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Regulating medicines and supplements – Expert Reaction

The coalition government has signalled its intention to repeal the Therapeutic Products Act. What might a return to the status quo look like?

In addition to medicines, the Act would cover medical devices and natural health products. It would require any claims on natural health products to be substantiated by scientific evidence, evidence of traditional use, or both.

The SMC asked independent experts to comment.

Dr Ian Shaw DSc, Professor of Toxicology, School of Physical & Chemical Sciences, University of Canterbury, comments:

“The Therapeutic Products Act 2023 was a long time in the making. It provides overarching legislation to ensure the safety of medicines (and their active components), medical devices (e.g., pumps for insulin) and natural health products (e.g. complementary medicines). Its implementation was planned to span a reasonably long timescale. It is a key act that aims to promote New Zealanders’ health by making sure that devices and products used to treat and manage illnesses are safe.

“Frankly, I can’t understand why a government would even consider repealing it, let alone initiate the repeal process.

“Medical devices are currently difficult to regulate from a safety perspective. Arguably more importantly, natural products have escaped robust legislation. The Act was valuable in that it provided the framework for safety considerations being introduced into regulation of these products.”

“There is a plethora of natural products on the market for sale in supermarkets and pharmacies. They are often packaged like medicines, although they are not permitted to have a medicinal claim (e.g., X is effective in the treatment of disease Y), but their packaging and label statements might mislead consumers into thinking that they are safety tested and beneficial. This is not necessarily the case.

“The Therapeutic Products Bill 2023 provides the wherewithal to apply some degree of safety assessment to natural products. For a medicine to be licensed its benefit (i.e. its efficacy) must outweigh its toxicity, but since natural products are not medicines, they do not have to pass this stringent and important safety assessment.

“In my opinion, if the only benefit of the Act is to facilitate risk assessment for natural products, it will have served a very important role in assuring New Zealanders’ safety. But it does far more than that, and so to repeal it smacks of a lack of understanding of its purpose and value.”

No conflict of interest declared.

Dr Sanya Ram, Senior Lecturer, School of Pharmacy, University of Auckland, comments:

“Medicines are the most common therapeutic intervention used. Laws and regulations are among the most impactful ways we can ensure medicines are safe, effective, and of acceptable quality, but in New Zealand the Medicines Act 1981 and its associated Medicines Regulations 1984 are more than 40 years old.

“The new Therapeutic Products Act 2023 (TPA) provided a well-needed opportunity to design regulations that were contemporary and fit for purpose, incorporating the advances in biotechnology and healthcare delivery, and reflecting international standards and norms.

“Updates and amendments over the years haven’t reflected the requirements with the clarity needed for today’s environment – from manufacture, development, and clinical trials, to import-export, registration, distribution, prescribing and dispensing, supply, and classification of medicines, labelling and advertising, and the safe selection and provision of medicines to patients.

“The development of the TPA regulations provided the opportunity for New Zealand to modernise our laws, remove those sections of the law that were not conducive to supporting optimal practice and enhancing health outcomes, and develop regulations for the significant advancement of therapeutic products for the future. Medical device regulations and gene, cell, tissue, and other therapeutic products require appropriate regulations and standards to ensure the safety of the public. As does appropriate pharmacovigilance for ensuring that appropriate changes can be made to alerts and real-world data, making therapeutics safer and improving the health of patients.

“Greater emphasis should be applied to widening the lens surrounding medicines regulations when reviewing their effect on health outcomes. The influence of regulations results in outcomes beyond health, and legal barriers to accessing medicines should constantly be researched and reviewed so that we can better understand the legal determinants of health.”

No conflicts of interest declared.

Dr Phil Rasmussen, Founder of Phytomed, Pharmacist, Consultant to the Natural Health Industry, and Honorary Senior Lecturer in Pharmacy, University of Auckland, comments:

“The Natural Health Product (NHP) Industry has the potential to become a massive export earner for Aotearoa New Zealand, but has been held back by our woefully inadequate regulatory environment. Current regulations – the 1981 Medicines Act and the 1985 Dietary Supplements Regulations – are hopelessly outdated, and give prospective exporters little credibility or respect, in international marketplaces.

“Successive governments have spent more than 20 years and have made three attempts to get fit for purpose and internationally recognized regulations for the NHP industry sector, passed into law. They finally succeeded when the Therapeutic Products Act (TPA) was passed in July last year, after being supported by the majority of the local industry. While playing catchup and raising the bar in terms of regulatory requirements, the TPA finally gave the sector much needed clarity and mana, and created a framework to help foster greater exports. And yet, the new government will soon repeal it, as part of its coalition agreement.

“Under current regulations, obtaining export certificates can be difficult for local manufacturers. It is often unclear whether products are ‘dietary supplements’ or medicines, leading to many inconsistencies and sometimes a lack of the necessary regulatory oversight. It is also virtually impossible for local companies to say much on the packaging about the product’s purpose, or make therapeutic claims. However, imported products routinely do so, thus creating an uneven playing field in the domestic market.

“The local NHP industry has the potential to become a sustainable and lucrative export earner with sales surpassing those of the dairy or tourism sectors, but only with an internationally respected regulatory environment. It is time for certain politicians to wake up to 21st century market trends and opportunities, and stop using this promising and strategically valuable industry as political football from one election to the next.”

Conflict of Interest: “I am the founder and a director and shareholder of Phytomed Medicinal Herbs Ltd, in Auckland, and I have a Masters degree in Pharmacology from the University of Otago. I am a board member of Natural Health Products New Zealand, and a former President of the New Zealand Association of Medical Herbalists. However, the views, thoughts, and opinions expressed in this text belong solely to myself, and do not reflect those of any of the above entities or organizations.”