Issue # 11
September 27, 2004
Calí, Colombia
In this issue Informative round Costa Rica:
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PLHA Organizations and associations express their concerns in regards to antiretrovirals being taken off the WHO list Informative Round |
The announcement sets the stand of these organizations and associations against the WHO, governmental bodies and pharmaceutical industries. The WHO stated that the measure was taken after inspections made to the organization contracted by RANBAXY to do the research on the bio-equivalency of various antiretrovirals and whose results showed that they are not bio-equivalent, nor do they respond to international standards of good manufacturing laboratory practices. The organizations and associations expressed their position through a press release and explained that in less than two months the WHO has announced the withdrawal of 5 antiretroviral medication manufactured by CIPLA and RANBAXY from their list of pre-qualified products, and this has caused an alarm at a world level, affecting the PLHAs as well as national public health systems.
What is being asked of the WHO? Both in Latin America and the Caribbean the WHO's announcement have had a string impact on access to treatment, on the PLHAs and on the medication supply programs by Health Ministries. For the organizations and associations, both facts confirm, once again, the repeated accusations made by the community sector referring to Health Ministries “they do not run the exhaustive and rigorous tests which they are held accountable by National Constitutions, to guarantee the right to health and life through quality control, efficacy and safety inspections of the antiretroviral drugs that come into the country. To make it worse, these have already been dispensed by Health Ministries to PLHAs”. They also note “it is not enough to argue hat the Health Ministries have been following the WHO announcements, they should also require definite guarantees regarding the certification process of pre-qualified drugs”. In their statement, they demand that the WHO, in their role as Health Consultant to the United Nations, takes on the responsibility for the global, Latin American and Caribbean community, offering immediate recommendations and specific technical orientation to health ministries, to the community sector and to the public opinion, to face the current situation. They are also asking the international body to report to the public opinion, their practices used to grant pre-qualification and in particular, certification, of bio-equivalence to pharmaceutical products, especially to antiretroviral drugs, drugs to treat infections associated with AIDS and reactors for diagnostic testing, control and follow-up. Another request is to report the results of quality control tests done on all antiretrovirals manufactured by the pharmaceutical laboratories RANBAXY and CIPLA ( India ), as well as on the investigative organizations hired by these pharmaceuticals to perform the bio-equivalency studies. Another demand is for the publication of a complete list of all the pre-qualified medication (innovative and generic) that had the bio-equivalency test performed and those that came out as being bio-equivalent during their last inspection. Health and Social Development ministries are being asked to guarantee the right to life, health and access to advances in science and technology, as observed in the constitutions of Latin American and Caribbean countries, as well as in pacts, treaties and international agreements signed by the nations. The associations and organizations are asking the ministries to declare the emergency of the antiretroviral supply programs to speed up the acquisition process of the antiretrovirals that are missing and to be able to normalize the access to treatments in Latin America and the Caribbean . A call is also made to these government bodies to follow the Commitments Declaration in the fight against HIV/AIDS, signed by the Governments in Latin America and the Caribbean during the United Nations General Assembly Special Session (UNGASS 2001). To the pharmaceutical industry They are asking RANBAXY and CIPLA to manufacture pharmaceutical products that meet established and proved technical scientific procedures, in accordance with the good manufacturing practices of this industry and quality control tests performed according to current international guidelines. In addition, they are asking the WHO that during their inspections they run bio-equivalency tests to pharmaceutical products, according to established international procedures. Lastly, HIV/AIDS organizations and associations from the civil society sector in Latin America and the Caribbean , restate their commitment to continue their social advising and auditing actions when facing any situation that threatens the well being of PLHAs, as well as the Latin American answer to the epidemic. Download the document, (File in PDF format, 4 pages, 23 Kb) / Back to top |
Cali, RedLa+.- 46 HIV/AIDS ONGs and associations of people living with HIV/AIDS (PLHA) from different countries in Latin America and the Caribbean, expressed their concerns about the impact that the lives of PLHA and access to antiretroviral treatments in Latin America and the Caribbean (see chart) can have from the withdrawal of three antiretroviral medication from the list of pre-qualified products of the World Health Organization (WHO) manufactured by RANBAXY.
Costa Rica Government and NGOs unite their forces for the same cause San José de Costa Rica. – Three non-governmental agencies have been working in prevention causes with funds granted to Costa Rica by the Global Fund during the second round. The Costa Rican Association of People Living with HIV/AIDS (ASOVIHSIDA, initials in Spanish), has been working in three AIDS clinics, at the association's office and in two shelters for PLHA. In addition, they involve three self-help groups for men and one for women, while also promoting and organizing national PLHA meetings. In the mean time, CIPAV runs prevention tasks through an HIV/AIDS information hotline and renders psychology services. They work with young gay men in HIV/AIDS prevention. FUNDESIDA, works with young women on sexual exploitation. Government action There are four public institution working along with these non-governmental organizations: 1) The Justice and Fairness Ministry works with that relating to people being deprived of their liberties. 2) The Education Ministry develops sexual education programs within the educational system. 3) The Health Ministry (Department: Project Coordinating Unit for the Global Fund), works with sexual workers and transvestites. 4) The Costa Rican Social Security has sexual education activities at the preventive level for the adolescence population. These activities are being developed in this Central American country despite the delay in the disbursement of monies. The different organizations and people that are involved with the projects are working continuously to reach their objectives./ Back to top
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