What China can learn from Malaysia to achieve the goal of “eliminate hepatitis C as a public health threat” by 2030 – a narrative review

Abstract

Background: To discuss a range of strategic options for China to improve the accessibility of direct antiviral agents (DAAs) as the treatment for hepatitis C. Methods: We adopted a narrative review approach for comprehensive comparisons and in-depth analyses of the country context, and barriers of increasing the DAA treatment rate of hepatitis C in Malaysia and China, and how the two countries have been navigating the hepatitis C agenda. Findings: Malaysia adopted a series of successful strategies to scale up the diagnosis of hepatitis C and DAA treatment, which have valuable implications for China. Interpretation: The potential game-changing strategies for China to adapt from Malaysian experiences range from the stepping-up of political commitment and leadership, enhanced market competition, simplified and decentralized treatment at the strengthened primary care level, integrated healthcare services, coordinated government initiatives, to multi-organizational participation and civil society's active role in raising public awareness, and training of non-specialist physicians. Embarking on scale-up of hepatitis C treatment marks another contribution of China to improve the health of not only the Chinese citizens but also mankind, which is an important component for building healthy Chinese and global communities. Funding: No funding supported this study.

Eliminate Hepatitis C as a Public Health Threat: A Narrative Review of Strategies, Gaps, and Opportunities for China

“…Although part of SOF's patent in China was challenged in 2020, the generic SOF has already been registered by a local company, the National Intellectual Property Review Committee has again initiated a re-examination of SOF's core pre-drug patent and is likely to grant patent protection accordingly [54]. This means that domestic generic SOF cannot be officially marketed and sold until the expiration of the core patent of SOF in 2028 [55][56][57][58]. In practice, the local company must market its own novel DAA by adding the generic SOF as a gift to form a pan-genotype combination.…”

Feasibility of Hepatitis C Elimination in China: From Epidemiology, Natural History, and Intervention Perspectives

“…Some scholars have noted that integrating HCV healthcare and surveillance systems, strengthening primary care level, and coordinating government initiatives are essential in providing effective HCV preventive measures and treatments ( Chow et al, 2014 ; Sun et al, 2021 ). Disparities in healthcare resources across the provinces increased following the economic reform, and the socioeconomic status is associated with healthcare resources ( Bakkeli, 2021 ).…”

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

“…In the current system, to return their investment in development, companies charge a monopoly price for new patented medicines, which is often much higher than the cost of production [14,[24][25][26]. The method is based on the notion that other nations that were not involved in the R&D and commercialization activities (involuntary) contribute to its financing by buying patented medicines at high prices [14,15].…”

“…TRIPS Flexibilities Database (Medicines Law & Policy) [42] Compulsory licenses (CLs) and government use of patents Under TRIPS, a country is authorized to license IP rights for a patented medical product for domestic production without the patent holder permission to increase access to a particular drug Malaysia, an upper-middle-income country, was excluded from VLs of costly patented DAAs despite a high burden of HCV infection (prevalence of 2.5% among the adult population in 2009). Patented sofosbuvir, a core of DAAs, was sold in Malaysia at about US$11,000, while its production was estimated to be below US$136 [24]. In 2017, the government issued a compulsory license, which was also followed by the country's inclusion in bilateral VLs.…”

“…In 2017, the government issued a compulsory license, which was also followed by the country's inclusion in bilateral VLs. In about two years, generic versions of sofosbuvir under the compulsory license brought down the public procurement price to US$300 per 12-week treatment [24,38].…”