Expert Life Sciences & Healthcare Lawyers

Life Sciences law covers a broad range of matters related to the development, production and distribution of medical devices, pharmaceuticals, and biotechnological products. It helps ensure the safety and efficacy of medical technology. Healthcare lawyers require extensive knowledge of the regulatory entities and relevant laws.

If you are looking for a Healthcare & Life Sciences law firm in Sydney, or for further information in relation to Life Sciences & Health Care, contact any member of our Commercial Law Team.

What To Expect From A Life Science Lawyer

The pharmaceutical, biotech and medical devices sectors have been impacted by a changing global landscape. Increased governmental regulations, new medical technologies, a shift in age demographics and the steady inflation of healthcare have all proved powerful market forces. 

To meet these challenges, Atkinson Vinden helps our clients integrate their practices with the health industry’s regulatory and legal frameworks. Our health lawyers have vast experience with navigating the complex legal environment that accompanies all stages of the company’s life cycle.

The life cycle of life sciences companies is not typical to that of other industries, and requires expert handling. A major prerequisite for the life cycle of life sciences is the need to formally apply to national regulatory organisations to secure market approval. Market approval requires comprehensive research data that demonstrates product safety, quality and efficacy. Human clinical trials are mandated under the Good Clinical Practice (GCP) standards, as referenced by the International Conference on Harmonisation (ICH). If a trial is not compliant with GCP standards, it is automatically invalid in Australia according to the Therapeutic Goods Regulations 1990. 

Regulatory approval is a key milestone in the product’s life cycle, and marks the beginning of revenues. This period is often accompanied by the need to secure reimbursement through either the Pharmaceutical Benefits Scheme (PBS) or the Medical Benefits Scheme (MBS). 

Ultimately, the process from product conception to commercialisation can take years due to the overwhelming intricacies and legal criteria that need to be fulfilled. As a result, companies often seek an independent life sciences law firm to help simplify this process.

A healthcare lawyer can provide assistance in areas such as regulatory consulting, compliance review, intellectual property and more.

Learn about the services our life science lawyers provide below.

  • OUR UNDERSTANDING

    Atkinson Vinden currently acts for a number of companies operating in the life sciences and healthcare area, including Device Technologies, Omega Pharma, AMSL, and Elekta, along with numerous health care providers including medical specialists, radiology, dental, cosmetic, pharmacy and veterinarian practices.

    Through our work with such clients, our life science lawyers have developed an acute understanding of the industry in such areas as compliance, product liability, professional negligence, bioethics, regulation (especially arising under the Therapeutic Goods Act 1989 (Cth), intellectual property, competition and trade practices, and distribution and indemnity agreements.

    On top of operating as a life sciences law firm, AV Lawyers have depth of legal services across such areas as HR advice (employment law), dispute resolution and litigation, commercial law, leasing and property law, means that we are well placed to provide all of the allied legal services that life science and health care businesses are likely to ever need.

    We currently offer mediation services to members of the MTAA to facilitate the resolution over disputes involving alleged breaches of the industry Code of Conduct.

  • OUR FOCUS

    The focus of our work is on finding commercially pragmatic solutions that facilitate business development and profitability for our life sciences and health care clients.

    Areas our life science lawyers specialise in iInclude:

    • Distribution agreements and indemnities

    A distribution agreement is a contract between a supplying company and the company that will market and sell the product. These agreements often include a clause on what percentage of overall sales each party will make, so it is important to ensure you create a strong distribution agreement to mitigate any risks of potential conflict later on. 

    • Therapeutic Goods Administration compliance

    The TGA monitors and enforces compliance with laws designed to regulate therapeutic goods. Before a product can be sold in Australia, it must be recorded in the Australian Register of Therapeutic Goods (ARTG).

    • Terms and Conditions

    Terms and conditions function as a legally binding contract between the user and the service supplier. 

    • Licensing

    Licensing describes an agreement in which intellectual property rights are transferred to a third party. Licensing options are an inevitable consequence of the development of new drugs, and can simplify a company’s expansion into new markets.

    • Intellectual property

    Healthcare intellectual property covers a range of areas such as the use of generic medicines, standards regarding access to medicines, and the marketisation of new products. 

    • Sale and purchase of business

    The process of selling or purchasing a medical business, whether it is a local practice or a pharmaceutical firm, encompasses a long list of stages including vetting, negotiation, and transition.

    The high costs of research and development of new products, combined with economies of scale, means that pharmaceutical mergers and acquisitions are becoming relatively common. 

    • Privacy

    The pharmaceutical industry relies on the use of personal data in areas such as clinical research, marketing and patient outreach. However, privacy and the use of personal data has become increasingly regulated and protected by the law.

    • Biotechnology

    Scientific advancements have revolutionised the way society utilises biotechnology, in areas such as genetic modification, biopharmaceuticals and the use of human biomaterial. While legislators and courts sometimes struggle to respond to these advances in a timely manner, there is an established legal basis that regulates biological resources and biosafety in Australia.

    • Registration, professional standards and bioethics

    The TGA has developed a comprehensive series of standards that monitor the registration requirements for prescription medicine applications. These applications must be supported by nonclinical, clinical and/or bioequivalence data and can be divided into two phases: a pre-submission phase, and submission phase in which a dossier is submitted for evaluation.

    • Employment and Award obligations

    The Fair Work Ombudsman ensures that employers meet the National Employment Standards. The Pharmaceutical Industry Award covers employers in the pharmaceutical industry, along with their employees who work in the manufacturing, production, warehouse and distribution sectors.

    Atkinson Vinden are proud members of the Medical Technology Association of Australia.Contact our healthcare lawyers today and ensure expert and comprehensive advice on the legal framework that supports life sciences and healthcare in Australia.

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