Combat Hepatitis C

Malaysia moves forward to combat Hepatitis C;issuing compulsory license to produce generic treatment

This sets Malaysia as the first country to initiate such move, amidst global headlines highlighting this distressing financial matter. In light of the difficulties governments are facing – especially in Malaysia – patient advocates have commended the move in widening access to treatments. 

Putting things into perspective, MIMS previously reported that roughly 500,000 or 2.5% of the Malaysian population are said to be living with chronic liver conditions.

Different approach to tackling increased costs.

Executive Director of South Centre, a non-governmental organisation based in Switzerland, Martin Khor wrote to The Star publication stating, “The government decision is the key to opening the door to affordable treatment. The government will have freedom to choose which drug to buy from which firm, at what prices, and with which other drugs to combine it.”

This latest update comes after the government initial plans to issue a supposed government-use license that was announced last month. Following this, Gilead Sciences went on to expand a 2014 licensing deal. This allows for seven larger generic drug makers, with operations in India, to sell copycat forms in middle-income countries like Malaysia, Ukraine, Belarus and Thailand.

The deal was originally thought up to increase access in 101 low-income nations and shut down criticism over the pricey drug status. However, Gilead still endured objections because some of those from middle-income countries cannot afford the Sovaldi drug. Thus, the Malaysian government has decided to roll out generic licensing to bypass the Gilead patent altogether. 

Consumer activists say that Malaysia chose to pursue the license as a less restrictive option. They elaborated that Gilead’s ways would jeopardise an ongoing Malaysian project whereby the authorities are working hand in hand with Drugs for Neglected Diseases Initiative – a non-profit and an Egyptian company to produce a generic treatment.

Varying responses – to commend or remain sceptical

Sangeeta Shashikant, a legal advisor to Third World Network (TWN), opined that with this move, Malaysia is projected to obtain combination Hepatitis C treatments for USD300 and perhaps less. The Gilead license, on the other hand, may not reflect the most affordable prices, as pricing relies on the level of generic competition in the country.

Consumers Association of Penang stated that “It is imperative that the government sticks to its decision to issue a government-use license. This is because there are strict limits to what Malaysia can do or cannot import or produce under the Gilead license, and other factors that restrict the freedom to choose the generic companies that it can work with.”

It continued, “…Therefore, it is best for Malaysian consumers and patients that the government have both the government-use license as well as the license scheme that Gilead will extend to Malaysia. Both can co-exist, providing Malaysia with maximum policy choice.”

However, The Galen Centre for Health and Social Policy said Putrajaya should deliberate negotiating the best possible deal with Gilead – including technical support, concessions and additional assistance.

Chief executive Azrul Mohd Khalib said, “This hard-won development would see increased access to a treatment which will improve the quality of life for patients and most importantly, save lives. It represents a moral victory for the government which has worked hard to enhance access for Malaysians to innovative drugs and treatment to treat emerging health challenges.”

However, “implementing a government-use license would be outside that framework. It could represent a pyrrhic approach to a long-term problem with possible consequences and complications,” cautioned Azrul. MIMS

Sources:
https://www.statnews.com/pharmalot/2017 … hepatitis/ 
http://www.themalaymailonline.com/malay … fD7zXVU.97 
http://www.thestar.com.my/opinion/colum … 3jYhMOr.99 
http://www.raps.org/Regulatory-Focus/Ne … is-C-Drug/ 
http://www.themalaymailonline.com/malay … ph4mmc0.97