Photo: UNAIDS

Patient-friendly but unapproved

JOHANNESBURG,  – Delays in registering antiretroviral (ARV) medication may keep cheaper, more patient-friendly drugs out of reach as South Africa prepares to launch the world’s largest tender for medicines.

In a letter to Dr Aaron Motsoaledi, the Minister of Health, the South African HIV Clinicians Society called on the country’s drug registration body, the Medicines Control Council (MCC), to fast-track the approval of certain ARVs, the generic versions of others, and fixed-dose ARV combinations that combine multiple ARVs into a single pill.

The new ARV tender will allow pharmaceutical companies to bid for supplying the biggest HIV treatment programme in the world, but drugs without MCC approval are unlikely to be included in the tender process. Many activists have said that excluding these as yet unapproved drugs will lead less companies to apply for the tender  and push up prices, while also depriving patients of fixed-dose combination therapy.

“My biggest concern is that the MCC is just not functioning well – they’re trying to repair the system but they’re not giving priority to these drugs,” said Dr Francois Venter, president of the Clinicians Society, who noted that some drugs had been awaiting approval for more than two years due a backlog in the MCC.

“These drugs need to be pushed to the front of the queue; these are not experimental drugs we are talking about here, these drugs have been registered in Europe for more than a year,” Venter told IRIN/PlusNews.

According to the HIV Clinicians Society’s letter, all fixed-dose combinations, some of which are likely to form part of first-line regimens, and new, heat-stable paediatric formulations are among the drugs awaiting registration.

“I cannot think of another drug that is more important drug than ARVs,” Venter said. “If the MCC can’t fulfil its role as a registering body then, frankly, it must get out of the way.”

The South African Department of Health could not yet comment on the matter, according to department spokesperson Fidel Hadebe.

South Africa has an HIV prevalence of about 18 percent, and its national ARV programme reaches an estimated 1.7 million people, according to UNAIDS.

Dealing with the backlog

The MCC has taken steps to address the backlog, but the organization remains understaffed said Jonathan Berger, a senior researcher at the AIDS Law Project and a member of the MCC, who spoke to IRIN/PlusNews in his personal capacity.

Long delays in registering new drugs have prompted calls by the Joint Civil Society Monitoring Forum (JCSMF) – a civil society body that monitors implementation of the government’s National Strategic Plan for HIV and AIDS – for the government to waive the registration process for drugs already approved by stringent regulatory bodies such as the US Food and Drug Administration and the World Health Organization.

South African law prohibits this, but Berger said the health department might not have ruled out switching to an abbreviated review process for some drugs that have already been approved overseas.

What it means

Andy Gray, a pharmacist at the Centre for the AIDS Programme of Research in South Africa (CAPRISA) at the University of KwaZulu-Natal, said adherence and provision were a lot harder without fixed-dose combinations.

“If these [fixed combinations] aren’t registered, we won’t be able to take advantage of them as we increase the number of patients on treatment, and as we increase the number of sites providing ARVs, and as we increase the use of nurses to provide treatment,” he told IRIN/PlusNews.

“There are great advantages to using fixed-dose combinations – they reduce errors with prescribing them, they’re quicker for pharmacies to dispense, and they’re easier for patients to comply with.”

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Photo: Kate Holt/IRIN

“How will we now put so many more people on ARVs?”

NAIROBI,  – Global funding shortfalls for fighting AIDS could make it impossible for developing countries to implement new World Health Organization treatment guidelines, activists have said.

WHO released new guidelines on antiretroviral therapy (ART) in December 2009, raising the CD4 count – a measure of immune strength – at which HIV-positive people should start ART from 200 to 350. Research has shown that starting ART earlier reduces the rate of death and opportunistic disease.

“WHO’s new recommendations are excellent in theory, but they did not give us a practical way of implementing the guidelines – already we have shortages of drugs in trying to put people with CD4s below 200 on treatment,” said James Kamau, coordinator of the Kenya Treatment Access Movement.

“How will we now put so many more people on ARVs? The increased number of people on drugs means not just more drugs, but more labs, more health centres and health workers, more general care – the expense is enormous.”

An estimated four million people around the world are currently on ART – a 10-fold increase since 2003, when the drugs became widely available – but this figure still represents just over one-third of the people who need the medication.

“If WHO’s new recommendations are not implemented, the international community risks subsidising less expensive yet sub-standard care for developing countries,” said Sharonann Lynch, MSF’s HIV/AIDS policy advisor, in a press release.

“Avoiding this will depend on the willingness of donors to make new commitments. Although this is not easy in today’s financial environment, donor countries cannot back away from supporting the promise of universal access to treatment made five years ago.”

“The situation is now an emergency”

In Uganda, where the government plans to release new treatment guidelines reflecting WHO’s recommendations, officials said the number of people needing treatment would rise from 300,000 to about 750,000. The country recently suffered drug shortages in its public health sector, partially caused by funding problems.

The situation is now an emergency: new treatment enrolments in many countries are coming to a standstill, the risk of drug resistance is increasing

“The numbers will be too great for us to manage,” said Dr David Kigawalama, head of prevention services at the Uganda AIDS Commission. “We need to sit with our AIDS development partners to forge a way forward.”

Ahead of a high-level meeting between Group of Eight (G8) leaders and AIDS advocates in London on 10 March, AIDS activists met with British International Development Minister Gareth Thomas on 9 March and called on the world’s wealthiest nations to honour their 2005 Gleneagles pledge to achieve universal access to HIV prevention, treatment and care by 2010.

“Instead of building on progress, some donor nations and governments of highly affected countries are backing away from the universal access commitment with a series of poorly funded half-measures on AIDS,” the executive director of the International AIDS Society, Robin Gorna, said in a press statement.

“The situation is now an emergency: new treatment enrolments in many countries are coming to a standstill, the risk of drug resistance is increasing, and fragile gains made over the last 10 years may soon erode, with potentially serious consequences for future efforts to control this epidemic.”

The activists singled out Canada – the only G8 nation firmly opposed to the Financial Transactions Tax, a tiny tax on financial transactions that could raise the billions of dollars needed to fulfil the universal access pledge.

The global economic downturn forced the Global Fund to Fight AIDS, Tuberculosis and Malaria, the world’s largest funder, to cut disbursements by 10 percent in 2008, while the US President’s Emergency Plan for AIDS Relief (PEPFAR) has flat-lined funding to many countries, limiting the growth of PEPFAR-funded treatment programmes.

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Photo: Jane Some/IRIN

Congolese refugees at Base Camp II in the Nakivale settlement: At least 45,000 Congolese live in Nakivale and Kyaka II refugee settlements

NAKIVALE,  – With at least 67,000 refugees in southwest Uganda, the government and aid workers are still battling inadequate resources in what a UN official described as a “silent emergency”.

“We can hardly meet international standards of indicators such as water, health and food,” Nemia Temporal, deputy representative of the UN Refugee Agency (UNHCR) in Uganda, told IRIN on 8 March. “For instance, we are delivering 15 litres [of water] per person per day instead of the standard 20l.”

After years of protracted conflict in eastern Democratic Republic of Congo (DRC), with large influxes to neighbouring countries, the situation of the majority Congolese refugees is no longer considered that urgent by the wider aid community, Temporal said.

At least 45,000 Congolese live in the 217sqkm Nakivale settlement in Isingiro District and Kyaka II in Kyegegwa District, where, thanks to the Ugandan government’s refugee-friendly policy, they cultivate small pieces of land.

Temporal said the delivery of quality services was complicated by new arrivals fleeing fighting between government troops and rebels, as well as militia groups, in North Kivu.

“We plan for the existing refugee population but, often, many others continue arriving and this has an impact on the quality of the services we provide,” she said.

Temporal said among the aid delivery gaps were the provision of shelter (plastic sheeting), water, health and sanitation, infrastructure and refugee protection.

She urged a shift in humanitarian assistance so that relief aid goes hand-in-hand with livelihood support “right from day one. We need money to get livelihood interventions going at the same time that we are offering emergency humanitarian assistance.”

Photo: Jane Some/IRIN

A newly arrived Congolese man at a reception centre in Kyaka II refugee settlement

Asylum seekers

UNHCR and other agencies also cater for asylum seekers and urban refugees, bringing the total to 142,758, according to UNHCR’s 28 February figures.

“Overall, the food security situation in the country deteriorated last year in comparison to the previous year,” UNHCR said in a briefing document. “For the refugee programme, WFP [UN World Food Programme] is planning to roll out a ‘cash-in-lieu-of-food’ project with a pilot expected to start in Oruchinga – a refugee settlement with some 2,032 refugees in southwest Uganda.”

Stanlake Samkange, Uganda’s WFP country director, told IRIN the project, due to begin in April, would help improve the plight of Rwandan refugees who have not been receiving food as they are long-time residents – some for up to 14 years.

“We hope the pilot project will help the refugees to better cope with breakages in the food pipeline,” he said, adding that food distributions for March and April were in place but that a gap was looming in May.

In October-November 2009, refugees in Nakivale rioted over delays in food distribution. Officials said most of those who took part were new arrivals.

“Interim assessments indicate that if the food shortage is not adequately addressed by the next distribution, UNHCR operations in settlements will be affected, with limited staff access on safety grounds,” UNHCR said in a January briefing document.

Limited funding for the refugees’ care and maintenance programme continues to bring protection risks, such as insufficient quantities of water, inadequate health services, limited access to post-primary education services and lack of follow-up in cases of sexual and gender-based violence, according to UNHCR.

Service gap

Mupepelo Songa Nyangi, chairman of Base Camp II or the New Congolese Village, told IRIN most refugees were grappling with myriad problems, high on the list being inadequate food (for both those on full rations and those who arrived earlier than 2006 who receive half rations), lack of specialized treatment for those suffering from stress-related ailments, poverty-induced sexual exploitation and abuse and limited access to education as well as different syllabuses and languages of instruction.

“The life we lead as refugees is hard,” Nyangi said. “We don’t know what the future holds for us; our children who go to school study in congested classrooms in languages different from what they were taught at home and most of the time when we visit health centres the medication prescribed is not available or there is no special doctor to handle the more difficult cases of mental illness.”

However, UNHCR and aid officials in Nakivale said efforts were made to meet the refugees’ needs, with investigations of sexual violence cases being made, monthly visits by a psychiatric specialist, and schools being improved or expanded, including a new secondary school that began operations this year.

Agency officials said it was focusing on boosting refugees’ livelihood activities in 2010, with various projects, such as goat-rearing and cooperatives planting vegetables in both Nakivale and Kyaka II settlements.

Moreover, UNHCR officials said, adult literacy programmes were in place and a youth centre was being renovated at Nakivale to offer vocational and recreational support for the mostly idle youths.

Photo: Jane Some/IRIN

Refugees at a food distribution in a village inside Nakivale settlement, southwestern Uganda

Side by side

Established in the 1950s, Nakivale has served hundreds of thousands of refugees. About 20,000 Ugandan nationals live inside the settlement alongside the refugees; they are allowed to build permanent iron-roofed buildings while the refugees are only allowed semi-permanent structures, with tarpaulin and plastic sheets.

Nakivale is divided into three zones, with different aid agencies operating in each zone. Four health centres serve the refugees as well as Ugandan nationals living close by. There are seven primary schools and one secondary school within the settlement.

Further southwest is the 209sqkm Kyaka II refugee settlement, home to at least 16,785, mainly Rwandan, refugees, according to UNHCR.

In 2009, UNCHR, local and international partners and the Ugandan government conducted a voluntary repatriation programme for thousands of South Sudanese refugees, resulting in a sharp drop in their number to 21,151 as of January 2010.

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Photo: Vincent Mayanja/IRIN

Landslide-displaced people receive bottled water at Bukalasi, eastern Uganda

BUKALASI , 1 – Rose Nakhayetse is lucky to be alive, but her ordeal is far from over. Having narrowly escaped last week’s deadly landslides in eastern Uganda, she and thousands of others are facing fresh dangers.
The 24-year-old and her nine-month-old baby were saved from a muddy avalanche by the wall of her house. “I heard cracks and sounds of explosion but when it persisted, I went outside, only to discover that the earth was moving towards us,” she told IRIN.

“Things were happening so fast, so I decided to run with my baby. That is how I survived. Thank God the moving mud stopped just behind our house, but my two other boys were in the neighbourhood and I have not seen them since. Maybe they are among those who died, but we have not found their bodies,” she said.

Ninety-two bodies have been recovered from the scene of the disaster, and some 367 people are still missing, according to Ugandan officials.

Nakhayetse is one of more than 1,000 people camping in the grounds and four classrooms of a primary school in the village of Bukalasi, where relief efforts have yet to meet the many needs of the displaced. There is a single pit latrine for all of them.

“The numbers here are too big and we do not have enough toilets, so that is making this place dirty,” she said.

Sanitary crisis

“A sanitary epidemic is in the offing [in Bukalasi],” warned David Mulele, a medical worker in the local health centre.

“We have recorded up to 100 cases of diarrhoea and vomiting among children and some adults. The health centre had drug stocks, but now all essential drugs for such ailments, like oral rehydration salts, Flagyl and other such drugs have all run out and we are just improvising to keep these people going,” Mulele told IRIN.

“We have the skills, but we lack the tools.”

Photo: Vincent Mayanja/IRIN

Some of the displaced in a classroom at Bukalasi Primary School

Among the immediate humanitarian needs are “safe drinking water, water storage containers, water purification/chlorination tablets, latrines and soap”, according to the UN Office for the Coordination of Humanitarian Affairs (OCHA).

“Other urgent needs include: trucking of water to the affected populations; drilling of boreholes and rehabilitation of water springs; completion and extension of a gravity water flow scheme in Bulucheke; water quality surveillance; and provision of mobile and Ecosan toilets,” OCHA said in a report.

Also required is specific assistance for some of the children who came to the camp without their parents, who are among the missing or dead.

“We have no arrangements yet for these unaccompanied minors,” said Kevin Nabutuwa of the Uganda Red Cross Society.

Patrick Tibet, a community development worker in Bukalasi, said the displaced were in dire need of shelter and clothing as many had run away from their homes with only the clothes they had on.

Nabutuwa said tents had been secured from the government and would be distributed.

Rain risk continues

Heavy rainfall is set to continue in parts of Uganda for several weeks, prompting the government to consider permanently relocating up to half a million people living in mountainous regions.

“A total population of about 500,000 is at risk of landslides and floods. We plan to resettle this population from these very high-risk locations both in the east and west of the country, once emergency operations for the current situation end,” Junior Minister for Disaster Preparedness Musa Ecweru told IRIN by phone.

The rains have flooded many villages near Bukalasi. According to OCHA, many crops and infrastructure, such as roads and schools, in the low-lying Butaleja district are under water.

“In the sub-counties of Budumba, Busaba, Nawanju, Busolwe, Busabi and Busolwe Town Council, thousands of acres of paddy rice fields, cassava, sweet potatoes, maize, sorghum, millet and vegetables – the major source of livelihood – have been affected by water, translating into an-as-yet undetermined loss of crop yield,” according to the OCHA report.

“In total, as many as 20,000 households may have been affected by the disaster with 1,000 households (6,000 people) of immediate concern,” it said.

OCHA warned that some 15,000 households risked waterborne diseases because of submerged pit latrines. “Additionally, Doho Health Centre II in Mazimasa sub-county and Namulo Health Centre II in Himutu sub-county are surrounded by water and have been rendered inaccessible,” the report said.

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Nigeria’s Vice President Goodluck Jonathan attends the “India-Africa Forum Summit 2008″ in New Delhi, April 9, 2008. Photo/REUTERS