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There Are New Transfer of Value Disclosure Regulation Rules in New Zealand: Are You Prepared?
Jan 05, 2021
Medicines New Zealand (MNZ), the professional trade association representing the Pharmaceutical industry in the country, in collaboration with the New Zealand Medical Association, which represents New Zealand Healthcare Professionals (HCPs), announced new Transfer of Value (ToV) transparency reporting guidelines developed by a joint working group comprising members of both organizations.
The directive encompasses a range of ToVs such as event registration fees and expenses, along with fees paid for consultative and other services. These new transparency reporting obligations became effective in New Zealand as of January 1, 2021, and the first disclosure deadline is set for June 30, 2022. Companies that implement proactive compliance strategies will be at a competitive advantage.
The working group published details of its Joint Transparency Initiative on the Medicines New Zealand website (https://www.medicinesnz.co.nz/transparency-guidelines/) on December 22, 2020. They said the new guidelines are intended as a voluntary framework for defining, enumerating and reporting financial as well as in-kind support provided to HCPs in the context of furthering their medical knowledge through activities like educational speaker programming. The guidelines also align with the Medicines New Zealand Code provisions that pertain to HCP interactions and relationships.
The joint group said in an FAQ on the Medicines New Zealand website that the intention is that this disclosure guidance will facilitate “increasing trust and confidence” among the general public that interactions involving ToVs between doctors and drug-makers “both support patient care and increase medical knowledge.”
The new Joint Transparency Initiative guidelines stipulate that pharmaceutical companies — members of MNZ — are obligated to disclose both payments as well as in-kind transfers made to HCPs and Healthcare Organizations (HCOs). The new protocols apply to payments to HCPs in exchange for services such as hosting a presentation or serving as a consultant; expenses incurred in the course of providing these services such as airline tickets, lodging and meals; professional and educational event registration fees, along with any associated expenses incurred in the course of attending those functions.
Industry stakeholders should take note: There is no minimum threshold for ToV reporting requirements. No matter how minimal, each and every payment and ToV must be accounted for and reported. Additionally, disclosure and reporting is required for ToVs made directly by manufacturers as well as those conferred by intermediaries.
The scope of professionals and organizations to whom these requirements apply is broad, including: medical, dental, nursing and pharmaceutical professionals, professionals outside these categories who provide prescription medicine advice or access, as well as HCOs, including hospitals and medical practices.
The initial reporting period began on January 1, 2021, and the first reporting deadline is fast approaching: June 30, 2022, at which time all ToVs made during calendar year 2021 must be disclosed via reports — which must be publicly available — on member companies’ websites. In subsequent years, reporting will continue on a calendar year basis, and disclosure reporting will be due 6 months after each reporting period has concluded. Documentation must be accessible online for at least three years following publication. While the disclosure guidelines are voluntary, member companies are encouraged to comply with these rules as part of their own risk mitigation strategies.
For the Life Sciences industry, this is significant. While collaboration between HCPs and manufacturers is a key component to advancing both medical knowledge and improved patient health outcomes, the regulatory and organizational framework in which this partnership takes place has undergone dynamic changes.
In recent years, more countries and regions have begun adopting Sunshine Law-type regulatory regimes around transparency disclosure and reporting. It is incumbent on manufacturers to adopt policies and protocols — and invest in the necessary technological infrastructure — that allow them to proactively adapt to these kinds of changes.
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