NZ missing out on innovation
New Zealand could be missing out on earning over NZ$200 million per year because we lack a comprehensive strategy to support clinical trials, the Researched Medicines Industry Association says.
In its submission to the health select committee inquiring into improving New Zealand’s environment to support innovation through clinical trials, the drug industry group says many countries recognise the economic, health and scientific benefits of clinical trials, and actively compete to attract this research.
For New Zealand to figure in this, the group says a competitive environment and clear strategy is needed – including tackling numerous difficulties faced by the research community – before New Zealand can become a destination for international clinical research investment.
The RMI submission represents the views of its member companies and follows consultation with clinicians involved in running clinical trials in New Zealand and some patient advocacy groups.
Although containing only a fraction of the world’s population, the RMI says Australia contributes 3% of global medical research. With a similarly well-trained health workforce, similar patient-doctor ratios, and an efficient clinical trials infrastructure, “New Zealand should aspire to producing a similarly scaled body of research”.
A level of research in New Zealand similar to that in Australia in 2007 (adjusted for population size) would result in an annual spend of NZ$223.6 million at current exchange rates, RMI chief executive Denise Wood says in the submission.
The RMI recommends improving the speed of application processes to allow rapid start to trials, developing a critical mass of experienced clinical trials staff, establishing a trials infrastructure, formulating sustainable tax incentives and developing improved relationships with the pharmaceuticals industry.
Earlier, medical researcher Shaun Holt, in an article published in the New Zealand Herald last year, had labelled the country’s ethics system “unethical” for being unwieldy and, thereby, restraining innovation.
“The process has grown into a hugely complicated bureaucracy that has lost touch with its original aims,” Dr Holt was quoted as saying.
The article was subsequently rebutted by Tim Dare, who claimed our health ethics committees are up with world standards.
But health select committee chair Paul Hutchison says Dr Holt may have a point in the wider context.
“As a country that spawned and then lost Glaxo, which became one of the world’s largest pharmaceutical companies (GlaxoSmithKline, with a yearly revenue of $75 billion dollars), New Zealand should be aspiring to create conditions where clinical trials, pharmaceutical innovation and manufacturing can thrive,” Dr Hutchison says.
“Speak to the founder of Douglas Pharmaceuticals and he will describe the enormous regulatory obstacles that he has had to encounter. There is huge room for improvement and huge opportunity. This is all about brains and low volume, high value products.”
Citing the example of Singapore, Dr Hutchison says only 40 years ago New Zealand was giving aid to the city state, which is now developing significant clinical trial capabilities, and has aligned to that a substantial pharmaceutical industry worth billions of dollars yearly.
“Singapore’s top university (19th in world ranking) and their extraordinary ‘Biopolis’ are indications it is vital we must support world-class research here in New Zealand if we are to have any hope of keeping up,” he says.
“Any changes to our ethics committee system in New Zealand should be all about vigilantly maintaining and improving quality, as well as introducing practical common sense, to ensure the system is efficient and reflects the degree of risk associated with the trial.”
Eminent scientist Sir Peter Gluckman, in his briefing to the select committee, said New Zealand is unlikely to be a significant player in large scale phase 2B and phase 3 research because of our small population base, made effectively smaller by the scientific need to control for ethnic diversity.
While the governments of Australia, Denmark, Ireland, Singapore, the UK and US spend much more than ours on medical research per capita, Sir Peter says the discrepancy is made worse by charitable trusts in the UK, US, Australia and the EU.
“Furthermore, there are other limitations. Our hospitals do not have access to large amounts of the high technology equipment, such as magnetic resonance spectroscopy, PET scanning and metabolic essays, which are increasingly being used in clinical physiology and phase 1 and 2 studies….In Singapore, access to such infrastructure is a point of attraction together with building an environment in which the ecology of doing such research can flourish.”
However, Sir Peter says, where New Zealand could and should be particularly strong is in the area of clinical physiology.
“Clinical proof of concept studies are increasingly seen as an accelerating variant on phase 1 and phase 2A studies,” he says.
“New Zealand is also competent to undertake phase 2B studies of a smaller scale, and clearly we have the capacity to undertake phase 1A proof of concept studies.”
According to him, a further issue is the lack of focus of the hospital system and failure to see it as a source of innovation for new knowledge and economic drivers.
Comparing the New Zealand hospital system with the UK’s National Health System, Sir Gluckman says the development of NHS innovations London Ltd has meant the combined innovation capacity of the nurses, doctors and other health professionals in London hospitals has been leveraged into an environment which is positive for supporting a wide variety of innovative outcomes out of the health service, including clinical trials, new technologies, new software and a number of other exploitable developments.
“This has been highly successful and discussions have started as to whether there are lessons to be learnt for the New Zealand health system from the UK experience,” he said.
While insisting his experience with New Zealand’s regulatory framework was no different from what one would expect in Singapore, Sir Peter said the only issue that may exist is the need for multiple organisational approvals over relatively small geographical distances.
“I think the major impediment to improving clinical trials in New Zealand is fundamentally one of changing New Zealand’s culture to see science and innovation as being at the forefront of New Zealand’s growth.”
Sir Peter suggests the Health Research Council Act and priorities be reviewed to encourage research in ethnic-specific clinical trials. He says the country’s ethnically diverse population means we are able to compare people of European, Pacific and Asian origins in the same clinical trials.
“Finally, I think the National Health Board should be encouraged to consider arrangements that would foster an innovation-focused environment.”
The health select committee will collate the responses before handing over its recommendations to the Government.
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