November 2006
Contact:
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
Email:
s.m.apatow@humanitarian.net
Internet:
www.humanitarian.net
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).
Pharmaceuticals:
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 pharmaceuticals.
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 international public health emergency.
Currently we have three significant public health emergencies in
continental Africa, each that would warrant compulsory licenses for all
necessary pharmaceuticals.
I. HIV/AIDS
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).
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