Nga Kaitiaki Tuku Iho Medical Action Society (“Applicant”) applied for an interim injunction to halt the supply of Pfizer’s COVID-19 vaccine. They stated it was available to a wider group of people than the consent allowed under the Medicines Act 1981 (“Act”).
The High Court acknowledged the possibility they were correct in their claim. But, despite ruling there was a legitimate case to argue, Justice Ellis decided not to exercise the High Court’s discretionary powers to halt the supply of Pfizer’s vaccine until a full trial.
Under s 20 of the Act, vaccines and other new medicines are only made available to the public once granted consent by the Minister of Health. In considering an application for consent, the Minister looks at a number of factors related to the medicine’s safety and effectiveness.
Provisional consent can be granted for temporary availability to a specific group of people under s 23 of the Act. An application for provisional consent has a reduced number of factors to consider.
The Minister of Health delegated authority to give consent to Medsafe. Medsafe granted Pfizer’s Comirnaty vaccine for COVID-19 provisional consent for 9 months with special conditions, including requiring updates on the safety and effectiveness of the drug. Originally intended for front-line workers who could be exposed to COVID-19, the vaccine was soon made available to everyone over the age of 16 in New Zealand.
The Applicant sought an interim injunction pending a full judicial review on the lawfulness of the consent given to Pfizer and the legality of the subsequent roll-out. This injunction would have stopped the ongoing supply of the vaccine until the full hearing. The courts have discretion when determining whether to make an interim order.
In making its determination, the Court looked at whether the Applicant had standing (a right to make a complaint), whether it was arguable that the provisional consent to the Pfizer vaccine was unlawful under s 23 of the Act, and what the public and private repercussions would be if the Court granted the interim order.
Generally on serious questions on the legality of state action, courts are generous when considering if an applicant has standing. The judge decided in this case they did because they are affected by the ongoing roll-out, and by the time the substantive proceeding concluded, the Pfizer roll-out would be largely complete.
Lawfulness of the consent under s 23
The judge stated the purpose of provisional consent was to allow the limited distribution of a new medicine where there was a “clear and immediate need” for it, but “it was not possible to go through a full consent process because all the information necessary to establish its safety was not available.” For this, Medsafe had to be of the opinion that it was desirable to supply the vaccine on a restricted basis and for the treatment of a limited number of people.
The judge ruled that while the availability of the vaccine to everyone over the age of 16 was “more limited than all New Zealanders” it was arguable this was too wide of a class of people to satisfy the ‘limited number of patients’ requirement. With that, the Applicant had an arguable case that the provisional consent was not lawful.
Public and private repercussions
COVID-19’s unique threat to public health was a considerable factor against an interim order. Looking at international medical sources, the Pfizer vaccine significantly reduced chances of infection. And a halt in the roll-out could risk public health, hurt public confidence and delay national recovery.
The judge decided the repercussions were too great to grant an interim order, and did not use her discretionary powers to stop the roll-out.
While this case was only for an interim order and not the substantive proceeding, it demonstrates the public policy elements the Court takes into account when deciding whether to exercise its discretionary powers. Applicants are not owed an interim order even when their case is reasonably arguable.
Public policy matters play a role in the Court’s choice in applying discretionary power. The circumstances of COVID-19 and the need to pursue public immunity is a unique situation. Even when government action might be unlawful, discretionary remedies may not be given when the risk to the public good is too great. Despite policy factors preventing a remedy in this case, the consent may yet be determined to be unlawful. Parliament has subsequently changed the Medicines Act, allowing for provisional consent to authorise similar roll-outs in future.
If you are interested in understanding more about this case or similar areas of law, please contact Senior Consultant Brigitte Morten.