Legal and ethical considerations in AMR data

Introduction

This module introduces fundamental concepts in medical, public health and animal ethics, and how they relate to AMR. It then introduces the role of international legal frameworks and governance mechanisms relevant to AMR, highlighting that this is an emerging area of research and practice.

After completing this module, you will be able to:

• define the four key principles of medical ethics
• identify key ethical issues relevant to AMR
• describe guidelines for ethics in healthcare, health research and public health, and how they are relevant to AMR
• describe guidelines and key concepts in animal ethics relevant to AMR
• describe the current and potential role of international legal frameworks in supporting action on AMR.

1 An introduction to ethics

What are ethics? What does it mean to be ‘ethical’?

Ethics is a process of understanding, evaluating and recommending a set of principles that guide human behaviour. We all practice ethics in our daily decision-making: it is about deciding, as individuals and societies, what we consider to be ‘right’ and ‘wrong’ based on a set of rules or standards that governs proper conduct.

Our approach to determining ethical issues can change over time in response to new information, emerging values and different ways of seeing the world.

Watch this short video (McCombs School of Business, 2018a) to find out more about ethics:

Morals are what each person believes to be ‘right’ or ‘wrong’. They are based on a set of principles and values at societal or individual levels, and can vary between societies and individuals.

You can learn more about morals by watching this short video (McCombs School of Business, 2018b):

The terms ‘ethics’ and ‘morals’ are often used interchangeably. However, they are distinguishable: ethics is typically associated with a set of rules or standards within a community or professional setting (for example, a medical code of ethics); morals are typically associated with an individual’s own values and principles (Gert and Gert, 2020).

One of the branches of ethics relevant to AMR, and thus to this module, is ‘applied ethics’. Applied ethics seeks to answer practical issues of moral importance: for example, whether a wealthy country is morally obliged to provide Covid-19 vaccines to low- and middle-income countries (LMICs) that are unable to access sufficient vaccines for their populations, for reasons of cost or availability.

Healthcare ethics and animal ethics are particularly relevant to antimicrobial resistance (AMR), which will be discussed in the following sections.

1.1 Healthcare ethics

Healthcare ethics is concerned with the set of principles and values applied to patient care, public health and medical research. It can be subdivided into:

• medical/clinical ethics – ethical issues and dilemmas in individuals in medical practice
• research ethics – protection of research participants, informed consent, etc.
• public health ethics – ethical issues and dilemmas at population level
• bioethics – the study of ethical issues brought about by advances in biology and medicine.

This module focuses on the first three branches of ethics.

Medical/clinical ethics

Medical ethics are the principles that govern the conduct of medical professionals, and their interactions with patients and others in the medical field.

You might have heard of the ‘Hippocratic oath’, which is a pledge (or promise) that physicians have traditionally taken at the start of their medical career to uphold high ethical standards in their practice. The oath dates to Classical Greece, to the time of Hippocrates (c. 460–370 BCE), a Greek physician, who is traditionally referred to as the ‘Father of Medicine’ and is credited with coining the Hippocratic oath.

Because language and medical practice has changed, medical schools in many countries no longer use the Hippocratic oath; instead, they use their own, modern version, or alternatively the Declaration of Geneva (sometimes called ‘the modern Hippocratic oath’). The Declaration of Geneva, adopted by the World Medical Association (WMA) in 1948, builds on the principles of the original Hippocratic oath and reflects the ethical and moral decision-making in the modern era (Parsa-Parsi, 2017).

The Declaration of Geneva should be read in parallel with ethical guidelines such as the International Code of Medical Ethics. The two documents together provide ethical guidance on how physicians should interact with their patients. For example, the Declaration of Geneva includes the pledge that ‘the health and wellbeing of my patient will be my first consideration’, while the International Code of Medical Ethics declares that ‘a physician shall act only in the patient’s interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient’.

While the Hippocratic oath and the Declaration of Geneva are not legally binding, most countries have a medical licensing authority (such as the General Medical Council in the UK) that regulates doctors according to the principles derived from the oath and/or the declaration. Similar bodies also exist for veterinarians. Practitioners found to be in breach of the principles may have their licence revoked and would be prevented from working as a doctor or veterinarian.

(If you’re interested in these topics, you can read more about the Hippocratic oath (NLM, 2002), the Declaration of Geneva (WMA, 2018a) and the International Code of Medical Ethics (WMA, 2018b).)

Research ethics

Medical research involves human subjects. In this respect, research ethics is concerned with upholding high ethical standards that promote and protect human participants involved in research studies.

For medical researchers, the Declaration of Helsinki, developed by the WMA, is a statement of ethical principles and guidance for medical research involving human subjects. At its core is the principle that it is the ‘duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject’.

(If you’re interested in this topic, you can read more about the Declaration of Helsinki (WMA, 2001).)

There are many examples of unethical medical experiments where the rights of participants have been violated. Well-known examples of notorious experiments include those done by the Nazis, the Stanford prison experiment and the Tuskegee syphilis study. The ethical standards that medical researchers around the world adhere to today aim to prevent malevolent experimentation on vulnerable people.

The activity below highlights why research ethics is important.

Public health ethics

Compared to medical ethics, public health ethics is a relatively new field. It shares many of the foundations of medical ethics, but with the crucial difference that it concerns the judgements and decisions that affect the health and wellbeing of populations.

Ethical conflicts can arise in the practice of public health in much the same way as they do in the field of medical research:

• Controlling infectious diseases might restrict an individual’s freedom of movement.
• Using routinely collected healthcare data to investigate the epidemiology of sensitive conditions (such as drug-resistant gonorrhoea) has implications for individual privacy and right to personal data.

1.2 Animal ethics

Animal ethics concerns the set of values that apply to human–animal relationships and interactions, including the rights, treatment and welfare of animals. Animal ethics evolved from the need to regulate animal research practices and from increasing societal concerns about the treatment of animals.

It wasn’t until the 19th century that principles regulating the use of animals in research came of age. Today, many countries have legislation and frameworks protecting the right of animals and their wellbeing when used in research. An example of a framework is the pledge taken by veterinarians to uphold ethical standards in veterinary practice. Similar to the Hippocratic oath sworn by medical physicians, veterinarians pledge to protect the health and welfare of animals, prevent disease where possible, advocate for animals, and minimise pain and suffering.

(If you’re interested in these topics, you can read more about the global veterinary oath and see many countries’ own version of it (WSAVA, 2019).)

Notably, the veterinary oath encourages veterinarians to support One Health principles. This is because veterinarians are uniquely placed to protect human health alongside animal health. This could be at the individual level, such as treating a pet infected with a zoonotic parasite and informing the owner of the risk to themselves, or at the population level; for example, controlling an outbreak of Salmonellosis in chickens to prevent people from consuming infected eggs or meat and getting sick.

1.3 The four principles of medical ethics

The ‘four principles’ approach to medical ethics – respect for autonomy, beneficence, non-maleficence and justice – provides healthcare professionals with guidance when making moral decisions involving patients. An explanation of each of the four principles is given in Table 1.

The four principles form a moral framework and a common language for health professionals worldwide to reflect on healthcare ethics. They are intended to be neutral to cultural, political, religious and philosophical differences.

All four principles are equally important; none should be violated to pursue another. For example, scientists pursuing research that might produce positive outcomes for society overall cannot violate the principle of autonomy by forcing people to participate in such research.

2 Why is ethics important for AMR?

The threat of AMR is well-known: infections that have previously been successfully treated will no longer be treatable. Our knowledge of the risks of AMR means we must take actions to slow resistance and find new ways of treating infections (Parsonage et al., 2017). The implications of action or inaction on AMR are a serious ethical consideration (Littmann and Viens, 2015).

Inevitably, ethical questions on how to respond to AMR come back to antimicrobial use (AMU):

• How do we balance addressing the critical lack of access to antimicrobials faced by large proportions of the global population against overuse and misuse?
• Who should receive antimicrobials and who should not?
• Can we preserve the effectiveness of antimicrobials whilst ensuring everyone (and every animal) has access to effective treatment for bacterial diseases?

Radically reducing AMU raises questions about the ethical limits of preserving antimicrobial effectiveness (Littmann and Viens, 2015).

2.1 Ethical considerations of AMR in animal health and production

Ethical issues on AMR are not limited to human health care settings; ethical questions about AMU in animals must also be considered.

Consider this list of ethical questions related to AMR and AMU in animals:

• Should we stop giving food animals antimicrobials to promote their growth or to prevent disease when they are showing no clinical or subclinical signs of illness, if we think this action poses a threat to the future health and safety of people?
• Do we know if stopping or severely restricting AMU in food animals will reverse trends in emerging AMR in human health and in animal health?
• How can we moderate AMU in livestock production systems while meeting the needs of individuals, communities and nations who rely on agriculture to survive and thrive?
• How can we moderate AMU in food animals to protect their welfare and ensure they do not suffer debilitating or life-threatening infectious diseases, while also safeguarding the effectiveness of antimicrobials for human health?
• How can we modify the way in which antimicrobials are used in pet/companion animals and horses to reduce the risk of AMR that may spread from animals to their owners?
• Veterinarians have professional and societal expectations to treat animals who are sick and require antimicrobial agents. How can animals be treated whilst minimising the risk of AMR affecting the health of animals and of people?

These are some of the ethical questions we face as we look at ways to minimise the risk of AMR in animals and people who interact with pets, horses and food animals, and consume animal products.

Already in the European Union and some nations, bans have been introduced on the use of medically important antimicrobials in food animals. In 2017, the WHO published its Guidelines on the Use of Medically Important Antimicrobials in Food-producing Animals, which makes four recommendations, including the restriction of all classes of medically important antimicrobials for prevention of diseases that have not been clinically diagnosed (WHO, 2017a).

Widespread societal concerns about AMU practices in food animals, like growth promotion, are also driving these restrictions. However, some of the recommendations made in the WHO’s guidelines were controversial in the veterinary sector, given the WHO’s admission that there is sparse scientific evidence supporting their recommendations (Scott et al., 2019).

(If you are interested in learning more, The World Organisation for Animal Health publishes a regularly updated list of veterinary antimicrobials of importance to animals (OIE, 2021), and the Antimicrobial stewardship in animals module discusses AMU in animals in detail.)

2.2 Global impacts of AMR

Inaction on AMR has global consequences, particularly for those living in LMICs who are disproportionately affected by bacterial diseases. People may also face the risk of losing their livestock animals if AMR means that common animal diseases cannot be treated. Figure 1 shows how AMR disrupts the Sustainable Development Goals (SDGs)). (The WHO has published a report about AMR and the SDGs (WHO, 2018).)

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Figure 1 Five ways that AMR disrupts the SDGs.

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This figure shows five ways that AMR could disrupt sustainable development goals:

• SDG 1, no poverty: AMR could push an additional 24 million people into extreme poverty by 2030.
• SDG 2, zero hunger: Livestock production in low-income countries would be affected the most. Under a high AMR impact scenario, there is a possibility of a 7% loss in productivity by 2030. Animal protein plays an important role in nutrition for children and women.
• SDG 3, good health and wellbeing: Effective antibiotics are needed to treat infections. AMR puts patients treating cancer, recovering from surgeries or from diabetic foot ulcers at risk for life-threatening infections.
• SDG 8, decent work and economic growth: AMR’s impact on global GDP might be as large as the 2008–09 global financial crisis, amounting to losses of $3.4 trillion by 2030.
• SDG 10, reduced inequality: any reductions in economic growth would be faced primarily by low-income countries. AMR could further widen economic inequality between countries.

Figure 1 Five ways that AMR disrupts the SDGs.

The ethical consequences of inaction on AMR throughout the world include the following points:

• AMR presents a direct risk to patients: In the presence of AMR, the risks of undergoing surgery will drastically increase if post-operative infections cannot be effectively prevented or treated. This will require clinicians to change their assessments of the benefits of surgical and other medical procedures, balanced against the potential risk of untreatable infection.
• AMR is not a problem that can be ‘fixed’ Micro-organisms continually evolve and develop AMR mechanisms, from exposure to antimicrobials or via transfer of resistance genes. Acting now can only reduce, not fully eliminate, AMR. Future generations will also have to take continuous actions.
• AMR is a high-cost burden on the healthcare system: We face a future where common bacterial infections may be untreatable. Patients with multidrug-resistant infections require extended hospital stays, which increase the pressure on health systems overall. Antimicrobials are a relatively cheap intervention; alternatives to antimicrobials are often more expensive.
• AMR is a food security risk: Antimicrobials are essential for food security. The growing burden of AMR in food-producing animals could affect productivity, decrease the availability of meat, eggs, dairy and fish, increase food prices, and impact food safety.
• AMR will cost the world: Perhaps some of the most severe impacts of AMR will occur through the impact on economic growth. This will be through lost productivity through days of work due to prolonged infections, death and costs to government. It has been estimated that the cost of AMR to global GDP will be up to US$100 trillion by 2050 if nothing is done (O’Neill, 2014).

Now that we have some ideas about the ethical impacts of inaction, let’s also consider some of the ethical considerations when choosing to take action on AMR:

• Developing and distributing new antimicrobial medicines: Ethical considerations include asking:
  • Whose responsibility is it to develop new antimicrobials? Is it governments, private companies, or public-private partnerships?
  • Who should pay for this new drug development? Is it the moral duty of high-income countries to develop these drugs if LMICs cannot afford to?
  • How can research and development of antimicrobial medicines be incentivised, while ensuring access to the most vulnerable, especially in LMICs with limited purchasing power for patented medicines?

• A 2015 report commissioned by the UK government, Securing New Drugs for Future Generations – the Pipeline of Antibiotics, aims to answer some of these questions (O’Neill, 2015).

• Monitoring and surveillance of AMR and AMU: Ethical considerations relate to the conflict between the individual’s rights to privacy and ownership of personal data and the need to understand AMR and AMU on the population scale. For example, balancing benefits of having local-level indicators of AMR, used to guide treatment and stewardship decisions, against the risk of re-identifying individuals or groups.
• Animal welfare and responding to AMR: How does action on AMR and AMU conflict with society’s moral duty to care for animals’ health and wellbeing? For example, should we modify the treatment of food animals with antimicrobials to protect the health of people? How do we respond to animals who are in pain and suffering? What impact will this decision have on individuals and communities who rely on animal agriculture?

2.3 AMR surveillance and the ethics of privacy and confidentiality

Protecting the privacy and confidentiality of the personal information of the patient or individual participating in research is an important ethical consideration. Central databases that hold large amounts of personal data carry the risk of privacy violation. This is especially the case as more institutions embrace ‘big data’ technologies in healthcare. The use of big data in medical decision-making raises ethical considerations about the use of patient data or stored biological specimens (such as blood or tissue), especially without the informed consent of the subject.

Public health programmes can complicate the privacy of patient records. Ethical principles such as the right to privacy may conflict with the need to rapidly share surveillance data in the context of an outbreak or emergency. For example, it may be necessary to notify all hospitals in an area of an outbreak of an AMR infection without seeking permission from each affected patient for their data to be shared.

In surveillance, ethical lines can be blurred. Individuals have the right to expect that their information will not be shared or used other than directly for their care, but this may be overridden in the interests of the broader population.

Ethical guidance on the use of big data in healthcare is sparse. The WHO is leading an international effort to develop ethical guidance on the use of big data in public health, although guidelines are yet to be published (WHO, 2017b).

3 The role of international legal frameworks in AMR

In this section we will look at the laws that aim to protect people from public health threats. Many of these laws focus on sanitation, food safety and controlling the spread of infectious diseases – including those caused by resistant bacteria.

3.1 Public health law and ethics

Governments worldwide have a responsibility to fulfil their moral mandate to protect citizens from foreseeable threats of harm, including health threats. Public health laws provide the government with the authority to take action to protect its citizens. The laws often include provisions that deter certain behaviours; for example, issuing fines or jail terms for adulterating food.

Have you noticed how your government is handling the Covid-19 pandemic? For example, are people required to stay at home? Have schools been closed? Are face masks required when you leave the house? Government actions in response to the pandemic are often governed by the public health laws enacted in your country.

There are also international public health regulations that affect how governments respond to pandemics and other infectious disease outbreaks. (International frameworks are discussed later in this section.)

Laws and ethics in public health serve unique yet complementary purposes: whereas laws are formal, and include statutes and regulations, ethics are less formal, involving moral norms, codes of conduct and so on. Laws provide the boundaries of what you must do and must not do, but they often cannot tell you what you should do. Sometimes, laws may conflict with our moral values (what we ought to do). Laws and ethics can be synergistic: ethics can provide moral guidance when the law is indeterminate or allows discretion.

Essentially, we must justify whether interference with a person’s rights is justified to protect public health and whether it is proportionate to the threat. And so we arrive at the central problem with public health law and ethics: balancing the rights and responsibilities of the individual, the community and the government. In public health law, the collective rights outweigh the individual’s rights, but there must be some discretion when making decisions to protect the community.

3.2 International legal frameworks for action on AMR

Our response to AMR will be led by the laws and policies of our governments. These government mechanisms need to address the ethical issues related to managing AMR. Where government mechanisms currently exist, they tend to focus on interventions to reduce AMU or the types of AMU in certain populations.

International legal agreements specifically for action on AMR have been proposed but not yet fully enacted. Possible forums for developing such an agreement include WHO, the World Trade Organization (WTO) and the United Nations General Assembly. This section will present some examples of how these ideas are being considered and enacted.

3.3 AMR governance

Our response to AMR requires establishing governance mechanisms at the global, national and local levels. However, recent global health crises have exposed deficiencies in the global health governance framework. Specifically, inadequate investment in capacity-building in human and animal health systems, lack of funding to support global responses to disease emergencies, and non-compliance with the IHR 2005 (trade and travel restrictions) (Bennett and Iredell, 2020).

In recognition of these shortcomings, the 2019 final report of the United Nations (UN) Interagency Coordination Group (IACG) on AMR, No Time to Wait: Securing the Future from Drug-resistant Infections, recommends the urgent establishment of a One Health Global Leadership Group on AMR (IACG, 2019). The Global Leadership Group is expected to drive forward the global response to AMR.

Members of the Global Leadership Group will include a broad range of stakeholders from all sectors affected by AMR – human health, animal health, agriculture, environment, heads of state, and global leaders across the spectrum of geo-economic situations.

3.4 AMR and trade agreements

The risk of AMR contamination from food animals and agriculture is becoming a consideration in trade negotiations between countries. These trade negotiations require international cooperation and advocacy to ensure that future trade decisions have a foundation in scientific evidence. For many LMICs that are net exporters of animal food products (such as Brazil, Argentina and Indonesia), changes in how trade agreements are negotiated based on perceived AMR risk may structurally affect the way that individual farmers use antimicrobials and care for their livestock.

One example of how trade is being affected is the new European Union (EU) legislation that imposes restrictions on medicated feed (Regulation 2019/ 4) and veterinary medicines (Regulation 2019/ 6) (EUR-Lex, 2019a/2019b). In 2022, the EU legislation will come into full force in all Member Countries. The legislation prohibits all forms of routine AMU in farmed animals, including for growth promotion and preventative (prophylaxis) group treatments, with some critical exceptions. Some critically important antimicrobials will not be permitted for use in food animals to preserve their effectiveness in human health. Importantly, these new legislative standards will be reciprocal for imported food, meaning trading partners will have to respect the ban on antimicrobials for growth promotion and the restrictions on critically important antimicrobials.

The EU legislation will substantially influence antimicrobial prescribing and usage in food animals, not just in Europe but in farming businesses of major trading partners. The impact of these laws on trading partners may be difficult to predict: for example, countries outside the EU that export milk and milk products to the EU may require dairy farmers to modify some practices, such as the use of dry cow therapies (DCT), as this practice would be considered a preventative use of antimicrobials under the new EU legislation. These changes may require substantial structural change in the way dairy cattle are managed at the individual herd level to comply with the EU laws. In some cases, this may not be possible, meaning that some farmers may miss out on export opportunities.

You may be asking yourself what the relationship is between international trade, ethics and AMR:

• How do we think about balancing ethical concerns about responding to AMR with the notion of free and fair trade?
• How should the international trading system evolve to be equitable and sustainable as we respond to AMR?
• Is it OK for one country (or a group of countries) to restrict trade by prohibiting certain types of antimicrobials and/or the way they are used in another country?
• Can we draw a line between the protection of consumers (such as reducing exposure to potential resistant foodborne bacteria) and protectionism (imposing barriers to trade)?

Such questions have become more pronounced as some countries lose patience with the slow pace of a global response to AMR.

Case Study 2 shows how countries such as Argentina and the United States have responded to the EU legislation on veterinary medicines at the World Trade Organisation (WTO).

4 End-of-module quiz

Well done – you have reached the end of this module and can now do the quiz to test your learning.

This quiz is an opportunity for you to reflect on what you have learned rather than a test, and you can revisit it as many times as you like. 

• End-of-module quiz

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5 Summary

In this module, you have learned about fundamental concepts in ethics as they relate to AMR. You have reviewed ethics as they related to healthcare, public health and animals. We looked at the interaction between animal ethics and animal welfare, and considered the legal and governance frameworks related to actions we take to control AMR in our societies, highlighting that this is an emerging area of research and practice.

You should now be able to:

• define the four key principles of medical ethics
• identify key ethical issues relevant to AMR
• describe guidelines for ethics in healthcare, health research and public health, and how they are relevant to AMR
• describe guidelines and key concepts in animal ethics relevant to AMR
• describe the current and potential role of international legal frameworks in supporting action on AMR.

Now that you have completed this module, consider the following questions:

• What is the single most important lesson that you have taken away from this module?
• How relevant is it to your work?
• Can you suggest ways in which this new knowledge can benefit your practice?

When you have reflected on these, go to your reflective blog  and note down your thoughts.

6 Your experience of this module

Now that you have completed this module, take a few moments to reflect on your experience of working through it. Please complete a survey to tell us about your reflections. Your responses will allow us to gauge how useful you have found this module and how effectively you have engaged with the content. We will also use your feedback on this pathway to better inform the design of future online experiences for our learners.

Many thanks for your help.

Now go to the survey.

References

Acknowledgements

This free course was collaboratively written by Melanie Bannister-Tyrrell and Clare Sansom, and was reviewed by Siddharth Mookerjee, Claire Gordon, Joanna McKenzie, Adrienne Chattoe-Brown and Peter Taylor.

Except for third party materials and otherwise stated (see terms and conditions), this content is made available under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 Licence.

The material acknowledged below is Proprietary and used under licence (not subject to Creative Commons Licence). Grateful acknowledgement is made to the following sources for permission to reproduce material in this free course:

Images

Module image: melpomen/123RF.

Figure 1: ReAct, https://www.reactgroup.org/.

Text

Case Study 1: GHSA, 2019.

Case Study 2: WTO, 2018.

Tables

Table 1: Gillon, 1994.

Every effort has been made to contact copyright owners. If any have been inadvertently overlooked, the publishers will be pleased to make the necessary arrangements at the first opportunity.