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TWN Info Service on Intellectual Property Issues (Feb17/01)
2 February 2017
Third World Network

Article on BDQ Donations in India and need for Compulsory Licensing for scale up

For the first time, the Government of India is accepting large donations of a drug for a public health crisis. Johnson & Johnson’s bedaquiline, a life-saving drug, is trickling down via charity as thousands wage a hopeless battle against a superbug

https://the-ken.com/CHARITY-SUPERBUG-INDIA/
https://the-ken.com/author/ruhikandharigmail-com/

by RUHI KANDHARI - JANUARY 31, 2017

The evil superbug is on the lookout for new hosts. The hero has the weapon, he can conquer it, but only if he is willing. The superbug is antibiotic-resistant bacteria, which causes multi-drug-resistant tuberculosis (MDR-TB), the life-saving weapon is bedaquiline and the reluctant hero is the government.

The World Health Organisation (WHO) has estimated that 79,000 Indians?the largest number anywhere in the world?were infected in 2015. Without large-scale treatment or prevention of transmission, it is estimated that at least a similar number of Indians contracted the superbug in 2016.

Doctors treating patients suffering from TB say that the figures are an understatement as a large number of cases are not even diagnosed, leave alone reported. One of the best cures is bedaquiline, the first drug to be approved in 50 years for such a resistant TB.

The Belgian drugmaker Janssen, a sister company of Johnson & Johnson (J&J), has developed the drug, which became available in the global market in 2012. In 2014, Janssen made a donation for 600 patients in India, which the Directorate General of Health Services in New Delhi approved for ‘conditional access’. It’s a drop in the ocean, where at least 79,000 patients are estimated to be infected every year and do not have access to bedaquiline. A pilot has been going on in five cities but only patients in these cities could access the drug until a fortnight ago.

So while the donation in the past meant that the drug could enter India, it also meant that it was not available in the market. Patients are scrambling. Two weeks ago, the Delhi High Court ruled http://www.hindustantimes.com/delhi/18-year-old-girl-to-get-drug-resistant-tb-drug-
health-ministry-to-delhi-high-court/story-xx7gCKxco4d5pScu4IQpmN.html
  in favour of an 18-year-old girl from Patna who had filed a case against the Government of India for denying her access to this drug on the basis of her domicile.

The distribution of the drug remains a challenge but the government has now sought more donations?2000 courses out of a pledged package by J&J of 10,000 courses, under the USAID
https://www.usaid.gov/what-we-do/global-health/tuberculosis/technical-areas/tuberculosis-india.

“The pilot was used for a programmatic feasibility study, to study any adverse events through pharmacovigilance. About 200 patients are on treatment, and there have been three deaths [which is within acceptable limits],” said Soumya Swaminathan, Director-General of the Indian Council of Medical Research in Delhi.

The restricted use of this drug is fuelling the spread of MDR-TB. Studies in South Africa have shown that the sooner such patients are put on bedaquiline, the better the outcomes for them and the community. Then why is the government not negotiating a price and making the drug more widely available? More importantly, why is J&J donating and not selling the drug in India?

The answer resides somewhere in between a patent regime that cannot allow patent violation for cheap Indian generic drugs and a government that makes silent promises to maintain the status quo.

The reach of the superbug

The WHO’s number of MDR-TB cases in India in 2015 is a gross underestimation because the private sector, where more than 70% of India’s healthcare lies, does not always notify cases. Moreover, it’s a number that has most likely grown as the infection spread without
treatment throughout 2016.

“If India continues to drag its feet on daily drug regimens and does not invest adequately in TB control, then I see the drug-resistance problem getting worse in future,” said Madhukar Pai, associate director of the McGill International TB Centre in Montreal, Canada, in an email.

Among the cities, Mumbai is the worst hit. One of the studies showed that 25% of the newly diagnosed http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0110461  and 44% of previously treated HIV-infected patients had contracted drug-resistant TB in 2013.

“These are some of the highest rates reported in the world, which means that places like Mumbai will only become further hotspots as this strain can spread extensively in the community,” said Jennifer Furin, a professor of Global Health and Social Medicine at Harvard Medical School.

It’s true that not each one of these drug-resistant TB patients might need bedaquiline. As per a conservative estimate, 26,000-35,000 patients would benefit from access to bedaquiline each year, said Furin.

But even this ‘conservative’ number can have a multiplier effect because this airborne disease spreads by just coughing and sneezing. And a slow, exclusive government programme only for the city dwellers is adding to the burden.
 

WHO: The estimated incidence of MDR/RR-TB in 2015, for countries with at least 1000 incident cases

A half-hearted punch

In March 2016, the Revised National Tuberculosis Control Programme (RNTCP) rolled out bedaquiline at six public health facilities?National Institute for Research in Tuberculosis, Chennai; National Institute of TB and Respiratory Diseases, New Delhi; Rajan Babu Institute for Pulmonary Medicine and Tuberculosis, New Delhi; Sewri Hospital, Mumbai; BJ Medical College & Hospital, Ahmedabad; and Government Medical College, Guwahati.

Cases started piling up in judicial courts from patients who did not belong to these cities and were challenging the government programme. They needed the drug. For a government that launched TB-Mission 2020, proclaiming to eradicate the disease by 2020, the RNTCP has applied for another 2000 courses of ‘donated’ bedaquiline. The irony couldn’t be starker.

The government has argued that the distribution of bedaquiline needs to be controlled to prevent further drug resistance among patients. Experts, on the other hand, counter that resistance develops to any drug over time and that it is no excuse for not providing patients with treatment.

A request to speak with the deputy director general Sunil D Khaparde on why RNTCP was looking for more donations instead of making the drug affordable and available in the market did not elicit any response. In a telephone call, the director of the National Institute for Research in
Tuberculosis in Chennai refused to answer any questions on TB. It was soon after the Delhi High Court ruling and he said he was not “allowed to talk to the media; only the Union Minister of Health and the Secretary could answer any questions.”

Even if the pledged 10,000 courses were to be donated to RNTCP, it would not treat the 79,000 and counting patients every year.

First large donation of its kind

India does accept a small number of drug doses as donations from pharmaceutical companies. But that’s mostly for neglected diseases, like GSK’s donation for elephantiasis, said Swaminathan. It’s the first time that such a large donation has been offered and accepted, and that too for MDR-TB, which will turn into a major public health crisis without adequate access to medication.

There’s a strong correlation to the choice that the present government made last year. In March, India’s Patent Office made a ‘private reassurance’ http://nhrc.nic.in/dispArchive.asp?fno=23893 to the United States-India Business Council (USIBC) that it would show ‘restraint in allowing the production of cheaper versions of the drugs patented with the American firms’. That was the government’s way of avoiding the tug of war between the local generic drug manufacturers and patent-holding American drug companies.

It appears that by accepting the donation from J&J, the government has solidified its commitment to the patent regime. The drug has patent protection until 2023. People in the government and industry agree that invoking compulsory licensing?a provision under the World Trade Organisation
https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm
that allows governments to override patents in a national emergency?could ensure better access to the drug for the patients who need it. The drug is not inexpensive. J&J has determined the sale price of bedaquiline at $30,000 in high-income countries, $3,000 in middle-income countries and $900 in low-¬income countries.

In an email response, J&J confirmed donating 600 courses to RNTCP. On the  10,000 courses donation, the company said that Janssen and USAID signed an agreement in December 2014 to formalise a four-year collaboration beginning in April 2015 in which “Janssen is contributing 30,000 courses of bedaquiline to USAID for use in over 100 low- and middle-income, Global Fund-eligible countries for the treatment of MDR-TB.” The number of courses donated via USAID, it said, will be agreed between the Indian government and the USAID

“Obviously when companies do donations, it is more for PR value. They [usually] do it if the case reaches the courts,” says DG Shah, secretary-general of the Indian Pharmaceutical Alliance. “Donation is good [but] it is not an alternative to compulsory licensing, competition and affordable access because the quantity of drugs donated is limited. However, the market of drug-resistant TB is so small. There is no need to feel threatened as of now.”

So far, no Indian drugmaker has objected to the donation. According to Swaminathan, “The government is currently not paying any attention to the compulsory licensing of bedaquiline. They are just looking at donations.”

The undisputed global TB capital of the world, India has a few examples to follow. Two countries, Russia and South Africa, says Furin, have negotiated with J&J
https://www.janssen-emea.com/sites/default/files/PressReleases/Janssen%20Announces%20Agreements
%20to%20Expand%20Research%20and%20Development%20Efforts%20in%20Russia.pdf

for affordable pricing and accessibility of this drug. It’s not a donation. As compared to South Africa, which has more than 4,000 people on bedaquiline, and Russia, which has more than 1300 people on bedaquiline, India has about 200 patients being treated with bedaquiline currently.

The glacial government programme surely needs to speed up and show a willingness to treat patients. More importantly, it needs to spell out its strategy to engage with the private sector, as a majority of the patients are managed outside of the national TB programme.

 


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