Policy Tag: Epidemic

Adopted by the 74th WMA General Assembly, Kigali, Rwanda, October 2023

 

PREAMBLE

Public health emergencies (PHEs) are regular occurrences that put the life and health of populations at risk. They have multiple origins and are frequently characterised by urgency, uncertainty and rapidly escalating demands to which health services may struggle to respond. Public health emergencies frequently transcend jurisdictional boundaries giving rise to co-ordination challenges for governments and other actors. They can also involve large scale displacement of people. Some of the PHEs are localised, some present threats of international concern. Climate change, conflict and extremes of global inequality are direct drivers of PHEs.

World Health Organization (WHO) defines a public health emergency as “an occurrence or imminent threat of an illness or health condition, caused by bioterrorism, epidemic or pandemic disease, or (a) novel and highly fatal infectious agent or biological toxin, that poses a substantial risk of a significant number of human fatalities or incidents or permanent or long-term disability”. Public health emergencies can result from a wide range of hazards and complex emergencies.

PHEs confront physicians, other health professionals, public authorities and at times the international community with severe challenges. Although fundamental ethical principles in medicine remain unchanged, the combination of urgency, uncertainty and extreme shortages of health resources can present health professionals with extreme difficulties in applying them. The familiar tension in medicine between obligations to individual patients and obligations to the public good can be distinctly pronounced during PHEs. This is particularly the case where the need for life-saving interventions overwhelms the available supply. PHEs can also require restrictions on individual and population rights and liberties that present their own ethical challenges.

This statement focuses on the medical ethical aspects of public health emergencies.

 

BASIC PRINCIPLES

  1. During a PHE, physicians and all other health responders should consider the following principles:
  • The obligation to help reduce overall suffering;
  • The obligation to show full and equal respect to all;
  • The requirement for justice and fairness in the allocation of scarce resources;
  • The requirement that any restrictions on individual choice or liberty must be proportionate, lawful and evidence-based;
  • The obligation to maximise overall health outcomes.
  1. Some physicians and health professionals will solely be focussing on population aspects of the response to PHEs. Their primary concern will be maximising benefits and minimising harms at a population level. The above principles will guide them as they seek to realise the greatest overall benefit for the largest number of people.

Issues of particular ethical concern during PHEs

  1. Although the basic ethical duties of physicians do not change during a PHE, their application in certain areas can be challenging. Issues of particular ethical concern during a PHE include but are not limited to:

Confidentiality

  1. Access to large amounts of accurate, real-time data is an essential part of the health response to many PHEs. Physicians and other health professionals retain ordinary duties of confidentiality to their patients. Information can be disclosed during a PHE where a patient or legal surrogate consents to its disclosure. In the absence of consent such information can be disclosed where there is a lawful justification or for overriding reasons of public interest. The disclosure of information should be limited only to the necessary information for the treatment of PHEs. Consideration must also be given to ensuring the ethical use of data including what happens to the data after the purposes for which it was collected are achieved.

Consent

  1. Patients retain the right to consent to or refuse treatment at all times during a PHE. Some compulsory interventions that do not amount to treatment may be acceptable where there is a lawful and ethical mandate supporting them. For example, where individuals present a serious risk of harm to others, and they refuse to accept necessary public health restrictions, confinement may be considered.

Restrictions of liberty

  1. PHEs, particularly where they involve emerging communicable pathogens, may require restrictions on individual and population freedoms. Social distancing and self-isolation are highly effective public health interventions and may be mandated by law during a PHE. Any interference with fundamental rights, including restrictions of liberty, must be justified in the public good, necessary, proportionate, based on lawfully-provided powers and authority, and only imposed for as long as necessary based on scientific evidence. The basic needs of any confined person must be met at all times.

Public engagement

  1. PHEs can have a profound effect on individuals, communities and societies. They are frequently characterised by fear, uncertainty, and involve severe socio- economic disruption. During PHEs, there is a risk of the widespread circulation of misinformation including conspiracy theories and direct attempts to undermine medical and scientific expertise. Clear communication of evidence-based medical and scientific information, including the justification for any decisions that impact social or economic functions, is essential. Active steps should be taken to tackle misinformation and disinformation, especially when it is coming from health professionals.
  1. PHEs frequently require challenging decisions involving trade-offs between fundamental goods. All people affected have a right to know that such decisions are being made and the criteria on which the decisions are based.

Resource allocation and triage

  1. Serious PHEs are often characterised by extreme shortages of health resources. This can present physicians and other health professionals with difficult decisions. In ordinary circumstances priority should be given to those with the greatest health need, provided they have capacity to benefit from the health intervention. Those with equal health needs have equal rights to health resources, whether or not the need arises directly from the PHE.
  1. In some circumstances, where health needs overwhelm available resources, it may be necessary to triage patients. Triage is a form of resource allocation that involves sorting or prioritizing individuals based on their health needs and their likelihood of responding to an intervention. In extreme conditions it can involve setting aside some people for non-treatment where others have a higher likelihood of benefiting from treatment, or where more people can be saved.
  1. Any form of triage must be based on open and defensible ethical principles and must be flexible enough to respond to rapidly changing circumstances. Triage must principally be based on factors determined by the medical community and directly relevant to an individual’s health status.
  1. Attention must also be paid to health trade-offs arising from decisions made to tackle public health emergencies. A focus on tackling communicable pathogens may, for example, require health resources to be diverted away from other health needs. Any such decision must be based on good moral reasons.

The rights and interests of health professionals

  1. There is a limit to the risks that health professionals can be expected to take during the exercise of their duties in a PHE. Physicians and other health professionals should be knowledgeable of ethical and legal issues and disaster response, including their rights and responsibilities to protect themselves from harm, issues surrounding their responsibilities and rights as volunteers, and associated liability issues. Where health professionals are exposed to risk, corresponding duties arise on employing bodies to mitigate those risks as far as possible.
  1. Health professionals responding to PHEs must be properly equipped to deal with the risks they will face, including access to appropriate personal protective equipment (PPE) at all times.
  1. Where health professionals face particular risks as a result of their role in responding to PHEs it may be appropriate for them to have priority access to interventions such as vaccines.

Research

  1. Research is an essential part of the health response to PHEs. Ethical principles guiding research in ordinary conditions are not changed during PHEs. Undertaking research in PHEs can nevertheless be challenging. Those participating in research can also be particularly vulnerable. It is essential that research in PHEs is undertaken with full respect for the principles set out in the WMA Declarations of Geneva, the WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, and the WMA Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks.

PHEs of international concern

  1. Some PHEs, such as those caused by communicable pathogens or highly-dispersed toxins, can rapidly cross national boundaries and present regional or global health risks. During these emergencies of international concern, the ethical principles outlined above remain unchanged. Given the persistence of serious global inequalities, particular attention must however be paid to transnational questions of justice and fairness in the allocation of health resources.

 

 

Adopted by the 73rd WMA General Assembly, Berlin, Germany, October 2022

 

PREAMBLE

SARS-COV-2 Pandemic caused more than 400 million cases and nearly 6 million deaths. It is quite comforting that vaccines that ensure protection from the disease have been produced, and data relating to the course of the pandemic in countries with high vaccination coverage is promising. 62.3% of the world population has received at least one dose of a COVID-19 vaccine. Only 11.4% of people in low-income countries have received at least one dose. Deep inequalities in access to vaccines are still observed globally and failure to achieve collective immunity leads to the -further spread of new, more contagious and immunity-evading variants of the disease through mutation. Worldwide application of vaccines is of critical importance in terminating the Covid-19 pandemic. Every minute of delay in vaccinations means further spread of the disease at global scale and more lives lost. It is not sufficient to immunize all citizens in any given country; immunization has to reach a sufficient level in the world as a whole to effectively combat and control the pandemic.

 

RECOMMENDATIONS

The WMA urges all parties to:

1.Remove barriers to promote equity of access to COVID-19 vaccines that are globally proven to be safe and effective;

2. Work with governmental and appropriate regulatory bodies to encourage prioritization of equity when providing COVID-19 pandemic-related resources such as diagnostics, free medications, therapeutics, vaccines, raw materials for vaccine production, personal protective equipment, and/or financial support, and guarantee universal accessibility and free distribution;

3. Establish vaccination strategies that consider the specific peculiarities, challenges and vulnerabilities of each region, prioritising the most vulnerable people, including health professionals;

4. Insist on the importance of vaccination and take action to achieve maximum coverage and protect the population in need;

In this context,

5. Confront vaccine hesitancy by providing evidence-based guidance on the safety and necessity of vaccines;

6. Share of knowledge required for vaccine production to the COVID-19 Technology Access Pool created by WHO to ensure that vaccines are produced at as many centres as possible and sharing of this knowledge;

7. Allocate public funds to improve the capacity of vaccine production centres and increase the channels of safe distribution so as to ensure fair access, to provide equitable and efficient vaccine supply and distribution;

8. Design national vaccine programmes that take into account a global analysis rather than only national considerations;

9. Promote sustainable solutions to patent issues. This may include the temporary lifting of patents on COVID-19 vaccines under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) and similar agreements to promote equity of access in global emergency situations, while ensuring fair compensation for the intellectual property of the patent holders if asked, global investment in manufacturing sites, training of personnel, quality control, and the transfer of knowledge, technology and manufacturing expertise;

10. Support WHO efforts and initiatives to increase production and distribution of therapeutics and vaccines necessary to combat COVID-19 and future pandemics in order to provide vaccine doses to low and middle-income countries with limited access, including:

  • technological transfers relevant for vaccine production;
  • other support, financial and otherwise, necessary to scale up global vaccine manufacturing; and
  • measures that ensure the safety and efficacy of products manufactured by such means.

11. Call on governments and the United Nations to take all necessary measures to facilitate equitable access to vaccines throughout the world by supporting and promoting the sharing of all vaccine-related processes for combating pandemics (R&D, patenting, production, licensing, procurement and application).

 

 

Adopted by the 65th WMA General Assembly, Durban, South Africa, October 2014
and rescinded and archived by the 74th WMA General Assembly, Kigali, Rwanda, October 2023

In the case of Ebola virus, the WMA strongly supports the intention of Paragraph 37 of the 2013 revision of the Declaration of Helsinki, which reads:

In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

Adopted as a Council Resolution by the 198th WMA Council Session, Durban, October 2014 and
adopted by the 65th WMA General Assembly, Durban, South Africa, October 2014
and rescinded and archived by the 74th WMA General Assembly, Kigali, Rwanda, October 2023

 

BACKGROUND

A number of viral diseases have caused occasional health emergencies in parts of Africa, with local or wider spread epidemics.  These include Lassa, Marburg and Ebola Viral Diseases (EVD).  The 2013-14 outbreak of EVD in West Africa has proven far more difficult to control than previous epidemics and is now present in Sierra Leone, Liberia and Guinea with more than 2000 deaths.  This epidemic appears to have a case related mortality of approximately 55% against a range for EVD of 50-95%.

Following infection, patients remain asymptomatic for a period of 2-21 days, and during this time tests for the virus will be negative, and patients are not infectious, posing no public health risk. Once the patient becomes symptomatic, EVD is spread through contact with body fluids including blood.  Symptoms include diarrhea, vomiting and bleeding, and all these body fluids are potentially sources of infection.

Management is primarily through infection control, the use of personal protective equipment (PPE) by health care workers and those disposing of body fluids and of bodies, and supportive care for sick patients including using IV fluids and inotropes. Contact tracing is also important but may be difficult in many of the communities currently affected.  Vaccines are in development as are some antivirals, but they will arrive late in this epidemic if they are proven successful.

Evidence from those treating patients in affected communities is that a shortage of resources, including health care workers and PPE, as well as poor infection control training of health care workers, caregivers and others at risk are making epidemic control difficult.

Some governments have indicated that they will build new treatment centres in affected areas as a matter of urgency, while others are directly providing personal protective equipment and other supplies.

RECOMMENDATIONS

  1. The WMA honours those working in these exceptional circumstances, and strongly recommends that national governments and international agencies work with health care providers on the ground and offer stakeholders training and support to reduce the risks that they face in treating patients and in seeking to control the epidemic.
  2. The WMA commends those countries that have committed resources for the urgent establishment of new treatment and isolation centres in the most heavily burdened countries and regions.  The WMA calls upon all nations to commit enhanced support for combatting the EVD epidemic.
  3. The WMA calls on the international community, acting through the United Nations and its agencies as well as aid agencies, to immediately provide the necessary supplies of PPE to protect health care workers and ancillary staff and reduce the risk of cross infection.  This must include adequate supplies of gloves, masks and gowns, and distribution must include treatment centres at all levels.
  4. The WMA calls on all those managing the epidemic, including local and national governments and agencies such as WHO, to commit to adequate training in infection control measures, including PPE for all staff and caregivers who might come into contact with infective materials.
  5. The WMA calls on national and local governments to increase public communication about basic infection control practices.
  6. The WMA calls upon WHO to facilitate research into the timeliness and effectiveness of international interventions, so that planning and interventions in future health emergencies can be better informed.
  7. The WMA strongly urges all countries, especially those not yet affected, to educate health care providers about the current case definition in addition to strengthening infection control methodologies and contact tracing in order to prevent transmission within their countries.
  8. The WMA calls for NMAs to contact their national governments to act as described in this document.