Show­down: SA takes on US for cheaper drugs

When the US went to bat for Big Pharma in the fight against this killer dis­ease, South Africa wasn’t hav­ing any of it. Here’s what hap­pened next

Mail & Guardian - - Health - Laura Lopez Gonzalez

Grave­yard cough, white plague, con­sump­tion. A killer by any name, TB has stalked the hu­man race for aeons, lurk­ing in crowded ten­e­ments or fol­low­ing min­ers deep un­der­ground, hang­ing in the air of our hos­pi­tals.

Al­ways there, yet rarely spo­ken about.

To­day, it kills more peo­ple than HIV and malaria com­bined, the World Health Or­gan­i­sa­tion (WHO) re­ports. In South Africa, Sta­tis­tics South Africa’s lat­est data shows TB re­mains the lead­ing cause of non­vi­o­lent deaths.

Yet it took the United Na­tions 73 years to call a meet­ing on TB — and only be­cause a very ex­citable South African health min­is­ter ag­i­tated enough for it.

On Wed­nes­day heads of state rat­i­fied the first UN dec­la­ra­tion on the most deadly in­fec­tious dis­ease on Earth. In do­ing so, the world com­mit­ted to cur­ing 40-mil­lion peo­ple of TB by 2022.

To ful­fil their prom­ises, in­ter­na­tional lead­ers must also en­sure that al­most an equal num­ber of peo­ple get treat­ment to pre­vent them from de­vel­op­ing TB.

If the world lives up to its prom­ises, it will save the nearly two-mil­lion lives lost to TB each year, ac­cord­ing to WHO data. An­other 10-mil­lion will de­velop the ill­ness and sur­vive, but with the rise of drug-re­sis­tant forms of the bac­te­ria, they may have to for­feit their hear­ing — or their men­tal health — to the harsh drugs needed to treat drug-re­sis­tant TB.

Older, cheaper treat­ments for TB that is re­sis­tant to the two most com­monly used TB drugs, in­volve at least six months of painful, daily in­jec­tions. The treat­ment, which can take years to com­plete, risks pa­tients’ hear­ing and psy­chosis is a side ef­fect.

Newer, shorter and kinder treat­ments us­ing drugs such as be­daquiline are avail­able — but at a cost. South Africa re­cently ne­go­ti­ated a price drop for the medicine from phar­ma­ceu­ti­cal com­pany John­son & John­son. The drug, which used to cost mid­dle-in­come coun­tries such as South Africa R42 000 a course, now costs about R6000 for a six-month reg­i­men, in­ter­na­tional hu­man­i­tar­ian or­gan­i­sa­tion Doc­tors With­out Bor­ders (MSF) says in a state­ment.

But that’s still too high, ar­gues MSF’s HIV and TB ad­viser Sharo­nann Lynch.

“Drug-re­sis­tant TB is so un­der­tested and treated be­cause of the three Cs: cost, the com­plex­ity of treat­ment and the crappy cure rates. By us­ing be­daquiline rather than the in­jectable [drugs] we can re­move all those bar­ri­ers,” she ex­plains.

Given this, Lynch says, “the show­down be­tween South Africa and the United States on the dec­la­ra­tion ahead of this week’s meet­ing was al­most in­evitable”. South Africa had nearly 333 000 TB cases in 2017, ac­cord­ing to the World Health Or­gan­i­sa­tion’s lat­est re­port.

“Of course it made sense for South Africa to go to the mat [on the TB dec­la­ra­tion] and fight for their and other coun­tries rights to utilise [pa­tent] flex­i­bil­i­ties.

“South Africa should be able to dou­ble the num­ber of peo­ple on [drug-re­sis­tant] TB treat­ment if they had fair pric­ing.”

South Africa didn’t just help to put TB on the ta­ble at the UN. It also took a cru­cial hard line dur­ing heated ne­go­ti­a­tions on the dec­la­ra­tion’s fi­nal word­ing. The coun­try spear­headed last-minute protests over a July 20 draft state­ment that failed to in­cor­po­rate im­por­tant ac­cess to medicine is­sues.

The bone of con­tention: lan­guage that would have af­firmed coun­tries’ rights to put pa­tients be­fore patents for the pub­lic good.

In the wake of the Septem­ber 11 ter­ror­ist at­tacks in 2001, strange parcels laced with deadly bac­te­ria be­gan to ar­rive at US of­fice build­ings, in­clud­ing those of high-rank­ing govern­ment of­fi­cials. News re­ports showed teams in haz­mat suits col­lect­ing non­de­script en­velopes from build­ings and quar­an­tin­ing of­fices.

The tiny bugs in­side, once in­haled, could give way to an in­fec­tion known as an­thrax that is al­most al­ways fa­tal, the US re­search or­gan­i­sa­tion Mayo Clinic ex­plains.

Fear­ing a chem­i­cal weapons at­tack, the US be­gan to stock­pile an­tibi­otics to treat what could be­come a mass out­break. The only trou­ble was that the patented medicine by phar­ma­ceu­ti­cal com­pany Bayer was too costly for a widescale re­sponse.

So the US threat­ened to use the World Trade Or­gan­i­sa­tion’s 2001 Agree­ment on Trade-Re­lated As­pects of In­tel­lec­tual Prop­erty Rights (Trips) to is­sue a com­pul­sory li­cence for the drug. This kind of ar­range­ment would al­low other com­pa­nies to pro­duce Bayer’s prod­uct with­out a pa­tent be­cause of the pub­lic health emer­gency. Trips pro­tects coun­tries’ rights to safe­guard ac­cess to medicine by chal­leng­ing con­ven­tional pa­tent pro­tec­tion on pub­lic health grounds.

Faced with the prospect of a com­pul­sory li­cence, Bayer chose to sell the drug to the US govern­ment at dis­counted rates.

Al­though the US has dab­bled in Trips flex­i­bil­i­ties it­self, trade of­fi­cials have had a nasty habit of be­ing less wel­com­ing when oth­ers do. Given the his­tory, South African of­fi­cials may not have been sur­prised when the July 20 ver­sion of the TB dec­la­ra­tion made no men­tion of the tools un­der Trips at coun­tries’ dis­posal.

It did, how­ever, con­tain this line: “[We recog­nise] that in­tel­lec­tual prop­erty rights are an im­por­tant in­cen­tive in the de­vel­op­ment of new health prod­ucts.”

MSF was quick to point out that the state­ment is un­true in re­la­tion to epi­demics such as TB that are con­cen­trated in de­vel­op­ing coun­tries.

South Africa halted de­lib­er­a­tions in protest and MSF’s head of its Ac­cess Cam­paign for af­ford­able medicines shot back.

“For al­most two months, ne­go­tia­tors have been in heated talks that re­sulted in a draft dec­la­ra­tion that widely di­verged from lan­guage in pre­vi­ous UN dec­la­ra­tions on health and ac­cess to medicines,” Els Tor­reele said.

“This ag­gres­sive push by sev­eral coun­tries backed by Big Pharma lob­bies would se­verely un­der­cut needed guar­an­tees to pro­tect ac­cess to vi­tal tools and medicines for peo­ple liv­ing with TB.”

South Africa’s ob­jec­tions led to a face­off with US trade of­fi­cials. Ul­ti­mately, South Africa suc­ceeded in get­ting a scant men­tion of Trips into the doc­u­ment but not in lan­guage that ex­plic­itly out­lines coun­tries’ rights.

In an in­ter­view with spe­cial­ist news ser­vice In­tel­lec­tual Prop­erty Watch, MSF ad­vi­sor Leonardo Palumbo ex­plains the sig­nif­i­cance:

“The pre­am­ble text is meant to be de­scrip­tive. But in the text of the doc­u­ment, there is no cor­re­spond­ing op­er­a­tive para­graph or com­mit­ment to be agreed upon and acted upon by [UN] mem­ber states,” he says.

“This def­i­nitely wouldn’t stop states from mak­ing use of Trips flex­i­bil­i­ties, but the po­lit­i­cal dec­la­ra­tion would not be an­other tool for coun­tries to do so.”

The ten­sions sur­round­ing the is­sue were vis­i­ble at Wed­nes­day’s meet­ing as both Pres­i­dent Cyril Ramaphosa and US Health and Hu­man Ser­vices Sec­re­tary Alex Azar reaf­firmed their op­pos­ing stances.

“TB is not just a med­i­cal con­di­tion. Poverty, unem­ploy­ment, poor nu­tri­tion, over­crowd­ing and so­cial stigma ... fuel the spread of dis­eases. This means that the poor and marginalised carry a dis­pro­por­tion­ate dis­ease bur­den,” Ramaphosa said.

“We need to en­sure drugs are af­ford­able, we must ad­here to Trips flex­i­bil­i­ties.”

Just hours later, Azar tweeted about the US’s firm com­mit­ment to uphold­ing patents:

“Just be­cause an or­gan­i­sa­tion has stock­hold­ers or prof­its doesn’t mean they aren’t in­ter­ested in help­ing to solve the health prob­lems our world faces. In­deed, the in­cen­tives they have for in­no­va­tion can make them a vi­tal part of our ef­forts to con­front in­fec­tious dis­ease.”

The ink is dry on the dec­la­ra­tion. Now, ac­tivists say the real test will be whether coun­tries put their money and ac­tions be­hind bring­ing its words to life. Or whether they re­turn home from New York to the same deadly si­lence.

But Lynch and oth­ers don’t deny it’s a vic­tory South Africa — and oth­ers — can claim. “It’s South Africa’s right and those of coun­tries like In­dia to ... ex­plore util­is­ing Trips flex­i­bil­i­ties rather than wait­ing again for a drug com­pany to take some benev­o­lent ac­tion … and soak up the PR.

“They ef­fec­tively won.”

Trade-off: Health Min­is­ter Aaron Mot­soaledi and his team ne­go­ti­ated for lan­guage in a po­lit­i­cal dec­la­ra­tion on TB that recog­nises coun­tries’ rights to chal­lenge con­ven­tional pa­tent rights on pub­lic health grounds. Photo: Alon Skuy/Gallo Im­ages/Sun­day Times

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