Medical Device Regulation and the Proposed Therapeutic Products Bill: Devising a New Regime

2021 ◽  
Vol 52 (2) ◽  
pp. 319-342
Author(s):  
Laura Hardcastle
Keyword(s):  
Patient Safety ◽  
New Zealand ◽  
Medical Devices ◽  
Cosmetic Products ◽  
Regulatory Oversight ◽  
Speed To Market ◽  
The Government ◽  
The Right ◽  
Promote Patient Safety ◽  
Medical Device Regulation

Despite medical devices being integral to modern healthcare, New Zealand's regulation of them is decidedly limited, with repeated attempts at reform having been unsuccessful. With the Government now indicating that new therapeutic products legislation may be introduced before the end of the year, the article considers the case for change, including to promote patient safety, before analysing the draft Therapeutic Products Bill previously proposed by the Ministry of Health, and on which any new legislation is expected to be based. It concludes that, while the proposed Bill is a step in the right direction, introducing regulatory oversight where there is currently next to none, there is still significant work to be done. In particular, it identifies a need to clarify whether the regime is indeed to be principles-based and identifies further principles which might be considered for inclusion. It further proposes regulation of cosmetic products which operate similarly to medical devices to promote safety objectives, while finding a need for further analysis around the extent to which New Zealand approval processes should rely on overseas regulators. Finally, it argues that, in an area with such major repercussions for people's health, difficult decisions around how to develop a framework which balances safety with speed to market should not be left almost entirely to an as yet unknown regulator but, rather, more guidance from Parliament is needed.

scholarly journals Medical Device Regulation and the Proposed Therapeutic Products Bill: Devising a New Regime

2021 ◽  
Vol 52 (1) ◽  
pp. 319-342
Author(s):  
Laura Hardcastle
Keyword(s):  
Patient Safety ◽  
New Zealand ◽  
Medical Devices ◽  
Cosmetic Products ◽  
Regulatory Oversight ◽  
Speed To Market ◽  
The Government ◽  
The Right ◽  
Promote Patient Safety ◽  
Medical Device Regulation

Despite medical devices being integral to modern healthcare, New Zealand's regulation of them is decidedly limited, with repeated attempts at reform having been unsuccessful. With the Government now indicating that new therapeutic products legislation may be introduced before the end of the year, the article considers the case for change, including to promote patient safety, before analysing the draft Therapeutic Products Bill previously proposed by the Ministry of Health, and on which any new legislation is expected to be based. It concludes that, while the proposed Bill is a step in the right direction, introducing regulatory oversight where there is currently next to none, there is still significant work to be done. In particular, it identifies a need to clarify whether the regime is indeed to be principles-based and identifies further principles which might be considered for inclusion. It further proposes regulation of cosmetic products which operate similarly to medical devices to promote safety objectives, while finding a need for further analysis around the extent to which New Zealand approval processes should rely on overseas regulators. Finally, it argues that, in an area with such major repercussions for people's health, difficult decisions around how to develop a framework which balances safety with speed to market should not be left almost entirely to an as yet unknown regulator but, rather, more guidance from Parliament is needed.

scholarly journals Free and Frank Advice and the Official Information Act

2018 ◽  
Vol 14 (2) ◽  
Author(s):  
Andrew Kibblewhite ◽  
Peter Boshier
Keyword(s):  
Decision Making ◽  
New Zealand ◽  
Government Agency ◽  
Government Officials ◽  
The Public ◽  
Good Government ◽  
Work Programme ◽  
The Government ◽  
The Right ◽  
Official Information

Concern exists that New Zealand hasn’t struck the right balance between two potentially competing principles of good government: officials should provide free and frank advice to ministers, and the public should have opportunities to participate in decision making and hold the government to account. Steps we have taken to address this include: strengthening constitutional underpinnings for free and frank advice (Cabinet Manual changes and issuing expectations for officials); a work programme to improve government agency practice in relation to the Official Information Act; and the Office of the Ombudsman reducing uncertainty about when advice can be withheld by issuing new principles-based guidance and providing more advisory services.

scholarly journals An Integrated Approach to Redistribution: Issues of Policy, Economics and Information

2021 ◽  
Author(s):  
◽  
Mark Prebble
Keyword(s):  
New Zealand ◽  
Policy Development ◽  
Personal Information ◽  
Integrated Approach ◽  
Well Being ◽  
The State ◽  
Philosophical Foundations ◽  
The Government ◽  
The Individual ◽  
The Right

<p>This thesis considers how best to administer redistribution policies. It focuses particularly on the information needed to assess relative circumstances, the implications of the government collecting such information, and processes by which the appropriate information may be assembled and assessed. In New Zealand, as with many other OECD nations, the Government's redistribution policies are administered through a range of different agencies, with duplication in some areas and gaps in others. An integrated approach to redistribution systems may offer a means to improve equity and efficiency. Part One discusses the assessment of relative well-being, and adopts the choice set as the intellectual device for this purpose. The time period for the assessment of income is examined in detail, with the conclusion that a long period should be used except where the individual is constrained to operate under a short time horizon. A new concept of "bankability" is developed as a means of identifying those operating under such constraints. Part Two uses the philosophical foundations of the value of privacy to develop a new statement of the right to privacy, such that everyone should be protected against the requirement to divulge information, unless that information is the "business" of another party. A view on the business of the state depends on one's ideology of the state. Since it is generally accepted in New Zealand in the late twentieth century that the state has a role in redistribution, the state has some right to collect information for that purpose. However, the rights of the state are moderated by the existence of a common law tradition of respect for individuals. A set of criteria for evaluating redistribution systems is devised in Part Three. These criteria, which include consideration of the information to be collected, individual control over personal information, and administrative simplicity, are then used to identify significant weaknesses in the systems currently used in New Zealand. The main problems identified are the collection of inadequate information, duplication, and complex institutional structures; the main virtue of the current systems is that information provided is only used for the purpose for which it was provided. An alternative approach is outlined which would address the problems while retaining the current protection of privacy interests. This thesis is a mix of inter-disciplinary academic enquiry and policy development. Part One is an amalgam of economic and philosophical approaches, Part Two involves philosophy and politics, and Part Three applies the theoretical considerations to issues of public administration.</p>

scholarly journals Who Owns Native Nature? Discourses of Rights to Land, Culture, and Knowledge in New Zealand

2009 ◽  
Vol 16 (3) ◽  
pp. 325-339 ◽  
Author(s):  
Michael Goldsmith
Keyword(s):  
New Zealand ◽  
European Origin ◽  
Cultural Assumptions ◽  
Native Culture ◽  
Native Nature ◽  
The Government ◽  
The Right ◽  
New Zealanders

AbstractMichael Brown famously asked ‘Who owns native culture?’ This paper revisits that question by analyzing what happens to culture when the culturally defined boundary between it and nature becomes salient in the context of disputes between indigenous and settler populations. My case study is the dispute between the New Zealand government and Maori tribal groupings concerning ownership of the foreshore and seabed. Having been granted the right to test their claims in court in 2003, Maori groups were enraged when the government legislated the right out of existence in 2004. Though the reasons for doing so were clearly political, contrasting cultural assumptions appeared to set Maori and Pakeha (New Zealanders of European origin) at odds. While couching ownership of part of nature as an IPR issue may seem counter-intuitive, I argue that as soon as a property claim destabilizes the nature/culture boundary, IPR discourse becomes pertinent.

scholarly journals The compromise of conscience: Conscientious objection in healthcare

2021 ◽  
Author(s):  
◽  
Louise Newman
Keyword(s):  
Patient Safety ◽  
New Zealand ◽  
Healthcare Service ◽  
Time Dependent ◽  
Personal Beliefs ◽  
Health Practitioners ◽  
Medical Emergencies ◽  
Competence Assurance ◽  
The Right ◽  
Direct Referral

<p>This paper discusses a medical practitioner’s right to conscientiously object to providing a legally available healthcare service in New Zealand, on the grounds of their personal beliefs. Currently, the right to conscientiously object is enshrined in the Health Practitioners Competence Assurance Act 2003 and the Contraception, Sterilisation and Abortion Act. This paper argues the current legislative arrangement regulating a health practitioner’s right to conscientiously object under New Zealand law is vague, and risks cementing uncertainty, due to scope of the protection being unclear. In addition, the current protection risks patient safety, as it does not exclude the right to conscientiously object in medical emergencies, or when the efficacy of the treatment is time dependent. To remedy this unsatisfactory situation, it is recommended that the right to conscientiously object in healthcare be rendered impermissible in the aforementioned scenarios. It is further recommended that direct referral to a non-objecting colleague be mandatory in the event a practitioner wishes to exercise their right to conscientiously object. This is because access to healthcare may be compromised by a practitioner exercising the right to conscientiously object, with no corresponding direct referral requirement, a risk borne by patients.</p>

scholarly journals Materiovigilance: Concept, Structure and Emerging Perspective for Patient’s Safety in India

Drug Research ◽  
2020 ◽  
Vol 70 (09) ◽  
pp. 429-436
Author(s):  
Farazul Hoda ◽  
Rishabh Verma ◽  
Mawrah Arshad ◽  
Ali Nasir Siddiqui ◽  
Mohammad Ahmed Khan ◽  
...  
Keyword(s):  
Patient Safety ◽  
Adverse Events ◽  
Medical Devices ◽  
Safety Data ◽  
Current Review ◽  
Ensure Patient Safety ◽  
Regulatory Perspective ◽  
Controller General ◽  
Ultimate Objective ◽  
Medical Device Regulation

AbstractThere has been an escalation in the number, diversity, and complexity of medical devices. Regulation of these devices has also advanced due to the requirement of better regulatory perspective induced due to elevation in the number of adverse events associated with medical devices. All over the globe, various measures are undertaken to provide better safety to the patients along with attempts to improve the standard of medical devices. The initial and ultimate objective of the concept happens to be unfailingly to ensure patient safety as well as impart required guidance for both manufacturers and adept authorities enabling them to superintend cases coherently and appropriately. Materiovigilance programme of India (MvPI) was launched by the Drug Controller General of India at the Indian Pharmacopoeia commission (IPC) in Ghaziabad in 2015. The main purpose of this initiative is to monitor adverse events associated with medical devices in order to generate safety data, create awareness among the various stakeholders, and prescribe best practices for patient safety. Whilst the reforms in regulations have proposed policies and designs to elucidate, consolidate and accelerate the processes involved in manufacturing and importing medical devices to India, they consistently carry their challenges and limitations. To eliminate such complications the guidelines and regulations are anticipated to be implemented appropriately with the efficacious conclusion. India has been evident in matching with advancements in the World Medical Device regulation scenario, the current review at hand takes upon the question of ‘how successful has it been so far’?

scholarly journals "Strangers in the House": The Maori Language in Government and the Maori Language in Parliament 1840-1900

2001 ◽  
Vol 32 (3) ◽  
pp. 865
Author(s):  
Phil Parkinson
Keyword(s):  
New Zealand ◽  
House Of Representatives ◽  
Parliamentary Debates ◽  
Legislative Council ◽  
Treaty Of Waitangi ◽  
The Government ◽  
Adequate Provision ◽  
The Right

The Treaty of Waitangi conferred upon Her Majesty's new subjects "all the rights andprivileges of British subjects" and that included, in theory, the right to be represented in the infantgovernment. In practice, however, the right of Maori to vote in elections was not taken seriouslyuntil 1858 and the presence of formally elected members in the House of Representatives was not achieved until August 1868. When they did speak in 1868 the first four Maori members spoke inMaori, and no adequate provision was made for the translation of their words, or for the words ofother members to be translated for them. The proceedings of the House were not printed in Maoriand the Maori members' speeches were not translated except when it suited the government of theday.Over the next few decades after 1868 there was only an irregular compliance with the standingorders of the House of Representatives and the Legislative Council that Bills and Acts be prepared inboth Maori and English for the better information of "Her Majesty's subjects of the Native Race".This study traces the extent of the use of the Maori language in the House and in the Council andpoints to a large number of extant Bills and Acts in Maori as well as to the large number whichhave not survived but which are referred to in the New Zealand parliamentary debates. These little-known texts deserve recognition as expressions of legislation in an indigenous tongue reflectingindigenous concerns but they have usually been disregarded in a European-dominated GeneralAssembly.

Konstytucyjne gwarancje praw jednostki. Model szwedzki i nowozelandzki

2019 ◽  
Vol 76 ◽  
pp. 322-340
Author(s):  
Katarzyna Sikora
Keyword(s):  
New Zealand ◽  
Bill Of Rights ◽  
Or Education ◽  
Legal Standards ◽  
The People ◽  
Treaty Of Waitangi ◽  
International Obligations ◽  
The Government ◽  
The Right ◽  
Right To Dignity

The purpose of this article is to analyse and describe fundamental individual rights in relation to the Constitution of Sweden and New Zealand. Basic human rights include the right to dignity, right to liberty and the right to equality. Everyone is equally entitled regardless of origin, race, gender or education. Based on the analysis of several acts concerning the constitutional legislation of both countries it is evident that there is a lack of uniformity the nature of these have been complex and difficult to convey. Concerning Sweden, the Constitution consists of four acts in which the act of government includes standards governing and representing protection of the rights a liberty of a citizen. Constitutional legislation of New Zealand is more complicated because it consists of the Treaty of Waitangi 1840, The New Zealand Bill of Rights Act 1990, numerous laws, statutes setting up by the New Zealand Parliament as well as numerous constitutional customs, which may constitute legal standards and translate into precedent acts of courts. Despite the daily violation of rights in both Sweden and New Zealand, the complex legal systems protect and secure the rights of the people in their countries by introducing a series of laws and other regulations. The government of both countries, as well as public authority and other non-governmental organisations do their best to ensure they are respected and not violated. It should be noted that both Sweden and New Zealand have proven to comply with the obligations imposed on them under their national and international obligations with some undoubtable success, with generally well accepted principles in the whole civilised world.

Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic

2021 ◽  
Vol 47 (2-3) ◽  
pp. 291-326
Author(s):  
Katelynn Maxwell
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Antibody Test ◽  
Public Health Emergency ◽  
Long Term Results ◽  
Regulatory Oversight ◽  
Speed Up ◽  
Harsh Criticism ◽  
Medical Device Regulation

The FDA already subjects most medical devices to much less stringent approval requirements than drugs and biologics, and attempts to speed up rollout during the COVID crisis have been problematic. Agency decisions, including to allow antibody test marketing without emergency use authorization or review, and the back-and-forth guidance on laboratory-developed tests, have met harsh criticism and unreliable results. Though the long-term results of these decisions are unclear, the FDA’s credibility, reliability, and commitment to safety are threatened by even further lessening medical device regulatory oversight during the coronavirus pandemic. The relaxed and fix-it-later approach to many of the FDA’s public health emergency decisions regarding medical devices reflect the ongoing criticisms of medical device regulation in general, specifically the 510(k) process and laboratory developed test regulation, offering a point of reflection towards reform. Adaptive legislation and a risk-based and evidentiary approach to premarket and postmarket review can begin to address these issues both generally and in an emergency context.

scholarly journals The compromise of conscience: Conscientious objection in healthcare

2021 ◽  
Author(s):  
◽  
Louise Newman
Keyword(s):  
Patient Safety ◽  
New Zealand ◽  
Healthcare Service ◽  
Time Dependent ◽  
Personal Beliefs ◽  
Health Practitioners ◽  
Medical Emergencies ◽  
Competence Assurance ◽  
The Right ◽  
Direct Referral

<p>This paper discusses a medical practitioner’s right to conscientiously object to providing a legally available healthcare service in New Zealand, on the grounds of their personal beliefs. Currently, the right to conscientiously object is enshrined in the Health Practitioners Competence Assurance Act 2003 and the Contraception, Sterilisation and Abortion Act. This paper argues the current legislative arrangement regulating a health practitioner’s right to conscientiously object under New Zealand law is vague, and risks cementing uncertainty, due to scope of the protection being unclear. In addition, the current protection risks patient safety, as it does not exclude the right to conscientiously object in medical emergencies, or when the efficacy of the treatment is time dependent. To remedy this unsatisfactory situation, it is recommended that the right to conscientiously object in healthcare be rendered impermissible in the aforementioned scenarios. It is further recommended that direct referral to a non-objecting colleague be mandatory in the event a practitioner wishes to exercise their right to conscientiously object. This is because access to healthcare may be compromised by a practitioner exercising the right to conscientiously object, with no corresponding direct referral requirement, a risk borne by patients.</p>

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