Exercise*: The International Health

Regulations and Influenza Pandemic

July 16, 2009

Allyn TaylorGeorgetown University Law Center

With thanks to John Kraemer, Mike Stoto and Larry Gostin

July 2009

Welcome to the summer of unease. The new H1N1 influenza virus that emerged in Mexico in April quickly ignited outbreaks as far away as the U.K. and Japan.

As epidemiologists accumulated data and scientists probed the novel virus, they found H1N1 was neither as virulent nor as lethal as first suspected. But the quick-mutating influenza virus should never be underestimated.

To learn what might happen—and what should happen under international law— this hypothetical exercise has been created….

Brief Overview of the Swine Flu:National and Global Responses

Influenza The Normal Burden of Disease

• Seasonal Influenza– Globally: 250,000 to 500,000 deaths per year– In the US (per year)

• ~35,000 deaths• >200,000 Hospitalizations• $37.5 billion in economic cost (influenza & pneumonia)• >$10 billion in lost productivity

• Pandemic Influenza– An ever present threat

Swine Influenza A(H1N1) Introduction

• Swine Influenza (swine flu) is a respiratory disease of pigs caused by type A influenza that regularly cause outbreaks of influenza among pigs

• Most commonly, human cases of swine flu happen in people who are around pigs

• Swine flu viruses do not normally infect humans, however, human infections with swine flu do occur, and cases of human-to-human spread of swine flu viruses have been documented

Swine Influenza A(H1N1) History in US

• A swine flu outbreak in Fort Dix, New Jersey, USA occurred in 1976 that caused more than 200 cases with serious illness in several people and one death

– More than 40 million people were vaccinated– However, the program was stopped short after

over 500 cases of Guillain-Barre syndrome, a severe paralyzing nerve disease, were reported

• 30 people died as a direct result of the vaccination

• In September 1988, a previously healthy 32-year-old pregnant woman in Wisconsin was hospitalized for pneumonia after being infected with swine flu and died 8 days later.

• From December 2005 through February 2009, a total of 12 human infections with swine influenza were reported from 10 states in the United States

Swine Influenza A(H1N1) Transmission to Humans

• Through contact with infected pigs contaminated with swine flu viruses

• Through contact with a person with swine flu

– Human-to-human spread of swine flu is thought to occur in the same way as seasonal flu, through coughing or sneezing of infected people

Swine Influenza A(H1N1) March 2009Timeline

• In March and early April 2009, Mexico experienced outbreaks of respiratory illness and increased reports of patients with influenza-like illness (ILI) in several areas of the country

• April 12, the General Directorate of Epidemiology (DGE) reported an outbreak of influenza in a small community in the state of Veracruz to the Pan American Health Organization (PAHO) in accordance with International Health Regulations

• April 17, a case of atypical pneumonia in Oaxaca State prompted enhanced surveillance throughout Mexico

• April 23, several cases of severe respiratory illness laboratory confirmed as influenza A(H1N1) virus infection were communicated to PAHO

• Sequence analysis revealed that the patients were infected with the same strain detected in 2 children residing in California

– Samples from the Mexico outbreak match swine influenza isolates from patients in the United States

Source: CDC

Swine Influenza A(H1N1) March 2009Facts

• Virus described as a new subtype of A/H1N1 not previously detected in swine or humans

• CDC determines that this virus is contagious and is spreading from human to human

• The virus contains gene segments from 4 different influenza types:

– North American swine– North American avian– North American human and – Eurasian swine

Global Distribution of Reported Cumulative Laboratory Confirmed Cases of Swine Influenza A(H1N1) by Countries, June 11, 2009 (14:00 GMT)

Source: WHO

Swine Influenza A(H1N1) May 25, 2009Status Update

• MEXICO: March 01-June 09, a total of – 6,241 Laboratory confirmed cases– 108 deaths reported – All 32 States

• UNITED STATES: March 28-June 09, a total of 

– 13,217 Laboratory confirmed cases, – 27 deaths – All Sates plus District of Columbia and Puerto

Rico– Vast majority of cases mild

• CANADA: As of June 10, a total of– 2,978 Laboratory confirmed cases, – 4 deaths – 12 of 13 States– 533 new Laboratory confirmed cases June 8– Vast majority of cases mild

Source: Secretaria de Salud, Mexico, CDC, Public Health Agency of Canada, European CDC, WHO

Swine Influenza A(H1N1) May 25, 2009Status Update

• EUROPEAN UNION & EFTA COUNTRIES: April 27- May 25, a total of

– 1,565 Laboratory confirmed cases– no deaths – 26 countries– 126 confirmed cases reported on June 09– 567 in-country transmissions– Vast majority of cases reported between 20-49

years of age

• GLOBALLY: March 1-May 25, a total of – 27,737 Laboratory confirmed cases, from 74

countries– 144 Deaths among laboratory confirmed cases

from 7 countries• Mexico: 108 deaths• US: 27 deaths• Canada: 04 death• Chile: 02 deaths• Costa Rica: 01 death• Columbia: 01 death• Dominican Rep.: 01 death

Source: Secretaria de Salud, Mexico, CDC, Public Health Agency of Canada, European CDC, WHO

Swine Influenza A(H1N1) National Responses

United States• The Strategic National Stockpile (SNS) released one-

quarter of its – Anti-viral drugs and personal protective equipment

• President Obama asked Congress for an additional $1.5 billion to fight the swine flu

• On April 27, 2009, the CDC issued a travel advisory that recommends against all non-essential travel to Mexico

Egypt• Killed 300,000 pigs

EU• EU Health Commissioner issues health warning

against non-essential travel to Mexico and US

China• Quarantines Mexican, American and Canadian

nationals, cuts flights to Mexico and bars import of pig products

Source: CDC

The International Health Regulations (IHR)

• Key international legal instrument designed to provide a framework for global coordination and cooperation to control global health threat posed by infectious diseases

– Purpose is to ensure maximum protection against international spread of diseases with a minimum interference with world traffic

– Minimum interference principle base on legal and public health arguments

• IHR (1969)

– Only applies to traditionally quarantinable diseases of cholera, plague and yellow fever

– Restricts surveillance to information provided only by governments

– Lacks mechanisms to swiftly assess public heath risks

– Fails to generate compliance

• Swine flu is first test case of new IHR (2005)

New IHR (2005)• Like old IHR, the new IHR aimed at providing a public health

response to the international spread of disease in a manner that avoids unnecessary interference with international travel and trade

• Focuses on serious public health threats with potential to spread beyond a country’s borders to other part of the world

• The new IHR contains several major provisions designed to improve communication and coordination:– Establishes a new surveillance system:

• broadens type of events that need to be reported to WHO. “Public Health Emergency of International Concern” (PHEIC) is an extraordinary event determined by DG to (1) constitute a public health risk to other States through the international spread of disease, and (2) potentially require an international response

• Contain a decision instrument (annex 2) to help states determine PHEIC that focuses on risk assessment criteria of public health importance

• Enhances event management-especially alert and response mechanisms

New IHR (2005)• Other IHR innovations:

– Authorizes WHO to look at outside sources of information to evaluate PHEIC – enhances monitoring

– Formalizes WHO authority to issue recommendations in event of PHEIC and coordinate communication among States Parties

– Requires WHO to seek external advice regarding operation of IHR and declaration of PHEIC as well as recommended health measures

– Applies human rights principles to implementation of IHR

– Incorporates provisions on international collaboration and assistance.

New IHR (2005)• Among other things, States Parties are required

to:– Establish national IHR focal points for communication with WHO– Meet core surveillance capacity requirements– Inform WHO in a timely fashion of incidents that may be a public

health emergency of international concern and respond to additional requests for information from WHO

– Apply human right principles to public health interventions under the IHR

• Like all international instruments, strengths and limitations of IHR must be understood within context of state system– WHO has no ‘enforcement powers” to compel compliance

• Pandemics are unpredictable– Mortality, severity of illness, pattern of spread

• A sudden, sharp increase in the need for medical care will always occur

• Capacity to cause severe disease in nontraditional groups is a major determinant of pandemic impact

• Epidemiology reveals waves of infection– Ages/areas not initially infected likely vulnerable in future

waves– Subsequent waves may be more severe

• 1918- virus mutated into more virulent form• 1957 schoolchildren spread initial wave, elderly died in second

wave

• Public health interventions delay, but do not stop pandemic spread

– Quarantine, travel restriction show little effect• Does not change population susceptibility

• Temporary banning of public gatherings, closing schools potentially effective in case of severe disease and high mortality

– Delaying spread is desirable• Fewer people ill at one time improve capacity to cope with sharp

increase in need for medical care

Lessons Learned formPast Pandemics

Conclusions and Recommendations (WHO and CDC)1. Past experience with pandemics have taught us that the second wave

is worse than the first causing more deaths due to:– Primary viral pneumonia, Acute Respiratory Distress Syndrome (ARDS),

& Secondary bacterial infections, particularly pneumonia– Fortunately compared to the past now we have anti-virals and antibiotics

(to treat secondary bacterial infections)– Though difficult, there is likelihood that there will be a vaccine for this

strain by the emergence of the second wave– Based upon past experience and the way the current H1N1 pandemic is

acting (current wave is contagious, spread rapidly and based upon preliminary data affecting the healthy), there is a likelihood that come fall there might be a second wave which could be more virulent

2. Each locality/jurisdiction needs to – Have enhanced disease and virological surveillance capabilities– Develop a plan to house large number of severely sick and provide care if

needed to deal with mildly sick at home (voluntary quarantine) – Healthcare facilities/hospitals need to focus on increasing surge capacity

and stringent infection prevention/control– General population needs to follow basic precautions

Conclusion/Recommendations

3. At present most of the deaths due to H1N1 strain has been reported from Mexico.

• The disease, though spreading rapidly across the globe, is of a mild form (exception Mexico)

• Most people do not have immunity to this virus and, as it continues to spread.

4. Disease seems to be affecting the healthy strata of the population based upon epidemiological data from Mexico and EU

• 60 years and above age group seems to show some protection against this strain suggesting past exposure and some immunity

Conclusion/Recommendations

5. In the Northern Hemisphere influenza viral transmission traditionally stops by the beginning of May but in pandemic years (1957) sporadic outbreaks occurred during summer among young adults

– Likelihood that • This wave will fade in North America by the end of June or will cause disease

in a few cases (influenza virus cannot survive high humidity or temperature) • Will reappear in autumn in North America with the likelihood of being a highly

pathogenic second wave• Will continue to circulate and cause disease in the Southern Hemisphere

6. Border Closure and Travel Restrictions:– The disease has already crossed all borders and continents, thus, border

closure or travel restrictions will not change the course of the spread of disease• Most recently, the 2003 experience with SARS demonstrated the

ineffectiveness of such measures • In China, 14 million people were screened for fever at the airport, train

stations, and roadside checkpoints, but only 12 were found to have probable SARS

• Singapore reported that after screening nearly 500,000 air passengers, none were found to have SARS

• Passive surveillance methods (in which symptomatic individuals report illness) can be important tools

• Human rights implications

Conclusion/Recommendations7. School Closures:

– Preemptive school closures will merely delay the spread of disease – Once schools reopen (as they cannot be closed indefinitely), the disease

will be transmitted and spread – Furthermore, this would put unbearable pressure on single-working

parents and would be devastating to the economy (as children cannot be left alone)

– Closure after identification of a large cluster would be appropriate as absenteeism rate among students and teachers would be high enough to justify this action

8. High priority should be given to develop and include the present “North American” (swine) influenza A(H1N1) virus in next years vaccine. A critical look at manufacturing capacity is called for

9. It is imperative to appreciate that “times-have-changed” • Though this strain has spread very quickly across the globe and seems to

be highly infectious, today we are much better prepared than 1918. There is better surveillance, communication, understanding of infection control, anti-virals, antibiotics and advancement in science and resources to produce an affective vaccine

A NEW OUTBREAK…..

HYPOTHETICAL EXERCISE

Exercise Roles• Thailand

– District Health Officer – Secretary of Health – Secretary of Commerce– Prime Minister– Legal Counsel to Sec. Health

-- Legal Adviser, Foreign Affairs Department

-- Public Affairs Officer to the Prime Minister

-- Representative of Human Rights Commission

• World Health Organization– Director General – Exec. Dir., Communicable Diseases– Legal Adviser– First Legal Officer – Public Affairs Officer – Financial Officer– Human Rights Officer– Representative of World Trade Organization

Background: December, 2009

• In Thailand since 2004

– sporadic outbreaks of influenza A(H5N1) have decimated bird flocks and neighboring countries in Southeast Asia

– 25 human cases of H5N1 influenza A have been reported, with 17 deaths

• In Thailand, seasonal influenza typically peaks in the fall and winter months

Friday, December 25, 2009

• December 8, 2009: two poultry farmers (cases A & B) were seen at a clinic in the rural Kalasin province of northeastern Thailand– Both presented with conjunctivitis (inflammation of the eye’s

outer layer) and upper respiratory symptoms – doctor diagnosed a mild viral illness, treated conjunctivitis, and

sent patients home • December 11, 2009: a 48 year old farmer from the same

village (case C) died of pneumonia – More than half of his flock of chickens and ducks had died in the

previous week• December 14, 2009: Case A returns to the clinic with

high-grade fever and pneumonia– Bacterial pneumonia secondary to influenza is suspected, and

he is admitted and started on a course of antibiotics– discharged on December 18

• December 16, 2009: Case D brought to the clinic by her husband– She is a nurse who had treated Case A– In acute respiratory distress; placed on the clinic’s one ventilator– Couple has a small backyard flock of chickens, and a few pigs

• December 17, 2009: A teacher in the village who had helped care for Case C came to the clinic with respiratory symptoms (Case E)

• December 20, 2009: Case E’s wife (Case F) developed severe pneumonia and died four days later– No evidence that she was in contact with poultry

• December 25, 2009: The clinic’s doctor notified the District Health Officer of the cases– Ministry of Health notified immediately

Friday, December 25, 2009

Saturday, December 26, 2009: 8:00 am Health Ministry Meeting

• Issues:– Is this a public health emergency? – What steps should be taken?– Who should be alerted? – What legal obligations does Thailand have under international law?

• The Ministry of Foreign Affairs has informed the Health Ministry that Thailand is a party to the WHO IHR (2005) and has binding legal obligations under this instrument.

• In preparation for the meeting, participants should review the facts and the IHR (Articles 2-18, 42-45, 48-49, Annex 1 (Section A ) and Annex 2). Most importantly, the scope of Thailand’s duty to notify WHO is defined under Articles 6-8 and Annex 2.

• WHO officials have heard rumors that there may be an outbreak in Thailand and are now in the process of reviewing the IHR to determine scope of legal responsibilities of Thailand, other State Parties and WHO.

Saturday, December 26, 2008: Ministry Meeting

• Is this a public health emergency? – Are IHR criteria for WHO notification met?– Whom should be alerted, and when?

• What steps should be taken?– Epidemiologic and laboratory investigation to better

characterize the epidemic– Enhanced/active surveillance– Request help (What kind? From whom?)– Preparation for surge in health care demand

• Considerations– What legal obligations does Thailand have under

international law?– Potential consequences (positive and negative) from

notification or failure to notify

Wednesday, January 7, 2009:News Report

• “Authorities in Thailand confirmed today that over 1000 people have been sickened by what appears to be a new strain of influenza. Officials report that about 30 people have died to date. Cases were initially reported in rural farming villages in early December, but more than 50 patients suspected to have the illness have been treated in Bangkok in the last week.”

Wednesday, January 7, 2009:WHO Statement

• “The Thai Ministry of Health today confirmed widespread human outbreaks of a novel influenza strain, currently localized to Thailand. Laboratory results received yesterday confirm the presence of influenza A(H7N7), for which a vaccine is not currently available. Epidemiologic investigation suggests efficient human transmission. At present, 1027 cases have been reported, with 28 deaths. WHO and the Thai government urgently request donation of antiviral medications and public health assistance.”

Wednesday, January 7, 2009:WHO Videoconference

• WHO Director-General requests an international videoconference to deal with the A(H7N7) crisis

• Both WHO and the Thai government should meet prior to the videoconference and determine what their interests in—and optimal outcome of—the videoconference would be

Wednesday, January 7, 2009:WHO Videoconference

• Participants include– Thailand representatives: Secretary of Health

& legal counsel, District Health Officer of the index region

– WHO Experts: DG & legal counsel, Communicable Diseases, Financial, Human Rights and Public Affairs Officers

– International representatives: Representative of the WTO, EU Health Commissioner, CDC Director & Public Affairs Officer

• Is this a global public health emergency? • What international public health measures

should be adopted?

Wednesday, January 7, 2009• What steps should be taken?

– Isolation and quarantine in Thailand– Provide international help to Thailand to aid

epidemiologic and laboratory investigation – Enhanced/active surveillance (in Thailand? other

countries?)– Preparation for surge in health care demand (in

Thailand? other countries?)– International travel restrictions

• Considerations– Scarce supply of antivirals– Obligations of Thailand and developed countries

under international health law– Potential consequences (positive and negative) of

cooperation or failure to cooperate

Hot wash (debrief)

• In each phase

– What happened?

– What went well?

– What should have been done differently?

• What is needed now to improve future response?