[Ip-health] Text of Thai government use license for patents on Efavirenz

[James Love]

This is from the Thai Ministry of Public Health.  Jamie

-------Letter-------
Have been carefully reviewed by Department of Disease Control,
Ministry of Public Health, Efavirenz, an antiretroviral drug has been
proved to be highly effective and safer for the treatment of HIV
infection. Nevertheless, the price of the patented product is much
higher than the generics produced in India. The limited budget
allocated for HIV/ AIDS patients under the National Health Security
Systems and its high price has thus limited the access to Efavirenz.

To increase access to Efavirenz under the universal access to
antiretrovirals policy, the Department of Disease Control , Ministry
of Public Health has decided to use the patent rights of the
products, permitted under Article 51 of the Thai Patent Act BE 2522
(as amended BE 2542) and authorized the Government Pharmaceutical
Organization (GPO) to import or produce Efavirenz for public
interests. This will significantly makes the drug more accessible
under the national health insurance schemes. The detail and the
conditions are contained in the attached announcement.

Please keep us informed if any recommendation regarding this matter
is concerned.

Department of Disease Control

Encl   Announcement of Compulsory Licensing for Pharmaceutical Products

------Announcement---

Announcement of the Department of Disease Control, Ministry of Public
Health, Thailand  on the
Public use of patent for Pharmaceutical Products

=09By the virtue of provisions of Article 51 of the Thai Patent Act
B.E. 2522 (as amended by the Thai Patent Act no.2 B.E. 2535 and no.3
B.E. 2542), ministries, bureaus and departments are allowed to use
the patent rights of a product for public interests without prior
permission from the patent owners.  The public use of patent rights
clearly aimed for non-commercial purposes and for public interests.
In other word, the government has a right to use any patent right for
public health services.

=09It is generally known that HIV/AIDS is an important public health
problem. More than 1 million Thais have been infected with HIV, among
this, more than 500,000 people are still alive.  These infected
individuals will eventually need long-term uses of antiretroviral
drugs to maintain their productive lives..  However, budget for
health services in the national health security system allocated for
HIV /AIDS patients in the fiscal year 2006 (B.E. 2549) is only
2,796.2 million baht for the target group of 82,000 patients.

=09There are several effective anti-retrovirals that can extend the
life of HIV infected individuals currently available in the Thai
market. The Thai Government has launched a policy of universal access
to anti-retrovirals since 1st October 2003, and has a budget
specifically allocated for them. However, it is still difficult to
get accessed to some effective and safer anti-retrovirals.  The high
price of these patented anti-retrovirals have hindered their
accessibility under the universal access policy.

=09Efavirenz is a highly effective and safe anti-retroviral.   It is
also placed in the Thailand=92s National List of Anti-retrovirals.
However, the price of the patented Efavirenz is twice of those
generics produced by WHO certified GMP factories in India.  With this
higher price, the budget allocated from the Thai Government can only
cover some patients with Efavirenz, whereas the rest has to use other
non patented more toxic anti-retrovirals

=09According to the Doha Declaration on the TRIPS Agreement and Public
Health, member countries have a right to issue a safeguard measure to
protect public health, especially for universal access to essential
medicines using  compulsory licensing on the patent of pharmaceutical
products.  Based on the Declaration, the compulsory licensing measure
can be used for the purposes of emergency cases and public uses.
These flexibilities applied to drugs used for treatment of HIV/AIDS,
tuberculosis, malaria, and other outbreaks.  Under the Thai Patent
Act,  ministries, bureau, and departments are  allowed to use the
patent rights of any products for non-commercial public uses.

By the virtue of provisions of Article 51 of the Thai Patent Act B.E.
2522 (as amended by the Thai Patent Act no.2 B.E. 2535 and no.3 B.E.
2542), the Department of Disease Control, Ministry of Public Health,
thus use the patent right of a medicine called Stocrin=AE (or efavirenz
as a generic name) and endorse  the Government Pharmaceutical
Organization of Thailand to exercise  the rights contain within Para
1 of Article 36 of the Thai Patent Act B.E. 2522 (as amended by the
Thai Patent Act no.2 B.E. 2535 and no.3 B.E. 2542) under these
conditions:-

(1) The use of the above patent rights are effective from today to
the 31st December 2011.
(2) The use of the above patent rights will be limited to the
provision of Efavirenz to not more than 200,000 patients per year,
for those covered under the National Health Security System Act B.E.
2545, Social Security Act B.E. 2533, and the Civil Servants and
government employees medical benefits scheme..
(3) A royalty fee of  0.5 percent of the Government Pharmaceutical
Organization=92s total sale value of the imported or locally produced
Efavirenz will be paid to the patent holder.

=09The Department of Disease Control, Ministry of Public Health will
notify the patent owner and the Department of Intellectual Property,
Ministry of
Commerce immediately.

=09=09=09=09=09=09Announced on 29th November 2006

=09=09=09=09=09=09Singed=09     Thawatch Soontarajarn
=09=09=09=09=09=09=09(Mr. Thawacht Soontatajarn)
          =09        Director General
   =09Department of Disease Control


---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

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