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."
----------------------------------------------------
http://bmj.bmjjournals.com/cgi/content/full/330/7487/321
BMJ 2005;330:321-322 (12 February),
doi:10.1136/bmj.330.7487.321
Editorial
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
(www.who.int/csr/outbreaknetwork/en/)—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}hpa.org.uk
)
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
Box appears on bmj.com
Competing interests: None declared.
The views expressed here do not necessarily represent the views of
the organisations employing the authors or their national authorities.
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