We provide cutting-edge advice for healthcare and life sciences innovators on the full spectrum of regulatory and commercial issues inherent in transactional and contentious matters.
JWS advises an extensive list of leading clients, including biotechnology, medical device developers and suppliers, medtech and pharmaceutical clients. We have deep industry expertise to help clients navigate these heavily regulated industries with specialist advice that tailors to the concerns of emerging technological and commercial needs.
We assist clients in commercialising bioscience products in Australia, from supporting with clinical trial documentation to guiding clients on the compliant promotion and advertising of therapeutic goods. We are seeing huge growth in software as a medical device, as the line between technology and healthcare becomes blurred with the use of AI in products. Our regulatory team handles privacy and health records issues, ensuring patient consent and managing data breach obligations. We provide an integrated service, with our regulatory, commercial, tax and dispute resolution teams collaborating to advise our clients.
We represent life sciences businesses from emerging businesses right through to established global players, including Blackmores, Boehringer Ingelheim, BSN Medical (Essity), CurveBeam Al, Johnson & Johnson, Life Healthcare, Ramsay Health Care, St Vincent's Health Australia and Teva Pharmaceuticals.
Work highlights
Boehringer Ingelheim Australia
- a wide variety of regulatory matters including advice in relation to the Therapeutic Goods Act, the National Health Act and the poisons legislation
- drafting a variety of commercial agreements including research and collaboration agreements with hospitals, foundations, universities and medical research institutes, transport agreements, warehousing agreements, manufacturing agreements and supply agreements
- pricing and rebate arrangements, price disclosure regimes under the National Health Act and listing of medicines on the Pharmaceutical Benefits Scheme
- advertising requirements and regulations related to human pharmaceuticals and animal health, and
- privacy compliance and medical records obligations.
CurveBeam AI
Drafting various agreements, including:
- product collaboration agreement for medical devices and medical scan analysis software (included related cross-licences)
- medical device placement agreement for use with institutions
- terms and conditions for supply of scan analysis software as a service, and
- agreements with various universities.
Global pharmaceutical company
Negotiation of its agreement with the Australian Government for the establishment of an mRNA vaccine manufacturing facility in Australia and the supply of vaccines from that facility; negotiation of the 2021 vaccine supply contract with the Australian Government; and incorporation of local subsidiary and regulatory advice.
BSN-Medical (Essity)
Therapeutic Goods Act compliance and the termination of distribution arrangements, drafting commercial contracts, and co-ordinating an Australian compliance program, including consumer protection and privacy.
LifeHealthcare
Regulatory compliance for therapeutic goods, medical devices and medtech products; advising on pricing and rebate arrangements; drafting various agreements including manufacturing and distribution agreement, purchase agreements and patient consent forms; managing and handling disputes related to manufacturing and distribution; providing privacy audit and ongoing privacy advice, including on health records regulatory obligations.
Alessa Theraputics, Inc.
Clinical trials in Australia. This involved: reviewing offerings from potential CROs and then in the negotiation and drafting of a CRO services agreement with the preferred CRO; advising on the requirements for clinical trials in Australia, including the template clinical trial agreement; and drafting an inter-company agreement for the conduct of clinical trials.
