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India and Argentina call for hepatitis C generics Posted 31/03/2017

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. 

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].

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

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