Australia has, for decades, been a leading nation in medical advances and the health industry. In the last several years we’ve seen this trend continue with Australian health startups leading the way in innovation and commercialisation. Our team at Allied Legal has worked with countless health startups along their journey. This article sets out some of the challenges, regulations, and opportunities that Australian health startups should look out for.
Therapeutic Goods Administration:
The Therapeutic Goods Administration (TGA) is responsible for regulating therapeutic goods throughout Australia. The TGA has a wide reach in Australia due to the broad meaning of therapeutic goods, which generally includes products used by people which helps, prevents, or impacts their physical or mental health.
TGA’s reach grew for startups in February 2021 when TGA’s reach was broadened to include regulating software that meets the definition of a medical device. The TGA has itself noted that regulating digital devices comes with a level of difficulty and complexity. Whether your software constitutes a medical device will come down to the strict application of the law to the specific functionality of your software.
Privacy and Data:
Australia’s privacy regime is broadly governed by the Privacy Act 1988. Generally speaking, the Privacy Act only applies to businesses that generate a revenue of $3m or more on an annual basis. There are, however, exceptions to this rule, including that the Act applies to small and medium businesses that provide a health service. This includes services that:
- Diagnose or treat an illness or disability;
- Assess, maintain or improve an individual’s physical or psychological health;
- Manage an individual’s health;
- Record an individual’s health to assess, maintain, improve or manage it.
If your startup provides services that may be included in the above list, then there is a good chance that your business falls under the scope of the Privacy Act. This imposes requirements on your business as to the collection, use, storage, and treatment of personal information. For startups that operate SaaS or other software based services, these requirements should be taken seriously, as there is a good change that you will be collecting some degree of personal information from your customer base.
If you are a health startup, we strongly recommend consulting with a legal practitioner to determine whether the Privacy Act applies to your business before going to market, so that you are confident that any collection or use of personal information is compliant with Australian law.
Grants Available to Health Startups:
Biomedical Translation Bridge (BTB)
The BTB is part of the Medical Research Commercialisation initiative, and aims to develop new treatments, drugs and devices to improve and innovate within the Australian health space. It provides funding for early-stage health and medical research to assist eligible organisations to commercialise their findings. Eligible applicants for BTB funding can receive up to $1,000,000 in matched funding for their research or project. The BTB program is intended to fund projects to support:
- The commercialisation of early-stage research into innovative medical devices, therapies, or procedures.
- The accelerated development or research that has the potential to be commercialised, with the ultimate goal of transforming the research into a product that will improve the health sector and the Australian economy.
- Procuring capital from existing and new sources of investment.
VicHealth
The Victorian Health Promotion Foundation, or VicHealth, is a government funded organisation that provides programs, support, and funding to improve Victoria’s health state-wide. As well as providing community programs and events, VicHealth provides funding to a wide range of health initiatives. Its latest round of funding, Reimagining Health: A VicHealth Grant, saw funds go to more than 700 organisations to promote physical and mental health in their communities. The successful applicants for this round of funding were announced on 15 June 2021. While there are no grants currently open at VicHealth, it has run some 30 grants in the last 6 years alone, so this is definitely a space to watch for more opportunities.
CSIRO Kick-Start
Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO) Kick-Start program matches funding for founders seeking to scale their startup. The grant enables Australian startups to undertake research to test a novel product, or to develop or improve an offering. Through the scheme Australian startups are eligible for between $10,000 and $50,000 in funding under a key few provisions.
Accelerators for Australian Health Startups:
Australia is also home to some leading health accelerators. These accelerators provide mentoring, tutelage, and commercialisation support to health startups nationwide:
ANDHealth
ANDHealth is a leading digital health accelerator based in Melbourne. ANDHealth’s mission is “to build a world-leading, integrated ecosystem for the development, commercialisation and implementation of evidence-based digital health technologies in Australia.” ANDHealth offers a variety of programs dedicated to accelerating the commercialisation of digital healthtech startups.
MedTech Actuator
The MedTech Actuator offers an accelerator to health startups in the Asia Pacific, which includes a 15 month elite program, hands on mentorship, an initial investment of up to $200,000, and lifetime access to MedTech Actuator’s network.
The BHx
The Bendigo Health Accelerator, or BHx, is the first regional health accelerator in Victoria. The program provides early stage health startups access to a state of the art digital hospital to validate and test their offerings, and helped accelerate their startups into the health sector. The BHx started in 2020, and is currently planning its 2021 program, so be sure to keep an eye on this space.
Need help? Contact us
At Allied Legal, we understand the challenges and opportunities that present themselves to health startups. We’ve worked with countless health startups and health practices over the years, so we know the landscape you’re playing in. If you need help with compliance, starting up, or just understanding the legal framework that applies to your business, give us a call on 03 8691 3111 or send us an email at hello@alliedlegal.com.au.
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