[Ip-health] Aidsmap news: 2001 Doha trade agreement failing to improve access to medicines, Oxfam says

[Thiru Balasubramaniam]

<SNIP>

Last month two US politicians who will be powerful committee chairmen
in the new Democrat-controlled congress requested an investigation of
the effects of US trade policy on public health from the Government
Accountability Office. Senator Edward Kennedy and Rep. Henry Waxman
called for the US to drop pressure on WHO to bury a report on trade and
health critical of US policies.

Rep. Waxman said: =93Administration trade agreements have numerous
provisions that threaten access to affordable medicine. We have to
recognise that the Bush administration=92s single-minded pursuit of
intellectual property protections for drug companies can have
potentially devastating consequences for the public health in
developing countries.=94

<SNIP>

But James Love of the Consumer Project on Technology points to one
country that has devised a fairly succesful process for exporting
medicines under the 2003 Cancun agreement =96 India.

But, he notes, India is able to export most medicines because they are
not yet patented, and the real test will only come when patent
applications for newer products have been processed. India is currently
in a transitional phase from a patent regime which explicitly blocked
patent protection for medicines towards one which is TRIPS-compliant.
 From 2005 the country was required to accept the patenting of
medicines, and some Indian manufacturers are nervous that tightening of
the country=92s patent regime will eventually remove the ability to make
newer antiretroviral products.

But national laws still often fail to fully exploit the flexibilities
of the TRIPS Agreement, says James Love. Little or no assistance to
exploit the TRIPS flexibilities is coming from the World Health
Organization, and the agency is woefully under-resourced to help
developing countries improve access to the essential medicines that are
contained on WHO=92s Essential Medicines list.

He proposes that national governments, health advocates and the UN
system now need to look at another approach: patent pools for
developing countries which identify all the patents on essential
medicines necessary for treating particular diseases, and take the
burden of voluntary licensing away from manufacturers by seeking
standard terms for voluntary licenses across the developing world. The
pool would also create a smoother system for drawing down generic drugs
from manufacturers, advocates claim, although the means for achieving
this remain to be specified (follow this link for a description of the
proposed scope of a patent pool).

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http://www.aidsmap.com/en/news/32E9675E-B18A-4841-8947-
BDDC37AD42DD.asp?type=3Dpreview

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  2001 Doha trade agreement failing to improve access to medicines,
Oxfam says


Keith Alcorn, Tuesday, November 14, 2006

Public health exemptions from world trade agreements negotiated five
years ago have had no significant impact on improving access to
medicines in developing countries, Oxfam said today in a report Patents
versus Patients.

Oxfam argues that since 2001, no country has been able to take full
advantage of the public health safeguards built into international
agreements on patents. The Doha agreement in November 2001 reaffirmed
that intellectual property rules contained in the TRIPS agreement
should not prevent countries from protecting public health, and in
August 2003 the World Trade Organization agreed that generic
manufacturers could export essential medicines if compulsory or
voluntary licenses were issued by countries without the capacity to
make the drugs themselves.

But since then, says Oxfam, the US government has pursued trade
agreements with countries and regions that undermine the public health
flexibilities, and sought even higher levels of intellectual property
protection than required in the TRIPS agreements =96 so-called TRIPS Plus
provisions.

These requirements include prohibiting generic manufacturers from using
data generated by innovator companies in their licensing applications
for five years after the earliest marketing approval =96 even though that
data may be publicly available on the internet and in medical journals.

It also includes inserting protections for new formulations of existing
products into the patent laws of countries that don=92t currently
recognise slight changes in drug formulation to be significant new
innovations worthy of patent protection.

The World Bank recently highlighted the cost of such TRIPS Plus
protections to one country currently negotiating a free trade agreement
with the US. Thailand would no longer be able to manufacture its own
versions of some second-line antiretrovirals, said the World Bank,
requiring the Thai government to spend an extra $3.2 billion over the
next 20 years on antiretrovirals.

"If implemented, these deals will result in Colombia having to pay an
additional =A3494 million per year by 2020 to cover the increased cost of
medicines, affecting nearly six million patients," said Oxfam=92s Make
Trade Fair campaign head Celine Charveriat.

The US also attempts to use trade sanctions against countries which
make generic drugs, says Oxfam. In 2006 the US placed India on the
Special 301 Priority Watch List for failing to insert a data
exclusivity clause into its patent law (the watch list is the last step
before trade sanctions are imposed). A data exclusivity clause in
Indian patent law would delay the development of generic versions of
any new antiretroviral for five years if the patent holder filed a
patent application in India within one year of the first marketing
approval of the product anywhere in the world. This means that generic
versions of new second-line drugs would now take at least five years to
appear in India after they are approved in the US.

Last month two US politicians who will be powerful committee chairmen
in the new Democrat-controlled congress requested an investigation of
the effects of US trade policy on public health from the Government
Accountability Office. Senator Edward Kennedy and Rep. Henry Waxman
called for the US to drop pressure on WHO to bury a report on trade and
health critical of US policies.

Rep. Waxman said: =93Administration trade agreements have numerous
provisions that threaten access to affordable medicine. We have to
recognise that the Bush administration=92s single-minded pursuit of
intellectual property protections for drug companies can have
potentially devastating consequences for the public health in
developing countries.=94

Oxfam charges that other rich countries have largely stood by and done
nothing while the US has pursued its self-interest through free trade
agreements. Although the UK and French governments have spoken out in
support of the public health flexibilities granted in the TRIPS
agreement, Oxfam charges that European pharmaceutical companies benefit
from US policies just as much as their American competitors.

A particular feature of the Cancun trade agreement in 2003 was the
concession that countries without manufacturing capacity could import
generic drugs under a compulsory license. However, no country has yet
used the provision, according to a report of the World Trade
Organisation=92s own TRIPS Council. This is despite the fact that Canada
implemented legislation allowing Canadian manufacturers to make generic
antiretrovirals for export.

Richard Elliot of Canada=92s HIV/AIDS Legal Network explains why the
Canadian legislation hasn=92t worked: =93The WTO decision embodied in
Canada=92s law ignores the realities of generic drug manufacturers and
developing countries. Developing countries need simple contract
processes that will ensure sustainable supplies of essential medicines;
these contracts must be flexible enough to adjust to changing needs.
The WTO decision enacted by Canada forces generic companies to get a
license to manufacture each and every patented drug, and only in a
pre-negotiated quantity and to a single country.=94

Recently adopted European Union legislation contains a similar
requirement for each and every import to be subject to a separate
compulsory license.

Medecins sans Frontieres says it has been trying to use the Canadian
legislation to buy antiretrovirals for its developing country treatment
programmes for two years without success. However it says that the 2003
Cancun decision is inherently unworkable, and points to the following
flaws:

     * Generic manufacturers are required to negotiate with the patent
holder; voluntary license agreements are often lengthy, and it=92s
unclear when generic manufacturers can say that talks have failed and
move ahead regardless, adopting a compulsory license.


     * Anti-diversion measures to prevent leakage of generics back into
rich markets require the products to look different and be packaged
differently from any similar products available in rich countries, and
information about the quantities of each batch and its destination must
be posted on the internet. MSF says this provision is too onerous,
although in practice generic products always look different from the
branded products sold in rich countries.


     * Countries that want to import drugs under this provision have to
inform the WTO TRIPS Council of the drugs and the quantities they want
to import, and prove that they don=92t have the domestic capacity to make
the drugs. MSF says that providing this information could expose
importing countries to pressure from opponents of compulsory licensing.


     * The Cancun agreement requires countries to seek compulsory
licenses for every batch of medicines ordered, and to go through
negotiations with the patent holder for every order. This is not
feasible, says MSF, and has discouraged manufacturers in Europe and
Canada from getting involved in production of generic antiretrovirals.
The volume of licensing work that a generic manufacturer has to take on
in order to get into this line of business is a huge disincentive, they
point out.



But James Love of the Consumer Project on Technology points to one
country that has devised a fairly succesful process for exporting
medicines under the 2003 Cancun agreement =96 India.

But, he notes, India is able to export most medicines because they are
not yet patented, and the real test will only come when patent
applications for newer products have been processed. India is currently
in a transitional phase from a patent regime which explicitly blocked
patent protection for medicines towards one which is TRIPS-compliant.
 From 2005 the country was required to accept the patenting of
medicines, and some Indian manufacturers are nervous that tightening of
the country=92s patent regime will eventually remove the ability to make
newer antiretroviral products.

But national laws still often fail to fully exploit the flexibilities
of the TRIPS Agreement, says James Love. Little or no assistance to
exploit the TRIPS flexibilities is coming from the World Health
Organization, and the agency is woefully under-resourced to help
developing countries improve access to the essential medicines that are
contained on WHO=92s Essential Medicines list.

He proposes that national governments, health advocates and the UN
system now need to look at another approach: patent pools for
developing countries which identify all the patents on essential
medicines necessary for treating particular diseases, and take the
burden of voluntary licensing away from manufacturers by seeking
standard terms for voluntary licenses across the developing world. The
pool would also create a smoother system for drawing down generic drugs
from manufacturers, advocates claim, although the means for achieving
this remain to be specified (follow this link for a description of the
proposed scope of a patent pool).

Oxfam argues that a review of the effects of TRIPS on essential
medicines is urgently needed, and that G8 countries should give support
to poor countries that want to enact the TRIPS safeguards. It also
calls on the US to stop `coercing` developing countries through free
trade agreements.

Pharmaceutical companies argue that a systematic policy of voluntary
licensing is being pursued by virtually all antiretroviral
manufacturers apart from Abbott (manufacturer of Kaletra) in developing
countries, but critics say that the benefits of this approach in price
reduction are not reaching middle-income countries, which
pharmaceutical companies argue are still capable of paying higher
prices for medicines.

------------
Thiru Balasubramaniam
Geneva Representative
CPTech
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@cptech.org