Advocacy for accelerated, more equitable delivery of HIV treatment and prevention and advances on human rights
Advancing medicines access
The multiple issues involved in access to medicines include intellectual property law, trade agreements, purchasing arrangements, drug pricing and supply, as well as the social and legal issues involved in access to health services.
In this issue of Community Advocacy Update we hear from five leading advocates working to advance medicines access and finding the connections between HIV, Hepatitis C, tuberculosis and other movements for health equity.
Advocates in Their Own Words
Othoman Mellouk
Othoman Mellouk, an orthodontist by training, has joined Moroccan association against AIDS (ALCS) in the mid-90s where he participated to the launch of the first HIV programs targeting MSM and sex workers in the Arab world in 1995. From 2002 to 2010 he was the chair of the Marrakech city branch of ALCS, and was in charge of international relations of ALCS. In 1998, he actively engaged in access to treatment in Morocco and the MENA region and contributed to the introduction of the first generic versions of ARVs in Morocco. Today, he is one of the most active advocates for access to treatment in the MENA region with a particular focus on the question of intellectual property rights and their effect on access to treatment. He has published several articles and reports about access to medicines in Morocco and the MENA region and has been involved in research on monitoring access to treatment progress with the Treatment Monitoring and Advocacy Project of ITPC.
In 2015, Othoman Mellouk joined the Global team of the International Treatment Preparedness Coalition (ITPC) as Intellectual Property and Access to Medicines Lead. He is currently coordinating a multi country initiative funded by UNITAID aiming to remove Intellectual property barriers on key ARVs in middle income countries by using law reform and selective use of TRIPS flexibilities (patent oppositions and compuslory licences). Othoman is also an active advocate for access to new anti HCV antivirals where he contributed actively to access to such drugs in Morocco and Egypt.
What got you involved in medicines access issues?
I am a dentist by training. When I was student at the university, I started volunteering at the Moroccan association against AIDS ALCS. At that time, I wanted to do something for the LGBT community and the only space to do it in Morocco was AIDS organizations. We did a good job and we put in place in Morocco the first HIV prevention program for MSM. It was a unique experience in the Muslim countries. But our key message for our clients was to avoid getting HIV, since most people infected with the virus were dying although we had AZT mono-therapy. The announcement of efficacy of HAART in 1998 was a great news. But the cost of medicines was high. For me it was a big injustice: we had the science to make people stay alive but only the rich could access it. Together with colleagues at ALCS under the leadership of Hakima Himmich we made significant efforts to make ART available in Morocco. We successfully put in place the first treatment program in 1999, however we were able to treat only 100 persons. There was a waiting list and people had to wait until someone died to be enrolled in the program. It was horrible. Then we heard about affordable generic ARVs in Thailand, India and Brazil… We did all what was possible to access them. It was successful and in 2003 Morocco generalized access to ART for free to all people eligible to treatment. It was a great victory!
Where are you focusing your work on medicines access and what do you think are the most urgent priorities for advocacy to advance access to medicines?
Our main focus is to make sure all people have access to good quality treatment regardless of where they live. By good quality we mean optimal treatment regimens that are more potent, easy to take by people and with fewer side effects and also good monitoring of treatment efficacy with routine viral load testing as well as treatment of all co-morbidities. To achieve this, we need to address Intellectual Property barriers that constitute a major threat for access to treatment. Without this, we may end up in the same situation as in 1998, with a double standard of care -- good quality for rich countries; and obsolete treatments in the poorest areas. This is already happening if we consider which first line regimens are used in different parts of the world. And this is particularly true for middle-income countries that are excluded from most pharmaceutical access programs and voluntary licenses. The treatment quality gap is going to increase significantly during the next years if IP barriers are not addressed adequately in developing countries, especially middle income countries. Today, ITPC is implementing an ambitious program in four key middle income countries: Argentina, Brazil, Thailand and Ukraine to support local civil society organizations to remove patent barriers to generic competition on key ARVs including the most recent ones, to allow more access and generate savings for governments that could be used to invest in other areas of the response to the epidemic. We do this through supporting patent law reform to be more protective of public health, by supporting public health approaches to patent examination, by challenging unmerited and abusive patents and advocating for the use of flexibilities allowed by international intellectual property agreements such as compulsory licences to allow market entry of generic ARVs. We are using these four countries as models that could be documented and lessons shared with civil society groups in other parts of the world.
What are the connections between medicines access issues for HIV, TB, Hep C and other conditions and how can advocates work more closely together to advance on medicines access across diseases?
TB remains the main killer of PLWHIV and Hepatitis C is very common among people living with HIV, especially key populations such people who inject drugs. Even if we are doing well treating people for HIV, it is unacceptable that people still die from these diseases that are now curable. The response to the HIV epidemic has been a laboratory of new and innovative ideas, mainly pushed by communities and civil society -- these can be used for action on other diseases. The role of communities in treatment literacy and education, demand creation, community based testing and treatment models is key to address these diseases. Lessons learned from HIV with regards to the role of generic competition in price reductions of medicines should be used for new drugs to treat new forms of resistant TB that are still extremely expensive and unaffordable in most settings. Some work is done now for HCV direct acting agents (DAAs), mainly by HIV groups, and we starting to see massive price reductions in some countries who started producing generic DAAs. This cannot be achieved without increasing support for civil society groups to work on IP issues. This support is unfortunately still very limited. The role of civil society is not only important to challenge patents but also to increase demand for treatment and create a volume of demand that could incentivize generic producers to invest in drug production.
What advice to you have for a young advocate interested in medicines access issues?
Access to medicines includes different aspects like intellectual property, procurement, quality issues that may look complicated or reserved for specialized persons. Young advocates should understand that they don’t need to be public health professionals or experts to work on these issues. I am a dentist by training but throughout the years I accumulated significant knowledge on intellectual property rights without being a lawyer. This is on of the strengths of civil society. The role of the older generation of activists is to transfer this knowledge to the newer generation. Maybe one mistake that has been done by the past is addressing treatment education and IP issues separately or by different groups. We need now more than ever to link the two and make sure people are informed about what treatment they should receive and what are the barriers that inhibit them from getting it. This is especially true in the context of relying more and more on new medicines not only to keep people living with HIV healthy and alive but also to prevent new infections from happening through strategies like TASP or PreP.
Asia Russell
Asia Russell has been a leader in the fight against HIV for over 20 years, first as a community organizer and treatment activist working with urban communities hard hit by HIV in the United States, and ultimately as part of the group who founded Health GAP in 1999, serving as Director of International Policy until 2014 when she became the Executive Director. Health GAP is an international policy and advocacy organization founded to end HIV and to overcome barriers to access to medicines for all. She is based primarily in Uganda, where she works in partnership with civil society organizations, health rights groups, and networks of people living with HIV nationally and from across Eastern and Southern Africa.
She helps coordinate multiple civil society campaigns on the right to health, increasing the size and improving the impact of donor and indigenous health and HIV investments, and ending preventable maternal mortality and unsafe abortion alongside programs to accelerate and strengthen the impact of the HIV response.
Asia is also part of the Developed Country NGO Delegation to the Global Fund Board, and sits on the Global Fund's Strategy Impact and Investment Committee (SIIC) representing Developed Country NGOs. Asia participated in the 2013 WHO ART Guidelines development process, as a member of the Programmatic Guidelines Development Group and is currently a member of the 2015 ART Operational Guidelines Development Group.
Asia’s leadership has been recognized through a number of awards, including the Keith Cylar Courage Award from Housing Works (2008), the 2010 Kiyoshi Kuromiya Award from Philadelphia FIGHT, the 2011 John M. Lloyd Leadership Award, and an award in 2011 from The AIDS Service Organization (TASO), Uganda for her exceptional contribution as an AIDS activist.
What got you involved in medicines access issues?
When I became an AIDS activist working with people with HIV in the US, triple combination therapy was not yet available. When powerful, life saving treatment was finally approved for use in the US and other rich countries, the profiteering of pharmaceutical companies compromised access for people with use drugs, sex workers, homeless people, prisoners and poor people even in rich countries. We were demanding price reductions as early as 1996—but for HIV positive people in the Global North. In 1998, Health GAP joined activist groups from around the world—in South Africa, Thailand, India, Brazil, Uganda—who were confronting Big Pharma and governments that were prioritizing protecting patent monopolies, undermining access to treatment in poor countries. We began organizing together, around the world, demanding generic competition to drastically reduce prices and ensure medicines access in the Global South—where the vast majority of people with HIV live. Everyone said it couldn’t be done—HIV treatment was too expensive and the regimens were too complex. As activists we knew these were hollow excuses and we kept demanding the impossible—affordable treatment for all. Our analysis was correct.
Where are you focusing your work on medicines access and what do you think are the most urgent priorities for advocacy to advance access to medicines?
In order to ensure all people have access to the treatment they need, barriers to affordable prices must be tackled, including the access barriers created by intellectual property rights protection and enforcement. As an organization based in the US, we have a particular responsibility to challenge the US government—frequently the biggest bully in the room, pressuring and punishing countries that are increasing access to affordable generics. New proposed trade agreements such as the Trans Pacific Partnership will drive up the cost of vital new medicines—as activists, we need to mobilize to challenge and halt passage of these deals.
What are the connections between medicines access issues for HIV, TB, Hep C and other conditions and how can advocates work more closely together to advance on medicines access across diseases?
We are more powerful when we combine our demands for access to all key medicines, whether for cancer or for hepatitis C or HIV, and when we fight back against pharmaceutical company profiteering and greed and harmful government policies that obstruct access. Ultimately the same communities are suffering without access to treatment, and we must show solidarity with each other if we are going to win health justice and access for all.
What advice to you have for a young advocate interested in medicines access issues?
This area of work is incredibly vibrant and powerful—combining daring grassroots activism with cutting edge academic and policy work on new ways to reward relevant innovation. The current model, focused on higher and higher prices, is broken and is keeping medicines out of the hands of people in dire need. If confronting that challenge excites you, join us.
Nelson Otwoma
Nelson Otwoma has over 10 years working in the public health sector mainly with civil society organizations, including PLHIV networks. He is currently the Executive Director, National Empowerment Network for People living with HIV/AIDS in Kenya (NEPHAK) where he works to provide strategic, accountable and professional leadership to enhance the voice and visibility of people living with HIV and those affected by TB and AIDS. His interest is to ensure access to services, commodities and information needed to prevent and treat HIV and TB. He serves in a number of national health, HIV and TB coordination and management bodies and structures. He is member of the HIV Equity Tribunal, the Kenya CCM to the Global Fund and member of the Expert Advisory Group to the Medicines Patent Pool.
What got you involved in medicines access issues?
First was the information and knowledge that people living with HIV in Kenya could not access HIV treatment drugs in public health facilities before 2004 even as other countries, mainly in the West had these drugs. Second, was the fact that the HIV medicines people living with HIV in Kenya were using were different from the medicines being used by PLHIV in some countries in Europe and the USA. Third, was the fact that even with an increased access and availability of HIV medicines in Kenya, there were no child friendly formulations. As a person living with HIV, I was surprised at the above but was reminded of the laws, policies and regulations that guide the manufacture, procurement and distribution of medicines, including ARVs. I took keen interest in access to medicines because I later learned that at the centre of these policies, laws and regulations, there is the need for profits required by those who conceive of and manufacture drugs.
Lastly and more importantly, my interest in access to medicines and especially HIV medicines has been renewed because Kenya just became middle income after rebasing her economy. This means that the concessions that have been enabling Kenya to access cheaper ARVs shall be reviewed in 3 to 5 years and this may significantly increase the cost of HIV medicines.
Where are you focusing your work on medicines access and what do you think are the most urgent priorities for advocacy to advance access to medicines?
My focus is on the HIV drugs and the urgent need for better, safer, affordable medicines for both children and adults infected with HIV. I am looking for an opportunity and a scenario where HIV treatment in the world is standardized and accessible to all regardless of income status. This brings in the issue of property barriers of access to medicines.
While we as communities and PLHIV support trade and international engagements, including treaties, we are looking for trade and conventions that support access to HIV treatment and care. We are looking for trade and regulations that promote and do not hinder universal access to HIV treatment.
There is also a challenge facing access to HIV medicines that is unique to Kenya and other African countries that are over-reliant on external funding for HIV and AIDS response. The experience in Kenya is that access to ARVs is influenced by projects. As such, what the US Government through PEPFAR procures and distributes may differ from what the Global Fund procures and distributes. Why is that? Here, the solution lies with domestic funding. In other words, countries that do not fund their response to HIV are more vulnerable to external pressures that hinder access to HIV medicines. They may not even exploit their full TRIPs provisions and trade concessions.
We also note that PLHIV in Kenya have increasingly been presenting with non-communicable diseases. Together with colleagues in Kenya and at NEPHAK, we are now focusing on medicines that help manage HIV- related co-morbidities, including non-communicable diseases.
What are the connections between medicines access issues for HIV, TB, Hep C and other conditions and how can advocates work more closely together to advance on medicines access across diseases?
Trade restrictions, patents and intellectual property barriers are common to all type of medicines and health products. There are valuable lessons to be learned by the TB and Hep C affected communities on how to mount and sustain targeted advocacy and communications needed to ensure increased access to HIV medication. Only through joint advocacy initiatives shall communities ensure that their voices can be heard.
What advice to you have for a young advocate interested in medicines access issues?
The first step is to take keen interest and learn the issues that affect access to medicines. That knowledge shall be vital to enable young people understand where medicines and health products come from. A deeper understanding of the policies, rules and regulations that guide medicines production, procurement and distribution are important for anybody interested in a campaign for access to medicines. The second most important step is to ensure partnership with like-minded individuals and agencies. Partnerships are needed with scientists, doctors, industrialists and fellow advocates. Also, the young advocates will need to have a better understanding of their countries and communities and the national policies and laws that related to trade, health and medicines.
Maria Lorena Di Giano
Maria Lorena Di Giano is Executive Director of Fundación Grupo Efecto Positivo and General Coordinator of RedLAM - FGEP is the leading organization of RedLAM. Currently, she is coordinating a regional program focused on improving access to ARVs by addressing intellectual property barriers in countries of the Latin American region. She is a lawyer who specialized in Human Rights and HIV and AIDS. She is an experienced advocate who has dedicated her professional background to defending the human rights of people living with HIV (PLHIV). She has offered legal support and representation for PLHIV in local and national courts in Argentina, as well as at the Inter‐American Commission on Human Rights in cases of human rights violations. In the past she has worked for the Argentinean Network of Women Living with HIV/AIDS, as the Project Manager and Campaigner, and also undertaken facilitation and training activities in topics such as human rights, gender, leadership and advocacy. From 2004 and 2007 she served as a member of UNAIDS Theme Group in Argentina, representing people living with HIV. She has a law degree from Universidad Nacional de Mar del Plata in Argentina.
What got you involved in medicines access issues?
I am a woman with HIV diagnosed in 1998. I am a lawyer specializing in Human Rights, my own experience living with HIV helped me make linkages, from the very beginning of my infection, with other people and groups/organizations of people with HIV, at the local level. In my country, Argentina, since the creation of the National Aids Program in 2000 (after a series of advocacy efforts from groups of people living with HIV) access to HIV treatment is universal. As part of the movement it was always a motivation to contribute to support people living with HIV to timely access quality medicines. Besides the universal public policies in force in Argentina there were always a series of challenges to maintain timely procurement of medicines and provision of health services for our community. We realized the importance of creating a movement to provide us with strength to promote public policies that improve the quality of life of our colleagues. Treatment barriers were always our main focus, giving the critical role medicines play in keeping people alive.
Where are you focusing your work on medicines access and what do you think are the most urgent priorities for advocacy to advance access to medicines?
Our main focus is the area of intellectual property barriers of access to medicines. By gathering information from different sources, including direct data from our own peers who face obstacles to access to medicines, we realized that a great percentage of the medicines we need were extremely high priced. Even in a context of “universal access policies” people were facing a variety of problems. Second and third line treatment was only authorized by exception and people had to complete complex and long bureaucratic processes to get approval of this authorization. So, a key question we asked ourselves was: why are medicines so expensive? Our research found monopolies generated by intellectual property rights are the main cause for medicines price levels, as exclusivity granted by patents and other exclusive rights (e.g. data exclusivity) make companies seek the greater profits they can get. This is “natural” market behavior; companies invest if they know they have a market to make high profits. The problem is that when we speak about medicines we speak about the health and life of persons. Medicines should be considered for what they are, public goods for the realization of the right to health of people. And not commodities left to the fate of the markets. I think this is the main problem that the patent system presents today. It was intended to promote research and development of new health technologies, but has served little for such purposes, because markets are not designed to meet health needs of the population but to make profits. This is a matter that not only concerns the poorest countries; this is an issue that is mainly facing middle and high-income countries. Essential life-saving drugs, such as the new DDAs to treat hepatitis C are out of reach for many who live in middle and high-income level countries. The main legal tools we currently have to face obstacles generated by the patent system are the health safeguards that are included in TRIPs. However, over the years we have gathered countless evidence of the difficulties, mainly political, that emerge when government or civil society make use of these measures. Civil society, groups of people with HIV and HepC, have been making significant efforts to overcome barriers of intellectual property and will continue doing for this. We need UN agencies and donors to work closely with us and support our work. However it is necessary to start thinking about a change in the system. We need a new system that promotes the definition of health needs, investment in research and development for new medical technologies, and access to those technologies that is based on the responsibility of States to meet obligations to provide the assurance of human rights of their people. In my point of view the Ban Ki-moon High Level Panel on Access to Medicines should play a key role to start the process of change communities all around the world need for the realization of their right to health.
What are the connections between medicines access issues for HIV, TB, Hep C and other conditions and how can advocates work more closely together to advance on medicines access across diseases?
Intellectual property barriers are common to all diseases. There is a funding gap for work on the promotion, adoption and use of TRIPS health safeguards. Very few donors support the kind of work we do, that is to overcome IP barriers of access to medicines in order to make medicines affordable and accessible for all. Donors need to increase investment to support capacity building of communities to encourage their involvement in advocacy on these issues, as well as help communities to mobilize around the need to secure sustainability of HIV-HepC universal access. We need to work in collaboration to make medicines affordable.
What advice to you have for a young advocate interested in medicines access issues?
It is very important that we make efforts to involve young people in our mobilization efforts. We prioritize young people's inclusion in the training workshops we do each year. Participants learn from others, drawing on actual advocacy actions. In so doing, we give participants the opportunity to be a part in building their own future.
Shiba Phurailatpa
Shiba Phurailatpam is the director of the Asia Pacific Network of People Living with HIV (APN+). HIV-positive individuals from different Asia and pacific countries founded APN+ in 1994 and today its membership includes national networks of PLHIV from 31 countries in the region. APN+ was established in response to the need for a collective voice for people living with HIV in the region, to better link people living with HIV in the region with positive networks throughout the world, and to support regional responses to widespread stigma and discrimination and better access to treatment and care. Before joining APN+, Mr. Phurailatpam worked with the United Nations Development Programme, ActionAid International and several community groups including Manipur network of people living with HIV. He has devoted his life to fighting for the rights of people living with HIV in India and across the region. He is a longtime treatment advocate and activist fighting for the rights of people living with HIV as well as marginalized communities.
What got you involved in medicines access issues?
In early days when ARV started becoming available in developed countries those medicines were extremely expensive. Due to this high cost no one in my country was able to afford them and as a result so many people died. I myself as a person living with HIV needed those medicines and I was not able to afford them. I was already doing HIV work that time and we started lobbying our government to provide those medicines. Around the same time we also started learning about intellectual property rights and patents on those medicines were among the key reasons why those medicines were expensive. Due to patents, other companies were not allowed to produce those medicines and the patent holders were maintaining high prices. This made many of us very angry and pushed us to do more work around this issue. Additionally, when we see so many of our friends dying on a daily basis simply because they could not afford treatment, we had to respond to that situation.
Where are you focusing your work on medicines access and what do you think are the most urgent priorities for advocacy to advance access to medicines?
Our work on access to medicines is focused on two areas, 1. Intellectual property rights related issues and 2. financing. A patent is a monopoly that restricts other companies from producing generic versions of medicines. When only one company (patent holder) produce the medicine the company can charge as much as they want. Whereas when there are multiple companies producing the same medicine it leads to lower price because of competition. So it is important that our work on access to medicine covers this area. And no matter how much the medicine costs someone has to pay so it is important that our work also cover financing.
Currently there are free trade agreements going on between developed and developing countries. Through these trade negotiations developed countries are pushing intellectual property rights provisions that are beyond TRIPS agreement. Such provisions will make medicines more expensive. This is one area we all need to address urgently. We also need to build the capacity of civil society and community groups on intellectual property and medicines access so that they are aware of how intellectual property rights impact access to medicines. It will also allow them to lobby their government to use flexibilities provided in TRIPS agreement such as patent opposition, compulsory licenses etc.
What are the connections between medicines access issues for HIV, TB, Hep C and other conditions and how can advocates work more closely together to advance on medicines access across diseases?
As mentioned above intellectual property rights related issues apply to all medicines so advocates who work on any disease should come together so that their voices can be louder and stronger. They can also work together on financing and other issues related to access, such as community and public mobilization.
What advice to you have for a young advocate interested in medicines access issues?
From our own personal experiences it is clear that patent and other intellectual property rights related issues keeping the price of medicines high, so young advocates should urgently learn about this and start addressing this issue.
