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6.
J Leg Med ; 39(2): 121-136, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31503528

RESUMO

Empowered to play a larger role in the delivery and administration of health care, a number of states are attempting to solve the pharmaceutical pricing crisis in creative and varied ways. This essay summarizes three particular states' more activist approaches, including states that have sought to empower their Medicaid programs to limit coverage of certain drugs based on price, attempted to use leverage to impose cost-efficiency requirements, and, in the most dramatic example, relied on new usage of "gouging" laws to bring down the costs of prescription drugs. Although all three approaches have met substantial resistance, they illustrate a new era of state experimentation in an effort to bring down the cost of prescription drugs.


Assuntos
Controle de Custos , Custos de Medicamentos/legislação & jurisprudência , Honorários Farmacêuticos/legislação & jurisprudência , Medicamentos sob Prescrição/economia , Governo Estadual , Custos e Análise de Custo/legislação & jurisprudência , Política de Saúde/economia , Política de Saúde/legislação & jurisprudência , Legislação como Assunto , Maryland , Massachusetts , Medicaid/legislação & jurisprudência , New York , Ativismo Político , Estados Unidos
9.
J Leg Med ; 39(2): 177-211, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31503531

RESUMO

The federal government subsidizes the research and development of prescription medications. Thus, a captivating critique of expensive medications is that prices are too high because of taxpayer co-financing. This critique is often framed in terms of "paying-twice"-first for the research and second through the above market pricing of resulting products. Reasonable pricing clauses-which place some kind of pricing limitation on the exercise of license or patent rights governing a federally funded medication-are one proposed policy tool for addressing the pay-twice critique. This article provides increased analytical clarity as well as historical context to present-day debates about the privatization of federally funded research and prescription drug pricing. It makes three arguments. First, despite its pervasiveness and intuitive plausibility, the pay-twice critique is subject to differing interpretations which has important implications for the appropriateness of proposed solutions. Second, despite their initial attractiveness, the costs, necessity, and effectiveness of reasonable pricing clauses render the wisdom of this policy tool uncertain. However, third, given continued interest in reasonable pricing clauses, the NIH's previous experience with such a policy offers some useful lessons.


Assuntos
Custos de Medicamentos/legislação & jurisprudência , Controle de Medicamentos e Entorpecentes/economia , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Legislação de Medicamentos/economia , Medicamentos sob Prescrição/economia , Honorários por Prescrição de Medicamentos/legislação & jurisprudência , Custos e Análise de Custo/economia , Custos e Análise de Custo/legislação & jurisprudência , Governo Federal , Financiamento Governamental , National Institutes of Health (U.S.) , Pesquisa Farmacêutica/economia , Pesquisa Farmacêutica/legislação & jurisprudência , Privatização/economia , Privatização/legislação & jurisprudência , Estados Unidos
10.
J Leg Med ; 39(2): 151-167, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31503532

RESUMO

U.S. consumers pay high drug prices. Brand-name drug companies claim that these prices are justified by pathbreaking research and development. But, sometimes the prices result from anticompetitive conduct. This article offers three case studies of how such behavior can increase price based on wakefulness drug Provigil, the allergic-reaction-treating EpiPen, and infection-treating Daraprim. The article contends that behavior that makes no sense other than by harming a competitor, that undercuts a regulatory regime, or that involves collusive conduct should not be protected. In targeting this behavior, antitrust scrutiny promises to lower drug prices.


Assuntos
Custos de Medicamentos/ética , Custos de Medicamentos/legislação & jurisprudência , Honorários Farmacêuticos/ética , Honorários Farmacêuticos/legislação & jurisprudência , Modafinila/economia , Pirimetamina/economia , Leis Antitruste , Indústria Farmacêutica/economia , Indústria Farmacêutica/ética , Indústria Farmacêutica/legislação & jurisprudência , Competição Econômica , Humanos , Estados Unidos
14.
Expert Opin Ther Pat ; 29(8): 653-662, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31298053

RESUMO

Introduction: The Ecuadorian Institute of Intellectual Property (IEPI) granted several compulsory licenses between 2011 and 2017. In 2009, the President of Ecuador signed a decree that was intended to facilitate the request of compulsory licenses (CL) in the country, not only for Enfarma EP but for any privately owned local company in order to produce more accessible medicines. Areas covered: The national and international regulatory framework of pharmaceutical patents and the local applicability of CL in Ecuador. The authors also analyzed the results of requesting unplanned and epidemiologically unnecessary CL at a national level. Finally, the authors reviewed the effects of requesting, granting or denying CL on price per unit in the last 7 years of available data. Expert opinion: The authors think that compulsory licenses are useful tools when negotiating drug prices or when the demand cannot be satisfied due to economic constrain within the local health system. However, the authors' experience suggests that Ecuador did not have an established and reliable production system neither an adequate plan before requesting CL, therefore the positive effects of this measure were not clearly established.


Assuntos
Custos de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Licenciamento/economia , Indústria Farmacêutica/economia , Equador , Acesso aos Serviços de Saúde , Humanos , Propriedade Intelectual , Patentes como Assunto/legislação & jurisprudência , Preparações Farmacêuticas/economia , Preparações Farmacêuticas/provisão & distribução
15.
Int J Equity Health ; 18(1): 89, 2019 06 13.
Artigo em Inglês | MEDLINE | ID: mdl-31196109

RESUMO

BACKGROUND: Out-of-pocket (OOP) payments can constitute a major barrier for affordable and equitable access to essential medicines. Household surveys in Kyrgyzstan pointed to a perceived growth in OOP payments for outpatient medicines, including those covered by the benefits package scheme (the Additional Drug Package, ADP). The study aimed to explore the extent of co-payments for ADP-listed medicines and to explain the reasons for developments. METHODS: A descriptive statistical analysis was performed on prices and volumes of prescribed ADP-listed medicines dispensed in pharmacies during 2013-2015 (1,041,777 prescriptions claimed, data provided by the Mandatory Health Insurance Fund). Additionally, data on the value and volume of imported medicines in 2013-2015 (obtained from the National Medicines Regulatory Agency) were analysed. RESULTS: In 2013-2015, co-payments for medicines dispensed under the ADP grew, on average, by 22.8%. Co-payments for ADP-listed medicines amounted to around 50% of a reimbursed baseline price, but as pharmacy retail prices were not regulated, co-payments tended to be higher in practice. The increase in co-payments coincided with a reduction in the number of prescriptions dispensed (by 14%) and an increase in average amounts reimbursed per prescription in nearly all therapeutic groups (by 22%) in the study period. While the decrease in prescriptions suggests possible underuse, as patients might forego filling prescriptions due to financial restraints, the growth in average amounts reimbursed could be an indication of inefficiencies in public funding. Variation between the regions suggests regional inequity. Devaluation of the national currency was observed, and the value of imported medicines increased by nearly 20%, whereas volumes of imports remained at around the same level in 2013-2015. Thus, patients and public procurers had to pay more for the same amount of medicines. CONCLUSIONS: The findings suggest an increase in pharmacy retail prices as the major driver for higher co-payments. The national currency devaluation contributed to the price increases, and the absence of medicine price regulation aggravated the effects of the depreciation. It is recommended that Kyrgyzstan should introduce medicine price regulation and exemptions for low-income people from co-payments to ensure a more affordable and equitable access to medicines.


Assuntos
Custos de Medicamentos/legislação & jurisprudência , Custos de Medicamentos/estatística & dados numéricos , Medicamentos Essenciais/economia , Financiamento Governamental/legislação & jurisprudência , Financiamento Governamental/estatística & dados numéricos , Gastos em Saúde/legislação & jurisprudência , Gastos em Saúde/estatística & dados numéricos , Humanos , Quirguistão
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