Prospects for the World Health Assembly’s pandemic instrument

The World Health Assembly (WHA) has established an intergovernmental negotiating body to “draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”.

The Assembly’s decision was made at the special session of the WHA (29 November – 1 December 2021), convened for the specific purpose of considering the benefits of such an instrument.

The proposed pandemic instrument will almost certainly materialise too late to mitigate the impact of the global Covid-19 pandemic.

There is plenty of irony in the fact that while the European Union has led the push for a legally binding pandemic convention (see here and here), the EU continues to resist the proposal for a waiver of intellectual property rights under the World Trade Organisation’s TRIPS convention – in order to accelerate access to Covid vaccines and other technologies.

(See the TRIPS and Covid-19 waiver proposal here, and the EU’s counter-proposal here).

What do we know so far about the proposed pandemic instrument?

The World Health Assembly has opted for a World Health Organisation instrument, rather than a treaty negotiated under the broader, United Nations system, such as the UN Framework Convention on Climate Change.

There has been some drift in the governance of global health issues away from WHO in recent years to the broader UN system.  This is illustrated by the High-level meetings of the UN General Assembly on non-communicable diseases (2011, 2014, 2018, 2025), the health agenda embodied within the Sustainable Development Goals, and many other instruments, strategies and processes.  Of course, as the specialised health agency of the UN, the WHO remains centrally involved in helping to coordinate the response to many global health challenges.

The point, however, is that a multi-sectoral, all-of-government response is crucial if governments want to effectively tackle many of the world’s leading health challenges, from tobacco control to pandemics.

The envisaged pandemic instrument, however, will be a WHO instrument, overseen by a body that convenes the world’s health ministers, rather than heads of state. Implementation will be everything.

What kind of instrument?

Under the WHO Constitution, the World Health Assembly has authority to adopt conventions (Article 19), adopt Regulations (Article 21), or make recommendations (Article 23).

For the moment, all of these options are on the table.

The negotiating body will meet by 1 March 2022 in order to elect two co-chairs and four vice-chairs, who are required to develop a process to “identify the substantive elements of the instrument” and to begin the development of a working draft.

This draft must then be presented to the intergovernmental negotiating body at its second meeting in August 2022 – by which time it is intended that the negotiating body will identify the constitutional basis for the new instrument: whether a convention, or regulations, or recommendations.

Timeline

The intergovernmental negotiating body has been given a three-and-a-half-year timeline.  It must present the outcomes of its deliberations to the World Health Assembly in May 2024 (WHA77), with a progress report to the WHA in 2023 (WHA76).

Relationship with the International Health Regulations

Legally-binding international instruments are rare in global health. Non-binding normative instruments (so-called “soft law”), are far more common: see discussion here.

Two of the best known legally-binding agreements are the WHO Framework Convention on Tobacco Control, and the Protocol to Eliminate Illicit Trade in Tobacco Products.

Another binding instrument is the International Health Regulations (IHR) which (amongst many other things) impose obligations on WHO Member States to report and respond to events that constitute “public health emergencies of international concern”.

The IHR were revised and updated in 2003 following the SARS outbreak.

The limitations of the IHR, compliance problems, and lack of progress in implementation, have been investigated by many committees and expert bodies (see eg here, and here).

It’s safe to say that the failure of the IHR to effectively prevent and manage the Covid-19 pandemic, which has so far claimed nearly 5.6 million deaths, remains a driving force behind the WHA decision.  What better illustration of the need for effective global governance of pandemics than Covid-19?

That doesn’t mean that any new pandemic instrument will replace or supplant the IHR.  Far from it.  The WHA decision calls for “coherence and complementarity” between the process of developing a new pandemic instrument and the work of the “Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies” (a group established at the World Health Assembly in May 2021) “particularly with regard to implementation and strengthening of the IHR” (see para 1(4) here).

Content of an international pandemic instrument

The Report of the Member States Working Group to the WHA special session in November 2021 includes a list of matters that might be included in a global instrument.  They include:

  • global equity issues; for example, the problem of grossly inequitable access to vaccines
  • strengthened accountability for compliance with IHR obligations
  • “potential targeted amendments” to the IHR to enhance prevention, rapid risk assessment, detection and response
  • enhancing surge capacity in countries through strengthening health systems
  • sharing of pathogens, genetic information, biological samples and information
  • responding to misinformation and disinformation in national responses
  • elevating the political response to pandemic preparedness and response through an all-of-government approach

There is a growing literature that discusses the opportunities provided by this new instrument.  See, eg here, here, and here.

Are you interested in studying health law? For more information on Sydney Law School’s Master of Health Law degree, including units of study addressing the legal response to pandemics, see here and here.

COVID-19, medical research governance, and public health orders

Image: Mika Baumeister

Posted by Belinda Reeve on behalf of Cate Stewart

The impact of coronavirus-related biomedical research and public heath laws have been considered in recent articles co-authored by Cameron Stewart, Professor of Health, Law and Ethics at the University of Sydney Law School.

Science at warp speed: COVID-19 medical research governance

In biomedical research focused on developing COVID-19 vaccines and therapies, the need for speed is taken for granted. But “what, if anything, might be lost when biomedical innovation is sped up”? In a timely article in the Journal of Bioethical InquiryProfessor Cameron Stewart and colleagues, consider a study (on the use of anti-malarial drug hydroxychloroquine for treatment of COVID-19) recently retracted from The Lancet to illustrate the potential risks and harms associated with speeding up science.

As Professor Stewart and his co-authors note:

[T]the potential damage caused by not ensuring effective governance of research during epidemics may be immense. Harmful drugs and devices might go on to injure millions of people, useful drugs and devices might be abandoned, the public’s faith in science and medicine might be undermined, and irrational and ineffective healthcare might proliferate.

The article goes on to suggest a range of measures to address weaknesses in technical or methodological rigour, lack of peer oversight, and unmanaged conflict of interest in pandemic research.

“This is a difficult conversation, but one that must be undertaken. After all, this is not the first time that science has been sped up during pandemics with problematic effects, and we will undoubtedly need to speed science up again, many times in the future.”

COVID-19 public health orders and mental health practitioners

Professor Cameron Stewart and colleagues look at restrictive practices in Australian COVID-19 public health orders and their implications for mental health practitioners in the October 2020 issue of the International Journal of Mental Health Nursing.

Their article notes that due to the COVID-19 pandemic, health authorities in all Australian jurisdictions can invoke public health orders that allow for an extremely broad range of coercive orders, including forcible detention, testing, and treatment of any person reasonably suspected of being COVID-19 positive.

The article highlights relevant public health laws for mental health practitioners to be aware of and suggests that mental health units and public health units establish lines of communication to work together.

Professor Stewart and his colleagues conclude with a call for nationally consistent regulation as “the best way to encourage best practice, fair decision-making, the protection of human rights, and the promotion of public safety”.

Cameron Stewart teaches in Sydney Law School’s Master of Health Law program, including subjects on Death Law, Health Care and Professional Liability, and Government Regulation, Health Policy and Ethics.

Related posts on COVID-19 from the Sydney Health Law team:

https://sydneyhealthlaw.com/2020/03/18/whos-in-control-of-australias-response-to-coronavirus-part-1-legal-frameworks/

https://sydneyhealthlaw.com/2020/03/19/whos-in-control-of-australias-response-to-coronavirus-part-2-operational-responses/

https://sydneyhealthlaw.com/2020/08/26/rule-of-law-in-the-covid-19-response

Named reporting of HIV: A positive step for public health?

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Image from Flickr.com

In Australia, doctors must notify public health authorities of new cases of HIV/AIDs. However, strict confidentiality requirements apply to the testing, treating and notification of HIV, protecting the identity of patients.

As part of its review of the New South Wales Public Health Act 2010, the Department of Health is considering whether to remove these confidentiality requirements from NSW public health legislation. Is this a move that should be welcomed by health care professionals and patients?

Infectious disease notification

All Australian jurisdictions have laws that require the notification of certain infectious diseases. In NSW, notification requirements can be found in the Public Health Act 2010, which creates five categories of diseases that must be reported by medical practitioners, pathology laboratories, and hospitals, including HIV/AIDs.

Section 56 of the Act places confidentiality requirements on information relating to a patient’s HIV status. There are three main components to section 56:

  • Notifications for HIV/AIDs must be made in a de-identified format;
  • A person’s identifying details must not be used when arranging a diagnostic test for HIV (except in hospital situations or with the person’s consent);
  • A person who, in the course of providing a service, obtains information that an individual has been tested for HIV or has HIV/AIDs, must take reasonable steps to prevent that information from being disclosed. However, the information may be disclosed to a person involved in the provision of care of the patient, so long as it is relevant to the provision of such care.

Section 56 allows for disclosure of identifying information in certain other circumstances, including if there are reasonable grounds to suspect that failure to disclose the information would likely be a risk to public health. This allows for the Secretary of the Department of Health to identify and manage HIV positive individuals who pose a risk to the health of others, including (as a last resort) through public health orders that allow for the mandatory treating and detention of patients living with HIV.

Review of the Public Health Act 2010 (NSW)

NSW Health recently published a discussion paper on the review of the Public Health Act 2010 (NSW). The Ministry’s preliminary view is that HIV-specific confidentiality protections should be wound back. The paper notes several difficulties that stem from the confidentiality requirements for HIV notification:

  • De-identified notification increases the likelihood of duplicate testing and errors in notification, and impacts negatively upon the collection of epidemiological data, surveillance, and monitoring, and follow-up care of HIV positive patients;
  • Confidentiality requirements create a barrier to testing for HIV in combination with testing for other conditions as there are different consent procedures for HIV tests and other tests; and
  • They prevent healthcare professionals from being informed of patients’ HIV status where they are not providing treatment directly related to the patient’s HIV condition, but it would assist in providing care to know about the patient’s status (given that HIV and ART treatment have a range of health implications).

The policy of de-identifying HIV/AIDs notifications was first developed in the 1980s, at a time when most HIV infections occurred in gay men and there was considerable stigma and discrimination against the gay community and those living with HIV/AIDs. At that time, no effective treatment options were available for HIV/AIDs, making it a terminal condition. Many activists, clinicians, and community organizations were strongly against notification, and confidential notification provisions were adopted to encourage at-risk individuals to access HIV testing and care without fear of recrimination or discrimination.

The situation has changed significantly since then. Anti-retroviral therapy (ART) has made HIV a manageable, chronic condition, and has demonstrable benefits in preventing onwards transmission. Community attitudes towards the gay community and people living with HIV have changed considerably over the past 30 years, assisted by the introduction of laws that address discrimination and privacy concerns.

The discussion paper lists a number of benefits that would flow from rolling back HIV-specific confidentiality requirements:

  • Named notification would enable more accurate epidemiological data on HIV to be collected, for example, by allowing for better linking of HIV notifications with notifications of other conditions, which would assist with tracking and managing HIV co-infections; and
  • It would potentially allow better service provision and care of people living with HIV: one outcome would be that it would enable public health officers to follow up with HIV positive patients directly; liaise with clinicians; and refer people living with HIV to the relevant health services.

However, there is significant disagreement between NSW Health and HIV activists over whether named reporting would improve epidemiological data and access to care. Advocates argue that while named reporting may provide some benefit, this would be outweighed by its impact on privacy, testing, surveillance, and treatment.

HIV remains heavily stigmatized, and many people living with HIV continue to experience discrimination. These concerns are particularly relevant given that NSW criminalizes individuals with HIV (and other STIs) who fail to disclose their condition to their sexual partners.

Named reporting may deter people from being tested for HIV, particularly people from culturally and linguistically diverse backgrounds, recent migrants, highly sexually active men with multiple STIs, sex workers, and non-gay identifying men who have sex with men. People diagnosed with HIV may also be less willing to report sensitive personal information (e.g., injecting drug use), particularly if it could be used for law enforcement purposes. This would undermine the effective care of people living with HIV, as well as the quality of population-level data.

Advocates recognize that making information about a person’s HIV status, co-morbidities, and treatment regimen more widely available in clinical settings could improve care outcomes. However, they say that there are not enough examples of non-disclosure causing adverse effects to warrant the proposed changed, and the amendment would undermine the right of people living with HIV to disclose their HIV status to medical and healthcare workers at a time of their choosing.

Winding back “HIV exceptionalism”?

Writing on the legal environment of sexual health care practice, Roger Magnusson describes HIV as an “exceptional STI,” with unique legislation regulating counselling, diagnosis, and reporting of HIV. The central concerns of this legislation are the provision of supportive treatment and maintaining patient confidentiality.

Professor Magnusson describes how some countries are now winding back HIV exceptionalism, for example, in the US, CDC guidelines now recommend opt-out screening for all patients, i.e., patients are notified that screening will take place unless they decline consent. Some states, such as California, have adopted these recommendations, and while anonymous testing is still offered in many states, named HIV reporting is now the norm.

Notification of HIV/AIDs is a contentious subject, engaging issues around rights to privacy and autonomy, as well as on the role notification plays in data collection, testing, and treating. Many jurisdictions are streamlining the legal treatment of HIV testing with that of other infectious diseases; the question is whether NSW will – or should – do the same.