[Ip-health] WHO backs use of Trips flexibilities in new report

[Kannikar KIJTIWATCHAKUL]

WHO backs use of Trips flexibilities in new report

ACHARA ASHAYAGACHAT

Bangkok Post, Monday February 18, 2008

The World Health Organisation (WHO) mission to
Thailand has added its support to the use of
flexibilities in the Trade-Related Aspects of
Intellectual Property Rights (Trips) agreement to
improve access to essential medicines. In its 31-page
report entitled ''Improving access to medicines in
Thailand: The use of Trips flexibilities'', the WHO
mission said the use of compulsory licences is one of
several World Trade Organisation (WTO) mechanisms used
for patented essential medicines not affordable to
public health insurance schemes.

The seven-member team _ which comprises experts from
the WHO, WTO, the United Nations Development Programme
and law experts _ met representatives of Thai health
authorities, drug firms, patient networks and civil
groups on compulsory licensing from Jan 31 to Feb 6.
The report has been released amid debate on whether
overriding drug patents, approved by the
coup-appointed government, should be continued.

New Public Health Minister Chaiya Sasomsab stated
clearly on his first day in office that he wanted the
scheme to be reversed. His stance drew harsh criticism
from civil groups and health experts.

The report provides technical information and policy
options on the general rules and mechanisms available
to countries for use of the flexibilities contained in
the Trips and other international agreements, in order
to promote greater access to pharmaceutical products.
The WHO mission, led by German Velasquez from its
headquarters in Geneva, said its report is not
intended to make any evaluation or assessment of the
use of Trips flexibilities in Thailand.

Kannikar Kijtiwatchakul, a campaigner for Medecins
Sans Frontieres, said the report implied that
Thailand's past acts regarding the issuing of
compulsory licences were legal and transparent as far
as public health matters were concerned.

The mission said in its report that the Trips
agreement contains a range of mechanisms and options
to protect public health that countries can consider
when formulating intellectual property laws and public
health policies.

''The use of compulsory licences and government-use
provisions to improve access to medicines is one of
several cost-containment mechanisms that may be used
for patented essential medicines not affordable to the
people or to public health insurance schemes,'' the
report says.

It is acknowledged that the decision to grant
compulsory licences and use other Trips flexibilities
is often complicated and involves different
stakeholders.
''It is therefore important to establish clear
decision-making processes, including the determination
or designation of the authorities or bodies charged
with responsibility for the various stages of
decision-making,'' the report said.

The Trips does not specify the nature of the authority
or the process that is mandated to grant compulsory
licences or determine the level of compensation.
However, WTO members may designate authorities and a
system to proceed with the granting of compulsory
licences.

''It is noted that the systems vary in different
countries, with some adopting administrative
procedures and others a mixed system, where initial
decisions relating to the granting of compulsory
licences and compensation are made administratively
and appeals are made to the judicial system,'' the
report said
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Bangkok Post, Business >> Monday February 18, 2008
The CL Debate

Compulsory licensing of pharmaceuticals remains one of
the most controversial policies of the Surayud
Chulanont government. First used in November 2006 with
the Aids drug Efavirenz, compulsory licensing (CL) was
later applied to a number of other pharmaceuticals
used in treating heart disease, cancer and Aids.

Dr Mongkol Na Songkhla, the public health minister at
the time, justified the move as necessary because high
imported drug prices had limited access for local
patients.

Compulsory licensing has opened the door for low-cost
generic versions to be produced locally by the
Government Pharmaceutical Organisation at a savings of
more than 50% over the prices of the original drugs.
But while the policy was widely welcomed by consumer
groups and non-governmental organisations, others have
questioned the move.

Though CL is legal under global trade rules, they
wonder if it has been worth the cost as foreign
pharmaceutical producers and governments have raised
protests about the policy.

The commerce, foreign affairs and health ministers
under the new Samak Sundaravej government are expected
to debate the policy again this week.
Below are the views of two of the most outspoken
figures on each side of the CL debate.

A life-saving measure

by Jon Ungphakorn is the chairman of the Thai NGO
Coordinating Committee on Development.

1. Compulsory licensing is legitimate. Compulsory
licences are explicitly allowed under the 2001 Doha
Declaration on Trips and the Thai Public Health and
Patent Act (section 51). Thailand's previous use of
compulsory licences was fully compliant with
international and national law.

Governments all over the world, including rich ones,
use compulsory licences to protect the public
interest, ensure equitable access, promote innovation
and control anti-competitive prices.

Thailand has the right to protect its citizens from
illness. Threats, real or imaginary, from vested
interests should play no role in Thailand's decision
to protect its citizens from death and disease through
the use of compulsory licences.

2. Compulsory licences save lives. Without compulsory
licensing, Thailand could not afford to offer
universal access to effective but very expensive
treatments for cancer, heart disease, diabetes and
other conditions. If there are no compulsory licences,
poor people will die, not because there is no
available treatment but because they don't have enough
money.

Money saved by compulsory licensing can finance an
expanded national health-care programme. By breaking
up monopolies, compulsory licensing allows
competition, which results in enormous savings in the
price of medicines. Previous licences on essential
drugs for HIV/Aids, cancer and cardiovascular diseases
resulted in dramatic savings that have not only
allowed universal access to treatment for these
diseases but also financed budgets to expand treatment
of other serious illnesses such as renal failure.

3. Thailand can have compulsory licensing without
affecting trade. Many Thai business sectors have
enjoyed GSP benefits with the US, but these will now
end not because of compulsory licensing, but because
Thai purchasing power per person has crossed the
threshold for graduating from GSP.

All three firms owning the patents of the anti-cancer
drugs proposed for compulsory licences are European,
so this should not directly affect Thai-US trade
relations. In the year following Thailand's first
three compulsory licences, exports to the US
increased, even for products enjoying GSP privileges.

4. Compulsory licences will not prevent Thai access to
new drugs. When Abbott refused to register Aluvia in
Thailand, Lopi/Rito from India was registered instead
with the same quality but much lower prices. The
refusal by a firm to register a key drug can be
grounds for a compulsory licence.

And compulsory licences will not stop innovation.
Compulsory licences provide access to drugs for those
who could not otherwise afford them. Pharmaceutical
companies will still profit from their main markets _
the rich countries and rich people in poor countries _
and can still fund research and development.

Certainly compulsory licences do not kill the
pharmaceutical industry. Thailand has so far issued
only seven compulsory licences on essential,
life-saving, expensive drugs. Between 1969 and 1993,
Canada issued 613 licences, enjoyed the lowest prices
for drugs in the developed world and had a more
vigorous pharmaceutical industry than the US.

5. Objections to Thailand's use of compulsory
licensing from supporters of transnational
pharmaceutical companies are often based upon
untruthful, misleading or ignorant assertions and
assumptions designed to appeal to prejudice. The myths
that they propagate include claims that patents
protect access to medicines for the poor, that drug
researchers can be motivated only by patents and that
monopoly prices are the only way of funding research.
History has shown these self-serving claims to be
false.

.....................

A publicity stunt

by Teera Chakajnarodom is the president of the
Pharmaceutical Research and Manufacturers' Association
of Thailand

1.A government forcing any company to give up its
property, intellectual or otherwise, for whatever
reason, is not good. It undermines the basis of our
economic system when a politician can say, ''We want
your product, but we can't afford it, so we will just
copy it.'' When governments start doing that, they
undermine both local and foreign investor confidence
in our country. Foreign investment is one of the key
drivers of our economy, and when the economy suffers,
all 65 million Thais suffer.

2. Compulsory licensing (CL) ruins our reputation in
the international community. When CL was announced,
Thailand received some of its worst coverage ever, in
important newspapers including the Financial Times and
the Wall Street Journal, which ran headlines that
presented our country as a ''thief''.

Whether that is correct or not is one thing but what
we cannot deny is that it did terrible damage to our
country's standing. When it was claimed that CL could
help save the government money, we have to ask whether
those savings are really worthwhile when we see how
much it costs to create those savings.

How can we ever hope to be an innovation or R&D centre
for health care if people are not 100% certain of the
protection of their intellectual property in our
country?

3. There is a likelihood that Thailand may lose some
of its export benefits to the United States because of
its track record on intellectual property protection.
The CL actions of the last government may have
contributed to that track record.

If we do lose export privileges to the United States,
that will affect many industries and millions of
workers in garments, shoe manufacturing and a host of
other industries exporting to the United States. It
will also affect many farmers and others working in
the agricultural sector with exports to the United
States.
Thailand exports 131.5 billion baht worth of goods to
the United States under the special low-tariff
Generalised System of Preferences programme. Last
year, the government saved 15 million baht from CL for
HIV/Aids drugs. Instead of putting the livelihoods of
millions of people at risk, why doesn't the government
directly assist HIV/Aids patients by buying them the
drugs that they need under the free health-care
scheme.

4. Thai patients deserve better than getting copy
medicines. Patients deserve original medicines and the
government should ensure that its programmes give
patients access to dependable, high-quality medicines.


5. Issuing CLs is a good publicity stunt. But it just
makes us overlook the real solution to Thailand's
health-care issues. Copying a few medicines will not
solve these problems but will create many other
problems affecting many other people.

We need to allocate more budget to the Ministry of
Public Health so that it can afford to buy quality
medicines and help more people gain access to the
world's best medicines.

We allocate too small a proportion of our budget to
health care.

Even countries in Africa, including Liberia,
Mozambique, Rwanda, Sudan and Senegal, allocate a
higher proportion of their GDP to health than
Thailand's meagre 3.3.%, according to the World Health
Organisation.
We also have a chronic shortage of doctors. Countries
such as Pakistan, Malaysia and Iraq have almost twice
as many doctors as a proportion of their populations
than Thailand. Algeria, Mexico and Ecuador have three
times as many. Only countries such as Burma, Botswana
and Tonga have a similar proportion of doctors to
their populations as Thailand, at around only four per
thousand people.





Kannikar KIJTIWATCHAKUL (Kar)
Access to Essential Medicine Campaigner
MSF Belgium - Thailand Mission,
522 Mooban Nakorn Thai 14,
Ladphrao Soi 101/1,
Bangkapi, Bangkok 10240
Tel (+66) 2370 3087
Fax (+66) 2731 1432
Mobile (+66) 85-070-8954


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