Medicines Patent Pool sign historic agreement with Gilead Sciences to increase access to HIV medicines in developing countries

GENEVA, 12 July 2011—The Joint United Nations Programme on HIV/AIDS (UNAIDS) strongly welcomes the new license agreement between the Medicines Patent Pool and the pharmaceutical company Gilead Sciences to increase access to antiretroviral therapy in developing countries. This is the first time a pharmaceutical company has signed an agreement with the Medicines Patent Pool and marks a turning point for future private sector collaboration in sharing innovation to advance the response to HIV. 

Under the agreement, Gilead will share intellectual property on a range of medicines to treat HIV. The agreement will allow for the production of the HIV medicines tenofovir, emtricitabine, cobicistat, and elvitegravir as well as a combination of these products in a single pill known as the “Quad.” Cobicistat, elvitegravir and the Quad are products still in clinical development. Companies interested in producing generic versions of the medicines for developing countries will be able to approach the Patent Pool to negotiate licensing terms.

“This agreement between the Medicines Patent Pool and Gilead signals a new era in the response to HIV with private and public sectors working hand in hand for the best interests of public health,” said Michel Sidibé, Executive Director of UNAIDS. “I hope today’s announcement will inspire other pharmaceutical companies to follow suit to share intellectual property and innovation to make new technological advances in HIV treatment available sooner to the people that need them most.” 

The agreement is particularly significant and represents a major step forward as Tenofovir is one of the first-line medicines for HIV recommended for use by the World Health Organization as per guidelines released in 2010. Under the new agreement Tenofovir will also be licensed for use to treat Hepatitis B, a common and serious co-infection of HIV.

The inclusion of products still under development is a rare and important advance and will allow for generic versions of new medicines to rapidly enter the market, lessening the inequality between developed and developing countries in accessing new medicines. 

In low- and middle-income countries, UNAIDS estimates that around 6.6 million people are currently accessing HIV treatment––however a further 9 million are still in need. At the recent United Nations High Level Meeting on AIDS, UN Member States unanimously adopted a declaration which set bold new targets which included increasing access to antiretroviral therapy to 15 million people by 2015. 

The Medicines Patent Pool is a creative new approach which was established in 2010 with the support of UNITAID to increase access to newer antiretroviral medicines by creating a
pool of patents and intelligence on antiretroviral production donated by medicine producers. It is currently in negotiations with six other patent holders.

Use of TRIPS flexibilities, including compulsory licensing and rejection of data exclusivity clauses, in trade agreements by India to ensure sustained access to life-saving medicines for people living with HIV

India’s Commerce Minister Mr Anand Sharma (left) met with UNAIDS Executive Director Mr Michel Sidibé at the Ministry of Commerce and Industry on 6 July 2011.
Credit: Sarabjeet Singh

NEW DELHI/GENEVA, 6 July 2011—UNAIDS welcomes the assurance given by India’s Commerce Minister, Mr Anand Sharma, that India will reject any efforts to include ‘data exclusivity’ clauses in bilateral trade agreements. This assurance came at a meeting between Mr Sharma and UNAIDS Executive Director Michel Sidibé, held today at the Ministry of Commerce and Industry.

“We reject data exclusivity clauses in free trade agreements,” said Mr Sharma. Welcoming the Minister’s assurance, Mr Sidibé said: “Millions of people will die if India cannot produce generic antiretroviral drugs, and Africa will be the most affected. For me, it is an issue of life or death.”

India’s pharmaceutical industry produces more than 85% of the first-line antiretroviral drugs used to treat people living with HIV. The cost of the least expensive first generation treatment regimen has dropped to less than US$ 86 per patient per year. But as increasing numbers of people move towards more efficacious and tolerable first-line treatment, drug prices could double compared to first-generation regimens. In addition, as patients develop drug resistance and require more expensive and patent-protected second- and third-line antiretroviral medicines, some projections indicate treatment costs escalating by as much as twenty-fold.

“The Government of India reaffirms its full commitment to ensure that quality generic medicines, including antiretroviral drugs, are seamlessly available, and to make them available to all countries,” said Mr Sharma. “India will also use the flexibilities allowed under TRIPS, including the use of compulsory licensing, to ensure that people living with HIV have access to all life-saving medicines,” Mr Sharma added.

“India, together with Brazil, South Africa, China and Russia, must forge an alliance with other high-income countries to ensure that no single person in the world dies because they could not afford to buy life-saving medicines or health care,” Mr Sidibé said.

An estimated 15 million people are eligible for antiretroviral treatment in low- and middle-income countries, and about 6.6 million people have access to HIV treatment. The Government of India provides free antiretroviral treatment to more than 420 000 people living with HIV in India.

Current treatment approaches are not sufficient to provide access to all who need it. UNAIDS and other partners advocate for Treatment 2.0—a framework that seeks to simplify the way treatment is currently provided. For this approach to succeed, TRIPS flexibilities as well as innovation and protection of intellectual property rights will play an important role for treatment access in the future.

Efforts to increase access to HIV prevention and treatment services must be scaled up alongside societal efforts to eliminate homophobia

NEW DELHI, 5 July 2011—UNAIDS lauds efforts by India’s National AIDS programme to provide HIV services for men who have sex with men and transgender people. Currently around 67% of men who have sex with men in India are accessing prevention services. According to estimates of the National AIDS Control Organization, there are more than 400 000 men who have sex with men inIndia; HIV prevalence in this population is about 7.3% compared to a national adult HIV prevalence of 0.31%.

“India’s rich tradition of inclusivity and social justice must include men who have sex with men and transgender people,” said Michel Sidibé, UNAIDS Executive Director, on the side lines of the National Convention of Parliamentarians and elected representatives. “India’s successful AIDS response has been possible due to the strong participation of communities of men who have sex men, sex workers, people who inject drugs and transgender people backed by a strong and progressive National AIDS policy.”

UNAIDS welcomes the call by the Prime Minister of India, Dr Manmohan Singh, to have an “HIV sensitive” policy and programmes so that the marginalized populations affected by HIV are not denied the benefits of health and development programmes. “We should work to assure for them a life of dignity and wellbeing. We have to ensure that there is no stigma and discrimination towards HIV infected and affected persons,” said Dr Singh. During the inauguration of the National Convention, Dr Singh reiterated his government’s strategy to provide HIV services to groups at higher risk of HIV infection.

“There is no place for stigma and discrimination on the basis of sexual orientation,” said Mr Sidibé. “I welcome the bipartisan call by Mrs Sonia Gandhi and Mrs Sushma Swaraj to end all forms of stigma and discrimination against people at increased risk of HIV infection.”

In 2009 the Delhi High Court overturned a law that criminalized consensual adult sexual behaviour. This stand was also supported by the Government of India in its affidavit filed with the Supreme Court.

“Consistent with WHO’s disease classification, UNAIDS does not regard homosexuality as a disease,” said Mr Sidibé. According to the recently released UNAIDS and WHO guidelines on prevention and treatment of HIV and other sexually transmitted infections among men who have sex with men and transgender people, legislators and other government authorities should establish anti-discrimination and protective laws in order to eliminate discrimination and violence faced by men who have sex with men and transgender people.

UNAIDS is committed to providing support to India’s successful AIDS response, which has seen new HIV infections drop by more than 50% in the last decade. India currently produces more than 85% of high-quality generic antiretroviral drugs for the majority of low- and middle income countries.India’s courts have progressively protected the human rights of people living with HIV and men who have sex with men by striking down discriminatory laws. 

UNAIDS will work with the Government of India, civil society and community groups in realizing the vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths in India.

Unprecedented global participation at UN General Assembly High Level Meeting on AIDS leads to new commitments, targets, and momentum in the AIDS response

Michel Sidibé, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), addresses the opening of the General Assembly High-Level Meeting on AIDS on 8 June 2011.
Credit: UN Photo/Paulo Filgueiras

NEW YORK/GENEVA, 10 June 2011­­—The Joint United Nations Programme on HIV/AIDS (UNAIDS) welcomes the bold new targets set by world leaders at the United Nations General Assembly High Level Meeting on AIDS which concluded in New York today. Countries agreed to advance efforts towards reducing sexual transmission of HIV and halving HIV infection among people who inject drugs by 2015.

They also agreed to push towards eliminating new HIV infections among children in the next five years. Leaders pledged to increase the number of people on life saving treatment to 15 million and to reduce tuberculosis related deaths in people living with HIV by half in the same time period.

“This Declaration is strong, the targets are time bound and set a clear and workable roadmap, not only for the next five years, but beyond,” said Joseph Deiss, President of the United Nations General Assembly. “UN Member States have recognized that HIV is one of the most formidable challenges of our time and have demonstrated true leadership through this Declaration in their commitments to work towards a world without AIDS.”

The bold targets come at a time when international assistance for the AIDS response has dropped for the first time since 2001. Member States agreed to increase AIDS-related spending to reach between US$ 22 billion and US$ 24 billion in low- and middle-income countries by 2015.

These far reaching goals are set in the Political Declaration on HIV/AIDS: Intensifying our Efforts to eliminate HIV/AIDS adopted by the General Assembly on 10 June, 2011. The declaration notes that HIV prevention strategies inadequately focus on populations at higher risk—specifically men who have sex with men, people who inject drugs and sex workers, and calls on countries to focus their response based on epidemiological and national contexts.

“These are concrete and real targets that will bring hope to the 34 million people living with HIV and their families,” said Michel Sidibé, Executive Director of UNAIDS. “Through shared responsibility, the world must invest sufficiently today, so we will not have to pay forever.”

The declaration calls on all UN Member States to redouble their efforts to achieve universal access to HIV prevention, treatment, care and support by 2015 as a critical step towards ending the global AIDS epidemic. A pledge to eliminate gender inequality, gender based abuse and violence, and to increase the capacity of women and adolescent girls to protect themselves from HIV infection was also made.

The Declaration recognizes that access to sexual and reproductive health has been and continues to be essential to the AIDS response and that governments have the responsibility of providing public health services focused on the needs of families, particularly women and children. Member states also agreed to review laws and policies that adversely impact on the successful, effective and equitable delivery of HIV prevention, treatment, care and support programmes to people living with and affected by HIV.

With nearly 7000 new HIV infections each day, the declaration reaffirms that preventing HIV must be the cornerstone of national, regional and international responses to the AIDS epidemic. It calls for expanding access to essential HIV prevention commodities, particularly male and female condoms and sterile injecting equipment. Calling for intensifying national HIV testing campaigns; it urges countries to deploy new bio-medical interventions as soon as they are validated including earlier access to treatment as prevention.

Taking note of the UNAIDS strategy, the Declaration commends UNAIDS for its leadership role on AIDS policy coordination and support to countries and calls on the joint programme to revise indicators for success and support the Secretary-General of the United Nations in providing an annual report on the progress made by Member States in realizing the commitments made in the declaration.

(Left to Right): Ban Ki-Moon, Secretary-General of UN; President Bongo Ondimba of Gabon (speaking) at the United Nations Security Council on June 7, 2011 at UN Headquarters, NYC. Credit: UNAIDS/B.Hamilton

NEW YORK, 7 June 2011—The Joint United Nations Programme on HIV/AIDS (UNAIDS) welcomes a new United Nations (UN) Security Council resolution on HIV which has been adopted at the UN Security Council in New York. The resolution calls for increased efforts by UN Member States to address HIV in peacekeeping missions. It also calls for HIV prevention efforts among uniformed services to be aligned with efforts to end sexual violence in conflict and post-conflict settings.

"The Security Council has made major strides in addressing sexual violence in conflict. But rape is still a weapon of choice. This is an atrocious human rights violation and a public health threat,” said United Nations Secretary General Ban Ki-moon. “I urge all Member States to link efforts to combat HIV with our campaigns against sexual violence and for the rights of women."

The resolution builds on the previous UN Security Council resolution 1308, which was adopted in 2000. The new resolution calls on the United Nations and UN Member States to bolster global and regional partnerships and integrate comprehensive HIV programmes into efforts to prevent conflict, ensure security and build peace.

“Global, national and personal insecurity undermine efforts to prevent new HIV infections and increase access to HIV services for both peacekeepers and civilians,” said the President of Gabon, Ali Bongo Ondimba. “This resolution will help to mitigate the impact of HIV among uniformed services and civilian populations affected by conflict and increase access to HIV services.”

The resolution, which was tabled by Gabon, President of the Security Council for June 2011, recognises that HIV can have a uniquely devastating impact on all sectors and levels of society and that in conflict and post-conflict situations these impacts may be felt more profoundly. It also recognizes that conditions of violence and instability in conflict and post-conflict situations can exacerbate the spread of HIV because of displacement, conflict-related sexual violence and reduced access to HIV services.

Since the adoption of resolution 1308 in 2000, progress has been made in addressing HIV and security. About 60% of UN Member States have integrated HIV programmes for military, police and other uniformed personnel. However the quality of programmes is variable and resources to fund the programmes are often insufficient.

“Peacekeepers can play a leading role in HIV prevention as they secure peace around the world,” said Michel Sidibé, Executive Director of UNAIDS. “Uniformed personnel can act as agents of positive change, particularly in relation to preventing sexual violence in conflict and post-conflict situations.”

Evidence shows that the threat AIDS poses to peace and security is far more nuanced than initially thought. Both the characteristics of conflict and the epidemic itself have evolved significantly over the past 10 years with sexual violence being increasingly used as a tactic of war. Addressing this requires a broadening and strengthening of HIV programmes for peacekeepers to ensure an effective response to HIV and sexual violence in conflict and post-conflict settings.

“Renewed commitment around the new agenda is needed to ensure that the AIDS response effectively contributes to all UN peacekeeping efforts to ensure security and promote and build peace,” said Alain Le Roy, Under-Secretary General for United Nations Peacekeeping Operations.

During the UN Security Council session, both the United Nations Secretary-General Ban Ki-moon and the Executive Director of UNAIDS paid tribute to the late US Ambassador to the United Nations, Richard Holbrooke, for championing resolution 1308. In 2000, Ambassador Holbrooke said, “Resolution 1308 should be well known and it should be fully implemented. It should not be the end of the process, but only a cornerstone for the future.”

Reinvigorated efforts around a new HIV security agenda will be instrumental in addressing the impact of AIDS on peace and security. UNAIDS will work with member states to scale-up access to HIV prevention, treatment, care and support for all uniformed services, including police, immigration, prison and the navy, to prevent HIV and end violence against women and girls.

Message from UNAIDS Executive Director Mr. Michel Sidibé

GENEVA, 17 May 2011—The world is faced with stigma and discrimination that can lead to violence and block the AIDS response. This impacts the lives of lesbians, gays, bisexuals and transgender people.

The AIDS response has shown that when people are stigmatized because of their sexual orientation or gender identity, they are less likely to access the HIV services they need. This leads to new HIV infections and AIDS deaths.

We must replace violence and discrimination with acceptance and tolerance.

I call on governments to create social and legal environments that ensure respect for human rights and universal access to HIV prevention, treatment, care and support.

http://www.youtube.com/watch?v=vFSqHH1iXXg

Message from UNAIDS Executive Director Mr. Michel Sidibé

GENEVA, 24 March 2011—I am pleased to see that growing collaboration between HIV and tuberculosis (TB) programmes is bearing fruit. Since 2002 there has been an 80-fold increase in the number of TB patients who were tested for HIV.

For TB patients who test positive for HIV, knowing their status will allow them to seek access to life-saving HIV treatment and care.

However, on this World TB day, I am concerned. We are seeing an emerging epidemic of drug resistant TB. It is a sobering thought that an estimated two million people living with HIV could die of TB between now and 2015, if urgent action is not taken.

The tools are now available to prevent many of these deaths––A faster, more accurate TB test has been developed––and access to antiretroviral therapy has been significantly improved. TB and HIV communities must continue to scale-up joint efforts to rapidly roll-out these services and save lives.

Let us not forget that HIV and TB are two diseases –– but we are talking about one life.

UNAIDS has committed to halving TB deaths in people living with HIV by 2015. I believe we can not only achieve this goal, but surpass it.

http://www.youtube.com/watch?v=yaldyxe3tI8

Delivered by Michel Sidibé, Executive Director of UNAIDS

Washington, DC, 2-3 December 2013

I am pleased to send greetings to this important gathering of leaders from government, the private sector, civil society and others supporting the Global Fund to Fight AIDS, Tuberculosis and Malaria. I thank theUnited Statesfor hosting.

We are at a crucial turning point.  With your support, we have made major advances. Leading economies are providing consistent resources for the response to AIDS, TB and malaria while low- and middle-income countries have also significantly increased domestic expenditures.  I welcome this.

At the same time, financing from the international community remains a lifeline for millions of people.  We must act with resolve to preserve these gains, which remain fragile.  If bed-nets and anti-malarials are not delivered and used in time, malaria will continue to spread.  Drug-resistant tuberculosis is on the increase.  An AIDS-free world is in sight but success depends on our unwavering resolve to bring treatment to the nearly three in ten children and adults who still do not have access to it. We need to work smarter and better to truly end these infectious diseases.

The Global Fund is an essential institution in this battle. It is delivering results with a commitment to reform.  As part of this process, the Global Fund has worked even more effectively with other organizations and groups.  I am especially encouraged that the Global Fund and the UN development system, particularly UNAIDS, continue to deepen their collaboration. This model of partnership can ensure that strong health and community systems can deliver results and address other problems including maternal and child mortality.

This Fourth Replenishment comes at a propitious moment. Financing committed now will straddle the 2015 deadline for achieving the Millennium Development Goals, sending a clear signal that we will do everything possible to reach our targets.

I applaud all countries and partners that support the Global Fund. As the world continues to grapple with the effects of the 2008 financial crisis, I commend governments and others for stepping up to ensure that progress is preserved.

I urge all stakeholders to continue to demonstrate your unwavering support by making the strongest possible commitment to the Global Fund.  This is a morally and financially sound investment in our shared future.

By Macky Sall, President of Senegal and Chairperson of the NEPAD Heads of State and Government Orientation Committee; Hailemariam Desalegn, Prime Minister of Ethiopia and Chairperson of the African Union; and Michel Sidibé, Executive Director of the Joint United Nations Programme on HIV/AIDS.

2 December 2013

The international community will decide this week in Washington whether or not to take the next big step on the path to ending AIDS. At a special conference, they will be pledging new contributions to replenish the Global Fund to Fight AIDS, Tuberculosis and Malaria. This is one of the best investments in global health and development we know.

Over the past decade, Global Fund-supported programs have saved millions of lives. With governments, multi-lateral organizations and civil society working in partnership, this global health response has quite literally changed the course of health and economies in countries around the world.

We believe full replenishment of the Global Fund can reap even greater benefits in the coming years, dramatically reducing HIV infection rates, AIDS deaths and malaria and TB cases. We are close to a “tipping point,” at which investments now could help put these diseases firmly under control—or, if we wait, risks tipping us decades behind. In short, either we can pay now, or pay forever.

This replenishment conference is focused on shared responsibility and global solidarity. Today investing in health is a shared responsibility—with more than half of all HIV-related spending coming from developing countries themselves. As we urge donor governments to sustain and increase their funding, African governments are also recommitting to increase their contributions to end these diseases.

If the measure of a good investment is found in the numbers, we are succeeding. The Global Fund saves more than 100 000 lives every month. Since its founding, the Global Fund has provided HIV treatment to 4 million people, delivered more than 300 million anti-malaria bed nets and diagnosed and treated almost 10 million cases of TB. These lifesaving initiatives have also saved billions of dollars by reducing health care costs, preserving families and growing economies.

The benefits go far beyond pills and bed nets. Early on, policymakers learned from families and communities on the ground that focusing on these diseases in isolation was not enough—we also needed to leverage Global Fund investments to strengthen health systems and provide support to help people affected by HIV, TB and malaria rebuild their lives with dignity.

The African Union and the New Partnership for Africa’s Development (NEPAD) are working together to transform Africa. In the spirit of shared responsibility, many countries have stepped up their domestic investments and an increasing number are taking ownership of their health programs. We are seeing the returns on these investments. For example, in Senegal, the number of new HIV infections has dropped more than 50% between 2001 and 2012.

In Ethiopia, Global Fund support has enabled the Ministry of Health to train more than 30 000 extension health workers—nearly all women—to provide basic health care such as immunizations and HIV testing and counseling to families in their homes. With the help of these new health professionals, rates of new HIV infections in adults dropped an astonishing 90% between 2001 and 2011.

To truly understand what these investments mean, you need to talk with someone like Bizunesh Wada, a mother of four in Ethiopia. Bizunesh’s husband had died of AIDS, and she was also diagnosed with HIV. She worried about raising a family on her own. Global Fund-supported programs provided her not only with life-saving treatment but also with entrepreneurship training and a microloan, which she used to purchase a single ox that has since led to a thriving farm that is helping her put her children through school.

The replenishment conference is an inspiring example of what can happen when the world unites around an urgent need. Many donors have been generous, the United States particularly so, contributing a third of the Global Fund’s total funding. With this continued strong support, from the US and all partners, the Global Fund will be well positioned to deliver continued results.

As a result, mothers and fathers remain healthy enough to raise their children. Farmers can continue to tend their crops so their communities don’t go hungry. Young people are staying in school, starting businesses, and generating the new ideas we need to move our economies forward.

In Africa we say: "if you want to go fast, go alone—but if you want to go far, go together". We stand in solidarity with our peers in Africa, Asia, America and Europe to ensure the continued success of the Global Fund. It’s a lifesaving investment with an incomparable payoff: the potential end of the deadly AIDS, TB, and malaria epidemics.

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners to maximize results for the AIDS response. Learn more at unaids.org and connect with us on Facebook and Twitter.

GENEVA, 11 July 2013—The Joint United Nations Programme on HIV/AIDS (UNAIDS) welcomes the appointment of Phumzile Mlambo-Ngcuka as the new Executive Director of the United Nations Entity for Gender Equality and the Empowerment of Women (UN Women).   

Ms Mlambo-Ngcuka was the first woman to hold the position of Deputy President of South Africa. She also played a central role in the government’s HIV programme, serving as chair of the South African National AIDS Council where she took the lead in ensuring broader and more cohesive collaboration with international and civil society partners.

“Ms Mlambo-Ngcuka is a respected leader and brings with her a wealth of experience in promoting the human rights of women and girls,” said Michel Sidibé, Executive Director of UNAIDS. “She will be an important partner in the AIDS response as women continue to be disproportionately affected by HIV. We look forward to working closely with her to improve the lives of women and girls everywhere.”

Gender equality and respect for women’s sexual and reproductive health and rights, especially for women living with HIV, are essential for an effective response to HIV. Persistent gender inequalities and women’s rights violations are continuing to make women and girls more vulnerable to HIV and prevent them from accessing HIV services. In 2011 there were nearly 17 million women living with HIV and HIV continues to be the leading cause of death in women of reproductive age.

UN Women was established in 2011 to provide a dynamic and powerful voice at national, regional and global levels for women’s rights and equality. It ensures that new opportunities for women and girls are central to UN programmes and that the UN system continues to protect the rights of women and girls around the world.

UN Women also highlights the contributions and priorities of women living with or affected by HIV and has contributed to integrating gender aspects into the plans and policies developed by national AIDS councils in more than 35 countries and regional programmes. UN Women is the newest of UNAIDS 11 Cosponsoring organisations, having joined in June 2012.

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners to maximize results for the AIDS response. Learn more at unaids.org and connect with us on Facebook and Twitter.