The Government is aware of a High Court decision today about processes to grant provisional consent to some approved medicines, and is making a technical amendment to modernise the law.
The Court has said that while the Minister of Health can, under Section 23 of the Medicines Act, grant approval for Medsafe-approved medicines to be used by a limited number of patients, it’s arguable whether it can be done for the whole population.
Health Minister Andrew Little says Section 23 has been used over 40 years by successive Governments to grant early access to approved therapeutic substances when it is in the public good.
“The law has for some time now, lacked clarity over how it can be applied,” Andrew Little said.
“We already knew the Medicines Act was out of date, which is why we were planning to replace it with a new Therapeutic Products Act.
“Treatments approved under Section 23 go through a rigorous Medsafe approvals process. There are occasions when the health needs of a population call for urgent access to a medicine, vaccine or treatment and we need to keep this option available for some circumstances.
“There are six products currently in use under Section 23, including two types of contraceptives, two pandemic flu vaccines, the Pfizer COVID-19 vaccine and an electrolyte solution used in hospitals, potentially affected by the decision.
“The Government will introduce a Bill tomorrow to make sure New Zealanders continue to have timely access to the medicines and treatments they need. The Medicines Amendment Bill is expected to be passed under urgency tomorrow in order to protect New Zealanders early access to medicines when needed,” Andrew Little said.
The Therapeutic Products Bill that will replace the outdated Medicines Act is expected to be introduced into Parliament next year.