The WHO now recommends all DR-TB patients receive an all-oral regimen of medicines, including the new blockbuster drug bedaquiline. In June South Africa became the first country in the world to announce it would switch to the bedaquiline regimen, replacing the highly toxic injectable drugs which cause hearing loss in up to half of patients who take them.

The country recently made another bold move when it ‘broke the silence’ during contentious negotiations ahead of the United Nations’ High-level Meeting (UN-HLM) on TB which is set to take place in September.

For over two months countries have been in heated talks drafting a political declaration on the disease, which is the world’s top infectious disease killer.

TB declaration and TRIPS

Resisting buckling to the pressure Big Pharma and certain governments led by the United States (US) have exerted in these negotiations, on July 24 South Africa raised objections to the draft declaration that was submitted to the president of the UN.

According to international medical and advocacy organisation Doctors Without Borders (MSF), the draft declaration failed to include public health safeguards that nations, particularly poor countries, can use under the World Trade Organisation’s Agreement on Trade-related Aspects of Intellectual Property (TRIPS).

These safeguards allow countries to use mechanisms to circumvent patent rights in the interests of making essential medicines affordable, particularly in public health emergencies.

Wealthier nations and big business who have argued that there is no need to include the TRIPS flexibilities in the declaration “are spitting in the faces” and “turning their backs on” the millions of people living with TB who cannot access newer and safer drugs, wrote Section27’s Umunyana Rugege and the Treatment Action Campaign’s (TAC) Sibongile Tshabalala in the Daily Maverick this week.

“For the United States and other countries to attempt to roll back these rights in a TB declaration, a declaration on a disease that impacts mostly poor people of all things, is deeply cynical. Do these countries really not care whether we live or die? Or is their only real concern that we will get on planes and bring TB to their countries? Is the UN declaration nothing more than PR for them?” they wrote.

Recommendations signal hope

MSF’s Julia Hill told Health-e News that the new recommendations from the WHO brings hope to those advocating for this political declaration to make a strong commitment on making new anti-TB drugs affordable and accessible.

She said the WHO’s announcement has come at a “crucial time” as negotiations have reopened giving countries an opportunity “to speak up and ensure language promotes the principles of access and affordability”.

“As happened with the fight for affordable HIV treatment, countries like the U.S. are placing pressure on countries to drop access language in the declaration—pushing back against this will be essential for making sure better TB treatment reaches people with TB,” she said.

Bedaquiline, an example of such better treatment and the first new anti-TB drug developed in over 50 years, costs US$400 per course in South Africa but as much as US$30 000 in other countries. However, according to Section27 and TAC, a course can still be produced profitably for as low as US$100.

SA considering new wording

The National Department of Health’s Dr Yogan Pillay told Health-e News that Japan, one of the countries facilitating the negotiations, has since proposed alternative language to what was contained in the first draft.

He said that the reason for South Africa’s intervention was specifically to make provisions for TRIPS flexibilities to be included in the interests of broad access to new medicines and other potential future innovations like vaccines and diagnostics.

“We are now in discussions internally between the Department of Trade and Industry and the Department of International Relations and Cooperation to decide if we are happy with this new language,” he said.

The UN-HLM is set to be held in New York on September 26.

Said Pillay: “My own view is that it is looking optimistic, but until it’s done it’s not done.” – Health-e News.

An edited version of this story was published by Health24.com