amfAR, The Foundation for AIDS Research

Addressing the Challenges to HIV/Hepatitis C Treatment Access

The Treat Asia Report Interview: Leena Menghaney

Published March 17, 2016

 (Photo: MSF Access Campaign)(Photo: MSF Access CampaignLeena Menghaney, a lawyer and the South Asia Manager of the Access Campaign at Médecins Sans Frontières, has fought to remove obstacles that restrict the availability of affordable and effective medicines for all who need them. Recent years have seen the development of new drugs to treat hepatitis C virus (HCV)—direct-acting antivirals (DAAs)—that have higher cure rates and fewer side effects than older HCV drugs and are recommended for use by the World Health Organization. In this interview, Ms. Menghaney talks about efforts to ensure access to HCV treatment for people in the Asia-Pacific region, including those who are coinfected with HIV.

TA Report: What factors prevent many people infected with HCV from receiving the new medicines? Can you describe the legal means countries can and should use to ensure affordable access?

Menghaney: There’s a huge disparity within Asia between those who have access and those who don’t. I think there are two factors that make treatment inaccessible for those who need it most. One is that the medicines are too expensive in many countries.

The second factor is whether or not the governments have programs in place to test and treat patients for viral hepatitis. China and Australia have such programs. Thailand, Malaysia, India, and Indonesia are in the process of setting them up. What form these programs will take depends on how they work to increase access to the direct-acting antivirals. It is important for governments to learn the lessons from HIV regarding the effect of patents on drug accessibility.

“There’s a huge disparity within Asia between those who have access and those who don’t.”

There are two main legal means that countries use to increase drug access. One is the stricter examination of patent applications. This is the policy in countries like India, where originator companies have to meet patentability standards that filter out claims that do not meet the novelty or inventive step standard. Patent claims for new direct-acting antivirals like sofosbuvir are being carefully examined and are now being disputed, with ongoing challenges in India and other countries. If rejected, then there can be open competition among suppliers of the generic versions. Another means called compulsory licensing is used in countries where these drugs are patented, such as Thailand and Malaysia. Compulsory licensing allows countries to import more affordable generics even when a patent is in effect.

Dr. Menghaney presents during the 2014 regional consultation on hepatitis C access organized by TREAT Asia 
Dr. Menghaney presents during the 2014 regional consultation on hepatitis C access organized by TREAT Asia

TA Report: What are the principal barriers to the implementation of national programs to treat patients with hepatitis C?

Menghaney: The lack of viral hepatitis programs in a number of Asian countries is a key factor that prevents many from receiving the recommended care. And countries are struggling with basic testing tools. National programs need a system for testing people and prioritizing them for treatment, as well as providing the medications themselves. Currently many of the testing tools are not registered. For example, rapid diagnostic tests for hepatitis C such as OraQuick are not registered in countries like India.

It is essential for national treatment programs to test people for chronic hepatitis C before they develop symptoms. Right now the lack of such comprehensive testing is the biggest barrier to the implementation of effective programs. Programs need to figure out how to roll out testing for vulnerable communities and high risk groups. They need to decide how to offer testing, at which point, and to whom. Should testing be offered to pregnant women? To drug users? To people living with HIV? Should testing be offered to healthcare workers? If we want to achieve good public health outcomes we shouldn’t be testing only people who already have liver damage and cirrhosis; we should be testing vulnerable people early, so they can be treated with DAAs before they get sick.

TA Report: How are these barriers different in the context of HIV coinfection?

Menghaney: Because HIV treatment programs already exist, HIV/HCV coinfected patients are likely to get treatment first. Hepatitis C testing and treatment is beginning to be integrated into HIV programs. It is actually more difficult for patients mono-infected with HCV to receive treatment because there are not yet programs in place for them. If countries want to achieve the public health goal of preventing transmission of HCV, treatment of mono-infected patients must also be a priority. It would make sense for HIV and viral hepatitis programs to be integrated for the simple reason that these diseases affect many of the same communities. “It would make sense for HIV and viral hepatitis programs to be integrated for the simple reason that these diseases affect many of the same communities.”

TA Report: What are some of the regulatory and intellectual property-related challenges that need to be addressed if hepatitis C treatment is to be comprehensively scaled up in the Asia-Pacific?

Menghaney: A major regulatory issue is that many local food and drug administrations (FDAs) insist that local clinical trials be conducted before a drug can be registered. This is creating an unnecessary barrier in countries such as Vietnam, Thailand, China, and Pakistan. The FDAs can and should register the generic medicines first and ask for local clinical trial data to be produced in parallel. Countries with a high burden of hepatitis C need to prioritize the registration of DAAs, not create delays.

Another registration barrier is that FDAs in several Asian countries ask that the drugs of the originator company, the brand name company, be registered first. But sometimes the company is not interested in registering their drugs, so in that case there needs to be a regulatory pathway for generics to be registered directly.

Access to generic DAAs depends on the patent and the license. Voluntary licenses between brand name companies and generic companies allow for access to generics, even when patents are in effect. Ironically, countries such as Myanmar, Pakistan and India do not have patent barriers, yet there are a number of voluntary licenses that provide for access to generic DAAs. On the other hand, China, Malaysia, and Thailand have patent barriers but are not covered by the voluntary license.

Also India and Egypt, countries which did not grant patent protection for the DAAs, were nevertheless prioritized by pharmaceutical companies for the launch of their drugs. The companies wanted to give India access to their products before generics would be developed and take over the market. Meanwhile countries that granted patents, like Malaysia and China, have not been prioritized by brand-name companies because they know they have a monopoly and can delay their product launch to maximize profits. The lesson countries need to learn is that by granting patent monopolies too easily they can end up with restricted access to both brand-name and generic drugs.

TA Report: Can you describe the pressure on India to change its system for dealing with patent applications?

Menghaney: The U.S. government and the pharmaceutical companies have criticized India’s patent office for rejecting patents of brand-name companies. But changing the Indian system would require amendments to the patent law, which would involve a public debate. They are now using indirect pressure. The U.S. Congress has launched investigations against India,1 and pharmaceutical company representatives have exerted pressure in meetings with the Indian Ministry of Commerce. In addition, the controversial “Special 301” Report, which is issued every year by the U.S. Trade Representative, heavily criticizes countries that don’t agree with its demands and puts them on a watch list. Both India and Thailand have been put on this watch list.2

The Indian government should ignore and avoid responding to the pressure as it will always exist. Its generic industry is always going to be under attack as it competes with brand-name companies.  

TA Report: Can you tell us about your current priorities at the MSF Access Campaign in India and how the organization is addressing some of the challenges we have discussed?

Menghaney: We are working to support India in standing up to the pressure from the U.S. Trade Representative and from pharmaceutical companies in the U.S. and Europe, as well as to potential threats posed by the [Trans-Pacific Partnership] free trade agreement. We have an overarching campaign called “Hands Off Our Medicine” that describes why India is so central to the production of affordable medicines; it is a message to the U.S. and other governments that want to restrict India’s generic production. We work on a drug by drug, country by country level to fight regulatory and patent barriers to direct-acting antivirals, new TB drugs, and of course HIV medicines. We also provide technical support for a network of organizations and civil societies that are challenging patent barriers before the patent offices in India and other developing countries where we work. Some of the groups MSF Access Campaign has been working with include the Delhi Network of Positive People in New Delhi and harm reduction networks in Mumbai and the North East of India. 

TA Report: What else has MSF been doing to influence both the U.S. and Asian governments to improve treatment for patients with HIV, hepatitis C, and drug-resistant tuberculosis?

“Our message is that treatment is possible, even in very remote, marginalized communities with the most restricted resources.”

Menghaney: By setting up medical projects and models of treatment in resource-poor countries, MSF creates models for how treatment can be accomplished in resource poor countries. Our message is that treatment is possible, even in very remote, marginalized communities with the most restricted resources. We also work in partnership with civil society to convince governments of the need to treat HIV irrespective of CD4 count, to provide viral load testing, and to increase access to treatment for neglected co-infections like HCV.

It is critically important for treatment providers and people affected by HIV, hepatitis C, and drug-resistant tuberculosis to hold their governments accountable for providing treatment without discrimination. There can’t be a hierarchy of who gets treatment first or who gets it last. When healthcare is treated as a human right, then governments take action to increase access to generics.

Read more about the Access Campaign in India

  1. See, for example: http://www.thehindu.com/news/international/world/us-probing-discrimination-in-indian-trade-policies/article5682120.ece

  2. https://ustr.gov/about-us/policy-offices/press-office/press-releases/2015/april/ustr-releases-annual-special-301