Pyres: 2001 UK FMD Outbreak - Photo: Murdo Macleod.  Slides L-R: Smallpox, SARS Coronavirus , Foot and Mouth Disease, West Nile Virus.
11 February 2005

As per our current discussions associated with international law and emerging infectious diseases, the following BMJ editorial may be of interest.

I would also like to expand discussion associated with the current influenza crisis and compulsory licensing with respect to pharmaceuticals, to allow developing and other countries to build up stockpiles of anti-virals (
pharmaceuticals: IDSA, Clinical Infectious Diseases, 2003;37:1405-1433).  

The TRIPS Agreement, as clarified by the Doha Declaration, makes it clear that WTO members can engage in compulsory licensing with respect to pharmaceuticals needed to address an influenza crisis.

This need is immediate (Flu at the Door: Kommersant News, February 11, 2005):

"Russia’s chief officer of health Gennady Onishchenko announced yesterday start-up of the flu epidemic in the country. The flu has taken root in 13 cities of Russia and is expected in Moscow and St. Petersburg in the near term. This year, fighting the flu is not only a medical but also a commercial problem. Anti-virus medicine is out of the list of discount drugs approved by the Ministry of Health."

As noted in ProMED, 28 October 2004: Avian influenza discovered in Novosibirskaya region (Russia):

"avian influenza type H5N1 has been discovered in migratory birds in the Novosibirskaya region. As suggested by Alexander Shestopalov, the head of the zoonoses laboratory in the State Scientific Center for Virology and Biotechnology "Vector," preliminary data indicate that the virus was brought from south-east Asia by migratory birds, such as ducks and geese, which annually winter there.

Scientists have warned of possible mutations, and genetic reassortment, of avian and human influenza viruses. They have warned that conditions for such a scenario might prevail [also] on Russian territory."


BMJ  2005;330:321-322 (12 February), doi:10.1136/bmj.330.7487.321


Proposed new International Health Regulations

Agreement must be reached to protect the global village from pandemic influenza

Infectious diseases have never respected national boundaries, and ever increasing movement of people and goods means that no country or region, no matter how wealthy, can make itself invulnerable to infections emerging elsewhere.1 2 Equally neither can any country be confident that it will not be the source of a threat to the global community.2 The International Health Regulations are legal instruments designed to provide the maximum security against the international spread of infectious disease with minimal interference with world traffic.3 4 Although the World Health Organization is responsible for the regulations, they are agreed collectively by its member states. Individual states may state a reservation, but great trouble is taken to come up with regulations that almost every country will sign up to. The current regulations (in place since 1969) have been recognised to be inadequate for today's global village and the acid tests that countries may face (box).5 6 WHO has been revising the regulations since 1995. Progress was initially slow, but the relative irrelevance of the regulations during the outbreaks of severe acute respiratory syndrome (SARS) gave added momentum to the process, which is now approaching its intended end—approval of new regulations by the World Health Assembly in May 2005.

The current regulations require notification only of cases of three diseases—yellow fever, plague, and cholera—and contribute little when faced with established foes such as pandemic influenza, let alone emerging infections such as SARS or new multidrug resistant organisms. Furthermore, they have no authority over the detection, prevention, and control of disease within individual member states.

Intrinsic to the current regulations is an optimistic philosophy that infections can be stopped at borders by regulation of travellers, aircraft, and cargoes. However, borders will always be permeable to infections with incubation periods longer than the duration of an air flight. When SARS occurred, what mattered was how the disease was controlled in exporting areas (Guangdong and Hong Kong) and how safely acute respiratory infections were managed in emergency departments and hospital wards in receiving countries. Exit screening played a part, but entry screening was of little value.7 8 In addition, entry or exit screening in major airports will need commitment of considerable human resources that will probably be better used elsewhere during an infectious disease crisis.7

The new regulations take a radical approach, requiring countries to apply a decision instrument (an algorithm) to any "event potentially constituting a public health emergency of international concern."9 avian influenza in humans) that might represent the start of the next influenza pandemic or a covert bioterrorist attack (box). Then they would have to satisfy WHO that their response is adequate to contain the threat. Countries facing difficulties could then receive assistance through WHO—for example, by using its global outbreak alert and response network (—a mechanism that worked well during SARS and after the recent tsunami. WHO will officially be allowed to use information from informal sources such as the media. All countries will have to develop internal surveillance and response mechanisms that can detect issues within the country that threaten the global community.5 Countries would then have to report events (for example,

These revisions are responding to shifts in the political, economic, and technological climates that have brought about new collective ways of thinking about public health governance.3 4 During SARS all states (apart initially from China) openly reported outbreaks and cooperated with WHO without legal obligation.8 Most countries have also been open about avian influenza. The new regulations will provide the legal framework in which these modern public health systems can rest.

The draft regulations were recently considered by an intergovernmental working group meeting in Geneva.5 9 Progress was slow and the meeting will reconvene in February. Some countries have concerns over sovereignty and loss of control, others want extensive disease lists as well as or instead of the algorithm, and yet more question who will pay for the modernisation and strengthening of surveillance and response systems. Another issue is whether the regulations will apply in large economic groupings such as the European Union or whether current European mechanisms should apply.6 The interface of the regulations with pre-existing treaties is a complex area.10 However, some aspects of the European Union make it more, rather than less, vulnerable to infectious diseases. Its legislative base for public health, article 152 of the Consolidated Treaty, is weak—considerably weaker than the legal basis for the protection of animal health.11 Furthermore, the laudable European policy of free internal movement of goods and people facilitates the easy spread of infections.6 12 European citizens should receive the same levels of protection that the new regulations will provide in other well resourced regions.

The world faces many threats from infection. Most topical is the risk of pandemic influenza, which seems to be the highest in three decades. WHO is updating its pandemic plan and proposing that should avian influenza become a pandemic strain in one country the international community should combine to help the country stamp the strain out.13 However, this requires that affected countries report such events immediately to the world community, which is what the new regulations are about. People with national responsibilities must argue these issues to an acceptable compromise before May. Some national sovereignty will need to be ceded in return for collective protection from infection. The status quo is not compatible with any adequate response to the threats that all countries face from emerging and re-emerging infections.1 9 10

Angus Nicoll, director

Communicable Disease Surveillance Centre, Health Protection Agency Centre for Infections, London NW9 5EQ (angus.nicoll{at} )

Jane Jones, consultant epidemiologist

Communicable Disease Surveillance Centre, Health Protection Agency Centre for Infections, London NW9 5EQ

Preben Aavitsland, state epidemiologist

Department of Infectious Disease Epidemiology, Division of Infectious Disease Control, Norwegian Institute of Public Health, PO Box 4404, Nydalen, N-0403 Oslo, Norway

Johan Giesecke, state epidemiologist

Smittskyddsinstitutet (SMI), S-171 82 Solna, Sweden

  {webplus.f1} Box appears on

  Competing interests: None declared.

  The views expressed here do not necessarily represent the views of the organisations employing the authors or their national authorities.


  1. Smolinski MS, Hamburg MA, Lederberg J, eds. Microbial threats to health: emergence, detection, and response. Washington: Institute of Medicine, 2003. (accessed 14 Jan 2005). 
  2. Editorial team. At least five workers infected with highly pathogenic avian influenza (HPAI) during outbreak of avian influenza in poultry farms in Holland. Eurosurveill Wkly 2003;7:11. (accessed 14 Jan 2005). 
  3. The international health regulations and beyond. Lancet Infect Dis 2004;4: 606-7.[CrossRef][ISI][Medline] 
  4. Gostin LO. International infectious disease law—revision of the WHO's International Health Regulations. JAMA 2004;291: 2623-7.[Abstract/Free Full Text] 
  5. World Health Organization. Review and approval of proposed amendments to the International Health Regulations. (accessed 28 Jan 2005). 
  6. Van Loock F, Gill ON, Wallyn S, Nicoll A, Desenclos JC, Leinikki P. Roles and functions of a European Union Public Health Centre for Communicable Diseases and other threats to health. Eurosurveill 2002;7:78-84. (accessed 14 Jan 2005). 
  7. St John RK, King A, deJong D, Bodie-Collins M, Squires SG, Tam TWS. Border screening for severe acute respiratory syndrome (SARS). Emerg Infect Dis (in press). 
  8. Anderson RM, Fraser C, Ghani AC, Donnelly CA, Riley S, Ferguson NM, et al. Epidemiology, transmission dynamics and control of SARS: the 2002-2003 epidemic. Philos Trans R Soc Lond B Biol Sci 2004;359: 1091-105.[CrossRef][ISI][Medline] 
  9. World Health Organization. Review and approval of proposed amendments to the International Health Regulations: explanatory notes. (accessed 14 Jan 2005). 
  10. World Health Organization. Review and approval of proposed amendments to the International Health Regulations: relations with other international instruments. (accessed 14 Jan 2005). 
  11. Consolidated version of the treaty establishing the European Community. Article 152. (accessed 14 Jan 2005). 
  12. van Pelt W, Mevius D, HG Stoelhorst H, Kovats S, van de Giessen A, Wannet W, et al. Increase of salmonella infections in 2003 in the Netherlands: hot summer or side effect of the avian influenza outbreak. Eurosurveill 2004;9:3-4.  (accessed 13 Jan 2005).
  13. Monto AS. The threat of an avian influenza pandemic. N Engl J Med 2005;352: 323-5.[Free Full Text]


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