The Medicines Amendment Bill will continue to be considered by the Health Committee over the next two months. Photo: 123RF
MPs on Parliament's Health Select Committee were told by the public this week that, while the government's Medicines Amendment Bill is a step in the right direction, changes are still needed to ensure it balances safety with efficiency.
The bill, which amends the Medicines Act 1981, received its first reading in April, and is a component of a wider push by the government to loosen burdensome regulation across sectors.
Under current settings, prescription medicines can take a long time to be approved, funded, and made available to the New Zealanders that need them. Historically, we have ranked well below the OECD average for access to medicines.
In his oral submission on the bill, New Zealand Initiative chief economist Dr Eric Crampton suggested that New Zealand simply wasn't a desirable target market for medicine companies.
"We are a small, relatively poor country at the far end of the world that will not be at the top of anyone's agenda in getting their regulatory affairs team to deal with paperwork… It can take years after a drug has been approved by at least two markets overseas before anybody puts it into the New Zealand approvals process."
In his submission, Crampton mentioned the concept of an "invisible graveyard," referring to the people who may have died or been harmed as a consequence of not having access to unapproved medicines.
The Medicines Amendment Bill seeks to shake up the status quo, improving patients' access to medication by doing three things.
Primarily it would introduce what has been dubbed as 'the rule of two', whereby if a medication has been approved for use in two recognised overseas regulators, Medsafe (New Zealand's medicines regulator), can bypass its usual, often lengthy, assessment process. The government hopes this will reduce the time it takes for new medicines to reach patients. The recognised overseas regulators are those from Australia, Canada, the EU, UK, USA, Switzerland and Singapore.
As well as these fast-tracking medicine approvals, the bill also expands the power to prescribe medicine to a wider range of healthcare professionals, such as nurse practitioners, midwives, dentists, and optometrists, so long as the medication falls within their scope of practice.
Thirdly, the bill updates some of the settings around the Medicines Classification Committee, which makes recommendations to the Minister of Health around how new medicines should be classed.
This week the Health Committee also heard from Dr Graeme Jarvis, CEO of Medicines New Zealand, which represents pharmaceutical companies. While in support of the bill's intent, he told MPs, it needs refinement in order to better achieve its goal outcomes.
When asked by Labour's spokesperson for Health Ayesha Verrall, why he was sceptical of the automatic approvals that Dr Crampton had suggested to the committee earlier, Dr Jarvis suggested that doing so would create "unintended consequences around parallel importing and other activities".
"People flood the market, and the product may not necessarily be what you think it is, you may end up with counterfeit products coming in. There is no clawback for the regulator to go after a sponsor who has been acting in an unsatisfactory manner."
Reliable overseas regulators?
When New Zealand lawmakers look outward for policy inspiration, they tend not to just throw a dart at a map on the wall and hope for the best. There are generally agreed comparable countries, commonly drawn on as case studies for good lawmaking here, which vary depending on the topic.
The Medicines Amendment Bill's 'rule of two' provisions reflects this tradition, using a familiar set of jurisdictions in its list of recognised overseas regulators.
Members of the Wellington Community Justice Project, a volunteer group made up of Victoria University law students, suggested to the Health Committee that while these overseas regulators have been historically reliable, that does not mean they always will be.
"While the bill allows the minister to make rules for verification through secondary legislation so they can be refined to reflect changes in best international practice, we feel as though there needs to be something within the text of the bill itself, ensuring that the regulatory authorities themselves are regularly assessed and upheld to the standards of best international practice," the students told the committee.
They went on to cite the current changes being made to the United States FDA, which has long been the world leader in approving medicine.
"The FDA's placement on this list, most notably for the reason that the FDA is currently headed by RFK Jr, a health secretary who has been described as a conspiracy theorist, and relevant to this bill, has cancelled or frozen billions of dollars of research grants for the development of the medicines. Clearly, this bill [will outlast] RFK Junior's appointment. However, this example illustrates the need for a process to review the regulatory authorities in Section 22A, so when the questions arise about jurisdictions' suitabilities to be on the two-step verification process, these are able to be addressed."
The Medicines Amendment Bill will continue to be considered by the Health Committee over the next two months, before being reported back to the House by the 9 August.
You can listen to the audio version of this story by clicking the link near the top of the page.
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