Sunday, August 3, 2014
The International Health Regulations (2005) and their Significance in Stemming Pandemics
By Bakampa Brian Baryaguma
[Dip. Law (First Class) – LDC; LLB (Hons) – Mak; Cert. Oil and Gas – Mak; GC Candidate – GCA]
Pandemics (sometimes also referred to as epidemics) are extensive and far-impacting disease outbreaks, which although have no agreed definition,  literally mean diseases that are prevalent over a very wide area, like a country or continent,  claiming numerous lives. The World Health Report 2007, observed that, ‘Throughout history, humanity has been challenged by outbreaks of infectious diseases and other health emergencies that have spread, caused death on unprecedented levels and threatened public health security’ 
In a bid to control and prevent further infections, people in the past responded rudely and awkwardly to pandemics, by removing the sick from the healthy population until the epidemic ended.  Since diseases would spread across state borders,  many times it also involved imposition of international restrictions on travel and trade, which negatively affected economies and livelihoods, thus undermining international socio-economic and political relations.
Fortunately, ‘With time, scientific knowledge evolved, containment measures became more sophisticated and some infectious disease outbreaks were gradually brought under control, with improved sanitation and the discovery of vaccines.’  But these great developments among states were uncoordinated, yet the states faced common problems.
Hence the need for cooperation beyond state borders, to regional and international level, leading to the emergency of the phenomenon of international health cooperation, geared towards strengthening global public health security and surveillance. 
2. International Health Regulations (2005)
The need for global cooperation in stemming pandemics, without unduly interrupting international processes resulted in the emergency of international rules to guide and oversee the implementation of international health cooperation mechanisms. The International Health Regulations (2005) (hereinafter ‘the Regulations’) are the latest in this regard.  The Regulations represent a major development in the use of international law for public health purposes.  They are designed to prevent the international spread of disease,  ‘... in response to changes in the human world, the microbial world, the natural environment and human behaviour, all of which posed increased threats to global public health security ...,’  instead of concentrating on preset measures for specific diseases.  They reflect ‘Ways of collectively working together in the face of emergency events of international health importance ...,’  ‘... focus[ing] on containing public health threats where and when they occur, rather than solely at ports and borders,’  in a manner ‘... flexible enough to anticipate the unexpected and strong enough to respond to potential emergencies before they spill across borders.’  They encompass the strongest existing tool for global health governance. 
3. Significance of the Regulations
The Regulations have novel in-built mechanisms that enhance global public health security. In these innovations lays their significance. They include the following:
1. Wide scope, not limited to any specific disease or manner of transmission, but covering ‘... illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans.’  It encompasses communicable and non-communicable disease events, whether naturally occurring, accidentally caused, or intentionally created;  and intends to maintain the Regulations’ relevance and applicability for many years, even with continued evolution of diseases and of the factors determining their emergence and transmission. 
2. Obligations on states to strengthen disease surveillance, by developing certain minimum core public health capacities, for example, the ability to detect, assess, notify and respond to public health threats.  States are also urged to mobilize the resources necessary for that purpose,  in order to respond promptly and effectively to public health risks and emergencies of international concern.  With increased surveillance, pandemics can be detected early enough,  eventually supporting improved disease prevention and control both within and between states. 
3. Obligations on states to notify WHO of events that may constitute a public health emergency of international concern (PHEIC) according to defined criteria.  Immediate alert is necessary for preventing the rapid spread of disease and promoting expeditious response to disease outbreaks and other incidents that could spark epidemics or spread globally. 
4. Provisions authorizing WHO to consider unofficial reports of public health events and to obtain verification from states concerning such events.  This is a revolutionary departure from previous international practice, which restricted surveillance to information provided only by governments.  It improves the sensitivity of WHO’s surveillance system  and pre-empts official notifications especially, in situations where countries may be reluctant to reveal events in their territories. 
5. Procedures for the determination by the WHO Director-General of a PHEIC and issuance of corresponding temporary recommendations, after taking into account the views of an Emergency Committee.  This provides a framework for preparedness. 
6. Protection of human rights and freedoms. States are required to implement the Regulations with full respect for human rights and freedoms, guided by the UN Charter, the WHO Constitution and the principles of international law.  For instance, travellers may not be subjected to medical examinations, without their prior express informed consent or that of their parents or guardians. 
7. The establishment of a new framework for the coordination of the management of events that may constitute a PHEIC, comprising of National IHR Focal Points and WHO IHR Contact Points for urgent communications between states and WHO.  This framework negates isolated decision making and improves operational coordination and information management,  by establishing a global network that improves the real-time flow of surveillance information from the local to the global level and also between states. 
Disease compromises peace, because rampant and widespread sickness eventually becomes a threat to public security.  Disease control and management are therefore, matters of critical importance especially, in today’s globalized world,  characterized by routine air travel and disease multipliers born of human behaviours, such that a public health crisis anywhere in the world is a potential problem everywhere.  With this state of affairs, the International Health Regulations (2005) could never have been more opportune. The successful containment of the H1N1 influenza A virus in 2009,  gives reason to trust the Regulations’ ability of stemming pandemics.
Notes and References
1. Says Professor Mark Harrison, during the Week 6 lecture on pandemics, in the Global Civics Academy lecture series on global civics.
2. AS Hornby, AP Cowie & AC Gimson, Oxford Advanced Learner’s Dictionary of Current English (1983), at 616.
3. World Health Organization, A Safer Future: Global Public Health Security in the 21st Century (2007), at 1.
5. For example, cholera, which originated from India and spread across Africa, Asia, Europe and Latin America. See, ibid., at 4.
6. Ibid., at 1.
7. Article 1(1) of The International Health Regulations (2005) defines the term surveillance as ‘... the systematic ongoing collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary.’
8. The earliest were the International Sanitary Regulations (1951), which were succeeded by the International Health Regulations (1969). The International Health Regulations (2005) have been in force since 15 June, 2007. They are an international legally-binding agreement.
9. Michael G. Baker and David P. Fidler, ‘Global Public Health Surveillance under New International Health Regulations’ 12 EID (2006), at 1058.
10. In conformity with Articles 21(a) and 22 of the Constitution of the World Health Organization (WHO); Article 21 of which allows the World Health Assembly (WHA) to adopt measures within specific focus areas, including prevention of the international spread of disease; Article 22 of the same states that these WHA‐adopted regulations become legally binding on member states without any further action (for example ratification) unless they notify the WHO Director‐General of rejection or reservations within a specified time – through what is known as the opt out clause.
11. World Health Organization, supra note 3, at 8.
12. Julie E. Fischer, Sarah Kornblet and Rebecca Katz, ‘The International Health Regulations (2005): Surveillance and Response in an Era of Globalization’ (2011), at 2.
13. World Health Organization, supra note 3, at 8.
At page 13 of the report, WHO notes that the Regulations focus on inclusion of public health emergencies (unlike the 1969 regulations which focussed on controlling the spread of infectious diseases) and this extends the scope of the Regulations to protect global public health security in a comprehensive way.
14. Julie E. Fischer, Sarah Kornblet and Rebecca Katz, supra note 12.
15. Ibid., at 4.
16. Rebecca Katz and Julie Fischer, ‘The Revised International Health Regulations: A Framework for Global Pandemic Response’ 3 GHG (2010), at 8.
It should be noted though, that much as this is so, the Regulations face their own peculiar challenges: first, at page 7 of the essay, the writers highlight the challenge of striking a balance between global governance of disease control measures and national sovereignty, since nations are sovereign entities that make their own decisions in response to public health threats, regardless of global health governance structures. At page 16 of the essay, the writers reveal that this challenge was highlighted during the outbreak of the novel swine influenza A (H1N1) triple reassortant virus in 2009, when many countries made unilateral decisions that were neither scientifically sound nor consistent with WHO guidance, and dismissed IHR (2005) principles obligating countries to respect human rights and cause minimal disruption to the international flow of people and goods. For example, it is reported that twenty countries banned the importation of pork and pork products from Mexico, Canada and the US.23 Bans occurred in spite of a joint statement by WHO, the United Nations Food and Agriculture Organization (FAO), the World Organization for Animal Health (OIE) and the World Trade Organization (WTO) that pork and pork products were not a source for H1N1 influenza infections.
Second, at page 9 of the essay, the writers note the challenge of building public health capacities necessary for countries to detect and respond to public health events wherever they occur. As they explain on page 14 of the essay, Since WHO does not have power to force nations to comply with the Regulations’ obligations, this lacuna inevitably translates into other related challenges: lack of adequate enforcement mechanisms, such that nations may not report potential public health emergencies of internal concern (PHEICs); weak links in the global disease surveillance network, because low and middle-income nations in Asia, Africa, and Latin America, suffer critical shortages of skilled health workers, including laboratory and public health workers that are rarely the focus of global health workforce strategies; and dependence on state capacities and willing coordination, because although the Regulations mandate global information sharing and coordination, all public health actions still originate in the community, requiring government capacities at local, state and national levels.
17. International Health Regulations (2005), 2nd Edn, Article 1, on the definition of disease.
This is unlike the 1969 Regulations, which were highly limited in terms of diseases covered. Initially they covered six “quarantinable diseases” but following the 1973and 1981 amendments of those regulations, these diseases were reduced to three (yellow fever, plague and cholera). The amendments also marked the global eradication of smallpox.
Article 2 of the Regulations contains another related innovation, stipulating their purpose and scope i.e. ‘... 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.’ To this extent, the Regulations address two historical challenges: managing cross-border spread of diseases, while maintaining harmonious global relations: talk of the proverbial hitting of two birds with one stone.
18. Michael G. Baker and David P. Fidler, supra note 9, at 1059.
19. International Health Regulations (2005), supra note 17, at 2.
A major challenge in the past was that regulations then were targeted at controlling a handful of diseases, such that once they faded as threats to public health and commerce, the regulations themselves lost significance.
20. Ibid., Art. 5(1).
More so in developing countries, because the World Health Report 2007, supra note 3, at 6, notes that some diseases continue to thrive in developing countries, due to limited ability to detect and respond, leading to the potential for them to spread internationally at great speed.
Under Articles 5(3) and 44(2) of the Regulations, WHO is obliged to assist and collaborate with state parties, particularly developing countries, in meeting their surveillance system obligations, but as noted by Michael G. Baker and David P. Fidler, supra note 9, at 1063, these provisions do not include financing mechanisms, which leaves each state party to bear the financial costs of improving its own local, intermediate and national level surveillance capabilities; and the obligation on state parties and WHO to collaborate in mobilizing financial resources is a weak obligation at best.
Rebecca Katz and Julie Fischer, supra note 16, at 9, also observe that, ‘Low-and middle-income nations have been obligated to meet IHR core capacity requirements in disease surveillance, reporting and response without a standing commitment of financial resources.’
21. International Health Regulations (2005), supra note 17, Article 44(1)(c).
Article 44 requires states to collaborate and assist each other in providing technical cooperation and logistical support for surveillance capabilities and in mobilizing financial resources to facilitate implementation of the Regulations. Yet, as observed by Julie E. Fischer, Sarah Kornblet and Rebecca Katz, supra note 12, at 13, ‘Despite this, donors have been slow to roll out comprehensive assistance packages to help resource‐constrained countries achieve the core capacities.’
22. Ibid., Art. 13(1).
23. Professor Mark Harrison, supra note 1.
24. Michael G. Baker and David P. Fidler, supra note 9, at 1061.
25. International Health Regulations (2005), supra note 17, Art. 6.
Professor Mark Harrison, supra note 1, states that 80% of human diseases are shared with animals. Therefore, an event ‘that may constitute a public health emergency of international concern’ may be what the World Health Report 2007, supra note 3, at 6, categorizes as new diseases emerging in human populations on a sporadic basis, often the result of a breach in the species barrier between humans and animals, permitting microbes that infect animals to infect humans as well, causing unexpected outbreaks that can also spread internationally.
26. World Health Organization, supra note 3, at 11.
27. International Health Regulations (2005), supra note 17, Art. 9(1).
Unofficial reports may come from intergovernmental organizations, non-governmental organizations, individuals, the internet, etc. They may also come from information provided by states on events occurring outside their borders. This is catered for under Article 9(2), under which states are obliged to inform WHO of evidence of a public health risk identified outside their territory that may cause international disease spread, as manifested by exported or imported human cases, infection or contamination-carrying vectors, or contaminated goods. This effectively introduces the policing principle of neighbourhood watch in public health administration.
The World Health Organization, supra note 3, at 13, observes that verification is important for determining the accuracy and veracity of such information, because at a time when information is shared at the click of a button, reputable sources of information – that are capable of separating rumours from real events – are critical in maintaining public awareness and support of prevention and control measures.
28. Michael G. Baker and David P. Fidler, supra note 9.
29. Ibid., at 1062.
30. World Health Organization, supra note 3, at 13.
31. International Health Regulations (2005), supra note 17, Art. 12.
PHEIC is the acronym for public health emergency of international concern. It is defined in Article 1 of the Regulations as meaning an extraordinary event which is determined, as provided in the Regulations, to constitute a public health risk to other states through the international spread of disease and to potentially require a coordinated international response.
32. World Health Organization, supra note 3, at 11.
33. International Health Regulations (2005), supra note 17, Art. 3.
34. Ibid., Art. 23(3).
As a general rule however, under Article 23(1)(iii) of the Regulations, states may subject travellers, to non-invasive medical examinations on arrival or departure, in the least intrusive examination that would achieve the public health objective.
It is clear, as stated by Julie E. Fischer, Sarah Kornblet and Rebecca Katz, supra note 12, at 14, that there is a daunting challenge of balancing individual rights (especially where a person objects to suggested medical procedures) against the public good to control the spread of disease.
But this challenge may perhaps be counter-balanced by exceptions to protected rights such as stipulated under Article 31(2) i.e. denial of entry; compulsory medical examination; vaccination or other prophylaxis; or additional health measures like isolation, quarantine or placement under public health observation.
35. International Health Regulations (2005), supra note 17, Art. 4.
The Regulations, under Article 1, define National IHR Focal Points and WHO IHR Contact Points. The former is defined as ‘... the national centre, designated by each State Party, which shall be accessible at all times for communications with WHO IHR Contact Points under these Regulations. The latter is defined as meaning ‘... the unit within WHO which shall be accessible at all times for communications with the National IHR Focal Point.’
These centres and units are vital for global networking because, as Rebecca Katz and Julie Fischer, supra note 16, at 12, say, ‘... cooperation with the regulations depends on international trust, and the understanding that populations and threats to populations are interconnected.’
36. World Health Organization, supra note 3, at 9.
37. Michael G. Baker and David P. Fidler, supra note 9, at 1060.
It should be noted that the Regulations don’t just stop at establishing new coordination and management frameworks: Rebecca Katz and Julie Fischer, supra note 16, at 12, state that they also update and revise many of these framework’s technical and other regulatory functions, including certificates applicable to international travel and transport and requirements for international ports, airports and ground crossings. This ensures the maximum possible global public health security.
At page 13 of the essay, the writers submit that this is done by redirecting the focus from an almost exclusive concentration on measures at seaports and airports aimed at blocking the importation of so-called “foreign diseases” towards a rapid response at the source of an outbreak, thereby strengthening collaboration on a global scale by seeking to improve capacity and demonstrate to countries that compliance is in their best interests, for three compelling incentives: to reduce the disruptive consequences of an outbreak, to speed its containment and to maintain good standing in the eyes of the international community.
38. This explains why for a long time, there has been a “securitization” of health issues, which seriously took a global perspective when, as reported by Julie E. Fischer, Sarah Kornblet and Rebecca Katz, supra note 12, at 8, in January 2000, the UN Security Council recognized HIV/AIDS in sub‐Saharan Africa as an international peace and security issue. This pronouncement was followed by the United States (at the White House), a few months later, taking the similarly unprecedented step of designating infectious diseases a threat to US national security. Collectively, these actions leveraged new resources and political will to tackle public health risks on a global scale.
39. Professor Mark Harrison, supra note 1, points out forces like international trade, terrorism, climate change, migration and environmental degradation, which pose risks to our health and threaten to halt the global economy.
No wonder that Rebecca Katz and Julie Fischer, supra note 16, at 2, state that, ‘By the 1990’s, consensus emerged amongst the global health community that the threat of emerging (e.g. Ebola virus) and re-emerging (e.g. dengue) infectious diseases was increasing. Accelerated globalization facilitated the rapid spread of these diseases.’
40. Julie E. Fischer, Sarah Kornblet and Rebecca Katz, supra note 12.
41. See, Rebecca Katz and Julie Fischer, supra note 16, at 4-6.