Patient-Groups Worldwide Press India to Issue Compulsory Licenses for TB Drugs

"So many lives depend on it,” a letter submitted to the government, signed by 60 organisations from around the world that work on TB, said.

New Delhi: Last night, Prime Minister Narendra Modi tweeted about a major international tuberculosis (TB) summit India is hosting – that he would launch the ‘Tuberculosis Free India Campaign’ on the occasion. This campaign plans to take the activities of the National Strategic Plan for TB elimination forward in mission mode.

Earlier in the day yesterday, 60 organisations from around the world wrote in a letter to Modi of the urgent need for him to issue a compulsory license for two experimental lifesaving drugs (bedaquiline and delaminid) for drug-resistant TB patients in India.

A compulsory license on the patent for these drugs will allow generic companies to legally make cheaper drugs available. The 60 organisations, many of whom are patient-groups, say this could bring the price of bedaquiline and delaminid down by 95%.

“We are writing to appeal to the Indian government to continue to play its crucial role in global health by addressing the urgent treatment needs for drug-resistant tuberculosis,” the letter says.

Beginning today, the ‘Delhi End TB’ Summit 2018 will see various world leaders deliberate on strategies to tackle the disease, which killed 17 lakh people around the world in 2016. Modi and Tedros Ghebreyesus, the World Health Organisation’s (WHO) director-general, are set to address the summit today.

But even as these deliberations go on, about 1.3 lakh drug-resistant TB patients in India will need access to drugs like bedaquiline and delaminid – both of which have a reputation as ‘breakthrough drugs’ because they were discovered after about 40 years of little advancements in treating drug-resistant TB.

Lack of treatment for drug-resistant TB

TB is the world’s top infectious killer disease. The WHO has specified that TB will need to be “eliminated” by 2030. However, even with the world’s largest number of TB patients, India has declared it will eliminate TB five years earlier.

The Delhi summit is being hosted by the Ministry of Health and Family Welfare, the WHO and the ‘Stop TB Partnership’. The summit and events around it will demonstrate India’s “resolve to fast-track efforts to end the killer disease,” a press release from the WHO said.

Yet the Indian government has been conservative in dispensing the drugs. For example, India has not been purchasing the drug, instead choosing to rely on donations from the manufacturers: Janssen (US) and Otsuka Pharmaceuticals (Japan).

Moreover, the drugs’ access is restricted only to government centres since the government has been trying to monitor the substances’ side effects. This is because phase-three trial data has not been made available for the drug globally. “Bedaquiline and delaminid are cardio-toxic and side effects associated need to be strictly monitored,” Arun Kumar Jha, a senior health ministry official, said on Twitter. “Sans phase three trials, regulatory authority only permitted conditional access.”

It is against this backdrop that the 60 organisations submitted their letter to the prime minister, demanding immediate access to this drug for Indian drug-resistant TB patients. Another letter on the same issue had been sent to the government earlier this week by doctors in Karnataka.

A compulsory license on bedaquiline and delaminid in India is crucial because India has about 1.3 lakh drug resistant TB patients. Bedaquiline and Delamind offer hope here.

So far India’s programme to reach these patients has been getting by on “donations” from Jannsen and Otsuka, which has come from USAID. Once the small stock of these donations run out, India will have to begin purchasing the two drugs from these companies to ensure patients have a constant supply. Activists have estimated that, for a six-month course per patient, the Indian government will have to pay Rs 1 lakh for delaminid and Rs 58,000 for bedaquiline.

But given the scale at which India has to deal with ‘regular’ TB and its drug-resistant variety, these numbers won’t be feasible. The price of bedaquiline and delaminid will have to be brought down. As the letter said, “So many lives depend on it.”

India also has had a strong generics industry capable of producing cheaper versions of the drugs. However, this will not be possible for as long as Jannsen and Otsuka hold the patents. As it happens, the companies have thus far not shown any indication of issuing a voluntary license – which is when patent holders license their drugs to other companies, who will in turn pay royalties.

In this scenario, patient-groups from around the world have been asking the Indian government to step in and use such legal provisions as are available to induce competition and bring the prices down.

The specific mechanism they have their eyes on is compulsory licensing (CL) – which is when a government directs a patent-holder to license the drug out to others. India’s patent act allows the government to issue CLs for public, non-commercial use – a criterion the government-controlled TB programme would fulfil.

India has issued only one compulsory license so far, which was given in 2012 to Natco, for Bayer’s cancer drug Nexavar. Here the price crashed from Rs 2.8 lakh per month to Rs 8,880 when the CL was issued. Natco payed Bayer a 6% royalty on sales.

Phase three trial data for bedaquiline is awaited globally. India has not conducted its own phase three trials but has instead given approval to this drug based on the decisions to give access by the US Food and the European Medicine Agency.  Even while waiting on this, bedaquline and delaminid for adults, were added to WHO’s Essential Medicine List in 2015. Delaminid for children, was added in 2017.