ABSTRACT

This study aimed to analyze the challenges of access to medicines in four universal health systems in Australia, Brazil, Canada and the United Kingdom. Critical-reflexive qualitative study through Integrative Literature Review. The great challenge of the systems studied is the incorporation of high-cost drugs, through cost-effectiveness analyses to fulfill the difficult task of reconciling social justice and access equity with economic sustainability. Canada, in particular, despite being a developed country, still deals with the dilemma of how to finance a health system in which access to medicines is also universal. Brazil deals with two problematic realities: first, to grant access to medicines that are already standardized by the Unified Health System (SUS), in the face of insufficient funding. Secondly, similarly to the Australian, Canadian, and English systems, the dilemma of how to incorporate new efficient medicines considering its economic feasibility, as well as the issue of health judicialization, a complex phenomenon resulting from public fragility in the organization, financing, and consolidation of the SUS.

KEYWORDS
Access to essential medicines and health technologies; Health systems; Social justice

Introduction

Medication is an important element in health systems and ensuring its availability, accessibility and rational use, maintaining cost effectiveness and sustainability is a challenge for most countries in the world, especially in the face of increasing demand. This phenomenon occurs due to population aging, inadequate living habits, associated chronic conditions, medicalization of society and pressure from the pharmaceutical market¹1 World Health Organization. WHO Medicines Strategy-countries the core: 2008-2013 [internet]. Geneva: WHO; 2008 [acesso em 2017 fev 12]. Disponível em: http://www.who.int/medicines.
http://www.who.int/medicines... .

The availability of essential medicines in the public sector, in many countries around the world, is still considered low. Median availability of medicines in low-income countries in 2016 was 60%, and in middle-income countries was 56%²2 World Health Organization. World health statistics 2016: monitoring health for the SDGs, sustainable development goals. Geneva: WHO; 2016..

The ways of promoting access to medicines for the population differ between countries, as they vary according to the type of health system and the current medicine policy. In universal health systems, based on social justice, whose guiding principles are universality and equal access to health services, access to medicines is expected to be equal and broad. However, the subject of gratuity gives rise to different approaches that are expressed through total gratuity in some countries, gratuity according to the degree of vulnerability of users, and also the co-payment or co-participation system, being part of the expenses covered by the health and social system and the other party by direct disbursement from the user.

In most European countries (United Kingdom, Denmark, Sweden, Finland, Norway, Switzerland, Germany and France), public spending on medicines is higher than private spending, unlike countries like the United States of America, where private expenses are much higher³3 Contandriopoulos AP. Conselho Nacional de Secretários de Saúde. Relatório do Seminário Internacional de Assistência Farmacêutica do CONASS, realizado em 15 e 16 de junto de 2009, em Brasília/DF. Conselho Nacional de Secretários de Saúde. Brasília, DF: CONASS; 2010.. In Brazil, free access to full therapeutic care through the Universal Health System (SUS) is the right of all citizens guaranteed by art. 6 of Law nº 8.080/90⁴4 Brasil. Lei nº 8.080 de 19 de setembro de 1990. Dispõe sobre as condições para a promoção, proteção e recuperação da saúde, a organização e o funcionamento dos serviços correspondentes e dá outras providências. Diário Oficial da União. 20 Set 1990., which regulates the principle of universality adopted by the Federal Constitution of 1988.

Access to medicines is a worrying theme and is therefore incorporated into the health-related goals of the Millennium Development Goals of the World Health Organization (WHO) and the 2030 agenda for sustainable development, set by the United Nations (UN)⁵5 Organização das Nações Unidas. A Agenda 2030 para o Desenvolvimento Sustentável. Nova York: ONU; 2015.. Furthermore, the theme also integrates national and international studies, especially in the last two decades (2000-2018)⁶6 Matta SR, Bertoldi AD, Emmerick ICM, et al. Fontes de obtenção de medicamentos por pacientes diagnosticados com doenças crônicas, usuários do Sistema Único de Saúde. Cad. Saúde Pública. 2018; 34(3):1-13.

7 Nascimento RCRM, Alvares J, Guerra-Junior AA, et al. Disponibilidade de medicamentos essenciais na atenção primária do SUS. Rev saúde pública. 2017; 51(supl2):1s-12s.

8 Alsairi R. Access to Medicine in Developing Countries. Am j med sci. 2017; 7(6):271-276.^-99 Emmerick ICM, Luiza VL, Camacho LAB, et al. Barriers in household access to medicines for chronic conditions in three Latin American countries. Int j equity health. 2015; 14:115-129.. The emergence of this issue comes in the context of an installed economic and humanitarian crisis, a circumstance that has accentuated the barriers of users' access to health services.

Thus, this study aimed to analyze how the theme of the challenges of access to medicines in four universal health systems in Australia, Brazil, Canada and the United Kingdom is addressed in scientific publications.

Material and methods

This is a qualitative study with a critical-reflexive character conducted through an integrative literature review. The descriptors selected were: Access medicines. Access Drugs. Health System. Access to Essential Medicines and Health Technologies. The search was carried out on the following databases: Pubmed, Scientific Electronic Library Online (SciELO), Latin American and Caribbean Center on Health Sciences Information (Bireme), Medline, Latin American & Caribbean Health Sciences Literature (Lilacs), Web of Science and Scopus; and the selected period was from 2008 to 2018.

Initially, 3,168 articles were found: 1,898 were deleted by duplicity in the databases; 1,075, after reading the title and abstract; and 29, because they are editorials, delimiting 166 articles selected for further careful reading. After applying the inclusion criteria, that is, articles published in full in peer review scientific journals; conducted in countries with universal health systems, resulting from quantitative or qualitative field research, there were, in the end, 63 articles left to compose the corpus of the study.

This study is linked to a research project called 'Access to Health as a Right in Universal Systems' of the Center for Integrated Research in Collective Health (Nupisc) of the State University of Feira de Santana (UEFS) – BA, evaluated by the Research Ethics Committee of the UEFS and approved under CAAE nº 65693716.7.0000.0053.

Results and discussions

The access to medicines in Brazil through the SUS occurs in two ways, either through the legal or extrajudicial way, or through the judicial way, in case the right is denied to the citizen. The percentage of access to medicines by SUS by the law between 2003 and 2015 was, on average, 50%⁶6 Matta SR, Bertoldi AD, Emmerick ICM, et al. Fontes de obtenção de medicamentos por pacientes diagnosticados com doenças crônicas, usuários do Sistema Único de Saúde. Cad. Saúde Pública. 2018; 34(3):1-13.^,1010 Monteiro CN, Gianini RJ, Barros MBA, et al. Access to medication in the Public Health System and equity: populational health surveys in São Paulo, Brazil. Rev bras epidemiol. 2016; 19(1):24-37.

11 Boing ACA, Bertoldi AD, Boing AF, et al. Acesso a medicamentos no setor público: análise de usuários do SUS no Brasil. Cad. Saúde Pública. 2013; 29(4):691-701.^-1212 Bertoldi AD, Barros AJD, Wagner A, et. al. Medicine access and utilization in a population covered by primary health care in Brazil. Health Police. 2009; 89:295-302.. The results show that, after 20 years of approval of the National Medicines Policy, free access to medicines through the SUS has increased in recent years. However, considering WHO parameters¹³13 World Health Organization. The World Medicines Situation Report [internet]. 3. ed. Geneva: WHO; 2011. [acesso em 2017 fev 12]. Disponível em: http://www.who.int/medicines.
http://www.who.int/medicines... , this percentage is classified between low and medium, especially in the context of a universal health system such as the Brazilian, in which a political paradox emerges that indicates flaws in the National Policy on Medicines and Pharmaceutical Assistance, affecting and compromising access to medicines.

When it comes to medicines intended for the treatment of chronic diseases, access through the SUS is around 45%¹⁴14 Tavares NUL, Luiza VL, Oliveira MA, et al. Acesso gratuito a medicamentos para tratamento de doenças crônicas no Brasil. Rev saúde pública. 2016; 50(supl2): 1s-10s.

15 Oliveira MA, Luiza VL, Tavares NUL, et al. Acesso a medicamentos para doenças crônicas no Brasil: uma abordagem multidimensional. Rev saúde pública. 2016; 50(supl2):1s-10s.

16 Katrein F, Tejada COV, Méndez-Restrepo MC, et al. Desigualdade no acesso a medicamentos para doenças crônicas em mulheres brasileiras. Cad. Saúde Pública. 2015; 31(7):1416-1426.^-1717 Viana KP, Brito AS, Rodrigues CS, et al. Acesso a medicamentos de uso contínuo entre idosos, Brasil. Rev saúde pública. 2015; 49(14):1-10., and increases for specific chronic diseases such as hypertension and diabetes, reaching 69% for hypertension and 75% for diabetes, without accounting for access through the Brazilian Popular Pharmacy (copayment)¹⁸18 Mengue SS, Bertoldi AD, Ramos LR, et al. Acesso e uso de medicamentos para hipertensão arterial no Brasil. Rev saúde pública. 2016; 50(2):8s, p.1s-9s.

19 Costa K, Francisco PMSB, Malta DC, et al. Fontes de obtenção de medicamentos para hipertensão e diabetes no Brasil: resultados de inquérito telefônico nas capitais brasileiras e no Distrito Federal, 2011. Cad. Saúde Pública. 2016; 32(2):1-13.

20 Barreto MNSC, Cesse EAP, Lima RF, et al. Análise do acesso ao tratamento medicamentoso para hipertensão e diabetes na Estratégia Saúde da Família no Estado de Pernambuco, Brasil. Rev bras epidemiol. 2015; 18(2):413-424.

21 Costa KS, Tavares NUL, Mengue SS, et al. Obtenção de medicamentos para hipertensão e diabetes no Programa Farmácia Popular do Brasil: resultados da pesquisa Nacional de Saúde, 2013. Epidemiol serv saúde. 2016; 25(1):33-44.

22 Paniz VMV, Fassa AG, Facchini LA, et. al. Free access to hypertension and diabetes medicines among the elderly: a reality yet to be constructed. Cad. Saúde Pública. 2010; 26(6):1163-1174.^-2323 Mengue SS, Tavares NUL, Costa, KS, et al. Fontes de Obtenção de medicamentos para tratamento da hipertensão arterial no Brasil: análise da pesquisa Nacional de Saúde, 2013. Rev bras epidemiol. 2015; 18(2):192-203.. Increased access to medicines for hypertension and diabetes is mainly due to the increasing prevalence of these diseases in the Brazilian population. This scenario led the Ministry of Health²⁴24 Brasil. Ministério da Saúde, Secretaria de Vigilância em Saúde, Departamento de Vigilância de doenças e agravos não transmissíveis e promoção da saúde. VIGITEL BRASIL 2016 - Vigilância de fatores de risco e proteção para doenças crônicas por inquérito telefônico. Brasília, DF: Ministério da Saúde; 2017. to create programs such as HiperDia²⁵25 Brasil. Ministério da Saúde. Portaria nº 371 de 04 de março de 2002. Instituir o Programa Nacional de Assistência Farmacêutica para Hipertensão Arterial e Diabetes Mellitus, parte integrante do Plano Nacional de Reorganização da Atenção a Hipertensão Arterial e Diabetes Mellitus. Diário Oficial da União [internet]. 4 Mar 2002. [acesso em 2016 nov 12]. Disponível em: http://www.saude.gov.br/doc/portarialei371.htm.
http://www.saude.gov.br/doc/portarialei3... to reorganize attention to the population segments with hypertension and diabetes, with the encouragement of the free distribution of antihypertensive and antidiabetic medicines through the Popular Pharmacy Program and the Health Program has no price²⁶26 Araujo JLO, Pereira MD, Bergamaschi CC, et al. Access to medicines for diabetes in Brazil: Evaluation of the "health has no price" program. Diabetol metab syndr 2016; 8(35):1191-1195..

After the creation, in 2010, of the Specialized Pharmaceutical Services Component (Ceaf) by the Ministry of Health, SUS started to offer, through Clinical Protocols and Therapeutic Guidelines (PCDT), access to high cost medicines, with improvements in the access to these medicines²⁷27 Rover MRM, Vargas-Pelaez CM, Farias MR, et al. Acceso a medicamentos de alto precio en Brasil: la perspectiva de médicos, farmacéuticos y usuarios. Gac. sanit. Barc, Ed impr. 2016; 30(2):110-116.. However, in PCDT, there are limiting barriers to access, such as problems in health system regulation, bureaucratic protocols and difficulties in accessing services for diagnostic tests and consultations to meet their requirements²⁷27 Rover MRM, Vargas-Pelaez CM, Farias MR, et al. Acceso a medicamentos de alto precio en Brasil: la perspectiva de médicos, farmacéuticos y usuarios. Gac. sanit. Barc, Ed impr. 2016; 30(2):110-116..

Although access to medicines through the SUS is universal, egalitarian and free to all Brazilian citizens and the result of a historical achievement legally put in practice, it is not yet a reality, as inequalities in access to medicines between the regions of Brazil are visible, especially in the socioeconomically disadvantaged regions that, to a certain extent, reproduce the socioeconomic inequality of the Country. In the South and Southeast regions, the achievement of medicines from the public system is higher⁶6 Matta SR, Bertoldi AD, Emmerick ICM, et al. Fontes de obtenção de medicamentos por pacientes diagnosticados com doenças crônicas, usuários do Sistema Único de Saúde. Cad. Saúde Pública. 2018; 34(3):1-13.^,1010 Monteiro CN, Gianini RJ, Barros MBA, et al. Access to medication in the Public Health System and equity: populational health surveys in São Paulo, Brazil. Rev bras epidemiol. 2016; 19(1):24-37.^,1818 Mengue SS, Bertoldi AD, Ramos LR, et al. Acesso e uso de medicamentos para hipertensão arterial no Brasil. Rev saúde pública. 2016; 50(2):8s, p.1s-9s.^,2323 Mengue SS, Tavares NUL, Costa, KS, et al. Fontes de Obtenção de medicamentos para tratamento da hipertensão arterial no Brasil: análise da pesquisa Nacional de Saúde, 2013. Rev bras epidemiol. 2015; 18(2):192-203.. Regional differences in the organization, structuring and financing of services impact on the pharmaceutical assistance provided.

In Brazil, universal access to medicines by the public sector is still a major challenge, because a large portion of the population still needs to resort to direct disbursement to obtain the medicines necessary for their treatment⁶6 Matta SR, Bertoldi AD, Emmerick ICM, et al. Fontes de obtenção de medicamentos por pacientes diagnosticados com doenças crônicas, usuários do Sistema Único de Saúde. Cad. Saúde Pública. 2018; 34(3):1-13.^,1515 Oliveira MA, Luiza VL, Tavares NUL, et al. Acesso a medicamentos para doenças crônicas no Brasil: uma abordagem multidimensional. Rev saúde pública. 2016; 50(supl2):1s-10s.^,1818 Mengue SS, Bertoldi AD, Ramos LR, et al. Acesso e uso de medicamentos para hipertensão arterial no Brasil. Rev saúde pública. 2016; 50(2):8s, p.1s-9s.^,1919 Costa K, Francisco PMSB, Malta DC, et al. Fontes de obtenção de medicamentos para hipertensão e diabetes no Brasil: resultados de inquérito telefônico nas capitais brasileiras e no Distrito Federal, 2011. Cad. Saúde Pública. 2016; 32(2):1-13.^,2323 Mengue SS, Tavares NUL, Costa, KS, et al. Fontes de Obtenção de medicamentos para tratamento da hipertensão arterial no Brasil: análise da pesquisa Nacional de Saúde, 2013. Rev bras epidemiol. 2015; 18(2):192-203.^,2828 Alvares J, Guerra-Junior AA, Araújo VL, et al. Acesso aos medicamentos pelos usuários da atenção primária no SUS. Rev. saúde pública. 2017; 51(2):1s-10s.. This reality represents a significant impairment of family income with health expenses and, consequently, characterizes a penalty to the population with lower purchasing power.

Inequalities of access also occur between different population strata⁶6 Matta SR, Bertoldi AD, Emmerick ICM, et al. Fontes de obtenção de medicamentos por pacientes diagnosticados com doenças crônicas, usuários do Sistema Único de Saúde. Cad. Saúde Pública. 2018; 34(3):1-13.^,77 Nascimento RCRM, Alvares J, Guerra-Junior AA, et al. Disponibilidade de medicamentos essenciais na atenção primária do SUS. Rev saúde pública. 2017; 51(supl2):1s-12s.^,1919 Costa K, Francisco PMSB, Malta DC, et al. Fontes de obtenção de medicamentos para hipertensão e diabetes no Brasil: resultados de inquérito telefônico nas capitais brasileiras e no Distrito Federal, 2011. Cad. Saúde Pública. 2016; 32(2):1-13.^,2626 Araujo JLO, Pereira MD, Bergamaschi CC, et al. Access to medicines for diabetes in Brazil: Evaluation of the "health has no price" program. Diabetol metab syndr 2016; 8(35):1191-1195.^,2929 Paniz VMV, Fassa AG, Facchini LA, et al. Acesso a medicamentos de uso contínuo em adultos e idosos nas regiões Sul e Nordeste do Brasil. Cad. Saúde Pública. 2008; 24(2):267-280.^,3030 Baldoni AO, Dewulf NLS, Santos V, et al. Dificuldades de acesso aos serviços farmacêuticos pelos idosos. Rev ciênc farm básica apl. 2014; 35(4):615-621., segments of the most socially vulnerable population have obtained their medicines through SUS, preferably because SUS is the health care option for this population.

Another way to obtain access to medicines in Brazil through the SUS is the use of judicial protection. It is a way of enforcing rights in the Judicial Branch when the citizen faces difficulties in access. In this case, most actions for requesting medication through the SUS are individual, that is, the decisions resulting from the demands only ensure the attendance of their applicants, opposing the principles of universality and equity³¹31 Pereira JR, Santos RI, Nascimento JJM, et al. Análise das demandas judiciais para o fornecimento de medicamentos pela Secretaria de Estado da Saúde da Santa Catarina nos anos de 2003 e 2004. Ciênc. Saúde Colet. 2010; 15:3551-3560.

32 Boing A, Bloemer NS, Fernandes S, et al. A judicialização do acesso aos medicamentos em Santa Catarina: um desafio para a gestão do sistema de saúde. Rev direito sanit. 2013; 14(1):82-97.

33 Pepe VLE, Ventura M, Sant'ana JMB, et al. Caracterização das demandas judiciais de fornecimento de medicamentos "essenciais" no Estado do Rio de Janeiro, Brasil. Cad. Saúde Pública. 2010; 26(3):461-471.

34 Carvalho MN, Leite SN. Itinerário dos usuários de medicamentos via judicial no estado do Amazonas, Brasil. Interface comun saúde educ. 2014; 18(51):737-748.

35 Stamford A, Cavalcanti M. Decisões judiciais sobre o acesso aos medicamentos em Pernambuco. Rev Saúde Pública. 2012; 46(5):791-99.

36 Campos-Neto OH, Acurcio FA, Machado MAA, et al. Médicos, advogados e indústria farmacêutica na judicialização da saúde em Minas Gerais, Brasil. Rev Saúde Pública. 2012; 46(5):784-790.

37 Lopes LC, Barberato-Filho S, Costa AC, et al. Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil. Rev Saude Publica. 2010; 44(4):620-628.

38 Chieffi AL, Barata RB. Judicialização da política pública de assistência farmacêutica e equidade. Cad. Saúde Pública. 2009; 25(8):1839-1849.

39 Lisboa ES, Souza LEPF. Por que as pessoas recorrem ao judiciário para obter acesso aos medicamentos? O caso das insulinas análogos na Bahia. Ciênc. Saúde Colet. 2017; 22(6):1857-1864.

40 Borges DCL, Ugá MAD. Conflitos e impasse da judicialização na obtenção de medicamentos: as decisões de 1ª instância nas ações individuais contra o Estado do Rio de Janeiro, Brasil. Cad. Saúde Pública. 2010; 26(1):59-69.^-4141 Machado MAA, Acurcio FA, Brandão CMR, et al. Judicialização do acesso a medicamentos no Estado e Minas Gerais, Brasil. Rev saúde pública. 2011; 45(5):590-598..

Likewise, access to justice is also unequal and conditioned by socioeconomic determinants, as evidenced by the predominance of representation of private lawyers in lawsuits and by prescriptions from private health services with plaintiffs, mostly from low-income population strata or no social vulnerability. These data indicate that people with lower purchasing power and unable to afford the lawsuits end up resorting less to judicial means⁴²42 Chieffi AL, Barata RB. Judicialização da política pública de assistência farmacêutica e equidade. Cad. Saúde Pública 2009; 25(8):1839-1849.

43 Lopes LC, Barberato-Filho S, Costa AC, et al. Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil. Rev saúde pública. 2010; 44(4):620-28.

44 Machado MAA, Acurcio FA, Brandão CMR, et al. Judicialização do acesso a medicamentos no Estado e Minas Gerais, Brasil. Rev saúde pública. 2011; 45(5):590-598.

45 Campos-Neto OH, Acurcio FA, Machado MAA, et al. Médicos, advogados e indústria farmacêutica na judicialização da saúde em Minas Gerais, Brasil. Rev saúde pública. 2012; 46(5):784-790.^-4646 Pereira JR, Santos RI, Nascimento JJM, et al. Análise das demandas judiciais para o fornecimento de medicamentos pela Secretaria de Estado da Saúde da Santa Catarina nos anos de 2003 e 2004. Ciênc. Saúde Colet. 2010; 15:3551-3560.. We understand that access to medicines through the judicial system in Brazil is reflecting and perpetuating inequalities in Brazilian society by privileging the portion of the population with the best socioeconomic conditions who have access to justice, in addition to reinforcing the individual right of citizens to the detriment of the collective.

In general, the requests for medicines not incorporated into the protocols and programs executed by SUS are high⁴⁶46 Pereira JR, Santos RI, Nascimento JJM, et al. Análise das demandas judiciais para o fornecimento de medicamentos pela Secretaria de Estado da Saúde da Santa Catarina nos anos de 2003 e 2004. Ciênc. Saúde Colet. 2010; 15:3551-3560.

47 Boing A, Bloemer NS, Fernandes S, et al. A judicialização do acesso aos medicamentos em Santa Catarina: um desafio para a gestão do sistema de saúde. Rev direito sanit. 2013; 14(1):82-97.

48 Chieffi AL, Barata RB. Judicialização da política pública de assistência farmacêutica e equidade. Cad. Saúde Pública. 2009; 25(8):1839-1849.

49 Machado MAA, Acurcio FA, Brandão CMR, et al. Judicialização do acesso a medicamentos no Estado e Minas Gerais, Brasil. Rev saúde pública. 2011; 45(5):590-598.^-5050 Macedo EI, Lopes LC, Barberato-Filho S. Análise técnica para a tomada de decisão do fornecimento de medicamentos pela via judicial. Rev saúde pública. 2011; 45(5):706-713., and the percentage of nonstandard medicines requested ranges from 56.7% to 77%. Most of the time, they are expensive medicines, some not approved by the National Health Surveillance Agency or requested for treatments that are not indicated, the off-label use; or clinical indications for which there is no clinical evidence of its efficacy³⁷37 Lopes LC, Barberato-Filho S, Costa AC, et al. Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil. Rev Saude Publica. 2010; 44(4):620-628.^,5050 Macedo EI, Lopes LC, Barberato-Filho S. Análise técnica para a tomada de decisão do fornecimento de medicamentos pela via judicial. Rev saúde pública. 2011; 45(5):706-713.. In Brazil, the incorporation of new health technologies by SUS passes the National Commission for incorporation of Health Technologies (Conitec)⁵¹51 Brasil. Lei nº 12.401 de 28 de abril de 2011. Dispõe sobre a assistência terapêutica e a incorporação de tecnologia em saúde no âmbito do Sistema Único de Saúde - SUS. Diário Oficial da União. 29 Abr 2011., which evaluates new technologies based on evidence of efficacy, accuracy, effectiveness and safety, as well as comparative economic evaluation of benefits and costs in relation to existing technologies, also aiming at the sustainability of the health system.

Finally, access to medicines in Brazil through the SUS involves problems related to the incorporation and supply of new medicines through the system, but mainly due to the difficulties faced by users to have access to medicines already covered.

In the English National Health Service, NHS, as well as Medicare, the Australian public health system, both considered universal systems, access to medicines occurs through a list of standardized medicines, with free access only in specific situations such as hospitalizations; treatments for diseases such as tuberculosis, sexually transmitted disease, mental disorder; elderly patients; pregnant women with children up to 1 year of age; students up to 18 years old; people with disabilities and low-income people. For the rest of the treatments, the provision is mediated by co-payment or co-participation, in which part of the expenses is covered by the health system and the other part comes from the direct disbursement of the user. Currently, in the United Kingdom, co-payment is around £ 8,40 per prescribed item⁵²52 Australian Institute of Health and Welfare. Australia's health 2016. Australia's health series no. 15. Cat. no. AUS 199. Canberra: AIHW.^,5353 NHS. Understand the News NHS. England: BMJ; 2017..

In both systems, the main dilemma is the incorporation of new technologies, including new medicines, through cost-effectiveness, safety, effectiveness assessments, in order to balance priorities and maintain equitable distribution of resources⁵⁴54 Wonder M, Milne R. Access to new medicines in New Zealand compared to Australia. N Z med j. 2011; 124(1346):12-28.

55 Wilson A, Cohen J. Patient access to new cancer drugs in the United States and Australia. Value Health. 2011; 14(6):944-52.

56 Karikios DJ, Schofield D, Salkeld G, et al. Rising cost of anticancer drugs in Australia. Intern Med J. 2014; c44(5):458-463.

57 Vitry A, Mintzes B, Lipworth. Access to new cancer medicines in Australia: dispelling the myths and informing a public debate. J Pharm Policy Pract. 2016; 9:13-18.

58 Chim L, Salkeld G, Kelly P, et al. Societal perspective on access to publicly subsidised medicines: a cross sectional survey of 3080 adults in Australia. PLos ONE. 2017; 12(3):1-24.

59 Mason A, Drummond M, Ramsey S, et al. Comparison of Anticancer Drug Coverage Decisions in the United States and United Kingdom: Does the Evidence Support the Rhetoric? J clin oncol. 2010; 28(20):3234-3238.

60 Zhang Y, Hueser HC, Hernandez I. Comparing the Approval and Coverage Decisions of New Oncology Drugs in the United States and Other Selected Countries. JMCP. 2017; 23(2):247-254.

61 Faden RR, Kalipso C, Apleby J, et al. Expensive cancer drugs: a comparison between the United States and the United Kington. Milbank q. 2009; 87(4):789-819.^-6262 Jaroslawski S, Toumi M. Design of Patient Access Schemes in the UK. Appl health econ. health policy. 2011; 9(4):209-215..

In the United Kingdom, the National Institute for Health Clinical Excellence (Nice) is a non-departmental public body that publishes guidelines in four areas, among them, the use of health technologies within the NHS, such as the use of new and existing medicines. Nice assessments lead to whether or not new technologies are incorporated into the NHS. Its assessments are based primarily on efficacy, cost-effectiveness and safety and are often used informally in drug price negotiations around the world⁶³63 Towse A. Value based pricing, research and development, and patient access schemes. Will the United Kingdom get it right or wrong? Br j clin. pharmacol. 2010; 70(3):360-366.. However, decisions based on cost effectiveness are usually associated with a range of more restrictions and delay in approving new technologies, with the average approval time or not of a 2-year medicine in Nice⁵⁹59 Mason A, Drummond M, Ramsey S, et al. Comparison of Anticancer Drug Coverage Decisions in the United States and United Kingdom: Does the Evidence Support the Rhetoric? J clin oncol. 2010; 28(20):3234-3238.^,6060 Zhang Y, Hueser HC, Hernandez I. Comparing the Approval and Coverage Decisions of New Oncology Drugs in the United States and Other Selected Countries. JMCP. 2017; 23(2):247-254.. In this respect, the center of discussion in most universal health systems is cancer treatment drugs, mainly due to the worldwide increase in the prevalence of the disease and the amount of high-cost cancer drugs⁵⁷57 Vitry A, Mintzes B, Lipworth. Access to new cancer medicines in Australia: dispelling the myths and informing a public debate. J Pharm Policy Pract. 2016; 9:13-18..

Nice faces controversy over decisions to deny cancer drugs, mainly, given the lack of therapeutic alternatives for specific cancers. Even using robust methodologies, there is a lack of available evidence on the efficacy of newly launched products compared to those available in the market⁵⁹59 Mason A, Drummond M, Ramsey S, et al. Comparison of Anticancer Drug Coverage Decisions in the United States and United Kingdom: Does the Evidence Support the Rhetoric? J clin oncol. 2010; 28(20):3234-3238.^,6262 Jaroslawski S, Toumi M. Design of Patient Access Schemes in the UK. Appl health econ. health policy. 2011; 9(4):209-215.^,6464 ONeill PO, Devlin NJ. An Analysis of NICE's "Restricted" (or "Optimized") Decisions. Pharmacoeconomics. 2010; 28(11):987-993..

Another controversial issue for Nice is the strategy sought to balance competing objectives of patients, taxpayers, in the face of the need to encourage innovation and protect the British pharmaceutical industry. In this case, one form of confrontation has been pharmaceutical price regulation that attempts to establish a fair return on pharmaceutical industry investment and flexible pricing that allows the price of a drug to be raised or lowered according to its evidence of effectiveness⁶¹61 Faden RR, Kalipso C, Apleby J, et al. Expensive cancer drugs: a comparison between the United States and the United Kington. Milbank q. 2009; 87(4):789-819., but if the medicine fails, the burden remains on the manufacturer, and must take up risk and reimburse the NHS. Another way to make Nice more flexible has been the Patient Access Schemes (PAS), which constitute alternative drug access agreements between the NHS and the high-cost drug manufacturers not yet approved by Nice where the manufacturer provides discounts for a specific patient, but not on the general price list, a fact that may increase the price paid by the NHS and indirectly influence the price of medicines worldwide⁶²62 Jaroslawski S, Toumi M. Design of Patient Access Schemes in the UK. Appl health econ. health policy. 2011; 9(4):209-215.^,6565 Ciu Y, Andrew JKO, Hammond A, et al. Access to the next wave of biologic therapies (Abatacept and Tocilizumab) for the treatment of rheumatoid arthritis in England and Wales. Clin rheumatol. 2012; 31(6):1005-1012.. However, the NHS is concerned about the high costs of implementing PAS and, at the same time, collecting evidence for approval of new technologies by Nice⁶³63 Towse A. Value based pricing, research and development, and patient access schemes. Will the United Kingdom get it right or wrong? Br j clin. pharmacol. 2010; 70(3):360-366.. A suggestion by members of the Conservative Party was to improve cooperation between Nice and the pharmaceutical companies, which should better demonstrate the clinical value of the product by shifting the burden of proof from Nice to them⁶⁶66 Carroll SBA. Is There Anything Nicer than NICE? A Question the Conservative Shadow Health Team Is Right to Ask. Value Health. 2009; 12(5):631-633..

In the Australian healthcare system, access to medicines is provided by the Australian Pharmaceutical Benefits Scheme (PBS) which subsidizes the value of preselected medicines to the population. Retirees, the elderly, the unemployed and other vulnerable people pay substantially less than the rest of the population, and medicines given in hospitals are free. To be on the PBS list, medicines must be approved by the Pharmaceutical Benefit Advisory Coommitee (PBAC), an independent body responsible for evaluating the medicine through cost-effectiveness and clinical needs analysis. However, like Nice, PBAC faces problems regarding the quality and strength of experimental evidence to prove the clinical efficacy of new drugs, especially those for cancer treatment⁵⁴54 Wonder M, Milne R. Access to new medicines in New Zealand compared to Australia. N Z med j. 2011; 124(1346):12-28..

The co-payment adopted as the main form of access to medicines by the United Kingdom, Australia and Canada is considered by some authors as a hindrance to access to medicines⁶⁷67 Kesselheim AS, Huybrechts KF, Choudhry NK, et al. Prescription drug insurance coverage and patient health outcomes: a systematic review. Am j public health 2015; 105:17-30.^,6868 Mann BS, Barnieh L, Tang K, et al. Association between drug insurance cost sharing strategies and outcomes in patients with chronic diseases: a systematic review. PLos ONE. 2014;3:1-8.; and, by others, as a way of maintaining the sustainability of the systems. This maintenance would be achieved by controlling the abuse of medicines, especially in view of the increasing health expenses due to population aging, poor health habits and the increasing prevalence of associated chronic diseases⁶³63 Towse A. Value based pricing, research and development, and patient access schemes. Will the United Kingdom get it right or wrong? Br j clin. pharmacol. 2010; 70(3):360-366.^,6464 ONeill PO, Devlin NJ. An Analysis of NICE's "Restricted" (or "Optimized") Decisions. Pharmacoeconomics. 2010; 28(11):987-993.^,6969 Weale A, Clark S. Co-payments in the NHS: an analysis of the normative arguments. Health econ policy law. 2010; 5(2):225-246.^,7070 Manning J. Priority-setting processes for medicines: the United Kingdom, Australia and New Zealand. J L Med. 2011; 18(3):439-452.. However, in Australia, a 24% increase in copayments in 2005 led to a significant reduction in dispensing volumes of 12 drug categories⁷¹71 Hynd A, Roughead EE, Preen DB, et al.The Impact of co-payment increases on dispensings of governement-subsidised medicines in Australia. Pharmacoepidemiol Drug Saf. 2008; 17:1091-1099., including Parkinson's drugs, platelet antiaggregant drugs and osteoporosis drugs. The reduction was greater for the most vulnerable population, whose copayments are lower than the general population, a serious situation, as discontinuation of the use of drugs for chronic diseases can aggravate the morbid condition of the patient and lead to death.

Since 2000, the expenses of the Australian system with medicines for cancer treatment has increased by 20% per year, the use of cost-effective comparative studies has led to restrictions on access, late approvals and controversies in society, thus, the PBAC has made difficult choices trying to balance priorities and equitable allocation of resources⁵⁴54 Wonder M, Milne R. Access to new medicines in New Zealand compared to Australia. N Z med j. 2011; 124(1346):12-28.^,5555 Wilson A, Cohen J. Patient access to new cancer drugs in the United States and Australia. Value Health. 2011; 14(6):944-52.^,5757 Vitry A, Mintzes B, Lipworth. Access to new cancer medicines in Australia: dispelling the myths and informing a public debate. J Pharm Policy Pract. 2016; 9:13-18.. The evidence-based approach now adopted in Australia is associated with low prices and better accessibility and has the approval of the population⁷²72 Robertson J, Newby DA, Walkon EJ. Health Care Spending: Changes in the Perceptions of the Australian Public. PLos ONE. 2016; 11(6):1-12.. Despite the high prevalence of cancer in Australia, the country has one of the lowest mortality rates among developed countries due to its universal public drug tracking and funding policy⁵⁷57 Vitry A, Mintzes B, Lipworth. Access to new cancer medicines in Australia: dispelling the myths and informing a public debate. J Pharm Policy Pract. 2016; 9:13-18..

In Canada, a country which also has a universal health system, each province or territory has its own health system, but is subject to the Canada Health Act⁷³73 Canadá Health Act. Annual Report 2016-2017. Health Canada. Otawa, 2019. which establishes the universality of primary health services. However, each province has its own way of operating the system and sets out what is specifically covered beyond primary services. That is, it is not about one health system, but 15. This means that each province can choose how its health system works based on the particular needs of its respective residents.

However, for all provinces, the law does not ensure drug coverage, with the exception of blood products, vaccines, and medicines given in hospitals and outpatients that are fully funded by the system⁷³73 Canadá Health Act. Annual Report 2016-2017. Health Canada. Otawa, 2019.. With regard to outpatient medications, all Canadian provinces currently fund drug insurance plans that are available to all residents. Citizens with incomes of U$ 55,000 or more may not receive any financial support for their medicines from government insurance plans. However, one in 10 Canadians who receive a prescription reports cost-related non-adherence, and the lack of drug insurance coverage seems to be one of the main reasons behind this phenomenon⁷⁴74 Wang C, Quing L, Sweetman A, et al. Mandatory universal drug plan, access to health care and health: evidence from Canada. J. health econ. 2015; 44:80-96.^,7575 David JT, Campbell MD, Braden JM, et al. Comparison of Canadian public medication insurance plans and the impact on out-of-pocket costs. CMAJ Open. 2017; 5(4):808-813..

The use of age-based plans and income-based coverage varies across the country. In addition, each province and, occasionally, different plans within a province use a variety of cost sharing mechanisms, this variation leads to different direct costs for the same type of patient depending on the province of residence. Finally, the situation of pharmaceutical insurance plans in Canada is that of a 'patchwork quilt', with each province having separate medicine insurance plans. This leads to variations in copayment values in all provinces⁷⁴74 Wang C, Quing L, Sweetman A, et al. Mandatory universal drug plan, access to health care and health: evidence from Canada. J. health econ. 2015; 44:80-96.^,7676 Lemos ML, Boyce K. Comparison of cancer drug access and funding in three Canadian provinces. J clin oncol. 2011; 9(15):1-16.^,7777 Chafe R, Culyer A, Dobrow M, et al. Access to cancer drugs in Canada: looking beyond coverage decisions. Health Policy. 2011; 6(3):27-36.

High-cost therapies such as cancer drugs also have varying coverage across provinces. Variations range from medicine eligibility criteria, bureaucratic procedures for access to copayment value; this situation results in cancer patients in different provinces with access to differentiated medicines, which puts equity and equal access at risk⁷⁴74 Wang C, Quing L, Sweetman A, et al. Mandatory universal drug plan, access to health care and health: evidence from Canada. J. health econ. 2015; 44:80-96.^,7676 Lemos ML, Boyce K. Comparison of cancer drug access and funding in three Canadian provinces. J clin oncol. 2011; 9(15):1-16.^,7777 Chafe R, Culyer A, Dobrow M, et al. Access to cancer drugs in Canada: looking beyond coverage decisions. Health Policy. 2011; 6(3):27-36..

A pungent perspective in the academic literature of Canada is the creation of a National Pharmacy System to replace the current pharmaceutical insurance patchwork system, a universal system, with public coverage of prescription drugs across Canada, including limited patient copayments and a basic list of medications available to all Canadians. Recent research has shown that the national system could reduce private insurers' costs by U$ 8,2 billion and increase costs for public plans by U$ 1 billion, a total reduction in drug spending of U$ 7,3 billion. This savings would be achieved through the creation of greater market share, thereby, allowing, lower prices for medicines to be negotiated. The analysis also assumes that a larger market would also be more efficient in medicine selection⁷⁵75 David JT, Campbell MD, Braden JM, et al. Comparison of Canadian public medication insurance plans and the impact on out-of-pocket costs. CMAJ Open. 2017; 5(4):808-813..

In chart 2, we highlight the main challenges and perspectives faced by the Australian, Brazilian, Canadian, and English health systems.

Final considerations

Although the four health systems studied are considered universal, there are major differences between them, especially regarding their structure, management, organization, maturity, financing, size and distribution of morbidities in populations. These differences, whose complexity, per se, require analysis, do not allow comparative studies to be carried out, but they do not prevent us from analyzing their main dilemmas and perspectives on the future. The United Kingdom and Australian systems are systems with massive public health financing and investments, where economic rationality is important for their sustainability. In them, access to medicines for the majority of the population is through copayments and it is precisely the issue of incorporating new technologies, such as high-cost medicines, that is the center of attention of these systems.

These systems, through Nice (United Kingdom) and PBAC (Australia), by incorporating medicines via cost-effectiveness analysis, have been trying to fulfill the difficult task of reconciling social justice, equity and equal access with economic sustainability.

Canada, although recognized as a developed country, still faces the dilemma of how to fund a health care system in which access to medicines is also universal, as Canadian health law does not ensure medicine coverage. All provinces have some type of medicine coverage plan, and the variability is very large, leading to differentiation among Canadian citizens, hurting equality within the system. The problem is greater when it comes to expensive medicines such as anticancer drugs, in which case copayments can be of high value, a circumstance that hinders access for patients.

Brazil, in turn, lives with two problematic realities: the first one regarding the guarantee of access to medicines that are already standardized by the SUS in the face of poor health financing and a growing population; the second, similarly to the Australian, Canadian and English systems, is the dilemma of how to incorporate new effective and economically viable medicines. Added to this is the issue of the judicialization of health, a complex phenomenon that results from public fragility in the organization, financing, consolidation, regulation, supervision and control of the SUS.

This study provided a synthesis of production on access to medicines in Australia, Brazil, Canada and the United Kingdom universal health systems, signaling the main challenges and perspectives of these systems in the task of providing rational and equitable access to their citizens. In this way, it may contribute to the reflection of health managers on the difficulties of balancing the promotion of access to medicines and the sustainability of health systems. In the present integrative review, despite the careful inclusion of peer-reviewed primary studies, the limitations of the study refer to the sample, since only articles available online and the small number of studies found on access to the study were included. Australia and Canada may have hampered the analysis.

References

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