Browsing by Author "Young, Hugo"

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Open Access
“Devicive”: Medical Device Regulation and the New Zealand Therapeutic Products Act 2023
(Te Herenga Waka—Victoria University of Wellington, 2023) Young, Hugo; Atkin, Bill
This paper analyses aspects of the Therapeutic Products Act 2023 (“Act”). The Act creates a regulatory regime that oversees medical devices, medicines, natural health products and active pharmaceutical ingredients. This paper focuses on the regulation of medical devices, asking whether the drafting of the Act reflects the guiding principle that regulation should be proportionate to benefits and risks, and whether the Act aligns New Zealand with international standards. The paper begins by considering the concept of risk and outlining the provisions that are key to the analysis of the Act. It is concluded that the Act does not sufficiently facilitate risk proportionate regulation of medical devices. The paper continues, comparing the regime created by the Act to regimes in comparable jurisdictions, which influenced and informed the recommendations made. It is found that the Act does not necessarily reflect international best practice. The paper then considers the issues and unintended consequences that the Act may create, which were highlighted in the submissions to the Select Committee. There is a danger that the importers New Zealand relies on for its medical devices skip the market entirely and a concern that the Regulator will quickly become overwhelmed. Finally, recommendations are made to address these issues, align New Zealand with international best practice and ensure that the regulation of medical devices is risk proportionate. Firstly, it is recommended that a risk-based classification system be implemented in the Act and that devices are evaluated differently based on their classification. Secondly, the role of overseas approvals in the evaluation process should be clarified, allowing sponsors of devices to use them to expedite the evaluation process. Included are draft amendment options for each recommendation. The paper finishes by considering the delegation of power under the Act and recommending that more guidance be provided in primary legislation.
Open Access
State to State Aid and Intervention: Permission to Help Yourself?
(Te Herenga Waka—Victoria University of Wellington, 2024-09-03) Young, Hugo
This paper examines how some donor states use aid to influence and intervene in the affairs of receiving states. It starts from the assumption that aid is generally good and altruistic. The analysis of state behaviour in this paper leads to a conclusion that this is not always the case because aid can be used by donors as a tool for intervention. The paper begins by examining international agreements and instruments which demonstrate that obligations to aid can be vague, providing little practical guidance on how assistance should be rendered and what may be taken in return. It follows by providing examples of “aid for policy” agreements, under which states give aid but receive significant benefits themselves. These examples illustrate how such agreements can erode a receiving state’s ability to self- determine and how donors use aid to further their own interests. The paper then considers whether this behaviour is lawful under the principle of non-intervention. It ultimately concludes that it is lawful to provide aid to influence policy, unless the consent to that aid is found to be invalid. It may, however, be arguable in particularly serious circumstances that it is unlawful to withdraw aid for the purposes of intervening with another state’s affairs. The paper finishes by outlining some potential solutions which could address the problem it has highlighted but acknowledges that it is a complex issue which will be hard, if not impossible, to solve entirely.