Blog

Articles and legal news from the Atkinson Vinden Team.

Life Sciences and Healthcare

Commercial Law

Life Sciences & Healthcare: A booming industry on Sydney’s North Shore

Atkinson Vinden has a growing presence in the Life Sciences & Health Care sector, and is an active member of the Medical Technology Association of Australia (MTAA). Senior Partner Sheena Vinden explains what is involved in this exciting area of legal practice.

Q: What sorts of businesses are involved in this sector?
Sheena: Many different business types, but all having a common interest in better health outcomes. It includes companies who manufacture or import and distribute medical devices, pharmaceutical companies, medical practices, dental and radiology practices, and all allied health types. It even extends to veterinary practices!

Q: How did AV get involved in this area?
Sheena: Serendipity! Our firm is situated right in the heart of where the action is  – with business precincts located at our doorstep at Macquarie Park, Pymble and Belrose, we have great opportunities to work with substantial medical device and pharmaceutical companies. Over many years we have also built up a substantial number of clients involved in medicine and health care, and we have a strong core of skills in the areas that these businesses generally require our help. It has been a natural fit, and quite organically we have grown a strong client base in this field.

Q: What do you like about working with companies in this sector?
Sheena: There is a strong set of values that I resonate with. Patient care, and a concern to improve health outcomes. We have also found that a lot of the clients we work with in this sector are a strong cultural fit for our firm, especially so far as age, education, and concern for issues such as a work-life balance.

Q: What sort of work does AV do for life sciences businesses?
Sheena: It’s an incredible array of issues. Given the massive amount of regulation specifically aimed at the life sciences industry, a lot of emphasis is upon compliance. We also help with product liability issues, professional negligence and misconduct, intellectual property, competition and trade practices. We also prepare practical commercial documents such as distribution and indemnity agreements. And then there are all of the same issues that all businesses need help with.

Q: What are some key pieces of advice you would have for businesses operating in this industry?
Sheena: There are a few issues I would highlight. Due to the peculiarities of the life sciences industry it is vitally important that our clients have assurances that suppliers will comply with our clients’ standards. The last thing a client needs is for their courier company to say they “didn’t know” that a product had to be stored at less than 4 degrees Celsius, resulting in an entire batch being unsuitable for sale. We recommend that our clients have a quality agreement with their suppliers. This agreement must set out a clear procedure for notification of product requirements (whether these relate to temperature, quality levels or any other issue that may arise). It would also set out the procedure to be followed if the standards are not met, which aids in ensuring that unsafe products do not make it to market. Our clients are usually well aware that the ACL (Australian Consumer Law) imposes certain protections when goods or services are supplied to consumers. What is less-well known is that these protections can often be passed up the supply chain, so a manufacturer/wholesaler can be held responsible if their products do not meet the relevant standards. This can be of particular concern for companies who import goods, as they will often be the one liable (both under the ACL and as sponsor for any goods listed on the ARTG), even though the products are being manufactured by someone else. It is vitally important to ensure that our clients have appropriate protections in their distribution agreements to ensure that their supplier indemnifies them for any faults. Particular care is also required regarding warranties, as these are often superseded by the provisions of the ACL.

Q: You mentioned earlier that life sciences clients share many of the same legal problems as other businesses. Can you think of some examples of this?
Sheena: Sure! One good example is employment law. Our clients will often have sales or managerial staff with a wealth of information that would be very helpful to their competitors if those employees chose to jump ship. It is not uncommon for a poorly drafted restraint clause to be insufficient to stop ex-employees seeking to join a competitor, so it is important to have these reviewed regularly. We also help with HR issues, and all property related matters, such as commercial leasing.Given the highly sensitive nature of medical information, privacy issues are of great importance in the life sciences industry. Since 2013 certain organisations (including those with turnover of more than $3m, or those who provide health services and keep health records) have been required to comply with the Australian Privacy Principles, including the requirement that they have privacy procedures in place and a publicly available privacy policy. There are also provisions regarding when and how personal information can be collected, used and disclosed, which are more stringent when applied to medical information.