Archive for April, 2007
by Ed Silverman
Published at pharmalot.com
The patent dispute with Thailand is about to get hotter.
Although the US Trade Rep previously indicated that Bangkok hasn’t violated world trade rules, the office this morning placed the Thai goverment on its Priority Watch list. This is reserved for countries that don’t “provide an adequate level of intellectual property rights protection or enforcement, or market access for persons relying on intellectual property protection.”
There are 11 other nations on this year’s list: Argentina, Chile, China, Egypt, India, Israel, Lebanon, Russia, Turkey, Ukraine, and Venezuela. Thailand was added after recently issuing compulsory licenses on three drugs, which sparked outrage by drugmakers, notably Abbott, which retaliated by refusing to sell new meds there.
“In announcing the elevation of Thailand to the Priority Watch List, the report cites a range of intellectual property concerns, including deteriorating protection for patents and copyrights. Priority Watch List countries will be the subject of particularly intense engagement through bilateral discussion during the coming year,” say the federal office. “While the United States acknowledges a country’s ability to issue such licenses in accordance with WTO rules, the lack of transparency and due process exhibited in Thailand represents a serious concern.”
“This report underscores the Administration’s scrutiny in pinpointing challenges in protecting IPR and signals to our trading partners that effective IPR protection will remain a critical focus in US policy,” says US Trade Rep Susan Schwab.
The decision comes after numerous members of Congress, both Democrat and Republican, wrote Schwab and asked her to get tough with Bangkok. Last week, an advocacy group led by Ken Adelman, a member of the Defense Policy Board and a senior advisor to Edelman Public Relations, which reps Abbott, called for sanctions and an end to military aid to Thailand.
One activist, Robert Weissman, who heads Essential Action, called the decision “outrageous, cynical and shameful.” Conversely, Abbott’s Miles White should be encouraged by the move, which strongly suggests Washington is now going to get more involved in this controversy on big pharma’s side.
For Immediate Release
For More Information, contact Robert Weissman, 202-387-8030
Statement of Robert Weissman, director, Essential Action, in response to USTR’s placement of Thailand on the “priority watch” list in its annual Special 301 Report:
The Office of the U.S. Trade Representative (USTR) has today taken the outrageous, cynical and shameful step of elevating Thailand to its “priority watch” list for allegedly providing insufficient protection to intellectual property.
In its annual Special 301 Report, USTR lists concerns about copyright and trademark violations in Thailand, but the new development — and presumably the one that led to Thailand’s elevation to the “priority watch” list — is Thailand’s issuance of compulsory licenses on three pharmaceutical products.
USTR knows that Thailand’s actions do not violate its international trade obligations,^1^ and — contrary to claims by Big Pharma and its representatives — the agency does not claim that Thailand is violating is obligations under World Trade Organization rules. Instead, it complains that “the lack of transparency and due process exhibited in Thailand represents a serious concern.” That is a deceptive way of complaining that Thailand issued the compulsory licenses without previously requesting licenses from the patent holders.
This is deeply cynical claim for USTR to make, since it knows that a) under WTO rules, Thailand has no obligation to enter into negotiations for a license before issuing a compulsory license; and b) the United States routinely issues compulsory licenses for government use without prior negotiations with the patent holder.
USTR’s action is outrageous, because the agency’s Special 301 Report claims that “the United States strongly supports the 2001 Doha Declaration on the TRIPS Agreement and Public Health.” The Doha Declaration “affirm[s] 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.” When in fact a country seeks to exercise its rights under the WTO — and fulfill its duties under international human rights law — to provide access to important medicines, USTR responds not with the congratulations that are due, but the threats implied by placement on the “priority watch” list.
USTR’s action is shameful, because it undermines public health. By using legal methods to authorize price-lowering generic competition on overpriced AIDS and heart-disease drugs, Thailand has shown the world what it means to place public health over commercial considerations. Thailand has been very clear that the savings it accrues will be used to expand access to important medicines. The message from USTR is that Thailand should back down — but worse, that other countries should not dare to follow Thailand’s example.
USTR’s Special 301 Report is replete with invocations of the importance of innovation. No one concerned about public health denies the importance of innovation — indeed, many of the public health advocates most concerned about access to medicines are the most passionate about spurring medical innovation. Patents, however, are only one tool to promote medical R&D, and a highly inefficient one, measured by the amount of R&D they incentivize as compared to cost to consumers. Thailand has been a leader at the World Health Organization and in other venues in trying to promote global conversations about how to promote medical R&D while also ensuring access to medicines. If USTR was genuinely concerned with this issue, rather than simply representing the interests of Big Pharma, it would applaud Thailand, join the conversation and immediately drop its reprehensible bullying of Thailand, a country with a per capita GDP of roughly one-sixteenth that of the United States.
^1^ For a detailed examination of this issue, see the recent report from American University’s Washington College of Law’s Program on Information Justice and Intellectual Property.
Excerpt from the Special 301 Report, available at ustr.gov
Thailand will be elevated to the Priority Watch List in 2007, reflecting a concern that the past year has been characterized by an overall deterioration in the protection and enforcement of IPR in Thailand. The United States appreciates that many Thai law enforcement officials continue to work, amid challenging circumstances, to conduct actions against infringing activity. However, these efforts appear not to have had a measurable effect on piracy and counterfeiting rates, which remain unacceptably high. The weak nature of Thailand=92s legislation governing optical disc media constitutes a particular challenge in addressing the large scale of pirated disc production. Book piracy, cable and signal theft, and entertainment and business software piracy have likewise not been addressed in a meaningful way. Production and distribution of infringing copies of trademarked products, such as apparel and footwear, also remain widespread. With respect to all of these areas, insufficiently deterrent legal penalties contribute to ongoing infringement problems. In addition to these longstanding concerns with deficient IPR protection in Thailand, in late 2006 and early 2007, there were further indications of a weakening of respect for patents, as the Thai Government announced decisions to issue compulsory licenses for several patented pharmaceutical products. While the United States acknowledges a country=92s ability to issue such licenses in accordance with WTO rules, the lack of transparency and due process exhibited in Thailand represents a serious concern. These actions have compounded previously expressed concerns such as delay in the granting of patents and weak protection against unfair commercial use for data generated to obtain marketing approval.
Article Misleads in Support of Big Pharma
by Robert Weissman, Professor Brook K Baker, Sean Flynn, and Judit Rius
Published at Bangkok Post
Peerapan Tungsuwan and William McKay (Business Post, April 23) misleadingly and incorrectly argue that Thailand’s compulsory licensing actions violate World Trade Organisation rules.
This comes as little surprise. The two work at the global law firm Baker & McKenzie, which has a huge business representing Big Pharma. Among Baker & McKenzie’s clients is Abbott, the drug multinational attempting to blackmail Thailand by withdrawing drugs it has submitted for marketing approval in the country. Other clients include Aventis and
Bristol-Myers Squibb, Pfizer and Eli Lilly.
The lawyers’ arguments do not pass the laugh test.
They argue that Thailand’s action does not constitute “public non-commercial use” because the compulsory licence permits the Government Pharmaceutical Organisation (GPO), an arguably commercial organisation, to use the patents. That is irrelevant. The licences are for government use – distribution through the public health sector – which is what matters.
The United States, for example, routinely issues “public non-commercial use” licences in the defence sector to clearly commercial ventures (like Boeing and Lockheed Martin).
They complain that Thailand’s royalty rate is too low. They neglect to mention that the patent holders are free to appeal the royalty rates, but have in fact been uninterested in negotiating or litigating over royalties.
And they contend that Thailand did not consider each licence on its own merits. They ignore the reasoned basis that the Thai government has set out for its decision in each case. They creatively interpret provisions of WTO rules to suggest that governments must always enter negotiations prior to issuing compulsory licences, despite explicit language to the contrary – and despite common practice in the United States and elsewhere, where government-use licences are issued with no prior negotiations.
Peerapan Tungsuwan and William McKay aim to confuse readers by misleadingly citing international law with which few non-specialists are familiar. Had they disclosed their firm’s ties to Big Pharma, everything would have been much clearer.
Director, Essential Action, Washington DC
PROFESSOR BROOK K BAKER
Health GAP, Northeastern University School of Law, Programme on Human Rights and the Global Economy, Boston
Associate Director, Programme on Information Justice and Intellectual Property, Washington College of Law, Washington DC
JUDIT RIUS SANJUAN
Foreign law adviser, Knowledge Ecology International, Washington DC
Bangkok Post, April 23, 2007
Compulsory drug licences violate world trade treaty
PEERAPAN TUNGSUWAN and WILLIAMMCKAY
We are familiar with the controversy that has been swirling around the issue of compulsory licensing (CL) of patented pharmaceuticals in Thailand.
The Public Health Ministry has issued a white paper called “10 Burning Issues”, which is an apologia for CL. The ministry proclaims CL is “a form of social movement that aims at improving access to essential medicines and the health of people”.
In spite of substantial increases in budget expenditure in other areas, the ministry justifies CL by asserting that patented pharmaceuticals are too expensive for the Thai budget. It proclaims that the “public health interest must come before commercial interests”.
With this line of reasoning, the ministry might just as well announce that it will be compulsorily acquiring beds in private hospitals. Private beds are undoubtedly too expensive. Such an action would also improve access and place public health before commercial interests.
Perhaps sensing that it needs to find some additional rationale, the ministry also asserts that its CL is in “full compliance with the Thai national and international framework”. In this context, this means in full compliance with section 51 of the Thai Patents Act and Article 31 of the World Trade Organisation’s Agreement On Trade Related Aspects of Intellectual Property Rights (Trips).
In reality, we think the ministry has failed to comply with Trips in a number of important respects. In this article we will explain why this is so. In the next article, we will discuss what might be done about it.
First, we believe the ministry has failed to comply with Article 31(b) of Trips because it did not have prior consultations with patent holders. In our view, the CLs in favour of the Government Pharmaceutical Organisation (GPO) are for commercial use, not for “public non-commercial use” as the government claims and as required by Article 31 (b).
Second, the ministry has failed to comply with Article 31(h) of Trips because the royalty rates stipulated (0.05% in every case) are not “adequate” and fail to take into account the “economic value of the authorisation” (the CL).
And third and most important, the ministry has failed to comply with Article 31(a) because it has not considered each case “on its own merits”.
Let’s discuss each of these failures in more detail:
Failure to Consult: Article 31(b) of Trips mandates prior consultations with the patent holder except in cases of emergency or “public non-commercial use”. The ministry does not claim there is an emergency. However, it does assert that the CLs in favour of the GPO are for a “non-commercial purpose”.
We think the GPO’s use of the CL will be for a commercial purpose. In fact, Section 6(5) of the GPO Act states that the GPO carries on “business”. Sections 34 and 35 reinforce this basic objective.
For example, legislators envisaged the organisation making a surplus and having an obligation to pay this surplus to the government. The GPO also has joint ventures with private pharmaceutical companies. In the past, some wanted the GPO privatised.
The GPO will be selling the products for which Thailand is issuing CLs. The royalty obligations are expressed as a percentage of the GPO’s “sale value”. In short, the activities are commercial, both in form and substance. They do not cease to be such simply because the GPO is owned by the government.
Contrary to what the Public Health Ministry asserts in its white paper, Section 51 of the Patents Act is in fact silent on the issue of whether there ought to be prior consultations with the patent holder. However, Article 31(b) of Trips does say negotiations are required if the CL is issued for commercial use, and we think the ministry has failed to comply.
Inadequate Royalty Rate: The royalty rate of 0.05% of the GPO’s sales value is not “adequate” and does take into account the “economic value” of the CL as required by Article 31(h) of Trips. The sales value, and hence the economic value, of each product varies. Prima facie, one would expect that the royalty rates for each product should vary. But they do not. The rate is the same for all three products.
There is some curious logic in the White Paper. The ministry asserts that since the GPO will charge high retail prices for the products, royalty rates paid to the patent holders should be low.
The opposite conclusion is more apt. If prices are high, royalty rates ought also to be high to provide adequate compensation to the patent holder. To make the royalty rate “adequate” within the meaning of Article 31(h), authorities should assess what rate might be applicable if this was a voluntary licensing situation, not just a CL situation.
In our experience, rates in voluntary licensing situations would be much higher, typically in the range of at least 5% to 7.5 %, and quite possibly substantially more. In one recent case in South Africa, a 5% rate was determined for an antiretroviral, and that involved a licence to settle a competition dispute. In short, any adequate rate would be likely to be way in excess of the derisory 0.05% stipulated by the ministry.
Failure to Consider Individual Merits: The ministry failed to comply with Article 31(a) of Trips because it did not consider each case on “its individual merits”. This is the most basic and fundamental of all of the ministry’s failures to comply.
To consider any case on “its individual merits” by definition requires prior consultations with the affected party. That party must be given the opportunity to make its case and provide relevant evidence. These principles resonate in provisions such as Article 41(3) of Trips, which says: “Decisions on the merits of the case shall be based only on evidence in respect of which parties were offered the opportunity to be heard.”
In the case of every announcement of a CL, the ministry ignored these principles. It deliberately decided not to hold prior consultations. It seems the ministry had a preconceived view that any prior consultations were unlikely to be productive as far as it was concerned.
By stipulating a blanket, uniform royalty rate of 0.05% for each product, the ministry also failed to consider the individual merits of the products. Had it done so and given the patent holders the opportunity to present their cases, it may have realised each product and each CL is different, and accordingly the rates ought to have been different and more adequate.
Trips is an international treaty to which Thailand is as signatory. Under the new interim constitution, Thailand has an obligation to comply with its obligations under international treaties, including Trips. We will explore the legal implications of this obligation in our next article.
Peerapan Tungsuwan is a partner at Baker & McKenzie. She can be reached at firstname.lastname@example.org. William McKay is a consultant with the firm, and can be reached at email@example.com.