Medicine Prices Research Articles

Relationship between Prices and Quality of Essential Medicines from Different Manufacturers Collected in Cameroon, the Democratic Republic of the Congo, and Nigeria.

Achieving universal access to affordable medicines and at the same time ensuring the quality of medicines presents a challenge, especially in low- and middle-income countries. Here, the relationship between medicine prices and medicine quality was investigated in three African countries. From different types of health facilities and medicine vendors, 711 samples of 18 different essential medicines were purchased and analyzed for quality (assay and dissolution) according to the United States Pharmacopeia. Without exception, all originator brand medicines and all SRA generics (generic medicines manufactured in countries with stringent regulatory authorities [SRAs]) complied with pharmacopeial specifications. In contrast, 21.1% of the non-SRA generics (manufactured in countries without SRAs) were substandard. The median prices of originator brands and SRA generics were three times and two times higher than those of non-SRA generics, respectively. Within the non-SRA generics, no positive correlation was observed between medicine quality and medicine price. Medicines manufactured in India, China, or African countries showed similar quality and similar prices. Only a single WHO-prequalified medicine sample was found among the 711 samples. Non-SRA generic medicines produced by manufacturers for which WHO had published Public Inspection Reports showed a significantly lower rate of substandard medicines (7.3%) and, at the same time, significantly lower prices (by 33%) than other non-SRA generics. Falsified medicines (total 2.0%) were found among all categories of medicines and had prices similar to those of non-SRA generics. Our findings indicate that adequate quality assurance does not necessarily imply an increase in medicine prices.

WHO Model list of essential medicines: visions for the future.

The first version of the World Health Organization Model list of essential medicines contained 186 medicines in 1977 and has evolved to include 502 medicines in 2023. Over time, different articles criticized the methods and process for decisions; however, the list holds global relevance as a model list to over 150 national lists. Given the global use of the model list, reflecting on its future role is imperative to understand how the list should evolve and respond to the needs of Member States. In 2023, the model list Expert Committee recommended the World Health Organization (WHO) to initiate a process to revise the procedures for updating the model list and the criteria guiding decisions. Here, we offer an agenda outlining priority areas and a vision for an authoritative model list. The main areas include improving transparency and trustworthiness of the recommendations; strengthening connection to national lists; and continuing the debate on the principles that should guide the model list, in particular the role of cost and price of essential medicines. These reflections are intended to support efforts ensuring the continued impact of this policy tool.

Stakeholder perceptions of issues and possible solutions to access to oncology medicines: a case study of multi-stakeholder engagement

Aim This case study reports on a series of multi-stakeholder dialogues on challenges to access to oncology medicines in both the public and private sectors. Methods Key stakeholders, identified from various points in the pharmaceutical supply chain, were invited to attend a series of virtual discussion sessions to address specific medicines access challenges to the provision of cancer care in South Africa. For each session, a case scenario, based on a real world situation/event was presented for discussion, and viable solutions and areas requiring further research or legislative changes were identified. Topics covered in these discussions included registration pathways and obstacles; limitations of current medicine pricing policies; alternate reimbursement models; funders’ initiatives to ensure access to oncology medicines; and essential medicine selection and procurement in the public sector. Findings The key issues raised in the discussions included: non-transparency in the approval and pricing of unregistered medicines accessed in terms of section 21 of the Medicines and Related Substances Act of 1965 (as amended); commercial decisions related to the small market for oncology medicines in South Africa; inequities between public and private sector access; alternate forms of price negotiation in the private sector; the restrictions imposed by the single exit price model; and the role of co-payments for those medicines not included as prescribed minimum benefits. Conclusions There is a clear need for a forum where all stakeholders and actors in this field can engage in discussions to find solutions to the oncology medicines access conundrum, including the development of legislative amendments.

Analysis of Factors Affecting Beef Cattle Business Income (Case in Cipari Village, Cigugur District, Kuningan Regency)

The purpose of this study is to find out the factors that affect the income of beef cattle business in Cipari Village, Cigugur District, Kuningan Regency. This research was carried out at the Beef Cattle Farm Owned by Cipari Village, Kalibaru Village, Cigugur District, Kuningan Regency, West Java Province. The time of this research will be carried out in May - July 2024. The method in this study uses a quantitative descriptive method with a survey approach. The sampling technique in this study is to use saturated sampling (census). The sample in this study is all cattle breeders in Cipari Village consisting of 17 farmers with the ownership of 2 to 4 beef cattle. The Data Analysis Techniques carried out in this study include descriptive analysis quantitative, i.e. Multiple linear regression analysis. The results of the study show that (1) The number of beef cattle, the selling price of livestock, the labor cost factor, the price of beef cattle, the feed price factor, and the price of medicines, simultaneously have a significant effect on the income of the beef cattle business in Cipari Village, Cigugur District, Kuningan Regency; (2) The most influential factor on the income of the beef cattle business is the Number of Beef Cow Factor, because the number of beef cattle has the most significant influence on income.

An assessment of the implications of distribution remuneration and taxation policies on the final prices of prescription medicines: evidence from 35 countries

AbstractThis paper analyses the structure of and variability in taxation and prescription drug distribution policies and quantifies the impact of such policies on the cost of prescription drugs to health systems in 35 countries. Taxes on prescription drugs remain highly prevalent (83% of the sample) although 63% of the sample countries implement a lower than standard VAT rate. Three remuneration types of the wholesale and retail distribution chain have been identified. Wholesale and retail distributors are remunerated on a regressive mark-up basis, which is price-dependent, although fixed fees and fixed percentages, which are non-price dependent, are also highly prevalent. Price component analysis for three groups of products classed as high-, medium- and low-priced suggests that mark-ups plus taxes varied significantly across countries and products, and ranged from 5% to 187% of ex-factory prices. Average margins also vary significantly by countries and products ranging 5–65% of retail prices. The cost of distribution and taxation contributes significantly to prescription drug costs for health systems. Although distribution chain remuneration raises efficiency and overall affordability questions, these need to be considered together with the regulatory framework shaping market structure of the distribution chain, as well as any prevailing horizontal and vertical integration policies. The overall cost of prescription drugs could be reduced immediately by eliminating taxation; this could go some way to alleviate fiscal pressures on health budgets, whilst avoiding resource re-allocation from health to other sectors.

Assessment of innovativeness, and price and reimbursement negotiation of medicines: recommendations of an expert panel

This paper illustrates the recommendations of a Working Group (WG) on the assessment of drugs innovativeness and the negotiation of price and reimbursement. The WG included researchers, institutions, clinicians, patient representatives and pharmaceutical companies. The first part of the contribution summarizes the literature on drug pricing models, which was considered in the WG, and, in particular, the pricing criteria, the evaluation and negotiation processes, the management of the uncertainty of the evidence, the use of cross-reference pricing and price negotiation for new indications of existing drugs. The second part illustrates the results of the WG with a focus on innovativeness assessment, value framework and price negotiation. The main recommendations of the WG are: to define more specific criteria for the identification of comparators and endpoints for macro therapeutic areas/settings; to produce guidelines on the use of indirect comparisons and studies supporting this evidence; to consider the drug value as the main driver of price and reimbursement negotiation; to maintain flexibility in the negotiation process, but, at the same time, to give greater structure and predictability in the assessment of value for money, with a more qualified role of cost-effectiveness and a range of threshold values for the incremental cost-effectiveness ratio; to selectively reintroduce Managed Entry Agreements and the Indication-based pricing model; to implement an early dialogue between the Italian Medicine Agency and the pharmaceutical companies in order to optimize the negotiation process, and a structured involvement of scientific societies and patient representatives.

Estimating The Effects Of COVID-19 On Globalized Markets For Active Pharmaceutical Ingredients.

Global supply chains for active pharmaceutical ingredients (APIs) are highly centralized in certain countries and are susceptible to supply-chain shocks. However, there is no systematic monitoring or global coordination to manage risk and ensure equitable supply continuity during public health emergencies. In this study, we applied quasi-experimental methods on shipment-level customs data to determine how prices and export volume for APIs exported from India were affected by the COVID-19 pandemic. We found that API prices for key essential medicines not used for COVID-19 did not change significantly in the year after the World Health Organization pandemic declaration, but volume decreased by 80percent. Prices for medicines speculatively repurposed for COVID-19, such as hydroxychloroquine and ivermectin, increased by as much as 250percent compared with prices for nonrepurposed medicines, but only ivermectin saw a decrease in volume. Systematic monitoring of API markets, investments to promote supply diversification, and legal and political reforms to disincentivize price speculation could support supply-chain resilience and safeguard access to medicines.

Key Issues of Economic Evaluations for Health Technology Assessment in China: A Nationwide Expert Survey

ObjectivesHealth technology assessment (HTA) is increasingly crucial in medicine price negotiations in China, yet previous appraisals revealed national discrepancies on key economic evaluation issues: willingness-to-pay threshold, pricing models for multi-indication medicines, and comparator selection principles. This study aimed to collect expert opinions on these issues for future HTA evaluations. MethodsA nationwide anonymous web-based survey encompassing experts across academia, HTA, consultancy/contract research organization/industry, service provider, and payer. In 2023, a generic invitation containing a web link to the questionnaire was disseminated via WeChat using convenience and snowball sampling. Agreement rates for questionnaire views were analyzed using descriptive statistics. The relationship between participants’ responses and demographics was examined using appropriate logistic models. ResultsA total of 303 responses were received from experts in 34 cities. Key expert views include a suggested base willingness-to-pay threshold ranging from 0.5 to 1.5 times gross domestic product (52.1% agreement); elevated thresholds for childhood diseases, rare diseases, end-of-life diseases, and first-in-class medicines (>78.0% agreement); a single pricing model for multi-indication medicines (60.4% agreement); consideration of multiple medicines as comparators (79.9% agreement); and avoiding the use of centrally procured medicines as comparators for medicines with a time to market of less than 3 years (71.0% agreement). Participants who are service provider had lower odds of selecting higher thresholds (odds ratio 0.26; P < .01) than responders from consultancy/contract research organization/industry. ConclusionsExpert views indicate the need for substantial changes in China’s current HTA methods, highlighting the need for increased investment in HTA processes and expertise cultivation.

A conceptual framework to build effective medicine pricing policies for low and middle-income countries (LMICs)

Building effective medicine pricing policies is a challenging task in all high-, middle- and low-income countries. In high-income countries have stable health systems in place, trained workforce, as well as specialised agencies to evaluate innovative drugs for reimbursement. However, in low- and middle-income countries (LMICs) the challenges are manifold. A large majority of low- and middle-income countries lack technical expertise either to evaluate new medicines or to set efficient medicine prices. The countries also lack comparator reference pricing data to set prices. Also, there are significant out-of-pocket expenditures as people pay for medicines by themselves. An effective medicine pricing policy is vital in the context that it can be used as a tool to improve access and affordability among the masses. This discussion paper presents a conceptual framework to build effective medicine pricing policies for low and middle-income countries (LMICs). The enablers to build effective medicine pricing policies are also discussed. This includes (a) data and statistics on the pharmaceutical situation of the country (b) Having a national medicine policy in the country (c) The availability of the medicine pricing data and (d) Human resources and technical capacity. WHO has recommended several strategies including External Price Referencing (EPR), Internal Reference pricing, Value-based pricing, Cost-plus pricing, and Generic medicine policies to build a pricing policy. However, this information is generic and it's a complex task for countries to tailor to their needs, hence a critical analysis is provided on these policies. The concepts related to fair medicine pricing, providing information to consumers and price transparency are also discussed.

A proposed analytical framework for qualitative evaluation of access to medicines from a health systems perspective

ObjectiveDespite global recognition that access to medicines is shaped by various interacting processes within a health system, a suitable analytical framework for identifying barriers and facilitators from a system’s perspective was needed. We propose a framework specifically designed to find drivers to access to medicines from a country’s health system perspective. This framework could enable the systematic evaluation of access across countries, disease areas and populations and facilitate targeted policy development. This framework is the byproduct of a larger study on the barriers and facilitators to childhood oncology medicines in South Africa.ResultsEight core (pharmaceutical) functional processes were identified from existing frameworks: (I) medicine regulation, (II) public financing and pricing, (III) selection, (IV) reimbursement, (V) procurement and supply, (VI) healthcare delivery, (VII) dispensing and (VIII) use. National contextual components included policy and legislation and health information systems. To emphasize the interlinkage of processes, the proposed framework was structured as a pharmaceutical value chain. This framework focusses on national processes that are within a country’s control as opposed to global factors, and functional mechanisms versus a country’s performance or policy objectives. Further refinement and validation of the framework following application in other contexts is encouraged.

The regional aspect of Russian healthcare development (using the example of the Krasnodar territory)

The article examines the modern aspects of the development of Russian healthcare in the regional context with an analysis of the main implemented measures and sources of financing. The efficiency of the industry's functioning directly affects the life expectancy and health of citizens; therefore, the analysis of priorities and sources of their financing is an urgent area of research. Most of the projects and plans in healthcare are focused on the long term, so the main part of the subprograms does not change significantly, defining the strategy, but priorities may change in the short term, and accordingly funding will be adjusted in the context of the main sources. Taking into account the leading positions of the region, we can note its leadership in the development of the industry in question. The socio-economic situation in the country also has an impact, for example, most experts pay attention to the fact that prices for medicines and medical equipment have increased, and this creates additional difficulties during planning and forecasting. Some expenses are simply necessary and at the same time take away significant funding - paying for medical care to the insured unemployed population and providing subsidies to state budgetary healthcare institutions, reducing the possibilities of other areas. The main source of financing for most subprograms is the budget of the Krasnodar Territory, the federal budget participates to a much lesser extent. The article touches upon the factors influencing the implementation of the state program «Development of healthcare» in the region and, as a result, the main key indicators of quality of life. The conducted practical research made it possible to determine in detail the current trends in the development of the industry in the regional aspect (using the example of the Krasnodar Territory).

The impact of proposed price regulations on new patented medicine launches in Canada: a retrospective cohort study.

The Patented Medicine Prices Review Board (PMPRB), the agency that regulates the prices of patented medicines in Canada, published proposed amendments to the regulatory framework in December 2017. Because of a series of changes and delays, the revised policy has not yet been finalized. We sought to evaluate the potential early impact of the uncertainty about the PMPRB policy on patented-medicine launches. We developed a retrospective cohort of patented medicines (molecules) sold in Canada and the 13 countries that the PMPRB currently uses or has proposed to use as price comparators, from sales data from the IQVIA MIDAS database for 2012-2021. The outcome was whether a molecule was launched (i.e., sold) in a specific country within 2 years of its global first launch (2-yr launch). We compared the change of 2-year launch before (2012-2017) and after the proposed amendments were published ("uncertain period," 2018-2021) in Canada with the change in the United States and the other 12 countries as a group ("other-countries group"), using interrupted time series and logistic regressions, respectively. We further conducted analyses for each individual country and subgroups by molecule characteristics, such as therapeutic benefit, separately. We included 242 and 107 new molecules launched before publication of the proposed amendments and during the uncertain period, respectively. The corresponding 2-year launch proportions were 45.0% and 30.8% in Canada, 81.4% and 82.2% in the US, and 83.9% and 70.1% in the other-countries group. All analyses showed changes in 2-year launch during the uncertain period in the US and in the other-countries group that were similar to the changes in Canada. Greater decreases were observed in Norway and Sweden than in Canada. The 2-year launch proportion for molecules with major therapeutic benefit decreased from 45.8% to 31.3% in Canada during the uncertain period and from 87.5% to 62.5% in the other-countries group, but increased from 91.7% to 100% in the US. No negative impact of the PMPRB-policy uncertainty on molecule launches was observed when comparing Canada with price-comparator countries, except for molecules with major therapeutic benefit. The reduction in launches of medicines with major therapeutic benefit in Canada requires continuing investigation.

Genesis of People’s Medicine Centre (PMC) for popularisation of generic medicine: A critical qualitative inquiry

IntroductionThe concerns of inaccessibility to essential medicines in India are well-studied and documented. Pradhan Mantri Bhartiya Janaushadhi Priyojana (PMBJP) is one of the policy initiatives to address the inaccessibility of essential medicine. Janaushadhi Kendra (People's Medicine Centre), which is part of PMBJP is being enquired in a limited way to understand its effectiveness. The province of Odisha has been chosen as the study area for the evaluation of People's Medicine Centres. ObjectiveThe present study intends to inquire into the nature of People's Medicine Centre ownership, pharmacists' motivations and incentives to engage in business, perceived customers' trust and satisfaction, scheme beneficiaries, and challenges. MethodsA qualitative research approach has been adopted to evaluate the broader subjective accounts of the pharmacists and People's Medicine Centre. An open-ended interview guide was used. The topics of ownership, motivation, incentives, trust, satisfaction, perceived benefits, and challenges has been recorded from the participants. A total of seventeen in-depth interviews were conducted in the province of Odisha, India. ResultsThe study found that the ownership of People's Medicine Centre was of two types in the province of Odisha: public-NGO-owned People's Medicine Centres and public-private-owned People's Medicine Centres. The financial incentive provisions in the scheme attracted the private pharmacists. Pharmacists highlighted about the lower price of generic medicines compared to branded medicines, which is very popular among patients. They also pointed out that there is no difference in the efficacy of both medicines. The attitude of physicians, especially private physicians, were considered problematic for popularity and acceptance. ConclusionThe People's Medicine Centres in Odisha established themselves as trusted outlets despite physicians' unfavourable attitudes. Although the centres have not reached the required geographical coverage, economically developed regions have large number of centres, while backward regions have minimal presence. The scheme needs to be more conducive to the welfare of the masses living in remote and rural areas.

The economic impact of 14 compassionate use programs for medicines in Italy, in the perspective of the National Health Service

Background: Compassionate use programs (CUP) for medicines allow patients, not recruited in trials, accessing medicines before marketing approval. The evidence on the economic impact of CUP is limited to one paper that did not include the possible long-term economic impact of medicines used in CUP compared to alternative treatments, like avoided hospitalization costs. This paper aims at covering this information gap, updating and integrating the existing evidence, with a cost analysis in the perspective of the Italian National Health Service (SSN). Methods: Data were retrieved from the Roche CUP Database, the peer-reviewed literature (e.g. published cost-effectiveness studies, if any), the gray literature (e.g. regional documents for the alternative treatment cost) and unpublished data (e.g. cost-effectiveness analysis provided for price and reimbursement negotiation for medicines in CUP). Results: We retrieved data from 14 CUPs and 3,485 patients (70% affected by tumors) (Jan 2015-August 2022). The alternative treatment mean cost per patient ranged from € 11.1 k to € 18.8 k. The net economic benefit ranged from € 47 million to € 75 million (€ 13.5 k-€ 21.5 k per patient). Avoiding alternative treatments mostly contributes to the economic benefit. The long-term economic impact accounted for 20/30% of the net economic impact. The net economic benefit for cancer drugs ranged from € 12.6 million to € 40.0 million. Conclusions: Despite research limitations, this paper provides additional evidence on the economic impact of CUP in Italy. This could represent the first step of a broader analysis of the economic impact of early access schemes for drugs.

Time trends and regional variations in prices of anticancer medicines in China.

High prices, as a main factor, contributed to the lack of adequate access to essential anticancer medicines, especially for patients in developing countries. The Chinese Government has introduced a series of policies to control the prices of medicines during the last decade, but the effect on anticancer medicine is not yet clear. To evaluate the time trends and regional variation in the price of essential anticancer medicines in China, we used the procurement data of anticancer medicines from 2015 to 2022. We selected 29 anticancer medicines from the 2018 Chinese National Essential Medicines List. To measure the cost of a medicine, we used defined daily dose cost -the cost per defined daily doses. At national level, we focused on the price changes over time and compared the price between medicine categories. At provincial level, we assessed price variation among provinces over time. For prices at the national level, all 6 targeted medicines exhibited a continuous decrease trend in price. Out of 23 non-targeted medicines, 4 (17·39%) experienced continuous increases in prices, and 9 (39·13%) showed price decreases from 2015 to 2019 and then an upward trend during 2019-2022; Of the remaining non-targeted medicines, 7 (30·43%) had continuous price decreases and 3 (13.04%) had price increases followed by decreases. For prices at the provincial level, provincial price variation became smaller for almost all targeted medicines, except rituximab; for 11 out of 23 non-targeted medicines, provincial price variations became larger. During the study period, the proportion of price-increased medicines in each province was geographically correlated, and no significant relationship between prices and GDP per capita was observed for both targeted and non-targeted anticancer medicines. The prices and regional disparity of most targeted anticancer medicines were decreasing, while for nearly half of the non-targeted anticancer medicines, the prices were increasing and the regional disparity became wider, which may lead to compromised access to these essential anticancer medicines and raise inequity health outcome among regions.

A study on the price variability of branded medicines and Jan aushadi versions of selected commonly prescribed psychiatric medications in India using a cost-comparative approach and a passive evaluation of the Jan aushadhi scheme in India.

The cost of medications poses a significant financial burden on patients. It limits access and adherence to treatment. Psychiatric disease burden is rising and it needs treatment for long durations. The high cost of branded medicines and lack of access to medicines at affordable prices can limit adherence. A cost comparison study was done to investigate the price difference between branded and Jan aushadhi versions of 20 selected psychiatric drugs was done at the Department of Community Medicine of a Government medical college in Southern India. The average (mean) price of branded medicines of each drug was calculated with minimum, and maximum using online data, and comparison was done by calculating the percentage price difference between branded and Jan aushadhi medicines. The overall percentage price difference between branded and Jan aushadhi medicines was calculated. The overall percentage price difference between the mean price of branded medicine and Jan aushadhi medicine was + 252% for antipsychotics, indicating that the mean branded price was 252% (2.52 times) Jan aushadhi price. Similarly, the overall percentage price difference between the mean branded price and Jan aushadhi price among antidepressants was +277.54%, and the overall percentage price difference between mean branded price and Jan aushadhi was +227.73% for anticonvulsants. Similarly, price differences of maximum and minimum branded prices and Jan aushadhi were high. The study was able to estimate variation in the price of branded drugs and compare the price of branded medicines with Jan aushadhi by estimating price differences. The results of the study are useful in further reference regarding the subject for public, policy makers and healthcare providers. It gives valuable evidence into medication costs in India.

What is a fair price for a medicine? Establishing the main elements of a fair price based on the current policy debate

ObjectiveUnfair medicines prices have been discussed widely as an obstacle for patient access. This article aims to structure the discussion about fair pricing of medicines, analyses the elements for a fair price, and assesses its practical implications. MethodsA systematic literature research has been undertaken and complemented by gray literature. Definitions and elements of a fair price have been extracted from the sample, categorized via a thematic and a quantitative analysis, and mirrored against the traditional framework of ‘iustum pretium’ (fair price). ResultsThe most often attributes of a fair price mentioned were affordability (n = 30), followed by value and research and development (R&D) investment (n = 20). Other frequently mentioned attributes are profitability (n = 19), transparency of R&D costs (n = 18), cost-effectiveness (n = 17), and manufacturing (n = 14). Nearly all definitions present fair price as a balance between different objectives. ConclusionsMost publications stipulate that medicines are a common good and should be affordable. At the same time, most publications also propose a pricing approach based on covering costs for R&D and/or on value. Consequently, most of the attempts to clarify fair price result in a value-affordability dilemma, which does not necessarily warrant patient access. Many social health systems implement pricing regardless of the debate. This systematic review offers a set of attributes for fair price and helps refining the existing pricing and reimbursement regulations. Once complemented by empirical datapoints, it provides the basis for developing a framework for fair pricing.

Developing Nepal's medicines pricing policy: evidence synthesis and stakeholders' consultation.

The objectives of this paper are to (a) explore stakeholders' opinions regarding Nepal's existing medicines pricing practices/situation and (b) build and present a set of medicines pricing policies for Nepal. A review of the literature and field visits to community retail pharmacies, hospital pharmacies, wholesalers, and distributor outlets in Kathmandu were conducted to assess the medicines pricing situation. Following the literature review, preliminary meetings with stakeholders and field visits were held and a draft interview guide was prepared. Consultative sessions subsequently were undertaken in Kathmandu, Nepal, in January 2023 with representatives from the Department of Drug Administration, Ministry of Health and Population, Association of Pharmaceutical Producers of Nepal, consumer groups, Transparency International, Medicines Importers Association of Nepal/ Pharmaceutical Distributors Association of Nepal, Nepal Chemist and Druggist Association, and Nepal Pharmaceutical Association. Notes were taken during these meetings regarding issues and concerns raised as well as experiences and recommendations for the future, as outlined in the interview guide. The stakeholders in general stated that they do not have any objection to price regulation; however, they believe such regulation should be subject to periodic review. Both the importers and the Ministry of Health and Population have the view that an independent body/authority should be charged with regulating the prices of medicines. A set of policy options to be considered for use in Nepal include cost-plus pricing, external price referencing, internal reference pricing, and mark-up regulations. Key issues related to pricing were identified and suggest that a set of pricing policies and updated regulations need to be considered to establish changes that are transparent, rational, and acceptable to the related stakeholders. Hence, suggestions made in this paper could be useful to inform a rational and fair pricing structure and to improve access to medicines.

Availability, pricing, and affordability of essential medicines for pediatric population in Malawi.

Lack of access to essential medicines negatively impacts on the quality of healthcare delivery and increases morbidity and mortality, especially to the vulnerable pediatric population. We assessed the availability, pricing, and affordability of pediatric formulations in Malawi. The study was conducted in 76 health facilities (public, faith-based and private pharmacies, and clinics) from the northern and southern regions of Malawi from March to May 2023. We adapted the WHO/HAI method for the assessment of both availability and pricing of medicines. Data on availability were collected from stock card records using a WHO/HAI template and medicine prices were provided by the pharmacy personnel who were managing the facilities. Availability of medicines was calculated as the percentage of facilities which had a stock of the respective medicine at the time of data collection while medicine prices was assessed by calculating the median prices of each medicine. To assess the affordability of the medicines, we calculated the number of days it takes for a person who is receiving the government-set minimum wage to work to pay for a treatment course of common indications. The study was approved by the KUHES ethics committee under the numbers U.12/22/3900 and U.12/22/3903. The overall availability of pediatric medicines was 38.1% for public health facilities, 53.7% for private retail pharmacies and drug stores, 49.5% for private clinics and 48.3% for Christian Health Association of Malawi (CHAM) facilities. We found the illegal availability of prescription-only medicines of up to 54% in medicine stores. Medicine median prices were higher in the private clinics followed by retail pharmacies and drugs stores. CHAM had the lowest median prices for medicines of all the sectors. More than 50% of medicines were found to be affordable as less than a day's wage was required to purchase the treatment. We found poor availability of pediatric formulation among public, CHAM, and private sectors in Malawi. This may affect the quality of care among pediatric patients and therefore contribute to morbidity and mortality in Malawi. The supply of medicines and health commodities needs to consider needs of special populations such as children to achieve universal health coverage.

The impact of changing the reference countries on the list prices for patented medicines in Canada: A policy analysis

Background: Canada's Patented Medicine Prices Review Board (PMPRB) uses external and internal reference pricing (IRP) to regulate patented drug list prices. PMPRB has changed external reference countries from 7 to 11 to include countries with prices closer to the OECD median. We examined the impact on the list prices for patented medicines had the amendment been implemented from 2013.Methods: Using IQVIA MIDAS® quarterly sales data, we selected branded products that were launched in Canada in 2013–2018. The list price for each product in each country was calculated as its average annual price during the 3rd year post Canadian launch. The median international price (MIP) was the median of the list prices of PMPRB7 (MIP7) and PMPRB11 (MIP11). We assumed the same IRP would be (scenario 1) or would not be used (scenario 2).Results: Among the selected 400 products, 80.3 % (321) had MIP7 and MIP11 (launched in at least one reference country); 18.3 % did not have MIP11. The total current expenditures were $7,134.4 M. In scenario 1, MIP11 would not be binding for most products and expenditures would decline only by 0.7 %. If IRP were abolished, expenditures might decline by 14.1 % if the launching sequence would not change.Conclusions: MIP11 might not be binding for most medicines. The impact depends on whether to retain the IRP and approaches taken for medicines without MIP11.