National Innovation and Science Agenda - Healthcare
The Australian Government's National Innovation and Science Agenda (the "Agenda") was announced on 7 December 2015.
Focusing on four key pillars: culture and capital, collaboration, talent and skills, and government as an exemplar, the Agenda has been developed 'to derive new sources of growth to deliver the next age of economic prosperity in Australia'1.
While the Agenda includes 28 initiatives, the following initiatives will be of particular interest to the Healthcare industry:
- a Biomedical Translation Fund will be created to co-invest A$250 million with the private sector in the commercialisation of biomedical research.
- a new independent body, Innovation and Science Australia, will be established with the responsibility for providing strategic advice on science, research and innovation matters.
- the Australian Research Council’s Linkage Projects scheme will be open to continuous applications to fast track highly competitive research and development projects.
- over the next 10 years, the government will provide A$2.2 billion in funding certainty for cutting-edge, national research infrastructure.
- there will be a A$61 million investment in programs to boost digital literacy and skills in science, technology, engineering and mathematics ("STEM") among young Australians.
- the introduction of a systematic national assessment to measure the economic, social and environmental impacts of university research.
- the introduction of new research funding arrangements for universities that have greater emphasis on research-industry collaboration.
Full details of the Australian Government's National Innovation and Science Agenda can be viewed here.
DoH - Expert review of medicines and medical devices regulation
In October 2014 the Department of Health ("DoH") announced that it would conduct a review of Australia's medicines and medical devices regulatory framework and processes. The objective was to identify any areas of “unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia”, and to identify any “opportunities to enhance the regulatory framework” to ensure that Australia continues to be well placed to respond to global trends relating to the “development, manufacture, marketing and regulation of therapeutic goods”.
The first report, made public in June this year, addressed the regulatory frameworks for medicines and medical devices. The report made 32 recommendations, including.
The introduction of new pathways by which sponsors can apply for marketing approval for a therapeutic good (including medicines and medical devices). Pathways could include:
- a sponsor submitting a dossier of information for de novo assessment. Responsibility for the assessment may be undertaken by the Australian National Regulatory Authority ("NRA") on its own, or in a work-sharing agreement with a foreign, but comparable, NRA where the sponsor may also be seeking to list a product;
- a sponsor submitting an un-redacted evaluation report from a comparable NRA, along with a copy of the dossier of information provided to that NRA. The Australian NRA will then consider the application and data within the Australian context; or
- a sponsor applying for expedited approval of a medicine in certain limited circumstances.
These pathways would be dependant on the DoH developing and applying transparent criteria which would enable them to identify comparable overseas NRAs.
- A comprehensive review of the entire legislative framework underpinning the regulation of therapeutic goods, including the Therapeutic Goods Act 1989 (Cth) and associated Regulations with a view to make them more accessible with a simplified structure and greater transparency.
- Consideration of organisational structures to facilitate the improvement and enhancement of post-market monitoring for safety, efficacy and cost-effectiveness.
The second report, made public in November, addressed the regulatory framework for complementary medicines and the advertising of therapeutic goods. The report made a further 26 recommendations including the following.
- Enhancing and streamlining the advertising framework to facilitate and maximise compliance by sponsor companies. This would include:
- that future requirements for advertising therapeutic products to the public are made consistent for all medicines and medical devices; and
- that that the whole process of vetting and pre-approval of advertisements to the public is stopped in favour of a more self-regulatory regime.
The DoH has undertaken a consultation with key stakeholders in order to consider the two reports and their recommendations. Following completion of the consultation, the DoH is now preparing a response document setting out how they anticipate actioning any or all of the recommendations. No time-frame has been set for publication of the response document.
Medicines Australia Code of Conduct Annual Report
The Medicines Australia Annual Report for 2014/2015 was published in October.
The report identified that since 2008-2009 (when the first Annual Report was published), the number of complaints received by Medicines Australia each year alleging breaches of the Code has fallen considerably. However, there has been a slight rise in the number of complaints received in the past year. In 2008-2009, Medicines Australia received 59 complaints of Code breaches. This fell to 18 complaints in 2012-2013, and to a record low of 10 complaints in 2013-2014.
This year the Medicines Australia has received 15 complaints. Of those 15 complaints, 6 were found to not constitute a breach of the Code and 9 were found to be in breach of the Code in respect of either some or all of the alleged breaches. Most complaints received were submitted by member companies and the Monitoring Committee, with five complaints each. Healthcare professionals submitted 4 complaints, whilst only one complaint was made by a member of the public.
The 15 complaints related to:
- Promotional Material – 6 complaints (4 upheld)
- Advertising – 2 complaints (1 upheld)
- Educational Events – 2 complaints (1 upheld)
- Conduct, invitation to receive hospitality, media releases, detail aid, and presentations – 1 complaint each (complaints upheld in relation to detail aid, presentation and media releases)
Of the 9 breaches of the Code which were upheld, 7 member companies faced financial penalties of less than A$45,000, whilst the remaining 2 companies faced fines in the range of A$90,000 - A$100,000.
New Zealand announces a new regulatory regime
The New Zealand Ministry of Health has announced that is it working on a new and comprehensive regulatory regime to regulate therapeutic products in New Zealand, which will replace the Medicines Act 1981 (NZ) and its Regulations. This follows the 2014 abandonment of the Australia New Zealand Therapeutic Products Agency project ("ANZTPA") which had intended to form a single regulatory entity to oversee therapeutic goods in both countries. ANZTPA was abandoned due to concerns about the costs, timing and benefits of implementation.
It is anticipated that a bill will be introduced to the New Zealand Parliament in 2016. To date, no further information has been published about the nature of the new regime, although the Ministry of Health anticipates that the regime will regulate all therapeutic goods, including goods which are not currently fully regulated, such as medical devices and cell and tissue therapies.