E-DRUG: Health vs economic interests
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Why are the ministries of commerce and foreign affairs doing nothing to explain to the outside world Thailand's decision on compulsory licensing?
By APIRADEE TREERUTKUARKUL , Bangkok Post, 4 May 07
In a move that hopefully will instigate all developing countries to step up their rightful fight for access to affordable medicine, the Thai government's bold decision to bypass patent laws on three drugs for the treatment of AIDS and heart ailments is, however, coming under increasing pressure from domestic as well as international politics.
From abroad, the United States' Office of the Trade Representative's downgrading early this week of Thailand on its ''Priority Watch List'' of countries to be closely monitored for protection of intellectual property rights, is viewed as a punishment for Thailand's announcement of compulsory licensing (CL) for the AIDS drugs efavirenz and Kaletra [ritonavir/lopinavir] and the heart drug Plavix [clopidogrel].
This downgrade could lead to a lifting of the generalised system of preferences (GSP) currently enjoyed by Thai exporters, particularly in the gems and jewellery sector whose trade volume is worth around 7.5 billion baht annually.
Despite US ambassador to Thailand Ralph Boyce's statement that the USTR's decision did not stem from the compulsory licensing alone, the issue is the only new reason cited in the Special 301 Report, the USTR's annual review of the global state of intellectual property rights protection and enforcement.
Public Health Minister Mongkol Na Songkhla, who spearheaded the daring policy to give wider access to important medicines for people who cannot afford expensive drugs, and Department of Intellectual Property chief Puangrat Assawapinit, were not really surprised.
Dr Mongkol insists Thailand's move is lawful and fully within the framework allowed by the World Trade Organisation's Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and that the Thai people's health should come first. ''We carefully considered the economic interest and the matter of life and death of the people before announcing the compulsory licensing. Economic interests cannot be compared with saving human lives and protecting the public health,'' Dr Mongkol said.
The health minister said the latest response from the United States clearly demonstrates the clout American pharmaceutical companies have on the USTR.
Thailand's issuing of CL has rattled the multi-billion-dollar ''big pharma'' business from the very start. Drug firms continue to claim that the move to forcibly substitute more expensive, patented drugs for lower-priced generic versions would destroy the pharmaceutical industry, and make patients happy for a day but produce long-term shortages.
Thanks to Thailand's implementation of the compulsory licensing for the Aids drug Efavirenz last November, the patent owner Merck announced a worldwide price cut to 725 baht from 1,500 baht per month per patient.
In addition, the announcement of the licences to override patents for Aids and heart drugs Kaletra and Plavix in late January has led to radical changes in the response from Kaletra's patent holder Abbott Laboratories.
The pharma giant at first declared it would not register new drugs in Thailand but later changed its tone to offer a price cut for both Kaletra and its improved version called Aluvia [heat-stable ritonavir/lopinavir] at an equal price of 3,488.20 baht. Although the planned CL has not yet been implemented and the decision to buy either the original or generic drugs will not be made until the existing stockpile of these medicines runs low, probably in August, the movement has evidently proven effective and beneficial to Thailand.
It has also offered hope for developing countries to follow in this direction if they hope to have any bargaining power with the powerful pharmaceutical business.
There is no doubt the drug companies including the US-based Abbott will lobby their governments to put pressure on Thailand for breaking their drug patents. There is the question, however, that whether the Thai attempt to bypass patents _ an action permitted by the WTO _ so as to save millions of lives, should be tied to the illegal violation of property rights relating to entertainment or luxury products, leading to trade retaliation.
''Unfortunately, most people affected by these diseases are the poor who have neither power nor money to pay for lobbyists unlike the pharmaceutical giants.
''For a small, low-income, developing country like Thailand, even if what we've done is the right thing, it can turn out to look wrong in the eyes of big countries like the United States,'' Dr Mongkol said. He added that the United States itself had granted compulsory licenses for several drugs.
In 2005, the Federal Trade Commission announced a consent agreement which would protect competition and consumers in several significant medical device markets. Abbott was awarded a compulsory licence for Boston Scientific's patented stent technology that is now poised to generate huge profits for the firm, after a study showed the drug-coated stent was better at treating clogged heart arteries.
With a per capita GDP of roughly one-sixteenth that of
the United States, the Thai health system is, on the other hand, under threat of going bankrupt: one of the biggest expenses is the cost of medical treatment. A huge healthcare budget has been spent on providing free drugs under the three health schemes for civil servants, employees of the private sector and the estimated remaining 47 million population.
Among these drugs are costly anti-Aids medicines and those for chronic illnesses such as cancer and heart disease which are the country's top three causes of death each year. Therefore, seeking the right to access cheaper drugs via compulsory licensing seemed the last resort to save the national health system.
Is the Public Health Ministry the only Thai agency
which sees the importance and necessity of breaking the drug patents for the survival of its healthcare services? And here comes the squeeze from within. Since the announcement was made several months ago, Dr Mongkol seems to be the only minister defending the action. No support has come from such related agencies as the Commerce or Foreign Affairs portfolios. Former Bangkok senator and health activist Jon Ungpakorn pointed to the lack of unity among the relevant ministries in pushing for the CL to succeed, as a possible flaw which Washington may have picked up on before bringing in the trade retaliation.
After this, the US can negotiate with Thai trade-related authorities who are seen as being more keen on commercial interests than on in-depth details related to access to affordable medicine.
''The three involved authorities should have worked together as a team rather than deserting the Public Health Ministry to handle the task alone. We're living in a world of capitalism in which everything, even the matter of life and death of one person, can be turned into profit and benefits for others,'' Mr Jon commented.
''The issue of CL is very important not only for Thailand but also other developing nations. If involved authorities of this government fear to do the right thing for the nation simply because of a threat from a big country this time, don't even hope that we will have a chance to fight for anything right in the future,'' Mr Jon said.
As executive secretary-general of the Aid Access Foundation, Mr Jon late last month participated in the annual meeting of Abbott Laboratories stakeholders held in Chicago, and found there was a lot of misunderstanding in the eyes of foreigners regarding Thailand's decision to push for CL, mainly because of the lobbyists for drug companies. Some claimed Thailand was breaking the patents for up to 30 drugs.
He believed the Ministry of Foreign Affairs should be more responsible in explaining the issue _ of Thailand's necessity and needs _ to the global community so that they will at least understand that the action taken has been a lawful one.
Meanwhile, Jiraporn Limpananont, an academic at Chulalongkorn University's Faculty of Pharmaceutical Sciences, said it was essential that the Commerce Ministry and the Department of Intellectual Property proceed cautiously and leave some room for the protection of public health when amending the Patents Act.
The amendment was part of the US' proposal on the protection of intellectual property (IP) rights, which would be included in the still-to-be concluded Thai-US FTA pact. The US has demanded Thailand allow it to patent not only drugs but also diagnostic, therapeutic and surgical procedures for the treatment of humans or animals, which would inevitably force Thais to shoulder high medical treatment costs.
The US has also called for a three- to 10-year extension of the patent protection on drugs and agricultural chemical products.
Ms Jiraporn foresaw that the Thai public welfare system, including the 30-baht healthcare scheme, would completely collapse if the government submitted to Washington's demands.
However, according to the revised version of the Patents Act that was put to the scrutiny panel of the Prime Minister's Office and which awaits cabinet approval for the National Legislative Assembly's endorsement, the amendment includes an alteration to Article 7 of the law to allow evergreening patents on plants and animals, which would enable the patent holder to extend their patent duration by declaring new chemical substances.
Another concern is the proposed cancellation of the pre-grant opposition system. It has been the practice to allow concerned people to oppose a patent application before it is granted. However, the ministry proposed a so-called ''post-grant opposition'' for the amendment, meaning they would grant a patent first and listen to any opposition later.
Ms Jiraporn also said that allowing the Commerce Minister to identify which illnesses are in line with the language of the Doha Declaration, was highly inappropriate.
Banyong Limprayoonwong, deputy director-general of the Department of Intellectual Property, said that health officials could not do anything to the amended Patents Act since it had already passed the revision process. It was now up to the cabinet's prerogative to either accept or reject the submitted draft before sending it to the National Legislative Assembly for endorsement.
Though it may appear that Dr Mongkol and the Health Ministry have won this round in expanding access to drugs at more affordable prices for the people, the battle is proving to be longer and more arduous than anybody may have thought.
With continuing pressure from the United States and from our own Commerce Ministry to amend the Patents Act, it remains to be seen if public health will triumph over commercial interests and win the war to make drugs cheaper for everyone in the long run.
Kannikar KIJTIWATCHAKUL (Kar)
Mobile 66-85-0708954
kakablue@yahoo.com