From Sandbox to Pandemic: Agile Reform of Canadian Drug Regulation

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new agile licensing framework known as the Advanced Therapeutic Pathway (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. In addition, Bill C-97 informed Canada’s COVID-19 response in important ways, particularly in relation to clinical trials. The measures adopted by the drug regulatory authority, Health Canada (HC) during COVID- 19 may become the new norm in Canadian regulatory practice insofar as they help achieve the amend- ments introduced by Bill C-97. Finally, despite government rhetoric of transparency, the agenda-setting, formulation, and implementation of the amendments have occurred with little opportunity for scrutiny or public engagement

Transparency Too Little, Too Late? Why and How Health Canada Should Make Clinical Data and Regulatory Decision-Making Open to Scrutiny in the Face of COVID-19

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the number and use of expedited review processes for COVID-19 therapies, and at the same time, the proliferation of misinformation about any potential SARS-CoV-2 intervention4 reveals the limitations of recently implemented transparency measures

TURK SAGLIK SEKTORUNDE FINANSALLASMANIN GELISEN BOYUTLARI

Bu çalışma 2003 yılından beri Sağlıkta Dönüşüm Programı çerçevesinde sağlık hizmetleri sunumunun ve finansmanının neoliberal yeniden yapılandırılması ile finans sermayesinin sağlık sektörüne artan eklemlenmesi arasındaki ilişkiyi inceleyecektir. Çalışma neoliberal yeniden yapılandırma politikaları çerçevesinde finans sermayesinin sağlık sektörüne eklemlenmesinin a) hangi alanlar/mekanizmalar dolayımı ile gerçekleştiğini, b)düzeyini ve etkinliğini c) siyasi ve sosyal sonuçlarını araştırmayı amaçlamaktadır

Domestic contours of global regulation: Understanding the policy changes on pharmaceutical patents in India and Turkey

The last two decades saw sweeping changes in the pharmaceutical patent policies of the developing countries from weak/non patentability to strong patent regimes. Analysing the policy change from a political economy approach, this paper pursues two simultaneous objectives. Firstly, it explores the common factors underlying the recent changes in the pharmaceutical patent policies of the developing countries. Secondly, it analyses the sources of the differential policy outcomes on pharmaceutical patents in India and Turkey

Pharmaceuticals and intellectual property rights: A political economy of the recent policy changes across the developing world and in Turkey

This paper explores the sources of the recent policy changes from weaker to stronger intellectual property regimes (IPRs) for pharmaceuticals across the developing world, and in Turkey. Analysing the policy change from a political economy approach, the paper argues that the increased structural power of the transnational capital in the 1980s had been the most important common factor in setting the ground for changes in the IPRs for pharmaceuticals across the developing world. Against the state-centric theories that interpret the policy change primarily as a matter between the nation states from developed and developing countries, the paper contends that the nature and scope of policy outcomes on pharmaceutical IPRs have been shaped by the dynamics of the class struggles across the developing world. The latter argument is supported through an analysis of the Turkish public policy processes and outcomes which resulted in strengthening the IPR for pharmaceuticals. The paper concludes that rather than a mere external imposition on the ‘’Turkish state’’ by the advanced capitalist countries or the European Union (EU), the policy change in favour of stronger IPRs for pharmaceuticals was sustained and shaped by the Turkish conglomerate capital which pursued reintegration with the transnational capital as a political strategy.Publisher's Versio

Financialisation in health care: An analysis of private equity fund investments in Turkey

The 2007-2008 global financial crisis revived interest in the impacts of financial markets and actors on our social and economic life. Nevertheless, research on health care financialisation remains scant. This article presents findings from research on one modality of financial investments in health care: global private equity funds' investments in private hospitals. Adopting a political economy approach, it analyses the drivers and impacts of the upsurge of global private equity investments in the Turkish private hospital sector amid the global financial crisis. The analysis derives from review of research and archival literature, as well as six in-depth interviews held with owners/executive board directors/general managers of the largest private hospital chains in Turkey and the general partners of their PE investors. The interviewing process took place between January and November 2016. All interviews were conducted by the author in Istanbul. The findings point to a mutually reinforcing relationship between neoliberal policies and financialisation processes in health care. The article shows that neoliberal healthcare reforms, introduced under consecutive Justice and Development Party (JDP) governments in Turkey, have been important precursors of private equity investments in healthcare services. These private equity investments, in turn, intensified and broadened the process of marketisation in health care services. Four impacts are identified, through which private equity investments hasten the marketisation of health care services. These relate to the impacts of private equity investments on a) advancing the process of chain formation by large hospital groups, b) spreading financial imperatives into the operations of private hospitals c) fostering internationalisation of capital, and d) augmenting inequities in access to health care services and standards

Transparency Too Little, Too Late? Why and How Health Canada Should Make Clinical Data and Regulatory Decision-Making Open to Scrutiny in the Face of COVID-19

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the number and use of expedited review processes for COVID-19 therapies, and at the same time, the proliferation of misinformation about any potential SARS-CoV-2 intervention4 reveals the limitations of recently implemented transparency measures

The prevalence of childhood psychopathology in Turkey: a cross-sectional multicenter nationwide study (EPICPAT-T).

Aim: The aim of this study was to determine the prevalence of childhood psychopathologies in Turkey