Sustainable Health Economy Module Recap PDF

Sustainable health economy: module recap January 22, 2025 Petra Sevcikova L1: Health economy, historical and political influences on health care reform Health system’s aim: “improving health and health equity, in ways that are responsive, financially fair, and make the best, or most efficient, use of available resources” Sustainable health systems – minimizing negative impacts on the environment, … to the benefit of current and future generations Limited resources and their allocation L2: Economic perspective, perfect markets and market failure in health care Resource allocation and opportunity costs Efficiency (allocative and productive) and equity Interactions between the supply and demand sides in perfect markets lead to allocatively efficient use of resources Perfect market assumptions Market failure Monopoly Information asymmetry Externalities Public goods L3: Health care as an economic good and demand for health care Derived demand for health Demand elasticities (price, income) Social determinants of health Information asymmetry and agency relationship (principal agent problem) Supplier induced demand S2: Health information systems S3: Measuring health need Availability and quality of data “to enable decision-makers at all levels of the health system to identify problems and needs, make evidence-based decisions on health policy and allocate scarce resources optimally“ (WHO Health Information Systems. Toolkit on monitoring health system strengthening, 2008) L4: Public-private roles in health care Market structure (perfect competition, monopolistic competition, oligopoly, monopoly) Economies of scale Public and private (for-profit and not-for-profit) roles in health care L5: Private sector involvement in healthcare delivery Make or buy decision and transaction costs (of contracts ex-ante and ex-post) Contracting out and its impact on savings achieved and quality (example: long term care in the UK) L6: Health care financing and health insurance Uncertainty Financing systems: tax-based, compulsory social health insurance, private voluntary insurance, out-of-pocket payments Most countries use a mix of these financing systems Health insurance Moral hazard Adverse selection and adverse selection death spiral Cream-skimming L7: Mobilising extra resources: donor aid and innovative financing Strengthening health system funding Reducing debt Mobilising extra resources Prioritisation of health Increasing technical and allocative efficiency of spending for health L8: Externalities and public goods Externalities Positive or negative Production or consumption Selfish or caring Public goods Non-rival and non-excludable (contrast with common pool goods, club goods, private goods) Access goods needed to enjoy benefits of public goods National, regional, international, global effects -> collective action needed to finance and provide them L9: Setting priorities and defining benefit packages setting priorities Who should be involved? What criteria should be used? Economic evaluation – systematic evaluation of costs and consequences Measures of consequences – lives saved, cataract treatments provided, proportion of population vaccinated; QALYs, DALYs To maximise the benefits from healthcare spending To define essential packages of interventions L10: Prof. Hensher – Ecological health economics for a post growth world Environmental impacts and externalities Overconsumption of healthcare (high quality vs. low quality health care; necessary / beneficial and unnecessary /non-beneficial care) Planetary boundaries and Ecological economics HE for a post-growth world Minimise unnecessary demand and supply Significant redistribution and strong social safety nets Sustainable financing in the context of de-growth ? Maintaining large and complex organizational infrastructure ? L11: Pharmaceutical supply chains and emergencies Medicines shortages Regulation of the pharmaceutical sector to ensure safety, efficacy and quality Complex global supply chains affected by economics, natural disasters, social unrest, public health emergencies Efforts to strengthen local/regional production of critical medicines Economic imperatives of profit maximization and their impact on R&D priorities, production and marketisation of medicines L12: Prof. Pollock - Prioritisation of Medicines and Essential Medicine Lists Interplay between trade and public health concerns in access to medicines Marketing authorisation of medicines based on safety, efficacy, quality (NOT need) Prioritisation of medicines through essential medicine lists linked to treatment guidelines Pharmaceutical markets and market failure Irrational prescribing, over-treatment, over-consumption, under-provision of essential and necessary medicines Waste and pollution caused by over-production L13: Health workforce Supply – incentives (remuneration, working and living conditions, training and career development, …) Demand – determined by policy makers (licensing, capacity of educational institutions, …), payers of health services cost-effectiveness, productive efficiency primary vs specialist care task-shifting from physicians to other healthcare providers Short test on Wednesday Feb 5 @14:00 Examination platform – link will be provided via iLearn Zoom link provided via iLearn Join the zoom session 15 minutes before the test Have your (student) ID ready Cameras on during the test Health workforce January 15, 2025 Petra Sevcikova Module: Sustainable Health Economy DEFINITIONS human resources for health (HRH) or health workforce –"all people engaged in actions whose primary intent is to enhance positive health outcomes“ (WHO World Health Report 2006) physicians, nursing professionals, midwives, dentists, allied health professions, community health workers, and other social service and health care providers (e.g. pharmacists; direct personal care services in the home, in health care and residential settings, assisting with routine tasks of daily life) “A well-performing health workforce is one which works in ways that are responsive, fair and efficient to achieve the best health outcomes possible, given available resources and circumstances. I.e. there are sufficient numbers and mix of staff, fairly distributed, they are competent, responsive and productive.” (WHO 2007) HEALTH WORKFORCE The most important component of any healthcare system the service providers who link people to technology, information, and knowledge A set of interconnected labor markets the products of which are substitutes for or complements of one another supply / demand analysis to some degree these markets respond predictably to wage changes, ie. the quantity of services increasing and the quantity demanded decreasing when wages/salaries rise BUT supply-side factors (e.g. long educational periods for professionals) demand-side factors (e.g. market power, regulations, financial constraints) may prevent, delay, or attenuate the typical adjustment Factors affecting healthcare labour supply income and the return on educational investment; the educational system capacity, curriculum and culture; employment conditions such as working conditions and job location; entry into the profession, the demographics of the healthcare labour choice of specialization force (e.g. age, gender, race, ethnicity, choice of geographic location, marital status, family responsibilities, amount of work provided (full- or part- income, and other personal characteristics); time), migration and emigration of the workforce; retention in the profession the economic system (e.g., a recession may bring more nurses back into nursing); and the global economic and political situation, which can produce net migration of health professionals Brain drain Internal Rural -> urban areas Public HS -> private for-profit and nonprofit health institutions HS –> other economic sectors External LMICs -> HICs (to HS or other sectors) Mullan (NEJM 2005) The Metrics of the Physician Brain Drain RETENTION - physicians Age is a major consideration in retention; the higher the proportion of physicians reaching retirement age, the more future supply will be affected US (2019): 16% of physicians were aged 65–75 & 27% were aged 55–64 Europe (2023): 40% of medical doctors were 55 or older Difficult working conditions can create burnout and dissatisfaction leading them to leave the profession Erosion of professional autonomy (utilization review, drug formularies, patient demands, lack of control over practice management, and government) Lack of time to accomplish necessary tasks (time pressures and high workloads) Lack of work–life balance (long work hours and busy schedules) Malpractice (physicians living in areas experiencing a malpractice crisis tend to be less satisfied than those in areas without such a crisis) Moral distress (when system and institutional factors affect their ability to treat patients) Nonmedical responsibilities (administrative paperwork required by insurance companies and government agencies; e.g. electronic health records, have increased administrative demands and do not meet their needs) Rice et al. 2023 RETENTION - registered nurse participation in the workforce declines with RNs’ age reasons for leaving or thinking about leaving: inadequate staffing, high workload, high work pressure, high job demands, lack of time to do adequate work, lack of supervisor support, lack of respect, disempowerment and low job control, and poor relations with physicians Rice et al. 2023 Effects of healthcare workforce on access to care higher supply of primary care physicians -> a greater utilization of preventive services Geographic undersupply of physicians in areas with high needs leads to medically underserved communities, lacking access to safe, effective, timely, equitable, and patient-centered care primary care shortages US: 20% people live in rural areas where they are being cared for by only 10% of the country’s primary care providers individuals living in rural areas report an inability to access care in cases of sudden or unexpected illness or injury skipping or delaying care; seeking care in emergency departments Rice et al. 2023 Effects of health workforce on quality of care - physicians Little evidence of a positive impact from the supply of physicians overall Evidence indicates a difference between primary care and specialty care higher numbers of primary care physicians associated with better population health longer life expectancy; lower age adjusted mortality; lower mortality from heart disease, stroke, and cancer; better diabetes care; lower neonatal mortality; and lower incidence of low infant birth weight early detection of breast and cervical cancers a higher specialist physician–to–population ratio associated with lower life expectancy and higher age-adjusted mortality, higher mortality from heart disease and cancer, higher neonatal mortality, and a higher incidence of low infant birth weight Possible explanations: the importance of primary care to vulnerable populations, the adverse effects from inappropriate or unnecessary specialist care Primary care physicians see problems in their early stages, more holistic approach to care, long- term relationships with patients Specialists see patients with more advanced stages of illness, do not deal with anything other than the particular illness, and do not maintain long-term relationships with patients Rice et al. 2023 Effects of health workforce on cost of care - physicians Some evidence showing healthcare expenditures are higher in regions with more specialist physicians a higher ratio of specialists to Medicare population is related to higher surgical rates and expenditures higher-spending areas are related to higher utilization of specialists quality and outcomes of care are no better or are worse in high-spending areas In contrast, several studies show that areas with a greater number of primary care physicians tend to have lower healthcare expenditures Rice et al. 2023 Effects of health workforce on quality of care - nurses overall supply of nurses has a positive effect on population health lower premature death and teen birth rates decrease in emergency department visits and hospitalizations better patient outcomes associated with higher nurse staffing in hospitals better resident outcomes associated with higher nurse staffing in nursing homes Rice et al. 2023 Effects of health workforce on cost-effectiveness - Nurses Higher RN-to-patient ratios or higher proportions of RNs are also thought to be cost-effective because related to shorter patient lengths of stay fewer readmissions fewer adverse events Other potential source of cost-effectiveness is the contribution of higher RN staffing nurse satisfaction, i.e. possible reduction in job turnover Turnover estimated to cost roughly the equivalent of the annual salary of a nurse for each turnover Costs of turnover: prehire costs of advertising, recruiting, and hiring, and posthire costs of orientation, training, and lower new-RN productivity Rice et al. 2023 DEMAND for health workforce Sociodemographic, epidemiological, political, technological factors Decision makers: ministry of education, ministry of health, ministry of finance, insurers, ministry of labour, professional associations Labour Markets for health workforce educational requirements and professional regulation = barriers to entry local markets may have monopsonistic power wages and salary tend to be “sticky” -> short-term and longer-term imbalances Imbalances in the availability of health workforce Workforce shortages Maldistribution geographic variation in health workforce does not match healthcare needs Physician supply tends to be lower in communities composed of minorities and low-income people with greater health needs. This set of circumstances has been called the “inverse care law” Urban versus rural Specialist versus general/primary health care Inefficient use of resources Additional considerations: sustainability and resilience of health systems Frenk et al. (2010) The Lancet commission – Health professionals for a new century Source: WHO (2024) ‘World health statistics 2024: monitoring health for the SDGs, Sustainable Development Goals’ Health Workforce Information System Few countries have a comprehensive and valid information base on available health workers “The WHO Global Health Observatory reports workforce data for 186 countries, but 53% of these countries have fewer than 7 annual data points on midwives, nurses and physicians across the past 20 years. Further, of the 57 countries identified in 2006 with low human resources for health density and low service coverage, 17 countries have no data point in the past five years.” Health workforce information systems strengthening in parallel to the overall health information systems National health workforce accounts launched in November 2017 -> as of January 2022, the number of Member States with nominated focal points has risen from 0 to 166 The primary purpose of national health workforce accounts is to strengthen national and subnational policy and planning Inter-agency data exchange established in 2019 by ILO, OECD and WHO to strengthen health workforce assessment and information exchange; strengthening country capacity, partnerships and mechanisms for improved availability, analysis, dissemination and use of health workforce data A UNIVERSAL TRUTH: NO HEALTH WITHOUT A WORKFORCE (WHO 2013 Third Global Forum on Human Resources for Health) “It is not all about numbers: the goal of universal health coverage requires a paradigm shift, going beyond a discourse on shortages but rather focusing more explicitly on the accessibility, acceptability, quality and productivity of the health workforce, placing equity at the centre of the agenda. Broader factors also need to be taken into account: an evolving epidemiological profile and population structure are increasing the burden of noncommunicable diseases and long-term care on health systems, and there is increased recognition that health workers can serve as change agents in society, reorienting health systems towards primary care and action on the social determinants of health. A transformative scaling up of health education will reflect such trends in determining health workers’ competencies in the 21st century.” availability, accessibility, acceptability and quality dimensions to the health workforce availability – the sufficient supply and stock of health workers, with the relevant competencies and skill mix that correspond to the health needs of the population; accessibility – the equitable access to health workers, including in terms of travel time and transport, opening hours and corresponding workforce attendance, whether the infrastructure is disability-friendly, referral mechanisms and the direct and indirect cost of services, both formal and informal; acceptability – the characteristics and ability of the workforce to treat everyone with dignity, create trust and enable or promote demand for services; and quality – the competencies, skills, knowledge and behaviour of the health worker as assessed according to professional norms and as perceived by users Key questions What health workforce is required to ensure effective coverage of an agreed package of health care benefits? What health workforce is required to progressively expand coverage over time? How does a country produce, deploy and sustain a health workforce that is both fit for purpose and fit to practice in support of universal health coverage? INTERVENTIONS Interventions to lower the demand for health workforce and decrease inefficiencies Reduce per capita demand - a coordinated preventative approach to healthcare delivery could make care more efficient, reduce duplication of services, and lower demand for specialty care, emergency department use, and hospitalizations prevention of avoidable problems through lifestyle changes, immunization, screening, and counseling; early detection of disease; coordination of care to reduce duplicate services and waste; disease management to help patients cope with their conditions and achieve a high quality of life; and patient involvement in care and selfcare Reducing both overuse and underuse of healthcare Overuse of certain preventive services (e.g., annual blood work screens, routine imaging) and treatments with little to no efficacy and which may cause harm can lead to iatrogenic illness, requiring greater demand for healthcare workers Underuse of healthcare (particularly preventative measures to change lifestyle) and lack of proper diagnosis and care for health problems as they emerge (largely because of underinsurance or lack of insurance) can also lead to a greater demand for the healthcare workforce Improving socioeconomic status Socioeconomic hardship is a hindrance to healthy living and to accessing needed healthcare; this leads to more severe health problems and greater and more intensive use of healthcare Rice et al. 2023 EDUCATION - interventions increasing investment in education and training focus on basic workers because of the importance of primary health care and the long-time lag and high costs of postsecondary education task shifting and task sharing—a process of delegating practical tasks from scarce professionals to basic health workers Community health workers, basic and ancillary health workers efforts to develop community health workers (CHW) to strengthen the formal health sector in service delivery and health promotion E.g., bare foot doctors in China, Behvarz primary care health workers in Iran, the Lady Health Workers programme in Pakistan, Ethiopia’s health extension programme, Thailand’s village health volunteers programme, Brazil’s family health programme, Uganda’s village health teams a wide range of primary health services, e.g. provision of safe delivery and counselling on breastfeeding, management of uncomplicated childhood illnesses; preventive health education on malaria, tuberculosis, noncommunicable diseases, and HIV/AIDS, rehabilitation of people suffering from common mental health problems important bridge between communities and health services Required: adequate resources to train, supervise, monitor and evaluate; certification and embedding CHWs into health systems; ensuring the support by and integration within communities (WHO 2020, Health policy and system support to optimize community health worker programmes for HIV, TB and malaria services: an evidence guide) (Frenk et al. 2010) RETENTION - interventions Promote decent working conditions in all settings Gender specific employment conditions Remuneration and non-financial incentives Ensure occupational health and safety Manageable workload, supportive supervision and organizational management Continuing education and professional development opportunities Ensure adequate motivation to deliver quality care and build a positive relationship with patients Family and lifestyle incentives, hardship allowances, housing and education allowances and grants RETENTION – interventions (cont.) Harness information and communication technology (ICT) opportunities e-learning electronic health records Telemedicine clinical decision-making tools links among professionals and between professionals and patients, supply chain management, performance management and feedback loops Retention – findings from the literature Interventions for health workforce retention in rural and remote areas: a systematic review (Russell et al. 2021) - HICs focus higher rural retention associated with preferential selection of students who grew up in a rural area is associated with increased rural retention undertaking substantial lengths of rural training during basic university training or during post-graduate training supporting existing rural health professionals to extend their skills or upgrade their qualifications Regulatory interventions requiring return-of-service (ROS) in a rural area in exchange for visa waivers, access to professional licenses – only temporary effect rural retention was higher if ROS was in exchange for loan repayments Retention – findings from the literature (cont.) WHO annex on retention of the health workforce in rural and remote areas – this systematic review includes examples from low and middle income countries too https://iris.who.int/bitstream/handle/10665/337187/9789240013896-eng.pdf To increase the number of heath workers in rural and under-served areas - recruiting health workers from rural and under-served areas - establishing educational institutions and providing training in these areas - salary top-up for rural workers identified as the most effective incentive (Zambia) TASK SHIFTING in PHC to tackle healthcare worker shortages (Leong et al. 2021 an umbrella review) (1/3) From physician to nurses caring for patients with chronic diseases (hypertension, diabetes) initiation and monitoring of patients with HIV/AIDS on antiretroviral therapy (ART) medication prescribing using an algorithm case managers to deliver care, monitor and manage diseases based upon clinical guidelines and validated tools more complex procedures such as abortions and care of people with mental health Outcomes improved access to care and was non-inferior on measures of clinical management such as cardiometabolic disease management, asthma control, antiretroviral therapy provision and hospitalisation rates more patients returned for consultations and had more face-to-face contact time leading to higher patient satisfaction scores TASK SHIFTING in PHC to tackle healthcare worker shortages (Leong et al. 2021 an umbrella review) (2/3) From physician to pharmacists independent prescribers expanded responsibility in managing patients with chronic diseases management of minor ailments such as diarrhoea, head lice or cough Outcomes access to healthcare services was improved due to the diversification of modes of provision weak evidence to support pharmacist-led care for management of chronic diseases (e.g. diabetes and hypertension) a small improvement in HbA1c levels and blood pressure with lower rates of onward referrals to primary care doctors TASK SHIFTING in PHC to tackle healthcare worker shortages (Leong et al. 2021 an umbrella review) (3/3) From physician to other healthcare professionals midwives and community healthcare workers took on additional roles e.g. provision of abortion procedures, telephone consultation, medication prescribing and health education promotion Outcomes a viable alternative for medical and surgical abortions to reduce the number of deaths compared to unsafe abortion, especially in low-resource settings Some evidence to support task shifting in blood pressure control ! importance of education and training activities to successfully implement task shifts need to enhance healthcare workers competencies, clinical supervision and support Summary Imbalances in the availability of health workforce faced by all countries Geographical maldistribution and skill-mix not addressing health needs Brain drain Task shifting Focus on PHC and UHC, social determinants of health and shifting prevention and care to primary settings Careful tailoring of incentives to attract and retain healthcare workers References Rice et al (2023) Chapter 8 Shreffler et al. (2020) The Impact of COVID-19 on Healthcare Worker Wellness: A Scoping Review. West J Emerg Med. 2020 Sep; 21(5): 1059–1066 Leong et al. (2021) Task shifting in primary care to tackle healthcare worker shortages: An umbrella review, European Journal of General Practice, 27:1, 198-210 Resources Global Health Workforce Network Women in Global Health Health Workforce Information Reference Group (HIRG) Human Resources for Health journal HRH Knowledge Hub, University of New South Wales, Australia Center for Health Workforce Studies, University of Albany, New York Canadian Institute for Health Information: Spending and Health Workforce Public Health Foundation of India: Human Resources for Health in India National Human Resources for Health Observatory of Sudan OECD Human Resources for Health Care Study Health workforce in the COVID-19 pandemic COVID-19 impact included the risk of infection and deaths, higher levels of moral distress and burnout of healthcare workforce industrial action and strikes related to deteriorating working conditions A scoping review (37 studies) ‘revealed consistent reports of stress, anxiety, and depressive symptoms in HCWs as a result of COVID-19’ (Shreffler et al. 2020) Human resources for health Global strategy on human resources for health: workforce 2030 Report by the Director-General (April 2022) overall 65 million health workers in 2020 (estimate based on data from 194 Member States) 29% increase since 2013 (51 million) a reduction in the global health workforce shortage to 15 million in 2020 and a projected global shortage of 10 million in 2030 based on current trends (mostly depicting a pre-COVID-19 situation) EDUCATION and TRAINING Deficiencies in professional education fragmented, outdated, static curricula produce ill-equipped graduates mismatch of competencies to patient and population needs poor teamwork persistent gender stratification of professional status narrow technical focus without broader contextual understanding episodic encounters rather than continuous care predominant hospital orientation at the expense of primary care weak leadership to improve health-system performance Astana Declaration 2018 40 years after the Declaration of Alma-Ata reaffirmed the commitment to strengthening primary health care (PHC) “the most inclusive, effective and efficient approach to enhance people’s physical and mental health, as well as social well- being, and that PHC is a cornerstone of a sustainable health system for universal health coverage (UHC) and health-related Sustainable Development Goals” Human resources for health create decent work and appropriate compensation for health professionals and other health personnel working at the primary health care level to respond effectively to people’s health needs in a multidisciplinary context invest in the education, training, recruitment, development, motivation and retention of the PHC workforce, with an appropriate skill mix strive for the retention and availability of the PHC workforce in rural, remote and less developed areas WHO (2019) Declaration of Astana: Global Conference on Primary Health Care https://iris.who.int/bitstream/handle/10665/328123/WHO-HIS-SDS-2018.61-eng.pdf?sequence=1 WHO (2021) ’Health labour market analysis guidebook’ https://iris.who.int/bitstream/handle/10665/348069/9789240035546- eng.pdf?sequence=1 Undertaking root cause analysis to identify the appropriate interventions Prioritisation of Medicines and Essential Medicine Lists 18th December 2024 Professor Allyson Pollock Module: Sustainable Health Economy Prioritisation of Medicines and Essential Medicine Lists https://www.ncbi.nlm.nih.gov/books/NBK559751 / https://www.statista.com/topics/1764/global- pharmaceutical-industry/#statisticChapter https://www.europarl.europa.eu/RegData/etude s/STUD/2021/662910/IPOL_STU(2021)662910_E N.pdf Objectives To examine the interplay between trade and public health concerns in access to medicines- authorization / approvals and EMLs The role of the WHO in ensuring access to medicines The influence of the WHO EML on national governments and public health care systems in low, middle and high income countries Priority setting mechanisms Licensing and Marketing Each country has different laws, drug policies , regulatory authorities, systems and procedures Each country has different Systems for licensing products, manufacturers, importing agents and distributors Eg : FDA (US); MHRA (UK); Central Drugs Standard Control Organisation (India); EMA (Europe); Department of Drug Administration (Nepal) www.who.int/medicines/areas/qulaity _safety/regulation_legislation/model_site/en www.whoint/entity/medicines/areas/quality_safety/regulation_legi slation/ListMRAWebsites.pdf Randomised Control Trials Safe Effective High Quality RCTs Phase 1, 2 3, https://gijn.org/heath-and-medicine-guide- chapter-1/ UK THE Committee on Safety of Drugs was set up in 1963 (post thalidomide). (Expert committee voluntary) which subsequently became the Committee on Safety of Medicines (CSM) under the terms of the Medicines Act of 1968, which provided the legal framework for the control of medicines in the UK. In 2005 this committee became the Commission on Human Medicines (CHM). The Act required medicines to be licensed before being allowed onto the UK market. Many of the provisions of the Act have now been superseded by regulations implementing European legislation on medicines. The Medicines Control Agency was created in 1989, and merged with the Medical Devices Agency to become the MHRA in 2003. CHM provides independent expert advice to the MHRA Since Brexit MHRA is now independent of EMA Countries give market access when they give marketing approvals/authorisations to pharmaceutical companies The Public health gap Medicines are not authorized/ approved on basis of public health need, effectiveness, or affordability This results in Huge numbers of medicines in the market place: medicines bill is rising – lack of affordability to governments and to patients- copayments How do government, physicians and patients choose and decide and prioritise medicines global pharma is very powerful and spends billions on DTCA and medical ‘education’ Pharmaceuticals are produced by private sector for the market place and not for needs This shapes i) production and sales priorities ii) distribution and availability iii)research priorities Source: https://www.getreskilled.com/pharmaceutical-companies/ 11 https://www.statista.com/statistics/258022/top-10- pharmaceutical-products-by-global-sales-2011/ 12 “Evergreening” The process where ‘‘companies seek to launch new formulation, combinations, delivery methods, and indications for drugs facing patent expiration to delay entry of generic competitors and maintain a high price for an aging product’’. HonymanGillespie_Jan08 14 The number of new drugs licensed remains at the long term average range of 15-25 a year However, 85-90% of new products over the past 50 years have provided few benefits and considerable harms The pharmaceutical industry devotes most research funds to developing scores of minor variations that produce a steady stream of profits Heavy promotion of these drugs contributes to overuse and accounts for as much as 80% of a nation’s increase in drug expenditure Overinflated estimates of the average cost of research and development are used to lobby for more protection from free market competition http://www.bmj.com/content/345/bmj.e4348 Donald Light,Joel Lexchin, 2012 Norwegian Medical Needs Clause the Norwegian “medical need” clause limited approval of new drugs to those that offered a therapeutic advantage over existing products.39 This approach led to Norway having seven non-steroidal anti-inflammatory drugs on the market compared with 22 in the Netherlands.40 Norway’s medical need clause was eliminated in 1996 when it harmonised its drug approval process with that in the EU. Role of the WHO: Medicines and the WHO Constitution International governance of medicines was framed in 1946 by the WHO constitution. Three key provisions: WHO as directing and coordinating authority WHO as medicine standards setter Health Assembly as medicine standard legislator Access to essential medicines as part of the fulfillment of the right to health Article 12.2d of the ICESCR of 1966 mentions access to health facilities, goods and services. In 1978, the Alma-Ata Declaration on Health for All provided a comprehensive vision and framework for health services based on primary health care (PHC), declaring that “the attain-ment of the highest possible level of health is a most important world-wide social goal”(10). By including the provision of essential drugs as one of the eight listed components of PHC it established the link between the social goal of the highest possible level of health and access to essential medicines. WHO’s launch of the first Model List of Essential Drugs a year earlier, in 1977, had already set the scene for essential medicines as an integral part of the Health-for-All strategy. In 1990, the UN Commission on Economic, Social and Cultural Rights further developed the concept of the right to health of the legally binding ICESCR into practical guidance, through its non-binding but authoritative “General Comments”. In General Comment 3, the Commission confirmed that States parties have a core obligation to ensure the satisfaction of minimum essential levels of each of the rights outlined in the ICESCR, including essential primary care as described in the Alma-Ata Declaration (11). General Comment 14 of May 2000 (already quoted in section 1.2) goes even further and specifically states that the right to medical services in Developments within WHO Through its focus on equitable access to essential medicines as part of PHC, in practice the core objectives of WHO’s Action Programme on Essential Drugs have always been in line with the human rights concept presented above. However, the link between universal access and the right to health was recognized for the first time as a new priority in the WHO Medicines Strategy of 2004–2007. The Department of Essential Medicines and Pharmaceutical Policies now actively promotes access to essential medicines as part of the right to health through studies, advocacy and policy guidance. http://apps.who.int/medicinedocs/documents/s18772en/s18772en.pdf History of WHO essential Medicines list response to low income countries demand for – Local production – Procurement – Essential medicines list: National drug policies and medicines list – The 1975 World Health Assembly asked WHO to assist member states in selecting and procuring essential medicines, assuring good quality and reasonable cost 1977 : launch of MODEL Essential medicines list : a compromise with global pharma Fierce opposition from Big pharma and UK and EK and Germany http://apps.who.int/medicinedocs/documents/s18772en/s18772en.pdf http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(03)13375-2/fulltext#article_upsell https://core.ac.uk/reader/9416867?utm_source=linkout World Health Organisation (WHO): concept of essential medicines Essential medicines are: Those that satisfy the priority health care needs of the population Selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness [Rational Medicines?] Intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford. For detail, read the information on the link http://www.who.int/medicines/services/essmedicines_def/en/index.html WHO EXPERT COMMITTEE The WHO Expert Committee on Selection and Use of Essential Medicines meets every two years to review the latest scientific evidence on the efficacy, safety and cost effectiveness of medicines in order to revise and update the WHO Model List of Essential Medicines for both adults and children. Committee members are selected from WHO Expert Advisory Panels based on equitable geographical representation, gender balance and professional competencies in order to provide a representation of different approaches and practical experience from all regions of the world. The 24th Expert Committee meetings June/July 2023 https://www.who.int/publications/i/item/WHO-MHP-HPS-EML- 2023.01 Essential Medicines Definition The Model List is a guide for the development of national and institutional essential medicine lists. It was not designed as a global standard. However, for the past 30 years the Model List has led to a global acceptance of the concept of essential medicines as a powerful means to promote health equity. Most countries have national lists and some have provincial or state lists as well. National lists of essential medicines usually relate closely to national guidelines for clinical health care practice which are used for the training and supervision of health workers. WHO complementary list The complementary list presents essential medicines for priority diseases, for which specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training are needed. In case of doubt medicines may also be listed as complementary on the basis of consistent higher costs or less attractive cost‐ effectiveness in a variety of settings. WHO Model formulary Complements EML Information on dosage, adverse effects and guidance on indications EML Library : on-line repositary of EML, model formulary, EC technical reports and drug applications Essential Medicines Lists (EMLs) Prioritise medicines for universal access and rational use Facilitate the procurement of appropriate medicines Linked to standard treatment guidelines Treatment Guidelines Guidelines are important means of legitimising medicines use and entry to EML and to gaining access to public purse http://abclocal.go.com/wabc/story?section=n ews/health&id=9002827 Fig 1.1 taken from p3 of The World Medicines Situation 2011 Selection of Essential Medicines. Rianne van den Ham, Lisa Bero, Richard Laing; World Health Organization, Geneva 2011 Systematic Reviews and Cochrane Systematic reviews seek to collate all evidence that fits pre- specified eligibility criteria in order to address a specific research question Systematic reviews aim to minimise bias by using explicit, systematic methods The Cochrane Collaboration prepares, maintains and promotes systematic reviews to inform healthcare decisions: Cochrane Reviews Read more about what a systematic review is, and why systematic reviews are needed in health care, in the Cochrane Handbook for Systematic Reviews of Interventions (Chapter 1.2). Where is the WHO? Why has it no taken the lead? Comparison of essential medicines lists in 137 countries with WHO model list 2017 Essential reading : https://www.who.int/bulletin/volumes/97/6/18- 222448/en/ https://list.essentialmeds.org/ https://global.essentialmeds.org/dashboard/countries - Table 1.1 taken from p7 of The World Medicines Situation 2011 Selection of Essential Medicines. Rianne van den Ham, Lisa Bero, Richard Laing; World Health Organization, Geneva 2011 Case Study of EML and Drug registers: Kenya, Tanzania and Uganda https://www.who.int/bulletin/volumes/98/8/19- 249433.pdf https://theconversation.com/east-african-countries- should-prioritise-their-essential-medicines-for-drug- registration-149638 Over-registration of non-essential medicines Kenya Tanzania Uganda 752; 706; 621; 798; 765; 1353; 36% 53% 47% 51% 49% 64% Essential Non-essential Essential Non-essential Essential Non-essential Under-registration of essential medicines Kenya Tanzania Uganda 33; 21% 52; 50; 29% 27% 127; 130; 137; 79% 71% 73% Registered Registered Registered Unregistered Unregistered Unregistered Registration of essential medicines in Kenya, Tanzania, and Uganda Drug registers: Majority of registered products are not EML-listed 6151 Most commonly registered medicines for non-communicable diseases analgesics (diclofenac, paracetamol, tramadol) cardiovascular (amlodipine, atorvastatin, telmisartan) 3896 3590 anti-diabetic (metformin, glimepiride) 71% 63% 58% Examples 85 diclofenac products in Kenya; none of them EML-listed 29 37 42 27, 14, and 24 telmisartan products in Kenya, % % % Tanzania, and Uganda, respectively; none of them ELM-listed 34 Registration of essential medicines in Kenya, Tanzania, and Uganda EMLs: Many essential medicines with no registered products Registered Not registered Incomplete info 71% 63% 58% Examples of classes with less than 50% essential medicines registered Anaesthetics (T, U) Antidotes and other substances used in poisoning (K, T, U) Medicines for mental and behavioural disorders (K) 35 Registration of essential medicines in Kenya, Tanzania, and Uganda Local production: limited focus on essential medicines Kenya Tanzania Uganda Local producers 9 4 6 Local products 946 97 181 Number of EML-listed local products 310 (33%) 39 (40%) 100 (56%) (% of all local products) Lead: Alex Green 36 Market failure and externalities to Irrational prescribing, overtreatment and over consumption : iatrogenic harms Over production : waste and pollution (water, environment) Costs : copayments , pressure on health systems, maldistribution of resources Underproduction of essential and necessary medicines Local producers diverted Why are some essential medicines not registered for use and not available? Why are many medicines registered for use but not on the country essential medicine list? Should countries prioritise essential medicines for registration? Registration of essential medicines in Kenya, Tanzania, and Uganda Our Recommendations Including EML status of products on the drug register would enable regular monitoring of Ems registration and of medicines at risk of shortages Regulators should prioritise registration of products corresponding to EML- listed medicines, esp. those with no or very limited number of products Regular audits would enable to monitor progress in developing regional pharmaceutical production 39 How do countries without an EML prioritise medicines? http://www.nice.org.uk/ http://www.pharmac.health.nz/ tools for priority-setting (selection, deselection and incorporation) and their level of function in the medicine and health systems Levels of decision- Tools for priority setting making Public health system Approved drugs are prioritised within the health system Essential medicines list e.g. WHO EML and National EMLs Reimbursement lists Approved drugs enter the market e.g. positive, Supranational negative and Market registration disease-specific lists National Research Stand Fast-track and ard approval, Health technology appro including assessment Regional Develop val expedited ment approval Local Formularies Standard treatment guidelines Private health system Uses a combination of the above mechanisms Formularies: national, local, health facility Reimbursement lists : positive lists Health Technology Assessment Health Technology Assessment Incorporation not selection cf EML very technical- capacity QALYs: individualized Does not consider priorities and needs of society and public as a whole Does not consider affordability to health system or impact END Essential Reading: World Medicines Situation Reports 2004 and 2011 The World Medicines Situation 2004 Chapters 6,7,8,and 9 http://www.who.int/medicines/areas/policy/ world_medicines_situation/en/ The World Medicines Situation 2011 – - Access to Essential Medicines as Part of the Right to Health – Selection of Essential Medicines Optional references International drug price indicator guide http://erc.msh.org.priceguide (or Google search ‘MSH Drug Price Indicator 2011’) http://www.government.nl/documents-and- publications/reports/2012/11/16/the-benefits-of- responsible-use-of-medicines.html Preston C et al. Strengthening medical product regulation in low- and middle-income countries. PLoS Med 2012; 9(10):e1001327. doi:10.1371/journal.pmed.1001327 How are priorities set and who sets them? http://www.publications.parliament.uk/pa/cm 200405/cmselect/cmhealth/42/42.pdf http://www.publications.parliament.uk/pa/cm 200405/cmselect/cmhealth/42/4202.htm#evi dence The influence of the Pharmaceutical Industry Defining Access Accessible Affordable Available Acceptable Appropriate https://www.who.int/publications/i/item/WH O-MHP-HPS-EML-2023.01 Factors affecting access Transport and travel time Cost:user charges Health systems : prescribers, location Supply: Stockouts, National health priorities (Medicines policy) Availability – multiple factors – Local manufacture v import (GMP) – Patent / Intellectual property rights Effective regulatory system – Assessment of quality, safety, efficacy (& cost-effectiveness?) – Manufacturing approval; Approval for distribution/sale; Import license Infrastructure – reliable storage, distribution systems Knowledge of use – Skills, training of care professionals – Evidence-based practice; rational medicines use WHO WHO is charged with the tasks of developing and maintaining global norms, international standards and guidelines for the quality, safety and efficacy of drugs, and providing guidance in harmonization efforts. The development of norms, standards and guidelines to promote quality assurance, medicines regulation and safety of medicines is an integral part of WHO’s Constitution and a unique responsibility. It has been endorsed and supported through numerous World Health Assembly resolutions, and more recently in those on the Revised Drug Strategy./en/index.html WHO as directing authority The first of its 22 listed functions is to act as the directing and coordinating authority on international health work. Article 1 – Objective “The objective of the World Health Organization (hereinafter called the Organization) shall be the attainment by all peoples of the highest possible level of health.” Article 2 - Functions “In order to achieve its objective, the functions of the Organization shall be: (a) to act as the directing and co-ordinating authority on international health work;…” Note: ‘authority’, not, e.g., ‘agency’, ‘body’, ‘organisation’, ‘institution’ etc. WHO as medicine standard setter The WHO also has the function of establishing standards for medicines and other products: Article 2: Functions; “In order to achieve its objective, the functions of the Organization shall be: … (u) to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products;” World Health Assembly as medicine standards legislator The World Health Assembly - one of the WHO’s three organs, consisting of country reps – determines the organization’s policy. It has specific authority to make regulations about the safety, purity, potency, advertising and labelling of medicines which are binding on each Member unless expressly rejected: Article 21 “The Health Assembly shall have authority to adopt regulations concerning:… (d) standards with respect to the safety, purity and potency of biological, pharmaceutical and similar products moving in international commerce; (e) advertising and labelling of biological, pharmaceutical and similar products moving in international commerce.” Article 22 “Regulations adopted pursuant to Article 21 shall come into force for all Members after due notice has been given of their adoption by the Health Assembly except for such Members as may notify the Director-General of rejection or reservations within the period stated in the notice.” The Assembly can also adopt a convention or agreement under Article 19 on any matter within WHO’s competence by a two-thirds majority, but these are not automatically binding. Pharmaceuticals have made an important but very small overall contribution to public health and life expectancy? Power Truth and Commerce The primary determinants of disease are mainly economic and social, and therefore its remedies must be economic and social G Rose in ‘Strategy of Preventive Medicine’ OUP 1992 Access to medicines Pharmaceutical supply chains and emergencies 11th December 2024 Petra Sevcikova Module: Sustainable Health Economy Access to medicines 3.8 Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all Access to medicines 3.8 Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all Those that satisfy the priority health care needs of the population Selected with due regard to disease prevalence, evidence on Regulatory requirements efficacy and safety, and comparative cost-effectiveness Scientific assessment of clinical data Intended to be available within the context of functioning health on safety and efficacy to ensure that systems at all times in adequate amounts, in the appropriate benefits outweigh risks dosage forms, with assured quality, and at a price the individual Quality assurance and the community can afford (WHO definition) Defining Access Accessible Available Affordable Acceptable Appropriate use ACCESSIBLE Factors affecting access: Transport and travel time Health system infrastructure: prescribers, pharmacies, clinics Ex. Access to ARVs in South Africa: “public transport to peripheral clinics, which public sector rely on heavily, is either absent or limited” (Magadzire et al. 2014; Frontline health workers as brokers: provider perceptions, experiences and mitigating strategies to improve access to essential medicines in South Africa) AVAILABLE Factors affecting access: Effective regulatory system ensuring quality, safety, efficacy National health priorities (Medicines policy) Stockouts - Procurement and distribution systems Production - Local manufacture versus import Ex. Olaniran et al. (2022) ‘Stock-outs of essential medicines among community health workers (CHWs) in low- and middle-income countries (LMICs): a systematic literature review of the extent, reasons, and consequences” AFFORDABLE Factors affecting access: User charges Patent / Intellectual property rights Brand vs. generic competition ACCEPTABLE Factors affecting access Convenience (oral administration vs. injectables; formulations for children) Socio-cultural norm (e.g. stigma in case of HIV and TB patients) Trust in health care professionals APPROPRIATE USE Knowledge of use: skill & training of care professional Evidence-based practice ( treatment guidelines) Appropriate use of medicines? ½ of all medicines are inappropriately prescribed, dispensed or sold ½ of all patients fail to take their medicine properly 2/3 of global antibiotic sales occur without any prescription studies in Indonesia, Pakistan and India: over 70% of patients were prescribed antibiotics up to 90% of injections are estimated to be unnecessary Inappropriate use of medicines widespread, costly and extremely harmful adverse drug events in the top 10 causes of death in the USA with associated costs of US$ 30 and US$ 130 billion each year Ensuring appropriate use of medicines WHO & the International Network for Rational Use of Drugs (INRUD) advocating proper documentation of medicine use since the late 80’s Core drug use indicators (1993): Poly-pharmacy Prescribing in generic name Antibiotic use Injection use Adherence to essential medicine list 2016 review showed that prescribing indicators for Africa still significantly deviate from the WHO targets (Ofori-Asenso 2016) Pharmaceutical supply chains Source: https://syntheticdrugs.unodc.org/syntheticdrugs/en/access/pharmaceutical/index.html Pharmaceutical supply chains Source: https://syntheticdrugs.unodc.org/syntheticdrugs/en/access/pharmaceutical/index.html Good Manufacturing Practice (GMP) GMP “is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorization” (WHO 2004) Good Distribution Practice (GDP) “That part of quality assurance that ensures that the quality of a medical product is maintained by means of adequate control of the numerous activities that occur during the trade and distribution process, as well as providing a tool to secure the distribution system from falsified, unapproved, illegally imported, stolen, substandard, adulterated and/ or misbranded medical products” (WHO 2020) Good Storage Practice (GSP) That part of quality assurance that ensures that the quality of medical products is maintained by means of adequate control throughout the storage (WHO 2020) GMP – who is regulated? Producers Parties involved in re-packaging and re-labelling of pharmaceutical products Distributors Procurers Pharmacies GMP – what does it involve? Quality management Personnel Production facilities and equipment Documentation and records Production and in-process controls Packaging and identification labelling Storage and distribution Laboratory controls Complaints and recalls … see eg. WHO GMP code http://www.who.int/medicines/areas/quality_safety/quality_assurance/GMPPharmaceuticalProductsMainPri nciplesTRS961Annex3.pdf?ua=1 Unpacking manufacturing API=active pharmaceutical ingredient Unpacking (global) manufacturing Example: China USA China -> India -> India -> Uganda Brazil India Proportion of API (active Proportion of FDF (finished dosage pharmaceutical ingredient) form) manufacturing facilities for manufacturing facilities for generic generic drugs by country or region, medicines by country or region, USA, USA, 2021 2021 The White House (2021) Building resilient supply chains, revitalizing American manufacturing, and fostering broad-based growth Countries of origin for medicines on the Ugandan National Drug Register, 2012 Source: The White House (2021) Building resilient supply chains, revitalizing American manufacturing, and fostering broad-based growth Channels of drug distribution Unpacking the distribution Example: India Source: http://www.domain-b.com/industry/pharma/20000107distribution_channels.html Large India Pharma Producer Small Counterfeit - more complex Pharma Producer Producer relationships Carriage and Forwarding Agent or Company Depot Super Stockist Wholesaler or Stockist Government Hospital or NGO Agency Retailer or Pharmacist Practitioner Patient or Representative Patterns of distribution of pharmaceuticals in India Key Main channels Other channels Channels for counterfeit drugs Source: Tracing Pharmaceuticals in South Asia Complexities of manufacturing/supply chains increased in the last 30 years Market factors: cost pressure -> consolidation of generic pharmaceutical market tendency to decrease diversification, redundancy, and investment in newer quality systems outsourcing production to countries with lower labor and manufacturing costs, and with weaker environmental and occupational codes Increasing reliance on foreign countries to manufacture the medicines, active pharmaceutical ingredients (APIs), and their key starting materials Complex multinational supply chains, manufacturing and distribution Risk of disruptions at multiple points Emergencies Hurricanes Maria and Irma, 2017 Drug manufacturing in Puerto Rico 10% of drugs consumed in the US manufactured on the island Shortages of intravenous fluids Explosion at a factory of Chinese Qilu Pharmaceutical Sole global producer of APIs for piperacillin-tazobactam Suspension of production Worsening of already existing shortages for this critical antibiotic Shift to other antibiotics -> increase in Clostridium difficile infections COVID-19 public health emergency Sudden increase in demand Lockdowns Foreign export restrictions Covid-19 vaccine production Emergent BioSolutions 2020 - $628 million U.S. government contract Mar 2021 - 100M J&J and 70M AstraZeneca doses put on hold Apr 2021 - quality issues with batches of J&J vaccine https://www.nytimes.com/ FDA inspectors identified violations of GMP Failure to follow procedures to prevent contamination Employees moving between zones without documented change of gowns and showering) Failure to handle manufacturing waste Issues with the design and condition of the building (peeling paint, crowded conditions) Covid-19 vaccine production (cont.) Production of AstraZeneca vaccines discontinued https://www.nytimes.com/ 60M J&J doses could not be used; ramifications for donations to LMICs Jul 2021 - production of J&J vaccines resumed Nov 2021 – government contract terminated Medicine shortages - root causes Quality issues Limited number of producers (older generic medicines, antibiotics; high specialization) Discontinuation of production (cost pressure, move to profitable products) Natural disasters Public health emergencies Medicine shortages - consequences Clinical effects No treatment available Delay in treatment Alternative treatment less effective or with more adverse effects, or both Negative externalities e.g. AMR Financial effects Additional costs of managing shortages Unexpected, significant increases in prices Medicine shortages - corrective measures Drug regulatory authorities monitoring the supply chain for shortages (eg. < 3 manufacturers with registered products) overseeing the quality of manufacturing facilities that produce these drugs (eg. GMP – complaints and recalls section amended) continued product safety monitoring, including preventing the entry of fraudulent medications into the supply chain and working to mitigate and resolve the impact of such shortages Procurers / Wholesalers redistribution and regional collaboration Medicine shortages - corrective measures (cont.) Local production of medicines the ability to manufacture essential medicines across therapeutic classes the ability to manufacture high-quality products diversification of the drug supply chain, e.g. a geographically diverse set of manufacturers redundancy in the supply chain, e.g. multiple manufacturers for each product, APIs and key starting materials The US and essential medicines August 6, 2020 - Executive order directing the US FDA to ‘identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.’ …’ can be used for the widest populations to have the greatest potential impact on public health’ targeted at acute care medical facilities, specialising in urgent medical conditions and provide short-term treatment for severe injuries or illnesses; some medicines, e.g. pain relief medicines and antibiotics are in wider use in the community The FDA has been directed to coordinate with other partners and develop strategies for purchasing, accelerating local manufacturing and monitoring supply chains to minimize the risk of shortages https://www.fda.gov/about-fda/reports/executive-order-13944-list-essential-medicines-medical-countermeasures-and-critical-inputs The EU and essential medicines Several countries have an EML (eg. Portugal, Malta, Latvia, Bulgaria, Czechia, Sweden, …) The EU executive proposed an EU list of critical medicines that will list drugs considered essential for health systems at the EU level so that citizens can have access to the medicines they need (Union list of critical medicines – see medicines#ema-inpage-item-64278 ) https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-and-availability-issues/availability-critical- to help “monitor the availability of essential medicines and address supply chain vulnerabilities” Two other measures to address drug shortages enhanced industry accountability (shortage prevention plans, reporting on measures taken, eg. the increase or reorganisation of manufacturing capacity, the adjustment of distribution an increased role of the EMA in monitoring and coordinating supply- related issues https://www.euractiv.com/section/health-consumers/news/eu-new-pharma-rules-strengthen-efforts-in-tackling-drug- shortages/ Medicines availability and antimicrobial resistance availability of quality-assured antibiotics is a global challenge (eg. in the EU >1000 shortages of antibiotics reported last year) additionally, lack of access to vaccines and diagnostics in LMICs ? Appropriate use of available antibiotics Registration of essential medicines in Kenya, Tanzania, and Uganda Antimicrobials account for over one third of registered products Antimicrobial classes with most registered 2105 products; total number (non-essential as % of total) 1563 1327 Kenya Tanzania Uganda 64% 53% 51% Antibiotics 1253 (70%) 760 (55%) 963 (58%) Antivirals 193 (33%) 199 (51%) 187 (36%) 36% 47% 49% Antimalarials 133 (53%) 114 (61%) 136 (36%) 42% Antifungals 242 (65%) 137 (46%) 157 (43%) Lyus et al. WHO Bulletin 2020 38 Registration of essential medicines in Kenya, Tanzania, and Uganda Antibiotics with the highest number of products by Access, Watch, Reserve category; total number (non-essential as % of total) Green et al. JRSMO 2023 39 Sustainable innovation of effective antibiotics 2017-2021 – 14 new antibiotics approved in the EU; most lack any innovative characteristics Large pharma companies have withdrawn from the area Most R&D driven by academia and SMEs, which often lack regulatory expertise Scientific challenges Market challenges – low volume sales, price competition European Observatory (2023) Sustainable innovation of effective antibiotics (cont.) Push incentives, eg. direct funding and grants Pull incentives, eg. financial rewards linked to R&D results, reimbursement reforms and regulatory changes Aligning incentives “public health factors targeting high-priority medical need, supporting antibiotic sustainability, promoting access, and protecting environmental health market factors improving return on investment and supporting SMEs implementation and operational feasibility considering potential political, regulatory, legislative, industry and financial hurdles” European Observatory (2023) Summary Pharmaceutical markets Information asymmetries -> market failure Need for regulation, licensing, and policies to ensure access to medicines and their appropriate use, while sustaining viable markets References The White House (2021) ‘Building resilient supply chains, revitalizing American manufacturing, and fostering broad-based growth. 100-Day Reviews under Executive Order 14017’(https://www.whitehouse.gov/wp-content/uploads/2021/06/100-day-supply-chain- review-report.pdf ) European Observatory (2023) ‘How can the EU support sustainable innovation and access to effective antibiotics?: Policy options for existing and new medicines‘ (https://eurohealthobservatory.who.int/publications/i/how-can-the-eu-support-sustainable-innovation-and-access-to- effective-antibiotics-policy-options-for-existing-and-new-medicines) Drug shortages in the EU (2023) Austria > 540 drugs not available or with limited availability France - a risk of amoxicillin shortages -> relocating pharma production Belgium - sufficient stock of Amoxicillin. In the event of a shortage, Belgian pharmacies equipped with a laboratory could be asked to produce paediatric Amoxicillin themselves Greece - 162 drugs missing from the market -> switching to domestic production Italy – shortages of > 3,000 drugs Bulgaria - >300 medicines incl. antibiotics missing Sweden – shortages of epilepsy medicines Czech Republic – shortages of some basic narrow- spectrum antibiotics -> prescribing broad spectrum antibiotics Poland - shortages of analgesic and antipyretic Slovakia - shortages of common over-the-counter medicines, including suppositories for children for fever and pain and tablets for sore throats https://www.euractiv.com/section/politics/news/antibiotics-expected-to-return-to-eu-capitals-in-a-month/ Ecological Health Economics for a Post- Growth World Martin Hensher Henry Baldwin Professorial Research Fellow in Health System Sustainability Menzies Institute for Medical Research University of Tasmania menzies.utas.edu.au 8 December 2024 Acknowledgement of Country I respectfully acknowledge the Muwinina people of the Palawa- Lutruwita nations as the traditional owners of the lands I live and work on. I pay my respects to their Elders past, present and future. About Me Overview Micro issues:  Environmental impacts and externalities  Overconsumption of healthcare Macro issues:  Healthcare under post-growth economic models  Heath economics for a post-growth world EXTERNALITIES Environmental Externalities Economic “externality”: Where costs and/or benefits of a transaction fall on actors who were not party to that transaction Positive externalities: Network effects Vaccination and herd immunity Negative externalities: Pollution Anthropogenic climate change Environmental Externalities Six out of nine planetary boundaries have now been transgressed Source: Richardson, Steffen et al, 2023 Environmental Externalities and Health Climate change Pollution Overconsumption and uneconomic growth Zoonotic epidemics Syndemics Healthcare Environmental Impacts Source: Hensher et al, 2020 Addressing Environmental Impacts in the Economic Evaluation of Healthcare Why worry about environmental impacts in economic evaluations of healthcare interventions? Links between the environment and health outcomes Healthcare decision makers’ objectives include wider social welfare concerns – the societal perspective To account for negative externalities (spillover effects) and re-internalise their costs back onto the original parties to the transaction For precautionary reasons, in anticipation of more stringent environmental regulation, carbon taxes etc. Incorporating Environmental Impacts – Are They Costs or Outcomes? Alternative approaches for incorporating environmental impacts: Include the health impacts (or health gains from reduced impact) into HRQoL outcome measures Consider healthcare decision makers’ Marsh et al, willingness to pay for environmental 2016 improvements Include environmental factors in Multi- Criteria Decision Analysis (MCDA) Include the societal costs of environmental Hensher, impacts as an additional cost within 2020 economic evaluations OVERCONSUMPTION Overconsumption “Today, the decisions made by executives and managers in the food, tobacco, alcohol, pharmaceutical, firearms, automobile and other industries have a far greater impact on public health than the decisions of health officials, hospital directors and doctors.” N. Freudenberg, Lethal but legal: corporations, consumption and protecting public health. 2014. Industry Impacts on Health Food and Beverages - “Hyperpalatable foods”, obesity, diabetes etc. Tobacco – new markets in low income countries Alcohol – new markets (youth, low income countries) Pharma – adverse events, overtreatment, US opioid epidemic Firearms – shootings Automobiles – accidents, air pollution Fossil fuels – climate change, air pollution Social media – depression, anxiety, suicide?? Marketing Resisting regulation (“codes of conduct” etc) Lobbying and political donation Intellectual property and free trade protections Syndemics Syndemics – the interaction between multiple diseases, social and environmental factors (Singer et al, 2017) The global syndemic of obesity, undernutrition and climate change (Swinburn et al, 2019) Common systemic drivers potentially allow for “double or triple-duty actions” to change the trajectories of multiple diseases We need a health economics that can capture the harms to health of overconsumption and syndemics Overconsumption of Health Care Increasing recognition that overconsumption of health care – “too much medicine” is common: Overdiagnosis Overtreatment Overuse / Overutilisation Low value care / questionable care Futile Care / Non-Beneficial Treatment at the end of life Pharmaceuticalisation Medicalisation Even while large numbers of people round the world lack basic access to essential care Overconsumption of Health Care Overuse appears to be widespread: Internationally, 10% to 30% of all healthcare activity might represent overuse (Morgan et al , 2017) On average, US doctors believe 20% of all care is unnecessary (one quarter believed 30-45% of all care was unnecessary) 13-33% of endoscopies were unnecessary across European countries (Brownlee et al 2017) 33-38% of patients approaching the end of life receive non-beneficial treatments (Cardona-Morrell et al, 2016) Harmful Health Care Also ever-increasing evidence that poor quality care causes substantial harm to patients around the world: 3% - 16% of all hospital admissions result in an adverse event across 14 high income countries (Baines 2018) 42.7 million incidences of seven common adverse events from 421 million hospitalisations globally (Jha et al, 2013) 134 million adverse events in low and middle income nations causing 2.5 million detahs (NASEM, 2018) Up to 15% of hospital expenditure goes on costs of dealing with adverse events (OECD, 2017) Antimicrobial resistance caused 1.3 million deaths globally in 2019 (Murray et al, 2022) Healthcare displays diminishing marginal returns Source: Donabedian (1980) Reproduced with permission, Health Administration Press Overconsumption and Failure Demand Conceptual framework for considering overconsumption and failure demand for health care Source: Hensher et al, 2020 POST-GROWTH HEALTH ECONOMICS Economic Growth – the Long View Health and Economic Growth Surgery c.1638 “The Surgeon” (1638) by David Ryckaert III (1612-1661) Surgery c.2020 Surgeons at Western General Hospital, Edinburgh using a Versius surgical robot, 2020 https://www.hospitaltimes.co.uk/nhs-surgeons-become-pioneers-in-robotic-surgery/ Technology, Professionalisation, Complexity First Australian ambulance service, 1895 - New South Wales Government Technology, Professionalisation, Complexity Scale – US Healthcare Spending as a Share of GDP, 1800-2016 Source: Catillon, Cutler & Getzen, 2018 Global Growth tending inexorably downwards… Global GDP Growth, 1961-2020 8 6 4 2 % GDP Growth 0 -2 -4 -6 Even in a world of slowing GDP growth… OECD members - % GDP Growth 1961-2020 OECD Average Annual GDP Growth Rate, 8 1961-2020 6 6 5 4 4 % GDP Growth 2 3 0 -2 2 -4 1 -6 0 1960s 1970s 1980s 1990s 2000s 2010s Source: World Bank Open Data, Indicator NY.GDP.MKTP.KD.ZG The Arc of Progress – or the Age of Consequences? Worldviews: Neoclassical Economics vs. Ecological Economics Economy Extract natural resources Dump waste and pollutants Ecosystem Adapted from Daly (1999) Worldviews: Ecological Economics – the economy and ecosystem in the “empty world” Solar Energy Human Welfare Ecosystem services Ecosystem Economic Services Recycle Matter Matter Economy Energy Energy Heat Adapted from Daly (1999) Worldviews: Ecological Economics – the economy and ecosystem in the “full world” Ecosystem services Solar Energy Human Welfare Ecosystem Economy Ecosystem Economic Services Recycle Recycle Matter Matter Matter Matter Energy Energy Energy Energy Heat Adapted from Daly (1999) The “Full World” is Here… Six out of nine planetary boundaries have now been transgressed Source: Richardson, Steffen et al, 2023 Planetary Boundaries and the Full World Source: University of Leeds, A Good Life For All Within Planetary Boundaries https://goodlife.leeds.ac.uk/national-snapshots/countries/#Australia Neoclassical, Feminist and Ecological Economics Ecological Economics Feminist Economics The study of: The study of social 1) Sustainable Scale provisioning 2) the Fair Distribution and systems1 3) the Efficient Allocation Neoclassical of society’s resources2 (Health) The study of the Economics allocation of scarce resources among unlimited wants 1. Power, 2004 2. Daly and Farley, 2011 Core Concerns of Ecological Economics Sustainable Scale How much is enough, how much is too much? Fair Distribution Equity and fairness within and between nations, between those who have caused the ecological crisis and those whom it most impacts Efficient Allocation Technical and allocative efficiency are even more important under ecological and real resource constraints From Economic Growth to Uneconomic Growth MU economic growth MU uneconomic growth a MU = 0 b e d c MDU MDU MDU -> ∞ Adapted from Daly (1999) Ecological Macroeconomics - Post-Growth Economic Models But has economic growth already become uneconomic growth? Can or should “growth” continue? That all depends on whether growth in GDP can be decoupled from environmental impacts – and whether that decoupling can be absolute and sufficient If we can dematerialise growth, then we could potentially have: Green Growth But if we cannot achieve absolute and sufficient decoupling, we need entirely new models: Steady State Economy Degrowth And if we fail, we risk: Involuntary degrowth and/or collapse Image: Raworth, 2017 Green Growth, Health and Healthcare Under “green growth”, health care will need to aggressively reduce its carbon footprint and wider environmental impacts But will a continued growth model really allow health systems to meet their other key challenges?  Reducing overuse  Stemming antimicrobial resistance  Reducing disease burden due to wider overconsumption  Expanding access to healthcare for the world’s poorest Post-Growth Health and Healthcare Remember the very strong association between growth in healthcare spending and GDP growth since WWII Post-growth models will pose significant challenges to healthcare systems, planning and health economics… …as well as important opportunities for better health Post-Growth Scarcity Under steady state or degrowth models (let alone collapse), scarcity of real resource will become an issue even in high-income health systems Health systems will compete with other sectors not just for funding, but for key resources (energy, chemical feedstocks etc.) Health systems will have to play their part in reducing overall natural / non-renewable resource consumption Resilience and Scarcity - Vaccine Adjuvants Quillara Saponaria bark extract a critical ingredient of vaccine adjuvants e.g.: Novavax RSV, Shingles vs. Malaria, Tuberculosis (GSK) Quillara Saponaria tree But Quillara Saponaria under increasing threat: Overexploitation (for export and local firewood) Megadrought Increasing frequency and scale of forest fires Overconsumption Transitioning to steady state or degrowth economies could finally allow real action to reduce harmful overconsumption of health-damaging products across the economy Addressing overuse of healthcare will be easier in post- growth systems, as the reality of scarcity becomes more clearly visible and accepted, and resources become targeted more tightly on their most beneficial uses But much hard work will be required to substitute a culture of sufficiency for today’s culture of abundance Sufficient Health for the World’s Poorest? Raworth, 2017 Sufficiency – How much is Enough Healthcare? 1. HALE and Total Health Expenditure (PPP$), 3 Segment 1. Amenable Mortality and Total Health Expenditure Model (PPP$), 3 Segment Model 80 900 Mortality Amenable to Medical Care 75 800 70 700 600 65 500 HALE 60 400 55 300 50 200 45 100 40 0 Total Health Expenditure per capita PPP$ Total Health Expenditure per capita PPP$ Healthcare Financing Steady state models usually envisage strong and stable financing for social services like health, including luxury, wealth and environment taxes But how will financing healthcare work when it cannot grow – especially as the elderly grow as a proportion of the population? Health system financing likely to be much more challenging under degrowth, as financing capacity (public and private) shrinks in line with the economy Degrowth theorists often sound a little thin when they get to the details of healthcare financing and resourcing… Public or Private Healthcare Steady state and degrowth models typically envisage significant redistribution and strong social safety nets The absence of growth – and the need to dramatically reduce the overuse of healthcare – make it likely that private, for-profit healthcare and health insurance will increasingly become untenable This is less problematic in nations with strong public healthcare already – but could be highly disruptive and politically explosive in countries with large private healthcare sectors (e.g. USA) But can non-profit social enterprises and charities play a role (as they did historically)? Scale and Complexity Modern healthcare is highly complex and relies on a set of very complex organisations Steady state models allow for the continued operation of large and complex organisations – hospitals, universities, corporations, government agencies Degrowth models, however, focus overwhelmingly on very local, small scale economic activities and organisation. Degrowth has little or nothing to say on how the complex organisational infrastructure that supports modern healthcare will be maintained. Understand the Alternative… Meadows et al, 1972 “The Limits to Growth: a report for the Club of Rome’s Project on the Predicament of Mankind.” TOWARDS AN ECOLOGICAL HEALTH ECONOMICS Minimise Unnecessary Demand and Supply Source: Hensher, 2023 Minimise Harm and Failure Demand Source: Hensher et al, 2020 Sufficient Care for All 1. HALE and Total Health Expenditure (PPP$), 3 Segment Model 80 75 70 65 HALE 60 55 50 45 40 Total Health Expenditure per capita PPP$ Bibliography Brand-Correa L, Brook A, Buchs M, Meier P, Naik Y, O’Neill D. Economics for people and planet: moving being the n

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