Antiretroviral Drug Prices Research Articles

Antiretroviral Therapy Coverage, Entrepreneurship, and Development in Low- and Middle-Income Countries

Improvements in the health capital of citizens are central to the development of countries. By exploiting steep decreases in antiretroviral drug prices and the subsequent increases in antiretroviral therapy (ART) coverage, we test whether the resulting improvements in the health of the population are associated with the prevalence of entrepreneurial activity and whether entrepreneurial activity strengthens the relationship between ART coverage and a country’s development. Drawing on a sample of 87 low- and middle-income countries (2006–2019), we find that a 1% increase in ART coverage is associated with a 1.5% increase in the number of newly registered limited liability firms; however, there is no significant relationship with (male or female) self-employment. Higher ART coverage is particularly associated with development—as proxied by gross domestic product (GDP) per capita and the Human Development Index—in countries with low levels of new business formation and high proportions of self-employment.

Efficiency of the EmERGE Pathway of Care in Five European HIV Centres.

We aimed to calculate the efficiency of the EmERGE Pathway of Care in five European HIV clinics, developed and implemented for medically stable people living with HIV. Participants were followed up for 1 year before and after implementation of EmERGE, between April 2016 and October 2019. Micro-costing studies were performed in the outpatient services of the clinics. Unit costs for outpatient services were calculated in national currencies and converted to US$ 2018 OECD purchasing parity prices to enable between clinic comparisons in terms of outcomes and costs. Unit costs were linked to the mean use of services formedically stable people living with HIV, before and after implementation of EmERGE. Primary outcome measures were CD4 count and viral load; secondary outcomes were patient activation (PAM13) and quality of life (PROQOL-HIV). Out-of-pocket expenditure data were collected. There were 2251 participants: 87-93% were male, mean age at entry was 41-47 years. Medically stable people living with HIVhad outpatient visits in four sites whichdecreased by 9-31% and costs by 5-33%; visits andcosts increased by 8% in one site, which had to revert back to face-to-face visits. Antiretroviral drugs comprised 83-91% of annual costs: the Portuguese site had the highest antiretroviral drug costs in US$ purchasing parity prices. Primary and secondary outcome measures of participants did not change during the study. EmERGE is acceptable and provided cost savings in different socio-economic settings. Antiretroviral drug costs remain the main cost drivers in medically stable people living with HIV. While antiretroviral drug prices in local currencies did not differ that much between countries, conversion to US$ purchasing parity prices revealed antiretroviral drugs were more expensivein the least wealthy countries. This needs to be taken into consideration when countries negotiate drug prices with pharmaceutical vendors. Greater efficiencies can be anticipated by extending the use of the EmERGE Pathway to people with complex HIV infection or other chronic diseases. Extending such use should be systematically monitored, implementation should be evaluated and funding should be provided to monitor and evaluate future changes in service provision.

Cost-Utility Analysis of a Dolutegravir-Based Versus Low-Dose Efavirenz-Based Regimen for the Initial Treatment of HIV-Infected Patients in Cameroon (NAMSAL ANRS 12313 Trial).

ObjectivesEvidence comparing the economic and patient values of the World Health Organization’s preferred (dolutegravir 50 mg [DTG]-based) and alternative (low-dose [400 mg] efavirenz [EFV400]-based) first-line antiretroviral regimens is limited. We compared patient-reported outcomes (PROs), costs, and the cost-utility of DTG- versus EFV400-based regimens in treatment-naive HIV-1 adults in the randomised NAMSAL ANRS 12313 trial in Yaoundé, Cameroon.MethodsWe used clinical data, PROs, and health resource use data collected in the trial’s first 96 weeks (2016–2019). Quality-adjusted life-years (QALYs) were computed using utility scores obtained from the 12-item Short Form (SF-12) generic health scale. Other PROs included perceived symptoms, depression, anxiety, and stress. In the 96-week base-case analysis, we estimated the unadjusted and multivariate-adjusted (1) mean costs (in US$, 2016 values) and QALYs/patient, (2) incremental costs and QALYs/patient, and (3) net health benefit (NHB). Outcomes were extrapolated over 5 and 10 years. Uncertainty was assessed using the cost-effectiveness acceptability curve and scenario and cost-effective price threshold analyses.ResultsIn the base-case analysis, the NHB (95% confidence interval) for the DTG-based regimen relative to the EFV400-based regimen was 0.056 (− 0.037 to 0.153), corresponding to an 88% probability of DTG being cost-effective. A 10% decrease in this regimen’s price (from $5.2 to $4.7/month) would increase its cost-effectiveness probability to 95%. When extrapolating outcomes over 5 and 10 years, the DTG-based regimen had a 100% probability of being cost-effective for a large range of cost-effectiveness thresholds.ConclusionsAt 2020 antiretroviral drug prices, a DTG-based first-line regimen should be preferred over an EFV400-based regimen in sub-Saharan Africa.Trial RegistrationClinicalTrials.gov Identifier: NCT02777229.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40273-020-00987-3.

Potential health gains in West and Central Africa through savings from lower cost HIV treatment.

Prices of antiretroviral (ARV) drugs in lower income countries have decreased substantially over the past two decades, helping to facilitate greatly expanded access to antiretroviral therapy (ART). However, ART coverage in many parts of the world remains low. We investigate the extent of epidemiological benefits that might be expected if ARV drug prices decline further. A modeling study using data from seven countries in West and Central Africa (Cameroon, Democratic Republic of the Congo, Côte d'Ivoire, Niger, Nigeria, Senegal, and Togo). We investigated how the timing of ARV cost reductions could affect the impact and compared three different possible investment strategies: reinvesting in ART, reinvesting in the HIV response according to historical allocations, and reinvesting with the aim of minimizing HIV incidence and mortality. If ARV drug prices fell by 37% relative to 2018 levels (i.e. following continued trend declines), we calculate ART unit costs could decrease by ∼20% (holding other cost components constant). If this could be achieved by 2020 and the savings were reinvested into ART, we estimate that an additional 8% of HIV infections and 11% of HIV-related deaths could be averted over 2020-2030 across the seven countries. Slightly greater gains could be attained if funds were reinvested in ART in combination with primary prevention. Delays in the year of introduction of ARV price reductions would reduce the impact by about 1% per year. ARV price reductions could free up funds that - if strategically invested - would help countries move closer toward the elimination of HIV.

Does the political will exist to bring quality-assured and affordable drugs to low- and middle-income countries?

ABSTRACTBackground: Increased coverage with antiretroviral therapy for people living with HIV in low- and middle-income countries has increased their life expectancy associated with non-HIV comorbidities and the need for quality-assured and affordable non-communicable diseases drugs . Funders are leaving many middle-income countries that will have to pay and provide quality-assured and affordable HIV and non-HIV drugs, including for non-communicable diseases.Objective: To estimate costs for originator and generic antiretroviral therapy as the number of people living with HIV are projected to increase between 2016 and 2026, and discuss country, regional and global factors associated with increased access to generic drugs.Methods: Based on estimates of annual demand and prices, annual cost estimates were produced for generic and originator antiretroviral drug prices in low- and middle-income countries and projected for 2016–2026.Results: Drug costs varied between US$1.5 billion and US$4.8 billion for generic drugs and US$ 8.2 billion and US$16.5 billion for originator drugs between 2016 and 2026.Discussion: The global HIV response increased access to affordable generic drugs in low- and middle-income countries. Cheaper active pharmaceutical ingredients and market competition were responsible for reduced drug costs. The development and implementation of regulatory changes at country, regional and global levels, covering intellectual property rights and public health, and flexibilities in patent laws enabled prices to be reduced. These changes have not yet been applied in many low- and middle-income countries for HIV, nor for other infectious and non-communicable diseases, that lack the profile and political attention of HIV. Licensing backed up with Trade-Related Aspects of Intellectual Property Rights safeguards should become the norm to provide quality-assured and affordable drugs within competitive generic markets.Conclusion: Does the political will exist among policymakers and other stakeholders to develop and implement these country, regional and global frameworks for non-HIV drugs as they did for antiretroviral drugs?

Can voluntary pooled procurement reduce the price of antiretroviral drugs? a case study of Efavirenz.

: A number of strategies have aimed to assist countries in procuring antiretroviral therapy (ARV) at lower prices. In 2009, as the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) commenced a voluntary pooled procurement scheme, however, the impact of the scheme on ARV prices remains uncertain. This study aims to estimate the effect of VPP on drug prices using Efavirenz as a case study. This analysis uses WHO Global price report mechanism (GPRM) data from 2004 to 2013. Due to the highly skewed distribution of drug Prices, a generalized linear model (GLM) was used to conduct a difference-in-difference estimation of drug price changes over time. These analyses found that voluntary pooled procurement reduced both the ex-works price of generic Efavirenz and the incoterms price by 16.2 and 19.1%, respectively ( P < 0.001) in both cases). The year dummies were also statistically significant from 2006 to 2013 ( P < 0.001), indicating a strong decreasing trend in the price of Efavirenz over that period. Voluntary pooled procurement significantly reduced the price of 600 mg generic Efavirenz between 2009 and 2013. Voluntary pooled procurement therefore offers a potentially effective strategy for the reduction in HIV drug prices and the improvement of technical efficiency in HIV programming. Further work is required to establish if these findings hold also for other drugs.

Do national drug policies influence antiretroviral drug prices? Evidence from the Southern African Development community.

The efficacy of low- and middle-income countries’ (LMIC) national drug policies in managing antiretroviral (ARV) pharmaceutical prices is not well understood. Though ARV drug prices have been declining in LMIC over the past decade, little research has been done on the role of their national drug policies. This study aims to (i) analyse global ARV prices from 2004 to 2013 and (ii) examine the relationship of national drug policies to ARV prices. Analysis of ARV drug prices utilized data from the Global Price Reporting Mechanism from the World Health Organization (WHO). Ten of the most common ARV drugs (first-line and second-line) were selected. National drug policies were also assessed for 12 countries in the South African Development Community (SADC), which self-reported their policies through WHO surveys. The best predictor of ARV drug price was generic status—the generic versions of 8 out of 10 ARV drugs were priced lower than branded versions. However, other factors such as transaction volume, HIV prevalence, national drug policies and PEPFAR/CHAI involvement were either not associated with ARV drug price or were not consistent predictors of price across different ARV drugs. In the context of emerging international trade agreements, which aim to strengthen patent protections internationally and potentially delay the sale of generic drugs in LMIC, this study shines a spotlight on the importance of generic drugs in controlling ARV prices. Further research is needed to understand the impact of national drug policies on ARV prices.

Cost and cost-effectiveness of an HIV pre-exposure prophylaxis (PrEP) programme for high-risk men who have sex with men in England: results of a static decision analytical model

BackgroundThe efficacy and effectiveness of pre-exposure prophylaxis (PrEP) for preventing HIV infection acquisition by high-risk men who have sex with men (MSM) is established. We estimated the cost and cost-effectiveness of a proposed daily oral PrEP programme covering 10 000 high-risk MSM attending genitourinary medicine clinics in England. MethodsFrom the perspective of public providers, a static decision analytical model was used to investigate lifetime HIV infections, treatment costs, and quality-adjusted-life-year (QALY) losses associated with daily PrEP given for 1 year, beginning in 2016, compared with no intervention. A cohort of MSM who were not known to be HIV positive at their first attendance in 2012 and had tested HIV negative between 42 and 365 days previously was identified. These men were followed up from the date of their earliest negative HIV test in 2012 for up to 1 year either until they seroconverted or until their last attendance. HIV incidence was calculated as the number of seroconversions (new HIV diagnoses) per 100 person-years. Data sources including genitourinary medicine clinic activity data were used to estimate HIV incidence in year 1 and thereafter. Costs were updated to 2013–14 values and both future costs and QALYs were discounted at 3·5%. Budgetary impact was undiscounted. FindingsAt 86% effectiveness, delivery of PrEP to 10 000 high-risk MSM in the first year (target population with an HIV incidence of 2·4 per 100 person-years in year 1) resulted in 178 fewer lifetime HIV infections, 28 delayed infections, and an incremental cost-effectiveness ratio (ICER) of £26 300, compared with no PrEP. More conservative assumptions of 64% PrEP effectiveness gave an ICER of £54 500, compared with no PrEP. ICER was highly sensitive to year 1 HIV incidence (eg, with HIV incidence of 3·3 per 100 person-years and at 86% PrEP effectiveness, ICER was £4170), PrEP effectiveness, PrEP drug costs, and potential changes in antiretroviral treatment cost upon patent expiry. An investment of £54 million in year 1 breaks even anywhere from year 42 (86% PrEP effectiveness) to beyond year 61 (64% PrEP effectiveness). InterpretationThe model shows that the estimated cost-effectiveness of PrEP is very sensitive to key variables (eg, year 1 HIV incidence and patient adherence), about which there is much uncertainty, especially if programme scale-up occurs. A substantial reduction in the price of antiretroviral drugs, when used for PrEP, is needed to give the necessary assurance of cost-effectiveness, and for an affordable public health programme of sufficient size. FundingNone.

Cost analysis of antiretroviral agents available in India

Background: AIDS is one of the most prevalent causes of death due to infectious origin which requires a lifelong therapy. There is variation in prices of antiretroviral drugs available in Indian market. Thus, a study was planned to find out variation in prices of antiretroviral drugs either as a single drug or in combination and to evaluate the difference in cost of various brands of the same antiretroviral drugs by calculating percentage variation in cost in Indian rupees. Methods: Cost of antiretroviral drugs manufactured by different pharmaceutical companies, in the same strength and dosage forms was obtained from “Current Index of Medical Specialties” July-October 2014 and “Indian Drug Review” Vol. XXI, Issue No. 4, 2014. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and percentage variation in cost was calculated. Results: Percentage variation in cost for antiretroviral drugs marketed in India was found to be zidovudine (100 mg) - 436%, lamivudine (100 mg) - 268%, tenofovir (300 mg) - 149.5%, didanosine (250 mg) - 73.75%, indinavir (400 mg) - 35.26%. Among the combination therapy, price variation was lamivudine + zidovudine (150 + 300 mg) - 314%, lamivudine + stavudine (150 + 40 mg) - 105%, lopinavir + ritonavir (133.3 + 33 mg) - 25%. Conclusion: There is wide variation in the prices of antiretroviral agents available in the market. Regulatory authorities, pharma companies, physicians should maximize their efforts to reduce the cost of drugs.

Viral load monitoring for antiretroviral therapy in resource-poor settings

Viral load monitoring for antiretroviral therapy in resource-poor settings

Antiretrovirals for low income countries: an analysis of the commercial viability of a highly competitive market

BackgroundThe price of antiretroviral drugs (ARVs) in low income countries declined steadily in recent years. This raises concerns about the commercial viability of the market of ARVs in low income countries.MethodsUsing 2 costing scenarios, we modeled the production cost of the most commonly used ARVs in low income countries in 2010 and 2012, and assessed whether, at the median price paid by low income countries, their manufacturers would still make profits. By interviews we consulted 11 generic manufacturers on the current state of the ARV market, and on what would be required to ensure their continued commitment to supply ARVs to low income countries.ResultsUsing the lowest prices for active pharmaceutical ingredients (API) quoted to WHO, and applying published assumptions about the production cost of ARVs, our baseline estimate was that Indian generic manufacturers would have made profits on only 1 out of 13 formulations of ARVs in both 2010 and 2012, and publicly owned manufacturers would have made profits on 5 and 3 out of 13 formulations in 2010 and 2012, respectively. We needed to assume a 20% and a 40% lower API cost for our model to predict that publicly owned and Indian manufacturers, respectively, would make profits on the sale of the majority of their ARVs. Between 2010 and 2012, we estimate that - across the ARV portfolio - the gross profit on sales of ARVs to low income countries decreased with between 6% and 7% of their sales price. Generic manufacturers consider that current prices are unsustainable. They suggested amendments to the tender procedures, simplified regulatory procedures, improved forecasting, and simplification of the ARV guidelines as critical improvements to maintain a viable ARV market.ConclusionsWhile recent price decreases indicate that there is still space for price reduction, our estimate that gross profit margin on sales decreased by 6 to 7% between 2010 and 2012 lends credibility to assertions by generic manufacturers that the ARV market in low income countries is under considerable price pressure. This might create problems for the quality and/or the continued supply of ARVs to low income countries.

Human resources needs for universal access to antiretroviral therapy in South Africa: a time and motion study

BackgroundAlthough access to life-saving treatment for patients infected with HIV in South Africa has improved substantially since 2004, treating all eligible patients (universal access) remains elusive. As the prices of antiretroviral drugs have dropped over the past years, availability of human resources may now be the most important barrier to achieving universal access to HIV treatment in Africa. We quantify the number of HIV health workers (HHWs) required to be added to the current HIV workforce to achieve universal access to HIV treatment in South Africa, under different eligibility criteria.MethodsWe performed a time and motion study in three HIV clinics in a rural, primary care-based HIV treatment program in KwaZulu-Natal, South Africa, to estimate the average time per patient visit for doctors, nurses, and counselors. We estimated the additional number of HHWs needed to achieve universal access to HIV treatment within one year.ResultsFor universal access to HIV treatment for all patients with a CD4 cell count of ≤350 cells/μl, an additional 2,200 nurses, 3,800 counselors, and 300 doctors would be required, at additional annual salary cost of 929 million South African rand (ZAR), equivalent to US$ 141 million. For universal treatment (‘treatment as prevention’), an additional 6,000 nurses, 11,000 counselors, and 800 doctors would be required, at an additional annual salary cost of ZAR 2.6 billion (US$ 400 million).ConclusionsUniversal access to HIV treatment for patients with a CD4 cell count of ≤350 cells/μl in South Africa may be affordable, but the number of HHWs available for HIV treatment will need to be substantially increased. Treatment as prevention strategies will require considerable additional financial and human resources commitments.

PIN3 Pursuing Financial Sustainability To Fulfill The Millenium Development Goal Six In A Fragmented SYSTEM. The Experience Of The Universal Access To Antiretroviral Drugs In MÉxico 2007-2009

To calculate the average annual cost per ART in IMSS, ISSSTE and MoH. To analyze the financial requirements for the provision of ART through the Universal Access Program to Antiretroviral Drugs (PAUMA) lead for the MoH and its implications for drug procurement policies at national level in the short and medium terms. We obtained data about patients under ART in 2007 for the three main institutions mentioned and in 2009 only for MoH. Information was analyzed to identify ART prescriptions according to official recommendations. Average annual cost of ART per patient and institution was estimated for 2007 and 2009. Projections of the financial requirements to ensure the provision of ART through the PAUMA for the period 2010-2017 were estimated. Analysis was developed in STATA 9.2. In 2007 average annual cost of ART for the three main institutions was MXP$64,800; per institution were as follow: ISSSTE MXP$74,300; IMSS MXP$67,600 and MoH MXP$61,600. Information for the MoH indicates that average annual cost of ART decreased between 2007 and 2009 by around 10.2% (in 2009 was MXP$55,300). First 20 ART options are prescribed to 80% of the patients and represent around 73% of the total costs in 2009. Projections for PAUMA in the period 2010-2017 indicate that on average annually 7,000 new patients require ART and 5,000 deaths will occurred. Assuming new cases, deaths and prices of antiretroviral drugs remain constant the average annual increase in financial requirements for PAUMA to ensure ART in the period studied will be 5.6%. Results generate evidence to strengthen the decision making, monitoring, containment costs, and purchase of antiretroviral drugs processes. It also provides information to allow policy makers optimize the use of limited public resources to support the demand for ART through the financial armor that contributes to maintain universal coverage, allowing the fulfillment of Goal 6 of the Millennium Development Goals.

Levels of Spending and Resource Allocation to HIV Programs and Services in Latin America and the Caribbean

BackgroundAn estimated 1.86 million people are living with HIV in Latin America and the Caribbean (LAC). The region is comprised of mainly middle-income countries with steady economic growth while simultaneously there are enormous social inequalities and several concentrated AIDS epidemics. This paper describes HIV spending patterns in LAC countries including analysis of the levels and patterns of domestic HIV spending from both public and international sources.Methods and FindingsWe conducted an extensive analysis of the most recently available data from LAC countries using the National AIDS Spending Assessment tool. The LAC countries spent a total of US$ 1.59 billion on HIV programs and services during the latest reported year. Countries providing detailed information on spending showed that high percentages are allocated to treatment and care (75.1%) and prevention (15.0%). Domestic sources accounted for 93.6 percent of overall spending and 79 percent of domestic funds were directed to treatment and care. International funds represented 5.4 percent of total HIV funding in the region, but they supplied the majority of the effort to reach most-at-risk-populations (MARPs). However, prevalence rates among men who have sex with men (MSM) still reached over 25 percent in some countries.ConclusionsAlthough countries in the region have increasingly sustained their response from domestic sources, still there are future challenges: 1) The growing number of new HIV infections and more people-living-with-HIV (PLWH) eligible to receive antiretroviral treatment (ART); 2) Increasing ART coverage along with high prices of antiretroviral drugs; and 3) The funding for prevention activities among MARPs rely almost exclusively on external donors. These threats call for strengthened actions by civil society and governments to protect and advance gains against HIV in LAC.

Cost-Efficacy Analysis of the MONET Trial Using UK Antiretroviral Drug Prices

In virologically suppressed patients, switching to darunavir/ritonavir (DRV/r) monotherapy maintains HIV RNA suppression, and could also lower treatment costs. The purpose of this analysis was to calculate the potential cost savings from the use of DRV/r monotherapy in the UK. In the MONET trial, 256 patients with HIV RNA < 50 copies/mL on current highly active antiretroviral therapy (HAART) for over 24 weeks (non-nucleoside reverse-transcriptase inhibitor [NNRTI] based [43%] or protease inhibitor [PI] based [57%]), switched to DRV/r 800/100 mg once daily, either as monotherapy (n = 127) or with two NRTIs (n = 129). The UK costs per patient with HIV RNA < 50 copies/mL at week 48 (responders) were calculated using a 'switch included' analysis to account for additional antiretrovirals taken after initial treatment failure. By this analysis, efficacy was 93.5% versus 95.1% in the DRV/r monotherapy and triple therapy arms, respectively. British National Formulary 2009 values were used. Before the trial, the mean annual cost of antiretrovirals was £6906 for patients receiving NNRTI-based HAART, and £8348 for patients receiving PI-based HAART. During the MONET trial, the mean annual per-patient cost of antiretrovirals was £8642 in the triple therapy arm, of which 55% was from NRTIs and 45% from PIs. The mean per-patient cost in the monotherapy arm was £4126, a saving of 52% versus triple therapy. The mean cost per responder was £9085 in the triple therapy arm versus £4413 in the DRV/r monotherapy arm. Based on the MONET results, the lower cost of DRV/r monotherapy versus triple therapy in the UK would allow more patients to be treated for fixed budgets, while maintaining HIV RNA suppression at < 50 copies/mL. If all patients meeting the inclusion criteria of the MONET trial in the UK were switched to DRV/r monotherapy, there is the potential to save up to £60 million in antiretroviral drug costs from the UK NHS budget.

Cost‐efficacy analysis of the MONET trial using Spanish antiretroviral drug prices

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

Use of Generic Antiretroviral Agents and Cost Savings in PEPFAR Treatment Programs

One of the biggest hurdles to the rapid scale-up of antiretroviral therapy in the developing world was the price of antiretroviral drugs (ARVs). Modification of an existing US Food and Drug Administration (FDA) process to expedite review and approval of generic ARVs quickly resulted in a large number of FDA-tentatively approved ARVs available for use by the US President's Emergency Plan for AIDS Relief (PEPFAR). To evaluate the uptake of generic ARVs among PEPFAR-supported programs in Guyana, Haiti, Vietnam, and 13 countries in Africa, and changes over time in ARV use and costs. An annual survey from 2005 to 2008 of ARVs purchased in 16 countries by PEPFAR implementing and procurement partners (organizations using PEPFAR funding to purchase ARVs). Drug expenditures, ARV types and volumes (assessed per pack, a 1-month supply), proportion of generic procurement across years and countries, and cost savings from generic procurement. ARV expenditures increased from $116.8 million (2005) to $202.2 million (2008); and procurement increased from 6.2 million to 22.1 million monthly packs. The proportion spent on generic ARVs increased from 9.17% (95% confidence interval [CI], 9.17%-9.18%) in 2005 to 76.41% (95% CI, 76.41%-76.42%) in 2008 (P < .001), and the proportion of generic packs procured increased from 14.8% (95% CI, 14.79%-14.84%) in 2005 to 89.33% (95% CI, 89.32%-89.34%) in 2008 (P < .001). In 2008, there were 8 PEPFAR programs that procured at least 90.0% of ARV packs in generic form; South Africa had the lowest generic procurement (24.7%; 95% CI, 24.6%-24.8%). Procurement of generic fixed-dose combinations increased from 33.3% (95% CI, 33.24%-33.43%) in 2005 to 42.73% (95% CI, 42.71%-42.75%) in 2008. Estimated yearly savings generated through generic ARV use were $8,108,444 in 2005, $24,940,014 in 2006, $75,645,816 in 2007, and $214,648,982 in 2008, a total estimated savings of $323,343,256. Among PEPFAR-supported programs in 16 countries, availability of generic ARVs was associated with increased ARV procurement and substantial estimated cost savings.

Soaring antiretroviral prices, TRIPS and TRIPS flexibilities: a burning issue for antiretroviral treatment scale-up in developing countries

The achievement of significant reductions in the price of antiretroviral drugs constitutes one of the main economic pillars of antiretroviral treatment scale-up in developing countries. Today this economic pillar is threatened. The prohibitive prices of newer first-line and second-line regimens have created a watershed in relation to the prices of earlier first-line treatments. These price increases are closely related to the World Trade Organization's Agreement on the trade-related aspects of intellectual property rights (TRIPS) that imposes an important barrier to generic competition. Intellectual property flexibilities foreseen by the TRIPS agreement allow the manufacture and supply of affordable generic versions of new generations of antiretroviral under certain conditions. However, the capacity to supply a specified list of generics under such conditions is tight and the utilization of such flexibilities in their current form remains complex and unattractive. The TRIPS agreement currently constitutes a significant barrier to providing access to new antiretroviral at affordable prices in developing countries. If the debate on initiatives for increased flexibility of intellectual property rights does not become more extensive or obtain the overwhelming support of the international community, serious consequences are to be expected in terms of the fight against AIDS in most of the developing countries.

The relation of price of antiretroviral drugs and foreign assistance with coverage of HIV treatment in Africa: retrospective study

Objective To determine the association of reductions in price of antiretroviral drugs and foreign assistance for HIV with coverage of antiretroviral treatment.Design Retrospective study.Setting Africa.Participants 13 African countries, 2003-8.Main outcome...

Drug resistance, patent resistance: Indian pharmaceuticals and the impact of a new patent regime

This article highlights potential public health effects of India's Patents Act of 2005, which was implemented to conform to the requirements of the World Trade Organisation's Trade-Related Aspects of Intellectual Property Agreement (TRIPS), a new legal regime that will likely have a significant impact on access to HIV/AIDS medications in much of the world. This new patent law may play a role in keeping new antiretroviral (ARV) medications, including improved first-line medications and second-line drugs that are being developed for first-line drug resistant HIV, financially out of reach for many people living with HIV/AIDS in poor countries. India's drug industry, which had thrived under earlier patent laws that protected processes but not products in the case of medications, had brought down the price of ARV drugs in South Asia and Africa by more than 90%. While most existing drugs are grandfathered under the new patent laws, newer ARV medications may be barred from manufacture by Indian companies. This article analyses the effects of the coming together of this new legal regime, the global political economy and emerging resistance to HIV/AIDS medications, and evaluates efforts to mitigate the negative public health effects of the new patent laws.