12 April 2018
Australia’s strong economy, skilled and multilingual workforce, diverse population and robust system for the protection of intellectual property make it an ideal location for conducting clinical trials.
Each year, around 1000 new clinical trials are commenced in Australia from phase 1 (first human trials) through to phase IV (post-market trials) for medicines and medical devices.
This article details five of the key advantages of conducting a clinical trial in Australia, and offers information about the requirement for clinical trials conducted in Australia to have an Australian ‘local sponsor’. The five key advantages are as follows:
1. Internationally recognised standards
The Australian Therapeutic Goods Act 1989 (Cth) requires trials of unapproved medicines or medical devices conducted in Australia to be carried out accordance with internationally recognised standards of Good Clinical Practice, including the standards of conduct developed by the International Conference on Harmonisation (ICH).
As a result, data from clinical trials conducted in Australia is generally viewed with confidence by international regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
2. Efficient regulatory processes
Australia has a streamlined regulatory process for the approval of clinical trials. Most clinical trials in Australia are conducted under the Clinical Trial Notification (CTN) scheme. Under the CTN scheme, all materials relating to the proposed trial are submitted directly to a Human Research Ethics Committee (HREC) for assessment. The HREC is solely responsible for assessing the scientific validity of the trial design and the safety and efficacy of the trial protocol and the medicine or medical device being tested.
To avoid duplication, the Australian Therapeutic Goods Administration (the Australian equivalent of, for example, the Indian Central Drugs Standard Control Organization, the US FDA and Japan’s Pharmaceutical and Medical Safety Bureau) does not review materials relating to the proposed trial, and is simply notified of the clinical trial once the trial has received ethics and site approval.
Generally, the approval process for a clinical trial in Australia takes between four and eight weeks. There are currently more than 200 HRECs across Australia. Many Australian univeristies and hospitals that carry out medical research have established their own HRECs. In addition, to streamline recruitment processes, participants in clinical trials in Australia can give written informed consent and there is no need for this consent process to be audio visually recorded.
3. Government investment and support
The Australian Government is currently conducting a number of significant projects to identify and address barriers to conducting clinical trials in Australia and boost patient recruitment. For example, the Australian Government has recently introduced a new legislative scheme to allow for accelerated public access to new medicines in Australia prior to the completion of a clinical trial’s collection of data, where the medicine is likely to provide a substantial benefit for Australian consumers.
In addition, the Australian Government has established a Research and Development (R&D) Tax Incentive Program which provides companies (including some foreign companies with a permanent establishment in Australia) with a tax offset in respect of expenditure previously incurred on eligible ‘R&D activities’ (including certain clinical trial activities) carried out in Australia. The program has two core components:
4. Industry approved standard form contracts
Medicines Australia (an industry body representing the discovery-driven pharmaceutical industry in Australia) together with the Health Departments of a number of Australian States, has developed template clinical trial research agreements for engaging Australian institutions to carry out clinical trials (including template indemnity documents).
Medicines Australia has designed these template documents to be ‘fair and reasonable to both sponsors and institutions and provide certainly of application in the commercial trial environment’.
The template agreements have been widely adopted by the clinical trial industry in Victoria, New South Wales, Queensland and South Australia, streamlining the negotiation process between sponsors and institutions in these States.
Further, in order to reduce uncertainty around the cost of conducting clinical trials in Australia, and to streamline the negotiation of project budgets, the Australian Office of the National Health and Medical Research Council (NHMRC) has prepared a list of standard costs associated with conducting clinical trial activites in Australia.
The NHMRC list of standard costs, which sets out the ‘typical’ costs involved in each activity in a clinical trial, is intended to provide an authoritative reference point for pricing negotiations between the funder of a clinical trial and the Australian health provider conducting the trial. Together with the Medicines Australia standard form contracts, the standardised list of costs should assist overseas funders of clinicial trials to streamline negotiations with Australian clinical trial sites.
5. Willing and informed participants
The Australian National Survery into Attitudes towards Clinical Trials, conducted in 2012, revealed a significant willingness amongst the Australian population to participate in clinical trials. The survey also revealed that the vast majority of people surveyed were familiar with the concept of a clinical trial.
The Australian Government is underaking a number of initiatives to encourage patient recruitment, including the creation of websites and guides designed to help participants understand the risks and benefits of participating in clinical trials in Australia. The Australian Government is also taking several steps to futher streamline and improve the ethics review process.
All clinical trials conducted in Australia must have an Australian ‘local sponsor’. The role of the local sponsor is to ensure that clinical trials are conducted in accordance with internationally recognised standards of good clinical practice. The local sponsor for a clinical trial is also responsible for liaising with the Australian Therapeutic Goods Administration and ethics committees in relation to the trial.
The local sponsor can be an Australian individual (such as a medical practitioner) or an organisation (such as a hospital, pharmacuetical company or contract research organisation). An overseas company or non-Australian individual cannot act as the local sponsor of a clinical trial in Australia.
For those overseas pharmaceutical companies who do not have Australian partners or subsidiaries that are able to act as the ‘local sponsor’ of a clinical trial, a number of Australian contract research organisations are willing to take on the role of local sponsor for a clinical trial, for a fee.
Corrs is experienced in advising on the conduct of clinical trials in Australia, including negotiating the engagement of local contract research organisations to act as ‘local sponsors’ on behalf of overseas companies. Please contact us using the details listed to the right if you would like to discuss further.
The content of this publication is for reference purposes only. It is current at the date of publication. This content does not constitute legal advice and should not be relied upon as such. Legal advice about your specific circumstances should always be obtained before taking any action based on this publication.