Red tape blocking access to HIV prevention measures — Global Fund head

THE head of the Global Fund to Fight AIDS, Tuberculosis and Malaria, one of the world’s leading financiers of HIV prevention and treatment, has told the Star Observer the slow pace of bureaucracy is limiting access to much-needed medicines.

Talking on Friday at the Australian Human Rights Commission in Sydney, Global Fund executive director Dr Mark Dybul (pictured above) said while every country had to be confident of the health of its own citizens, approval for HIV medicines was taking too long.

“There’s no question where we work the regulatory systems are very weak so it can take three to five years to get regulatory approval and that’s a problem,” he said.

Dybul said the Star Observer processes in Africa were particularly slow and this was impacting access: “If they don’t have regulatory approval they won’t get the cheapest product… its one of the real hurdles to getting effective product to people.”

According to the latest statistics from the United Nations, 35 million people worldwide were living with HIV in 2012 with 2.3 million new infections and 9.7 million people on anti-retroviral therapy.

While deaths are down 30 per cent since its peak in 2005, 1.2 million died from AIDS-related illnesses in 2012.

Dybul stressed the fund had no direct influence over regulatory frameworks and as its focus was on the developing world, he was unwilling to comment on Australia’s progress in bringing new HIV treatments to the public.

However, in an interview with the Star Observer in December, ACON chief executive Nicolas Parkhill criticised the slow rate of progress in approving pre-exposure prophylaxis (PrEP) and home-testing kits for use in Australia, saying they were being bogged down in federal bureaucracy.

“The requirements of TGA [Therapeutic Goods Administration] approval are probably too high and too expensive,” he said.

The ACON head said there was a danger people seeking PrEP and home-testing kits would turn to online sources and bypass local healthcare support.

“We don’t want to see a situation where Australia is so slow that effectively you develop an infrastructure that sits below the line – that would be the worst thing that could happen,” Parkhill said.

At the time, the TGA said they could not compel commercial organisations to lodge approval applications or circumnavigate the process.

The Federal Government has a goal of zero new infections by 2020.

Sussan Ley, who took over from Peter Dutton as health minister in late December, has yet to make any significant policy announcements regarding HIV.