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The government is scheduled to announce reforms to accelerate new medications based on previous approvals abroad, writes Catherine McGregor in today’s statement of the bulletin.
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Faster drug approvals on the way
The government must reveal reforms today that will allow faster drug approval already in use abroad, fulfilling a promise in the coalition agreement of the national act. The new regime allows the Minister of Health to sign new medicines if it has received total approval of at least two of the seven designated regulators, including US agencies, the United Kingdom, Australia, Canada and EU. Although the coalition agreement has promised that Medsafe should approve these drugs within 30 days, this specific deadline has not entered the legislation – although associate health minister David Seymour should commit to him in practice, reports Marc daalder in the newsroom.
A remarkable change: the declaration of regulatory impact of the legislation “provides for medsafe making the final decisions to approve, reject or transfer requests under the new path,” writes from Alder. “Instead, the written bill would give this power to the Health Minister, after the Director of Health assured that the request met the basic requirements to simplify.”
New Zealand ‘on the back of the line’ for new medicines
For years, critics have called the New Zealand drug approval process frustratingly slow, and sometimes dangerously. Medsafe’s Years-Delayed Approval of the Mpox Vaccine During a Global Outbreak is Just a recent example. The launch of the Covid-19 vaccine faced similar delays, with slower medsafe than the counterparts abroad to approve vaccines already in widespread use-a frustration that helped boost the development of this legislation, writes from Alder.
At the time of the last election, economist Eric Crampton began defending a “two rule”, allowing automatic approval after two approvals by reliable regulators abroad. He described the current process as actively harmful. “Demanding that companies jump on obstacles to New Zealand … When they have proven in shape, jumping more strict obstacles abroad, only puts kiwis on the back of the line.” He wrote in the newsroom in 2023. In fact, the new legislation closely reflects the system that Crampton recommended in its report ‘Following Safe: Faster access to drugs for Kiwis’.
WEGOVY: Better afternoon than ever
This week’s announcement comes that hot soon after Medsafe finally approving wegovyA high -profile semagluid drug used for weight loss. Wegovy, manufactured by New Nordisk, is often described as a “sister drug” for Ozepic, which is approved here for treatment of diabetes. Both medications work in similar ways, but are prescribed for different purposes. Seymour called Wegovy’s approval “very exciting,” but said it also illustrates why the reforms are late. “The fact that something was consented is not in itself evidence of [Medsafe’s] High performance, ”he told reporters. Wegovy had already been approved abroad for years – and transformed the treatment of obesity in many countries – when he went through the New Zealand process.
Who can get Wegovy and Ozepic?
The true promise of semaglutid drugs can go far beyond weight loss or diabetes. The research is now exploring its potential In areas as diverse as cardiovascular diseases, dependence and even dementia. Some studies suggest that they can help reduce The risk of stroke or Treat the fatty liver disease. However, for now, Ozepic and Wegovy remain strongly regulated in Aotearoa, as in most countries. Ozepic can be prescribed for type 2 diabetes, while wegovy-a time available will be restricted to those with an BMI that “classifies them as obese or overweight in the presence of at least weight-related comorbidity,” Jamie Ensor Reports in Herald.
For patients, this is a potentially transformative option. For the health system, Seymour argues, is an opportunity for cost savings. Although he notices that he respects Pharmac’s independence, he says he asked the agency “to start saying: How to spend more on pharmaceutical products save us money elsewhere? Wegovy and Ozepic can be perfect examples of this.”
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