This howtoregulate article explores the regulation of infectious diseases, an issue of global importance noting that an outbreak from any infectious disease is just a plane ride away. Global climate change has contributed to increases in vector-borne diseases¹ and zoonotic diseases², as animals move to populated areas in search of food. The World Health Organisation even has a placeholder for future unknown diseases (Disease X) on its list for determining which diseases and pathogens³ to prioritise for research. Evidently, effective public health regulations are critical for the effective surveillance, early detection and prevention of infectious diseases.

A. International and supranational regulatory framework, and centres of excellence

I. World Health Organisation (WHO)

1. The global agreement that aims to regulate public health crises, including from infectious diseases, is called the International Health Regulations 2005 (IHR). Signed by 196 countries, the IHR enables States Parties to work together to prevent and respond to public health crises such as infectious diseases. The WHO coordinates implementation of the IHR, including informing countries about public health risks and working with partners to help countries build capacity to detect, report and respond to public health events.The purpose and scope of the IHR are “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade”⁴. The IHR also provides the legal basis for important health documents applicable to international travel and transport and sanitary protections for the users of international airports, ports, and ground crossings.

2. The States Parties have agreed to a number of obligations that contribute to the efficient surveillance, response, verification and notification of certain public health events that could have an impact on the international community. Key obligations of States Parties include:

• Remaining accessible at all times for communications with WHO IHR Contact Points;
• On behalf of the State Party concerned, sending to WHO IHR Contact Points, urgent communications arising from IHR implementation, in particular:

1. 1. Notification (Article 6): Notifying WHO IHR Contact Points of all events which may constitute a public health emergency of international concern within a State Party’s territory in accordance with the Annex 2 decision instrument, as well as any health measure implemented in response, and, following notification, continuing to give WHO public health information about the notified event;
   2. Information-sharing during unexpected or unusual public health events (Article 7): Providing WHO IHR Contact Points with all relevant public health information if there is evidence of an unexpected or unusual public health event within a State Party’s territory which may constitute a public health emergency of international concern;
   3. Consultation (Article 8): If the State Party so chooses, keeping WHO advised on events occurring within a State Party’s territory which do not require notification, and consulting with WHO on appropriate health measures;
   4. Other reports (Article 9): Responding to WHO requests for consultations and attempts to obtain verification for reports from sources other than notifications or consultations on events occurring within the territory of the State Party; and informing WHO of receipt of evidence of a public health risk identified outside the State Party’s territory that may cause international disease spread, evidenced by imported/exported human cases, or contaminated vectors or products;
   5. Verification (Article 10): Responding to WHO requests for verification of reports from sources other than notifications or consultations of events which may constitute a public health emergency of international concern allegedly occurring in the State’s territory;
   6. Provision of information by WHO (Article 11): Serving as focal point for information sent by WHO under Article 11.1, and consulting with WHO as to making information available under this article;
   7. Determination of a public health emergency of international concern (Article 12): Consulting with the WHO Director-General on determination and termination of a public health emergency of international concern under this article.

• Disseminating information to relevant sectors of the administration of the State Party concerned, including those responsible for surveillance and reporting, points of entry, public health services, clinics and hospitals and other government departments
• Consolidating input from relevant sectors of the administration of the State Party concerned, including those responsible for surveillance and reporting, points of entry, public health services, clinics and hospitals and other government departments⁵.

The following key definitions are included in the IHR:

“public health emergency of international concern” – an extraordinary event which is determined, as provided in these Regulations [the IHR]:

(i) to constitute a public health risk to other States through the international spread of disease and

(ii) to potentially require a coordinated international response.

“public health risk” – the likelihood of an event that may affect adversely the health of human populations, with an emphasis on one which may spread internationally or may present a serious and direct danger.⁶

The expansive definition of “public health risk” includes a wide range of events whether biological, chemical or radionuclear in origin or source, and whether potentially transmitted by: persons (e.g. SARS, influenza, polio, Ebola); goods, food (antibiotics in animal feed), animals (including zoonotic disease risks); vectors (e.g. plague, yellow fever, West Nile fever); or the environment (e.g. radionuclear releases, chemical spills or other contamination).⁷

3. The WHO also manages various networks and systems to coordinate implementation of the IHR such as the:

• Global Outbreak Alert and Response Network (GOARN): during outbreaks the GOARN mobilises technical expertise and skills to the area of the public health event.
• Pathogens laboratory network (EDPLN): is made up of global and regional networks of high security human and veterinary diagnostic laboratories. EDPLN contributes to outbreak response and preparedness as well as rapid development of diagnostic assays (quantitative or qualitative test of a substance) for emerging and infectious pathogens globally.
• Public health logistics: the WHO provides logistics support at the field level during epidemics or pandemics, supporting countries through the IHR.
• Strategic Health Operations Centre (SHOC): the SHOC monitors global public health events 24/7, and facilitates international collaboration during the public health emergencies.
• Public Health Emergency Operations Network (ECOCNET): through the ECOCNET, countries are supported in establishing or improving their emergency operations centres, to strengthen their coordinations and response systems.
• International Coordinating Groups (ICG) on Vaccine Provision: manages and coordinates the provision of emergency vaccine supplies and antibiotics to countries during major outbreaks. The ICG works to improve cooperation and coordination of epidemic preparedness and response. It also works on forecasting vaccine stocks, negotiating vaccine prices through its networks or partners, evaluating interventions and standard protocols for managing diseases.
• The WHO Emerging Diseases Clinical Assessment and Response Network: deploysexpert clinicians during outbreaks for technical support, training and mentoring of the local, national and international health workforce.
• The WHO also coordinates a number of disease-related networks for example the Global Task Force on Cholera Control and Global Influenza Surveillance and Response System.⁸

4. The WHO has a toolkit for implementation in national legislation of the IHR, which includes model legislation and examples of legislation, regulation and other instruments used by other countries. Another useful resource is the brief introduction to implementation in national legislation which assists governments in considering the different roles for different areas of government in implementing the IHR.

II. United Nations (UN)

5. Although the WHO forms a part of the UN system many health-related matters and diseases are addressed directly by the General Assembly and the Economic and Social Council, as well as through the efforts of the Joint United Nations Programme on HIV/AIDS (UNAIDS); the work of the United Nations Population Fund (UNFPA) in support of reproductive, adolescent and maternal health; and the health-related activities of the United Nations Children’s Fund (UNICEF).

6. The focus of the UN in supporting the regulation infectious diseases arises from goal three of the Sustainable Development Goals on good health and wellbeing, where target 3.3 concerns diseases:

By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases⁹.

The UN plays an important diplomatic and coordination role in supporting countries, particularly developing countries, in strengthening their public health systems to combat infectious diseases through technical assistance in developing regulations, training to health workers and supplying medicines. An example of the important role the UN plays in rallying countries together to solve a global problem is the resolution adopted by the General Assembly on 10 October 2018 on fighting tuberculosis (A/RES/73/3).

III. European Union (EU)

7. The European Centre for Disease Control (ECDC) identifies, assesses and communicates current and emerging threats to human health posed by infectious diseases. It performs many of the same functions of the WHO but at the EU regional level. For example the ECDC provides:

• Country support to ensure that Member States’ have well-coordinated capacities to effectively prevent, detect, assess and control communicable diseases that threaten the health of the European population;
• Epidemic intelligence and outbreak response: monitoring and assessing threats to public health in Europe from infectious diseases and providing technical support to such threats;
• Health communication;
• Microbiology laboratory;
• Preparedness: supporting Member States and the European Commission in monitoring, identifying and responding to serious cross-border health threats;
• Pubic health training;
• Surveillance;
• Scientific advice: summaries of primary evidence acknowledging uncertainty to support informed decisions and actions at the Union and country level in relation to public health measures to prevent and/or control communicable diseases.¹⁰

IV. Centre for Disease Control (CDC)

8. The CDC is the national health protection agency working 24/7 to protect America from health and safety threats, both foreign and domestic. Although it is a national agency its expertise is recognised globally and influences the regulation of infectious diseases, in this way it is a centre of excellence. The CDC operates ten Global Disease Detection (GDD) Centres worldwide to strengthen laboratories’ response to outbreaks, train the workforce and create strong ties in countries to extend global health. An example of where CDC’s work has influenced regulations is in its GDD Centre in Kazakhstan where its project looks at the science behind vaccination and the epidemiology of their population. Based on the information from the project the government of Kazakhstan regulated for the influenza vaccination of pregnant women, including the sustainable financing of this intervention¹¹. The GDD programme helps build strong public health systems by:

• Detecting and responding to emerging infectious diseases
• Developing a global workforce of disease detectives
• Strengthening laboratory systems and training workers to use them effectively
• Increasing preparedness and communication activities
• Addressing the animal-to-human interface responsible for zoonotic infections
• Conducting critical research to inform public health decisions

The CDC also uses the GDD network to track diseases and syndromes of public health concern: acute febrile illness, antimicrobial resistance and respiratory disease.

9. To fight a disease outbreak well-trained health care providers who can treat the disease, laboratories to diagnose the disease, and supplies and equipment to support diagnostics and treatment are critical. The aforementioned together make up a health system and the CDC’s global work to strengthen health systems means better preparedness for disease outbreaks, such as Disease X, no matter what X may be.

B. National regulations

In this Part B national reference regulation will be examined against the IHR obligations of States Parties to regulate infectious diseases. Regulating for systemic approaches to detect, report and respond to infectious diseases is the best way to ensure thatsurveillance, response, verification and notification measures are effective.

I. Surveillance and response

1. Annex 1, Part A of the IHR requires States Parties to meet specific minimum core capacity requirements for surveillance and response. At the local community level and/or primary public health response level the capacities:

• to detect events involving disease or death above expected levels for the particular time and place in all areas within the territory of the State Party; and
• to report all available essential information immediately to the appropriate level of health- care response. At the community level, reporting shall be to local community health-care institutions or the appropriate health personnel. At the primary public health response level, reporting shall be to the intermediate or national response level, depending on organisational structures. For the purposes of this Annex, essential information includes the following: clinical descriptions, laboratory results, sources and type of risk, numbers of human cases and deaths, conditions affecting the spread of the disease and the health measures employed; and
• to implement preliminary control measures immediately.

At the intermediate public health response levels the capacities:

• to confirm the status of reported events and to support or implement additional control measures; and
• to assess reported events immediately and, if found urgent, to report all essential information to the national level. For the purposes of this Annex, the criteria for urgent events include serious public health impact and/or unusual or unexpected nature with high potential for spread.

At the national level the capacities:

Assessment and notification

• assess all reports of urgent events within 48 hours; and
• to notify WHO immediately through the National IHR Focal Point when the assessment indicates the event is notifiable pursuant to paragraph 1 of Article 6 and Annex 2 and to inform WHO as required pursuant to Article 7 and paragraph 2 of Article 9.

Public health response

1. to determine rapidly the control measures required to prevent domestic and international spread;
2. to provide support through specialised staff, laboratory analysis of samples (domestically or through collaborating centres) and logistical assistance (e.g. equipment, supplies and transport);
3. to provide on-site assistance as required to supplement local investigations;
4. to provide a direct operational link with senior health and other officials to approve rapidly and implement containment and control measures;
5. to provide direct liaison with other relevant government ministries;
6. to provide, by the most efficient means of communication available, links with hospitals, clinics, airports, ports, ground crossings, laboratories and other key operational areas for the dissemination of information and recommendations received from WHO regarding events in the State Party’s own territory and in the territories of other States Parties;
7. to establish, operate and maintain a national public health emergency response plan, including the creation of multidisciplinary/multisectoral teams to respond to events that may constitute a public health emergency of international concern; and
8. to provide the foregoing on a 24-hour basis.

2. Australia’s National Health Security Act (NHS) is an example of a complex framework of regulations and action plans that give effect to the International Health Regulation (IHRs), particularly the surveillance competencies. The NHS provides for a national system of public health surveillance to enhance the capacity of the federation and the States and Territories to identify and respond to public health events of national significance including communicable disease outbreaks. It provides for the sharing of information with the WHO and countries affected by a public health event.

3. The federal Department of Health is responsible for a range of surveillance activities that emerge from these international and national responsibilities, including:

• development and maintenance of policies, systems for surveillance and analysis of communicable and emerging infectious diseases;
• national coordination of surveillance through the Communicable Diseases Network Australia;
• ongoing review of the National Notifiable Disease List and collect data and information; and
• establishment of sentinel surveillance programs (such as for influenza surveillance) and laboratory analyses (such as strain typing for particular diseases).¹²

4. Australia’s National Framework for Communicable Diseases managed by the federal Department of Health is a good example of coordination within a federal system, where jurisdiction is shared such as in the area of public health. In such federations fragmentation can be problematic and in a public health emergency poor coordination can exacerbate the spread of an infectious disease. So frameworks of coordination such as Australia’s are important. Australia updates annually a notifiable disease list that list communicable diseases to be notified nationally and provided to the Commonwealth’s National Notifiable Diseases Surveillance System. Hospitals and health care centres are managed by the states and territories of Australia. In the Australian state of Western Australia any medical practitioner or nurse practitioner attending a patient whom he/she knows or suspects has a notifiable infectious disease or a related condition has a legal obligation to report the diagnosis to the Western Australian Department of Health.¹³If analysis of a sample undertaken at a pathology laboratory indicates that the patient from whom the sample was taken has or may have a notifiable infectious disease, the responsible pathologist of that pathology laboratory also has a legal obligation to report the diagnosis to the Department of Health.¹⁴ Noting the importance of communication for disaster preparedness and response and sharing information, Australia publishes all its reports on infectious diseases online.

5. Australia contracts out to others disease surveillance data collection activities and research on the data to ensure experts are in control of surveillance. For example surveillance in children is completed each month by a survey sent to paediatricians organised by the Australian Paediatric Surveillance Unit.¹⁵The survey has high completion rates of over 90%, making it an effective surveillance tool. The survey lists many communicable diseases, as well as other non-communicable disease under surveillance.National surveillance networks and centres facilitate early detection of disease as well as long-term epidemiological analysis. These in turn provide essential information for planning interventions, and form the foundation for future public health priorities and clearly focused evidence-based policy development and best practice. To ensure consistency in advice, surveillance and responding to a notifiable disease event, the federal Department of Health has developed a Series of National Guidelines (SoNGs). These guidelines capture the knowledge of experienced professionals, built on past research efforts, and provide advice on best practice based upon the best available evidence at the time of completion. SoNGs also include a plain language fact sheet and a sample case report form.

6. Brazil’s Law No. 9,782 defining the National System of Sanitary Surveillance (Sistema Nacional de Vigilância Sanitária) is an example of another complex framework but in a civil jurisdiction. Law No. 9,782 created the federal National Agency of Sanitary Surveillance (Agência Nacional de Vigilância Sanitária, ANVISA) linked to the Ministry of Health. It is responsible for protecting the health of the population by exercising sanitary control over the production and marketing of products and services subject to sanitary surveillance, including the environments, processes, supplies and technologies related to them, as well as the control of ports, airports and borders. The activities of epidemiological surveillance and vector control related to ports, airports, and borders must be executed by the ANVISA under the technical and normative guidance of the Ministry of Health. ANVISA also regulates, controls and inspects products and services that pose a threat to public health. The goods and products subordinated to the control and inspection of ANVISA is at Law No. 9,782. Brazil’s Department of Surveillance of Transmissible Diseases within the Ministry of Health, plays a key role in infectious disease surveillance, including:

• Developing regulations for (a) the prevention and control of transmissible diseases; (b) notification of transmissible diseases; (c) epidemiological investigation; and (d) epidemiological surveillance at ports, airports, borders and customs terminals;
• Establishing preventative measures and control of risk factors and diseases;
• Supplementary or complementary coordination of epidemiological measures and control of diseases in exceptional situations, when (a) the capacity of a State is surpassed; (b) there is the involvement of more than one State; or (c) there is a risk of national dissemination;
• Defining technical instruments related to information systems regarding the mandatory notification of diseases and diseases under surveillance;
• Analysis, surveillance, supervision and orientation in the execution of actions for the prevention and control of diseases that are part of a list of diseases requiring mandatory notification, or that may become important for public health;
• Monitoring the epidemiological behaviour of diseases under surveillance;
• Preparing the national list of diseases requiring mandatory notification;
• Preparing a basic mandatory vaccination plan;
• Coordination of investigations related to outbreaks and epidemics; and
• Regulation and supervision of the National System of Laboratories of Public Health with respect to health surveillance.

The Brazilian Penal Code punishes whom ever causes an epidemic or fails to comply with public health regulations.

7. An interesting feature of Brazil’s infectious diseases regulations is the waiving of patent rights for medicines critical to a national emergency or public interest. The government of Brazil may issue a compulsory licence for the use of a patent during a national emergency, in the event that the owner of the patent or its licensee does not comply with a request for its use. The national emergency must have been declared by an act of the executive branch of the federal government, and the compulsory license must be temporary and non-exclusive, and may not cause prejudice to the rights of the owner. Decree Law No. 3,201 (6 October 1999) was issued to regulate the issuance of compulsory licenses in cases of national emergency and public interest. The decree law provides that: (1) in cases of public interest the compulsory license is for noncommercial public use only; (2) the definition of “national emergency” if one of imminent public danger, even if it is only in part of the country; (3) defines “public interest” as the facts related to public health and environmental protection, as well as those of fundamental importance to the technological or socio-economic development of the country; and (4) regulates the procedures that must be observed for the issuance of a compulsory license. India also operates a compulsory licence scheme for patents but their regulation is comparatively more liberal than Brazil’s because it concerns any medical patent relevant to the Indian health system (see howtoregulate article Patented medicines: how to determine and curb prices? or Compulsory License – A Tool To Enable Availability Of Affordable Medicines).

8. Singapore’s surveillance and incidence reporting of infectious diseases is completed on a weekly basis. The Infectious Diseases Act (IDA) of Singapore, is the principal piece of legislation that deals with the prevention and control of infectious diseases in Singapore and is an example of a framework of medium complexity. This legislation is jointly administered by the Ministry of Health and the National Environment Agency (NEA).For the control of infectious diseases in Singapore, the IDA provides for the notification of specified infectious diseases. It empowers the Director of Medical Services to order medical examination and treatment of any person who is or suspected to be a case, carrier or contact of an infectious disease, post-mortem examination of any person who has died while being or suspected of being a case, carrier or contact of an infectious disease, epidemiological surveys and investigations into outbreaks to be carried out.¹⁶ The Act also permits the Director of Medical Services to order the treatment of premises or vessels, closure of food establishments if the establishment is suspected to be the source of or responsible for the transmission of an infectious disease. The Director can prohibit meetings and public entertainment if such gatherings are likely to increase the spread of any infectious disease.

9. Tonga’s approach to regulating the core surveillance capacities of its agencies is the most straight forward approach because it refers to the capacities directly listed in the IHR itself. The Tongan Public Health Act provides that once a disease regulated by IHR has been identified then the Tongan agencies are to follow IHR procedures. This approach is a less complicated example for jurisdictions that do not have a federal system of states or autonomous regions.

II. Designated airports, ports and ground crossings

10. Annex 1, Part B of the IHR requires States Parties to have at all times the capacities:

1. to provide access to
   1. an appropriate medical service including diagnostic facilities located so as to allow the prompt assessment and care of ill travellers, and
   2. adequate staff, equipment and premises;
2. to provide access to equipment and personnel for the transport of ill travellers to an appropriate medical facility;
3. to provide trained personnel for the inspection of conveyances;
4. to ensure a safe environment for travellers using point of entry facilities, including potable water supplies, eating establishments, flight catering facilities, public washrooms,
5. appropriate solid and liquid waste disposal services and other potential risk areas, by conducting inspection programmes, as appropriate; and
6. to provide as far as practicable a programme and trained personnel for the control of vectors and reservoirs in and near points of entry.

For responding to events that may constitute a public health emergency of international concern the capacities:

1. to provide appropriate public health emergency response by establishing and maintaining a public health emergency contingency plan, including the nomination of a coordinator and contact points for relevant point of entry, public health and other agencies and services;
2. to provide assessment of and care for affected travellers or animals by establishing arrangements with local medical and veterinary facilities for their isolation, treatment and other support services that may be required;
3. to provide appropriate space, separate from other travellers, to interview suspect or affected persons;
4. to provide for the assessment and, if required, quarantine of suspect travellers, preferably in facilities away from the point of entry;
5. to apply recommended measures to disinsect, derat, disinfect, decontaminate or otherwise treat baggage, cargo, containers, conveyances, goods or postal parcels including, when appropriate, at locations specially designated and equipped for this purpose;
6. to apply entry or exit controls for arriving and departing travellers; and
7. to provide access to specially designated equipment, and to trained personnel with
8. appropriate personal protection, for the transfer of travellers who may carry infection or contamination.

11. Australia requires international crew of vessels and aircraft to report passengers or crew that show symptoms of infectious disease or a death on board. Biosecurity Act 2015 requires that the operator of the aircraft or vessel to report this to a Biosecurity Officer from the Australian Department of Agriculture and Water Resources before arrival in Australia. A fact sheet on the crew’s reporting responsibilities also includes symptoms that crew should look for.¹⁷ Australia has a system for receiving disease alerts and once identified, travellers arriving in Australia from disease affected countries may be submitted for vaccination.¹⁸ Travellers and animals affected by a security-sensitive biological agent (eg. viruses, bacteria, fungi and toxins) are regulated by the National Health Security Regulations 2018, which outlines how those affected by a security-sensitive biological agent should be treated.

12. For departing travellers Australia maintains a good information traveller system called Smart Traveller, which contains updated security and health information for travellers to be aware of when travelling to a particular destination. Australia’s federal Department of Health publishes online information cards on infectious diseases so that the population are informed about symptoms and where to get treatment.

13. Australia’s regulatory treatment of particular diseases is worthy of a mention as its approach is rigorous, reflecting the complexity of its framework of regulations. Tuberculosis (TB) was declared a global emergency 25 years ago, it is still among the top 10 causes of death worldwide, which disproportionately affects developing countries, where 99 per cent of TB-associated deaths occur.¹⁹Treatment of TB is exacerbated by the rise of multidrug-resistant TB and access to affordable diagnostic tests and treatment. There are around 1200 to 1300 cases of TB each year in Australia, which means it is among the lowest-risk countries in the world. The WHO has identified Australia’s low rate of TB and high health-care standards, as one of the countries best placed to eliminate TB entirely.²⁰ Noting that over 85% of Australia’s TB cases are foreign born Australia has regulated strict measures for TB screening in the immigration process. Permanent visa applicants are tested for tuberculosis as part of the visa application process and some temporary visa applicants might be tested if they are assessed to be a risk (Migration Act 1958 sections 32, 60, 65). Visa applicants aged 11 years and over must have a chest x-ray for evidence of active TB. There are alternative tuberculosis testing arrangements for applicants aged 2 or more and under 11 from countries with a higher risk of TB. If active TB is found, Australian migration law does not allow a visa to be granted until the person has undergone treatment and been declared free of active.

14. China’s Frontier Health and Quarantine Law is regulation of medium complexity that regulates the quarantinable infectious disease management system, which includes diseases such as Ebola, pestis, cholera, yellow fever and other infectious diseases publicised by the State Council. Article 6 of the Quarantine Law provides that the State Council can issue orders to block borders or adopt other emergency measures when quarantinable diseases are prevalent abroad or in China. At frontier ports, officers are to quarantine patients suspected of a disease, with the isolation period determined by medical test results and apply for a provisional quarantine inspection licence (Article 10). At border points health and quarantine officers are to conduct sanitary inspections of luggage, cargo or postal parcels from epidemic areas and carry out a sanitisation treatment (Article 14). China’s quarantine law enables all ports of entry to be closed in the event an epidemic threatens China’s public health.

15. Thailand operates a simple regulatory approach to ground border crossings between Laos and Myanmar by examining all travellers complaining of fever and submitting them for blood testing to determine if the fever is caused by dengue, Zika virus or some other tropical disease. The aim of this rather invasive approach (drawing of a blood sample for testing) is to stop outbreaks from crossing borders.²¹

III. Vaccination

16. The IHR regulates the submission to vaccination of travellers to ensure that consent of the traveller is protected and that the least invasive procedure is followed in protection of the travellers human rights. The IHR regulates the form that certificates of proof of vaccination and States Parties are required to accept such certificates as proof that the traveller has complied with public health requirements to enter the country (Annex 6 of the IHR). Travellers who have completed a yellow fever vaccination are required to carry their proof of vaccination certificate (Annex 7 of the IHR).

17. Detection of infectious diseases is a key competency in the surveillance competencies required in Annex 1, Part A of the IHR, and a related activity to detection includes measures to prevent the prevalence or occurrence of that disease. Several States Parties has introduced strict measures to ensure immunisation rates are high so that the public can benefit from herd immunity.

18. Many jurisdictions regulate for compulsory vaccination of children and bar entry of children to state-funded child care facilities. Australia’s approach is comprehensive as access to tax benefits and child care services depends on the completion of the child’s state-funded immunisation, known as “No jab, No pay” and “No jab, No Play”.²² New Zealand’s Health (Immunisation) Regulations 1995 is less stringent requiring all childhood services and primary schools (public or independent) to keep an immunisation register of children attending, such a record helps reduce the spread of vaccine-preventable diseases (Section 4). The register also encourages completion of immunisation where parents or guardians may need a reminder. The immunisation register must be populated with information from a child’s Immunisation Certificate, and exactly as shown on the certificate. The Immunisation Certificate is included in the health booklet of every child born in New Zealand.²³Australia also maintains an immunisation register regulated by the Australian Immunisation Register Act 2015.

19. Good emergency preparedness for an an infectious disease outbreak requires stockpiling of vaccines or prophylaxis. In the USthe Office of the Assistant Secretary for Preparedness and Response oversees the Strategic National Stockpile, which is the largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency severe enough to cause local supplies to run out.

IV. Antimicrobial resistance: humans

20. Antimicrobial resistance (AMR) is the ability of a microorganism (like bacteria, viruses, and some parasites) to stop an antimicrobial (such as antibiotics, antivirals and antimalarials) from working against it.²⁴As a result, standard treatments become ineffective, infections persist and may spread to others. The World Health Assembly endorsed a global action plan to tackle AMR, including antibiotic resistance, the most urgent drug resistance trend. AMR is occurring everywhere in the world, compromising states’ ability to treat infectious diseases, as well as undermining many other advances in health and medicine. The goal of the global action plan is to ensure, for as long as possible, continuity of successful treatment and prevention of infectious diseases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them. The plan sets out five strategic goals:

• to improve awareness and understanding of AMR;
• to strengthen knowledge through surveillance and research;
• to reduce the incidence of infection;
• to optimise the use of antimicrobial agents; and
• develop the economic case for sustainable investment that takes account of the needs of all countries, and increase investment in new medicines, diagnostic tools, vaccines and other interventions.

The WHO encourages countries to develop national action plans and have an infographic for those countries with action plans. However, very few countries use regulatory measures to combat antimicrobial resistance.²⁵

21. A list of Critically Important Antimicrobials for Human Medicine 6th revision is developed by the WHO to rank antimicrobials according to their relative importance in human medicine. Clinicians, regulatory agencies, policy-makers and other stakeholders are expected to use this ranking when developing risk management strategies for the use of antimicrobials in food production animals. The use of the list will help preserve the effectiveness of currently available antimicrobials. The WHO recognises that implementation at the national level requires that national considerations be taken into account and may vary from country to country. Specifically the WHO List notes: “The experts recognised that the implementation of the concept at national levels required that national considerations would be taken into account, and consequently lists may vary from country to country…”²⁶. An example of such variations is Australia’s Importance Ratings and Summary of Antibacterial Uses in Human and Animal Health in Australia. The differences reflect the relatively low reliance on some of the antibacterials in Australia because resistance is widespread in many human pathogens causing infection in Australia.Indiahas its National Treatment Guidelines for AMR Use in Infectious Diseases. These guidelines list the recommend treatments for common infectious diseases that are based on scientific evidence, it emphasises that antimicrobials should be prescribed only when they are necessary in treatment following a clear diagnosis, recognising that not all patients need antibiotics and that non-drug treatment may be suitable.

22. The WHO created the global Antibiotic Awareness Weekto promote education about the problem of AMR. Many resources about education and awareness raising campaigns can be found on the WHO AMR site. Egypt is an example of a country working to reduce the misuse of antibiotics, which can be purchased over the counter without a medical prescription.²⁷Egypt, in partnership with the CDC, are tackling cultural roadblocks and barriers through a national programme that works with hospitals and communities to address health-care associated infections and change the way antibiotics are used. The programme started to count active infections in intensive care units in hospitals around Egypt, using smart devices to record information. Without knowing how widespread infections were or the main causes of drug resistant infections, evidently it was difficult to address. Secondly, armed with data collected, the programme addressed the problem of equipment critical for identifying infections quickly so that a suitable treatment could be administered quickly. Third, by identifying and treating infections quickly the programme was able to show a remarkable improvement to the infection rate which dropped by 36%. Armed with this success the programme then approached hospitals with the highest rate of ventilator-associated pneumonia and trained health-care workers on patient position and oral hygiene in order to prevent new infections. Training was also offered to hospitals with higher surgical site infection rates. And lastly, by significantly reducing the morbidity rate the programme was able to make the results social by launching a campaign to teach people to use antibiotics correctly, including a 10-day training course for primary health clinicians. Given the ease with which households can purchase antibiotics the programme enlisted the help of community leaders to go from house to house with information about when and how to take antibiotics. Following this door knocking campaign a striking reduction in antibiotic use was observed, proving that targeted education can lead to cultural change.

V. Antimicrobial resistance: food-production

23. Over 20 new pathogens have been discovered since the mid-1970s and 75% of emerging pathogens are of zoonotic nature. Progress towards global health security requires a greater focus on regulations that manage health at the interface between human health and animal health.

24. WHO guidelines on the use of medically important antimicrobials in food-producing animals, recommends that farmers and the food industry stop using antibiotics routinely to promote growth and prevent disease in healthy animals. These guidelines aim to help preserve the effectiveness of antibiotics that are important for human medicine by reducing their use in animals. The European Parliament agreed in December 2018 to a set of comprehensive new rules [Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018] that bans prophylactic, i.e. preventive, use of antibiotic medicated feed to animals (terrestrial and aquatic).²⁸Metaphylactic use, i.e. treating the whole group of animals when one is infected, is allowed only when the risk of spread of infection is high and there is no appropriate alternative (Articles 112-114). Trading partners will have to respect EU standards on the use of antibiotics when exporting food products to the EU.²⁹ India’s Food Safety and Standards Authority banned the use of antibiotics and several pharmacologically active substances in fisheries³⁰. In contrast, there is no regulation in the poultry or dairy industry where many of the commercially available pre-mixed feeds come with added antibiotics. However, it is a top priority in India’s National Action Plan on AMR 2017-2021 to develop regulations to address the problem (Strategic Priority 4):

• 4.1.2. Create/develop and enforce enabling regulatory framework and intersectoral coordination for regulations on use of antimicrobials in animals and food safety
• 4.1.2.1. Establish independent veterinary regulatory authority (NACA, MoAFW, FSSAI) S-M
• 4.1.2.2. Restrict and phase-out non-therapeutic use of antimicrobials such as their use as growth promoters and disease prevention in animals (Veterinary Regulatory Authority, CDSCO) S-M-L
• 4.1.2.3. Foster development of antimicrobial policies and evidence-based standard treatment guidelines for food animals (ICAR, MoAFW) S-M
• 4.1.2.4. Restrict and gradually eliminate the use of restricted antibiotics, which are critically important for humans in non-human sectors especially food-producing animals (Veterinary Regulatory Authority, FSSAI, CDSCO) M-L
• 4.1.2.5. Restrict antibiotics in animal feed, feed premix; ensure registration and use of registered products only; regulate their importation, direct distribution and online marketing; ensure appropriate labelling (Veterinary Regulatory Authority, BIS, CDSCO, ICAR, DADF) S
• 4.1.2.6. Ensure prescription sale of antibiotics and their use under supervision; regulate bulk selling, importation and labelling for species-specific use (CDSCO) S
• 4.1.2.7. Ensure labelling of food from animals produced with or without routine use of antibiotics (FSSAI) S
• 4.1.2.8. Develop policy for freshwater/inland fisheries to regulate freshwater/inland fisheries (FSSAI) S
• 4.1.2.9. Fast track implementation of the Codex Alimentarius and OIE guidelines on antimicrobial resistance (DADF, Veterinary Regulatory Authoirty, FAO, OIE) S-M-L

Key output: Regulatory authority established for rational use of antibiotics in food and animal sector.

Although the author does not know the names of the agencies in brackets, it is clear that agencies have been given responsibility and a timeline of short to medium to longterm for implementation.

D. What we missed

1. The regulation of infectious diseases globally is based on a superior piece of legislation from which subordinate regulations and policies are developed. This approach gives national health systems agility to develop and implement population wide policies without having to embark on time-consuming regulatory processes. Some jurisdictions researched required ministerial sign off on particular diseases eg. Australia’s national notifiable disease list. However, mechanisms for enforcement and sanction could be strengthened. For example failure of a medical or nurse practitioner or pathologist to notify the central body of a notifiable incident contained clear sanctions for non-compliance but regulations did not include veterinarians or other practitioners related with animals. Jurisdictions may need to audit their respective infectious diseases or public health regulation to determine whether enforcement and sanctions provisions are commensurate with the gravity of non-compliance. Please see the Handbook: How to regulate? about how to create the necessary empowerments to enforce infectious disease regulation and policy but also the two-part empowerments articles: Empowerments (Part I): typology and Empowerments (Part II): checklist. Specifically, jurisdictions could consider the following empowerments to better enforce infectious diseases regulation and policy:

• Sanctions and penalties, including: penalties for natural persons, financial sanctions for legal persons: direct sanctions and indirect sanctions like banning from receiving subsidies, public naming and shaming and withdrawing membership.
• Enforcement with the help of non-designated parties, including: establishing a complaints; alert or whistle-blowing portals or specific communication channels; and communicating with third parties to obtain further evidence and details.
• Enforcement via regional authorities, geographic entities or designated third parties, including: establishing minimum resource requirements for enforcement at the level of geographic entities or designated third parties; creating incentives for highly performing third parties, regional authorities or geographic entities;obliging to undertake certain enforcement activities (in some jurisdictions: to be specified); and obliging to inform about enforcement activities.
• Designation and supervision of public or private organisations entrusted to play a special role in the application of regulation, including: preselecting potential cooperating organisations in cases of high number of potential candidates; establishing selection criteria; selecting members of panels attributing subsidies, functions or other advantages; and taking discretionary decisions regarding the attribution of subsidies, functions or other advantages (which can exclude full legal control).
• Investigations and data, see full list at Empowerments (Part II): checklist.
• Enforcement in general, see full list at Empowerments (Part II): checklist.

Understandably, some of the more punitive approaches in enforcement may be inappropriate in developing countries where lack of training and resources are problematic. However, it should not be overlooked the importance of having the right enforcements, particularly ensuring that operators involved in the food-producing sector do not use non-therapeutic antibiotics.

2. Policing of food-producing operators for non-therapeutic use of antibiotics in feed could also include “citizen enforcers” and private, but public utility organisations. Very few of the jurisdiction´s examined in this howtoregulate article had an online complaint mechanism for “citizen enforcers” to report on infectious diseases. China is an example of a jurisdiction that provides a health hotline and also monitors the public health debate through its vast surveillance network of the population. To encourage more “citizen enforcers” it could be an incentive to offer to the “citizen enforcers” part of the proceeds of the fine collected for non-compliance. Whistle-blowing mechanisms can also be a useful tool for those in public and private organisations to reveal any concerning behaviour about infectious diseases. For more information about whistle-blowing schemes see our howtoregulate article Whistleblowers: protection, incentives and reporting channels as a safeguard to the public interest.

3. It was cited that the US does not control non-therapeutic use of antibiotics in animal feed due to commercial interests, which could relate to a problem with regulation of lobbying activities if commercial interests trumps the public health concern of AMR. The howtoregulate article Countering unfair lobbying which lists some reflections and recommendations that might help officials to defend the common interest against disproportionate lobbying.

4. A growing problem is the rise of drug resistant diseases such as TB and the limited commercial interest of pharmaceutical companies to invest in research and development of new drugs. The example of drug-resistant TB, predominantly occurs in developing countries where return on investment to the development of new drugs is a disincentive. For ideas on how to incentivise the development of new drugs to combat multi-drug resistant infectious diseases see the howtoregulate article Patented medicines: how to determine and curb prices?.

5. Through the course of research for this howtoregulate article there is, evidently, a global focus on education. For example ensuring key roles in the health system with a role in infectious disease management are well trained and that patients and citizens generally understand simple steps they can do eg. wash hands regularly or finish the course of antibiotics prescribed. However, there was not a lot of material about the benefits of using incentives for behavioural change noting that change through education requires time. For example could medical practitioners incentivise patients to complete the course of antibiotics by returning the empty packet, of course strategies would be required to determine that the patient did indeed consume each pill. Such practical measures could be shared on the online resources that the WHO has for example.

Further links

Australia

http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pubhlth-strateg-bio-factsheets.htm

Australia’s AMR site is a very good source of information for ordinary citizens, medical practitioners, veterinarians

China

http://en.nhc.gov.cn/

UN

http://www.un.org/en/sections/issues-depth/health/index.html

WHO

https://www.who.int/en/news-room/fact-sheets/detail/antibiotic-resistance

This article was written by Valerie Thomas, on behalf of the Regulatory Institute, Brussels and Lisbon. Elvira Fernando provided research and writing assistance on the Portuguese and Spanish speaking jurisdictions.