There Are New Transfer of Value Disclosure Regulation Rules in New Zealand: Are You Prepared?
Giuseppe Saporito,法律律师
Blog
2021年1月5日

代表该国制药行业的专业贸易协会新西兰药品(MNZ)与代表新西兰医疗保健专业人员(HCP)的新西兰医学协会合作宣布了新的价值转移(TOV)透明度报告,开发了必威手机APP由一个由两个组织的成员组成的联合工作组。

该指令涵盖了一系列TOV,例如事件注册费和费用,以及为咨询和其他服务支付的费用。截至2021年1月1日,这些新的透明度报告义务在新西兰有效,第一个披露截止日期定于2022年6月30日。实施主动合规战略的公司将具有竞争优势。

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.

联合小组在新西兰药品网站上的一个常见问题解答中表示,目的是,这一披露指南将促进公众之间的“增强信任和信心”,涉及医生和制药商之间的TOV的互动“既支持患者护理”医学知识。”

新的联合透明倡议指南规定,MNZ成员的制药公司有义务同时披露付款以及向HCPS和Healthcare组织(HCOS)进行的实物转移。必威手机APP新协议适用于向HCP的付款,以换取诸如主持演示文稿或担任顾问的服务;在提供这些服务的过程中产生的费用,例如机票,住宿和餐点;专业和教育活动的注册费,以及参加这些职能的任何相关费用。

行业利益相关者应注意:TOV报告要求没有最低阈值。无论多么最小,每笔付款和TOV都必须考虑并报告。此外,制造商以及中介机构授予的披露和报告需要直接制造商进行的TOV和报告。

这些要求适用的专业人员和组织的范围广泛,包括:医疗,牙科,护理和制药专业人员,这些类别外的专业人员提供处方药建议或访问权限,以及HCO,包括医院和医疗实践。

最初的报告期开始于2021年1月1日,第一个报告截止日期的截止日期快到了:2022年6月30日,届时必须通过报告披露所有在2021年日历年期间制作的所有TOV(必须公开可公开),以对会员公司公开可用。’ 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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