India and Argentina call for hepatitis C generics

Home/Policies & Legislation | Posted 31/03/2017 post-comment0 Post your comment

The high prices of hepatitis C drugs push the need for more generic versions to be approved worldwide. On 13 February 2017, Médecins Sans Frontières (MSF, Doctors Without Borders) reported that organizations in India and Argentina filed cases against the patents of certain hepatitis C drugs. 

26 AA011066

In their press release, MSF reported that in India, the Initiative for Medicines, Access & Knowledge (I-MAK) together with the Delhi Network of Positive People (DNP+), and supported by the MSF Access Campaign, filed four cases against existing hepatitis C drugs. Two of these were patent challenges on Bristol-Myers Squibb’s Daklinza (daclatasvir), and the others were against Gilead Sciences’ velpatasvir and sofosbuvir. In Argentina, it was reported that the Fundación Grupo Efecto Positivo (FGEP) also filed a patent opposition on sofosbuvir with support from I-MAK. These drugs are all examples of direct-acting antiviral (DAA) medicines.

MSF reported that these patent challenges have been made to help remove barriers to the production and distribution of affordable generic versions of these drugs. In addition, they claimed that patents on drugs not only restrict access to treatment, but also reduce progressive innovation which can be detrimental to patients. To illustrate this, they reported that in the case of HIV, patent barriers were overcome to allow generics competition, and this reduced prices by 99 per cent. Gilead was involved in such a deal in 2012 [1].

In 2014, it was reported that Gilead was in talks with generics manufacturers to bring a generic form of sofosbuvir to 80 developing countries, including India [2]. Even with such agreements that lead to price appreciable reductions, there are still drug access problems. MSF reported that Egyptian and Indian generics suppliers face intellectual property barriers when it comes to the registration and export of DAA medicines to a number of middle-income countries. This means that, although prices have been reduced in low-income countries, hepatitis C remains a widespread threat in middle-income countries.

Reportedly, the World Health Organization (WHO) estimates that 3% of the world’s population has been infected with the hepatitis C virus and that more than 170 million chronic carriers are at risk of developing liver cirrhosis, liver cancer or both. It is thought that about 350,000 people die due to the virus each year [3]. In November 2015, it was reported that the Medicines Patent Pool (MPP) made its first hepatitis C licencing agreement [4]. This was made with Bristol-Myers Squibb and allows sublicences for generics of Daklinza (daclatasvir). This drug was added to the WHO’s list of essential medicines, in 2016 which exemplifies its significant impact and the need for affordable versions across the globe [4]. In November 2016, Mylan Pharmaceuticals announced that they had signed a sublicence with the MPP to make a generic of daclatasvir. In this action, they joined a host of other generics manufactures in this agreement which marked the first time that generics manufacturers have worked, through a not-for-profit public health organization, to increase access to new hepatitis C medicines for patients in the developing world [3].

Related article
Costs and prices of entecavir to treat Hepatitis B

Is India ready to use only generics?

1. GaBI Online - Generics and Biosimilars Initiative. Gilead makes HIV generics deal []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 31]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Generic hepatitis drug to be made available to 80 countries []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 31]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Mylan to make generic hepatitis drug under MPP sublicence []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 31]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. Medicines Patent Pool signs first sub-licences for HCV med daclatasvir []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 31]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Panama embraces international pharmacovigilance standards
Pharmacovigilance V13F21
Home/Policies & Legislation Posted 09/07/2024
FDA proposal to remove biosimilar interchangeability status in FY25
01 AA007239
Home/Policies & Legislation Posted 12/06/2024
MHRA unveils strategy for regulating AI technologies
23 AA011020
Home/Policies & Legislation Posted 22/05/2024
Regulatory Certainty Strategy for biosimilars launched in Mexico
Home/Policies & Legislation Posted 09/04/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010