I’m at the NZBio conference in Auckland over the next couple of days, so in a good position to see what is preoccupying the country’s biotechnology sector.
One simmering issue has already been aired – the ad hoc and often ineffective way we approach conducting clinical trials of drugs and treatments in New Zealand. According to scientists, “big pharma” representatives and the chair of the health select committee, National MP Dr Paul Hutchison, our approach to clinical trials threatens to see us lose out to other countries that are better serving companies that want to test their drugs and treatments.
Click here to listen to a podcast of the discussion on clinical trials in New Zealand at the NZBio conference today…
This issue is currently the subject of a select committee inquiry which Dr Hutchison said is due to report back in the next couple of weeks. He didn’t reveal the recommendations the committee will make, but the tenor of his speech suggested some quite sweeping changes to the way clinical trials are undertaken in New Zealand will be put forward.
New Zealand is good at doing small, complex clinical trials. We are reasonably priced, we have robust ethics oversight and good researchers.
So, what’s the problem with clinical trials? Well, according to Hutchison, the value of clinical trials completed in New Zealand is going backwards – from $100 million a decade ago to between $20 – $40 million today. That is very concerning, because hosting clinical trials has very positive spin-offs. It bolsters R&D infrastructure meaning other health research efforts benefit. That includes build up a skilled health research base and international linkages with drug companies that leads onto more work. In comparison to New Zealand, phase I – IV trials undertaken in Australia are worth $450 million a year in direct foreign investment.
Other countries, such as Singapore and South Korea have streamlined their infrastructure and injected public money into clinical trials to attract more business. As a result, the number of clinical trials undertaken in South Korea has increased by 240 per cent since 2005.
Why isn’t New Zealand stealing a good share of this business? Apparently our ethics committee approval needs to be more efficient and faster. There needs to be less bureaucracy, a better focus on research among the DHBs and above all, a higher level of spending on health research from central government. – apparently we spend a third of what the Australians do on health research.
Jan Campbell, medical director for the New Zealand arm of major drug company Roche spoke frankly about the frustrations drug companies face in undertaking clinical trials in New Zealand, though was gave high praise at the same time. Unfortunately there is no central way of negotiating contracts for these trials she said, so deals have to be struck with individual DHBs. There are 20 DHBs so that’s potentially a lot of negotiating that has to go on. The Government has no national health research action plan, added Campbell.
The result is “ad hoc contracting, fragmented governance and short term relationships”.
Campbell’s view is that New Zealand really needs to focus on an area of health research and invest in it. This will then draw the interest of drug companies when they decide where in the world to base their clinical trials. She suggested for instance, that New Zealand could become a global leader in researching metabolic diseases – such as type 2 diabetes. The infrastructure that evolves to support trials in this area could then support other areas of health research.
Drug development model “unsustainable”
Matt Kepple, managing director of Primorus, which runs early phase clinical trials, said that updated figures suggest the total cost of taking a new mass market drug through to commercialisation is US$1.6 billion. Typically the process takes 12 – 15 years. Some 70 per cent of trials conducted in the US are delayed by 1 – 6 months. In Asia Pacific, which includes New Zealand, only 45 per cent of trials are delayed. Delays are serious, because they eat into the time covered by drug patents during which time a drug company has exclusivity on selling the drug.
The single largest cost in the research and development of a new drug is the clinical trials that must be carried out. Therefore, companies are looking to shave their costs by conducting trials in lower cost countries – such as those in Eastern Europe or Africa.
Campbell said the current method of taking a drug to market was unsustainable due to the huge cost involved and would result in a change in the way drugs are developed – though she didn’t elaborate on what would change.
However, University of Auckland PhD candidate Michelle Lockhart, who has studied in depth* how clinical trials are conducted in New Zealand. says the changing situation could play into New Zealand’s hands:
Globally the traditional model of drug development is changing and the large pharmaceutical companies are looking externally for innovative compounds, new technologies and cost-effective drug development services.New Zealand (NZ) can capitalise on its expertise in innovative drug discovery and development but needs to be able to define and promote its capabilities to the global drug development industry.
New Zealand for its part is particularly well suited to clinical trials in the area of immunology and treatments related to the central nervous system.
So there’s plenty of opportunity to follow Australia’s lead and really target the market for clinical trials. But structural changes need to happen to develop a more cohesive approach to clinical trials. Hopefully the select committee report will suggest some decent action steps that can be quickly taken up by the health sector, scientific institutions and drug companies.
* Lockhart, New Zealand Medical Journal, 25 June 2o10