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PURPOSE: The purpose of this study is to consider the mechanism of the reverse drug distribution chain as a non-code provision, introducing a type of act prohibited by the provisions of article 126b of Pharmaceutical Law. The article aims to analyse this practice, changes in the legal system and its consequences from the perspective of the economic problem and of protection of the health and life of citizens., DESIGN/METHODOLOGY/APPROACH: The article focuses on the analysis of statistical data and the legal regulations in force in Poland governing the discussed phenomenon., FINDINGS: The conducted analysis of the reverse drug distribution chain phenomenon shows that there is still a lack of effective solutions to minimise the occurring illegal practice, however, given the serious consequences for society, prosecution of this proceeding is absolutely necessary., PRACTICAL IMPLICATIONS: An analysis of the phenomenon of the reverse drug distribution chain, carried out in this article, makes it possible to draw conclusions as to whether the solutions and methods used to deal with the discussed procedure are purposeful and justified. In the assessment of the collected material, it can be concluded that although the current shape of specific solutions raises doubts, the introduction of changes to the legal system in the discussed scope is necessary and, over time, will allow for an effective solution to the problem., ORIGINALITY/VALUE: The conducted analysis is an original scientific study presenting a detailed description of the phenomenon of the reverse drug distribution chain and methods for its eradication., peer-reviewed

Conventional cost-effectiveness analysis—i.e., assessing pharmaceuticals through a cost per quality-adjusted life year (QALY) framework—originated from a societal commitment to maximize population health given limited resources. This "extra-welfarist" approach has produced pricing and reimbursement systems that are not well- aligned with the unique considerations of orphan drugs. This framework has been slow to evolve along with our increased understanding of the impact of rare diseases, which in turn has complicated the assessment of orphan drugs meant to treat rare diseases. Herein, we (i) discuss the limitations of conventional cost-effectiveness analysis as applied to assessing access to, as well as the pricing and reimbursement of, orphan drugs, (ii) critically appraise alternative and supplemental approaches, and (iii) offer insights on plausible steps forward.

Aims: One tool for protecting quality use of medicines in hospitals is a drug and therapeutics committee (DTC) that oversees medicines availability. Pharmaceutical industry marketing to prescribers is associated with less appropriate prescribing and increased costs. There is little data on decision-making practices of DTCs so it is unknown whether or how they might be vulnerable to pharmaceutical industry influence. This project explores DTC decision-making with a focus on how pharmaceutical industry influence on access and use of medicines is identified and managed. Methods: We used a qualitative methodology with individual interviews of 29 participants who were current or recent members of public hospital DTCs across New South Wales, Australia. Participants included medical, pharmacy and nursing staff and 1 citizen. Committees were linked to specific hospitals or regions, and some were affiliated with paediatric, neonatal, rural or mental health services. Results: Drug committee processes for oversight of medicines in public hospitals are vulnerable to pharmaceutical industry influence at several points. Applications for formulary additions are sometimes initiated and completed by company representatives. Conflict of interest disclosures among applicants and committee members may be incomplete. In some institutions, medicines are available from pharmaceutical companies without committee review, including through free samples and industry-supported medicines access programmes. Participants noticed the presence and impact of pharmaceutical company marketing activities to local clinicians, resulting in increased prescriber demand for products. Conclusion: Improved DTC practices and review of hospital policies concerning pharmaceutical marketing activities might preserve the independence of evidence-based decision-making for safe, cost-effective prescribing.

Background Drug price transparency is defined as readily available information on the price of pharmaceutical drugs to either authorities or consumers. Price transparency, together with other information, helps define the value of drugs and enables informed decision making. It has also been used as a reference in drug price setting mechanisms in some countries’ pricing policies. Objective To investigate the evidence available: 1) on government initiatives to mandate transparency in drug pricing worldwide, 2) on the reported effects of drug pricing transparency initiatives on drug price, and 3) on the limitations and barriers of the implementation of drug pricing transparency. Methods Databases such as Medline-Ovid, Cochrane Central Register, PubMed, and Science Direct were used to search for relevant literature from inception to February 2018. A manual search of grey literature such as policy papers, governmental publications, and websites was also performed to obtain the information that was not available in the articles. Using narrative synthesis, the results were critically assessed and summarized according to its context of drug pricing approaches. Results Of the 4382 relevant articles located, 12 studies met the inclusion criteria for drug price transparency initiatives. Only 3 studies reported the outcomes on the regulation of drug prices. Two studies in South Africa showed that price transparency initiatives did not necessarily reduce drug prices. Another study in the Philippines indicated a reduction in medicines’ price based on the effects of government-mediated access prices. The limitations and barriers in price transparency initiatives include fragmentation of the healthcare system and nondisclosure of discounts and rebates by pharmaceutical companies. Conclusion Drug pricing transparency initiatives have been implemented in many countries and commonly coexist with a country's pricing policies. Nevertheless, due to sparse evidence, the effect of drug price transparency initiatives on price control is still inconclusive.

In recent years, China has paid much more attention to its pharmaceutical policy than ever, and forecasting policy on pharmaceutical patent protection has become a public concern in China. This art...

Resumen El presente artículo tiene por objetivo realizar un contraste de los elementos de la política farmacéutica en Colombia frente a las políticas de la Organización Mundial de la Salud para garantizar el derecho de acceso a los medicamentos. Se llevó a cabo análisis basado en el método inductivo a partir del marco jurídico de referencia recopilado en normatividad, doctrina y jurisprudencia vigente, para así lograr abordar este escenario desde una óptica crítica y propositiva, a manera de resultados. Así, los autores presentan al final del texto una serie de lineamientos y recomendaciones que puedan servir de guía para mejorar los indicadores de acceso a los medicamentos en Colombia. Abstract This article has a contrast of the elements of pharmaceutical policy in Colombia versus the policies of the World Health Organization to guarantee the right of access to medicines. The authors make an inductive analysis, based on the legal framework of reference compiled in current norms, doctrine and jurisprudence to present a critique and make a proposal; as a result of this exercise. At the end of the text, a series of recommendations are presented as a guide to help improve indicators of access to medicines in Colombia.

Increasing pressure on healthcare demand and delivery has resulted in the development of new roles and services for pharmacists. As current models of pharmacy practice continue to be evaluated, pharmacists must be involved in identifying new areas that may require research. In order to do so, the current vision of the future of pharmacy practice is discussed in this commentary. Issues such as adequate funding, professional competency and building strong interprofessional relationships are still identified as major barriers to change. These barriers have been grouped into the themes that form a conceptual model of the factors affecting the future of pharmacy practice, which have led to the development of key questions for the future.

Background Mandatory co-payments attached to prescription medicines on the Irish public health insurance [General Medical Services (GMS)] scheme have undergone multiple iterations since their introduction in October 2010. To date, whilst patients’ opinions on said co-payments have been evaluated, the perspectives of community pharmacists and general practitioners (GPs) have not. Objective To explore the involvement and perceptions of community pharmacists and GPs on this pharmaceutical policy change. Methods A qualitative study using purposive sampling alongside snowballing recruitment was used. Nineteen interviews were conducted in a Southern region of Ireland. Data were analysed using the Framework Approach. Results Three major themes emerged: 1) the withered tax-collecting pharmacist; 2) concerns and prescribing patterns of physicians; and 3) the co-payment system – impact and sustainability. Both community pharmacists and GPs accepted the theoretical concept of a co-payment on the GMS scheme as it prevents moral hazard. However, there were multiple references to the burden that the current method of co-payment collection places on community pharmacists in terms of direct financial loss and reductions in workplace productivity. GPs independently suggested that a co-payment system may inhibit moral hazard by GMS patients in the utilisation of GP services. It was unclear to participants what evidence is guiding the GMS co-payment fee changes. Conclusion Interviewees accepted the rationale for the co-payment system, but reform is warranted.

This opinion argues that jurisdictions should adopt a more holistic approach to pharmaceutical patents in order to increase coordination between the law and the broader objectives and priorities that should guide health and pharmaceutical policy. The opinion uses Hong Kong as an illustrative case study to demonstrate that a system which fails to set out clear policies, aims and objectives for its patent laws often ends up agreeing to TRIPS-plus standards in free trade agreements without any evidence as to the effect of the measures on wider societal interest. The opinion is therefore a call for jurisdictions to take a holistic approach to pharmaceutical patent law instead of simply looking at it from the lens of patent law and to push back against the system of “coerced conformity” which simply transplants IP maximalist measures into local law without even attempting to tailor the measures to suit the local priorities or framework. Such an approach would better place jurisdictions to effectively balance obligations, efficiency, costs and access to medicines for the populace.

Payers have increasingly implemented a variety cost-containment measures to promote sustainability in the pharmaceutical sector. This paper provides an assessment of a range of different applications of pharmaceutical budgets and assesses their impact in the context of health financing goals. A comprehensive literature review was carried out in order to identify evidence on the presence and impact of pharmaceutical budget-setting and capping mechanisms and an analytical framework was developed outlining relevant tradeoffs between macroeconomic and microeconomic efficiency. Evidence from the literature was validated by expert opinion through a round-table meeting followed by a series of semi-structured interviews. Five broad types of pharmaceutical budgets were identified as relevant : global, regional, disease-specific, product-specific, and prescribing. Fixed global budgets on total pharmaceutical expenditure are used primarily to promote cost-containment; however, their use often restricts flexibility in terms of total health budget allocation. Disease-specific budgets without consequences for exceeding the budget are unlikely to promote fiscal sustainability as these budgets are frequently exceeded. Product-specific budgets and prescribing budgets can play an important role in contributing to microeconomic efficiency; however, evidence on their impact is mixed. Overall, pharmaceutical budgets are present at both macroeconomic and microeconomic levels. While they are important tools for promoting fiscal sustainability, additional policy measures are needed to further enhance value for money in the pharmaceutical sector.

Background Substandard and Falsified (SF) medical products are a growing global concern. They harm the individual patient, the healthcare system and the economy. The World Health Organisation (WHO) has highlighted contributing factors globally: insufficient national medicine regulation, poor enforcement of existing legislation, weak stakeholder collaboration and the rise of novel viruses, such as the COVID-19. The study aimed to assess the legislative and policy framework and institutional relationships governing pharmaceuticals and anti-counterfeiting strategies. Methods The study was explorative and consisted of two phases. The first phase was between 2016 and 2017. It looked at document analysis (annual reports and press releases from 2011 to 2016) from government institutions involved in medicines regulation and law enforcement for SF seizure reports between 2004 and 2017. The second phase was between 2016 and 2018 through in-depth semi-structured interviews (seven in total) with selected stakeholders. Results First Phase—the data collected and reported by various departments was sporadic and did not always correlate for the same periods indicating, a lack of a central reporting system and stakeholder collaboration. In South Africa, counterfeiting of medicines mainly involves the smuggling of non-registered goods. The most common counterfeit items were painkillers, herbal teas, herbal ointments, while some were medical devices. Furthermore, Customs identified South Africa as a transhipment point for SF infiltration to neighbouring countries with less robust regulatory systems. Second phase—interview transcripts were analysed by thematic coding. These were identified as the adequacy of legislation, institutional capacity, enforcement and post-market surveillance, stakeholder collaboration and information sharing, and public education and awareness. Conclusion Document analysis and interviews indicate that South Africa already has a national drug policy and legislative framework consistent with international law. However, there is no specific pharmaceutical legislation addressing the counterfeiting of medicines. Law enforcement has also been complicated by poor stakeholder engagement and information sharing.

[eng] Background: Drug distribution network management is one of the most important facilities in the ministry of health. This network is faced with several issues. The present survey was done to assess the roles of health policy makers in drug distribution among pharmacies. Methods: A Judgmental sampling method was used in this study. Five managers of the Department of Drugs, Food and Narcotics of the Ministry of Health, Tehran, Iran who were determined the country’s pharmaceutical policy, were selected in this survey. Designed questionnaire was presented to all 5 health policy makers. The data were stratified and the descriptive analysis method was used to test their partial and general hypotheses. Cronbach’s alpha test was used to assess the validity of the questionnaires. Results: As the Alpha= 0.850 was obtained for questions in the presented questionnaire, they have been approved as reliable. The study hypothesis (the impact of health policymakers’ trust on drug distribution marketing strategies) was accepted because 60% of respondents believed in the effect of gaining policymakers’ trust in marketing strategy and 35% of them believed gaining the trust of policymakers has a huge impact on marketing strategy. Conclusion: Findings showed that adhering to pharmacy quotas, provincial distribution criteria for drugs, adhering to approved drug prices, and having effective and efficient management affect marketing strategies. However, to found other factors affected the health policy makers drug distribution, several studies should perform., [spa] Antecedentes: La gestión de la red de distribución de medicamentos es uno de los servicios más importantes del Ministerio de Sanidad. Esta red se enfrenta a varios problemas. La presente encuesta se realizó para evaluar el papel de los responsables de la política sanitaria en la distribución de medicamentos entre las farmacias. Métodos: En este estudio se utilizó un método de muestreo criterioso. En esta encuesta se seleccionaron cinco gerentes del Departamento de Medicamentos, Alimentos y Narcóticos del Ministerio de Salud de Teherán, Irán, que determinaban la política farmacéutica del país. El cuestionario diseñado se presentó a los cinco responsables de la política sanitaria. Los datos se estratificaron y se utilizó el método de análisis descriptivo para probar sus hipótesis parciales y generales. Se utilizó la prueba alfa de Cronbach para evaluar la validez de los cuestionarios. Resultados: Al obtenerse un Alfa= 0,850 para las preguntas del cuestionario presentado, éstas han sido aprobadas como fiables. La hipótesis del estudio (el impacto de la confianza de los políticos sanitarios en las estrategias de marketing de la distribución de medicamentos) fue aceptada porque el 60% de los encuestados creía en el efecto de ganarse la confianza de los políticos en la estrategia de marketing y el 35% de ellos creía que ganarse la confianza de los políticos tiene un gran impacto en la estrategia de marketing. Conclusión: Los resultados mostraron que el cumplimiento de las cuotas de las farmacias, los criterios de distribución provincial de los medicamentos, el cumplimiento de los precios aprobados de los medicamentos y la existencia de una gestión eficaz y eficiente afectan a las estrategias de marketing. Sin embargo, para encontrar otros factores que afecten a la distribución de medicamentos por parte de los responsables de las políticas sanitarias, habría que realizar varios estudios.

One of the most important tasks of state policy is to protect the health of citizens, effective functioning health system, improving the level and quality of life of the population, maintaining its effectiveness. One of the central components of the health care system is the country's pharmaceutical industry. In this regard, various aspects of its functioning and development are the subject of research by scientists around the world. Thus, there is a problem of forming professional staff that could meet European standards of service. The current state of the pharmaceutical industry in Ukraine is considered in the work and proved the existence of demand for pharmaceutical workers with quality education. The article analyzes the educational programs in the specialty "Pharmacy" and the corresponding vacancies. The goals and elements of the National Pharmaceutical Policy are systematized. The dynamics of the number of pharmacies in the Ukrainian market was studied. Based on the analysis of scientific and literary sources, the structure of the governing bodies of the pharmaceutical industry is formed in the article. The main problems of pharmaceutical education in Ukraine are identified. In the article the basic legislative acts in the field of pharmaceutical education are studied. The current state of training for the pharmaceutical industry and the peculiarities of such education during a pandemic are considered. The foreign experience of development of pharmaceutical education is studied. Leaders in pharmaceutical education are Germany - 16 pharmaceutical faculties; France - 24; Great Britain - 19; Spain - 15; Belgium - 10; Poland -10. Therefore, the experience of these countries was thoroughly analyzed in the work. The Shostka Professional Medical College Municipal Institution of the Sumy Regional Council was analyzed as a case. The shortcomings of pharmaceutical education were identified and ways to improve it at the national level were proposed. Based on the experience of internships in Germany (Praktikumsborsen), the article proposes to introduce a system of signing contracts with private pharmacy chains and creating an electronic resource to promote employment and find a base of practice that would unite applicants, employers and educators. The purpose of the article is to study the main trends in the development of state policy of training of specialists in the pharmaceutical industry in Ukraine. The subject of the study is the relationship that arises between the state and customers in the training of pharmaceutical personnel. The object of research is the professional training of specialists in the pharmaceutical industry in Ukraine. Research methods: method of scientific cognition, system approach, expert method and extrapolation methods.

Background: Policy-makers have proposed and implemented various cost-containment policies for drug prices and quantities to regulate rising pharmaceutical spending. Our study focused on a major change in pricing policy and several incentive schemes for curbing pharmaceutical expenditure growth during the 2010s in Korea. Methods: We constructed the longitudinal dataset from 2008-2017 for 12 904 clinics to track the prescriber behavior before and after the implemented policies. Applying an interrupted time series model, we analyzed changes in trends in overall monthly drug expenditure and antibiotic drug expenditure per prescription for outpatient claims diagnosed with three major diseases before and after the policies’ implementation. Results: Significant price reductions and incentives for more efficient drug prescriptions resulted in an immediate decrease in monthly drug expenditures in clinics. However, we found attenuated effects over the long run. The top-spending clinics showed the highest rate of increase in drug costs. Conclusion: Future policy interventions can maximize their effects by targeting high-spending providers.

Objective: Florida-mandated Prescription Drug Monitoring Program (PDMP) use and restricted Schedule II opioid dispensing for acute pain to 3-day supply in 2018. This study assessed physician perception of these policies. Design: A cross-sectional study design. Setting: Large academic medical center. Patients/participants: Physicians in inpatient and outpatient practice, as stratified by physician specialty for psychiatry or addiction medicine (Psych/AM), primary care, and others. Interventions: A survey was administered electronically from July to September 2019, with survey items adapted from published opioid policy evaluations. Main outcome measure: Assessment of physician reason for the use of PDMP and perception of PDMP clinical utility. Responses by specialty were compared via chi square testing. Results: There were N = 214 responses (response rate ~10.9 percent), representing n = 15 from Psych/AM, n = 58 primary care, and n = 143 from other specialties. The most frequently reported reason for PDMP use across specialties was to examine prescribing history for patients currently using opioid analgesics (6.7 percent Psych/AM; 50.1 percent primary care; 38.6 percent others; p = 0.027). Fewer Psych/AM physicians agreed that the policy hinders the clinical work day as compared with primary care physicians (46.7 percent vs. 58.6 percent). More primary care agreed the policy was a good idea relative to Psych/AM (62.1 percent vs. 53.3 percent). More primary care than Psych/AMs agreed that the policy made it more challenging for chronic pain patients to access opioid therapies (77.6 percent vs. 53.3 percent). Conclusions: The perceived workflow burden and unintended consequence of decreased chronic pain patient access to opioid pharmacotherapies suggest further opportunities for pharmacist–physician collaboration in managing affected patients.

Recent and increasing discussion of prescription price transparency highlights the importance of defining, measuring and communicating prescription drug value. To help advance these goals, the authors propose a taxonomy of population-level prescription drug use patterns. The taxonomy assigns prescription use to one of five categories according to likely population-level health impact. The categories include effective, potentially discretionary, potentially harmful, wasteful, and lifestyle. The authors hope the proposed taxonomy will inform discussion of prescription drug value by providing estimates of population impact, especially the balance of anticipated benefit and harm.

Introduction: In recent periods the United Arab Emirates (UAE) has strengthened economic measures in its pharmaceutical policy by promoting local manufacturing and facilitating the use of generic medicines. International examples indicate the importance of quality control elements in the implementation of cost containment policies. Multicriteria Decision Analysis (MCDA) is increasingly used in health care to facilitate health care decision based on multiple objectives. Our objective was to develop a pilot MCDA tool for repeated use to support the value-based purchasing of generic medicines in the UAE.Methods: An international evidence framework was adapted to UAE in a multistakeholder workshop organized by Dubai Health Authority. After validating the relevance of nine criteria in the local jurisdiction, participants decided the ranking and weight of each criterion by anonymous voting.Results: The top four criteria focused on quality elements starting with real-world clinical or economic outcomes (with 19.8% weight), followed by the quality assurance of manufacturing (17.3%), then evidence on the equivalence with the original product (14.8%), and drug formulation and stability (12.3%). The pharmaceutical acquisition cost criteria ranked fifth with 9.4% weight. The bottom four criteria, including reliability of drug supply, macroeconomic benefit, pharmacovigilance and added value services related to the product had similar weights in the range of 5.5–7.7%.Conclusion: Policy-makers in Dubai put high emphasis of value-based health care by incentivizing manufacturers of off-patent pharmaceuticals to generate additional scientific evidence compared to the mandatory minimum and acknowledging efforts to improve quality standards. The MCDA tool is considered suitable to improve the transparency and consistency of decision making in UAE for off-patent pharmaceuticals, and subsequently for other health technologies.

For two decades, New Zealand has been placed consistently at the foot of OECD rankings for state expenditure on pharmaceuticals. In this article, we explore New Zealand's containment of pharmaceutical spending as a ‘divergent’ case of pharmaceutical policy in a liberal democracy. To elucidate the likely institutional mechanisms and interests behind this phenomenon, we conducted a case study of New Zealand's drug reimbursement policy. In doing so, we derived sensitising concepts from major accounts of pharmaceutical policymaking (Corporate Bias Theories and Reputational Theory) and theories of the western state (Historical Institutionalism and Corporate Domination Theory). Drawing on 28 expert interviews and documentary analysis, we identified three main mechanisms of spending containment. First, New Zealand's state bureaucracy use pricing strategies that rely on a spending containment strategy coordinated by bureaucratic managers. Second, these managers shape the policy preferences of expert committees involved in scientific drug assessment. Third, on a meta-level, conditions for spending containment are enabled by the judicial-legislative arena. As such, we find support for Historical Institutionalism and Reputational Theory and more limited support for Corporate Bias Theory and Corporate Domination Theory. Our explanation posits further conceptual linkages between the macro/societal and meso-organisational theoretical levels.

Policy decisions about healthcare coverage in Canada and the United States in the 1960s placed two virtually identical systems on different evolutionary paths in the physician and hospital sectors. However, prescription drug coverage remained outside Canada’s single-payer model, and employer-based coverage continued to be the norm for the workforce population, as is the case across the broad healthcare system in the United States. As a result the current debate about pharmacare in Canada mirrors in political microcosm the larger debate on universal health insurance among American Democrats. In each case the near-term prospects for a single-payer plan appear slim.

The study aimed to explore the priorities of authorities and payers related to policy options for pharmaceutical pricing and reimbursement and to understand the rationale of their preferences. Representatives of competent authorities for pharmaceutical pricing and reimbursement and public payers of the 28 EU Member States were invited to express their preferences of 16 pharmaceutical policy measures in a web-based questionnaire. Replies of 27 respondents from 22 countries were analysed through a Multi-Criteria Decision Analysis, using an outranking method based on the ELECTRE III algorithm. Follow-up focus groups were held with 47 representatives of authorities and payers from 29 countries. Respondents to the online survey highly prioritized the policy objectives of equitable access to medicines and long-term sustainability of the health care system. They considered a transparent reimbursement process based on clear rules, pharmacoeconomic evaluations, generic substitution, value-based pricing and tendering as most appropriate policy options to achieve intended policy aims. Least preferred policy options were discounts and similar arrangements, differential pricing and external price referencing. However, the latter is a commonly used pricing policy, and discount arrangements have also been increasingly used. Participants of the focus groups highlighted limitations of external price referencing, including over-paying due to referencing to official prices instead of actually paid, confidential discounted prices. Given the lack of perceived alternatives policy-makers continue applying existing tools. At the same time, they are searching for new policy options that should be based on the principles of fairness, solidarity and transparency.

Many countries use external reference pricing to help determine drug prices. However, external reference pricing has received little attention in the US-perhaps because the US is often the first adopter of drugs. External reference pricing could be used to set prices for drugs that were already established in the market. We compared the price differentials between the US and the UK, Japan, and Ontario (Canada) for single-source brand-name drugs that had been on the market for at least three years. We found that the prices averaged 3.2-4.1 times higher in the US after rebates were considered. The price differential for individual drugs varied from 1.3 to 70.1. The longer a drug remained on the market, the greater the differential. The estimated savings to Medicare Part D of adopting the average price of drugs in the reference countries was $72.9 billion in 2018. Medicare could use external reference pricing in Part D to improve affordability for patients.

Background Health Canada supplements its in-house expertise on pharmacotherapy and pharmaceutical policy through the use of scientific/expert advisory committees and scientific/expert advisory panels. This study was undertaken to examine the interests of the members of these Health Canada advisory bodies. Methods This was an observational study of the financial and intellectual interests of members of Health Canada's scientific/expert advisory committees and panels. The following information was extracted from Health Canada websites in December 2018: member's name, name of committee/panel, direct and indirect financial interests, and intellectual interests. Information extracted about the committees and panels included the number of meetings for which a record of proceedings was available and the topics discussed at the meetings. Results Of 81 unique committee and panel members, 12 declared a direct financial interest, 56 an indirect financial interest and 65 an intellectual interest. Five of 11 committees and panels had people who declared a direct financial interest. All 11 advisory bodies had members who declared indirect financial interests (n = 62) and intellectual interests (n = 81). Six of the 11 committees and panels had a majority of members who declared a direct or indirect financial interest. In the 10 advisory body meetings for which information was available, individual products were rarely discussed but recommendations from all but 1 of the meetings could potentially have affected sales. Interpretation Only a minority of members of Health Canada's advisory committees and panels declared direct financial interests but the majority of members of a majority of the advisory bodies declared indirect financial and intellectual interests. Because of the lack of individual voting records it was not possible to determine if financial or intellectual interests influenced voting patterns.

Background Countries with similar health systems but different medicines policies might result in substantial medicines usage differences and resultant outcomes. The literature is sparse in this area. Objective To review pharmaceutical policy research in New Zealand and Australia and discuss differences between the two countries and the impact these differences may have on subsequent medicine access. Methods A review of the literature (2008–2016) was performed to identify relevant, peer-reviewed articles. Systematic searches were conducted across the six databases MEDLINE, PubMed, Science Direct, Springer Links, Scopus and Google Scholar. A further search of journals of high relevance was also conducted. Using content analysis, a narrative synthesis of pharmaceutical policy research influencing access to medicines in Australia and New Zealand was conducted. The results were critically assessed in the context of policy material available via grey literature from the respective countries. Results Key elements regarding pharmaceutical policy were identified from the 35 research papers identified for this review. Through a content analysis, three broad categories of pharmaceutical policy were found, which potentially could influence patient access to medicines in each country; the national health system, pricing and reimbursement. Within these three categories, 9 subcategories were identified: national health policy, pharmacy system, marketing authorization and regulation, prescription to non-prescription medicine switch, orphan drug policies, generic medicine substitution, national pharmaceutical schedule and health technology assessment, patient co-payment and managed entry agreements. Conclusions This review systematically evaluated the current literature and identified key areas of difference in policy between Australia and NZ. Australia appears to cover and reimburse a greater number of medicines, while New Zealand achieves much lower prices for medicines than their Australian counterparts and has been more successful in controlling national pharmaceutical expenditure. Delays in patient access to new therapies in New Zealand have considerable implications for overall patient access to medicines; however, higher patient co-payments and relative pharmaceutical expenditure in Australia and its effect upon patient access to medicines must also be considered.

This study systematically compares HTA recommendations on a number of disease-modifying therapies for patients with Relapsing-Remitting Multiple Sclerosis. We analysed publicly available HTA reports for nine medicine-indication pairs across seven OECD countries using a methodological framework enabling systematic analysis of HTA recommendations. The analysis was conducted based on a number of value dimensions, including clinical and economic variables, as well as several other dimensions of value beyond cost-effectiveness. The material was qualitatively and quantitatively coded following the different stages of HTA decision-making process. Fifty-seven medicine-indication pairs were assessed across the study countries. Of those, eight medicine indication-pairs reported diverging HTA recommendations. Although HTA recommendations were based on the same evidence submitted in most cases, significant variations were identified in interpretation and acceptance of evidence resulting in different uncertainties raised and different ways of addressing them. Uncertainties arose both in terms of the clinical and the economic evidence, including the design of key trials or the data quality in economic models. Beyond costs and effects, additional dimensions of value had an impact in the direction of recommendations, however with different magnitude across countries. We show that there is heterogeneity across countries in HTA for evaluating DMTs for RRMS with a lack of standardised methods in evaluating clinical and economic evidence and the use of social value judgments to inform decision-making.

Background Expanding access to naloxone is crucial for mitigating the public health epidemic of opioid overdose deaths in America. Pharmacists now have greater independent authority to dispense naloxone to the public due to a wave of enhanced pharmacy naloxone access laws. It is unknown to what extent pharmacists are required to receive specialized training to serve in this capacity. Objectives The goal of this study was to review naloxone training mandates from states with enhanced pharmacy naloxone access laws. Methods Structured internet searches were completed using publicly available legislative, regulatory, and administrative records to identify the type of enhanced pharmacy naloxone access law and the presence and characteristics of a pharmacist naloxone training mandate in each state. Results As of November 22, 2017, all 50 states have implemented an enhanced pharmacy naloxone access law. Only 19 states mandated targeted naloxone education before pharmacists engaged in independent naloxone dispensing/prescribing activities. Conclusions A lack of standardized naloxone training requirements for naloxone-dispensing pharmacists may affect the rate of adoption of enhanced pharmacy naloxone dispensing practices at community pharmacies and suboptimal education of patients at risk of opioid overdose. Ensuring pharmacists' preparedness to serve as naloxone providers is necessary to meaningfully prevent opioid overdose deaths in their communities.

Background Drug shortage is a significant public health problem, especially for drugs related to life threatening conditions. Almost all countries affected by variety of supply problems and spent a considerable amount of time and resources responding to shortage. The aim of present study is to determine and prioritize strategies to achieve best solutions for these considerable healthcare system challenges and to evaluate this strategies base on practical criteria. Methods To achieve the study objectives, the research was conducted in two phases. Determining of the strategies to control drug shortage, and comprehensive assessments of priority of possible strategies. For each phase, a self-design questionnaire was developed. The five main managerial strategies dimensions including: regulatory, financial, supply chain, information system and policy-making were set out. Forty-five alternatives were elicited from literature, and were evaluated and trimmed to 37 strategies based on experts’ opinion. The Multiple criteria decision-making (MCDM) methods were applied in second phase. Five important criteria including cost, time, labor, compliance with law and culture were weighed by Analytic Hierarchy Process (AHP) technique. Then, 37 alternatives have been rated base on the five criteria on the Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) technique. Results “Creating integrated Supply chain information system to manage medicines inventory in the country”, “Creating and using the databases to predict the shortage of medicines”, “Using track and trace system” are alternatives 20th, 24th and 25th, which related to supply chain (SC) and information system (IS) dimensions have higher priority in the experts’ point of view. The results show IS dimension has 100 percentage of priority; following that policy and supply chain have higher priority, respectively. Conclusion Health systems rely on consistent supplying of pharmaceuticals to support patient care. The results show that information system, policy-making and supply chain are in the top-ranking priorities. Warning system needs to be improved to the advance system via better collaboration with stakeholders, publish precise and explicit national guidelines for drug shortage management, enforce the guidelines, and improve Iran FDA’s pharmaceutical market control capability.

Insufficient access to quality, safe, efficacious and affordable medical products in Africa has posed a significant challenge to public health for decades. In part, this is attributed to weak or absent policies and regulatory systems, a lack of competent regulatory professionals in National Medicines Regulatory Authorities (NMRAs) and ineffective regional collaborations among NMRAs. In response to national regulatory challenges in Africa, a number of regional harmonisation efforts were introduced through the African Medicines Regulatory Harmonisation (AMRH) initiative to, among others, expedite market authorisation of medical products and to facilitate the alignment of national legislative frameworks with the AU Model Law on Medical Products Regulation. The goals of the model law include to increase collaboration across countries and to facilitate the overall regional harmonisation process. The AMRH initiative is proposed to serve as the foundation for the establishment of the African Medicines Agency (AMA). The AMA will, as one of its mandates, coordinate the regional harmonisation systems that are enabled by AU Model Law domestication and implementation. In this paper, we review the key entities involved in regional and continental harmonisation of medicines regulation, the milestones achieved in establishing the AMA as well as the implementation targets and anticipated challenges related to the AU Model Law domestication and the AMA’s establishment. This review shows that implementation targets for the AU Model Law have not been fully met, and the AMA treaty has not been ratified by the minimum required number of countries for its establishment. In spite of the challenges, the AU Model Law and the AMA hold promise to address gaps and inconsistencies in national regulatory legislation as well as to ensure effective medicines regulation by galvanising technical support, regulatory expertise and resources at a continental level. Furthermore, this review provides recommendations for future research.

The decentralization of the Brazilian health system required that municipalities took responsibility for the local Pharmaceutical Policy and Services (PPS) system. This article presents and analyses an innovative experience of diagnosis of municipal PPS as a sociotechnical system. We adopted a multi-methods approach and various data sources. Sociotechnical theory was the framework of the methodology of evaluation and design of systems, analyzing the External System (health system, stakeholders, financing) and Internal System (goals, management, workforce, infrastructure, processes, technology and culture). The “objective” component of the PPS system was identified as the central element. The lack of a unified objective and of a central coordination and unmanaged pharmaceutical services prevented integrated internal planning and planning with other sectors. Stakeholders and documents referred only to technical elements of the system: Infrastructure, technical process, and technology. The social components of the workforce and culture were not mentioned. The organizational culture established was the culture of isolation: “Each one does his own”. The pharmacists working in the municipal health system did not know each other. There was no integration strategy between pharmacists and their work processes. Consequently, the municipal PPS had limited scope as a public policy. It had constrained the characteristics of PPS as a complex and open system. Understanding the municipal PPS as a sociotechnical system can push the development of a new level of policy and practice to ensure the population’s right to the access to and rational use of medicines.

In December 2020 a former NATO commander in Iraq appointed to lead vaccination logistics in the Public Health Agency of Canada announced that the country would adopt a “whole-of-nation” approach to achieve the goal of vaccinating all Canadians by the summer. Two months away from the summer, four into the announcement, and with 400 million doses procured to vaccinate 38 million people several times over, less than 3% of Canadians have received two doses of the leading, authorized products. A range of explanations have been proffered for the delay, including that the Liberal Trudeau Government is treating Big Pharma unfairly, thus causing unnecessary barriers to vaccine supplies. We argue that the assertion does not stand up to scrutiny. As our analysis will show, Canadian pharmaceutical policy is extremely corporate friendly and has been so for decades. This has led to both a predictably rocky vaccine effort and to the continuing failure by the government to guarantee equitable access to medically necessary drugs, prior to, during, and beyond the COVID-19 pandemic.

This chapter discusses the Indian pharmaceutical industry within the broader world scenario, the technical, legal and economic infrastructure, the quality of drug manufacturing, and quality testing laboratories. It provides a detailed analysis of the Draft Pharmaceutical Policy 2017, the National Essential List of Medicines, the necessity for rational formulations, deterrents to profiteering, and making low-cost generic drugs for all. It also discusses regulation of drug prices, the Western position, effects of cost reductions undertaken by the Central government, and concerns surrounding the growth of the industry. In addition, the chapter examines the issues of the thousands of ‘me-too’ and combination drugs, their registration, sanction and authenticity, banned drugs, and the loan licensing system. Abolishing the last is recommended. It analyzes the historical understanding of sensitive patent issues, interpreting the earlier and modified patent law, process and product patents. Newer technologies such as quality by design and blockchain technology for better-quality drugs and research are discussed, along with issues of pollution control and environmental protection in the pharmaceutical industry.

Aim: The objectives of our study were to establish the extent to which medical professionals are willing to upgrade their skills, to find out whether they have to resort often in their daily work to the support of colleagues in matters related to pharmaceutical policy, and to find out if they attend any forms of continuing education and whether such forms are available at their workplaces. The study also aimed to establish what web-based forms of continuous education the graduated medical professionals in Bulgaria, Croatia, and Slovenia know and consider to be up-to-date and adequate to their needs for specialised training programmes which ensure that their knowledge will be adequate to the constantly evolving environment in the area of pharmaceutical policy and pharmaceutical regulation. Materials and methods: A survey was carried out among a representative sample drawn from three Balkan countries: Bulgaria, Croatia, and Slovenia. The survey was based on voluntary participation and relied on the ‘snowballing’ technique in order to recruit respondents and disseminate questionnaires. Results: The results from the study demonstrate that the respondents are willing to, and are aware that they should, join forms of continuing education in the area of pharmaceutical policy since some of them encounter certain challenges related to the level of their knowledge in this domain, and that the deployment of specialised online programmes and other activities (such as workshops, conferences, etc.) for professional qualification of employees will certainly contribute to the enhancement of their qualification and to the improvement of the health services provided to citizens. Conclusions: To keep in pace with modern trends in the area of postgraduate education, the medical universities which are most trusted by the respondents from the three countries included in survey as well as the career development services providers which offer postgraduate training courses should focus on the development and implementation of innovative forms of web-based postgraduate/upskilling education in the area of pharmaceutical policy to ensure that more potential learners can join and update their understanding of this dynamic and rapidly evolving area of scientific knowledge.

Objectives To describe the main features of a pharmaceutical market in which the duration of guaranteed monopoly periods would correspond to a new pharmaceutical product’s value. Methods After reviewing patent and regulatory exclusivity-based mechanisms for protecting prescription drug markets from competition to incentivize drug innovation in developed countries, we model market protection mechanisms within the current framework to give the longest-lasting market protections to drug developers that bring the most affordable products to market with highest public health and clinical value. Results An approach tying pharmaceutical market exclusivity to value would have 3 main features. First, it would be based on regulatory exclusivity (ie, the drug regulator refrains from authorizing generic entry for a certain amount of time), rather than patents. Second, the duration of exclusivity period would be pegged to the magnitude of a product’s anticipated health impact and its proposed price by using modified methods from the field of health technology assessment. Third, the duration of the value-based exclusivity period would be reassessed routinely 3 years after the product’s launch to account for its real-world effectiveness. Conclusions Linking a drug’s proposed price to the duration of its regulatory-based exclusivities would both incentivize the development of high impact, low-cost products and motivate drug developers to introduce these products at lower prices.

Highlights • 20% of state Medicaid programs operate monthly prescription fill limit policies • Prescription fill limits may pose barriers to Medicaid-covered naloxone fills • Naloxone exemptions may improve naloxone access and prevent opioid overdose deaths, Background Expanding access to and utilization of naloxone is a vitally important harm reduction strategy for preventing opioid overdose deaths, particularly in vulnerable populations like Medicaid beneficiaries. The objective of this study was to characterize the landscape of monthly prescription fill limit policies in Medicaid programs and their potential implications for expanding naloxone use for opioid overdose harm reduction. Methods A cross-sectional, multi-modal online and telephonic data collection strategy was used to identify and describe the presence and characteristics of monthly prescription fill limit policies across state Medicaid programs. Contextual characteristics were described regarding each state’s Medicaid enrollment, opioid prescribing rates, and overdose death rates. Data collection and analysis occurred between February and May 2020. Results Medicaid-covered naloxone fills are currently subject to monthly prescription fill limit policies in 10 state Medicaid programs, which cover 20% of the Medicaid population nationwide. Seven of these programs are located in states ranking in the top 10 highest per-capita opioid prescribing rates in the country. However, 8 of these programs are located in states with opioid overdose death rates below the national average. Conclusions Medicaid beneficiaries at high risk of opioid overdose living in states with monthly prescription fill limits may experience significant barriers to obtaining naloxone. Exempting naloxone from Medicaid prescription limit restrictions may help spur broader adoption of naloxone for opioid overdose mortality prevention, especially in states with high opioid prescribing rates. Achieving unfettered naloxone coverage in Medicaid is critical as opioid overdoses and Medicaid enrollment increase amid the COVID-19 pandemic.

Information on rare adverse effects is often limited when a medication is initially approved for marketing. Medicines regulators use safety advisories to warn health professionals and consumers about emerging harms. This study aimed to identify characteristics and advice provided in cardiac safety advisories released by regulators in Australia, Canada, the United Kingdom, and the United States. This was a retrospective study of safety advisories about cardiac‐related adverse events issued by these four international medicines regulators between 2010 and 2016. A descriptive overview was followed by a more detailed content analysis, focusing on recommended actions for health professionals, including monitoring advice. For the latter, we applied the systematic information for monitoring (SIM) scale to assess adequacy. Over this period, 164 safety advisories about cardiac harms were issued by the four regulators. There were 61 drugs with advisories of cardiac risk, only 9 (14.7%) of which had advisories from all regulators in countries where the drug was approved. The most common adverse events were cardiac arrhythmias (n = 97, 59.1%) and coronary artery disorders (n = 39, 23.8%). The most frequent advice to prescribers was to monitor patients (n = 74, 45.1%), although only 41.2% of these advisories provided detailed advice on how monitoring should occur. We found many differences in the decision to warn and the advice provided. Patient monitoring was most often recommended, but key information such as frequency or thresholds for action was often lacking. Healthcare professionals and consumers need consistent information about rare serious harms so that they can make informed decisions., Between 2010 and 2016, there were few cases where all four regulators issued advisories about the same drug. The most frequent advice for health professionals was to monitor for adverse effects, though often this advice was too limited to provide useful clinical guidance. The decision about whether to warn about a potential new harm may have an impact on patient care and safety.

Introduction The pipeline of new antibacterials remains limited. Reasons include low research investments, limited commercial prospects, and scientific challenges. To complement existing initiatives such as research grants, governments are exploring policy options for providing new market incentives to drug developers. Materials and methods Reimbursement interventions for antibacterials in France, Germany, Sweden, US, and UK were reviewed and analysed by the authors. Results In France, Germany, and the US, implemented interventions centre on providing exceptions in cost-containment mechanisms to allow higher prices for certain antibacterials. In the US, also, certain antibacterials are granted additional years of protection from generic competition (exclusivity) and faster regulatory review. The UK is piloting a model that will negotiate contracts with manufacturers to pay a fixed annual fee for ongoing supply of as many units as needed. Sweden is piloting a model that will offer manufacturers of selected antibacterials contracts that would guarantee a minimum annual revenue. A similar model of guaranteed minimal annual revenues is under consideration in the US (PASTEUR Act). Conclusions The UK and Sweden are piloting entirely novel procurement and reimbursement models. Existing interventions in the US, France, and Germany represent important, but relatively minor interventions. More countries should explore the use of novel models and international coordination will be important for ‘pull’ incentives to be effective. If adopted, the PASTEUR legislation in the US would constitute a significant ‘pull’ incentive.

Background: Access to medicines and its rational use are persistent global concerns. It have a major impact on the quality and sustainability of the health system and on the health outcomes. In Brazil, access to medicines is a legal right and municipal government have the duty to ensure access and the best use of medicines in primary health care public facilities, stablishing the local Pharmaceutical Policy and Services (PPS) system. This article presents and analyses an innovative experience of diagnosis of municipal PPS as a sociotechnical system, aiming to prepare the interventions in the system.Methods:We adopted a multi-methods approach and various data sources were used. Sociotechnical theory was the framework of the methodology of evaluation and design of systems, analysing the Components of External System (health system, stakeholders, financing) and Components of the Internal System (Goals, Management, Workforce, Infrastructure, Processes, Technology and Culture).Results:The component “aim” was identified as the central element of the system. The other system components interrelate with its scope. Medicines availability was a key part of the PPS architecture. Lack of central coordination, pharmaceutical services without central management and a fragmented organization prevented an integrated internal planning, and with other sectors. The stakeholders and documents referred only technical elements of the system: infrastructure, technical process and technology. The social components of workforce and culture were not mentioned in the Municipal Health Plan. People are essential socio-technical elements, as well the components affecting them, but they are not privileged in the system. The organizational culture established was the culture of isolation: “each one does his own”.Conclusions:The municipal PPS emphasized medicines and technical components and had limited scope as a public policy. It had constrained the characteristics of a complex and open system. Stakeholders understood PPS as a set of technical processes, without planning or integration. PPS has had a great development in Brazil in the last twenty years. A new level of development to ensure the populations right to access of treatment requires a turning point of strategy to understand municipal PPS as a sociotechnical system.

The main goal of the pharmacoeconomics is to addresses whether an additional gain from a medical intervention is worth paying extra cost based on three aspects of health outcomes: Economic, Clinical and Humanistic outcome known as ECHO Model. Bys perceptive the principles, methods, and application of pharmacoeconomics, pharmacists will be prepared to make better, more-informed decisions regarding the use of pharmaceutical products and services, that is, decisions that ultimately represent the best interests of the patient, the health care system, and society. Pharmacoeconomics can be applied to any therapeutic area like hospital pharmacy, using a variety of application strategies. As the healthcare sector is progressing day by day the need to develop Pharmacoeconomics area is must. Healthcare sector is not just a small area but it became an industry now. It has more dimensions to explore. So, main goal of this article was to explain it with in a cumulative way by mentioning two examples- where the first one is direct cost that outlays money and then is indirect cost for the productivity effect. Patients also get benefit out of Pharmacoeconomics findings. Pharmacoeconomics research should be strongly supported in a country like India where majority of health care spending is done by the patient’s themselves. Keywords: Pharmacoeconomics, ECHO Model, Pharmacist, Pharmacoeconomic evaluation, Healthcare Sector, Pharmaceutical Policy, Drug Commercialization, Cost Utility Analysis, Cost Benefit Analysis, Cost of illness Analysis, Cost Minimization Analysis.

Our objective was to compare expected and observed biosimilar and generic entry dates for a recent cohort of brand-name drugs. Therefore, we estimated expected biosimilar and generic entry dates for all 328 new drugs approved by the Food and Drug Administration (FDA) between 2000-2012, which we defined as the later of the expiration of the key patent term or statutory exclusivity (12 years for biologics, 5 years for small-molecule drugs not indicated for a rare disease, and 7 years for small-molecule drugs indicated for a rare disease (plus 6 months if a pediatric extension had been granted). For drugs with expected entry prior to 2019, we calculated the proportion with observed biosimilar or generic entry. The expected biosimilar entry dates were estimated to be a median of 12.3 years (interquartile range [IQR]: 12.0-14.0, n=60) after FDA approval. The 12-year biologic statutory exclusivity period comprised 98% of the median expected protection period. By contrast, expected generic entry was estimated to be a median of 12.2 years (IQR: 8.4-14.0, n=268), or 7.2 years after the 5-year small-molecule statutory exclusivity (59% of the total expected market protection period). By 2019, observed biosimilar entry occurred in 12% of cases (3/25) and observed generic entry in 65% (101/155). We concluded that expected US market exclusivity periods are similar for biologic and small-molecule drugs. Statutory exclusivity plays a more substantial role in market exclusivity protection for biologics. Biosimilar competition, currently lagging far behind generic competition, will likely increase as the biosimilar market becomes established.

Evaluation of pharmaceutical systems performance is an essential prerequisite for promoting evidence-based policy-making and improvement in health system performance. This study attempts to evaluate the performance of Iran pharmaceutical system based on the world health organization (WHO)′s indicators, including access, quality, and rational use of medicines. In this cross-sectional descriptive study, inspired by the instructions proposed by WHO, public and private pharmaceutical service-providers were evaluated in three dimensions and 16 indicators. Accordingly, eleven separate checklists were developed and, in terms of translation, face and content validity were certified by pharmaceutical sector’s experts. Sampling was randomly carried out in five cities. Depending on the type of indicators, retrospective or prospective approaches was determined for data collection. The data were collected from April to November 2018 and analyzed by SPSS 24. The availability of targeted key medicines in various cities as well as in public and private pharmacies was 97.5% with no significant difference. Although the medicines cost was higher in private sectors than in public ones, they were affordable in both sectors. In quality indicators, public sectors enjoyed a higher level than the private sectors did. The average number of medicines per prescription in public pharmacies was 3.2 and it was 3.4 in private ones. On average, in public sectors 33% and 32% of outpatients received antibiotics and injectable medicines, respectively. Finally, 77% of medicines were prescribed by using their generic names and 25% of prescriptions were in accordance with key medicines list. This study reveals that the availability and affordability of targeted key medicines in Iran are in good condition; however, in terms of rational use of medicines, Iran fails to meet the standard levels.

Background The speed of adoption of new drugs and frequencies of substitutions leads to changes in health care expenditures as well as patient outcomes. In this study, we aim to understand the speed of adoption of new drugs and their prescription volume in health care institutions and evaluate the impact of policy options to manage pharmaceutical expenditure. Methods We conducted a retrospective cohort study of health care institutions prescribing NOACs, including Apixaban, Dabigatran, and Rivaroxaban, to address the speed of adoption and their substitution from October 1, 2010, through December 31, 2015, using the National Health Insurance Service-National Sample Cohort. Two threshold time points, including the extension of reimbursement with the need for the letter of opinion and the withdrawal of the letter of opinion, were noted in this study. Then, we applied a survival analysis to elucidate factors that affected the speed of adoption of NOACs, and interrupted time series analysis to estimate the effect of amendments in reimbursement coverage in prescription volume. Results Among 934 health care institutions in a study population, 334 institutions (36%) had prescribed NOACs at least one time during the study period, indicating that health care institutions were conservative in adopting new drugs. However, the speed of adoption was related to the characteristics of health care institution. We also found that prescriptions of NOACs before the withdrawal of the need for the letter of opinion were marginal, and the prescription volume of NOACs was significantly increased after the withdrawal of a letter of opinion. Conclusions Health care institutions were conservative in adopting new drugs, and the speed of adoption is not closely related to an increased prescription volume in the short run. Thus, policies that are centered on managing pharmaceutical expenditure should be devised with considering the impact of introducing new drugs in the long run. A letter of opinion, which was devised to manage prescriptions of NOACs, was effective in managing pharmaceutical expenditures in health care institutions, particularly for tertiary institutions. Conversely, the withdrawal of the need for the letter of opinion should be implemented with caution.

In this paper we outline and compare pharmaceutical pricing policies for in-patent prescription pharma- ceuticals with emphasis on external reference pricing (ERP) in eleven countries across the Middle East and North Africa (MENA) region and explore possible improvements in their pricing systems. Primary and secondary evidence was used to inform our analysis. Comparative analysis of ERP systems across countries followed an analytical framework distilling ERP into twelve salient features, while ERP system performance was benchmarked against a framework of best practice principles across (a) objectives and scope, (b) administration and operations, (c) methods used, and (d) implementation. Results suggest that ERP is the dominant pricing method for in-patent pharmaceuticals. Although several good practice cases were identified, none of the eleven countries satisfy all best practice principles. ERP basket sizes vary sig- nificantly and are commonly composed using geographical proximity and low-price countries as criteria. Nine countries do not use the mean or median prices, but resort to using the lowest. Exchange rate fluc- tuations are routinely used to arrive at price reductions in local currency. Significant opportunities exist for MENA countries to develop their ERP regimes to achieve greater compliance with best practice princi- ples. Over the short-term, incremental changes could be implemented to several ERP salient features and can be achieved relatively easily, thereby enhancing the functionality and performance of national ERP systems. Countries in the region can also focus on the development of explicit value assessment systems, and minimize their dependence on ERP over the longer-term.

Globally, there is no single representative policy directing pharmacy practice, and different nations show divergences in ongoing pharmaceutical policy and practice. Pharmacy practice and policy research is very important for any nation as it helps to drive the profession forward. This is even more important in developing nations where the health systems require a degree of strengthening to allow pharmacy to operate to its maximum potential. This chapter includes an analysis of what has been studied in Pakistan with regard to pharmacy practice and policy research over the period 2014–2019. This chapter follows a systematic approach to ensure that all the appropriate literature is included. Likewise, the analytic process followed an accepted approach and generated seven interesting domains of study that have occurred over a five-year period. These domains include drug utilization patterns and irrational practices, pharmacovigilance (PV) and adverse drug reaction reporting, community pharmacy practices, emerging role of pharmacists, access to medicines, the concept of generic medicines and practice-based research.

The following is a list of editorials that have been published over the past dozen years or so that we have been working together. But it’s more than that, more than a list of front-end articles for a fledgling journal (Southern Med Review) and its contemporary, the Journal of Pharmaceutical Policy and Practice. As readers we often flick through a range of journals and read interesting editorials and viewpoints. It is not often we will sit down and read the editorials from one journal source and ponder the issues that have developed over time. This body of work together reflects a degree of forward thinking about some of the key issues that are presented to us as researchers and practitioners in the pharmaceutical policy and pharmacy practice space. It is good practice as researchers to look backwards as well as forwards! Has much changed, are these issues still there or have some of them been addressed and are resolved?

Patient access to safe and cost-effective treatment is an important goal for the healthcare system. The development of biosimilar compounds and generic medicines is interesting to the industry and society to reduce healthcare costs, fulfill the needs of healthcare stakeholders and potentially increase accessibility to patients. Patient and physician acceptance, with many patients preferring biologics and branded products and physicians prescribing the same, limits the use of generic medicine and biosimilars. The growth of these products in part depends on various stakeholders' decisions to provide, pay for or use these products in a safe and thoughtful manner. Ongoing stakeholder collaboration, educational activities and review of current government and payer policies are required to optimize the uptake of generic medicines and biosimilars. Scopus

Global pharmaceutical policy encompasses various aspects, including access to medication. Access has been referred to as being deeply influenced by pricing, financing, reliable systems and rational selection, aspects detailed in other chapters of this book. In all of these areas however, the role of public participation is essential, which we detail in the current chapter, by providing the general context, discussing their role in research, in regulatory agencies and in health technology assessment. We finalize by providing specific examples of public participation, using case studies from HIV, cancer and rare diseases, all of which support the essential role of citizens in modelling access to medication.

This chapter explores the implications of trade agreements for the provision of health services and access to medicines and other health technologies. It first examines the potential effects of the General Agreement on Trade in Services and subsequent bilateral and regional trade agreements on the provision of universal health care and the ‘brain drain’ of health workers from low-income countries. Next, the intellectual property rights (IPRs) provided for pharmaceuticals by the Agreement on Trade-Related Aspects of Intellectual Property Rights are described, and the way in which these IPRs have been expanded and extended through subsequent bilateral and regional trade agreements elaborated. This chapter also considers other mechanisms through which trade agreements can affect access to health technologies including rules applying to marketing approval processes, pricing and reimbursement and pharmaceutical advertising.

Photograph of an anti-drug poster from the Qinghai Government.