Therapeutic Products Bill – object to keep your natural health products safe!

We encourage you to either prepare and file a submission with the Health Select Committee, which you can do utilising the template below.

Submissions on the Therapeutic Products Bill   [TEMPLATE]

[DD/MM/2023]

1. The Bill proposes:

   1. to replace the Medicines Act 1981 and the Dietary Supplements Regulations 1985 to regulate therapeutic products, such as medicines, medical devices, natural health products, and active pharmaceutical ingredients;

   2. introduces a new regulator within the Ministry of Health, headed by an independent statutory officer, with a wider remit than the medicines regulator Medsafe.

2. I oppose the Bill including natural health products in the Bill.

3. I also oppose….

   1. [list]

   2. [expand where you feel necessary]

4. I wish / do not wish to be heard on these submissions.

[Name]

[Contact details if you wish to be heard]

[Date]

MAIN POINTS

1. There are commonly used herbal ingredients mooted for potential regulation/restriction. We can establish that, rather than New Zealand-based nutritional biochemistry experts making these recommendations, this information comes from the International Coalition of Medicines Regulatory Authorities (ICMRA), based in Europe, a group with historically no practical interest in nutrition, dietary supplements and the role of food in preventing disease.

2. New Zealand is deviating from many (healthier) OECD nations by proposing to regulate food supplements via medicines legislation. Many countries, including the European Union, regulate natural health products that are traditional and herbal medicines, and vitamin and mineral supplements as foods or foodstuffs. They call them food, or dietary supplements.

3. Instead, Cabinet proposes that food supplements with a long history of safe use (and with known toxicity and safety profiles) should be regulated under the proposed Therapeutic Products Bill alongside synthetically derived medicines and biotechnologies that alter genes and gene function.

4. Dietary, or food supplements are currently regulated under the Dietary Supplements Regulations 1985 and under the Food Act 2014. Instead, would become regulated as ‘natural health products’ (NHPs) – inside what is already acknowledged will be gargantuan and highly complex (see 5/288) legislation that is already difficult to understand and negotiate.

5. The proposal directly downplays the potential for risk resulting from new technologies including biotechnology (and gene-editing such as CRISPR) – which change gene function. The Bill’s text very subtly (e.g. See clause 43) refers to biotechnology. This is surprising for novel technologies (biologics) that are historically regarded as high risk.

6. The Beehive press release shows that this Bill is envisaged as a ‘flexible regulatory framework’ that ‘enables New Zealand to take advantage of advances in medicine, such as cell and tissue therapies, emerging gene therapies, and the use of artificial intelligence and machine learning software.’ It’s industry friendly.

7. The proposed NZ Therapeutic Products Bill states that ‘Therapeutic products are divided into 4 types: medicines, medical devices, APIs (active pharmaceutical ingredients), and NHPs (natural health products) (see clause 20). The Bill regulates them differently because, by their nature, they have different benefits and risks.’ (p. 68/288).

8. The principles that define risk are loose and weak: ‘likely benefits of therapeutic products should outweigh the likely risks associated with them, and their regulation should be proportionate to those benefits and risks.’ Perceived risk depends predominantly on information and data supplied by the sponsor (manufacturer), or by other regulators, who may also depend on their sponsors. This distorts how risk will be evaluated.

9. No function authorises independent review of the scientific literature. Thus, any changing profile of risk in the scientific literature is out of scope. The Therapeutic Products Regulator will not conduct independent risk reviews and there is no provision for financial resourcing to ensure the Therapeutic Products Regulator (Part 9) can conduct their own separate review of the scientific literature to independently consider benefits and risks. Information gathering is limited to information from the sponsor or ‘reports, assessments, or decisions made by, or information received from, overseas regulators, overseas organisations, and other entities’ (pp. 132, 229/288).

10. It’s difficult to understand how biotechnologies are regulated. ‘Clause 32 provides for a medicine, a medical device, or an API to be a biologic if it contains human or non-human cells (including whole organs), viruses, and material derived from those cells or viruses.’ (9/288) Biotechnologies are subtly referred to as biologics that are ‘modified, engineered, or otherwise.’ (pp. 86, 91, 94/288)

11. The Bills Digest is empty; this is a helpful summary of the proposed law. The government stopped producing Bill Digests in June 2022, thus making proposed legislation more opaque.

a. No cost-benefit summaries have been provided for a proposed omnibus bill with thousands of pages of associated secondary legislation (see p. 5/288).

b. No survey of (e.g.) OECD nations with better health outcomes have been undertaken to identify what other nations have successfully inserted food supplements into medicines legislation. It appears most (healthier) nations regulate food supplements separately as a foodstuff.

12. New Zealand’s policy, research and education environment in relation to nutrition and dietary sufficiency is poor and under-serviced. Vitamins, minerals and fatty acids play an important role in supporting hormone (including neurotransmitter); metabolic; and (innate and adaptive) immune system function, and in prevention of cancer. This is under-recognised in policy and law in New Zealand.

13. The other major parties support the Bill. However, Dr Elizabeth Kerekere has drawn attention to Māori opposition to Rongoā Māori being captured under this legislation. Food supplements with a long history of understood use, which protect health and prevent and reverse disease should be excluded alongside Rongoā Māori.

14. This is an ‘enabling’ Bill, and as such is very vague. Under this legislation, a therapeutic product could include anything that has a beneficial effect on the body, or affects the body function in any way. Think

• Herbal teas
• Vitamin C
• Lemons
• Cinnamon
• Supplements
• Aloe Vera
• Turmeric
• Kawa kawa
• Ginger

Information regarding submissions on the Therapeutic Products Bill

1. The government is calling for submissions on the Therapeutic Products Bill, which it introduced late last year.  Those submissions close 11.59 pm Wednesday, 15 February 2023.

2. The Bill:

   a. is intended to replace the Medicines Act 1981 and the Dietary Supplements Regulations 1985 to regulate therapeutic products, such as medicines, medical devices, natural health products, and active pharmaceutical ingredients. This Act is functional and appropriate for NHP’s as it stands, it is not broken.

   b. Introduces a new regulator within the Ministry of Health, headed by an independent statutory officer, with a wider remit than the medicines regulator Medsafe.

3. For more information, you can review:

   a. the consultation information here and other Ministry of Health documents relating to the regulatory regime are here

   b. the Therapeutic Products Bill is here

   c. commentary in parliament on the Bill is here and here

   d. the Ministry of Health is required to prepare a disclosure statement to assist with the scrutiny of this Bill – the statement seeks to bring together in one place a range of information to support and enhance the Parliamentary and public scrutiny of that Bill and is available here.

4. We encourage you to either prepare and file a submission with the Health Select Committee, which you can prepare and:

   a. submit here

   b. if you are having difficulties submitting your submission as per 4.a, then you can email it to the Health Select Committee secretariat at [email protected]