Pyres: 2001 UK FMD Outbreak - Photo: Murdo Macleod.  Slides L-R: Smallpox, SARS Coronavirus , Foot and Mouth Disease, West Nile Virus.
November 2006


Stephen M. Apatow
Founder, Director of Research & Development
Humanitarian Resource Institute (UN:NGO:DESA)
Humanitarian University Consortium Graduate Studies
Center for Medicine, Veterinary Medicine & Law
Phone: 203-668-0282

Compulsory Licensing of Pharmaceuticals Needed to Address an International Public Health Emergency

UN leaders are meeting next week to focus on the current international public health emergencies impacting continental Africa and the spread of pandemic avian influenza (International Conference on HPAI in Bamako, Mali).

During the past 12 months, the Qinghai strain of H5N1 (CDC, Volume 12, 8.8.06) has migrated through Russia, Mongolia, Kazakhstan, Europe, the Middle East, and Africa (Evolution of Qinghai H5N1 Bird Flu, Recombinomics, 5.906).  This explosion is without precedent and was driven by H5N1 in long range migratory birds (H5N1 bird flu reaches Africa, New Scientist, 2.9.06).  To date outbreaks have been discovered in Egypt, Nigeria, Niger, Côte d'Ivoire and Burkina Faso, Uganda and Djibouti with possible cases being investigated in Somalia and Sudan.  

International attention has now shifted attention to human subclinical/atypical infections  (ProMED: Avian influenza, human (140): atypical infections) of influenza A subtype H5N1 (human transmissible strains of avian influenza virus that originated from H5N1 -  H3N2, H1N1 - H2, H9, H7).


The African continent's public health systems are currently viewed as incapable of handling the scope of current outbreaks, prompting the need for international intervention.  One area that we can facilitate immediate action is with regards to

he 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 international public health emergency.

Currently we have three significant public health emergencies in continental Africa, each that would warrant compulsory licenses for all necessary


The area in Africa south of the Sahara desert, known as sub-Saharan Africa, is by far the worst-affected in the world by the AIDS epidemic. The region has just over 10% of the world's population, but is home to over 60% of all people living with HIV. An estimated 3.1 million adults and children became infected with HIV during the year 2005. This brought the total number of people living with HIV/AIDS in the region to 25.8 million by the end of the year. HIV prevalence varies considerably across this region - ranging from less than 1% in Mauritania and Senegal to almost 40% in Botswana and Swaziland. -- Sub-Saharan Africa: Avert.

Although HIV/AIDS has reached almost every part of the world, no other region has been harder hit than sub-Saharan Africa, home to nearly three quarters of the world’s people living with HIV/AIDS. By the end of 2002, over 29 million people in sub-Saharan Africa were living with HIV/AIDS. Of those, 10 million were young people (aged 15-24) and almost 3 million were children under 15. In 2002 alone, about 2 million adults died of HIV/AIDS in the region. -- Africa's Orphaned Generations: UNICEF.

Eight out of every 10 children who have lost parents to HIV/AIDS live in sub-Saharan Africa. Between 1990 and 2001, the proportion of orphans whose parents died from HIV/AIDS rose from 3.5 per cent to 32 per cent. There are more than 34 million orphans in the region today, 11 million of them orphaned by HIV/AIDS.

Total number of orphans due to AIDS, 2003:
Nigeria:   1,800,000
South Africa:   1,100,000
Tanzania:   980,000
Zimbabwe:   980,000
Uganda:   940,000
DR Congo:   770,000
Ethiopia:   720,000
Zambia:   630,000
By 2003, 15 million children under 18 had been orphaned by HIV/AIDS worldwide.  About 12 million of these live in sub-Saharan Africa, and it is expected that this number will have risen to more than 18 million by 2010.  Most of the AIDS orphans who live outside of Africa live in Asia, where the total number of orphans - orphaned for all reasons - exceeds 87 million. There is however insufficient information in Asia to provide figures for the number of AIDS orphans in individual countries.

II. Tuberculosis

The incidence of human tuberculosis increased globally in 2003, but incidence, prevalence, and death rates were approximately stable or decreased in all countries except Africa. Of the 15 counties in the world with the highest rates of tuberculosis, 13 are in Africa. It is estimated that 2.4 million Africans become infected and 540 000 die annually from the disease. HIV infection results in humans becoming much more susceptible to all forms of tuberculosis and it is estimated that 50% or more of new cases are related to prior HIV infection. -- Status for Controlling Bovine Tuberculosis in Africa, Prof. Cheryl M E McCrindle, Department Paraclinical Sciences, Veterinary Faculty, University of Pretoria, South Africa and Dr Anita  Michel, Onderstepoort Veterinary Institute, Agricultural Research Council, South Africa.

-- TB emergency declared in Africa: Aids reduces the body's resistance to TB. African health ministers have announced a regional tuberculosis emergency due to a sharp rise in the number of cases.  BBC, 25 August 2005.

South Africa may forcibly isolate patients being treated for a highly drug-resistant form of tuberculosis to prevent new infections from spreading on the AIDS-hit continent, health officials said....."Holding the patient against their will is not ideal but may have to be considered in the interest of the public," Ronnie Green-Thompson, a special advisor to the Health Department, said in a statement. -- S.Africa urged to isolate "killer" TB patients, Reuters, 23 january 2007.

To get a grasp of the Global TB PandemicThreat:

Multi-drug resistant tuberculosis (MDR-TB) are strains of the airborne disease that are resistant to at least two of the most important first-line drugs....Cases of drug resistant tuberculosis are higher than previously estimated and three nations – China, India and Russia – account for more than half of all cases worldwide, according to new research. -- Drug resistant TB cases even bigger, IBN Live, 18 December 2006.

III. Pandemic: Avian Influenza

Officials at the Food and Agriculture Organisation (FAO) say Africa's monitoring systems simply are not adequate to cope effectively with outbreaks. The risk of human cases is also raising questions about the strength of the continent's public health systems. -- Africa 'too weak' to fight H5N1, BBC, 2.9.06.

It is my hope that Africa will serve as reference point for continued discussions associated with
compulsory licensing with respect to pharmaceuticals, for outbreaks classified by physicians, epidemiologists and scientific experts as an integral part of a public health emergency of international concern.  I also hope to fully engage the International Bar Association Human Rights Institute in this discussion in the context of the newly revised International Health Regulations (ProMED, 5.20.2005).

[Biodefense Threat Analysis Center]
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