As the year comes to a close, one major highlight has been the proposal at the World Trade Organization of Indian and South African governments to waive intellectual property (IP) rights, including patents, for Covid-19 medical tools. If the proposal is approved, it will pave the way for access to Covid-19 vaccines, medicines and other health products for developing countries. While initially developed countries fiercely opposed it, they gradually started supporting it as the pandemic continued to rage. This has earned accolades for both the governments.

However, on home front, New Delhi has allowed monopoly of pharmaceutical companies through patents on life-saving medicines, giving a contrary indication to the multinational pharmaceutical industry.

Earlier this year, the Supreme Court heard a petition demanding issuance of compulsory licence (CL) for Remdesivir. American company Gilead holds the patent, giving it monopoly over its production and on putting a price tag. This restricts supply as one company can manufacture only so much. After a huge uproar, Gilead signed voluntary licence pacts with six Indian companies, allowing them to produce the medicine.

However, during the second wave, acute shortage of Remdesivir proved that these companies were not able to meet the demand. Also, limited number of companies meant that price couldn’t be brought down to affordable levels. Shortages led to black marketing, resulting in significantly inflated prices for patients.

Compulsory licence

Compulsory licensing would have been an important step in curbing these practices. It would have allowed more companies to produce the drug and competition would have brought prices down. However, in its affidavit submitted to the Supreme Court on May 9, 2021, the Central Government not only denied CL for Remdesivir, it went on to advocate voluntary licences which had already proved grossly inadequate.

The Government estimated a requirement of one crore vials per month as Covid-19 peaked. The production was only 60,000 vials a day before the second wave and increased to two lakh a day by the first week of May. Meanwhile, people continued to lose lives, waiting for an effective treatment.

This is not the only instance. A public interest litigation for CL or government use licence was filed by NGO Jan Swasthya Abhiyan-Mumbai in the Bombay High Court for drug-resistant tuberculosis (DR-TB) drugs Bedaquiline and Delamanid. These drugs are a proven therapy that can save the lives of thousands of patients every year and improve their quality of life. They could have been effective during lockdowns as they are oral medicines and could replace the older, less safe injections.

The Government had also accepted their importance by adapting them in the guidelines for TB treatment. But these drugs cannot be scaled up due to patents held by US company Johnson & Johnson and Japan’s Otsuka. Despite this, the Government opposed the petition denying any national emergency for which CL needed to be invoked. This is in contradiction to the Government’s stated position.

On September 6, 2014, then Health Minister Harsh Vardhan had declared TB a “national emergency.” Since then, the number of TB cases in India has remained more or less constant, at 25-28 lakh. This includes DR-TB cases in which patients stop responding to standard treatment. According to India TB Report 2021 , nearly 50,000 DR-TB cases were detected in 2020, but only 10,489 were administered the new drugs.

The Government appears to be siding with multinational pharmaceutical companies on other fronts too. A recent Parliamentary Standing Committee report, Review of the Intellectual Property Rights Regime in India , recommends strengthening the enforcement of IP rights. It recommends reducing exceptions to patents allowed in Section 3 of the Indian Patents Act, 1970.

The report further advocates a Patent Prosecution Highway (PPH), a mechanism by which patents approved in other countries will be fast tracked in India. Clearly, the Committee has paid least regard to existing evidence about patents in India. A 2018 landmark study, led by Feroz Ali of the Madras High Court, showed that as many as 72 per cent of all pharmaceutical patents granted in India are not in consonance with Indian laws. This, in effect, leads to abnormally high prices of medical products. Instead of correcting this anomaly in implementation of law, the Committee recommends a more fertile ground for granting patents.

The Government should stand up for its people and challenge monopoly business practices of big pharma companies. India’s generic industry successfully helped in fighting the HIV/AIDS epidemic by producing low-cost drugs for developing and developed nations. India can do the same for Covid-19, TB and other diseases. If the Government has taken lead at the WTO against IP barriers, it should do the same at home, too.

The writer is a health journalist