The Therapeutic Products Bill attracted about 16,000 submissions. Photo / 123RF
Why should we care about the Therapeutic Products Bill?
It affects many people - patients, consumers, health practitioners, and businesses- and it is a contentious piece of legislation that has attracted thousands of submissions.
What does the bill do?
It will regulate how therapeutic products are manufactured, tested, imported, promoted, supplied, and exported. It will regulate medicines, medical devices, active pharmaceutical ingredients and natural health products that are either produced in New Zealand for domestic use or export or are imported into New Zealand. It will cover products ranging from highly sophisticated diagnostic equipment to lavender balms to assist with sleeping. The bill will also regulate blood products, advanced cell and tissue therapies, tissue grafts and whole organs.
Are medicines not regulated already?
Yes, they are under the Medicines Act 1981 and dietary supplements are regulated under Dietary Supplements Regulations 1985 mandated under the Food Act 2014.
But medical devices and natural health products, sometimes called complementary medicines, are not regulated. The bill sets up the framework to regulate them all but on the principle that lower-risk products will have lighter regulation.
Successive governments have agreed that the current regulator, Medsafe, does not cover all products and lacks proper enforcement tools.
Natural health products comprise $2.3 billion of New Zealand GDP and about $640 million of products are exported annually.
What are the main areas of disagreement or controversy?
- The question of whether natural health products should be part of the legislation at all or be more distinctly separated out is an issue for some groups.
- The ability of patients or carers to bring medicines into the country is a contentious issue.
- Whether New Zealand should continue to allow the advertising of medicines continues to be a contentious issue – the only other country that allows it is the United States.
- The degree to which the bill should impact traditional Maori healing practices, rongoa, attracted many submissions.
- Technical issues such as at what point software should be considered part of a medical device and subject to regulation have also been contentious.
How will the bill affect a person’s ability to get medicines from other countries?
At present, there are no restrictions on people being able to bring in medicines or non-prescription medicines either in their personal luggage or by post. The bill proposes to continue to allow people to bring in non-prescription medicines either with them personally when travelling or by post, with some limits on quantity. It would allow prescription medicines to be brought in with them if lawfully prescribed. But the bill at present curtails the ability to import prescription medicines by post. That area is likely to be a strong focus of the select committee.
How does the bill handle rongoa, traditional Maori healing practices?
The bill does not mention rongoa but the parts of it covering natural health products means it will capture ingredients used by traditional practitioners. Former Health Minister Andrew Little said it was important that New Zealand’s overall regulatory settings supported the traditional practice of rongoā while balancing the need to provide assurances for patient safety and export market access for rongoā practitioners. Policy work is being undertaken by Te Aka Whai Ora, the Maori Health Authority, and the Ministry of Health on the issue.
What don’t we know about the bill?
The bill of almost 300 pages is only the first part of a very complex process. An even bigger piece of secondary legislation is proposed to follow within three years with more detail of the regulation. For a guide, secondary legislation in Australia comprises 2500 pages. Because natural health products are much lower risk than medicines, they will be evaluated against different standards, but exactly what standards are not known because the current bill is only the framework. The detail on the actual standards and how to get approval is yet to come. The uncertainty is creating some anxiety.
How is medicinal cannabis currently regulated and how will that change?
The bill does not impact the current regulation of medicinal cannabis or drugs controlled under the Misuse of Drugs Act 1975, or psychoactive substances controlled under the Psychoactive Substances Act 2013.
Who will become the regulator?
The Therapeutic Products Regulator will be an independent officer within the Ministry of Health and will be appointed by the Director-General of Health. The regulator will act independently of the DG and minister but may be subject to general policy directions from the minister. The regulator will have wide-ranging powers to grant or deny market authorisations for the products in each of the categories to be produced or supplied to or from New Zealand. The regulator will be backed up by advisers.
What will the cost be to applicants?
One of the concerns is that the regulator will be required to set fees and levies to fund the administration costs of the new regime. That cost is unknown but the principle will be that the lower the risk of a product, the lower the cost.
What will the penalties be for contravening the law?
The maximum penalty for knowingly or recklessly committing an offence is, for an individual, imprisonment for 5 years and a fine of $200,000 for an individual, or a fine of $1 million for a company, or Crown organisation.
The penalties reduce in severity and lesser offences could incur civil liability rather than a criminal action, or incur an infringement notice issued by the regulator.
Why does the bill sound familiar and what is its history?
It has had an incredibly tortuous journey in the past 20 years.
When Annette King was Health Minister, she tried to get a joint transTasman agency to regulate medicines and natural health products in both New Zealand and Australia but National opposed it.
When National gained power in 2008, it promoted a very similar bill but in 2014 New Zealand Health Minister Jonathan Coleman and Australian Health Minister Peter Dutton abandoned the bid for a joint agency after a review of the costs and benefits of both countries.
The John Key cabinet agreed in 2015 to replace the Medicines Act with a new Therapeutic Products Bill – but not including natural health products.
A Natural Health Products Bill was being considered separately after having been introduced in 2011. It went to a select committee and passed its second reading in 2013 with wide support from all parties except Act. But NZ First reversed its support in 2017, citing pressure from Australia, and it lapsed after the Jacinda Ardern Government took office in coalition with NZ First.
A draft Therapeutic Products bill was produced in 2018 and consulted on widely – which did not include natural health products. But in 2021, after NZ First was voted out, the Labour cabinet agreed to include natural health products in the bill, which is what is now before the Parliament – a bill addressing regulation for both medicines and natural health products.
Who is in charge of the bill and which parties support it?
Andrew Little was Health Minister when the Therapeutic Products Bill was introduced in December 2022 but since then, Ayesha Verrall has been made Health Minister. Utikere Tangi was originally chair of the health select committee but since being promoted to senior Government Whip, Tracey McLellan is now chair of the health committee, which includes National health spokesman Shane Reti. The bill was supported at first reading by all parties except the Maori Party but the support was to allow greater scrutiny, not necessarily to advance it.
The committee received about 16,000 submissions. Officials are now working with the health committee towards its report date of June 14.
OPINION: Sir Robert Gillies died yesterday at the age of 99.