Dunne Speaks: Cannabis-based medicines edge a step nearer
Thursday, 19 December 2019, 8:47 am
Article: Peter Dunne
The new just announced regulatory scheme for cannabis based medicines is generally positive. But the government may be significantly underestimating the demand for licenses, raising the spectre of an underfunded industry regulator.
What is good about the new regime is the requirement that medicinal cannabis producers meet Good Manufacturing Practice (GMP) quality thresholds. This will ensure cannabis-based medicines meet the same high standards as all other pharmaceutical products. That high quality standard will be good news for patients. Provisions allowing the rapidly developing industry to access the vast knowledge and cannabis cultivars that already reside in the underground medical cannabis community are both positive and sensible. And the licence fee structure being proposed is broadly supportive of the industry and should not inhibit its development.
The Ministry of Health says its expects to issue 110 medicinal cannabis licences in the first year, while at the same acknowledging the inherent difficulty in estimating the number of industry participants in what is an emerging NZ industry. There has to be some concern, therefore, that the Ministry of Health may not be able to cope any unexpected surge in licence applications. Moreover, there is the additional risk the Ministry may have underestimated the time and cost of monitoring – especially planned and unplanned surveillance audits – and subsequent enforcement action where breaches and/or illegal activities are identified. It would be a major concern if the implentation of the new regime were to fall down or become subject to substantial delay because the regulator’s office was inadequately resourced.
However, so long as long as the government remains committed to quickly resourcing the new regulatory agency to meet actual demand, then the regime should be introduced relatively smoothly. But, the absence of appropriate resourcing would likely create a significant bottleneck to industry growth, especially if the numbers of applications are consistent with market expectations and not the Ministry’s more conservative estimates.
If there are bottlenecks which lead to significant delays New Zealand patients will be the loser. At best, this will mean local patients will be paying more for relatively expensive overseas products. At worst, patients with limited financial means may continue to suffer unnecessarily or turn to the black or grey market,which is precisely what the Ministry is trying to avoid.
One disappointment is that that the government has decided to leave the cannabis extract Cannabidiol (CBD) as ‘Prescription Drug’ rather than ‘Pharmacist Only’. CBD is non-psychotropic and non-addictive and there is a strong body of evidence that it can provide safe and effective relief for a number of conditions including inflammatory pain and sleep disorders. It has been reported that 230,000 New Zealanders were prescribed drugs for sleep disorders in 2018, and with an estimated 700,000 New Zealanders suffering from arthritis, there is a strong and growing demand for cannabis-based alternatives to mainstream drugs, which can be addictive and cause unwanted side effects. CBD products have a role to play here, and it is to be hoped that they will become generally more available both as ‘Pharmacy Only’ medicines and eventually as ‘Over The Counter’ (OTC) medicines, depending on their potency.
Overall, the new scheme will open the door to offering many New Zealanders relief from chronic pain and other symptoms, with non-addictive cannabis-based medicines. Cost-efficient New Zealand medicinal cannabis producers should enjoy a strong cost advantage and, in some cases, quality advantage relative to offshore-based providers of these cannabis-based medicines.
While the potential is there to establish a quality cannabis based medicines industry in New Zealand, progress could still be frustrated if the government does not put in place the appropriate infrastructure and oversight to allow medicinal cannabis products to be developed and brought to market in a timely manner. It has already taken two years to achieve regulatory certainty, and there is no excuse for further delay or uncertainty.
By way of disclaimer, I am Chair of SETEK Therapeutics, one of the new companies becoming involved in this market. SETEK is a New Zealand owned bioscience company looking to cultivate, process and manufacture pharmaceutical grade, pure organic, cannabis-based medicines and cannabis-infused skincare and wellbeing products for New Zealand, Australia, the Asia Pacific region and beyond.
My comments, however, are made from the perspective of someone with a long interest in this issue, who began the process of making access to cannabis based medicines more available to New Zealanders over five years ago (including declassifying CBD under the Misuse of Drugs Act), and who is generally pleased with the progress made subsequently. Interest, tolerance and understanding, both within government and the public, have grown considerably in that time, and the opportunity now exists to establish a viable cannabis based medicines sector in New Zealand.
On that note, Dunne Speaks takes its leave for 2019. Best wishes to everyone for a safe, and happy Christmas with family, friends, and those dearest to you. 2020 will offer a whole fresh set of challenges and opportunities, and Dunne Speaks will be back in a few weeks to comment on those as the year unfolds. Meantime, Merry Christmas!
Medicinal cannabis companies eagerly awaiting regulation announcement
Newstalk ZB, Mon, 16 Dec 2019
Medicinal cannabis is back front and centre this morning.
The government are set to announce their scheme this week, and medicinal cannabis companies want a decisive and swift move.
They say they’re ready to crack on and get people the help they need.
Former associate health minister Peter Dunne, who is now chair of medicinal cannabis company Setek Therapeutics, told Mike Yardley this has been a two year work in progress and they are keen to see results.
“What Setek is saying is we are very keen to see the regulations, we think they are heading in the right direction, but there’s still going to be a time after that before we can get products to market.”
He says the companies want to see the regulations so they can get the proper approval.
Dunne says that even with the regulators coming onboard, it will still take until the end of next year to get cracking.
AFT and SETEK sign medicinal cannabis MoU
Market and Media Release 8 October 2019
AFT Pharmaceuticals (NZX.AFT, ASX.AFP) and New Zealand medicinal cannabis company SETEK today announce they have signed a memorandum of understanding (MoU) to work together in the research, development and commercialisation of medicinal cannabis products.
The MoU seeks to combine, and take advantage of, AFT’s expertise in pharmaceutical development, commercialisation and distribution and SETEK’s expertise in cannabis cultivation and the extraction and processing of pharmaceutical grade cannabis compounds.
Earlier this year SETEK became the fourth New Zealand company to receive a license from the Ministry of Health to cultivate cannabis for scientific and medical research. It is developing a 100% organic cannabis propagation, cultivation, processing and manufacturing facility at Rotokawa, near Taupo.
AFT Pharmaceuticals Chief Executive Dr Hartley Atkinson said: “Medicinal cannabis represents a sunrise industry in New Zealand and is an obvious addition to our broad portfolio of prescription and over the counter medicines.
“SETEK is on track to become a leading New Zealand producer of medical cannabis and cannabis extracts. It has recently acquired a cannabis genetics company and is working towards the construction of a new, state-of-the-art medical cannabis facility that is due to commence production next year.
“These assets coupled with AFT’s expertise in the commercialisation and distribution of pharmaceuticals have the potential to create a winning combination in New Zealand’s emerging medicinal cannabis sector.”
SETEK Chief Executive Mark Mees said: “We are delighted to have reached this cooperation agreement with AFT. Hartley and his team are recognised internationally for their capabilities in taking medicines through clinical trials, regulatory approvals and then successfully distributing and selling these products in New Zealand, Australia and further afield.
“This agreement envisages SETEK and AFT each playing to their strengths. We are looking forward immensely to working with AFT to bring our shared vision to life.”
The MoU envisages the two companies jointly:
- developing business models for the development, manufacture, formulation and obtaining regulatory approval (if applicable) for selling, marketing and distribution of products;
- endeavouring to discover new medicinal cannabis opportunities;
- sharing expertise, experience and know-how; and
- cooperating in other areas of common interest.
It also envisages SETEK managing the propagation, cultivation, extraction, processing and manufacture of any medicinal cannabis products emerging from the collaboration. It will also be the exclusive supplier of these products to AFT.
AFT will meanwhile conduct any clinical trials and manage regulatory approvals of any product and will be granted exclusive right to sales, marketing and distribution of the medicinal cannabis products in Australia and New Zealand. It will also be granted the right of first refusal to do the same in other territories around the world.
Commercial arrangements between AFT and Setek will be agreed as part of any contract that emerges from the MoU.
CEO AFT Pharmaceuticals
The following high-res images can be downloaded at: www.aftpharm.com/news/
- AFT Chief Executive Dr Hartley Atkinson and Setek Chief Executive Mark Mees
- Concept drawings for Setek’s planned facility in Taupo
About AFT Pharmaceuticals
AFT is a growing multinational pharmaceutical company that develops, markets and distributes a broad portfolio of pharmaceutical products across a wide range of therapeutic categories which are distributed across all major pharmaceutical distribution channels: over the counter (OTC), prescription and hospital. Our product portfolio comprises both proprietary and in-licensed products, and includes patented, branded and generic drugs. Our business model is to develop and in-license products for sale by our own dedicated sales teams in our home markets of Australia and New Zealand and in certain Southeast Asian markets, and to out-license our products to local licensees and distributors in the rest of the world. For more information: https://www.aftpharm.com/
SETEK is a leading New Zealand medicinal cannabis company which aims to cultivate, extract, process and sell pharmaceutical grade, 100 percent NZ certified organic medicinal cannabis extracts and medicines throughout the Asia Pacific region and beyond. It holds a license to cultivate a prohibited plant for research purposes, including the cultivation of high THC cultivars. The company recently purchased a 26- hectare greenfield site overlooking Lake Taupo to house its new facility, which is targeted to enter production in 2020 with an initial annual scaled production capacity of circa 17,000kg of dried flower for processing. SETEK recently acquired a cannabis genetics company and a horticultural LED lighting company,and seeks to become one of the world’s first carbon neutral indoor cannabis operators. For more information: https://www.setek.co.nz
Proposed Regulations and Standards a small step forward – SETEK on TV1
11 July 2019 – SETEK Therapeutics on TV1 Breakfast Show
The proposed regulations and standards for medicinal cannabis was yesterday made public for a brief period for consultation in a “small step forward” toward legalisation, SETEK Advisory Board Chair Peter Dunne told the TV1 Breakfast Show.
SETEK Features in iHemp Magazine
21 June 2019 – SETEK Therapeutics features in i-Hemp Magazine
SETEK was featured in iHemp magazine (page 36). The magazine looks at how THC and CBD actually work, and one of our favourite topics – medical cannabis in ancient times … and of course our article.
SETEK Features in Taupo ‘Henry’ Magazine
4 June 2019 – SETEK Therapeutics features in the Taupo-based Henry magazine.
Legalising cannabis production has always been a contentious issue. A plant that has been prohibited and scrutinised, branded with a biased public perception and a lack of understanding of its real advantages – medicinal benefits. But is it possible to achieve this ethically? Yes, says SETEK Therapeutics, Taupō-based medicinal cannabis producer – and the only New Zealand company that has ruled out any involvement in the production of flower or ‘loose leaf’ for smoking.
SETEK Therapeutics emerged in late 2017 as a business collaboration between Mark Mees and chief operating officer, David Pearce.
“From the outset, our vision was to become New Zealand’s lowest cost-provider of pharmaceutical grade, 100% NZ certified organic cannabis-based medicines,” says Mark.
Following a rigorous process to obtain the license, SETEK are currently in their research phase, developing and stabilising the genetics to be grown, alongside commencing the design of their new, state-of-the-art good manufacturing practice (GMP) medical cannabis facility. With the facility expected to be complete by August 2020, the team are on track for a product launch in late 2020. Treatment areas include intractable pain, depression, anxiety, as well as specific illnesses such as cancer, Alzheimer’s, Parkinson’s, and several spasticity disorders.
SETEK are now the fourth company in New Zealand to receive a license to grow cannabis for research and development, and only the second granted permission to grow high THC cultivars.
Why Taupō? Along with its central location providing an ideal logistics and distribution hub in New Zealand, it also aligns perfectly with SETEK’s social responsibility goals and is key to their international branding strategy.
“Keeping it local also aligns with local Iwi / Hapu aspirations for the return of tangata whenua to their ancestral lands. If you are going to do that you need a model that includes the creation of sustainable jobs,” explains David. “There are also several factors unique to our location which will help SETEK to achieve its goal of becoming Oceania’s – and one of the world’s – first net-carbon-neutral indoor cannabis companies.”
A Taupō base also means the creation of over 100 jobs locally, potentially increasing to 250 or more as new opportunities in the natural health and nutraceutical markets open up.
Kapiti Coast Chamber of Commerce
21 May 2019 – SETEK Therapeutics featured as the lead story in the new Kapiti Coast Chamber of Commerce Magazine
Cannabis busines start-up
26 April 2019, as reported in the Taupo Times
New Medicinal Cannabis Company to Create 100 Jobs in Taupo
24 April 2019, as reported on Stuff
A medicinal cannabis company has been given the green light to set up its operations in Taupō, creating more than 100 jobs.
SETEK Therapeutics will establish its base in Taupō later this year after becoming the fourth company to receive a licence from the Ministry of Health to cultivate cannabis plants.
It’s only the second to receive permission to grow high THC cultivars for research in what is projected globally to be an $11 billion medical cannabis industry by 2022.
They will build their operation plant on a 26-hectare block of land on Rakaunui Rd, in Rotokawa.
SETEK chief operating officer, and Taupō local David Pearce (pictured left), said initially 100 jobs would be created but could grow to more than 250 if developments in the legislative environment opened up new markets in the natural health and personal care product markets.
Taupō mayor David Trewavas said he was confident that the business had done everything they needed to do to be given the go-ahead.
“The 100 jobs that they are proposing to have is certainly always welcome in this district. I certainly don’t foresee any problems,” he said.
“The Taupō district is always open for business and always has been. [Medicinal cannabis] opens up a whole new industry in our district.”
SETEK was founded last year by Pearce, and Kapiti businessman Mark Mees (pictured right), with the aim of becoming New Zealand’s leading cultivator and producer of pharmaceutical grade, 100 per cent New Zealand-certified organic medical cannabis products.
Mees, who is also chief executive, said obtaining a licence enabled the company to move into the research and development stage, commence the design phase for its new, state-of-the-art good manufacturing practice medical cannabis facility, carry out initial recruitment, and initiate its medical cannabis education programme.
“We expect the design phase to be completed in September this year, with construction commencing late 2019 and operational readiness expected mid-2020.
“We want to support local Iwi in their aims for the return of tangata whenua to their ancestral lands, and we recognise that local job creation is one of the keys to achieving this in a sustainable way.
“Taupō is also an ideal location in terms of logistics and distribution.”
Mees said SETEK has been methodical and deliberate about its development and looking ahead three to five years.
“This is a complex, rapidly evolving new industry that doesn’t even have a regulatory framework yet, but we have already seen the failure of several New Zealand start-ups before they’ve got out of the starting blocks.”
SETEK aims to have its first products on the market by the end of 2020.
The SETEK Therapeutics Advisory Board is chaired by former Associate Minister of Health Peter Dunne who said he joined the company because of their genuine focus on helping people.
However, he was aware of the significant challenges surrounding attitudes and views towards cannabis-based medicine from both the public and the medical profession.
“There seems to be this public perception that cannabis-based medicines are the new panacea that will cure any health issues, this is not the case,” Dunne said.
“But cannabis-based medicines will be hugely beneficial for a number of medical conditions, including those suffering from intractable pain and spasticity disorders.”
Link to Stuff Story
For information on upcoming jobs, send your CV or enquiry to email@example.com
SETEK Cites Challenges Around Public and Medical Education
17 April 2019
SETEK Therapeutics, a Taupo-based medical cannabis company, has cautioned that public education and helping the medical profession to better understand medicinal cannabis will be a key challenge.
Chair of the SETEK Advisory Board and former Associate Health Minister Peter Dunne says there are significant challenges surrounding attitudes and views towards cannabis-based medicines from both the public and the medical profession.
SETEK became the fourth company to receive a licence from the Ministry of Health to cultivate cannabis plants, and only the second to receive permission to grow high THC cultivars for research, in what is projected globally to be an $11 billion medical cannabis industry by 2022.
Mr Dunne says: “There seems to be this public perception that cannabis-based medicines are the new panacea that will cure any health issues, this is not the case.”
“But cannabis-based medicines will be hugely beneficial for a number of medical conditions, including those suffering from intractable pain and spasticity disorders.
“Significant work will be required to help the medical profession better understand how medicinal cannabis products can benefit the treatment of their patients,” says Mr Dunne.
Mr Dunne took up his position with the SETEK Therapeutics in September 2018.
“I joined SETEK because I was not only impressed with their vision and plans to build a successful international business, but also their genuine focus on helping people,” says Mr Dunne.
SETEK was founded in 2018 by Taupo businessman David Pearce and Mark Mees, with the aim of becoming New Zealand’s leading cultivator and producer of medical cannabis products.
SETEK Therapeutics is the only New Zealand company to preclude any involvement in the production of flower or loose leaf for smoking.
SETEK Chief Executive Mark Mees says the company fully supports the government’s Aotearoa New Zealand 2025 Smokefree goal, and say there are a number of healthier and more effective ways to consume medical cannabis.
The Government’s cannabis regulations are expected to be completed by the end of 2019, with associated licensing, audit and compliance functions completed by mid-2020 which Mr Mees says will signify the start of the cannabis market in New Zealand.
SETEK recently secured a 26-hectare block of land in Taupo to establish its operational plant, which is expected to create more than 100 jobs for the local economy.
Mr Mees says SETEK has been methodical and deliberate about its development and looking ahead three to five years, it aims to have built a successful commercial operation and established itself as one of the world’s leading medical cannabis brands.
“This is a complex, rapidly evolving new industry that doesn’t even have a regulatory framework yet, but we have already seen the failure of several New Zealand start-ups before they’ve got out of the starting blocks,” he says.
Mr Mees says SETEK aims to have its first products on the market by the end of 2020.
“We have always been more concerned with doing it right than getting there first, as we aim to become New Zealand’s most trusted and lowest cost-provider of pharmaceutical-grade, 100% New Zealand-certified organic medical cannabis products,” says Mr Mees.
SETEK Advisory Board Chair Talks About Medicinal Cannabis Sector
10 April 2019
Chair of the SETEK Advisory Board and former New Zealand Associate Health Minister Hon. Peter Dunne talks about his role with SETEK, the future of the medicinal cannabis sector and the need for public and medical education.
SETEK Management and Advisory Board at Taupo Site
2 April 2019
The Management team and Advisory Board of SETEK Therapeutics at the site of its proposed Taupo plant.
Pictured from left to right: Dr. Mike Nichols (Advisory Board, Horticultural Science), Jane Pearce (SETEK Finance & Administration), Mark Mees (CEO), Hon Peter Dunne (Advisory Board Chair), David Pearce (COO), Dr. Denise Taylor (Advisory Board, Clinical Pharmacology) and Martin Gray (Advisory Board, Commercial M&A).
New Zealand Just Days From Legalising Medicinal Cannabis
11 December 2018
Following the third reading of The Misuse of Drugs (Medicinal Cannabis) Amendment Bill and its passing by the House, it’s now just a matter of signing the bill into law by giving it the Royal assent, which is done on the advice of the Prime Minister and the Attorney-General.
Whilst this is tremendous news for many of those patients who will most benefit from medical cannabis, many are disappointed with the bill’s controversial exclusion of intractable pain as a general qualifying condition.
New Zealand’s emerging ‘canna-business’ sector now waits with baited breath for the new regulatory framework (medical cannabis scheme) which looks unlikely to be implemented before 2020.
30 November 2018
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Hon. Peter Dunne to Lead SETEK Advisory Board
12 September 2018
SETEK Chief Executive Mark Mees has announced two key appointments to the SETEK Advisory Board.
“I am delighted to report that the Hon Peter Dunne has accepted the position of Chairman of SETEK’s Advisory Board, joining experienced M&A specialist, Martin Gray of Armillary Private Capital.”
Hon Peter Dunne said his decision to join SETEK was ultimately an easy one to make.
“The SETEK Board of Directors impressed me not only with their vision and plans to build a successful international business, but also their genuine focus on helping people. Mark demonstrates a balanced mix of corporate thinking and good old-fashioned values that really resonated with me.”
“During my time as Associate Minister of
“With the Misuse of Drugs (Medicinal Cannabis) Amendment Bill making its way through Parliament, I am looking forward to working with the SETEK Board to achieve a mutual vision of making premium quality, New Zealand grown cannabis-based medicinal products available to all those New Zealanders who will benefit from them,” Dunne said.
Mr Mees said that the company is focused on ‘getting it right, not getting there first’.
“We may not be the first cab off the rank to produce Medicinal Cannabis in New Zealand, but our planning and execution will more than compensate. We’re passionately committed to setting the ‘Gold standard’ in this new industry in New Zealand; as a producer; as an employer and as a business partner.
The SETEK name will become synonymous with quality in everything we do.” said Mr Mees.
“Mark has assembled an impressive team and the opportunities ahead are exciting. As Advisory Board members, Martin and myself are looking forward immensely to working with SETEK in every way that we can to help them realise their goals—and I am sure you will see a number of announcements over the coming months,” said Hon Dunne.
Martin Gray added that the company has a number of exciting opportunities in front of it and is well placed to build a significant New Zealand and international business.
SETEK is a 100% New Zealand owned company primed to enter the CBD and Medicinal Cannabis market and expects its first CBD products to be ready for market in 2019. SETEK was co-founded by David Peace and Mark Mees in early 2018.