Assefa Yibeltal, Hill Peter S, Ulikpan Anar, Williams Owain D
School of Public Health, the University of Queensland, Brisbane, Australia.
Abt Associates, Brisbane, Australia.
Global Health. 2017 Sep 13;13(1):73. doi: 10.1186/s12992-017-0297-6.
The recent introduction of Direct Acting Antivirals (DAAs) for treating Hepatitis C Virus (HCV) can significantly assist in the world reaching the international target of elimination by 2030. Yet, the challenge facing many individuals and countries today lies with their ability to access these treatments due to their relatively high prices. Gilead Sciences applies differential pricing and licensing strategies arguing that this provides fairer and more equitable access to these life-saving medicines. This paper analyses the implications of Gilead's tiered pricing and voluntary licencing strategy for access to the DAAs.
We examined seven countries in Africa (Egypt, Ethiopia, Nigeria, Democratic Republic of Congo, Cameroon, Rwanda and South Africa) to assess their financial capacity to provide DAAs for the treatment of HCV under present voluntary licensing and tiered-pricing arrangements. These countries have been selected to explore the experience of countries with a range of different burdens of HCV and shared eligibility for supply by licensed generic producers or from discounted Gilead prices.
The cost of 12-weeks of generic DAA varies from $684 per patient treated in Egypt to $750 per patient treated in other countries. These countries can also procure the same DAA for 12-weeks of treatment from the originator, Gilead, at a cost of $1200 per patient. The current prices of DAAs (both from generic and originator manufacturers) are much more than the median annual income per capita and the annual health budget of most of these countries. If governments alone were to bear the costs of universal treatment coverage, then the required additional health expenditure from present rates would range from a 4% increase in South Africa to a staggering 403% in Cameroon.
The current arrangements for increasing access to DAAs, towards elimination of HCV, are facing challenges that would require increases in expenditure that are either too burdensome to governments or potentially so to individuals and families. Countries need to implement the flexibilities in the Doha Declaration on Trade Related Intellectual Property Rights agreement, including compulsory licensing and patent opposition. This also requires political commitment, financial will, global solidarity and civil society activism.
近期用于治疗丙型肝炎病毒(HCV)的直接抗病毒药物(DAAs)的推出,能够极大地助力全球在2030年实现消除丙肝的国际目标。然而,如今许多个人和国家面临的挑战在于,由于这些药物价格相对较高,他们难以获得这些治疗。吉利德科学公司采用差异化定价和许可策略,称这能让人们更公平、更平等地获取这些救命药物。本文分析了吉利德分层定价和自愿许可策略对获取DAAs的影响。
我们考察了非洲的七个国家(埃及、埃塞俄比亚、尼日利亚、刚果民主共和国、喀麦隆、卢旺达和南非),以评估在当前自愿许可和分层定价安排下,它们为治疗丙肝提供DAAs的财政能力。选择这些国家是为了探究不同丙肝负担程度以及有资格从获得许可的仿制药生产商处或通过吉利德的折扣价格获取药物的国家的经验。
12周疗程的仿制药DAAs成本从埃及每位患者684美元到其他国家每位患者750美元不等。这些国家也可以从原研药企吉利德采购同样的12周疗程DAAs,每位患者成本为1200美元。DAAs当前价格(无论是仿制药还是原研药生产商的产品)都远高于这些国家大多数人的人均年收入中位数和年度卫生预算。如果仅由政府承担普及治疗覆盖的费用,那么从当前支出水平所需增加的卫生支出幅度从南非的4%到喀麦隆惊人的403%不等。
当前为增加获取DAAs以消除丙肝的安排面临挑战,这需要增加支出,而这对政府来说负担过重,对个人和家庭而言可能也是如此。各国需要落实《与贸易有关的知识产权协定》多哈宣言中的灵活性条款,包括强制许可和专利异议。这也需要政治承诺、财政意愿、全球团结和民间社会行动主义。