Pharmaceutical and medical devices
Our team has a unique combination of scientific, regulatory and legal expertise in prescription pharmaceuticals, OTC and complementary medicines and medical devices and this has made us the legal firm of choice for many Australian and global pharma and medical device companies.
We advise our clients about all aspects of the product lifecycle, including the protection of IP, clinical trials, marketing approval, product labelling and other regulatory obligations, reimbursement, approval and registration processes and associated administrative law remedies, promotion and distribution, product risk, product liability and product recall.
Retirement villages, aged care and disability services
With Australia's demographic changes, and the implementation of the NDIS, these sectors are becoming increasingly important. We go beyond the relevant Commonwealth and State legislation to the numerous regulations, principles, and policy documents affecting the industry, and the commercial structures through which it operates, to give you advice that covers regulatory issues, commercial issues, and mergers and acquisitions.
Health sector regulation and governance
We act for hospitals and health services in the public and private sector, and for government policy-makers, funding providers and regulators, in relation to a wide range of regulatory and governance issues affecting the health sector. Our work includes:
- advising on regulatory requirements and governance obligations;
- developing standards, by-laws, policies and contractual provisions to ensure safety and quality of services;
- carrying out, or advising on, reviews, inquiries and investigations;
- challenging and defending registration and similar decisions; and
- advising on structures and processes for managing clinical and organisational risk.
With senior lawyers who have worked for government in the health area, we can draw on a sophisticated understanding of the special environment government healthcare operates in. We give practical, robust advice to Local, State and Federal Governments, including on the interaction between State and Territory legislation and relevant Commonwealth legislation. Our work includes regularly advising senior public servants heads and Ministers on critical issues affecting the health system, drafting health portfolio legislation (including private health insurance), pharmaceutical benefits and aged care, and working with agencies involved in the procurement, funding, oversight or regulation of health services.
Health and private health insurance
Clayton Utz has extensive experience in the full range of services required in the health and health insurance industry. For example, we've advised extensively on compliance issues, commercial agreements, mergers and acquisitions, privacy and governance issues. We also have a significant medical indemnity practice , and have acted for or advised medical defence funds, private health insurers, public sector health insurers and health service providers on medical negligence and claims.
Biotechnology companies come to us for advice on a broad range of issues, such as commercialisation, intellectual property, mergers and acquisitions, regulatory compliance, fund raising and product-related issues.
Pathology and diagnostic imaging
We have extensive experience in advising on the full range of matters relevant to the pathology and diagnostic imaging sectors including leasing, privacy, Medicare-eligibility under, and compliance with the anti-kickback provisions of, the Health Insurance Act, service agreements, mergers and acquisitions and structuring.
Health information and privacy
Our privacy and data protection practice includes senior lawyers with experience in the full range of information issues that specifically affect the health sector, including: management of medical records, e-health and health identifiers, use of information by clinical registries and surveillance systems and obligations relating to open disclosure, mandatory notification and requests for information from health regulators and complaints bodies.
We've acted in many major health infrastructure projects, including hospital construction redevelopment, public private partnership procurement of hospital facilities and services, co-location of public and private health services, and commercial developments within hospital precincts and associated leasing.
Hospital and health services operators
We have extensive experience in advising on the full range of legal issues relevant to private hospital and health services operators, including regulatory and licensing issues, mergers and acquisitions, dispute resolution, strategic partnerships and joint ventures, outsourcing and procurement and general contracting arrangements. Our experienced lawyers remain at the forefront of industry and legal trends and developments in these areas.