Timeline of Trade Disputes involving Thailand and access to medicines

Susannah Markandya
July 23, 2001

September 12, 1979. Patents Act. According to this law, the process of producing, maintaining or improving the quality of a pharmaceutical product or ingredients is granted protection, but pharmaceutical products or ingredients themselves are not eligible for a patent. According to Thai Government sources the principal objectives of this Act are "to promote inventive activities within Thailand and to induce the transfer of technology from abroad."

January, 1985. Government Pharmaceutical Organization (GPO) prohibits brand names to be used on government hospital purchase orders.

August 8, 1985. S. Douglas Sheldon, General Manager of Pfizer International Corporations, Thailand, submits the Pharmaceutical Products Association's position paper on `Patent Protection and the Pharmaceutical industry in Thailand' to David Mortlock at the American Chamber of Commerce in Thailand for his endorsement. The original document made the argument that "lacking patent protection.American pharmaceutical firms.are being intentionally deprived of a free market." However, the revised draft reads, "American pharmaceutical firms could provide better service to the Thai people if the Thai government gave better protection to intellectual property." Two areas they highlight:

February 1986. International Trade Association, US Chamber of Commerce, Intellectual Property Briefing states that the "Royal Thai Government has asked our advice on the elements of a good patent law." It attributes this request to pressure from "the GSP process, fear of a protectionist backlash in the US, and the publication by US pharmaceutical companies in Thailand of a "White Paper" on how they are being harmed by inadequacies in the Thai patent law."

April 16, 1986. Combined hearing of the US Department of Commerce Subcommittee on Oversight and Investigations and the Special Subcommittee on US-Pacific Rim Trade. Mr. Stephen F Sims, Special Assistant of the Committee on Energy and Commerce gives testimony relating to pharmaceuticals. He mentions the "questionable quality" of generic copies of new US or European drugs and the fact that "US firms have suffered a substantial market share loss."

May 28, 1987. PhRMA (formally PMA) files a petition with the US Government to withdraw benefits under the GSP to the Kingdom of Thailand.

September 14, 1987. Government of Thailand, represented by St Maxens & Co, submit their `Pre-hearing Statement Regarding Country Practices in the 1987 Annual Product Review of the US Generalized System of Preferences' before the GSP Subcommittee of the Trade Policy Staff Committee. The Government of Thailand stress that "it is not possible for a developing country like Thailand to provide the same level of protection as does the US" and "as a development tool, the patent system must be in tune with the levels of social, economic and industrial development of the country." They go on to provide responses to specific allegations in the PhRMA petition, among them:

December 17, 1987. A series of meetings take place hosted by the US Department of Health & Human Resources, Food and Drug Administration, and attended by members of the Thai Ministry of Commerce, Thai FDA, Thai PMA and officials from the Thai Embassy in Washington DC.

December 18, 1987. Thai delegation meet with PhRMA to discuss the GSP/patent petition. Amongst the PMA demands is protection for "products currently in the regulatory pipeline" and an "immediate interim provision which protects new patentable products until the patent law takes effect."

February 25, 1988. Edward M Rozynski, from PhRMA, writes to Dieter Hoinkes at US Patent and Trademark Office, explaining "five years of exclusivity with a safety monitoring requirement is our preferred approach as an interim solution in Thailand."

May 12, 1988. Robert B Duncan, at US Embassy writes to Sukon Kanchanalai, at the Thai Ministry of Commerce, with the US Government's proposed Patent Interim Protection Model and suggests meeting "for technical talks on the general issue of interim protection." Under the US scheme, the Thai Government "grants exclusive marketing, manufacturing and import" rights for up to a duration of 10 years for products that are in the process of being approved.

August 25, 1988. Memorandum of Law, regarding `Pharmaceuticals-Interim Protection via Safety Monitoring of Drugs and Exclusivity of Documentation in Thailand' is published, prepared by Tilleke & Gibbins, Thailand. This concludes that "it is legally permissible under Thai law" for the Ministry of Public Health and FDA to "adopt the proposed interim measures of safety monitoring." It advises that "the original confidential data and information submitted with the application for drug registration should not be disclosed or be made use of without the owner's consent." It also makes the suggestion that a pharmaceutical consumer protection association be established so that the private sector can work with the Ministry of Public Health and FDA in safety monitoring and exclusivity over information.

November 22, 1988. Gerald J Mossinghoff, on behalf of PMA, writes to C. William Verity, Secretary of Commerce stating that "if (the Thai Government) fail to act, we firmly believe that the removal of all or, at least, a substantial part of Thailand's GSP benefits by the US Government would be warranted."

November 29, 1988. United States and Royal Thai Government officials meet in Washington DC to discuss intellectual property issues.

December 19, 1988. US Secretary of Commerce writes to Gerald J Mossinghoff, President of PMA, in reply to the latter's correspondence on the status of patent protection in Thailand and the upcoming decision on Thailand's eligibility for benefits under GSP. The Secretary of Commerce assures him "we will continue to make every effort to persuade Thailand to take steps to provide adequate and effective patent protection."

January 1989. Thailand placed on the "Priority Watch List" under the "Special 301" provision of the 1988 Trade Act.

March 14, 1989. Proposed modified scheme for new drug registration in the Kingdom of Thailand is issued following bilateral technical discussions between representatives from PhRMA and a team of officials from the Thai Food and Drug Administration. This provides a uniform system for drug approval which treats both US and locally manufactured drugs in the same manner.

August 22, 1989. Amended procedure for New Drug Registration proscribes a period of safety monitoring and limited distribution prior to approval for unconditional registration and distribution.

Late 1989. Thailand constitutes an intellectual property committee chaired by its Commerce Ministry.

January 24, 1991. Pfizer General Manager and Local American Working Group Chairman S. Douglas Sheldon writes to Robert Downs at the American Embassy commenting on the revised provisions of the Patent Act set forth by the Thai Ministry of Commerce. His concerns touch on the time provided for working a pharmaceutical patent, the clause allowing a copy if a product is "sold at unreasonable high prices," and the lack of "any pipeline provisions."

January 25, 1991. Roger A Brooks from PhRMA writes to International Subcommittee of the Patent Committee, US Department of Commerce, stating that PhRMA "is in the process of formulating a Section 301 petition against Thailand for lack of intellectual property protection." He asks that the Subcommittee "evaluate the proposed changed in the current Thai Law" in view of the comments made by Pfizer, which he encloses.

January 30, 1991. PhRMA files a GSP petition under section 302 of the US Trade Act, alleging that the Government of Thailand does not provide adequate and effective patent protection for pharmaceutical products.

March 15, 1991. USTR initiates an investigation under section 302(a) of the Trade Act and requests public comment on the allegations in the petition

March 15, 1991. The US requests consultations with the Thai Government.

February 11, 1992. The USTR requests further public comment on whether the Government of Thailand's acts, policies, and practices with respect to providing patent protection are unreasonable and burden or restrict U.S. commerce, and if so, what responsive action, if any, should be taken.

March 15, 1992. In response to the complaint from PhRMA, USTR determines that the Government of Thailand's protection of patents is unreasonable and action is appropriate. However, the USTR decides to defer action to allow for consultations with the soon to be elected Thai government.

March 26, 1992. US Under Secretary for International Trade meets with Thai Ambassador Birabhongse Dasemsri. According to US sources, the two main issues raised by the Secretary are compulsory licensing provisions and "lack of transitional protection for pharmaceutical products as the law phases in."

September 9-11, 1992. The Thai Supreme Court prints a report entitled `National Experience on Judiciary and Intellectual Property System'. This states that "Thailand is not ready to change and improve the level of (pharmaceutical) patent protection," in other words, to move from the Act of 1979 which "intends to protect the public" to the new Act of 1992 which "aims to protect the inventors." However, Thailand has been forced by "countries who own technologies of producing pharmaceutical products to improve patent law for the exchange of trade benefits."

September 18, 1992. Act on Transfer of Some of the Authority and Administration of the Commercial Registration Department to the Intellectual Property Department. By this Act the Director-General of the Department of Intellectual Property assumes the authority of the Director-General of the Commercial Registration Department.

September 30, 1992. Patent Act (No.2) comes into force.

March 15, 1993. US Acting Under Secretary for International Trade meets with Thai Deputy Prime Minister Amnuai Wirawan. US talking points include compulsory licensing, the authority of the Pharmaceutical Patent Board and lack of transitional protection.

April 30, 1993. US Acting Under Secretary for International Trade meets with Thai Commerce Minister Uthai Pimchaichon. US talking points include "provisions in the current patent law regarding compulsory licensing," the authority of the Pharmaceutical Patent Board, and the lack of "transitional protection."

May 4, 1993. The Thai Cabinet approves the setting up of an intellectual property and international trade court.

May 5, 1993. Michael Kantor (USTR) writes to Uthai Pimchaichon, Minister of Commerce enclosing a paper enunciating the standards that he will use to determine "whether the RTG provided adequate and effective protection and enforcement in the areas of copyright, trademarks and patents." This list includes demands that the RTG abandon any collection of economic data from the pharmaceutical companies that is not already publicly available, to restrict compulsory licensing, and to create a non-patent system of market exclusivity for pharmaceuticals. Kantor goes on to warn that "if the RTG efforts produce the necessary results, I will seriously consider revoking Thailand's status as a priority foreign country and making a recommendation for positive changes in Thailand's treatment under the GSP. However, if adequate and effective protection and enforcement of IPR is not achieved, I will have no other alternative but to take appropriate action."

July 27, 1993. US Secretary for International Trade meets with Thai Deputy Prime Minister Supachai Panitchpakdi. According to US sources, they discuss "the progress made by Thailand on intellectual property rights issues."

August 24, 1993. Thai ministry of Commerce Secretary writes to Robert Cassidy, articulating commitments under a Bilateral Agreement between the US Government and the Royal Thai Government, which include the creation of a Safety Monitoring Program.

September 7, 1993. Michael Kantor (USTR) writes to Thai Deputy Prim Minister, Supachai Pantichpakdi, Minister of Commerce, informing him that Thailand is to be removed from the Priority Foreign Country List and placed on the Special 301 "Priority Watch List."

October 1, 1993. Thai government establishes;

February 9, 1994. Thai Deputy Prime Minister, Supachai Panitchpakdi writes to Ambassador Michael Kantor, USTR, informing him of the progress that has been make in the area of IP protection since September, which includes the drafting of a bill to establish a specialized intellectual Property Court.

October 18, 1994. US Deputy Under Secretary meets with US and Thai delegations to the US-Thai Economic Consultations.

July, 1995. Prime Minister Banharn Silpa-Archa's government takes office.

October, 23, 1995. US Secretary for International Trade at the Department of Commerce meets with Thai Deputy Prime Minister, Amnuay Viravan. The Secretary presses for "the creation of an Intellectual Property Rights court, and the establishment of mechanisms for continued vigorous enforcement" of Intellectual Property Rights laws.

November 29, 1995. Deputy Under Secretary meets with Thai Deputy Prime Minister Thaksin Shinawatra. US sources claim that the Secretary made clear that "much progress remains to be made" on intellectual property rights.

March 31, 1996. USTR publishes its annual National Trade Estimates report. The comment on Thailand included: "the [new patent] law did not provide protection for products patented in other countries that had not yet been marketed in Thailand ("pipeline protection"), and it contained extremely broad authority to issue compulsory licenses in cases where patented goods are not yet produced in Thailand. The legislation also created a pharmaceutical patent review board with unique and extraordinary powers to require sensitive cost and pricing information. These provisions are a significant disincentive to obtain product patent protection for pharmaceuticals in Thailand and seriously reduce the benefits of the patent protection provided in the 1992 law."

April 30, 1996. USTR announces that Thailand will remain on the 1996 Special 301 Watch List.

July 18, 1996. Michael Kantor, the Secretary of Commerce writes to Thai Minister of Commerce, Chucheep Hansaward, claiming that "enhanced IPR protection will benefit the Thai economy by attracting increased investment and technology transfer."

October, 1996. Legislation to establish Intellectual Property Rights Courts becomes effective.

October 18, 1996. US Embassy submits its memorandum outlining "the changes that the Royal Thai Government has proposed to make the current Thai Patent Act of 1979 (as amended in 1992) compatible with the TRIPs principles of the GATT Treaty."

November 12, 1996. USTR announces "out-of-cycle" review decisions under the `Special 301 Program," resolving that Thailand will remain on the Watch List.

December 9, 1996. In a memo from Roger Brooks (PhRMA) to the International Section Asia-Pacific Committee, he states "we are informed that some in the Royal Thai Government seem to believe that these current amendments would get them off the `Special 301' list," but he stresses that in PhRMA's view, "Thailand must do a great deal to meet certain standards for patent protection" and outlines what he considers to be "a number of unresolved issues."

January 14, 1997. Roger A Brooks, Assistant Vice President of PhRMA, writes to Robert Cassidy, Assistant US Trade Representative for Asia and the Pacific, enclosing their comments on the proposed amendments to the current patent law.

March 10, 1997. Meeting between US Ambassador Itoh and Under Secretary Eizenstat, intellectual property rights is one of the issues raised.

March 31, 1997. USTR published its annual National Trade Estimates report, which includes eight pages on Thailand. While acknowledging Thai government actions to narrow scope of compulsory licensing and restraints on the pharmaceutical patent review board, USTR complains that non-patent regulatory exclusivity periods are too short, -- "only five to six years."

April 23 - May 8, 1997. Ms Pajchima Tanasanti and Ms. Uraiwan Ngowroongrueng visit the US for a 21 day program in order to gain, according to US sources, "a deeper understanding and a greater appreciation of the specifics of US intellectual property rights laws and regulations, and how they are passed and enforced."

May 14, 1997. Deputy Under Secretary meets with Thai Commerce Minister Narongchai Akrasanee. Among the key points raised by the US official is "the enforcement end" of the Intellectual Property Rights legislation.

July 1997. The Thai Baht begins to a rapid devaluation against the dollar. Within six months the currently falls from 24 to 53 per US dollar.

December 1, 1997. Department of Intellectual Property and International Trade Litigation is set up and the Intellectual Property and International Trade Court is inaugurated.

December 2, 1997. Under Secretary Aaron meets with Thai Deputy Foreign Minister, Sukhumbhand Paribatra. According to US sources, Aaron urges that Thai government to change its patent legislation and "abolish the Pharmaceutical Review Board."

1997. Thai Joint Committee on the Suppression of Intellectual Property Rights Infringement is established.

January 1998. PhRMA prints `Review of Principle Trade Issues for the Research-based Pharmaceutical Industry in Selected Countries of the Asia-Pacific Region.' PhRMA voice their concerns over actions taken by the Ministry of Public Health to cope with the current economic crisis, for example the policy of instructing Government hospitals to `buy from Thai-owned' companies.

January 12, 1998. Patent application by Bristol Myers Squib for ddI is approved in Thailand. DdI is an NIH invention, and has been approved for marketing in the United States since October 1991.

January 22, 1998. Acting Assistant Secretary of International Trade Administration of the US Department of Commerce meets with representatives of US pharmaceutical industry. The Secretary states that "we have urged the Thai government to.abolish the Pharmaceutical Patents Review Board."

February 5, 1998. The Bangkok Post reports that importers of pharmaceuticals are voicing their opposition to government controls on medical expenses. According to this newspaper, Inthira Khemawatana, former president of the Pharmaceutical Producers Association, "said there was not much of a price difference because locally-made drugs contain imported material," and argued that "the government should consider that patients have no choice but to use expensive imports."

March 31, 1998. USTR publishes its annual National Trade Estimates Report. The section on Thailand is eight pages, and includes extensive discussion of pharmaceutical.

May 1, 1998. USTR issues its 301 review. Thailand is on the "watch" list. USTR says: "Thailand also needs to pass a TRIPS-consistent patent law (including abolition of the Patent Review Board)."

May 11, 1998. 51st World Health Assembly is held. US State Department representatives threaten to withdraw WHO funding when faced with aggressive WHO support for improved access to patented medicines in developing countries.

June 1998. The US Government and Thai Government conclude an "Action Plan" on Intellectual Property Rights in Thailand. According to US Sources, as a result of the announcement of this plan the US restored to Thailand certain benefits under the GSP, although Thailand remains on the Special 301 "Watch List".

Spring and Summer, 1998. Thai NGO, the Drug Study Group, holds meetings to discuss campaign for compulsory licensing of BMS formulation patent for ddI.

July 1998. A Thai government Working Group on the Cooperation and Monitoring of the Suppression of IPR Violation is established.

August 18, 1998. Viagra, manufactured by Pfizer, is cleared for sale by the National Drugs Commission, making Thailand the first country in Asia to allow marketing of the impotence treatment.

September 4, 1998. Demonstrators from Thai NGO Coalition on Aids, the Coordinating Committee for Primary Health Care of Thai NGOs, and another two groups of local and international NGOs rally in front of the US Embassy. Protesters lodge a petition with US Trade Representative Charlene Barshefsky demanding that the US administration stop pressuring Thailand to abolish some important provisions on its authority on compulsory licensing of pharmaceutical products, and also to disband a Pharmaceutical Patents Review Board. Another petition is submitted to Donna Shalala, Secretary to the Health and Human Services Department, calling on the agency to investigate the consumer price for ddI. The letter noted that the research and development of ddI was funded by the US National Institutes for Health and exclusive production rights in the US were then granted to Bristol-Myers Squibb, crucially, the agreement between NIH and BMS includes a reasonable-pricing clause.

1998. The Government Pharmaceutical Organization (GPO) asks the Royal Thai Government to issue a compulsory license for the manufacture of ddI. The RTG refuses.

Fall, 1998. Following a Thai NGO campaign, spearheaded by the Thai Drug Study Group, the generic local industry is permitted to produce fluconazole (Difulcan). In Thailand fluconazole (which was patented in the US by Pfizer in 1983) is not patented, however, the Safety Monitoring Program had until now effectively conferred a period of market exclusivity. At this point, three Thai companies begin to produce generic versions of the drug. Within nine months the price for fluconazole drops from 200 Baht to 6.5 Baht per pill, dramatically expanding access to the medicine. The Thai experience with fluconazole energizes public health groups, who make fluconazole the number priority for compulsory licensing in countries where Pfizer holds the patent.

February 16, 1999. PhRMA submission for 1999 "Special 301 Report" on Intellectual Property Protection in Thailand, promotes designation of Thailand as a Priority Watch Country.

February 16, 1999. Thai NGO, Access to Treatment, writes a letter to Donna Shalala, Secretary to the Health and Human Services Department, asking for a review of the reasonable pricing of ddI.

March 31, 1999. USTR National Trade Estimate Report. This publication refers to the most recent changes to the Patent Law and states that "according to initial observations, businesses in Thailand are generally pleased with the amendments. However, they foresee problems rising from new provisions regarding compulsory licensing authorizing the Director General of the Department of Intellectual Property to override a patent and issue a compulsory license if the patent is deemed as not being locally "worked" or if the price is deemed unreasonably high."

April 30, 1999. USTR announces Special 301 Annual Review, which places Thailand on `Watch List.' USTR notes that "the [Thai] government agreed to implement an IPR Action Plan embodying a number of priority reforms - including enactment of a world class patent law," but criticizes Thailand for its policies on copyright.

May, 17, 1999. 52nd World Health Assembly is held. As part of the `Revised Drug Strategy', the WHO is given a mandate to monitor the public health consequences of international trade agreements.

May 13, 1999. A group of US NGOs meet with officials from several US Government Departments. US Government officials give a commitment to investigate the pricing of ddI in Thailand.

April 20, 1999. Thai NGO, Access to Treatment receive a reply to their February 16, 1999 letter to Donna Shalala. The reply is written by Dana Delman, Policy Analyst, US FDA Executive Secretariat. She states that "neither FDA nor other segments of the US Federal Government have control over the pricing of drugs sold in the United States, let alone overseas," and that "marketing exclusivity through the use of patent laws in this country has been an important stimulus to the development of new products to treat a variety of diseases."

September 27, 1999. Thai Patent Act, as amended October, 1998, enters into force. These amendments,

October, 1999. The Center for Health Economics, at Chulalongkorn University, publishes a study of `The Implications of the WTO TRIPS Agreement for the Pharmaceutical Industry in Thailand'. They conclude that "it seems that more negotiation rounds and revisions of international agreements have maximized the exclusive rights of patentees, but minimized the rights of people who need innovations." They also argue that there has not been much technology transfer or foreign investment directly into the pharmaceutical industry in Thailand since 1992.

November 17, 1999. PhRMA makes a submission for the `Special 301' Report on Intellectual Property Barriers, regarding Thailand as Priority Watch Country. This outlines their objections to the current Thai Patent Law as reasons why "PhRMA believes that Thailand should be listed as a Priority Watch Country under Special 301 in 2000." These include:

November 1999. According to Dr Tido von Schoen-Angerer (MSF), the GPO intended to request the use of compulsory license for ddI but was advised by the Department of Intellectual Property to first attempt a voluntary license agreement with the Bristol Myers Squibb.

November 26, 1999. The Nation, a Thai newspaper, reports on a letter written by Dr Somsong Rakpao, head of the Communicable Diseases Control Department to the director general of the Department of Intellectual Property which claims, "only 5 per cent of Aids patients get access to the combination use of two major Aids drugs - AZT and ddI." According to the Communicable Diseases Control Department, the current high price of ddI is due to restrictions imposed by Bristol-Myers Squibb. However, this article also claims that NGOs and representatives of people living with HIV/Aids have concerns over the prospective deal with Bristol-Myers Squibb to provide ddI at deeply discounted prices to the GPO which would, in their view, "end up making the GPO only a distributor of ddI for the company."

November 30 - December 3, 1999. At the WTO meeting in Seattle President Clinton outlines a shift in US policy with regard to health care in developing countries; "the US will henceforth implement its health care and trade policies in a manner that ensures that people in the poorest countries won't have to go without the medicine they so desperately need."

December 3, 1999. PhRMA submission for 2000 National Trade Estimate Report on Foreign Trade Barriers in Thailand.

December 22, 1999. Thai NGO Rally at Thai Ministry of Public Health demands compulsory licensing of ddI.

2000. The Japanese company that is the main supplier of raw materials for ddI (also the main supplier to Bristol Myers Squibb) refuses to sell the raw materials to the GPO, reportedly due to pressure from BMS. As a result, the GPO is forced to approach a Canadian supplier for the raw materials for ddI. This supplier charges approximately twice the amount than the main supplier.

January 10, 2000. The Vice President of the United States appears at the UN Security Council to discuss the global HIV/AIDS crisis, and mentions the change in US trade policy enunciated by Clinton at WTO meeting in December 1999. The Vice President receives enormous positive press coverage for this announcement.

January 12, 2000. Act Up, Doctors Without Borders, the Consumer Project on Technology, Public Citizen and other NGOs meet with USTR, US Patent and Trademark Office, and DHHS to discuss public health trade disputes. These NGOs ask USTR to send a clear signal to Thailand that the US government has changed its trade policy, and that Thailand will face no pressure from the US government if it issues a compulsory license for ddI. The NGO groups request that the US government send the Thai government a letter outlining the new policy.

January 14, 2001. USTR official Sean Murphy contacts the Thailand embassy in Washington,DC, and warns them against the issuance of a compulsory license for the BMS ddI patent. According to Thai officials, Murphy says Thailand will face trade sanctions if it issues the license.

January 17, 2000. Thai Health Minister Korn Dabbransi refuses to invoke Article 51 to issue compulsory licensing for ddI. He says that the Ministry of Public Health has decided to permit the GPO to manufacture ddI in powdered form, which is not under patent.

January 18, 2000. Agence France-Presse reports approximately 100 protesters gather outside the US Embassy in Bangkok seeking a guarantee that Washington will not retaliate by raising tariffs on Thai goods if the ministry of health permits ddI to be made locally. A letter from campaigners to Clinton handed to the Embassy asks for an assurance that the United States would take "no punitive action" against Thailand if it issued a patent for local ddI production.

January 19, 2000. The US Government presents unsigned talking points to the Royal Thai Government regarding compulsory licensing for ddI. The undated and unsigned document stated that:

"We also understand the Thai Government is considering issuance of a compulsory license to permit local manufacture of ddI. We are hopeful that in choosing a course of action in this matter your government will explore all opportunities to obtain the lowest price possible for ddI, including through negotiations with BMS. The USG has generally viewed compulsory licenses as being undesirable because they may undermine intellectual property rights. However, if the RTG determines a compulsory license is necessary to obtain the lowest price for ddI, the TRIPS Agreement establishes conditions that must be followed."

The talking points emphasized several TRIPS provisions that were most favorable to the patent owners, and left out the provisions that most favorable to patient interests. US trade officials told NGOs that this communication was the promised signal to the Thai government that the US would tolerate a compulsory license for ddI.

January 22, 2000. James Love, from Consumer Project on Technology, writes to Thomas M. Rosshirt, Foreign Policy Spokesman for the Vice President, objecting to the US government January 19 communication with the Government of Thailand, noting: "The USG has generally viewed compulsory licenses as being undesirable because they may undermine intellectual property rights. Nowhere in the document does the US government ever say it would support a Thai decision to issue a compulsory license for ddI. The talking points also say that if the Thai government still wants to issue a compulsory license, it must comply with several WTO TRIPS conditions. The US government letter then goes on to quote only those sections of Article 31 of the TRIPS that emphasize patent owner rights, and omits the sections of Article 31 that emphasize user or government rights. For example, there is not mention at all of the provisions in Article 31 for government or non-commercial public use, even though the Thai compulsory license is for a public sector agency."

January 23 - 26, 2000. The Thai Drug Study Group and MSF- Thailand tells CPT about the January 14, 2000 Sean Murphy communications to the Thai embassy, threatening trade sanctions if the Thai issue a compulsory license for ddI. CPT contacts Gore officials and Paul Davis from the Health Gap Coalition. Paul Davis tells the Gore campaign AIDS activists will travel to New Hampshire to campaign against Gore's Presidential Bid if he doesn't fix the problem. According to Newsweek, Gore staffer Leon Fuerth directs the USTR to signal a new policy.

January 27, 2000. Joseph Papovich, assistant USTR writes to Mr. Paisan Tan-Ud, of PHA Network of Thailand. He states, "we encourage Thai officials to explore all options for extending access to effective treatments, including ongoing direct dialogue with pharmaceutical manufacturers. But the final choice is one for Thailand to make. If the Thai government determines that issuing a compulsory license is required to address its health care crisis, the US will raise no objection, provided the compulsory license is issued in a manner fully consistent with the WTO TRIPS Agreement."

January 28, 2000. Robert Fitts of the US Embassy send a letter to Mr. Karun Kittisataporn, Director General Business Economics Department, Royal Thai Ministry of Commerce, with a copy of the January 27, 2000 letter from Joseph Papovich to Mr. Paisan Tan-Ud.

January 29, 2000. Dr. Jakkrit Kuanpoth and Dr. Jiraporn Limpananont of the Thai Drug Study Group write to US Ambassador Barshefsky in response to PhRMA's submission to the 2000 USTR NTE Report. They ask that "the USTR to abstain from its previous "TRIPS PLUS" approach," and go on to respond to PhRMA's Report's specific objections.

February 1, 2000. The Thai Minister of Public Health is reported to say Thailand will not permit compulsory licensing of ddI because "it is uncertain about the effect this could have on international trade agreements." The Minister says he will opt for negotiations on the price of ddI from BMS.

February 2, 2000. The Bangkok Post reports Somsong Rukphao of the Thai Ministry of Health "remains unconvinced enforcement of compulsory licensing under the Thai patent law will not result in trade sanctions," and quotes Somsong as saying the USTR letter to Paisal Tan-up was merely "a diplomatic way of answering such issues".

February 7, 2000. US Trade Representative Charlene Barshefsky wrote to Thai Minister of Commerce Supachai Panitchpakdi, stating that "if the Royal Thai Government determines that issuing a compulsory license is required to address its health care crisis, the United States will raise no objection, provided the compulsory license is consistent with the provisions of the WTO Agreement TRIPS."

February 7, 2000. MSF reports that BMS threatens the Thai GPO with litigation if its produces d4T.

February 13, 2000. According to the Bangkok Post, Health Minister Korn Dabbransi "calls on developing countries' pharmaceutical industries to cooperate to produce quality drugs at affordable prices in order to reduce dependency on imports."

February 18, 2000, PhRMA writes USTR, asking that Thailand be placed on the "Special 301" Priority Watch List.

March 31, 2000. USTR publishes its annual National Trade Estimates report. The section on Thailand reports that Thailand has enacted TRIPS consistent amendments to its patent law, which were entered into effect in September 1999.

May 2-4, 2000. ASEAN Workshop on the TRIPS Agreement and its Impact upon Pharmaceuticals is held in Jakarta. The report concludes that "five years after the introduction of Safety Monitoring Program (in Thailand), it is estimated that the market exclusivity granted to the top 25 selling products under it had caused an increase in medicine expenditures of about US$ 50 million. This figure could increase 10-fold once the full impact of product patents is felt."

May 10, 2000. The Bangkok Post reports that the Network of People with HIV/Aids, the Coalition of Thai NGOs Working on HIV/Aids, and Access have decided to sue Bristol Myers for unfairly obtained patent rights. Paisal Tan-ud, chairman of the Network of People with HIV/Aids, argues that Bristol Myers had no right to patent ddI because first of all it had been made available in Thailand at least 12 months before the patent application was made to the Intellectual Property Rights Department, and secondly, the drug was not a new invention but a concoction which had been widely publicized at various research gatherings.

May 30, 2000. USTR issues its annual 301 report. Thailand is on the list, but only for copyright issues. This is the first 301 report under the new Clinton policy to be more sensitive to access to medicines issues.

June 15, 2000. An editorial in the Bangkok Post reports on MSF's campaign to "draw international attention to efforts of US administration to safeguard the monopoly on ddI enjoyed by Bristol Myers Squibb." This article argues that the USTR should appreciate that "drugs such as ddI cannot be lumped along with run-of-the-mill business," and something must be done to change this "21st Century aberration, in which profits are being put before human life."

December 7, 2000. Conference on IPR in the context of traditional medicine opens in Bangkok, representatives from the WHO urge developing countries to pay more attention to intellectual property rights protection on traditional medicine. Dr Doberstyn, the WHO representative to Thailand, reportedly said that although most medicinal plants originate from developing countries, multinationals have exploited these resources by converting them into products of commercial value without paying for the knowledge transferred along with the material.

February, 5, 2001. Thai FDA announces proposed changes regarding the Safety Monitoring Program. According to US official sources, these include a requirement that US pharmaceutical manufacturers submit lists of products qualifying for the SMP, or "sacrifice the protection of the test data for such products should they be introduced to the Thai market in the future."

March 16, 2001. Tido von Schoen-Angerer, MD, (MSF) writes a memo pointing out that "the Bristol Myers Squibb formulation patent was granted for simply combining two known components: ddI (developed by the US National Institutes of Health) and an antacid. Indeed, when BMS filed this patent application initially in the US it was rejected twice by the US Patent Office because `it was well within the ordinary skill in this art.' "

March 2001. Oxfam publishes a paper looking at the situation in Thailand with regard to the treatment of HIV/AIDS as part of their `Cut the Cost' Campaign.

March 31, 2001. USTR publishes its annual National Trade Estimates Report. On Thailand, USTR notes: "A Trade Secrets Act . . . [was] introduced into the legislature in 2000 but remain to be passed. The latest draft of the Trade Secrets Act reportedly would allow government agencies to disclose trade secrets to protect any "public interest" not having commercial objectives, giving rise to concerns that authorities will not be required to protect approval-related data against unfair commercial use."

May 11, 2001. Joseph Y Yun, at the US Embassy writes to Vichai Chokevivat, Secretary-General of the Thai FDA, regarding US Government concerns about data protection and safety monitoring program for pharmaceutical products. The USG argue that "continuation of the original SMP is necessary to offer some form of data protection until a satisfactorily TRIPS consistent Trade Secrets Law is passed . . . A gap in data protection coverage for US products would be unacceptable."

June 6, 2001. Bangkok Post reports that Krisda Manoowongse, Director of GPO has been dismissed for "neglecting to prevent corruption in the purchase of pharmaceuticals."

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