Willingness to pay brand premiums for generic medicines in Kenya: A bidding game experiment.

BACKGROUND: Recent growth in the market share of higher priced branded generic medicines in low- and middle-income countries (LMICs) has raised concerns around affordability and access. We examined consumer willingness to pay (WTP) for branded versus unbranded generic non-communicable disease (NCD) medicines in Kenya. METHODS: We randomly assigned NCD patients to receive a hypothetical offer for either a Novartis Access-branded medicine or for an unbranded generic equivalent. We then analysed WTP data captured using a bidding game methodology. RESULTS: We found that WTP for Novartis Access medicines was on average 23% higher than for unbranded generic equivalents (p = 0.009). The WTP brand premium was driven almost entirely by wealthier patients. CONCLUSIONS: Our findings suggest that the dominance of branded generics in LMICs like Kenya reflect in part consumer preferences for these medicines. Governments and other health sector actors may be justified in intervening to improve access to these medicines and equivalent non-branded generics, particularly for the poorest patients who appear to have no preference for branded medicines.

Coping with access barriers to non-communicable disease medicines: qualitative patient interviews in eight counties in Kenya.

BACKGROUND: There is rich literature on barriers to medicines access for the treatment of non-communicable diseases (NCDs) in high-income countries. Less is known about low- and middle-income countries, in particular the differences in coping with medicines access barrier by household wealth and disease. The aim of this study was to compare the coping mechanisms of patients with the lack of availability and affordability of cardio-vascular diseases, diabetes and asthma medicines in Kenya. METHODS: This qualitative study was part of a larger mixed methods evaluation study conducted in eight counties of Kenya from 2016 to 2019. Forty-nine patient interviews at study end line explored their NCD journey, perceptions of availability, stockouts and affordability of NCD medicines, their enrollment in health insurance, and their relationship with the private chemists. Transcribed interviews were coded using Nvivo software. A two-step thematic approach was used, first conducting a priority coding which was followed by coding emerging and divergent themes. RESULTS: Overall, we found that patients across all disease types and wealth level faced frequent medicine stock-outs at health facilities. In the absence of NCD medicines at health facilities, patients coped by purchasing medicines from local chemists, switching health facilities, requesting a different prescription, admitting oneself to an inpatient facility, establishing connections with local staff to receive notifications of medicine stock, stocking up on medicines, utilizing social capital to retrieve medicines from larger cities and obtaining funds from a network of friends and family. Categorizing by disease revealed patterns in coping choices that were based on the course of the disease, severity of the symptoms and the direct and indirect costs incurred as a result of stockouts of NCD medicines. Categorizing by wealth highlight differences in households' capacity to cope with the unavailability and unaffordability of NCD medicines. CONCLUSIONS: The type of coping strategies to access barriers differ by NCD and wealth group. Although Kenya has made important strides to address NCD medicines access challenges, prioritizing enrollment of low wealth households in county health insurance programs and ensuring continuous availability of essential NCD medicines at public health facilities close to the patient homes could improve access.

Access to medicines for asthma, diabetes and hypertension in eight counties of Kenya.

OBJECTIVE: To assess access to noncommunicable diseases (NCD) medicines in Kenya for patients diagnosed and prescribed treatment for asthma, diabetes and hypertension. METHODS: Households in eight purposively chosen counties were randomly selected. To be eligible, a household needed to have at least one member aged 18 years or older who had been previously diagnosed and prescribed medicines for one of the following NCDs: asthma, diabetes or hypertension. Using a logistic regression model, we explored the relationship between patient characteristics and the probability that patients had the medicines available at the time of the survey visit. RESULTS: A total of 627 individuals were included in the analysis. The highest percentage of medicines availability was in households with diabetes patients (83.1%), followed by hypertension (77.1%) patients. The lowest availability of medicines was found in households with asthma patients (53.1%). The median household expenditure on medicines per month was US$7.00 for households with diabetes patients; it was US$4.00 for asthma. In general, strong predictors of having medicines at home was being older, having some education compared to no education, few household members, wealth, being diagnosed at private nonprofit facilities and having only one patient with NCDs in the household. CONCLUSIONS: Our study found that nearly three-quarters of patients diagnosed and prescribed a medicine for hypertension, asthma or diabetes had the medicine available at home. Access challenges remain, in particular for patients from low-income households and for those diagnosed with asthma.

Access to Medications for Cardiovascular Diseases in Low- and Middle-Income Countries.

Cardiovascular diseases (CVD) represent the highest burden of disease globally. Medicines are a critical intervention used to prevent and treat CVD. This review describes access to medication for CVD from a health system perspective and strategies that have been used to promote access, including providing medicines at lower cost, improving medication supply, ensuring medicine quality, promoting appropriate use, and managing intellectual property issues. Using key evidence in published and gray literature and systematic reviews, we summarize advances in access to cardiovascular medicines using the 5 health system dimensions of access: availability, affordability, accessibility, acceptability, and quality of medicines. There are multiple barriers to access of CVD medicines, particularly in low- and middle-income countries. Low availability of CVD medicines has been reported in public and private healthcare facilities. When patients lack insurance and pay out of pocket to purchase medicines, medicines can be unaffordable. Accessibility and acceptability are low for medicines used in secondary prevention; increasing use is positively related to country income. Fixed-dose combinations have shown a positive effect on adherence and intermediate outcome measures such as blood pressure and cholesterol. We have a new opportunity to improve access to CVD medicines by using strategies such as efficient procurement of low-cost, quality-assured generic medicines, development of fixed-dose combination medicines, and promotion of adherence through insurance schemes that waive copayment for long-term medications. Monitoring progress at all levels, institutional, regional, national, and international, is vital to identifying gaps in access and implementing adequate policies.

Analyzing implementation dynamics using theory-driven evaluation principles: lessons learnt from a South African centralized chronic dispensing model.

BACKGROUND: Centralized dispensing of essential medicines is one of South Africa's strategies to address the shortage of pharmacists, reduce patients' waiting times and reduce over-crowding at public sector healthcare facilities. This article reports findings of an evaluation of the Chronic Dispensing Unit (CDU) in one province. The objectives of this process evaluation were to: (1) compare what was planned versus the actual implementation and (2) establish the causal elements and contextual factors influencing implementation. METHODS: This qualitative study employed key informant interviews with the intervention's implementers (clinicians, managers and the service provider) [N = 40], and a review of policy and program documents. Data were thematically analyzed by identifying the main influences shaping the implementation process. Theory-driven evaluation principles were applied as a theoretical framework to explain implementation dynamics. RESULTS: The overall participants' response about the CDU was positive and the majority of informants concurred that the establishment of the CDU to dispense large volumes of medicines is a beneficial strategy to address healthcare barriers because mechanical functions are automated and distribution of medicines much quicker. However, implementation was influenced by the context and discrepancies between planned activities and actual implementation were noted. Procurement inefficiencies at central level caused medicine stock-outs and affected CDU activities. At the frontline, actors were aware of the CDU's implementation guidelines regarding patient selection, prescription validity and management of non-collected medicines but these were adapted to accommodate practical realities and to meet performance targets attached to the intervention. Implementation success was a result of a combination of 'hardware' (e.g. training, policies, implementation support and appropriate infrastructure) and 'software' (e.g. ownership, cooperation between healthcare practitioners and trust) factors. CONCLUSION: This study shows that health system interventions have unpredictable paths of implementation. Discrepancies between planned and actual implementation reinforce findings in existing literature suggesting that while tools and defined operating procedures are necessary for any intervention, their successful application depends crucially on the context and environment in which implementation occurs. We anticipate that this evaluation will stimulate wider thinking about the implementation of similar models in low- and middle-income countries.

Differences in the availability of medicines for chronic and acute conditions in the public and private sectors of developing countries.

OBJECTIVE: To investigate potential differences in the availability of medicines for chronic and acute conditions in low- and middle-income countries. METHODS: Data on the availability of 30 commonly-surveyed medicines - 15 for acute and 15 for chronic conditions - were obtained from facility-based surveys conducted in 40 developing countries. Results were aggregated by World Bank country income group and World Health Organization region. FINDINGS: The availability of medicines for both acute and chronic conditions was suboptimal across countries, particularly in the public sector. Generic medicines for chronic conditions were significantly less available than generic medicines for acute conditions in both the public sector (36.0% availability versus 53.5%; P = 0.001) and the private sector (54.7% versus 66.2%; P = 0.007). Antiasthmatics, antiepileptics and antidepressants, followed by antihypertensives, were the drivers of the observed differences. An inverse association was found between country income level and the availability gap between groups of medicines, particularly in the public sector. In low- and lower-middle income countries, drugs for acute conditions were 33.9% and 12.9% more available, respectively, in the public sector than medicines for chronic conditions. Differences in availability were smaller in the private sector than in the public sector in all country income groups. CONCLUSION: Current disease patterns do not explain the significant gaps observed in the availability of medicines for chronic and acute conditions. Measures are needed to better respond to the epidemiological transition towards chronic conditions in developing countries alongside current efforts to scale up treatment for communicable diseases.

Quality and completeness of utilisation data on biological agents across European countries: tumour necrosis factor alpha inhibitors as a case study.

PURPOSE: For optimal decision making on access to and regulations around biologicals availability of national utilisation data is a prerequisite. This study characterises the main categories of critical issues in collecting available national utilisation data on tumour necrosis factor alpha (TNFalpha) inhibitors in different European countries. METHODS: Data were collected on characteristics of the nature of TNFalpha usage data and on usage of TNFalpha itself (2003-2007). Utilisation rates were expressed as defined daily doses (DDDs)/1000 inhabitants/day. Data from Denmark, Finland, Ireland, the Netherlands, Norway and Portugal were included. RESULTS: Characteristics of TNFalpha (usage settings and ways of distribution to patients) and databases (type of data collected, public availability and data sources) influenced the way data were collected and determined the type of research and policy questions that can validly be addressed. The prevailing differences in the structure of national databases are prohibitive for critical aspects of medicines utilisation studies. An increase in TNFalpha usage over time was observed in all countries and varied widely from 0.32 (Portugal) to 1.89 (Norway) DDDs/1000 inhabitants/day (2007). CONCLUSIONS: In the European countries studied data on national TNFalpha usage is not easily, if at all accessible. Intercountry collaboration and sharing of technical resources will facilitate harmonisation of data collection allowing independent, population based, health and outcomes research.

Phone-based monitoring to evaluate health policy and program implementation in Kenya.

Monitoring and evaluating policies and programs in low- and middle-income countries are often difficult because of the lack of routine data. High mobile phone ownership in these countries presents an opportunity for efficient data collection through telephone interviews. This study examined the feasibility of collecting data on medicines through telephone interviews in Kenya. Data on the availability and prices of medicines at 137 health facilities and 639 patients were collected in September 2016 via in-person interviews. Between December 2016 and December 2017, monthly telephone interviews were conducted with health facilities and patients. An unannounced in-person interview was conducted with respondents to validate the telephone interview within 24 h. A bottom-up itemization costing approach was used to estimate the costs of telephone and in-person data collection. In-depth interviews were conducted with data collectors and respondents to explore their perceptions on both modes of data collection. The level of agreement between data on medicines availability collected through phone and in-person interviews was strong at the health facility level [kappa = 0.90; confidence interval (CI) 0.88-0.92] and moderate at the household level (kappa = 0.50, CI 0.39-0.60). Price data from telephone and in-person interviews showed strong intra-class correlation at health facilities [intra-class correlation coefficient (ICC) = 0.96] and moderate intra-class correlation at households (ICC = 0.47). The cost per phone interview at health facilities and households were $19.73 and $16.86, respectively, compared to $186.20 for a baseline in-person interview. Participants considered telephone interviews to be more convenient. In countries with high cell phone penetration, telephone data collection should be considered in monitoring and evaluating public health programs especially at health facilities. Additional strategies may be needed to optimize this mode of data collection at the household level. Variations in cell phone ownership, telecommunication network and data collection costs across different settings may limit the generalizability of the findings from this study.

Availability, price and affordability of cardiovascular medicines: a comparison across 36 countries using WHO/HAI data.

BACKGROUND: The global burden of cardiovascular disease (CVD) continues to rise. Successful treatment of CVD requires adequate pharmaceutical management. The aim was to examine the availability, pricing and affordability of cardiovascular medicines in developing countries using the standardized data collected according to the World Health Organization/Health Action International methodology. METHODS: The following medicines were included: atenolol, captopril, hydrochlorothiazide, losartan and nifedipine. Data from 36 countries were analyzed. Outcome measures were percentage availability, price ratios to international reference prices and number of day's wages needed by the lowest-paid unskilled government worker to purchase one month of chronic treatment. Patient prices were adjusted for inflation and purchasing power, procurement prices only for inflation. Data were analyzed for both generic and originator brand products and the public and private sector and summarized by World Bank Income Groups. RESULTS: For all measures, there was great variability across surveys. The overall availability of cardiovascular medicines was poor (mean 26.3% in public sector, 57.3% private sector). Procurement prices were very competitive in some countries, whereas others consistently paid high prices. Patient prices were generally substantially higher than international references prices; some countries, however, performed well. Chronic treatment with anti-hypertensive medication cost more than one day's wages in many cases. In particular when monotherapy is insufficient, treatment became unaffordable. CONCLUSIONS: The results of this study emphasize the need of focusing attention and financing on making chronic disease medicines accessible, in particular in the public sector. Several policy options are suggested to reach this goal.

Measuring medicine prices in Peru: validation of key aspects of WHO/HAI survey methodology.

OBJECTIVES: To assess the possibility of bias due to the limited target list and geographic sampling of the World Health Organization (WHO)/Health Action International (HAI) Medicine Prices and Availability survey used in more than 70 rapid sample surveys since 2001. METHODS: A survey was conducted in Peru in 2005 using an expanded sample of medicine outlets, including remote areas. Comprehensive data were gathered on medicines in three therapeutic classes to assess the adequacy of WHO/HAI's target medicines list and the focus on only two product versions. WHO/HAI median retail prices were compared with average wholesale prices from global pharmaceutical sales data supplier IMS Health. RESULTS: No significant differences were found in overall availability or prices of target list medicines by retail location. The comprehensive survey of angiotensin-converting enzyme inhibitor, anti-diabetic, and anti-ulcer products revealed that some treatments not on the target list were costlier for patients and more likely to be unavailable, particularly in remote areas. WHO/HAI retail prices and IMS wholesale prices were strongly correlated for higher priced products, and weakly correlated for lower priced products (which had higher estimated retailer markups). CONCLUSIONS: The WHO/HAI survey approach strikes an appropriate balance between modest research costs and optimal information for policy. Focusing on commonly used medicines yields sufficient and valid results. Surveyors elsewhere should consider the limits of the survey data as well as any local circumstances, such as scarcity, that may call for extra field efforts.

Registration timelines of antiretroviral medicines in Ghana and Kenya.

: This study examines registration timelines of antiretroviral medicines (ARVs) in Ghana and Kenya, to assess whether prior reviews by the US Food and Drug Administration Tentative Approval or WHO prequalification (WHO/PQP) affect in-country approval timelines. Data were collected from online and national databases. Median in-country review period in Ghana was 9 months compared with 25 months in Kenya. ARVs with Tentative Approval and WHO/PQP status did not benefit from shorter in-country review periods.

Availability and prices of medicines for non-communicable diseases at health facilities and retail drug outlets in Kenya: a cross-sectional survey in eight counties.

OBJECTIVES: The objective of this study was to determine the availability and prices of medicines for non-communicable diseases (NCDs) in health facilities and private for-profit drug outlets in Kenya. DESIGN: Cross-sectional study. METHODS: All public and non-profit health facilities in eight counties (Embu, Kakamega, Kwale, Makueni, Narok, Nyeri, Samburu and West Pokot) that purchased medicines from the Mission for Essential Drugs and Supplies, a major wholesaler, were surveyed in September 2016. For each health facility, one nearby private for-profit drug outlet was also surveyed. Data on availability and price were analysed for 24 NCD and 8 acute medicine formulations. Availability was analysed separately for medicines in the national Essential Medicines List (EML) and those in the Standard Treatment Guidelines (STGs). Median price ratios were estimated using the International Medical Products Price Guide as a reference. RESULTS: 59 public and 78 non-profit facilities and 135 drug outlets were surveyed. Availability of NCD medicines was highest in private for-profit drug outlets (61.7% and 29.3% for medicines on the EML and STGs, respectively). Availability of STG medicines increased with increasing level of care of facilities: 16.1% at dispensaries to 31.7% at secondary referral facilities. The mean proportion of availability for NCD medicines listed in the STGs (0.25) was significantly lower than for acute medicines (0.61), p<0.0001. The proportion of public facilities giving medicines for free (0.47) was significantly higher than the proportion of private non-profit facilities giving medicines for free (0.09) (p<0.0001). The mean price ratio of NCD medicines was significantly higher than for acute medicines in non-profit facilities (4.1 vs 2.0, respectively; p=0.0076), and in private for-profit drug outlets (3.5 vs 1.7; p=0.0013). CONCLUSION: Patients with NCDs in Kenya appear to have limited access to medicines. Increasing access should be a focus of efforts to achieve universal health coverage.

Evaluation of pharmaceutical industry-led access programmes: a standardised framework.

Pharmaceutical industry-led access programmes are increasing in number and scope worldwide. We present a new standardised framework for evaluation of these programmes that includes three components: a taxonomy of 11 access programme strategies; a series of logic models, one for each strategy and a set of measurement indicators. The logic models describe pathways of potential programme impact. Concepts relevant across a broad range of strategies were prioritised for inclusion in logic models to ensure consistency and to facilitate synthesis and learning across programmes. Each concept has at least one corresponding measurement indicator with metadata that includes the definition, details on how it should be measured and recommended data sources. The framework establishes a shared language for the collection and reporting of meaningful industry-led access programme information. Broad adoption by programme developers and implementing partners in the for-profit sector and beyond could facilitate shared learning on effective strategies and best practices.

Effect of Novartis Access on availability and price of non-communicable disease medicines in Kenya: a cluster-randomised controlled trial.

BACKGROUND: Novartis Access is a Novartis programme that offers a portfolio of non-communicable disease medicines at a wholesale price of US$1 per treatment per month in low-income and middle-income countries. We evaluated the effect of Novartis Access in Kenya, the first country to receive the programme. METHODS: We did a cluster-randomised controlled trial in eight counties in Kenya. Counties (clusters) were randomly assigned to the intervention or the control group with a covariate-constrained randomisation procedure that maximised balance on a set of demographic and health variables. In intervention counties, public and non-profit health facilities were allowed to purchase Novartis Access medicines from the Mission for Essential Drugs and Supplies (MEDS). Data were collected from all facilities served by MEDS and a sample of households in study counties. Households were eligible if they had at least one adult patient who had been diagnosed and prescribed medicines for one of the non-communicable diseases targeted by the programme: hypertension, heart failure, dyslipidaemia, type 2 diabetes, asthma, or breast cancer. Primary outcomes were availability and price of portfolio medicines at health facilities, irrespective of brand; and availability of medicines at patient households. Impacts were estimated with intention-to-treat analysis. This trial is registered with ClinicalTrials.gov (NCT02773095). FINDINGS: On March 8, 2016, we randomly assigned eight clusters to intervention (four clusters; 74 health facilities; 342 patients) or control (four clusters; 63 health facilities; 297 patients). 69 intervention and 58 control health facilities, and 306 intervention and 265 control patients were evaluated after a 15 month intervention period (last visit February 28, 2018). Novartis Access significantly increased the availability of amlodipine (adjusted odds ratio [aOR] 2·84, 95% CI 1·10 to 7·37; p=0·031) and metformin (aOR 4·78, 95% CI 1·44 to 15·86; p=0·011) at health facilities, but did not affect the availability of portfolio medicines overall (adjusted ß [aß] 0·05, 95% CI -0·01 to 0·10; p=0·096) or their price (aß 0·48, 95% CI -1·12 to 0·72; p=0·500). The programme did not affect medicine availability at patient households (aOR 0·83, 95% CI 0·44 to 1·57; p=0·569). INTERPRETATION: Novartis Access had little effect in its first year in Kenya. Access programmes operate within complex health systems and reducing the wholesale price of medicines might not always or immediately translate to improved patient access. The evidence generated by this study will inform Novartis's efforts to improve their programme going forward. The study also contributes to the public evidence base on strategies for improving access to medicines globally. FUNDING: Sandoz International (a subsidiary of Novartis International).

Equity in access to non-communicable disease medicines: a cross-sectional study in Kenya.

INTRODUCTION: Wealth-based inequity in access to medicines is an impediment to achieving universal health coverage in many low-income and middle-income countries. We explored the relationship between household wealth and access to medicines for non-communicable diseases (NCDs) in Kenya. METHODS: We administered a cross-sectional survey to a sample of patients prescribed medicines for hypertension, diabetes or asthma. Data were collected on medicines available in the home, including the location and cost of purchase. Household asset information was used to construct an indicator of wealth. We analysed the relationship between household wealth and various aspects of access, including the probability of having NCD medicines at home and price paid. RESULTS: Among 639 patients interviewed, hypertension was the most prevalent NCD (69.6%), followed by diabetes (22.2%) and asthma (20.2%). There was a positive and statistically significant association between wealth and having medicines for patients with hypertension (p=0.020) and asthma (p=0.016), but not for diabetes (p=0.160). Poorer patients lived farther from their nearest health facility (p=0.050). There was no relationship between household wealth and the probability that the nearest public or non-profit health facility had key NCD medicines in stock, though less poor patients were significantly more likely to purchase medicines at better stocked private outlets. The relationship between wealth and median price paid for metformin by patients with diabetes was strongly u-shaped, with the middle quintile paying the lowest prices and the poorest and least poor paying higher prices. Patients with asthma in the poorest wealth quintile paid more for salbutamol than those in all other quintiles. CONCLUSION: The poorest in Kenya appear to face increased barriers to accessing NCD medicines as compared with the less poor. To achieve universal health coverage, the country will need to consider pro-poor policies for improving equity in access.

Access to Antihypertensive Medicines at the Household Level: A Study From 8 Counties of Kenya.

BACKGROUND: Estimates of hypertension prevalence in Kenya range from 12.3% to 50.1% nationally. Of those diagnosed, only 1 in 5 were taking medication. OBJECTIVES: This study aims to describe the access to antihypertensive medicines at the household level in 8 counties of Kenya, including factors associated with the location of purchase. METHODS: A household survey was conducted asking individuals with a diagnosis and prescription of antihypertensive medicines about the location of diagnosis and purchase of medicines, the availability of medicines at home, and the costs of medicines per month. A logistic regression model explores the relationship between patient characteristics and the probability that patients bought medicines at a public facility. RESULTS: Of 445 individuals diagnosed and prescribed medicines for hypertension, 20.9% were also diagnosed with another noncommunicable disease, including diabetes or asthma. The majority of study subjects received their diagnosis at a public hospital (67.5%) but the most common place of medicine purchase was a retail pharmacy (33.6%). Some study subjects bought their medicines at a public hospital (21.1%). The most frequent answer for not having medicines at home was that they could not afford their medicines (50.0%). Purchase in the public sector was associated with being less wealthy, having >1 noncommunicable disease, and living in urban areas. CONCLUSIONS: Affordability remains an important barrier to hypertension treatment access in Kenya. Programs to promote access to affordable treatment need to take into account that diagnosis of disease and choice of medicines takes place largely in the public sector, whereas the private sector is the gatekeeper for purchase of medicines.

Industry-Led Access-To-Medicines Initiatives In Low- And Middle-Income Countries: Strategies And Evidence.

Global biopharmaceutical companies are increasingly establishing access-to-medicines (AtM) initiatives in low- and middle-income countries. We reviewed the initiatives of twenty-one research-based global biopharmaceutical companies to assess their strategies for improving access and the quality of evidence on the impact of their initiatives. The number of operating initiatives increased from 17 in 2000 to 102 in 2015. Of the 120 different AtM initiatives identified, 48 percent used a medicine donation strategy, and 44 percent used a price reduction strategy. While companies have frequently claimed that their initiatives have had positive impacts, we found published evaluations for only seven initiatives, and nearly all of the evaluations were of low (62 percent) or very low (32 percent) quality. It is clear that the biopharmaceutical industry has increased its commitment to improving access to medicines in low- and middle-income countries. However, companies should do more to generate high-quality evidence on their initiatives, and the global health community should do more to assist the developing of evidence about the initiatives.

National medicines policies - a review of the evolution and development processes.

OBJECTIVES: Continuous provision of appropriate medicines of assured quality, in adequate quantities, and at reasonable prices is a concern for all national governments. A national medicines policy (NMP) developed in a collaborative fashion identifies strategies needed to meet these objectives and provides a comprehensive framework to develop all components of a national pharmaceutical sector. To meet the health needs of the population, there is a general need for medicine policies based on universal principles, but nevertheless adapted to the national situation. This review aims to provide a quantitative and qualitative (describing the historical development) study of the development process and evolution of NMPs. METHODS: The number of NMPs and their current status has been obtained from the results of the assessment of WHO Level I indicators. The policy formulation process is examined in more detail with case studies from four countries: Sri Lanka, Australia, former Yugoslav Republic of Macedonia and South Africa. RESULTS: The number of NMPs worldwide has increased in the last 25 years with the highest proportional increase in the last 5-10 years in high-income countries. Higher income countries seem to have more NMP implementation plans available and have updated their NMP more recently. The four case studies show that the development of a NMP is a complex process that is country specific. In addition, it demonstrates that an appropriate political window is needed for the policy to be passed (for South Africa and the FYR Macedonia, a major political event acted as a trigger for initiating the policy development). Policy-making does not stop with the official adoption of a policy but should create mechanisms for implementation and monitoring. The NMPs of the FYR Macedonia and Australia provide indicators for monitoring. CONCLUSIONS: To date, not all countries have a NMP since political pressure by national experts or non-governmental organizations is generally needed to establish a NMP. Case studies in four countries showed that the policy process is just as important as the policy document since the process must create a mechanism by which all stakeholders are brought together and a sense of collective ownership of the final policy may be achieved.

Measuring medicine prices in Peru: validation of key aspects of WHO/HAI survey methodology / Determinación de los precios de los medicamentos en Perú: validación de aspectos fundamentales del método de encuesta de la OMS/HAI

Objectives: To assess the possibility of bias due to the limited target list and geographic sampling of the World Health Organization (WHO)/Health Action International (HAI) Medicine Prices and Availability survey used in more than 70 rapid sample surveys since 2001. Methods: A survey was conducted in Peru in 2005 using an expanded sample of medicine outlets, including remote areas. Comprehensive data were gathered on medicines in three therapeutic classes to assess the adequacy of WHO/HAI's target medicines list and the focus on only two product versions. WHO/HAI median retail prices were compared with average wholesale prices from global pharmaceutical sales data supplier IMS Health. Results: No significant differences were found in overall availability or prices of target list medicines by retail location. The comprehensive survey of angiotensin-converting enzyme inhibitor, anti-diabetic, and anti-ulcer products revealed that some treatments not on the target list were costlier for patients and more likely to be unavailable, particularly in remote areas. WHO/HAI retail prices and IMS wholesale prices were strongly correlated for higher priced products, and weakly correlated for lower priced products (which had higher estimated retailer markups). Conclusions: The WHO/HAI survey approach strikes an appropriate balance between modest research costs and optimal information for policy. Focusing on commonly used medicines yields sufficient and valid results. Surveyors elsewhere should consider the limits of the survey data as well as any local circumstances, such as scarcity, that may call for extra field efforts.

Objetivos: Evaluar la posibilidad de sesgo debido a la limitación de la lista de referencia y del muestreo geográfico de la encuesta de precios y disponibilidad de medicamentos de la Organización Mundial de la Salud/Health Action International (OMS/HAI) usada en más de 70 muestras de encuestas rápidas desde el 2001. Métodos: En el año 2005, se realizó una encuesta en Perú, con una muestra ampliada de puntos de venta de medicamento, incluso en zonas remotas. Se recogieron datos integrales acerca de los medicamentos de tres clases terapéuticas, con el fin de evaluar la idoneidad de la lista de referencia de medicamentos de la OMS/HAI y el énfasis únicamente en dos versiones del producto. Las medianas de los precios al por menor de la OMS/HAI se compararon con el promedio de precios al por mayor del proveedor de datos mundiales de ventas farmacéuticas IMS Health. Resultados: No se observó ninguna diferencia significativa en la disponibilidad general ni en los precios de los medicamentos de la lista de referencia por localización de venta al por menor. La encuesta integral de los inhibidores de la enzima convertidora de la angiotensina, los antidiabéticos y los productos antiulcerosos reveló que algunos tratamientos que no están en la lista destinataria eran más caros para los pacientes y era más probable que no estuvieran a la venta, sobre todo en las regiones remotas. Los precios al por menor de la OMS/HAI y los precios al por mayor de IMS presentaron una correlación intensa en el caso de los productos de precio más alto, y la correlación fue débil en el caso de los productos de precio más bajo (que tuvieron márgenes de beneficio calculados más altos para el minorista). Conclusiones: El método de la encuesta de la OMS/HAI logra un equilibrio adecuado entre los costos de investigación moderados y la información óptima para la política. El énfasis en los medicamentos de uso frecuente produce unos resultados válidos y suficientes. Los encuestadores de otros...