First-call for healthcare and life sciences business.
JWS advises an extensive list of leading Australian and international health and life sciences clients, including biotechnology, medical device developers and suppliers, and pharmaceutical clients on the full spectrum of regulatory and commercial issues inherent in transactional and contentious matters.
Our cross-disciplinary teams, including regulatory, IP, technology and privacy, work seamlessly to provide legal solutions for businesses operating within a highly regulated field. We have a depth of experience in contracting with Federal and State government departments, which assists our clients with registered or listed products.
With our deep industry expertise, we represent life sciences businesses from emerging businesses and startups, right through to established global players, on a plethora of matters. We have represented numerous health and life sciences clients, including Blackmores, Boehringer Ingelheim, BSN Medical (Essity), CurveBeam Al, Johnson & Johnson, Life Healthcare, Ramsay Health Care, St Vincent's Health Australia and Teva Pharmaceuticals.
We assist clients at all levels in their journey to commercialise bioscience products in Australia. We also assist clients with the documentation required for running clinical trials and clinical investigations in Australia, including clinical trial agreements, agreements with clinical research organisations, patient consent forms and advice in relation to indemnities and liability. We also advise established clients in relation to permitted promotion of therapeutic goods in Australia in compliance with Medicines Australia's Code of Conduct and other relevant codes. Our regulatory team assists with related privacy and health records issues, including requirements for patient consent and data breach obligations. Our regulatory and commercial teams often work closely with our tax team in ensuring that contracts correctly reflect the chosen tax status of arrangements.
Clients rely on our breadth and depth of knowledge to solve their most significant challenges across technology and privacy issues. We extensively support businesses in heavily regulated industries – such as life sciences and healthcare technology – with specialist advice regarding private and publicly listed companies, government entities and not-for-profit organisations. Our technology and privacy team is experienced, responsive and alive to the requirements of businesses operating with technological, communication and innovation pressures. We are seeing huge growth in software as a medical device, as the line between technology and healthcare becomes blurred.
Our lawyers have a deep understanding of the legal, regulatory and commercial pressures affecting clients in the healthcare and medical research sectors. We act for both major acquirers and suppliers of technology, meaning we know the baseline negotiating positions of major technology suppliers and are able to bypass protracted negotiations, which results in lower legal costs. We regularly advise clients on the convergence of technology and data across a number of sectors – including the healthcare sector – creating new business opportunities through emerging and data-driven technologies.
Advising in relation to a wide variety of regulatory and commercial matters related to its human health business, including: assistance regarding research and collaboration agreements with hospitals foundations, universities and medical research institutes; its animal health arm in relation to the regulation of advertising and promotional material that can be provided to veterinary surgeons; and on privacy compliance and medical records obligations.
Assisting with the 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.
Drafting various agreements, including: product collaboration agreement for medical devices and medical scan analysis software (included related cross-licences); a 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.
Advising on ICT procurement and contracting, clinical and facilities management services arrangements, health regulation and funding arrangements, research and development, and intellectual property protection and management.
Advising on 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.
Providing privacy audit and ongoing privacy advice, including on health records regulatory obligations.