Policy Tag: Resistance

Adopted by the 48th WMA General Assembly, Somerset West, South Africa, October 1996,
revised by the 59th WMA General Assembly, Seoul, Korea, October 2008 and
by the 70th WMA General Assembly, Tbilisi, Georgia, October 2019

 

PREAMBLE

AMR is a growing threat to global public health that transcends national boundaries and socioeconomic divisions. AMR affects human, animal and environmental health. It is a multi-faceted problem of crisis proportions with significant economic, health, and human implications.

Addressing the threat of antimicrobial resistance is a fundamental global health priority, and the responsibility of all countries.

Antimicrobial drugs form an essential component of modern medicine, ensuring that complex procedures, such as surgery and chemotherapy, can be performed with lower risk.

AMR threatens the effective prevention and treatment of an increasing range of infections caused by bacteria, parasites, viruses and fungi.

AMR occurs when microorganisms develop the ability to resist the actions of antimicrobial drugs (such as antibiotics, antifungals, antivirals, antimalarials, and anthelmintics).

Infections caused by bacteria that are resistant to multiple classes of antibiotic are increasingly being documented.

While AMR is a natural evolutionary phenomenon, it is exacerbated by the overuse and misuse of antimicrobials in medicine, as well as in veterinary practice and agriculture, and can be exacerbated when antimicrobials are given as growth promoters in animals or used to prevent diseases in healthy animals.

The emergence and spread of AMR is further enhanced by lack of access to effective drugs, access to antibiotics “over the counter” in some countries, the availability of substandard and falsified products, misuse of antibiotics in food production, increased global travel, medical tourism and trade, and the poor application of infection control measures.

Another major cause of AMR is the release of antibiotics into the environment. This can occur as either as a result of poor manufacturing practices, the improper disposal of unused medication, human and animal excretion, and the inadequate disposal of human and animal corpses.

In many countries, particularly in low-and middle-income countries, access to effective antimicrobials as well as complementary technologies including vaccines and diagnostics continues to remain a significant challenge, furthering AMR.

The ramifications of resistance manifest themselves not just in the impact on human health, but also in potentially heavy economic costs. The World Health Organization (WHO) has warned that resistance has reached alarming levels in many parts of the world, and that a continued increase in resistance could lead to 10 million people dying per year and a reduction of 2-3.5% in global gross domestic product by 2050.

At the rate at which resistance is growing globally, it poses a significant threat to successfully achieving the UN Sustainable Development Goals and undermines efforts to reduce health inequalities. Without harmonized and coordinated cross-sector action on a global, scale, the world is heading towards a post-antibiotic era in which common infections and minor injuries can once again kill.

AMR has reached great prominence at the highest political levels including the UN General Assembly, and the agenda of the G7 and G20.

There is a need for an effective ‘one health’ approach to minimize unnecessary or inappropriate use of antimicrobials and to prevent and control the transmission of existing resistance. A ‘one health’ approach recognizes that action is required across human medicine, veterinary practice and agriculture.

 

RECOMMENDATIONS

Global

  1. The primary prevention of community and healthcare associated infections is necessary to reduce the demand for antibiotics. Addressing the social determinants of infectious disease, such as poor living conditions and sanitation, will have co-benefits of reducing health inequalities and tackling AMR.
  2. Nations have varying resources available to combat antimicrobial resistance, and must cooperate with the WHO, Food and Agriculture Organization and World Organization for Animal Health that support the WHO Global Action Plan on AMR which provides the framework for national action plans.
  3. The World Medical Association and its constituent members should advocate for:
    • investment in the surveillance of drug resistant infections across human health, veterinary medicine, agriculture, fishing industry, and food production, and international cooperation for data-sharing procedures to improve global responses;
    • the WHO and other UN agencies should examine the role of international travel and trade agreements on the development of antimicrobial resistance, and promote measures in those agreements to act as safeguards against the globalisation of drug resistant pathogens in our food supply;
    • the WHO should continue to encourage the use of Trade Related Aspects of Intellectual Property Rights (TRIPS) flexibilities to help ensure affordable access to quality medicines and oppose the proliferation of ‘TRIPS-plus’ provisions within trade agreements, which restrict the use of TRIPS flexibilities and limit their effectiveness;
    • the widespread application of verifiable technology such as track-and-trace systems to ensure the authenticity of pharmaceutical products;
    • equitable access to, and appropriate use of, existing and new quality-assured antimicrobial medicines. This requires effectively applying the Access, Watch and Reserve lists of the WHO Essential Medicines program. For the WHO global action plan and national action plans to be effective, access to health facilities, health care professionals, veterinarians, knowledge, education and information are vital;
    • greater use of vaccinations which will reduce the burden of infectious disease, reducing the need for antibiotics and therefore limiting the emergence of resistance;
    • for global health organisations and governments to scale up their action and coordination in promoting appropriate antibiotic use and work together to reduce AMR using a One Health approach, which recognises that human, animal and environmental health is inextricably linked. to reduce the spread of resistance.
  4. The World Medical Association and its constituent members should encourage their governments to:
    • fund more basic and applied research directed toward the development of innovative antimicrobial agents, diagnostic tools and vaccines (innovative antimicrobial vaccines), and on the appropriate and safe use of such therapeutic tools;
    • ensure parity between financial and technical resources towards the development of innovative antimicrobial medicines, vaccines, and diagnostics as well as innovative infection control and prevention methods across human health, veterinary, and agricultural sectors;
    • support Research and Development efforts for novel antimicrobial agents, vaccines, and rapid diagnostic methods that are needs-driven and guided by the principles outlined in the UN Declaration on AMR, adopted in September 2016, including affordability, effectiveness, efficiency, and equity;
    • initiate regulatory measures to control the environmental pollution that allows the spread of antibiotic-resistant genes across soil, water and air;
    • educate a sufficient number of clinical infectious disease specialists in every country, which is a fundamental requirement for tackling antimicrobial resistance and hospital-acquired infections.

National

  1. National medical associations should urge their governments to:
    • require that antimicrobial agents be available only through a prescription provided by healthcare professionals and/or veterinary professionals and dispensed or sold by professionals;
    • initiate national campaigns to raise awareness among the public of the harmful consequences of overuse and misuse of antibiotics. This should be supported through the introduction of national targets to raise public awareness;
    • support professional societies, civil society, and healthcare delivery systems to pilot and adopt proven behaviour change strategies to ensure appropriate use of antibiotics;
    • ensure access to appropriate and fit-for-purpose point-of-care diagnostics in hospitals and clinics to support decision making and prevent inappropriate prescribing of antibiotic;
    • mandate the collection of data on antibiotic use, prescriptions, prices, resistance patterns, and trade in both the healthcare and agricultural sectors. This data should be made publicly accessible;
    • promote effective programs of antimicrobial stewardship and training on the appropriate use of antimicrobials agents, and infection control;
    • actively pursue the development of a national surveillance system for the provision of antimicrobials and for antimicrobial resistance. Data from this system should be linked with or contributed to the WHO’s global surveillance network;
    • monitoring of antimicrobial use in food producing animals must be sufficiently granular to ensure accountability.
  2. National medical associations should:
    • encourage medical schools and continuing medical education programs to renew their efforts to educate physicians, who can in turn inform their patients, about the appropriate use of antimicrobial agents and appropriate infection control practices, including antibiotic use in the outpatient setting;
    • support the education of their members in areas of AMR, including antimicrobial stewardship, rational use of antimicrobials, and infection control measures including hand hygiene;
    • advocate for the publishing and communication of local information relating to resistance patterns, clinical guidelines and recommended treatment options for physicians;
    • in collaboration with veterinary authorities, encourage their governments to introduce regulations to reduce the use of antimicrobials in agriculture, in particular food producing animals, including restrictions on the routine use of antimicrobials for both prophylaxis and growth promotion, and on the use of classes of antimicrobial that are critically important in human medicine;
    • support regulation that prevents conflicts of interest among veterinarians, such as roles where veterinarians both prescribe and sell antibiotics;
    • consider the use of social media to educate and promote the proper use and disposal of antibiotic medications;
    • encourage parents to comply with the national recommended immunization schedules for children. Adults should also have easy access to vaccines against influenza and pneumococcal infections among others.

Local

  1. Health professionals and health systems have a vital role in preserving antimicrobial medicines.
  2. Physicians should:
    • have access to high-quality and reliable, evidence-based information free of conflict of interest and actively participate in and lead antimicrobial stewardship programs in their hospitals, clinics and communities to optimise antibiotic use;
    • raise awareness amongst their patients about antimicrobial therapy, its risks and benefits, the importance of adherence with the prescribed regimen, infection prevention practices, and the problem of AMR;
    • promote and ensure adherence hygiene measures (especially hand hygiene) and other infection prevention practices.

Adopted by the 53rd WMA General Assembly, Washington, DC, USA, October 2002,
editorially revised by the 164th WMA Council Session, Divonne-les-Bains, France, May 2003,
reaffirmed by the 191st WMA Council Session, Prague, Czech Republic, April 2012, and
revised by the 74th WMA General Assembly, Kigali, Rwanda, October 2023

 

PREAMBLE

Rapid advances in microbiology, molecular biology, and genetic engineering have created extraordinary opportunities for biomedical research and hold great promise for improving human health and the quality of life. However, the proliferation of these technologies provides the opportunity to create novel pathogens and diseases and simplified production methods for biological weapons. The technologies are relatively inexpensive and, because production is similar to that used in biological facilities such as vaccine manufacturing, they are easy to obtain. Capacity to produce and effectively disperse biological weapons exists globally, threatening governments and endangering people around the world.

The consequences of a biological attack would be insidious and devastating. Their impact might continue with secondary and tertiary transmission of the agent, weeks, months or years after the initial epidemic. Given the ease of travel and increasing globalization, an outbreak anywhere in the world could be a threat to all nations. A great many severe, acute illnesses occurring over a short span of time could overwhelm the capacities of health systems worldwide.

Physicians and other health personnel are on the frontline in alleviating human suffering caused by epidemic disease and will bear primary responsibility for dealing with the victims of biological weapons.

Participants in biomedical research have a moral and ethical obligation to consider the implications of possible malicious use of their findings. Through deliberate or inadvertent means, genetic modification of microorganisms could create organisms that are more virulent, are antibiotic-resistant, or have greater stability in the environment. Genetic modification of microorganisms could alter their immunogenicity, allowing them to evade natural and vaccine-induced immunity. Advances in genetic engineering and gene therapy may allow modification of the immune response system of the target population to increase or decrease susceptibility to a pathogen or disrupt the functioning of normal host genes.

Nonproliferation and arms control measures can diminish but cannot completely eliminate the threat of biological weapons. Thus, there is a need for the creation of and adherence to a globally accepted ethos that rejects the development, production, possession and use of biological weapons. International collaboration is critical to build such a universal consensus.

The United Nations Biological Weapons Convention (BWC) prohibits the development, production, acquisition, transfer, stockpiling and use of biological and toxin weapons. Having reached almost universal membership, the BWC constitutes a key element in the international community’s efforts to address the proliferation of weapons of mass destruction and has established a strong norm against biological weapons.

Medical associations and physicians have a responsibility in educating the public and policy makers about the implications of biological weapons and to mobilize universal support for condemning research, development, or use of such weapons as morally and ethically unacceptable. They have important societal and ethical roles in demanding the full respect of the BWC, stigmatizing the use of biological weapons, guarding against unethical and illicit research, and mitigating harm from use of biological weapons.

 

RECOMMENDATIONS

Recognizing the growing threat of biological weapons, the WMA and its constituent members condemn the development, production, or use of toxins and biological agents that have no justification for prophylactic, protective, therapeutic or other peaceful purposes, and makes the following recommendations:

Strengthening global preparedness and response to health emergencies

Governments and national health authorities:

  1. To develop a strategy for the effective coordinated and timely access to vital protective measures for new pathogens, whatever their origin, for all populations at risk. The strategy should assure surge capacity to address mass casualty care.
  2. In line with the WMA Statement on Epidemics and Pandemics, to meet the critical needs for:
  • Adequate investment in public health systems, including resources and supplies, to enhance capacity to effectively detect, investigate and contain rare or unusual disease outbreaks.
  • An operative global surveillance program to improve response to naturally occurring infectious diseases and to permit earlier detection and characterization of new or emerging diseases.
  1. To provide to WHO adequate means to fulfill its leadership role in ensuring appropriate international cooperation and coordination for surveillance and action on emerging infectious diseases.
  2. To support the development of a WHO legally binding instrument on pandemic prevention, preparedness and response, integrating principles of equity and human rights.
  3. To develop adequate and targeted health education and training for health professionals, civic leaders, and the public alike, as well as collaborative programs of research to improve disease diagnosis, prevention, and treatment.
  4. To develop communications strategies to inform health care professionals and the public about acts of bioterrorism and infectious disease outbreaks, including local information on available medical services.
  5. To fund research and development to counteract biological weapons, including:
  • to improve understanding of the epidemiology, pathogenesis, and treatment of diseases caused by potential bioweapon agents and the immune response to such agents;
  • for new and more effective vaccines, pharmaceuticals, and antidotes against biological weapons; and
  • for improving biological agent detection and defense capabilities.

Physicians, Medical Associations and other health entities:

  1. To participate with local, national, and international health authorities in developing and implementing disaster preparedness and response protocols for acts of bioterrorism and natural infectious disease outbreaks. These protocols should be used as the basis for physician and public education.
  2. To support and fulfill the critical role of physicians in early detection of unusual clusters of diseases or symptoms, potentially resulting from the use of biological weapons, so that they can promptly report it to the appropriate institutions.
  3. Physicians in relevant specialties should:
  • be alert to the occurrence of unexplained illness and death in the community;
  • be knowledgeable of disease surveillance and control capabilities for responding to unusual clusters of diseases, symptoms, or presentations;
  • be familiar with the clinical manifestations, diagnostic techniques, isolation precautions, decontamination protocols, and therapy/prophylaxis of biological agents likely to be used in an attack;
  • utilize appropriate procedures to prevent exposure to themselves and others; and
  • understand the essentials of risk communication so that they can communicate clearly and nonthreateningly about issues such as exposure risks and potential preventive measures.

Counteracting biological weapons research

Governments and national health authorities:

  1. To develop and implement national and global raising awareness strategies on the potential development of biological weapons among researchers and practitioners, with comprehensive information on the reporting system to be used if needed.
  2. To reinforce accountable and transparent supervision mechanisms and regulation of biological and toxin laboratory work with the potential for weaponized applications.

Physicians:

  1. Recognizing the societal responsibility of physicians as scientists and humanitarians, to decry scientific research for the development and use of biological weapons and to advocate against the use of biotechnology and information technologies for potentially harmful purposes.

Researchers:

  1. To consider the implications and possible applications of their work and carefully balance the pursuit of scientific knowledge with their ethical responsibilities to society.

Fostering global mechanisms monitoring the threat of biological weapons

Governments:

  1. To take necessary measures to guarantee the respect and implementation of the BWC and to reinforce its implementation with appropriate means, ensuring transparency and adequate accountability mechanisms for Member State Parties.

Physicians, Medical Associations and other health entities:

  1. To advocate, in cooperation with the United Nations, including the WHO, and other appropriate entities, for strengthening of the Implementation Support Unit under the BWC, including medical and public health leaders in order to monitor the threat of biological weapons, to identify actions likely to prevent biological weapons proliferation, and to develop a coordinated plan for scrutinizing the worldwide emergence of infectious diseases. This plan should address:
  • international monitoring and reporting systems so as to enhance the surveillance and control of infectious disease outbreaks throughout the world;
  • the development of an effective verification protocol under the BWC;
  • education of physicians and public health personnel about emerging infectious diseases and potential biological weapons;
  • laboratory capacity to identify biological pathogens;
  • availability of appropriate vaccines and pharmaceuticals; and
  • financial, technical, and research needs to reduce the risk of use of biological weapons and other major infectious disease threats.