E-DRUG: Lancet editorial: correction of moderators remarks
-----------------------------------------------------------
[correction of moderators remarks in the message on Lancet editorial 30
January:
Although first not available on the electronic Lancet website
(www.lancet.com), this was really published last friday as a Lancet
editorial!
The statement in the editorial that the PMA will take the SA government to
WTO must be a misunderstanding as only governments (WTO member states) can
take other governments to dispute settlement in WTO.
The criticism of the USA position of the watchlist is a bit unfair, as SA
was subsequently removed from the Watchlist, and president Clinton signed
an executive directive dated 10 May 2000 (published on E-drug) basically
saying that sub-saharan African countries could use TRIPS compatible
measures such as compulsory licensing and parallel import in their search
for affordable drugs in the disastrous AIDS epidemic.
Copied as fair use. WB]
EDITORIAL, The Lancet, Vol 357, page 243, January 27, 2001
World Trade Rules and cheaper drugs
Three years ago, the South African parliament gave the Minister of Health
power to permit parallel importation of drugs produced under licence in
another country where prices are cheaper. The Medicines and Related
Substances Control Amendment of 1997 would allow the government to bypass
the monopoly granted to companies holding the patents in South Africa. The
government argues that the measure is necessary to ensure access to
life-saving drugs, particularly AIDS drugs, which are typically priced far
beyond what most South Africans can afford.
The Pharmaceutical Manufacturers Association of South Africa, however,
moved quickly to halt implementation of Act, filing a suit in the Pretoria
High Court. The suit was suspended, for a time, while the government and
PMA tried to negotiate. Eventually, believing that the government was not
negotiating seriously, PMA took up the suit again. The case is now set to
go before the High Court on March 5. Should the court rule in the
government's favour, the PMA says it will take its case to the World Trade
Organization. PMA, joined by the international pharmaceutical industry, has
also been persuading many western governments to exert pressure on South
Africa. The USA went so far as to place South Africa on its "watch list" of
troublesome countries considered to be violating US trade interests, a
designation that can be a prelude to trade sanctions and cuts in foreign
aid.
The industry argues that the law is unjust, unnecessary, and unwise. Unjust
because the law, by giving the Minister of Health arbitrary power to ignore
patent rights, essentially allows the expropriation of intellectual
property rights without due process mandated by South African patent law
and guaranteed by South Africa's constitution. Unnecessary, the industry
contends, because the government could, if it so chose, take advantage of
tier-pricing offered by drug companies at rates far below those offered to
the private sector. And unwise, because the law will rob companies of
income they need to cover the costs of research and
development, discourage investment the country needs to develop, and
endanger consumers by encouraging the importation of substandard drugs. The
main health-care problem facing South Africa and other developing n!ltions,
the companies argue, is the lack of an infrastructure capable of providing
basic health services-for example, without the staff, clinics, and
laboratory services needed to oversee the use of AIDS drugs, resistant
strains will quickly appear, making a bad situation even worse.
The health systems of sub-Saharan countries are indeed inadequate, and
lower drug pricing is not the whole answer. However, there are health teams
in the cities, towns and villages who could prevent HIV infection in
thousands of newborn babies and improve the lives of thousands of people
already infected-if only they had access to medicines. They and their
patients should get that chance.
Even if the PMA prevails in the courts or with its appeal to the WTO, it is
unlikely to get public opinion on its side. The world's understanding of
the AIDS catastrophe has grown considerably in the 3 years since the PMA
filed suit. And there is increasing awareness that more needs to be done to
get essential medicines to people living in the developing world. The time
has come for the pharmaceutical industry and the governments who represent
them in trade disputes to acknowledge that the world is facing an
extraordinary challenge. The WTO's agreement on trade-related aspects of
intellectual-property rights does allow parallel importation and compulsory
licensing in the face of a public health emergency. AIDS/HIV in sub-
Saharan Africa is just such an emergency. Rather than fighting the efforts
of these nations to deal with this crisis, industry experts and government
officials should be working with WHO to ensure that trade agreements that
currently threaten already fragile economies can be adjusted to meet any
crisis affecting the health of developing nations now and their very
existence as trading nations in the future.
The Lancet
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.