New Zealand needs to act swiftly to streamline its ethical review process, promote co-ordination in clinical research, develop a national framework for trials through District Health Boards and formulate a National Health Research action plan to foster innovation and commercialisation if it wants to compete internationally as a centre for clinical studies, a parliamentary select committee has urged.
These were among a long list of recommendations in a Health Committee report looking at ways to improve the environment for clinical trials in New Zealand. It comes against a backdrop of declining revenues from clinical trials, increasing competition from countries in the Asia Pacific region that offer favourable conditions for research (e.g., South Korea, Hong Kong, Singapore and Taiwan) and in particular the relative boom in Australia’s clinical trial sector.
“By contrast with the most optimistic estimate of New Zealand’s income from trials,” the report states – estimates of current annual revenue range from $12 million to more than $45 million, compared with over $100 million from medicines alone 10 years ago – “Australia has a clinical trial industry with an annual value of AU$450 million from clinical trials of pharmaceuticals alone”.
This “significant reduction in the value of the New Zealand clinical trial industry is indicative of a weakening competitive advantage”, the report warns, noting also the particular importance to New Zealand of a thriving bioactive and functional foods sector, products that are “likely to be subject to more demand for proof of their efficacy and safety from clinical trials”.
Health Committee enquiry
The Health Committee launched an enquiry into the NZ clinical trial environment in February 2010, pointing out that the Australian government had set up an ‘action group’ to cement the country’s status as a destination of choice for clinical studies. The New Zealand government has until 6 September 2011 to respond to the Health Committee’s report.
Evidence submitted to the enquiry indicated that “the ethical review process [for clinical trials] was too slow and bureaucratic, there was a lack of co-ordination between New Zealand’s District Health Boards, friction between Pharmac and pharmaceutical companies, and investment into science research and development did not reach international benchmarks”, commented Health Committee chair and National Party MP Dr Paul Hutchison.
The committee wants to see its key recommendations, which were generally welcomed by the pharmaceutical industry in New Zealand, acted on within 12 months. It believes the main elements of the existing system for clinical trials “can be put right at almost no cost”, while “the returns for New Zealand patients, the health service, and the economy will be significant”.
If the committee’s recommendations are taken up by the government, Dr Hutchinson added, “we would also expect to see improved retention of key staff”.
The key recommendations in the Health Committee’s report on the Inquiry into improving New Zealand’s environment to support innovation through clinical trials include:
– Simplifying and streamlining the ethical review process, while ensuring that patient safety remains paramount.
– Establishing a strong collaborative framework between the Ministry of Health, the Ministry of Science and Innovation, the Ministry of Economic Development, and New Zealand Trade and Enterprise to co-ordinate and promote as efficiently as possible clinical trial activity in New Zealand.
– Ensuring a culture that values research is embedded in the New Zealand public health system through a national health research action plan, to be developed by the Ministry of Health, the Ministry of Science and Innovation, the Ministry of Economic Development, and New Zealand Trade and Enterprise, and to be implemented by a single agency such as the National Health Board.
– Establishing a national framework for clinical trials through District Health Boards.
– Working to build constructive, professional and transparent relationships with the international biotechnology and pharmaceutical industry, “through innovative mechanisms that do not undermine [the drug reimbursement agency] Pharmac’s role of purchasing pharmaceuticals at the best possible value”.
– Ensuring the scientific infrastructure to run high-quality clinical trials.
Industry response
The industry association Medicines New Zealand, which represents the country’s innovative pharmaceutical companies, welcomed the report, saying the Health Committee had “correctly identified the sense of urgency required if this country is to retain a competitive edge in clinical research”.
It backed the recommendations to build constructive and transparent relationships between government and industry and to improve the efficiency of the ethics system.
Developing a national framework for clinical trials through District Health Boards (DHBs) is “essential to the success of any research initiative”, commented Kevin Sheehy, general manager of Medicines New Zealand, adding: “If New Zealand is to become acknowledged as a high quality destination for research investment, we should aim to deliver consistent quality and timeliness across all DHBs”.
The industry association also strongly supports the recommendation that any research infrastructure set up in New Zealand “should be made available to as many institutions as possible, ensuring that all research centres are enhanced equally through any government funding”.
Major asset
Clinical research infrastructure “is a major asset to countries that use clinical research to improve healthcare and supplement funding streams”, Sheehy pointed out. “It is essential that the system accurately accounts for these income streams and allocates a portion of them to be reinvested in maintaining and enhancing research infrastructure.”
Medicines New Zealand feels the report’s recommendations could have gone further, though, in recommending that a single government agency or ministry should be charged both with developing and implementing the proposed national health research action plan.
“Currently there are at least four agencies that have some oversight of research and ensuring collaboration is likely to be difficult at best,” Sheehy said. “There is a real risk that responsibility for delivery of the initiatives will fall into the gaps between these agencies.”
The Health Committee report can be accessed online at http://www.parliament.nz/en-NZ/PB/SC/Documents/Reports/e/8/2/49DBSCH_SCR5154_1-Inquiry-into-improving-New-Zealand-s-environment.htm.
