Understanding of for whom, under what conditions and how the compulsory licensing of pharmaceuticals works in Brazil and Thailand: A realist synthesis

Abstract

When pharmaceuticals are not fully available mainly due to the high cost of medicines, a government can issue compulsory licensing (CL). It is well documented that Brazil and Thailand have notably attempted CL. A realist review was undertaken to understand the identical social interventions in comparative settings, and to draw practical implications for attempting CL relevant for middle-income countries in the era of high-cost medicines. CL is not only a politically well-devised measure to achieve universal health coverage, but also a tentative commitment, which is determined both at the country level and at the global level. At the country level, political will, with catalytic roles of civil activism, is important in order to guarantee the right to health. Through this will, the governments can achieve universal health coverage. In addition, electoral systems, political leaders, and a constitution are necessary to attempt CL. In addition, CL should operate along with other policy instruments, including a comprehensive essential medicines list, CL-friendly phrasing in patent law, and a competent pharmaceutical industry. At the global level, the balance of power between the WTO regime and the global justice movement is critical. This provides global-level context that can either encourage or prevent CL.

How Much Time Before Attempting Compulsory Licensing of Pharmaceuticals? A Non-parametric Event History Model With P-splines

“…Furthermore, it was reported that Thailand has notably issued several CLs even for non-HIV/AIDS medicines along with other policy instruments, including a comprehensive essential medicines list, a capable industry to manufacture the medicines, and CL-friendly phrasing in patent law. 23 In addition, we found notable CL cases and legislations or regulations regarding CL in several high- and middle-income countries. First, in 2016, the German Federal Patent Court ordered a CL for HIV/AIDS drugs under Section 24 of the Patent Act for the first time.…”

Leadership and Negotiation in Public Health Management: A Systematic Review of the Literature

“…Finally, most studies are cross-sectional (79.63%) to the detriment of longitudinal studies (20.37%); among the longitudinal studies, those that were carried out between periods of one to seven years (54.55%) prevail over those that were carried out from eight to 17 years (45.45%). (Addicott, 2016), policies and agreements to control tobacco consumption (Wranik et al, 2016), facilitation actions and support for changes (Wiler et al, 2019), analysis of the origins and effects of high prices of drugs on the market (Son et al, 2019), individual and organisational goals (Kwamie et al, 2017), conflicts and negotiation between government health areas and users (Natland and Hansen, 2017), funding bodies and governments (Wranik et al, 2017) and healthcare costs (Drennan et al, 2017).…”

“…As the complexity of the challenges faced by public administration increases, there are arguments that resources are insufficient and there is a need to insert new policies to prepare the workforce better, focusing on leadership and negotiation that integrate the central sustainability challenges related to economic development and population growth. In academic studies (Moyson et al, 2018;Garland et al, 2018) and in popular rhetoric, we find numerous appeals to the different problems encountered regarding health-related issues (Wiler et al, 2019;Son et al, 2019). Proper management is of great importance for the health system.…”

TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

“…Inclusion in the MPP territory mainly depends on countries' income group, previous licensing status, and negotiations with originator firms, regardless of country-specific medical needs or demand shocks [36,37]. Hence, despite their high prevalence of HIV or HCV, several middle-income countries (MICs) such as Thailand and Malaysia are excluded from MPP licenses and price discounts and must continue to rely on TRIPS flexibilities to access low-priced generics [38,39]. South Africa is an exception, and although it is a MIC, it is often included in voluntary licenses (VLs) and non-enforcement agreements for antiretroviral drugs on the basis of its high HIV prevalence.…”