Thomson

Sustaining access to antiretroviral therapy in the less-developed world: lessons from Brazil Nathan FordDavid WilsonGabriela Costa Chaves, Michel Lotrowskaand Kannikar Kijtiwatchakul Antiretroviral rollout in Brazil and Thailand Brazil and Thailand are among fewdeveloping countries to achieve universal access to antiretroviral therapy. Three factorswere critical to this success: legislation for free access to treatment; public sectorcapacity to manufacture medicines; and strong civil society action to support govern-ment initiatives to improve access.
Local production of affordable, non-patented drugs Many older antiretroviral drugsare not patented in either country and affordable generic versions are manufactured bylocal pharmaceutical institutes.
Efforts to ensure access to expensive, patented drugs Developing countries were notrequired to grant patents on medicines until 2005, but under US government threats oftrade sanctions, Thailand and Brazil began doing so at least ten years prior to this date.
Brazil has used price negotiations with multi-national pharmaceutical companies tolower the price of newer patented antiretrovirals. However, the prices obtained by thisapproach remain unaffordable. Thailand recently employed compulsory licensing fortwo antiretrovirals, obtaining substantial price reductions, both for generic and brandproducts. Following Thailand’s example, Brazil has issued its first compulsory license.
Lessons learned Middle-income countries are unable to pay the high prices of multi-national pharmaceutical companies. By relying on negotiations with companies, Brazilpays up to four times more for some drugs compared with prices available interna-tionally. Compulsory licensing has brought treatment with newer antiretrovirals withinreach in Thailand, but has resulted in pressure from industry and the US government. Aninformed and engaged civil society is essential to support governments in putting healthbefore trade.
ß 2007 Lippincott Williams & Wilkins Keywords: access, antiretrovirals, patent protection, Brazil, Thailand and support government initiatives to improve access.
This paper looks at strategies employed to improve access Increasing and sustaining access to affordable antiretro- to key antiretroviral drugs in these two countries and viral therapy (ART) continues to pose many challenges reflects on the relative successes of each in order to for the developing world. Brazil and Thailand are among identify factors for future success.
the few developing countries that can be said to haveachieved universal access to ART The success of thesetwo countries has depended on three positive factors: acommitment to ensuring universal access to ART with legislation giving free access to treatment; public sectorcapacity to manufacture medicines; and strong civil The Brazilian public health system began providing society action to challenge the lack of access to medicines antiretroviral agents (zidovudine monotherapy) in 1991.
From the aMe´decins Sans Frontie`res, Bangkok, Thailand, and the bMe´decins Sans Frontie`res, Rio de Janeiro, Brazil.
Correspondence to Me´decins Sans Frontie`res, 522 Mooban Nakorn Thai 14, Ladphrao Soi 101/1, Bangkok 10240, Thailand.
E-mail: ISSN 0269-9370 Q 2007 Lippincott Williams & Wilkins Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Table 1. Demographics, development status and HIV in Brazil and WHO, Me´decins Sans Frontie`res and Oxfam, helped strengthen Thailand’s newly established national HIV/ AIDS treatment programme and supported Thailand’sefforts to manufacture and procure generic antiretroviral medicines Since then, the number of individuals on ART has increased sharply from approximately 3000 at the start of 2002 to 27 000 by the end of 2003, rising to 53 000 by February 2005 and 83 000 by December ART, Antiretroviral therapy; GDP, gross domestic product. Sources:UNDP Brazilian Ministry of Health, Thai Bureau of AIDS, TB aEstimates for 15–49 year olds for 2004 In both countries the local generic production ofantiretroviral drugs by private (national) and state-owned At that time, new medicines were being clinically pharmaceutical institutes has been essential to ensuring approved internationally and civil society groups, which have played a central role in Brazil’s response to AIDS started to take legal action demanding that the govern- In Brazil, generic antiretroviral drugs are produced by ment supply these new drugs. This approach established a number of federal and state laboratories, the most the judicial basis for guaranteeing universal access to significant being the federal public laboratory Far- treatment for people living with HIV/AIDS within the Manguinhos. Local production of non-patented first- line drugs, coupled with price negotiations withpharmaceutical companies for newer drugs subject to Nationwide access to ARTwas kick-started in 1996 when patent, has helped the government steadily to reduce Brazil’s Congress enacted a law requiring free treatment its average annual cost for ART, from approximately for individuals with AIDS. Under this law, responsibility US$4350 per patient in 1999 to US$1517 in 2004 to provide ART came under the federal government (Unless otherwise stated, all prices in this article are public By the end of 1997, an estimated 35 900 people were sector prices.) Eight of the 17 antiretroviral drugs receiving ART; this increased to 105 000 by 2001 and currently purchased by the government are manufactured 153 000 by the end of 2004 Between 1996 and 2004 AIDS mortality was reduced by 50%, and AIDS-relatedhospitalizations fell by 80% Thailand’s Government Pharmaceutical Organization(GPO) began research and development into antiretro- Thailand began providing antiretroviral monotherapy viral drugs (zidovudine and didanosine) in 1992. Generic with zidovudine in 1992, switching to dual therapy zidovudine entered the market in 1995 at one-sixth the (zidovudine with either didanosine or zalcitabine) in price of the originator drug. Generic didanosine was 1995. Zidovudine became available generically in 1995, blocked in 1998 by a patent application by BMS (Bristol- but didanosine and zalcitabine were patented and Myers Squibb) GPO currently produces six anti- expensive. A joint evaluation by the World Bank, the retroviral drugs and two fixed-dose combinations in a World Health Organization (WHO) and the Ministry of range of dosages, which are between two (for nevirapine) Public Health (MOPH) concluded that the programme and 25 (for stavudine) times cheaper than the cheapest was high cost and low benefit but this economic originator equivalents. Triple therapy is currently available review did not take into account the possibility of lower as a fixed-dose combination (GPO-vir) at a monthly cost of drug prices. In 2000, the government began providing US$360 per patient per year, compared with US$4376 for triple therapy for individuals with HIV/AIDS, but again the patented, non-fixed-dose combination drugs.
reliance on expensive brand drugs limited the bene-ficiaries to 1500 individuals.
The average cost of treatment in both countries isincreasing as a result of the increasing need to access The wide-scale provision of ART began in 2003, once became broadly available, in particular the fixed-dose triple combination of stavudine, lamivudine and nevira- Local antiretroviral manufacture in Brazil and Thailand pine (GPO-vir). In February 2003, a delegation of senior has depended on the fact that these medicines were not officials from MOPH and individuals living with HIV/ patented in both countries. According to the World Trade AIDS from Thailand undertook a study visit to Brazil.
Organization’s Agreement on Trade-Related Aspects This exchange, which was supported by UNAIDS, of Intellectual Property Rights (TRIPS), developing Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Sustaining access to antiretroviral therapy in developing countries Ford et al.
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countries were not required to grant patents on medicines Review Board, with authority to collect economic data, until January 2005 Trade pressure, however, including the production cost of pharmaceuticals, but the particularly from the United States, pushed this forward United States objected and after a 1999 amendment in both countries, and the TRIPS Agreement was fully to the Thai Patent Act the Pharmaceutical Patent Review implemented in Brazil in 1997 and in Thailand in 1992 Board was disbanded and the right to issue compulsory licences for pharmaceuticals was restricted TheSafety Monitoring Programme remains in place.
Up until the early 1980s, Brazil’s intellectual propertylaws did not recognize patents on pharmaceutical products and processes. In response to US pressure, however, All HIV/AIDS treatment programmes need access to including economic sanctions, the Brazilian government newer medicines to provide treatment options in case of passed an industrial property law which was drug resistance or intolerance, and the need for these approved in 1996, the same year as the law guaranteeing medicines increases over time. These newer drugs are free AIDS treatment The new patent law included a under patent protection in the majority of countries number of provisions that go further than required by the and are far more expensive than those used in first-line TRIPS Agreement (TRIPS-plus provisions). The most detrimental of these to the availability of antiretroviralmedicines is the ‘pipeline mechanism’, which provides Brazil started to grant patents for pharmaceuticals in May retroactive patent protection for medicines not yet 1997. Within a year, new patented medicines were marketed in Brazil but which have been granted patent included in the national AIDS programme, and these protection elsewhere. Under this mechanism, a number began to consume an increasing amount of the treatment of key antiretroviral drugs, including abacavir, efavirenz, budget By 2003, three newer patented drugs, lopinavir/ritonavir, nelfinavir and amprenavir were lopinavir/ritonavir, nelfinavir, and efavirenz, were taking granted patent protection without any technical exam- up 63% of the total ART budget. In 2005, imports accounted for 80% of government expenditures onantiretroviral drugs, and total annual expenditures are As a result of concern over rising intellectual property projected to increase further with the inclusion of newer protection, an amendment was passed in 2001 that drugs such as atazanavir (US$2190 per patient/year) and included a number of public health flexibilities. One emtricitabine (US$17 000 per patient/year) in the such mechanism, called ‘prior consent’, authorizes the Brazilian Drug Regulatory Authority to assess patentclaims for pharmaceutical products and processes before a In Thailand, antiretroviral expenditure as a percentage of patent is granted This is a rare example of a the national health budget is expected to increase from government health authority playing a formal role in the 6.1% in 2004 to 10.2% in 2010. According to WHO examination of pharmaceutical patent applications.
estimates, second-line therapy for one quarter of allpatients will be absorbing three-quarters of the treatment Thailand has been under threat of trade sanctions from the budget by 2020, and the cost of ART with second-line US government to introduce strong patent protection for regimens could reach US$500 million per year if prices pharmaceuticals since 1985, even though process patents for pharmaceuticals had been introduced in the ThaiPatent Act since 1979 Out of concern for publichealth, Thai academics, lawyers, non-governmentalorganizations and health advocates formed an alliance to monitor this trade pressure, but public awareness remained low, and despite the efforts of civil societyintellectual property protection has increased. In 1992, Civil society and government in both countries have under US government pressure Thailand passed a fought hard to secure the availability of antiretroviral law introducing pharmaceutical product patent protec- drugs, using a range of strategies and policy options to tion and extending patent life from 15 to 20 years. In addition, ‘pipeline product protection’ was introduced toprovide market exclusivity for new drugs registered in Thailand that had been granted a patent elsewhere In Brazil, price negotiations, backed by the threat of between 1986 and 1991. The provision, known as the compulsory licensing and local generic production, have ‘Safety Monitoring Programme’ allows a period of been the main strategy used by the government to lower 2 years’ market exclusivity (renewable on request of the the price of patented antiretroviral drugs.
pharmaceutical company) for the purposes of collectingpostmarketing surveillance data As a safeguard, Between 2001 and 2003 the Brazilian government the government created the Pharmaceutical Patent negotiated discounts on a number of patented drugs.
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Sustaining access to antiretroviral therapy in developing countries Ford et al.
Table 3. Overview of strategies to improve access to affordable medicines in Brazil and Thailand.
Roche offers price of US$31 718 Government accepts price Health and Development Successful: application US government. Abbottoffers price of US$2000 (price $170), while localproduction is prepared GPO, Government Pharmaceutical Organization; MOH, Ministry of Health; MOPH, Ministry of Public Health; WHO, World HealthOrganization.
By basing negotiations on production cost estimates tactic of threatening to issue compulsory licences, without calculated by FarManguinhos and threats to issue a ever doing so, was losing credibility.
compulsory licence, significant price reductions wereobtained for efavirenz (73%), lopinavir/ritonavir (56%) With increasing numbers of patients on second-line and nelfinavir (74%). Although these percentage dis- treatments, the average treatment cost had risen by over counts appear impressive, the initial prices offered by US$1000 per patient per year to US$2616 by 2005; the pharmaceutical companies were very high (comparable to most expensive second-line drug, lopinavir/ritonavir, US prices) and the discounted prices obtained were still far higher than the best prices available internationally.
From 2003 onwards, the price of most patented anti- In June 2005, the Brazilian government took a first step retroviral drugs in Brazil fell only marginally It towards issuing a compulsory licence for lopinavir/ was becoming clear that the government’s negotiating ritonavir, announcing, in accordance with Brazilian law Table 4. Best price of key antiretroviral drugs in Brazil and internationally.
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that this was in the public interest to sustain the the scope of the original patent application Bristol- HIV/AIDS treatment programme. At the same time, the Myers Squibb objected that patients had no legal right to government gave the patent holder, Abbott, 10 days to challenge patents, but the court ruled that because offer a reasonable price, but in fact negotiations were pharmaceutical patents can lead to high prices and limit protracted over 4 months, and concluded with the access to medicines, patients are injured by them and government agreeing on a price of US$1380 per patient can challenge their legality. This ruling has important per year for the old version and US$1518 for the heat- consequences internationally, as similar cases in other stable version. The discounted price obtained was still far countries had been thrown out on this basis. Moreover, higher than the best prices available internationally by the court eventually found in favour of the plaintiffs, Abbott (US$500 per patient/year), and production cost opening the way for generic production. This court case estimates published by the WHO (US$338 per patient/ strengthened the confidence of people with HIV/AIDS year) In addition, the Brazilian government made in fighting for access to medicines, although the direct a number of concessions demanded by Abbott, includ- impact in terms of access to antiretroviral drugs in ing restricting the use of the compulsory licence, and a Thailand was limited because by the time the legal moratorium on future price negotiations until 2011 challenge had completed its course, standard national ARTregimens had been set and did not include didanosine.
In December 2005, these concessions forced civil societygroups (GTPI/REBRIP) together with the public In early 2006, the Health and Development Foundation attorney’s office to file a civil action lawsuit against both of Thailand filed a legal challenge against GlaxoSmith- the Brazilian government and Abbott, demanding the use Kline (GSK)’s application for a patent on the zidovudine/ of compulsory licensing for lopinavir/ritonavir. The lamivudine fixed-dose combination on the grounds of judges have so far prevented the case from moving ‘nothing new’, arguing that the combining of two known forward, arguing that a compulsory licence would pro- drugs, neither of which were patented in Thailand, could bably result in trade retaliation from the United States not be considered sufficiently inventive to merit a patent.
while Brazil does not have capacity for local production.
The cost implications of a patent would have been This is currently being challenged on the grounds that significant: zidovudine/lamivudine has been produced several laboratories (state-owned and private) do in fact generically by the Thai GPO since 2003 at a sales price of approximately US$276 per patient per year; theoriginator equivalent sales price was US$2436 per patient Brazil finally issued its first compulsory licence for an per year. The same legal challenge had been filed by civil antiretroviral drug in May 2007 for the drug efavirenz, society groups in India, and activists in both countries currently used by 75 000 patients in Brazil This co-ordinated their campaigns. In August 2006, several followed recent negotiations with the patent holder, hundred HIV-positive individuals demonstrated outside Merck, which was only willing to offer a 2% discount on GSK’s offices in Bangkok and Bangalore GSK the current price (US$580 per patient/year), more than withdrew the patent application in both countries the twice the price offered to Thailand (US$244) after the following day, and announced that it would also withdraw Thai government issued a compulsory licence (see applications or granted patents for this formulation in all below). A generic version will be bought from India at other countries Despite this promise, however, GSK less than US$170 in a first stage, pending local production continues to seek a patent for zidovudine/lamivudine by public a laboratory. This move, which was forcefully opposed by Merck, represents an important change inBrazil’s previous strategy of accepting industry conces- Compulsory licensing for government (non-commercial) sions without taking further action.
use has recently been employed in Thailand. The firstexample was for efavirenz. Since 2004, supply problems had resulted in stock-outs at several hospitals. Cost was In Thailand, direct negotiations with pharmaceutical also limiting access: Merck was charging over double companies have had mixed success Reducing (US$468 per patient/year) the price available from Indian the cost of antiretroviral drugs has focused on two generics (US$216 per patient/year), and the MOPH strategies: patent challenges and compulsory licensing.
budget was only able to cover two-thirds of the need.
Following failed negotiations with Merck for a lower The first successful challenge to an antiretroviral patent price, the Thai Minister of Public Health announced in was made by civil society groups against a patent for November 2006 that a compulsory licence would be didanosine. In May 2001, two patients and an AIDS non- issued for efavirenz, a move strongly supported by civil governmental organization filed a lawsuit against Bristol- society groups Merck responded by offering a price Myers Squibb, claiming that the patent application was of US$288 per patient per year, but at the same time invalid because details of the patent had been unlawfully lobbied the US government and the Director General of altered (a dose restriction in the original patent applica- the WHO to pressure the Thai government to tion was altered), extending the patent protection beyond negotiate with Merck rather than issue a compulsory Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Sustaining access to antiretroviral therapy in developing countries Ford et al.
licence Despite this pressure, the Thai government has followed through with the compulsory licence, and the first supply of generic efavirenz arrived in Thailand in Compulsory licences were issued for two more drugs in early 2007, clopidogrel (for heart disease), and theantiretroviral drug lopinavir/ritonavir The latter followed fruitless negotiations with the manufacturer, Abbott Laboratories, between 2004 and 2006 Until 2006, the best price Abbott had offered the Thai government was US$2967 per patient per year Under global pressure from activist groups, Abbottannounced in early 2006 a price of US$500 per year for least developed countries, but excluding middle countries such as Brazil and Thailand Following continuedpressure, Abbott announced a price of US$2200 per Fig. 1. Prices for lopinavir/ritonavir offered to Thailand and patient per year for a list of countries defined by the other middle-income countries. MOPH, Ministry of Public company as ‘middle-income’ countries. This is, however, Health; CL, Compulsory licensing. Note: In May 2007, the more than six times the current cost of first-line ART, and Thai MOPH was still paying the price for LPV/r offered by far too expensive for a country such as Thailand, where Abbott in August 2006. Later offers by Abbott had conditions the average annual wage is US$1600 per year.
unacceptable to the Thai MOPH (no further price reductionand withdrawal of CL).
At the end of January 2007, the Thai MOPH tooksteps to issue a government use compulsory licence for after pooled procurement negotiations, together with 65 lopinavir/ritonavir Abbott responded by offering other countries, facilitated by the Clinton Foundation a price of US$2000 per patient per year (at the time a generic company was offering $1333 per patient/year).
Given that the drug costs less than US$400 to manu-facture the MOPH proceeded with the com-pulsory licence. The company discounted the price again, to US$1000 per patient per year for both the old and thenew version of the drug, and this offer was made available Ensuring access to affordable generic medicines has been a to 40 ‘middle-income’ countries including Brazil.
cornerstone of Brazil and Thailand’s universal access pro-grammes. The long-term success of these programmes will At the same time, however, Abbott undertook an be limited unless access to newer medicines is ensured.
aggressive lobbying campaign to block the compulsorylicensing. They announced that they would withhold Middle-income countries such as Brazil and Thailand are registration of all new medicines from Thailand, stating caught in a double bind. Because they have manufactur- that ‘Thailand has chosen to break patents on numerous ing capacity they are heavily pressured by pharmaceutical medicines, ignoring the patent system. As such, we’ve companies, backed by the US government, to increase elected not to introduce new medicines there’. This was intellectual property protection. At the same time, they despite the fact that the WHO and several governments are viewed as emerging economies with rich elites have confirmed that Thailand’s actions are fully compliant representing lucrative markets, and so are excluded from with international law Abbott also mounted a mis- differential pricing policies offered to least-developed information campaign to spread false information about countries. The reality, however, is that HIV/AIDS is Thailand’s compulsory licensing process, and requested overwhelmingly a disease of the poor. Brazil and Thailand that the US government pressure Thailand for allegedly provide ART free to patients, but public health services ‘stealing’ their intellectual property; in response, the US in these countries are unable to pay the high prices government downgraded Thailand’s trade status to a demanded by multinational pharmaceutical companies.
country with poor intellectual property protection. Civil These concerns are not limited to antiretroviral medi- society groups responded by demanding that the Thai cines, but extend to all essential medicines.
Foreign Affairs and Commerce Ministries support theaction of the Public Health Minister more actively The right of governments to override patents to protectpublic health is clearly established in international trade In May 2007, a price of US$676 per patient per year for law, as affirmed by the 2001 Doha Declaration on generic heat-stable lopinavir/ritonavir was announced, TRIPS and Public Health, and has been promoted by Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
international institutions including the World Bank, Brazil and Thailand are not alone in facing these WHO and the United Nations Development Pro- challenges. India is another country with strong domestic gramme. In practice, however, developing country drug production capacity. The country has a weak governments have been pushed through trade pressure national HIV/AIDS program compared to Brazil and to implement much stricter intellectual property protec- Thailand but is an important exporter of generic tion than required under international agreements. They antiretroviral drugs, currently providing approximately are also subjected to further pressure not to use public half of all antiretroviral medicines used in the developing health safeguards when patents become a barrier to world. India only met TRIPS requirements in 2005, and accessing essential medicines. Abbott’s actions against it remains unclear which medicines will be granted patent Thailand are the clearest demonstration of this disregard protection, and to what extent public health safeguards for the public health safeguards in the patent system.
will be effective. These are critical issues for HIV/AIDStreatment programmes across the developing world.
Experience shows that negotiations with pharmaceuticalcompanies alone have largely failed to secure optimal An informed and engaged civil society is essential to prices. By relying on this strategy, Brazil is currently supporting governments in putting health before trade, paying up to four times more for second-line drugs and speaking out against pressure from industry and compared with prices available internationally. Company developed country governments. As the need for newer deals have also stunted the development of local generic antiretroviral drugs increases, so the efforts of civil society manufacturing capacity, and this is reflected by the fact that no new generic AIDS drug has been produced inBrazil since 2002. Thailand spent several years negotiatingwith companies who failed to offer reasonable prices, and this has limited treatment access for patients. By issuingcompulsory licences, the Thai government has given a The authors would like to thank Jiraporn Limpananont of clear indication to generics manufacturers both in the the Faculty of Pharmaceutical Sciences, Chulalongkorn country and abroad that generic production is worthwhile.
Cawthorne, Ellen ’t Hoen, Lawan Sarovat, and Tido The importance of compulsory licensing to the sustain- von Schoen-Angerer of Me´decins Sans Frontie`res for ability of treatment programmes was highlighted by a their valuable contributions to this manuscript.
recent World Bank evaluation of Thailand’s nationalHIV/AIDS programme. It stated: ‘Because Thailand Disclaimer: The production of this special Supplement stands to gain a great deal from bilateral agreements to was supported by the World Bank, the Joint United reduce trade barriers with trading partners like the United Nations Programme on HIV/AIDS and the World States, the Royal Thai Government may be tempted to Health Organization. The findings, interpretations relinquish its rights to grant compulsory licences for and conclusions presented in this paper do not AIDS drugs in exchange for proffered trade advantages.
necessarily reflect the views of these institutions or The report finds that the cost of such concessions would their constituent agencies or governments.
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