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A survey was conducted in countries in all six WHO regions and focused on the building blocks that are considered prerequisites to combat antimicrobial resistance: a comprehensive national plan, laboratory capacity to undertake surveillance for resistant microorganisms, access to safe, effective antimicrobial medicines, control of the misuse of these medicines, awareness and understanding among the general public and effective infection prevention and control programmes.
In the Trans Pacific partnership Agreement (TPPA) negotiations, the United States has proposed expanded patent protections that will likely impact the affordability of medicines in TPPA partners. This includes antiretroviral (ARV) medicines used in the treatment of HIV/AIDS. Vietnam has the lowest GDP per capita of the 12 countries participating in the TPPA negotiations. Using the current Vietnamese patent regime as our base case, we analyse the potential impact of alternative patent regimes on access to ARVs in Vietnam. The two other scenarios investigated are a patent regime making full use of TRIPS flexibilities, and a regime based on the US proposals in the 2014 leaked draft of the TPPA intellectual property chapter. Using World Health Organization (WHO) treatment guidelines, we identified the most commonly used chemical entities and combinations used in the treatment of HIV. We examined patent data sets to discover patents that had been registered for these medicines and used information from examination of these patents to identify which might be granted under alternative patent regimes. We then drew on the empirical literature to estimate prices under the three patent scenarios. The current ARV budget was used as a constraint, with the consequence that the results focus on the impact of alternative patent regimes on access to treatment. Our results indicate 82% of the HIV population eligible for treatment would receive ARVs under a full TRIPS flexibility scenario, while only 30% of Vietnam's eligible HIV patients would have access to ARVs under the US 2014 TPPA proposals – more than halving the proportion treated compared to the current 68% receiving treatment. Similar price impacts can be expected for other countries participating in the TPPA, though these are less economically vulnerable than Vietnam.
There are more than one hundred HIV rapid tests commercially available today, all of which can be used for screening pregnant women for the virus. These tests, which are generally antibody tests, have been widely adopted, especially in resource-limited settings, where they can be used in decentralized facilities, including prevention of mother-to-child transmission (PMTCT) and voluntary counselling and testing (VCT) centres, to provide same-day results to patients. In general, the technical performance of these HIV rapid tests, as reported by manufacturers, is strong. Sensitivities usually range from 99.3% to 100% and specificities range from 99.7% to 99.9%.
The report is intended to provide information primarily for public health policy-makers and managers, and for the wider medical and public health community (including pharmaceutical companies), as a support for informing strategic actions and programme planning. It will also be of interest to the other sectors that are directly involved, including veterinary drug and animal husbandry, agriculture and aquaculture.
The World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) Secretariat jointly organized an annual two-day consultation with pharmaceutical companies and stakeholders to present them with the draft forecasts for the demand of antiretroviral (ARV) drugs in 2013–2016.
Keywords: Anti-Retroviral agents, supply and distribution, HIV infections, therapy, drug industry
HCV has been described as a “dual epidemic” with HIV because it is highly prevalent in HIV-endemic areas and it disproportionately affects vulnerable populations that also have a high risk of developing HIV infection—especially in Asia and Eastern Europe.2 HIV/HCV co-infection has emerged as an urgent public health issue that is jeopardizing the progress made in addressing the HIV epidemic.
Keywords: hepatitis C, HCV, treatment, testing, prevention
The global effort to scale-up HIV treatment in low- and middle-income countries continues to move closer towards achieving the goal of 15 million people receiving treatment by 2015. By the end of 2012, 9.7 million people in low- and middle-income countries were receiving antiretroviral therapy (ART), which represents an increase of 1.7 million from the previous year.
The goal of this report is to provide countries and suppliers with a sense of how the global market for antiretroviral (ARV) medicines in low- and middle-income countries is likely to evolve from 2013 to 2016. The report also aims to provide suppliers with a global forecast of the estimated demand for active pharmaceutical ingredients (APIs) so that they can manage their manufacturing capacity accordingly.
By 2020, 90% of all people living with HIV will know their HIV status. By 2020, 90% of all people with diagnosed HIV infection will receive sustained antiretroviral therapy. By 2020, 90% of all people receiving antiretroviral therapy will have durable viral suppression. When these targets are achieved, at least 73% of all people living with HIV worldwide will be virally suppressed—a three-fold increase over current estimates of viral suppression. Modelling demonstrates that achieving these targets by 2020 will enable us to end the AIDS epidemic by 2030.
The report provides an overview of the patent landscape with respect to a select number of antiretroviral (ARV) medicines in developing countries as of April 2014. The focus is primarily on those ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.
Part 1 provides a brief introduction to patents and licences and their effect on the market for ARVs. It introduces key concepts that will facilitate an understanding of the report. It also explains which data sources were used for the report and notes a number of disclaimers with regard to the information contained in the report. Part 2 is the core of the report. It outlines the patent status and licensing status of each ARV in the 81 developing countries for which data are available. For each ARV the report indicates whether that ARV is included in fixed-dose combinations for which there may be patents. General conclusions are drawn in light of the data. The key purpose is to provide an overview of the patent landscape for each ARV and, in particular, to show in which countries market competition for a given ARV is possible in view of existing patents and licences.
Keywords: HIV, treatment, medicines, ART, ARV
This 17th edition of Untangling the Web of Antiretroviral Price Reductions is a departure from recent previous years. For this edition, the methods of collecting information on the sources and prices of antiretrovirals (ARVs) remain the same, but information is presented in a new, shorter format focusing on a few key drugs as well as future regimens, along with an analysis of the current opportunities, challenges and threats faced in keeping the price of ARVs down.