Research—reducing the cost of medicines
In 2018, Professor Susy Frankel from Te Kauhanganui Tātai Ture—Faculty of Law and Professor Jessica Lai from the School of Accounting and Commercial Law at the Wellington School of Business and Government were awarded a Marsden Fund Standard Grant worth $622,000 for their project, ‘Mission Creep’ in the Pharmaceutical Industry and its Impact on Innovation and Health.
Their research focuses on how two usually siloed systems—patents and pharmaceutical regulation—cross over with the introduction of regulatory data exclusivity with respect to pharmaceuticals, and the way that affects competition in the market. Both researchers are hopeful their work will result in better-designed laws around patents and drug regulation, which could lead to cheaper medicines for New Zealanders.
Professor Frankel says patents are the established main form of protection for pharmaceuticals. “Importantly, the patent regime is justified as necessary for innovation and includes checks and balances. In contrast, the regulatory review regime is primarily a framework to ensure the health and efficacy of pharmaceuticals,” she says.
“Pharmaceutical company behaviour creates an overlap of the two regimes through the operation of regulatory data exclusivity, which is where information about how pharmaceuticals work [clinical trials] is kept confidential for a defined period. But patents are public documents which serve to promote the dissemination of knowledge and in that way promote innovation,” she says. “The practical reality is that the pharmaceutical industry is gaming the system by increasingly relying on regulatory data exclusivity, which can have a negative impact on innovation and competition—the line between the rational scope of patents and the role of the regulatory system has blurred.”
This mission creep is problematic and even potentially dangerous, says Professor Lai.
Innovation policy has explicitly entered into the foreign terrain of health, which is based on very different assumptions, policy goals, and frameworks to achieve its goals.
Failure by policy- and law-makers to recognise the full extent of the interrelated nature of the two systems can allow the pharmaceutical industry to have protection in a system not designed to balance incentives for innovation and anti-competitiveness, the pair say.
“One of the points of our project was to get the detailed data and information that illustrates those points—it’s about creating the evidence base for New Zealand policy, which doesn’t otherwise exist.”
Professor Frankel and Professor Lai used a team of Te Herenga Waka research assistants to analyse data from four pharmaceutical jurisdictions: New Zealand, the US, the EU/UK, and Australia.
“We examined policy statements, legislative changes and developments in case law in each jurisdiction to find out how patent standards had strengthened over the last 30 years, and how the development of biologics [pharmaceuticals derived from living organisms as opposed to chemicals] has impacted the pharmaceutical industry’s use of the patent system to incentivise innovation,” says Professor Lai.
“The aim was to unravel the behaviour of pharmaceutical companies, and look at how that plays out in New Zealand,” says Professor Frankel.
We import most of our medicines, so it’s crucial for policymakers to get a better understanding of the way the industry is being gamed so that they can ensure our domestic settings actually help bring pharmaceuticals to the public at a cheaper price.
Professor Frankel and Dr Lai have a long track record of collaboration over the years, including co-authoring Patent Law and Policy in 2016. Their Marsden-funded research into the mission creep within the pharmaceutical industry has involved preparing publications, speaking at international conferences, and hosting a symposium on the topic.
“I've always been interested in why and the way that pharmaceuticals are patented—pharmaceutical cases drive a lot of the framing of patent law because it’s a sector that uses patents a lot. So when the pharmaceutical industry starts to say, ‘the patent system isn’t working for us’, that raises challenging issues,” Professor Frankel says. “I also do a lot of work around trade agreements and intellectual property—confidentiality of information within the regulatory system and extending patent law so it covers more things for a longer period of time, are heavily negotiated aspects in New Zealand’s trade agreements. So, for me, this project has been a nice confluence of all those areas.”
Te Kauhanganui Tātai Ture: Finding purpose through a shared community
This year, as always, my brilliant colleagues have produced world-leading research, taught over 2000 extraordinary students, and engaged widely to make Aotearoa and the world a better place. I know of no law school with fewer than 30 academic staff and as many students that manages such excellent teaching and research. Our equally amazing professional staff have done an extraordinary job in not just keeping things working but also making students’ lives just a little easier.
Our students are our future, and I tell them they are better versions of us—in some of the tough times this year, it is they who have helped us get through. I am constantly amazed at what our students get up to after they leave here, and just sometimes I like to claim a little bit of the credit that properly belongs to you!
But Tātai Ture is not just made up of those lucky enough to work or study here in the Old Government Buildings (OGB)—it is made up of all of you, wherever and whenever you get to read this.
We have decided to do V.Alum a bit differently so we can tell stories from within and from outside OGB. Please take a few minutes to read about our wonderful research, student leaders, and the achievements of some of our alumni.
The last couple of years have been unsettled for Te Herenga Waka, and I suspect that the next couple will be challenging for all our universities. The Law Faculty, however, has continued to be a thriving part of a university that is beginning to flourish again. We have five new academic staff who either have just started with us or will soon be here for us to nurture—emerging scholars in international trade, intellectual property, and comparative constitutional law; a leading mergers and acquisitions scholar from the US; and a new Professor of Public Health.
I am still getting used to working in the Dean’s office. Being Dean of the faculty that I have worked in for 30 years is a privilege and an honour but also, to be honest, a bit daunting. I have been amazed by all the goodwill and offers of help that I have received. I genuinely believe that despite the challenges 2025 will bring, we really can build an even better law school for our community. Priorities for next year include emphasising our links with the main University, joining with our friends across Bunny Street in Wellington School of Business and Government to create a unique Pipitea experience at the heart of our capital, emphasising the ‘place-based’ experience of learning law at VUW, and working to raise Pasifika achievement. Next year also is the first year of the new integrated tikanga curriculum that all students will study—we can’t wait to get started.
If we can do all this, it will be in no small part due to the tireless work of my predecessor, Lee Godden, who worked harder than any person I have ever known at the Law School. Lee had to return to Australia in August to care for whānau, but not before she had secured the funding for our new appointments.
It is summer, at least for those in Aotearoa. Just before Christmas, I will be in one of my happy places, Fiordland, walking the Kepler Track with my best man (whom I met in second-year law) and his family. On my to-do list are reading all the books that I missed out on during the year, fighting the ivy in our garden, and mostly just sitting in the sun—which is guaranteed this Wellington summer. I hope to finally make it in February to the top of Angelus Peak in Nelson Lakes. I also plan to catch up on some of my colleagues’ excellent research (really truly!)—you should too! Pick something from the list—it is all great.
One book I’m currently learning a lot from is Zest, written by my old torts student Daniel Kalderimis KC, who courageously writes about his recovery from depression, with the help of not only psychology but also philosophy. Daniel’s book is not so much about how to do law but is a lot about how we should choose to be more purposeful in those things that give us meaning. Daniel reminds me, though, that law is all about the narratives that connect people. Outside my family and friends, it has also been this university and our shared law community that have given me a sense of purpose and meaning. So I can’t wait for 2025.
Whiti te rā
Geoff