The Post, 22 June 2023

In among the well-publicised hurly burly of politics in an election year Parliament is still going about its core business of considering and passing legislation. Thus, just in this last week, quietly, and largely unheralded, the Health Committee reported back on the Therapeutic Products Bill.

This bill, if passed – as expected – will replace the Medicines Act of 1981. It is a once-in-a-generation piece of legislation that, if the longevity of the previous Act is any guide, could last another half century. Although accompanied by little media attention, the bill received more than 16,500 submissions and the Health Committee has published a 335-page appendix that goes through each clause responding to the submissions in detail, making many changes in the process.

What then are the major changes? The new name to the Bill – Therapeutic Products – points to one. No longer are we dealing just with prescription medicines. We now also need to cover medical devices and prostheses, cell and gene therapies, active pharmaceutical ingredients (APIs) generally, and even software. Indeed, this has been an area of failure internationally where there has been insufficient evaluation of devices and prostheses; think surgical mesh. In New Zealand we have had shortcomings with, for example, hip prostheses and breast implants where, after a perfectly serviceable original market authorisation, subsequent models and replacements were inadequately evaluated and have not worked nearly as well.

The other big area is what used to be called alternative and complementary medicine and is now termed Natural Health Products (NHPs). It was this area that scuppered a previous legislative initiative in 2006. It is obviously a topic that moves the emotions of a small but vociferous and politically important segment of the population. We are talking minerals, vitamins (eg Vitamin C), botanicals (eg St John’s Wort), and substances from a natural source (eg omega-3 fatty acids). Most of these substances are non-toxic and have effects that are hard to document scientifically. The legislation has adopted a risk-proportionate regime of evaluation and scrutiny, with associated regulations on how and what health benefits can be advertised and claimed. Māori activities and services are also covered under the rongoā category.

New Zealand, then, is engaging with the mainstream of international best practice in the area of therapeutic products regulation, and perhaps, such as NHPs and rongoā, it is in the advance guard. But there remains one area where we are completely out of step with the mainstream of international best practice, and that is in permitting the direct advertising to consumer advertising (DTCA) of prescription medicines. Only one other country permits this, the United States (US). Submissions opposing DTCA came from all major professional groups and, in something of a break with tradition, from the National Party. It is puzzling that the committee allowed this to advance.

The Medicines Act was ambiguous on the matter. Perhaps in the more gentlemanly era of the 1980s nobody even considered DTCA as a possibility, so it was not explicitly prohibited. In 1997 the US authorities permitted DTCA. Shortly thereafter, given the strong free market ethos of the 1990s, New Zealand experienced a raft of DTCA from pharmaceutical companies, something family doctors complained about at the time. This has continued ever since, although not with the same first flush.

Research in the US suggests DTCA focuses on medicines that are less effective, and it had a role to play in the disastrous epidemic of opioid addiction and death by providing a pincer movement with advertising both directly to doctors and professionals, and to the public (unbranded, such as so-called “disease awareness” campaigns).

Of course, nothing like this could happen in New Zealand. Or could it? In the early 2000s a new drug for relieving arthritic and related pain entered the market and was not funded by PHARMAC out of safety concerns, yet the manufacturer continued to market it in New Zealand, although it suspended marketing to the public. In both New Zealand and the United States the same manufacturer has shown people dancing because of the relief the drug provided.

In other words, it is as well to remember that DTCA ventures are not education programmes but marketing campaigns. Yes, there is supposedly self-regulation, but it is generally ineffective.

It is curious that, at a time when the government is trying to lower the level of unnecessary demand on family doctors and tackle health misinformation – much of it issuing from the pandemic – it is still prepared to extend a practice that was never fully sanctioned by the original legislation (or legislatively by any other country, including the US), despite united opposition from all relevant professional bodies.

When the legislation comes to Parliament for further scrutiny an amendment should be moved to delete the clause legalising DTCA (a global first – no other country has legalised DTCA, not even the US). It will almost certainly receive support from across the floor of the House!

Peter Davis, Emeritus Professor of Population Health and Social Science, University of Auckland