Thailand issues a compulsory license to produce generic copies of Kaletra!
February 12th, 2007This post was written by Diarmaid. You can read more posts by: Diarmaid or more posts in Campaign News
On 29th January 2007 the Thai Government issued a compulsory license to produce generic copies of Kaletra. Under the terms of the WTO’s TRIPS agreement, a country is permitted to issue a compulsory license without entering into negotiations with the patent holder if it is facing a ‘national emergency’. It is hoped by many HIV and AIDS campaigners that this decision could spur on other Governments to follow suit and encourage lower costs and better products in years to come.
Why did they need to do this?
The patent issued to Abbott Laboratories for Kaletra and other second line ARVs means no-one else can produce the drug for 20 years. This results in highly inflated prices for the medicine, as the patent holder is awarded a virtual monopoly. Thailand has around 580,000 people living with HIV and AIDS. The Thai government has a national AIDS programme aiming to provide universal access to treatment. However as more people become resistant to lower cost, 1st line ARVs and need to be moved onto newer, patented 2nd line drugs such as Kaletra, the national budget is struggling to meet the growing cost of treatments.
The decision has been applauded by AIDS campaigners who claim the inflated cost of second line ARVs is causing unnecessary suffering. Knowledge Ecology International (KEI) argue that Governments should do all they can to push for a new global framework which promotes access and medical innovation, rather than trying to maintain high prices on medicines. KEI conclude, ‘the prices that Abbott charges for Kaletra and other second line AIDS drugs are too high, and no developing country with significant HIV infection rates will be able to provide sustainable treatments for AIDS patients unless they stimulate a generic market for products’
The Backlash
No sooner had the license been issued when the opposition forces sprung into action. The Pharmaceutical research and Manufacturers Association expressed strong disapproval at the move, threatening that this could lead to Thailand’s isolation within the ‘global biotechnology community’. Most disturbing though, has been the reaction of the World Health Organisation. On a visit to the country Margaret Chan the Director-General of the WHO said that the Thai government should have entered into negotiations with Abbott before issuing the compulsory license. She warned that Thailand needed to improve its relationship with the drugs companies.
This move has surprised and disappointed AIDS Campaigners around the world. Nimit Tienudom, president of Thailand’s AIDS Access Foundation, said that the WHO “should have supported drug access and promoted the study of quality and inexpensive drugs for the sake of the global population rather than supporting pharmaceutical giants.” (Kaisernetwork.org).
To view the decree issued by the Thai Government click here:
http://www.cptech.org/ip/health/c/thailand/thai-cl-kaletra_en.pdf
This is a test case for access to medicines. If Thailand is supported in its use of the TRIPS flexibilities then it will pave the way for more countries to put the lives of patients above the profits of companies. If on the other hand, Thailand drops the case due to political pressure, the consequences could be very serious indeed. Watch this space!
A special thanks to Kelly Barber for researching this story for Stop AIDS!
February 13th, 2007 at 11:07 am
A great article I was emailed through a list serve. - Takes a considered look at the controversy surrounding the issuing of the Thai Compulsory License and the reaction of the WHO and NGOS…
Comments?…
Looking Back - More trust needed on shared health goals: Tim France, Thailand
An article from the HDN Key Correspondent Team
12 February 2007
Despite unprecedented investment in international health programmes, seven specific diseases still claim one in every four deaths worldwide. There has never been a more acute need or opportunity for the World Health Organization (WHO) to do its job. To do so, the agency must achieve an extraordinary partnership among diverse stakeholders. Hasty criticisms of WHO in the past week reveal some of the challenges working together presents.
With expectations rising about her leadership of WHO, Dr Margaret Chan’s recent unconsidered comments about compulsory licensing of essential drugs raise real concerns. But over-interpretation of her brief remarks by the media spawned a new analysis of WHO’s ‘position’ on compulsory licensing. AIDS organisations’ willing transformation of that analysis into an accepted truth appears increasingly like an unstrategic own goal with each passing episode.
Chan was in Thailand to take part in a conference on neglected diseases. Her keynote speech praised drug companies for their donations of drugs against diseases such as trypanosomiasis, lymphatic filariasis and schistosomiasis. These are medicines that are otherwise impossible to obtain for most of the people who need them. Media reports later referred to Chan as having “praised the pharmaceutical industry lavishly in her address,” without referring to the specific context of the drug donation programmes.
Earlier that same week, the military-appointed government in Thailand had exceptionally invoked three so-called ‘compulsory licenses’, giving the go-ahead for generic versions of corresponding drugs to be made - an entirely appropriate and permissible way for a country to get around the patent protection that companies hold. These mechanisms are legitimate exceptions to international agreements on trade-related intellectual property, or TRIPS, and aim to secure access to essential medicines. In the case of Thailand, two of the licenses were for HIV medicines, and the third was for a cardiac drug.
Not surprisingly given that news, during a briefing at the National Health Security Office in Bangkok, Chan referred specifically to the option of compulsory licensing: “I’d like to underline that we have to find a right balance for compulsory licensing,” Chan said, adding, “We can’t be naive about this. There is no perfect solution for accessing drugs in both quality and quantity.” She also encouraged the Public Health Ministry to improve the public-private partnership in order to give the public better access to drugs.
The Bangkok Post interpreted this comment under the predisposed headline: “WHO raps compulsory licensing plan.” [not available on-line, but printable scan here]
Hearing her comments, activists were clearly disappointed that Chan was not taking a clearer stand in favour of TRIPS exceptions, in this their first glimpse of her view on the issue.
Ellen ‘t Hoen, from Medicins sans Frontieres in Switzerland, said at a press conference: “It is not the role of WHO to protect the interests of the pharmaceutical companies.”
“The new DG of WHO should have stood up for the poor,” added James Love, head of a US-based group lobbying for cheaper generic drugs.
The Inter Press news agency filed these and other quotes in a story titled: “WHO Chief’s stand on generic drugs slammed.”
The US’ largest HIV healthcare and prevention and education provider, the AIDS Healthcare Foundation (AHF), promptly issued a statement alleging that the new WHO Chief “Fails to Stand Up for People Living with AIDS.”
Further details were added to the story by a report from the Kaiser Family Foundation, which elaborated: “The World Health Organization on Thursday cautioned the Thai government on its decision to allow the country to produce a lower-cost version of Abbott Laboratories’
antiretroviral drug Kaletra.”
A video clip posted to the Student Global AIDS Campaign web site showed former UN special envoy on AIDS in Africa, Stephen Lewis, imploring activists to take issue with WHO, which he claimed had “Effectively sided with the pharmaceutical industry, against the Government of Thailand and their decision to issue a compulsory licence for the creation of Kaletra at a much lower cost.”
The letter Lewis suggested they write duly arrived on Chan’s desk in Geneva on 8 February, eight days after her comments in Bangkok, bearing over 400 signatures of people living with HIV, and other organizations and advocates for treatment access from over 30 countries. It urged her to “reconsider her comments regarding the Thai government’s decision to issue a compulsory license.”
But had she “rapped” or “cautioned” the Thailand government about their decision? Has she really “sided with the pharmaceutical industry”? Did anyone take a moment to read beyond the headlines?
Chan’s comments are undeniably vague and now subject to endless interpretation. But rather than invest valuable energy and attention in responding to the possible implications of one uttered sentence, interpretation of WHO’s position should be based on their official statements on compulsory licensing and TRIPS. We should also rely more on the immeasurable advocacy that has already happened.
Surely collective energies would be better invested in openly and confidently assuring countries that the decision to issue any compulsory license is entirely theirs. There is no requirement for countries to negotiate with either the WHO or drug companies beforehand. So why create the impression that there is?
Years of activism, lobbying and nurturing of key relationships have got the TRIPS and drug patents debate to a place where countries like Thailand clearly are prepared to consider enacting - or even threatening to enact - TRIPS exceptions. Are we really ready to demean that solid foundation on the strength of one comment? And that from someone still in the first month of her new job?
If this was a shot across WHO’s bows to let them know they are subject to the scrutiny of AIDS NGOs and activists, then on that level it may have worked. So avidly and publicly doubting WHO’s position on TRIPS, however, is an implicitly weak and apprehensive position for advocates to adopt. Placing even the possibility of doubt so visibly in the spotlight may also, ironically, have helped inflate pressure for the Thailand Government to back down from using compulsory licensing. An outcome that has evidently already been reached (see Science and Development Network).
If Chan’s vague comments played into the hands of ‘big pharma’, as Lewis alleges, then their amplification by well-intentioned advocates can only have made matters worse. It certainly did not strengthen the hand of the Thailand authorities as they sat down to negotiations with Abbott Pharmaceuticals late last week.
Unquestionably, WHO should be front and centre when it comes to rigorous civil society scrutiny. To do its job properly, the organisation needs serious reconstruction work, as commentator Laurie Garrett recently suggested. “It is too soon to assess Margaret Chan’s leadership, but even if it is impressive, the WHO is likely to remain an imperfect institution,” she added. “Still, it could exercise the power of the pulpit to corral well intended but often competing NGOs, donors, philanthropies, and local government agencies into following a shared strategic vision.”
If working together to promote global health is part of what we are all striving for, then some well-intentioned stakeholders need to cut Margaret Chan, and WHO, some slack.