Modes of coordination for health technology adoption: Health Technology Assessment agencies and Group Procurement Organizations in a polycentric regulatory regime.

The challenge of novel and high cost health technologies has encouraged the growth of regulatory agencies such as Health Technology Assessment (HTA) organizations and Group Procurement Organizations (GPO). Yet the existence of several agencies in the same polycentric regulatory regime raises questions about whether and how their work can be coordinated. Drawing on a case study of GPOs and HTA agencies across four provinces in Canada, involving document review and key informant interviews (n = 44) conducted between 2013 and 2016, we explore the separate evolution of these agencies, emerging connections between them for non-drug technologies, and the organizational processes and evaluative judgments that underpin coordination efforts. HTA agencies and GPOs developed separately; connections emerged recently in three provinces and suggest four modes of coordination. One mode aligns most closely with that recommended by health economists and HTA practitioners, whereby HTA precedes procurement, with coverage decisions informing technology acquisition. The second mode is a version of the first, where procurement refers cases to HTA for coverage or technology management support; unlike the first, it recognizes procurement's evaluative strengths. Yet both the first and second modes focus on exceptional cases and will be infrequent. The third mode is more systemic, reflecting a generalized complementary of purpose as public agencies. HTA could support GPOs in contested technology acquisition efforts through timely and responsive input, while procurement could expand HTA's impact and inform HTA's growing interest in responsible innovation and environmental sustainability. The final mode is non-coordination, reflecting the potential for agencies to occupy quite distinct regulatory niches within the same regime. We conclude that consistency and convergence around a single model of resource allocation is not inevitable; nor is it necessary for coordinated effort. Thus, where differences in regulatory practice and epistemology persist, mutual accommodation and shared learning may prove most productive.

Changes of China's regulatory regime on commercial artificial breeding of terrestrial wildlife in time of COVID-19 outbreak and impacts on the future.

The basic attitude of Chinese law towards wildlife resources is differentiated protection plus rational utilizations. Artificial breeding of terrestrial wildlife was a big business and a way to alleviate poverty, but also raised concerns over wildlife conservation and public health. China's complete ban on the consumption of terrestrial wildlife, whether wild-sourced or artificially bred, was a drastic change of China's legal regime on wildlife conservation and commercial artificial breeding. This change will have impacts on the drafting of a new Biosafety Law and the revision and enforcement of the Wildlife Protection Law, the Husbandry law, the Fisheries Law, and the Animal Epidemic Prevention Law.

A "not-for-profit" regulatory model for legal recreational cannabis: Insights from the regulation of gaming machine gambling in New Zealand.

A dozen or more regulatory frameworks have been proposed for legal cannabis but many of the "not-for-profit" options have yet to be developed in any detail, reducing the likelihood they will be seriously considered by policy makers. New Zealand's innovative "not-for-profit" regulatory regime for gaming machine gambling (i.e. "slot machines") has reversed the previous increase in gambling expenditure, empowered local councils to cap the number of gambling venues, and is unique in requiring the societies operating gaming machines to distribution 40% of the gross expenditure from machines (i.e. $NZ 262 million in 2015) to community purposes (e.g. sports). However, the regime has been criticised for not addressing the concentration of gaming outlets in poorer communities, and not requiring grants to be allocated in the disadvantaged communities where outlets are located. There have also been cases of gaming societies providing community grants in exchange for direct or indirect benefits. In this paper we adapt this regulatory approach to a legal cannabis market. Under the proposed regime, licensed "not-for-profit" cannabis societies will be required to distribute 20% of cannabis sales to drug treatment and 20% to community purposes, including drug prevention. Grants must be allocated in the regions where cannabis sales are made and grant committees must be independent from cannabis societies. A 20% levy will be used to cover the wider health costs of cannabis use. A further 10% levy will be used to fund the regulator and evaluate the new regime. Local councils will have the power to decide how many, and where, cannabis retail outlets are located. Other important elements include a minimum price for cannabis, effective taxation of cannabis products, regulating CBD in cannabis products, higher taxation of traditional smoking products, advertising restricted to place-of-sale, no internet sales, and restrictions on industry involvement in regulation making and research.

Alcohol and cannabis: Comparing their adverse health effects and regulatory regimes.

The claim that the adverse health effects of cannabis are much less serious than those of alcohol has been central to the case for cannabis legalisation. Regulators in US states that have legalised cannabis have adopted regulatory models based on alcohol. This paper critically examines the claim about adverse health effects and the wisdom of regulating cannabis like alcohol. First, it compares what we know about the adverse health effects of alcohol and cannabis. Second, it discusses the uncertainties about the long term health effects of sustained daily cannabis use. Third, it speculates about how the adverse health effects of cannabis may change after legalisation. Fourth, it questions the assumption that alcohol provides the best regulatory model for a legal cannabis market. Fifth, it outlines the major challenges in regulating cannabis under the liberal alcohol-like regulatory regimes now being introduced.

Política de saneamento básico no Brasil: discussão de uma trajetória / Basic sanitation policy in Brazil: discussion of a path

O artigo demonstra que a posição de dominância das empresas estaduais de saneamento condiciona o processo decisório da política pública de saneamento no Brasil. A hegemonia dessas empresas é aqui explicada por meio da análise de uma trajetória que foi capaz de criar incentivos políticos e econômicos que permitiram sua consolidação no tempo. A partir da análise de conteúdo da legislação proposta para o setor e do material produzido pelos grupos de interesse envolvidos na aprovação de um novo marco regulatório setorial em 2007, o trabalho identifica as principais fontes de incentivo instituídas pela adoção do Plano Nacional de Saneamento que explicariam determinados aspectos estruturais na política atual de saneamento e sua forte resiliência às inovações propostas no contexto democrático.(AU)

This article demonstrates that the position of dominance enjoyed by state sanitation companies dictates the public policy decision-making process for sanitation in Brazil. These companies’ hegemony is explained here through the analysis of a path that generated political and economic incentives that have permitted its consolidation over time. Through the content analysis of the legislation proposed for the sector and the material produced by the stakeholders involved in the approval of new regulations for the sector in 2007, the study identifies the main sources of incentive introduced by the adoption of the National Sanitation Plan, which explain certain structural features of the current sanitation policy and its strong capacity to withstand the innovations proposed under democratic rule.(AU)

Política de saneamento básico no Brasil: discussão de uma trajetória / Basic sanitation policy in Brazil: discussion of a path

Resumo O artigo demonstra que a posição de dominância das empresas estaduais de saneamento condiciona o processo decisório da política pública de saneamento no Brasil. A hegemonia dessas empresas é aqui explicada por meio da análise de uma trajetória que foi capaz de criar incentivos políticos e econômicos que permitiram sua consolidação no tempo. A partir da análise de conteúdo da legislação proposta para o setor e do material produzido pelos grupos de interesse envolvidos na aprovação de um novo marco regulatório setorial em 2007, o trabalho identifica as principais fontes de incentivo instituídas pela adoção do Plano Nacional de Saneamento que explicariam determinados aspectos estruturais na política atual de saneamento e sua forte resiliência às inovações propostas no contexto democrático.

Abstract This article demonstrates that the position of dominance enjoyed by state sanitation companies dictates the public policy decision-making process for sanitation in Brazil. These companies’ hegemony is explained here through the analysis of a path that generated political and economic incentives that have permitted its consolidation over time. Through the content analysis of the legislation proposed for the sector and the material produced by the stakeholders involved in the approval of new regulations for the sector in 2007, the study identifies the main sources of incentive introduced by the adoption of the National Sanitation Plan, which explain certain structural features of the current sanitation policy and its strong capacity to withstand the innovations proposed under democratic rule.

O regime regulatório e o mercado de planos de saúde no Brasil / The regulatory regime and the health insurance industry in Brazil

O artigo analisa o regime de regulação do mercado de planos privados de assistência à saúde o Brasil. Identifica a origem da Agência Nacional de Saúde Suplementar (ANS) e descreve os instrumentos de regulação que detém para intervir na indústria de planos e seguro saúde brasileira. Estabelece a associação do modelo organizacional da agência independente aplicado à ANS aos processos de privatização e desenvolvimento da regulação dos serviços públicos de monopólio natural no Brasil. O artigo demonstra que o regime de regulação afeta fortemente as condições de entrada e saída do mercado de planos de saúde.

This paper analyzes the regulatory regime for health insurance and prepayment schemes in Brazil. It describes the ideas that have influenced the creation of the Agência Nacional de Saúde Suplementar-ANS (National Agency of Supplementary Health) in 2000, showing that the independent agency model was a direct result of the privatization process and of the induction of new competition mechanisms in a natural state monopoly. The paper concludes that the prepayment firms in Brazil are facing a new institutional environment as refers to their market entry or exit conditions.

Estratégia profissional e mimetismo empresarial: os planos de saúde odontológicos no Brasil / Professional strategy and institutional isomorphism: the dental health insurance industry in Brazil

O artigo analisa o modelo organizacional das empresas de planos de saúde odontológicos das modalidades de cooperativas de profissionais e a odontologia de grupo para compreender a dinâmica da oferta de serviços odontológicos no país. Adotou-se como referência a formulação institucionalista de Di Maggio e Powell. O mercado de planos de saúde odontológico é pulverizado, com o predomínio de empresas de pequeno porte, e apresenta um grande dinamismo, que favorece as empresas de pequeno, médio e alto porte. As modalidades analisadas concentram a maior proporção de beneficiários e receitas. A análise geral do desempenho do setor revela impressionante dinamismo na captação de clientes, mesmo após a criação da ANS. O regime de regulação tem imposto um novo padrão institucional à entrada, permanência e saída das empresas no mercado, que não afeta o desempenho setorial. Os dados analisados evidenciam que o setor de planos de saúde odontológicos é altamente rentável, apresentando uma grande capacidade na geração de receitas que explica o crescimento e a permanência destas modalidades no mercado. Os padrões de rentabilidade média, principalmente das empresas de odontologia de grupo, são extremamente elevados, ficando muito acima de qualquer atividade empresarial do Brasil.

This article analyzes the organizational model of the dental health industry. The main organizational leaders in this industry are the professional cooperatives and group dental insurance companies. The theoretical basis of the article is the organizational theory developed by Di Maggio and Powell. The dental health industry consists of a great number of small and very dynamic companies, however an expressive part of clients and profit are concentrated in a few large companies. The results show that the industry has expanded the number of clients after the creation of the National Health Insurance Agency. The regulation regime has forced institutional changes in the firms with regard to the market entry, permanence or exit patterns. There was no evidence that the regulatory rules have interfered with the development and financial conditions of the industry. The average profitability of the sector, especially among the group dental insurance companies, is extremely high.