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TWN Info Service on Intellectual Property Issues (Feb07/05) 12 February 2007
Recently,
the Thai government became the third Asian country to exercise its right
under the TRIPS Agreement and the Doha Declaration on TRIPS and Public
health. The other two were In
the last two months, The licenses are to import and/or to produce locally generic versions of the patented drugs for non-commercial uses (also known as government use licence), where in according to Article 31 of the TRIPS Agreement, there is no need for prior negotiation with the patent holder. In
the case of The
first licence (issued on 29 November 2006) is to initially import from
Following the issuance of this licence, there has been a lot of pressure from the pharmaceutical industry as well as the US Trade Representative (USTR) to withdraw the licence, with some stating that it is illegally issued under the TRIPS Agreement. This has led civil society groups (particularly from the US) to call on the USTR to not interfere with the Thai government’s decision to issue a license, adding that the licence was issued legally under the TRIPS Agreement and giving many examples of cases in the US wherein a compulsory licence had been issued to balance public and private interests. Letters addressed to Ambassador Susan Schwab (the USTR) as well as to Condoleeza Rice, Secretary of State, is available at http://www.cptech.org/ip/health/c/thailand/ustr12dec2006thailand.html and http://www.cptech.org/ip/health/c/thailand/riceschwabthailand21dec06.pdf 22 Members of the US Congress have also written to Ambassador Susan Schwab, in support of Thai’s government use licence. The letter is available at http://www.cptech.org/ip/health/c/thailand/congressional-schwabletter-thailand-10jan06.pdf The second government use license dated 29th January 2007 was issued to import/locally produce generic versions of Kaletra (Lopinavir/Ritonavir) frequently used in second line ARV treatment. The third license dated 25 January 2007 was to import/locally produce the patented version of Plavix (Clopidogrel) which is one of the most comment treatments for heart disease. The former license is expected to benefit up to 50,000 patients per year as it will significantly reduce the price at which Kaletra is made available. The move is expected to save the Thai government about US$ 24 million per year. Currently the patented Kaletra sales globally bring in about US$1.1 billion annually. According to Paul Cawthorne, local head of Doctors Without Borders (in a news report by Reuters), the Thai government was spending 11,580 baht ($347) per patient per month for Kaletra and it could cut that bill by two thirds if it switched to a generic medicines. As a result of the licence, Abbott the patent holder has sought to negotiate the price with the Thai government, and it has indicated that it would be reducing the price of Kaletra, although the amount of price reduction that it will grant is not very clear. The government use licence on Plavix (patented by Bristol Myers Squibb and Sanofi Aventis which had an annual sale of US$ 6 billion) is expected to drop the cost of the medicine by more than 90% to about 18 US cents per tablet. The patent holders of Plavix are also seeking to negotiate with the Thai government. Unofficial translations of the government use licenses are available below. Should you require more information on compulsory/government use licenses, please do not hesitate to contact us. Best Wishes Announcement of the Department of Disease Control, Ministry of Public Health, Thailand on the Public use of patent for Pharmaceutical Products 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), 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. It 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. There 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. Efavirenz
is a highly effective and safe anti-retroviral. It is also
placed in the According 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® (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’s total sale value of the imported or locally produced Efavirenz will be paid to the patent holder. The Department of Disease Control, Ministry of Public Health will notify the patent owner and the Department of Intellectual Property, Ministry of Commerce immediately. Announced on 29th November 2006 Signed Thawatch Soontarajarn (Mr. Thawacht Soontatajarn) Director General Department of Disease Control ------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------ DECREE OF DEPARTMENT OF DISEASE CONTROL, MINISTRY OF PUBLIC HEALTH, REGARDING EXPLOITATION OF PATENT ON DRUGS & MEDICAL SUPPLIES BY THE GOVERNMENT ON COMBINATION DRUG BETWEEN LOPINAVIR & RITONAVIR 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)states that, for the public use, ministry or department may exploit any patent without further negotiation with the patent holder. This implication makes clear that, for non-commercial use, especially in public affairs of the government such as public health services, government is well within its rights. The situation of HIV spreading is the key problem of Thai public health. 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.. 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 because of patent protection by law, then there’s no competition. The government cannot allocate enough budget. However, budget for health services in the national health security system allocated for HIV /AIDS patients in the fiscal year 2007 (B.E. 2550) is only 3,855.6 million baht for the target group of 108,000 patients. Some of this group have resistance to the first line ARVs and have to move to the second line. Lopinavir
+ Ritonavir under the tradename Kaletra is a highly effective
and safe anti-retroviral. It is also placed in the Under the Doha Declaration on TRIPs and Public Health , it notifies that each member state has the right to protect public health in particular to promote access for medicines for all, by granting compulsory licenses in cases which constitute a national emergency or other circumstances of extreme urgency and of public health crisis, including those relating to HIV/AIDS, tuberculosis, malaria or other epidemics. While Section 51 of Thailand’s Patent Act defines the right of "any ministry, or department of the Government," "by themselves or through others," to exercise the rights in any patent "for public consumption" , without commercial use as mentioned above. 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 Kaletra(tm)(or Lopinavir+Ritonavir 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 January 2012. (2) The use of the above patent rights will be limited to the provision of Efavirenz to not more than 50,000 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’s total sale value of the imported or locally produced Lopinavir+Ritonavir will be paid to the patent holder. The Department of Disease Control, Ministry of Public Health will notify the patent owner and the Department of Intellectual Property, Ministry of Commerce immediately. This decree is announced to the public. Issue on 29 th January 2007. (Mr.Thawach Suntrajarn) Director General of the Department of Disease Control Available at http://www.cptech.org/ip/health/c/thailand/thai-cl-kaletra_en.pdf -------------------------------------------------------------------------------------- Ministry of Public Health Announcement Regarding Exploitation of Patents on Drugs and Medical Supplies for Clopidogrel As part of Section 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 affirms that in order to carry out any service for public consumption, ministry or bureau or department of the government may exercise the rights in any patent without the requirement of prior negotiation with the patentee. Its objective is clearly aimed for non-commercial purposes and public interests, for example, public health service. Myocardial ischemia and cerebro-vascular accident are the most serious public health burden because of high mortality and disability loss. Its mortality rate is in top three annual ranking. Both diseases cause much DALY loss and are in top ten ranking for Thai male and female. Even though these diseases could be prevented by diet control, mental and physical exercise, but the incidents are high and need medicine for treatment and secondary prevention from thrombosis which leads to morbidity and mortality. Clopidogrel
or the trade name in Regarding the diseases incidents, only 45 millions members of the Universal Coverage scheme will need for 20.5 million pills per annum. However, since the high price and limited budget, 20 percent of patients covered under Universal Coverage scheme can access to the medicine. As a result of provision of market competition by imported or locally produced generics, price will reduce dramatically and accessibility will increase 6 to 12 times which will conform to the Universal Coverage policy. Under the Doha Declaration on TRIPS and Public Health stated that WTO members have rights to protect public health and, in particular, to promote access to medicines for all by granting compulsory licenses in a national emergency and public needs. In addition, the Thai Patent Act states that the ministry or bureau or department of the Government may exercise the rights in any patent for public non-commercial consumption. By the virtue of provisions of Section 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, Ministry of Public Health, thus use the patent right of medicine called Plavix(tm) and medicines contain Clopidogrel in all formulas, including its derivatives patented in Thailand and endorse the Government Pharmaceutical Organization of Thailand to exercise the rights contain within Para 1 of Section 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 is effective from today until the patent expired or no essential need. (2) The use of the provision of generic drugs of Clopidogrel is unlimited for patients covered under the National Health Security Act B.E.2545, Social Security Act B.E.2533 and Civil Servants and Government Employees Medical Benefit Scheme but is under doctors' judgment (3) A royalty fee of 0.5 percent of the Government Pharmaceutical Organization's total sale value Ministry of Public Health will notify the patentee and the Department of Intellectual Property in writing without delay. This announces to the public. Issue date 25 January 2007 (Mr Prat Boonyawongvirot) Permanent Secretary, Ministry of Public Health Available at www.cptech.org/ip/health/c/thailand/thai-cl-clopidogrel_en.pdf
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