[Ip-health] The FT's on the "consensus" that compulsory licenses should not be used for heart disease

[James Packard Love]

Below is the recent FT editorial criticizing the Thai compulsory
licenses, particularly the one for the patents on Plavix, the heart
disease drug.  The FT claims there is a "consensus" that compulsory
licenses should not be used for patented heart disease drugs, since
generic alternatives exist, and compulsory licenses should be limited
to "extremely poor countries suffering from public health emergencies."

As someone who invested considerable effort in the negotiations over
paragraph 6 of the 2001 Doha Declaration, I find this an odd and
historically inaccurate comment.  The US, EC and Japan wanted to
restrict the waiver of Article 31.k of the TRIPS to apply to only a
handful of diseases, including AIDS, or to public health
emergencies.   This was in fact perhaps the most contentious part of
the para 6 negotiation, particularly going into the Sydney Australia
mini-ministerial in the 2002, and later as played out over various
lists of diseases negotiators were asked to endorse.   But as
reported by the FT and other publications in 2002-2003, the effort to
limit the scope of diseases failed, in large part because of
opposition from the public health community.   The 2001 Doha
Declaration included a broadened understanding of what constituted a
public health emergency, but also an agreement that countries could
issue compulsory licenses for other grounds, and were not limited to
emergencies.

Efforts to distort the history of these negotiations are dishonest
and harmful to the aspirations of many who support more equality of
access to medicines.   They are also intellectually dishonest for a
paper that separately reports about "patent reforms" in the United
States that involve compulsory licenses, the mandatory compulsory
licenses in the UK for plant breeders, the various efforts by EU
countries to avoid the Myriad patents on breast cancer genes, or the
EC and EC compulsory licenses on Microsoft Windows protocols.

In Thailand, the price of the BMS/Sanofi product is 70 Baht per day,
or about 2 USD.  This is roughly half the US price, but the US has
average incomes that are sixteen times higher than Thailand.  (For US
citizens, imagine having a pay-cut of 93 percent, and then paying for
medicines).   UK average incomes are roughly fourteen times higher
than Thailand average incomes.  As a consequence of the current high
prices for Plavix, the Thai ministry of health estimates the product
is unaffordable to 80 percent of the Thai patients who have heart
disease.

I find it outrageous that Europeans or North Americans would question
the seriousness of heart disease in developing countries.   Since
apparently no reporters from the financial press do any research on
this topic, I would provide this pointer to the WHO page on
Cardiovascular disease (CVD), or as referred to by the WHO:  "the
global epidemic of heart disease and stroke:"  http://www.who.int/
cardiovascular_diseases/resources/atlas/en/

According to the WHO, CVD is responsible for 10 percent of the
disability adjusted life years (DALYs) lost in low and middle income
countries.  They provide this quote:

=93Unless current trends are halted or reversed, over a billion people
will die from  cardiovascular disease in the first half of the 21st
century. The large majority will be in developing countries and much
of the life years will be lost in middle age."  Anthony Rodgers,
Clinical Trials Research Unit, University of Auckland, New Zealand, 2004

BMS/Sanofi have priced Plavix at 70 Baht (2 USD) per day in
Thailand.  The initial generic purchases are priced at 6 Baht (.17
USD).   By issuing the CL, the Thai Ministry of Health has made the
product affordable.  People who oppose the CL are opposing the most
effective way to expand access to this product.  European or US
reporters who claim that Thailand has plenty of money to pay for the
higher prices don't seem to care what the facts are, or are unwilling
to do some simple math.

GNI per capita in 2005
USA          UK                 Thailand
43740       37600            2750

Finally, if the UK or other high income countries do not want to pay
for expensive drugs like Plavix, it does not mean that the Thai
should not issue a compulsory license to make the generic version
available, in order to improve health outcomes.  The Thai Ministry of
Health may reach its own conclusions regarding what is best for it's
citizens, and the degree to which it wants to use TRIPS
flexibilities, and is willing to implement an actual "consensus"  --
Paragraph 4 of the 2001 Doha Declaration --  which states that the
TRIPS Agreement "can and SHOULD be interpreted and implemented in a
manner supportive of WTO Members' right to protect public health and,
in particular, to promote access to medicines for all."

Jamie

------from the FT editorial----------------
*  But the WTO concessions won agreement between health activists and
pharmaceutical companies in the context of delivering low-cost
medicines to extremely poor countries suffering from public health
emergencies.  Widening the interpretation to include a patented
cardio-vascular blood-thinning preventative drug, when many more
affordable and off-patent alternatives are available, weakens that
consensus and could end up making the rules tougher in future.

http://www.ft.com/cms/s/37500f5c-
b0cf-11db-8a62-0000779e2340,dwp_uuid=3D063fb9c2-3000-11da-
ba9f-00000e2511c8.html


Drugs in Thailand

Published: January 31 2007 02:00 | Last updated: January 31 2007 02:00

After its brief dalliance with capital controls at the end of last
year, Thailand's military-installed government has delivered a fresh
shock to international investors with a threat to tear up
pharmaceutical companies' drug patents. It should proceed with caution.

At the end of November, the health ministry unveiled plans to issue a
"compulsory licence" under World Trade Organisation rules against
Merck of the US, allowing it to override the company's intellectual
property protection on Stocrin, an HIV drug, and buy cheaper supplies
from generic suppliers in India. This week, it threatened further
compulsory licences against another two products, including Plavix,
Sanofi-Aventis's best-selling blood-thinning drug.

At a human level, Thailand's move is understandable. The country has
committed to free universal healthcare, and faces a particular
challenge in treating a large number of HIV-positive patients with
drugs that are costly even for far richer countries.

In a strict legal sense, it may also be able to defend its position.
WTO rules do allow for the issue of compulsory licences for
pharmaceuticals to override the usual patent protection rights for
public health reasons. Drug companies certainly need to do more to
ensure that they are offering tiered pricing, ensuring that their
drugs are sold at significantly lower prices in poorer countries.
That makes good economic as well as moral sense.

Lower pricing would be helped by more aggressive sub-contracting or
out-licensing of their drugs to reliable generic producers that
specialise in making medicines at the lowest possible cost. But the
WTO concessions won agreement between health activists and
pharmaceutical companies in the context of delivering low-cost
medicines to extremely poor countries suffering from public health
emergencies.

Widening the interpretation to include a patented cardio-vascular
blood-thinning preventative drug, when many more affordable and off-
patent alternatives are available, weakens that consensus and could
end up making the rules tougher in future.

While Thailand remains relatively poor, it and other emerging
economies such as India (also currently subject to a legal challenge
to its patent regime) also have a growing middle class that can
increasingly afford to pay for medicines and should begin to help
share the cost of future drug innovation.

The debate over whether innovation is best protected and stimulated
by the existing patent regime is an important one. But forcing the
issue in Thailand when there is scant evidence of the effectiveness
of alternative models is counter-productive.

Thai consultation with the three pharmaceutical companies concerned
has been modest. Yet WTO rules say compulsory licences should be a
last resort. Their greatest power is their use as a bargaining tool.

----------------------------------------------
James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"