but I believe that the Ministry of Health answers on behalf of Medsafe and the new Therapeutic Products regulator.

The Purpose of the Therapeutic Products Act is to protect, promote, and improve the health of all New Zealanders. The Principles that guide the exercise of powers under the Act are that the: the likely benefits of therapeutic products should outweigh the likely risks associated with them, and their regulation should be proportionate to those benefits and risks. In addition that regulation should support timely availability, open and well-functioning markets, innovation and choice of, and equity of access to, therapeutic products for Māori and other population groups.
https://www.legislation.govt.nz/act/publ...

It is evident that ‘Many (more than a quarter but less than half) of the 16,586 written submissions to the Health Committee stated that the proposed regulatory scheme would adversely affect small-scale NHP producers, who may not be able to afford market authorisation fees, licence fees, and other compliance costs. Submitters said that some producers would likely be driven out of business despite considering their products have little or no risk to the public.
https://www.health.govt.nz/system/files/...

It is also evident that New Zealand is facing a tsunami of mental illness, for which a substantive proportion of these conditions include ADHD, depression and anxiety. Pharmacists privately report an upsurge of prescriptions to school age children post-COVID-19.

There is significant scientific evidence that ADHD, depression and anxiety are more frequently experienced by socio-economically disadvantaged populations. There is evidence that these populations are lack sufficient resourcing for optimum diets and so are often malnourished, with broad nutrient deficiencies (rather than deficiency for a single vitamin).

The scientific literature shows that broad-spectrum multinutrient formulations present a far lower side effect risk profile than clinical psychiatric medications. Multinutrients are best consumed with food, and the side effects are rare and short term, such as headaches that last for a few weeks and then dissipate. In comparison, erectile dysfunction and suicidal ideation are well established side effects associated with commonly prescribed psychiatric medications which might impose disproportionate harm on young people.

There seems to be no pathway to getting approval as a medicine, and so therefore getting onto the Pharmac schedule – for multinutrient formulations that might address the higher risk of ADHD, depression and anxiety experienced by socioeconomically disadvantaged populations including Māori. There seems to be no policy or law recognition that requires regulators to consider a very low risk (side-effect) profile. Such a low side effect profile can mean that patients could be prescribed such nutrient formulations by medical doctors (as the side effects are lower than many commonly prescribed medical treatments). We know that socioeconomically disadvantaged populations including Māori face higher structural barriers in getting to see clinical psychiatrists. There are major equity considerations if well-researched multinutrient formulations can be provided to these populations.

While many families are now electing to purchase multinutrient formulations privately, the costs are prohibitive for socio-economically disadvantaged populations.

PLEASE ADVISE UNDER THE OIA:

[1] The processes required for a company (who has market authorisation) seeking approval of broad-spectrum multinutrient formulations to secure approval as a medicines. This is so that this product may be approved on the Pharmac schedule.

[2] If Pharmac does not require a broad-spectrum multinutrient formulation to be approved as a medicine in order to go on the Pharmac register, please confirm.

[3] Please advise the fee structure at all stages to securing approval for a broad-spectrum multinutrient formulation. Please confirm that that fee structure is never altered during the application process.

[4] Please advise the processes by which a safety is judged when a risk profile is known and is very low.

[5] Please advise how improved access to socially disadvantaged populations and Māori and so addressing inequities for nutrient-deficient populations are judged.

[6] Please advise how exposures to young people are considered if a young person has a choice of psychiatric medication or a broad-spectrum multinutrient formulation. Is the impact of side-effects to young people and the potential for young people to stop medication (non-compliance) of a psychiatric medicine judged against a broad-spectrum multinutrient formulation?

[7] Are cohort studies as well as clinical trials included for consideration when the safety profile is considered for low-risk nutrients which have a known lower risk-threshold?

[8] How the new Act takes account of financial uncertainties for multinutrient formulations which are not patented and as such can be reverse engineered by other companies. I.e. drug companies with a newly patented product will understand that there will be a limited range of market entrants with similar claims - however this assurance does not apply to multinutrient retailers.

The Therapeutic Products Act is very unclear on what appear to be relevant considerations.

Yours faithfully,

Jodie Bruning