A lethal lapse
Cancer and tuberculosis patients have been urging a reluctant government to use compulsory licences to make life-saving drugs accessible
Around the same time when a sluggish government was announcing the new National List of Essential Medicines (NLEM) after seven long years, a cancer patient, who had filed a writ petition asking the government to use the compulsory licence (CL) flexibility in the patent law to provide more affordable medicines, died.
The unnamed patient from Ernakulam in Kerala was seeking less expensive generic alternatives to Novartis's patented ribociclib to treat her metastatic breast cancer.
In her writ petition filed in the Kerala high court (HC) in June this year, the woman had said she was a retired bank employee living on a meagre pension that did not allow her to buy the drugs she needed for targeted treatment.
She had sought the court's direction to the Union Government to use the relevant sections in India's laws to override the patent monopoly on Ribociclib so as to make cheaper versions available in the country.
Since the drug is not manufactured in India, the patient sought the court's direction to make use of Section 92 of the Patents Act, 1970, which provides for CL and Section 100 which empowers the government to use the invention free of any royalty or other remuneration to the patentee.
While naming several ministries from health and pharmaceuticals to women and child welfare as respondents, the petitioner had specially referred to the Department of Promotion of Industry and Internal Trade (DPIIT) which deals with patent matters.
The writ petition, filed after several representations were made directly to the ministries and departments, reflects the desperation of patients suffering from life-threatening diseases.
Most of them are unable to buy the newer patented medicines which are more effective in treating cancers, tuberculosis (TB) and other such ailments but are out of their reach. The Ernakulam woman's case hit the headlines because her lawyer informed the judge that her client had died recently.
Justice VG Arun, however, has decided to let the petition move forward as a suo moto case taking cognizance of the important issue it raises: the unaffordability of patented life-saving medicines.
Justice Arun who has been hearing the case since it was filed appears to find merit in the writ petition since "an alarming number of women succumb to breast cancer because of their inability to afford expensive treatment and medication."
In his view, the right to life guaranteed by the Constitution, coupled with the state's duty to improve public health, calls for effective action in the matter." In July he had directed the DPIIT to take up the representation and to pass a reasoned order within four weeks.
This is not the first such case. In 2020, TB patient Meera Yadav and Jan Swasthya Abhiyan, a network of Mumbai-based organisations and individuals collectively working on health issues, had filed public interest litigation (PIL) on similar grounds.
Yadav, suffering from drug-resistant TB, had asked the court to issue directions to the government to issue CL for the effective new patented TB drugs bedaquiline (Johnson & Johnson) and delamanid (Otsuka Pharmaceuticals) under Section 92 and/or issue authorisation for the use of the invention of the said patents under Section 100. This, the petitioner contended, was vital to combat the number of MDR/RR-TB-affected patients in India which has reached emergency proportions.
This is true since India bears a quarter of the global burden of TB cases. The petitioners argued that India's huge requirements of the drugs cannot be met through donations made by the patent-holding companies.
It is another story that the government was alleged to be in cahoots with Johnson & Johnson to conduct Phase III clinical trials on bedaquiline without informing the patients who were given this drug.
India's heavy reliance on donation programmes of multinational pharma companies to provide the required patented TB drugs is unconstitutional and violative of the Fundamental Rights (under Article 21) of lakhs of such patients.
In March 2021, the court had directed the DPIIT to consider the petitioner's representation and pass a reasoned and rational order within four weeks after deliberation with the other ministries. What happened to the case remains a mystery.
What is clear, however, is that the government will not issue a CL at any cost although the figures have become more daunting since then. The total incidence of TB patients (new and relapsed cases) notified during 2021 was 1.9 million, which was 19 per cent higher than in 2020 (1.6 million), says the TB Annual Report 2022. Childhood TB remains a staggering problem, contributing to approximately 31 per cent of the global burden, it says.
Even during the height of the pandemic in 2021, the government showed a characteristic reluctance to upset the global pharma industry by issuing CLs for much needed therapies to combat COVID-19. This despite the Delhi HC and the Supreme Court nudging it to consider CLs to tackle the public health crisis.
After the UPA government issued the first CL in 2012 to Hyderabad-based Natco Pharma to make a generic version of Bayer AG's overpriced kidney cancer drug sorafenib tosylate, India has not issued any more CLs. This despite the dramatic benefits such a step has in addressing public health concerns by bringing down drug prices.
Natco brought down the price of the drug (brand name Nexavar) from a whopping Rs 2,80,000 that a patient pays for a month's treatment of advanced liver and kidney cancer to just Rs 8,800.
Much is being made of the NLEM which has added four patented drugs to its list. These include bedaquiline and delamanid.
How big a deal is it? The patents on these drugs expire in 2023, in July and October, respectively. A price control on these drugs is unlikely to offer patients the kind of relief that a CL would.
The hope is that generic makers would be ready to come on the market with their lower-priced alternatives — that is, unless new patents extending the monopoly term on minor variations on the drugs have not been granted.
Patients with life-threatening diseases in India are paying far too heavy a price for the timorousness of their government. DTE
Views expressed are personal