Treatment Action Campaign Newsletter: 1 December 2000 Dear subscribers It's been a long time since the last newsletter, for which I apologise. However, as anyone who has been following HIV/AIDS news for the last few months will realise, TAC has had an enormous amount of work to do. The last week has produced some tangible results, with the Medicines Control Council conditionally granting a Section 21 exemption for a generic version of fluconazole and the reported drop in the price of nevirapine in the South African private sector to R400 per month. There is also the possibility, albeit one that needs to be treated with caution, of Pfizer's fluconazole donation finally reaching the public sector after months of delays and cynical public relations. We greatly appreciate all the subscribers, volunteers, doctors, nurses and other health-care workers who endorsed the defiance campaign and the petition for a section 21 exemption. We made extensive use of these petitions to pressurise the MCC. On a sad note, 5 people who volunteered or worked closely with TAC have died of AIDS in the last two weeks: Queenie Qiza, Sibusiso Mkhize, Fareeda Abrahams, Patricia Ntsangani and Nombuwiselo Lukhozi. Their deaths did not need to happen. They all needed more access to medicine and better health-care. TAC will honour their memories by ceaselessly campaigning for affordable medicine and better health-care infrastructure. The major pharmaceutical companies will always be held responsible for playing a critical role in their premature deaths. Today, we have placed an advert in the Mail & Guardian in their memories. It is World AIDS Day. Pharmaceutical companies, UNAIDS, political parties and the burgeoning AIDS beaurocracy are falling over their feet trying to make the most of ceremony, so that they can ensure their profits, jobs, votes and donations respectively. It would be comical, were the topic not so deadly. However, for people with HIV/AIDS and those organisations who are truly committed to fighting this disease, World AIDS Day begins on 1 January and ends on 31 December, every year until this epidemic is over. email: info@tac.org.za website: www.tac.org.za (finally updated about two weeks ago!) * * * News **** As usual, the news consists of two sections, a few briefs notes on major events, followed by in depth articles on some of them. IN BRIEF ******** * BRIEF: The Medicines Control Council (MCC) granted a conditional Section 21 exemption on Biozole, the generic fluconazole imported by TAC. The main conditions include that Biozole must be tested and that the exemption will be reviewed when Pfizer's fluconazole donation becomes available in the public sector. (See previous TAC press release for full details.) * BRIEF: According to a report in the Business Day yesterday, nevirapine has been registered by the MCC for mother-to-child transmission prevention. However, the registration has not been officially confirmed yet. * BRIEF: Pfizer and the SA government have announced that they have reached agreement on Pfizer's much publicised fluconazole donation. This has come about after almost a year of activist pressure. TAC has reacted skeptically, saying that the claim will be believed once the donation reaches the patients. TAC has also demanded that the original demand that the price be dropped to less than R4 per capsule, has not been met in the private sector, where many workers and poor South Africans buy their medication. (See previous TAC press release for full details.) * BRIEF: Boehringer Ingleheim has claimed that they have dropped the price of Nevirapine such that it can now be purchased at R400 per month in the private sector. Previously it cost R1200 per month. * BRIEF: Judge Edwin Cameron and Prof. Jerry Coovadia were the recipients of this year's Nelson Mandela Health and Human Rights Award. Judge Cameron announced that he would donate his $10,000 prize money to the Treatment Action Campaign. A warm congratulations to both recipients from TAC. * DEPTH: The minister of health has replied to a letter sent by the AIDS Law Project on behalf of TAC in regard to mother-to-child transmission prevention (see In Depth). * DEPTH: TAC sent a letter to Nestle enquiring about the cost of infant formula milk as used in mother-to-child transmission prevention programmes. Nestle replied. Both letters are reprinted. This is an area in which we have done very little research and would appreciate feedback from anyone who has additional knowledge on this issue (see In Depth). * DEPTH: The US govt. is likely to pass legislation approving parallel imports, an act for which they recently slammed the SA govt (see In Depth). * DEPTH: A reprinted article from Public Citizen with facts and figures on the prescription drug industry in the US (see In Depth). * DEPTH: The Cosatu resolution on HIV/AIDS is reprinted (see In Depth). * DEPTH: A reprinted article on a bill that is being considered in Kenya which will expand access to medicine. Please note that the article has an inaccuracy . The Clinton Administration HAS NOT issued a statement that they will not interfere with African countries that violated American patent laws to obtain cheaper AIDS drugs. This is an optimistic misinterpretation of the Clinton Executive Order released earlier this year (See In Depth). * DEPTH: Contribution by drug companies to the US election parties (See In Depth). * DEPTH: BMS tries to stop Costa Rica from distributing anti-retrovirals. Reproduced is a comment by Zackie Achmat and an article by Richard Stern (See In Depth). * DEPTH: A clipping from a press release on World AIDS Day by Médecins Sans Frontières containing a 6 month report card on the UNAIDS-drug company deal; a deal which has proved to be most disappointing (See In Depth). ******** IN DEPTH ******** Letter from the Department of Health to the AIDS Law Project in Response to a Fax Sent on Behalf of TAC ------------- RE: Outstanding Correspondence: mother-to-child HIV Transmission Your fax of 23 October 2000 and our subsequent conversation refer. In addressing your questions from the outstanding correspondence, the following: Letter of 22 August 2000 The Office of the President has not yet made the Report from the Presidential AIDS Advisory Committee available for the public. It is only the prerogative of that office to do so, and the Department of Health is not in a position to comply with your request. Letter dated 8 August 2000 and letter dated 19 July 2000 I trust these questions have been answered in our telephonic conversation. As I explained in that discussion the Department of Health and its provincial counterparts are embarking on a programme of expanding research into Mother-to-Child Transmission. Approximately 25 sites (a site may refer to either a single facility, or in other instances, to a collection of facilities) have been identified in all provinces to implement a programme using the drug Nevirapine. This programme will allow for better data on issues such as resistance to Nevirapine, Nevirapine and breastfeeding, and operational and training requirements for larger implementation. The protocol proposal will be submitted to Cabinet within the next 2 weeks, and after approval it will be available for wide distribution. In the meantime I want to assure you that the Department and provinces have put several mechanisms in place to ensure that implementation can start as soon as possible. I trust this provides sufficient information on the questions you have asked. Director-General: Health ******************************* Letter to Nestle from TAC Dr W. Bauer CEO of Nestle South Africa PO BOX 50616 Randburg 2125 30 October 2000 Tel: 011 889 6000 Fax: 011 889 6630 011 889 6628 Dear Dr Bauer COST AND PRICING OF INFANT FORMULA MILK The Treatment Action Campaign (TAC) is an organisation campaigning for affordable access to health-care for people with HIV. A particular area of concern for us is the vertical transmission of HIV from mothers to their children. Women have a much higher chance of passing the virus on to their children if they breast-feed, than if they use infant formula milk. There are a number of mother-to-child transmission prevention pilot projects in operation in South Africa at the moment. More will be introduced in the near future and the Treatment Action Campaign intends to ensure that a country-wide programme is implemented. We are taking legal action against the Minister of Health to ensure that this happens. Our analysis indicates that infant formula milk is the most expensive component of a mother-to-child transmission prevention (mtctp) programme. This conclusion has been reached on the basis that Nestle charges the state approximately R70 for one month's supply of infant formula milk until the child is 6 months old, and considerably more thereafter. In the mtctp programme in Khayelitsha, babies of mothers with HIV are given infant formula milk for 9 months. This implies a cost of at least R630 per child to the state, which far exceeds the costs associated with any other aspect of the programme, including medication. It is for these reasons that the Treatment Action Campaign respectfully requests the following information: 1. What is the exact price that the state pays Nestle for infant formula milk? 2. What is the cost of Nestle's infant formula milk in the private sector? 3. What is the cost of production of infant formula milk? Please supply us with a detailed analysis of this. 4. Is Nestle intending to reduce the price of infant formula milk for the purposes of mtctp? 5. What were the sales figures of infant formula milk in the public sector last year? 6. What are the expected sales figures of infant formula milk in the public sector this year. 7. What were the sales figures of infant formula milk in the private sector last year? 8. What are the expected sales figures of infant formula milk in the private sector this year. 9. Where is the infant formula milk manufactured? You will no doubt understand our legitimate interest in these matters. Also, please be assured that TAC does not wish to deny Nestle its profit margin on infant formula milk. We merely want to ensure that the price is fair and that excessive profits are not being made. We respectfully request a reply on or before November 15, to be sent to the Cape Town address above or to be faxed to 021 689 9465. Yours truly, Nathan Geffen On Behalf of the Treatment Action Campaign ***************************************** Letter from Nestle to TAC Dated 13 November 2000 Dear Mr Geffen Thank you for your letter regarding the cost and pricing of infant formula. We share your concern, at the alarming incidence of HIV in this country and in particular the problem of Mother-to-child transmission. You have raised the question of using infant formula in intervention programs as one of the possible ways of reducing this risk of mother-to-child transmission. You are aware that this policy has not yet been endorsed by our Ministry of Health, and that within a number of international NGOs there is still no universal acceptance that formula should be given instead of breast milk. The reason we point this out, is that the marketing of infant formula is governed by a local Code of marketing practice, and by the WHO Code for the Marketing of Breast- milk substitutes. These codes restrict the donation of free and reduced cost supplies of infant formula, and needs the approval of the Ministry of Health for any deviations from these requirements. Any contravention of these codes would have serious repercussions for us both locally and internationally. The State has approved and does procure infant formula through the State Tender. Pelargon which is being used in the Khayelitsha programme, is sold to the State at R10.67 (inc.VAT) per a 500g tin. This same tin would currently retail at a large supermarket for R21.12, and considerably more in small stores. As you can see, we have thus already reduced the price of this item considerably to the State for its intervention programmes. We would also like to point out that people such as UNICEF would prefer that we do not drop our prices below 80% of the retail price, as they are concerned about the affect it would have on influencing a switch away from breastfeeding. We believe that the question of using infant formula, and the costs involved should be brought up by yourselves with State and Provincial Health Departments, as well as UNICEF and WHO, who monitor the provisions in the WHO code. We also believe that Government, WHO, UNICEF and all stakeholders including the Infant Formula Manufacturers should hold joint discussions to formulate a strategy for MTCTP programmes. We trust you understand the position we find ourselves in, but assure you we have deep concern for the problems being faced on the HIV/AIDS issue, and that we have had many discussions with the authorities both in South Africa and our neighbouring states on the problems being faced Yours sincerely Mr DJ Upshon Director of Communications Regional Affairs Southern & Eastern Africa ************************************** Reprinted for fair use US to import cheap drugs Pierre Steyn Washington - As a direct result of the high cost of medicines, the United States Congress is likely to approve legislation to import drugs from foreign countries - an issue over which, until recently, it has slated South Africa. Five years ago, when former health minister Dr Nkosazana Zuma proposed legislation to implement the so-called parallel importation of drugs, the Clinton administration, spurred on by the American pharmaceutical industry, protested vehemently. South Africa was placed on a watch list following Zuma's proposals, which the pharmaceutical industry said, purportedly infringed on US patent rights. These tensions between South African and the US were only allayed earlier this year when President Bill Clinton signed an executive order making it possible for poor countries to manufacture or import cheaper generic drugs. And now it appears the US congress, despite strong opposition from the pharmaceutical industry in that country, is prepared to follow South Africa's example by importing cheaper drugs. ************************************** Reprinted for fair use October 11, 2000 Public Citizen Releases Detailed Analysis of Prescription Drug Industry Profitability as Debate Over Prescription Drug Issue Heats Up in Election WASHINGTON, D.C. - Public Citizen today released a comprehensive analysis of drug company profitability that will provide a useful resource to reporters writing about the issue during the closing days of Congress and leading up to the November elections. Using Fortune 500 data, the analysis includes 12 easy-to-read graphs and tables that provide a clear understanding of the extent of drug industry profitability and related issues Among the information contained in the analysis is the following: ¯ An overall comparison of the ratio of 1999 U.S. drug prices to those in Canada and Europe; ¯ A comparison of the number of new drugs placed on the market by Europe, the U.S. and Japan since ¯ Information showing that the 10 most profitable drug companies increased their profits by $4.8 billion, or 20 percent, from 1998 to 1999; ¯ Data showing that the 1999 profits of major drug companies far exceeded the profits of other Fortune 500 industries such as auto, oil, securities and airlines ¯ Information showing that Merck, the world's largest drug company, had 1999 profits that exceeded the profits of all Fortune 500 companies in each of the following industries: airline, railroad, entertainment and building materials companies; ¯ A comparison of 1999 drug industry profits with those of all Fortune 500 industries and the profits of the 12 largest drug companies - measured as a percentage of revenue, assets and equity; ¯ A historical look at the tremendous growth in drug industry profitability since 1970, as compared with all Fortune 500 industries; ¯ A comparison of 1999 drug company revenue dedicated to research and development, profits and marketing/administration. On average, companies devoted 50 percent more revenue to profits than to research and development (R&D) and three times as much revenue to marketing and administration than to R&D. Copies of the 12 graphs and tables are in PDF format at: http://www.citizen.org/congress/drugs/factshts/pharm$graphs.pdf They are also available at: http://www.citizen.org/congress/drugs/factshts/corporate$.htm For more information about the prescription drug issue, please visit: http://www.citizen.org/congress/drugs/home.htm ********************************************** Cosatu Resolution on HIV/AIDS 1 Resolution on HIV/AIDS Noting: 1. The HIV/AIDS pandemic threatens the social and economic fabric of our society and could undermine the gains of our democracy, 2. The poorest and the most vulnerable of our society, particularly working class women and youth are most at risk, Further noting 1. Government’s current macro-economic framework is largely responsible for 1.1.the lack of a comprehensive and coherent response to the demands for access to effective treatment of HIV and other opportunistic diseases, 1.2.inadequate social infrastructural resources for education, prevention, research and appropriate treatment of HIV/AIDS, and 1.3.inadequate supply of free male and female condoms, although most South Africans cannot afford to buy their own. 2. The pandemic has been a terrain of fierce ideological contestation as various forces assert their class interests in shaping society’s response, 3. The dominant role of imperialist governments and the transnational pharmaceutical companies in controlling the production of knowledge, dissemination of information and research on a cure. This they do through patenting of drugs and introduction of so-called intellectual property rights. 4. The failure of the pharmaceutical companies to respond constructively to the pandemic, especially by providing free drugs, underlines the gender and class attitudes of these imperialist elites who profit from the death and misery of millions of our people. 5. The completely unhelpful role played by the mainstream capitalist media in our country in sensationalising the HIV/AIDS pandemic. Believing 1. There is scientific evidence to support the efficacy of anti- retroviral drugs in the control of HIV/AIDS. 2. Providing medication to HIV-positive pregnant women is morally and medically right and makes economic sense in terms of costs saved on treatment of HIV-positive children, 3. Providing medication to rape victims is morally and medically right, Resolves 1. To reaffirm the declaration and resolution on HIV/AIDS passed at the Special Congress in August 1999 2. To condemn pharmaceutical companies who put profit above people, since they deny poor and working people access to appropriate treatment for HIV and opportunistic diseases, thus deriving super profits out of this social disaster. We call on them to provide affordable medication for HIV and opportunistic diseases. 3. To call on Government to declare the HIV/AIDS pandemic a national disaster requiring extraordinary measures and resourcing, including 3.1.to end its scientific speculation and expand education, prevention, treatment and research on the basis that HIV is the medical cause of AIDS, 3.2.in that context, to draw up a comprehensive programme of action to make support, care, and affordable treatment available to people living with HIV/AIDS; to investigate cheaper sources of medication; affordable treatment of opportunistic diseases such as TB, pneumonia etc; and to increase government spending on treatment; further research on finding a cure; heightened mobilisation of all sectors of our society; and decisive tackling of poverty and unemployment. 3.3.immediately to provide the necessary medication to HIV-positive pregnant women and rape victims, 3.4.to respond to the immediate and long-term needs of AIDS orphans and people living with AIDS, and 3.5.we need to encourage ongoing scientific research to find a vaccine against HIV/AIDS 3.6.to immediately begin implementing a national programme to reduce the risk of mother to child transmission. 3.7.urgently to address issues of gender inequity as this is feeding the AIDS pandemic. 3.8.as part of our comprehensive strategy we need to strengthen and develop the capacity of our national health care system and supportive institutions such as hospices and orphanages to respond to the pandemic by providing more resources such as adequate medicines and addressing staff shortages. 4. Call on companies producing medication to sell their products at hugely discounted rates to HIV infected expectant mothers and those who are breast-feeding. 5. Government and employers must ensure that all adult South Africans have access to an adequate supply of condoms, including female condoms. 6. Demand that employers contribute to the cost of treatment for workers with HIV/AIDS and abide by the Code of Practice on HIV/AIDS in terms of the Employment Equity Act. 7. COSATU must actively participate in awareness campaigns aimed at bringing about behavioural change amongst the sexually active sectors of our population. 8. COSATU must lead a campaign to end discrimination against people with HIV/AIDS, especially in rural areas, and to promote community care and support of people living with HIV/AIDS. 9. To call on the mainstream media on our country to refrain from sensationalism and publicly declare their strategy on HIV/AIDS by 1st December 2000. 10. the state should take active interest in ensuring that public higher education institutions and state research institutions play a key role in research and knowledge production on HIV/AIDS rather than being on the sideline watching the domination of transnational companies. 11. We call on the Alliance, MDM structures and progressive NGOS to engage in a massive National Day of Action on HIV/AIDS on 1st December 2000, International AIDS day which will include putting the transnational pharmaceutical companies on the spot. ****************** Reprinted for fair use Bill May Provide A Solution to the Growing Pandemic The Nation (Nairobi) November 1, 2000 Nairobi The new Bill might offer a solution to the Aids pandemic ravaging the country. The Kenya Industrial Property Bill, 2000, soon to be tabled in Parliament, may pave the way for local industries to manufacture cheap Aids drugs with a provision on compulsory licensing, and allow importation of medicines from countries where they are cheaper. "It would also enable the Government to act in the public interest in case of an emergency, which the HIV/Aids pandemic clearly is," said Dr Chris Ouma, the National Aids Programme Coordinator for Action Aid. The Bill, however, requires some amendments, especially in relation to essential drugs. These are mainly being pushed for by the Medicins Sans Frontieres- led Kenya Access to Essential Medicines Coalition. Medicins Sans Frontieres is the organisation spearheading a campaign for easy access to essential medicines worldwide. Dr Ouma said there are many factors that affect access to medicines. These include quality of diagnosis, accurate prescription, selection, distribution and dispensing of medicines. "But one of the most significant barriers to access is the price of drugs," he explained. Most essential drugs are manufactured by multinational pharmaceutical companies, and many of the drugs are patented under intellectual property law against exploitation until the patent expires. This gives the companies a monopoly and ensures high prices. In Kenya, for instance, only two per cent of the population can afford the high cost of the drugs. It is this situation that the coalition seeks to address through amendments to the Bill. It has analysed the Bill and come up with a document offering suggestions to the Kenya Industrial Property Office (Kipo), the government body concerned with incorporating the amendments. The head of Kipo, Dr Nora Olembo, said the organisation is open to suggestions that can be incorporated into the Bill before it is tabled in Parliament. Kipo has been looking into intellectual property law so that it conforms with requirements under the World Trade Organisation Agreement on Trade Related Intellectual Property Rights (Trips), which form the basis of the amendments to the Bill. "As a member of the World Trade Organisation," explained Mr. Robert Lettington, of the coalition and an expert in intellectual property law, "Kenya is obligated to amend her intellectual property legislation by writing Trips' safeguard provisions into its national laws." According to the Trips Agreement, the country is obliged to grant a 20-year patent protection for drugs. This minimum standard should have been enshrined in the national laws by next January. Prior to this, the country's patent law, under the Industrial Property Act of 1989, was connected to patents granted in the United Kingdom. They were granted for seven years from the filing date as opposed to 20 years. Thus the Trips safeguard provisions, with their extended patent protection, may neutralise the negative consequences of granting monopoly rights. The first of these safeguard provisions is compulsory licensing under Trips' Article 31. According to this article, WTO members may allow the use of a patent by a third party, say, a local manufacturer, without the owner's consent. Although the Trips Agreement does not limit the grounds that may justify the granting of compulsory licences, the 2000 Bill seems to considerably restrict these grounds as compared to the 1989 Act. "It strengthens the rights of patent owners at the expense of the public interest," says Mr. Lettington. Compulsory licences are usually included to ensure that patent owners make good use of their rights. The second critical safeguard is parallel imports under Trips Article 6, which is based on the principle of exhaustion of rights. When enshrined in law, parallel imports allow countries to import products from countries where they are sold by the patent holder or licensee at lower prices without the manufacturer's permission. National laws should include Bolar Provisions - they allow generic manufacturers to begin preparing production and completing regulatory procedures before patents expire so that upon expiration they can immediately begin selling their products. This provision allows for local research and it also means less expensive generic products can be available much more rapidly after patents expire. The coalition has suggested some amendments to ease access to the patented products. An important amendment to be incorporated in the Bill is the banning of the patenting of new uses for existing products. For instance, if a patent expires, companies are known to patent the same product again and use it for something else, thus prolonging their patent ownership. Another crucial incorporation regards government use. This will guarantee that the Government will have the right to make use of any protected intellectual property to address critical problems, or in instances where the holder of a monopoly privilege is found to be abusing it. While this remains to be seen, there is a certain assurance that this may not come to be. In May this year, to the annoyance of the pharmaceutical companies, the Clinton adminstration issued an executive order saying that the government would not interfere with African countries that violated American patent laws to obtain cheaper AIDS drugs. ******************* This is the Opensecrets.org list of top campaign contributor from the Health Care sector. (Article supplied by Public Citizen) http://www.opensecrets.org/industries/contrib.asp?Ind=H Rank Organization Amount Dems Repubs 1 Pfizer Inc $1,672,983 15% 84% 2 Bristol-Myers Squibb $1,650,693 17% 83% 3 American Medical Assn $1,177,806 49% 51% 4 Slim-Fast Foods $1,139,950 98% 2% 5 Eli Lilly & Co $1,097,801 22% 78% 6 American Hospital Assn $1,077,706 51% 49% 7 American Society of Anesthesiologists $ 869,002 39% 61% 8 Glaxo Wellcome Inc $ 858,198 18% 82% 9 Schering-Plough Corp $ 816,614 26% 74% 10 American Dental Assn $ 725,360 42% 58% 11 Metabolife $ 683,750 60% 40% 12 Pharmacia & Upjohn Inc $ 617,810 17% 83% 13 American Health Care Assn $ 505,279 43% 57% 14 United HealthCare Corp $ 501,925 19% 81% 15 Federation of American Health Systems $ 496,046 39% 61% 16 Aventis $ 475,580 21% 79% 17 Aetna Inc $ 465,150 37% 63% 18 American Home Products $ 447,055 31% 69% 19 Amgen Inc $ 439,797 13% 87% 20 American Optometric Assn $ 432,300 57% 43% ************* BMS Tries to Prevent Costa Rica from Providing Anti-retrovirals >From Zackie Achmat: Below is an article by Richard Stern on Bristol Meyers Squibb's attacks on the Costa Rican government's action to provide anti-retroviral drugs for its people. The Costa Rican Constitutional Court ruled that its government should provide anti-retrovirals to people with HIV/AIDS. Then, the government approached generic companies to manufacture these drugs. BMS went to the Supreme Court to overturn the government decision. They failed. Now they are blatantly attempting to use PWA organisations to say that the generics are unsafe and want these organisations to appeal to the Supreme Court to overturn this decision. Please remember that Bristol-Meyer Squibb did not invent or develop the drug. Yale University and the US Government invented and developed the drug that Bristol continues to make billions of rands from. They donate small change to buy AIDS organisations, doctors, people with HIV/AIDS and researchers off with. San José, Costa Rica 14 September, 2000 For immediate release... Bristol-Myers Squibb Fights Generics in Central America By Richard Stern* Bristol-Myers Squibb may have $100 million to share with Africans Living with AIDS, but the company's new found good will apparently has not spread to Central America. The company seems bent on doing every thing it can to maintain its Central American price structure and interfere with efforts by generic producers to enter the market. The company, threatened by competition from a generic producer in Costa Rica which recently won a government contract to produce the anti-retroviral product "Zerit" (D4T), sent a "Product Representative" to meet with People Living with AIDS here to convince them that the generic products are untested and potentially unsafe. Costa Rica has been providing anti-retroviral medications to its AIDS affected population since 1997. But in the other six Central American Countries, less than 10 percent of all People Living with AIDS have access to ARV's. Earlier this year, Bristol-Myers Squibb (BMS) also filed an administrative appeal designed to prevent the Costa Rican government health care provider (known as the CCSS) from buying the generic version Zerit which BMS sells for $145 per month per patient. However, Bristol-Myers appeal of the government's decision to buy generic D4T was denied. Bristol-Myer Squibb´s representative acknowledged that BMS prefers that subsequent legal actions, such as a Supreme Court appeal, come directly from the PWA population and not from the company itself. The generic producer, Gutis Laboratories, has offered to produce the medication for just over half of Bristol-Myers' price, or $85 per month per patient (based on an 80mg dosage daily). Gutis has now begun delivery of generic D4T to the CCSS. The Bristol-Myers' Product Representative came to a meeting of the Network of Non-Governmental AIDS organizations on Friday August 4th, 2000, about three weeks after the company lost the appeal. He addressed the group, which included several People who are taking ARV cocktails provided by the CCSS, and indicated that the CCSS was purchasing potentially untested and unsafe generic versions of ddI, AZT, 3TC and D4T. The representative alleged that some patients have had negative reactions to generic versions of AZT, and gave an example of a patient who nearly died of thrombosis after taking a generic version of a coagulant. He provided copies of a document indicating that original versions of medications must meet 25 different requirements to be approved by the government, but generic versions need only meet five requirements. PWA activist Guillermo Murillo pointed out to Bristol Myers' representative that members of various non-governmental organizations working in the AIDS field, recently held a meeting with CCSS pharmacology Director Albin Chavez who indicated that all generic medications approved for use in Costa Rica undergo rigid testing in the CCSS's own laboratory. Chavez also indicated that this Laboratory was open to be visited by any qualified consultant, in order to see records and confirm results of testing. Gutis Laboratories, located in San José, through its Director Anna Maria Fallas, has also indicated that it will cooperate completely in opening its doors for independent evaluation of the quality of its generic version of Zerit, as well as any other generic medications it produces. Fallas also has delivered samples of its generic products to PWA groups for independent evaluation. Bristol-Myers Squibb Regional Sales Director José Avendaño acknowledged that the company is worried about generic production of its product in Costa Rica and throughout the Central American region. Interviewed from Guatemala by telephone on August 24th, Avendaño recognized that BMS had filed a legal action designed to prevent the Costa Rica government from utilizing the generic product. "But this appeal is only on administrative level and we will not go to the Constitutional Courts without direct involvement from PWA's who would be willing to sign a complaint. We believe we are acting in their best interests," he stated, adding that "the tests used to assure the quality of the generic products are inadequate." Questioned about the Bristol-Myer Africa donation, Avendaño replied that this program was poorly understood outside of the African region. But the full page BMS ad on the back cover of POZ magazine's July edition seems clear enough: "As a company dedicated to extending and enhancing human life, Bristol Myers Squibb is...committing $100 million to Secure the Future: Care and support for Women and Children with HIV/AIDS an initiative in partnership with the countries of Botswana, Lesotho, Namibia, South Africa, and Swaziland and HIV/AIDS organizations across the globe." Avendaño indicated, in a meeting held on August 27th, that Non-Governmental Organizations in Central America could make applications to the Bristol-Myers Squibb Foundation in the United States to apply for support for their programs. According to figures published in the magazine "Chemical Marketing Reporter," just the drug Zerit alone generated $315 million in revenues in the United States during the year ending in February of 2000. There are about 900 people with AIDS on ARV therapy in Costa Rica. If half of them were taking Zerit, company revenue would be approximately $730,000 per year in this country. Dropping the price by 45%, as the generic producer has done, would imply a drop of about $330,000 in the company's revenues in Costa Rica. As one PWA who attended the NGO meeting commented: "Bristol-Myers seems to be trying to maintain its profits in Central America to pay for their program in Africa...we know we have to be vigilant about the quality of any medications we receive and we don't need anyone to tell us this. The strategy of trying to scare us into filing lawsuits against generic producers isn't going to work." Doctors Without Borders, the Nobel Peace Prize winning organization is beginning a campaign directed at increasing access to medications for AIDS affected people in the Central America Region. The group has indicated that it will offer qualified technical support to assure the quality of any generic AIDS medications used in the region. *Richard Stern is Director of the Agua Buena Human Rights Association in San José, Costa Rica, a non-profit organization promoting access to treatment for People with AIDS in Central America. He can bereached by telephone and fax at 506-234-2411 and by e-mail at rastern@sol.racsa.co.cr *************************** >From MSF, released today: Six-month Report Card - UNAIDS five company Accelerated Access Programme Number of countries that have negotiated price reductions to date One (Senegal) Number of people living with HIV in sub-Saharan Africa 26 million Number of patients that will benefit once this programme in Senegal is implemented (according to UNAIDS) Approximately 900 Number of patients that Brazil has put on antiretroviral therapy by using affordable generic medicines More than 90,000 Amount that prices of generic antiretrovirals have fallen because of introduction of generics in Brazil (1996-2000) 79% Amount of money Brazil has saved on hospitalisations and treatments for opportunistic infections avoided by successful use of antiretroviral therapy (1997 - 1999) $472 million (R3.64 billion) Annual cost of triple combination in the US $10 000 -15 000 (R77200-115800) Annual cost of triple combination offered by a generic Indian manufacturer (quality meeting international standards) $800-1000 (R6176-7720) ********************************