In the highly regulated pharmaceutical and medical sectors, failure to comply with the law can result in criminal convictions, large fines, reputational damage, and the loss or suspension of licences or product consents. Kensington Swan provides expert advice to guide and protect clients providing products and services in this environment.
Medicines Act compliance
Up-to-date and accurate advice is critical for companies undertaking clinical trials or supplying therapeutic products, including medicines and medical devices.
Our lawyers can advise clients on compliance with the Medicines Act on issues such as:
- product labelling
- conducting clinical trials
- advertising therapeutic products.
Clinical trials are frequently conducted in New Zealand, requiring specialised agreements and corresponding indemnities. Our lawyers have wide experience in this area and can also assist with drafting and negotiating contracts with research organisations.
Clinical trials must comply with specific guidelines published by Medsafe and may need to comply with the Researched Medicines Industry Guidelines on compensation. Failure to comply with the relevant legal requirements and guidelines may result in a trial proposal being declined.
Kensington Swan assists in contract negotiations with Pharmac, District Health Boards, and other purchasers of medicines, medical devices, and related products. These are unique as there are often limited suppliers and purchasers, and the products or services are frequently critical to end users.
Complexities arise when central buying agencies are contracting parties, and care needs to taken to ensure the effects of such arrangements are fully understood.
We assist overseas companies without a New Zealand presence to deal with regulatory matters, including agency and sponsorship arrangements. Regulation in this area is not confined to easy-to-use legislation, and familiarity with a range of guidelines is required, as is a good knowledge of industry practice.
We regularly assist a number of multi-national clients to negotiate the terms of listing agreements with Pharmac. We have recently advised one such client on Pharmac’s ability to de-list a product, and assisted the client in dealing with a dispute with Pharmac relating to that client’s ability to terminate supply under a listing agreement that had no express duration.
District Health Boards (DHBs)
We have advised clients on contract negotiations for the supply of medicines and medical devices to DHBs. We are also experienced in assisting with tenders, including a recent tender for the installation and servicing of theatre facilities at a North Island hospital. We have also negotiated clinical study agreements and indemnities between DHBs and private institutions.
Kensington Swan advises on sponsorship and agency issues relating to licensing under the Medicines Act, and can assist in identifying labelling requirements for therapeutic products, as well as herbal remedies and supplements. Our lawyers have also worked on determining whether certain new and novel products are subject to the regulatory regime prescribed under the Medicines Act and the Medicines Regulations.
Related legal services
Intellectual property law
Commercial contract law