Funding, prescription & importation of thyroid drugs 

Under New Zealand law, a registered medical practitioner (a doctor) is permitted to prescribe, administer, sell or supply, or procure the sale or supply of medicines for the treatment of thyroid conditions, regardless of whether these medicines and their use are approved or not (s25 Medicines Act 1981) ("procure the sale or supply" means obtaining medicines via a pharmacy or pharmaceutical company, or by importation.)

Pharmaceutical companies that wish to sell a medicine in New Zealand must first obtain consent from the Minister of Health. To obtain that consent, they have to follow a regulatory process in which they have to convince Medsafe that the medicine meets certain recognised standards for quality, safety and efficacy.

Unapproved medicines include medicines for which consent has been refused or lapsed; for which a new (changed) formulation has been approved (such as the "old" formulation of Eltroxin, which is still being made in Canada); or for which consent for sale, distribution or marketing in New Zealand has not (yet) been applied for (for example, Almus/Activis or Nature-Throid). In case of unapproved medicines, the legal permission granted to a doctor to sell or supply, or procure the sale or supply under the Medicines Act 1981, is limited to the treatment of a particular patient in the care of that or another doctor. The permission doesn't extend to bulk purchase of the drug.

A pharmacist is permitted by law to manufacture, pack, label, sell and supply any medicine (s26 Medicines Act 1981). While the sale or supply of unapproved medicines is allowed, the law imposes some notification requirements on the seller or supplier of that drug (s29 Medicines Act 1981).

Often, unapproved prescription medicines are not available in New Zealand. The prescribing doctor, or the seller or supplier of the unapproved medicine to that doctor, can in that case import the medicine from overseas.

A patient may also sometimes wish to import the medicine from overseas themselves. This is permitted under certain specified conditions. One of those conditions is that the patient has a "reasonable excuse" for importing the medicine. A reasonable excuse is an original letter or an original prescription from the doctor, which states why he or she has authorised the importation.

It is only permitted to import a maximum of three months' supply of the prescription medicine (there are only a few exceptions).

More information:

• Compliance: Use of Unapproved Medicines and Unapproved Use of Medicines (Medsafe, Revised: 4 December 2020)

• Compliance: Personal Importation of Medicines (Medsafe, Revised: 12 November 2021)

• Compliance: Importing Medicines - Frequently Asked Questions (Medsafe, Revised: 2 February 2021)

• Medsafe's Evaluation and Approval Process (Medsafe, 12 September 2019)

If a medicine is approved by Medsafe and the consent has been notified in the NZ Gazette, this doesn't automatically mean that it will be publicly funded. PHARMAC follows a thorough decision-making process to determine whether prescription medicines will be subsidised by the Government, or not. If PHARMAC decides to subsidise a medicine, this medicine is included in the Pharmaceutical Schedule.

All eligible persons are entitled to medicines in the Pharmaceutical Schedule, however, for some of these medicines a doctor must first apply for a Special Authority. This application will only be approved if a patient meets specific criteria. An example of a medicine only available under Special Authority is the anti-thyroid drug Propylthiouracil.

If a medicine is not listed in the Pharmaceutical Schedule, or a patient does not meet the criteria for a Special Authority, the medicine will in principle not be subsidised.

However, in exceptional circumstances these medicines can still be funded under the Named Patient Pharmaceutical Assessment Policy or when a Special Authority waiver is granted.

Please, be aware that before an application under the NPPA will be considered by PHARMAC, three core principles must be met. In order to determine whether that's the case, PHARMAC will consider the following questions:

• Does the person have exceptional clinical circumstances?

• Has the person tried all existing funded alternative treatments?

• Has PHARMAC considered the treatment for funding previously?

If an application meets the core principles, PHARMAC will assess the application against the so-called "Factors for Consideration" (these are decision criteria that PHARMAC takes into account to achieve its statutory objectives)

More information:

Eligible persons:

• Eligibility explained (Te Whatu Ora – Health New Zealand)

• Guide to eligibility for publicly funded health services (Te Whatu Ora – Health New Zealand)

Pharmaceutical Schedule (PHARMAC)

Special Authority:

• Medicine targeting (PHARMAC)

• Special Authority forms (PHARMAC)

Exceptional circumstances:

• Special Authority waiver (PHARMAC)

• Patient Info Sheet: Named Patient Pharmaceutical Assessment (PHARMAC)

• NPPA applications (explanation of the NPPA process) (PHARMAC)

• NPPA outcome data 2020/24 (PHARMAC)

Legal

• A doctor may not prescribe more than a 3 months’ supply of thyroid medicine (s 39A(1) of the Medicines Regulations 1984);

• A prescription for thyroid medicine must be filled within 6 months of the date on which it was printed (s 42(3)(c) of the Medicines Regulations 1984);

• The 3 month's supply of thyroid medicine will only be subsidised if the script is presented to a pharmacist within 3 months of the date on which it was printed (r 1.2 of the Rules of the Schedule).

Media release

• Dangers of purchasing medicines online highlighted (Medsafe, 25 October 2018)