The regulatory regime surrounding medicines and medical devices is complex and stringent. The Medicines Act and Misuse of Drugs Act sit alongside commercial, medico-legal and public law obligations. We understand the regulatory framework and relevant commercial and clinical context for the use of therapeutic products. We advise funders, providers and regulators across many areas of the therapeutic product industry, including funding contracts, prescribing, information management, and complaints.
When it comes to the therapeutic product industry:
- liability risk can extend well beyond the immediate commercial transaction
- prescription and administration of medication is high risk from a medico-legal perspective.
Examples of work done by Claro lawyers:
Prescription, administration and supply of medicines. The Medicines Act, Medicines Regulations and Misuse of Drugs Act contain important requirements relating to the prescription only medications and controlled drugs. We have advised on these various obligations, including whether such medications can be prescribed by text, SMS or email and whether these forms of prescription can be used to communicate a ‘verbal order’ for prescription only medications and controlled drugs. We have also advised on proposed legislative changes to the way in which prescribing rights are regulated and the impact of the Medicines Amendment Act 2013 and Misuse of Drugs Amendment Regulations, which create the new category of delegated prescriber.
Advice to the Ministry of Health in relation to appeals under s88 Medicines Act against conditions on a licence to operate a pharmacy, including a condition to prevent dispensing of controlled drugs. Our lawyers acted for the Licencing Authority in two of only a small number of appeals before the Medicines Review Committee, including advising on the appeal process, preparing evidence and submissions, and appearing before the Committee. The Authority was successful in defending both appeals.
Advice to a health regulatory authority on the Medicines Act implications of health practitioners delegating the administration of prescription medicines to unregulated staff members. Concerns had been raised by the professional association about the legality of this. We provided advice confirming that delegated administration was lawful, together with an overview of the statutory framework for administering prescription medicines. We also advised on the need for practitioners to ensure that any delegated administration was carried out by a person who was appropriately skilled, and in a manner likely to minimise harm.
Clinical trial agreements and structures. We frequently provide advice and review clinical trial agreements for a wide range of DHBs, and are experts at finding our way around the industry templates for clinical trial agreements, and related indemnity and compensation agreements. Alongside this, we provide advice on structuring arrangements for the funding and operation of clinical trials to suit various funding models, and the ownership of clinical research related intellectual property.
An inquest into the death of a baby following administration of fentanyl. We acted for an independent midwife during the inquest. Issues included the lawfulness of the administration of fentanyl by the midwife to the mother during labour. Submissions were made outlining the legal framework including the Medicines Act 1981, the Medicines (Standing Order) Regulations 2002 and the Ministry of Health’s Guidelines for the Development and Operation of Standing Orders. The coroner did not make an adverse finding against the midwife with respect to the administration of fentanyl.
Medical device manufacturing agreements. Our lawyers have experience in drafting quality assurance agreements to ensure that goods used in the manufacture of medical devices comply with stringent quality and regulatory requirements, agreements for the design and installation of manufacturing machinery and production lines, and testing agreements. We are familiar with the tough regulatory and quality system requirements that medical device manufacturers must negotiate on a day to day basis and the implications of those requirements on their business.
Medical device distribution and Original Equipment Manufacturer (OEM) agreements: We know the hooks to watch out for when negotiating and entering into distribution agreements (whether domestic or international, exclusive or non-exclusive) and are familiar with preparing distribution agreements with counter parties based all over the world. We also have experience in preparing OEM agreements both for products being sold by our client to be incorporated into another manufacturer’s product, and vice versa.