The Ugandan government is struggling to live up to its promises to protect the local production of antiretrovirals and anti-malarials from competition from abroad.

Following a 2008 agreement with Indian generic drug maker Cipla Limited, a Ugandan company, Quality Chemicals Limited (QCIL), began manufacturing antiretrovirals (ARVs) and artemesinin-based combination therapies (ACTs) in 2009.

But locally manufactured drugs are proving more expensive than generic ARVs produced in India, China and Pakistan, and even by big pharmaceutical firms in the West.

According to the Uganda Pharmaceutical Manufacturers Association, in 2010 Uganda’s pharmaceutical market was worth an estimated 276 million dollars; 90 percent of these medicines were imported.

Paul Asiimwe, a Ugandan lawyer knowledgeable about intellectual property laws and access to medicines, says QCIL and other pharmaceutical manufacturers in Uganda have not been given enough protection from foreign generic manufacturers eager to cash in on the multi-million-dollar Ugandan pharmaceutical market.

But he concedes the government has limited room to influence this. “The problem is that the government does not actually purchase most of these drugs, since they are largely paid for by donors and the Global Fund for AIDS, Tuberculosis and Malaria, which has insisted that all procurement should be competitively tendered out,” Asiimwe explained.

Denis Kibira, the medicines advisor with the Coalition for Health Promotion and Social Development (HEPS-Uganda), said prices for locally produced ARVs in Uganda will remain high until government and its partners such as the World Health Organisation [WHO] address what he referred to as “niggling concerns”.

“Prices of locally-produced medicines will only come down if costs of production are reduced through availability of affordable financing for the sector, improved road infrastructure as well as local production of active pharmaceutical ingredients,” Kibira said, adding that local  manufacturers still incur high costs for raw materials whose prices fluctuate widely depending on demand from other countries.

Emmanuel Katongole, QCIL’s chief executive officer, recently asked the government to intervene to help his firm strengthen local sourcing of raw materials.

“It is becoming too costly to import raw materials from India,” explained Katongole.

He added that the cultivation of Artemisia in parts of Uganda has not helped to lower the cost of producing anti-malarial medicine as raw Artemisia from Uganda was yet to be approved by the WHO.

Dr Gilbert Ohairwe, a board member of the Pharmaceutical Society of Uganda, explained that in addition to competition from manufacturers in India, China and Pakistan, the local pharmaceutical industry has had to contend with cheap drugs reaching Uganda via voluntary pooled procurement.

The Global Fund relies on pooled procurement, which secures medicines in bulk at preferential prices from the world’s leading drug companies, as an effective way to solve challenges of both prices and quality control.

But Ohairwe said with Big Pharma capturing the lion’s share of the nearly 20 billion dollars spent by the Global Fund on drugs for 144 countries in 2010, local producers are disadvantaged.

Advocates for better access to ARVs and other medicines suggest that Uganda should take better advantage of exemptions for Least Developed Countries under World Trade Organisation regulations – which were recently extended to 2021 – to acquire technology to produce high-quality, inexpensive medication.

Moses Mulumba, the executive director of the Centre for Human Rights and Development (CEHURD), which advocates for local generic manufacturing, said, “We can’t rely on importation of medicines forever. This is why I think that we need to deal with the challenges that make our ARVs more expensive.

“The time is now, when we have the policy space under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement, as recently extended. It will be more challenging to deal with these concerns when the policy space is finally closed.”

Sarah Opendi, the country’s national minister for health, agreed that the local pharmaceutical sector is facing challenges. “But nobody can say we have not supported Quality Chemicals Limited to reach where it is now. It is definitely in our interest to have more medicine manufactured here,” she said.

Dr Gordon Sematiko, director of the National Drug Authority, revealed that the NDA was formulating a new national pharmaceutical strategy in co-operation with the Ministry of Health.

The new policy, according to Sematiko, will put measures in place to reduce dependence on imported medicines.

“It is hoped that the plan will improve their manufacturing practices and thus enhance their competitiveness on the domestic market,” he said.

A major audit of the United States’ flagship global anti-HIV/AIDS programme, prepared for the U.S. Congress, notes “remarkable progress” over the past decade. However, it is also warning of insufficient monitoring and urging a stepped-up process of handing over greater control to partner countries.

Known as the President’s Emergency Plan for AIDS Relief (PEPFAR), the initiative is the largest such programme in the world, credited with saving millions of lives, particularly in Africa. Since its authorisation in 2003, at the behest of then-president George W. Bush, PEPFAR has disbursed more than 30 billion dollars through bilateral agreements in over 100 countries.

The legislation that created PEPFAR requires Congressional re-authorisation this year, however. As part of that process, Congress required the national Institute of Medicine (IOM) to conduct an audit on the efficacy of the programme’s first decade.When you start taking [anti-HIV drugs], you have to do so for the rest of your life... It’s much harder to pull funding that will directly cause people to die.

In many regards, the findings of PEPFAR’s impact over the past decade are extremely positive. IOM committee chair Robert Black, an international health expert, notes that his team “repeatedly heard PEPFAR described as a lifeline” during visits to partner countries.

“PEPFAR has achieved – and in some cases surpassed – its initial ambitious aims,” the IOM committee’s 700-page report, released Wednesday, states.

“These efforts have saved and improved the lives of millions of people around the world. That success has in effect ‘reset’ the baseline and shifted global expectations for what can be achieved in partner countries.”

Yet the report also notes that much work remains to be done, particularly to safeguard “hard-fought gains”.

The reporting committee is calling on PEPFAR to increase emphasis on funding for the far more difficult task of HIV prevention, rather than treatment. It is also pushing the agency to focus more on the ultimate impact of its funding on the ground.

“The report does a good job of being explicit about these data gaps and the need for better information on spending,” Victoria Fan, an international health specialist with the Center for Global Development (CGD), a Washington think tank, told IPS. “As PEPFAR wants to shift from measuring funding-related activities to measuring actual outcomes, they are going to need better data-monitoring systems.”

Collective ownership

Of particular prominence in the IOM evaluation is the move towards strengthening “ownership” of PEPFAR programming by partner countries, both in finances and programmatic approach.

“Today, the ability of many countries to respond to HIV relies heavily, and sometimes exclusively, on external funding,” the report states, noting later: “PEPFAR will gradually cede control, as partner countries take on more central roles in accountability and setting strategic priorities for investment in their HIV response … such an evolution in PEPFAR’s mission is vital.”

In part, this process relates to the willingness of the U.S. government to continue these investments over the long term.

“The United States may be thinking that it’s already been engaged in these programmes for the past 10 years, and in that time the epidemic has changed,” CGD’s Fan says. “So, maybe it’s time to let other countries take more ownership and invest more financially in these programmes – that’s a reasonable assertion.”

At the same time, HIV-positive people around the world are today able to live far longer due to new treatment innovations, while a generation of children that would have otherwise risked exposure is being born without HIV. Fan notes that this creates a “moral entitlement” that may have caught some U.S. legislators by surprise.

“Remember, when you start taking [anti-HIV drugs], you have to do so for the rest of your life,” she says. “That’s a long-term commitment that U.S. policymakers may not have been thinking about when they started investing in HIV/AIDS. It’s much harder to pull funding that will directly cause people to die.”

Others have stressed that as PEPFAR moves into a new phase of post-emergency funding, particularly as the U.S. government wrestles with concerns over debt and austerity, it will be increasingly important to determine where exactly that money is going.

“Country ownership doesn’t necessarily mean governments taking control, but rather is about partnerships between national governments, international donors and civil society,” Serra Sippel, the president of the Center for Health and Gender Equality (CHANGE), a Washington advocacy group, told IPS.

“Civil society engagement is particularly important when you look at countries that are not that friendly towards women’s rights or LGBT rights. It’s very important that PEPFAR continue to support and work with civil society to make sure no one is left out of HIV/AIDS-related access to care.”

Ultimately, country ownership today may mean ensuring that the money that has already been spent has a longstanding impact and sustainability.

Keeping Congress out

President Barack Obama is set to indicate his own vision for new PEPFAR funding when he unveils his national budget proposal for 2014, slated to take place in March.

CHANGE’s Sippel points out that funding for PEPFAR won’t actually halt if legislative re-authorisation does not take place, and she is urging that the president simply circumvent the politically fractious Congress.

“Given the climate with Congress right now, we don’t think we have a positive political climate in which to pass effective legislation,” she says.

Certain PEPFAR policies required in the past by the Congress have angered some advocates, and in 2007 a previous IOM report criticised Congress for too tightly controlling how PEPFAR programmes functioned. Yet the new report now vindicates stripping these out, particularly supporting moving away from a previous focus on sexual abstinence and fidelity within marriage.

More problematic is a continued requirement that groups receiving PEPFAR funding must declare their opposition to sex work. While the IOM cautions it didn’t have a mandate to work on this issue, it does note that sex-worker groups are best positioned to deal with prostitution-related HIV/AIDS issues – and warns that their efforts are currently being hampered by this requirement.

The report also shows that PEPFAR still hasn’t figured out how to comprehensively address gender, Sippel says, with the committee researchers noting that responses to women are still “ad hoc”.

“That tells us women are still a blind spot in the global AIDS fight, despite being half of the population living with HIV,” she says. “Until PEPFAR develops a gender strategy with clear objectives and outcomes, we can’t get ahead of HIV.”

By Julia Kallas
UNITED NATIONS, Dec 1 2012 (IPS)

On World AIDS Day, the fact that the number of children newly infected with HIV continues to decline is welcome news to UNITAID, the International Drug Purchase Facility hosted by the World Health Organisation.  But UNITAID is also well aware of how much more remains to be done for  children already living with the disease.

Philippe Douste-Blazy, of France, is a special advisor who promotes UNITAID and other sources of innovative financing for the achievement of the United Nations Millennium Development Goals (MDGs).

“There was some progress made but there is still a lot to be done by the international community,” Douste-Blazy told IPS regarding the fight against HIV/AIDS. “Unfortunately we do not have enough money to achieve the MDGs by 2015,” he added.

Douste-Blazy spoke to IPS U.N. correspondent Julia Kallas about the progress that has been made in preventing mother-to-child transmission of HIV but also how the international community must continue providing childhood HIV treatments to developing countries. Excerpts from the interview follow.

Q: What is the current funding scenario for treating childhood HIV in developing countries?

A: About 3.3 million children are living with HIV today. Unfortunately we do not have enough money to reach the Millennium Development Goals (MDGs) in general but in particular to reach the health-related MDGs – HIV, tuberculosis and malaria.

We must find funding now because with the current economic crisis, we will see a dramatic decrease in Official Development Aid (ODA). It will be difficult for all countries to help. We cannot ask the Greek government, for example, to donate 3 billion dollars for development countries because they are seeing an increase in poverty themselves. So we are going to see an increase in childhood mortality.

We have to create innovative financing for development. For example, UNITAID has placed a small tax on plane tickets. This funding helps combat childhood HIV.

Children are rarely born with HIV in wealthy countries because mothers living with HIV are treated during pregnancy to ensure that their babies are born HIV-free. Still, more than 1,000 children are born HIV-positive every day – 99 percent of them in Africa. Only 28 percent are treated.

We analysed what companies were interested in producing antiretroviral drugs. Our long-term funding gave suppliers the incentive to manufacture child-friendly formulations so we were able to buy pills for five years. Several generic suppliers that entered the market brought the price of the pills down by 70 percent.

Before, no child was treated by periotic antiretroviral, but with an adult’s syrup, 18 times a day. Now with only two pills a day, children can be treated.

Q: World AIDS Day is on Dec. 1. Should we be celebrating major progress?

A: Yes. We can see that there was some progress made, but there is still a lot to be done by the international community. For the first time more than 50 percent of the 15 million patients who need antiretroviral therapy have access to it.

It is also huge progress that we have 7 million fewer new HIV infections around the world, in particularly in Sub-Saharan Africa. Unfortunately in Eastern Europe, Russia and Indonesia, however, the infection has increased.

Q: Can you talk about the development of the three-in-one fixed-dose combination AIDS medicines for children?

A: Since its creation UNITAID has been working on combating paediatric HIV by creating a market for quality child-friendly antiretroviral treatments. Before, there was no incentive for pharmaceutical companies to invest in child-friendly antiretroviral drugs. HIV treatments for children in low-income countries were syrups designed for adults – up to 18 foul-tasting doses a day.

So the three-in-one fixed-dose combination AIDS medicines for children are a major innovation, from 18 doses a day to a pill twice a day. It is huge progress. Every year UNITAID finances the treatments of more than 100,000. Now is the time to follow up on our work with paediatric HIV.

Q: How should the new post-2015 sustainable development agenda address HIV/AIDS, and what can be done more effectively?

A: We cannot continue if we do not have money. Every head of state, head of government or member of parliament says we are going to reach the MDGs. It is not true.

To combat HIV we need three things. First is prevention. We need to help prevent high-risk people such as prostitutes and homosexuals from becoming infected. Secondly, we must ensure universal access of treatment. Only 54 percent of adults and 28 percent of children are being treated today.

Finally, we need to raise funds to achieve the MDGs – we need more innovative financing. With UNITAID, we proved that this is possible.

Q: Can you talk more about the one-dollar plane tax idea created by you, former Brazilian president Lula and former French president Chirac? What needs to be done to get more countries involved in this project?

A: UNITAID’s funding model is based on an air ticket solidarity levy. Every American who goes to France is going to pay one extra U.S. dollar to support our program. It is the same thing in 15 other countries. In five years we raised 2.5 billion dollars, and it is predictable, sustainable funding.

For the traveller, it is painless – people who can pay for a plane ticket can easily pay an extra dollar. It is not even the price of a coffee. With this funding we help combat childhood HIV. Eight out of 10 children are treated thanks to this system. Now we are working to convince more countries to become involved in this program.

Excerpt:

In Chile, not only do all people diagnosed with HIV/AIDS receive treatment, but the country also has advanced mechanisms for monitoring outcomes of the antiretroviral therapy.

“Treatment is available in many other parts of the world, but no one knows whether or not it is working,” Marcelo Wolff, an infectologist who studies HIV/AIDS at the University of Chile, told IPS.

In this South American country, “coverage extends to nearly everyone living with HIV,” added Wolff, who won a Richard and Hinda Rosenthal Award this year, which recognises innovative research that has made a notable contribution to improved clinical care in the field of internal medicine.

A red ribbon, the global symbol of the fight against AIDS. Credit: Gary van der Merwe CC BY-SA 3.0

Officially, some 22,000 people are living with HIV/AIDS in Chile, although the real number could be between 40,000 and 70,000, Wolff said.

“It is estimated that there are two to three undiagnosed people for every diagnosed person,” he said, “which means the total would be between 0.3 and 0.4 percent of the population over the age of 15” in this country of 16.5 million people.

The approach involves a monitoring system in 32 public healthcare centres around the country, which makes it possible to take timely measures addressing the specific needs of each case.

The monitoring is carried out by the Chilean AIDS Cohort (ChiAC), established by a team of professionals like Wolff, who joined a multidisciplinary and non-governmental network, SIDA Chile (AIDS Chile), founded in 2003.

“Knowing about what is happening to the people being treated is the main novelty,” Wolff said. “And the Chilean AIDS Cohort has been able to study that: the survival, morbidity and hospitalisation rates, and labour and social reinsertion.”

The same monitoring system is used for all patients taking the life-extending antiretroviral drugs, to evaluate the results of the therapy.

The data generated is used to inform policy-making. And specific measures can be taken to adapt the therapy to local conditions, based on the results. The information gathered also contributes to global assessments of the spread of HIV/AIDS.

“Results from developed countries and poor nations have traditionally been published, but there were few evaluations from the large group of middle-income nations, and the Chilean AIDS Cohort has provided that,” Wolff said.

Law 19,779, approved in December 2001, guarantees the rights of all Chileans to prevention, diagnosis, control and treatment, and safeguards the free and equal exercise of other rights and freedoms of those living with HIV/AIDS, expressly prohibiting discrimination in access to education, work and healthcare.

In addition, the “universal access of explicit guarantees plan”, which guarantees the right to treatment, with specific guidelines, was expanded to those living with HIV/AIDS.

And the “national programme of expanded access to antretroviral therapy”, in effect since 2001, ensures access to the latest treatment options for all patients.

As a result of the alliance between the government’s national programme and the Chilean AIDS Cohort, “mortality has been reduced by more than 80 percent, and the rate of hospitalisation has gone down, which has made it possible for people to take up their day-to-day lives again.

“Among our patients, we have achieved results comparable to those of developed countries,” he said.

Based on this joint effort, the social and economic conditions of those living with HIV/AIDS have improved, said Manuel Jorquera, the coordinator of the AIDS advocacy group Vivo Positivo. “There is more timely treatment, and it is guaranteed, along with the free monitoring,” he told IPS.

These benefits are tangible for Martín (not his real name), a 36-year-old journalist who was diagnosed with HIV four years ago.

“It was difficult to digest at first, but I had the support of several of my friends who are also living with HIV and who have managed to deal with the disease really well,” he told IPS.

Although HIV/AIDS remains underreported, a higher proportion of cases are now documented. Since the first cases were detected in this country in 1984, the highest AIDS (six out of 100,000 people) and HIV (9.6 out of 100,000) notification rates were recorded in 2011, according to the Health Ministry’s Epidemiology Department.

The evolution of HIV/AIDS in Chile is in line with global trends that reflect a 20 percent reduction in the number of new infections worldwide and a 17 percent increase in the number of people living with HIV in 2011, compared to 2001, when the AIDS epidemic was at its height.

There are 34 million people living with HIV/AIDS worldwide, according to the latest global report, published by UNAIDS Tuesday Nov. 22.

But not every aspect involving HIV/AIDS has been solved in Chile.

Martín said that in his company people do not “officially” know he is gay, although “many suspect it.” What they definitely do not know, he said, is that he is HIV-positive and receives antiretroviral treatment at a public hospital.

“I have a totally normal lifestyle,” he said. “I go to work, I go out with my friends. But not even my mother knows I am infected. It would just destroy her.”

His fears are not unfounded. Despite the advances made at the level of public policies in Chile, deep-rooted discrimination persists, which exacerbates the fear of having an AIDS test.

“People feel the real fear of suffering from discrimination once it is known that they are infected,” Wolff said.

In his view, the most important challenge “is to keep people from being infected,” and to do that, “prevention campaigns must be much more direct than they have been.”

In addition, he said, “we have to try and diagnose everyone who is living with HIV/AIDS, and extend treatment to them.”

But to do that, the stigma surrounding the disease must be fought, he added.