Who amongst us is fortunate enough to get a fighting chance against a killer disease by timely access to the latest therapies, and who is left to die for lack of access to life-saving medicines? The question raises ethical concerns since the obvious answer is that only the well-to-do are the lucky ones. Affordability is the cornerstone of access. So how can governments ensure that access to affordable, effective and quality medicines is integral to this right when pitted against the profit-driven pharma industry? Many decades after the world started grappling with the question, access to medicines remains unjust, arbitrary and vastly out of reach even though health is considered a fundamental human right. The biggest let-down has been in India, which is better placed than most others in the developing world to do a better job of providing access to medicines to its citizens.
The global scenario is disheartening. Two billion people, mostly in low- and middle-income countries, lack regular access to life-saving drugs because of systemic failures. The starting point is the primary contradiction between healthcare as a basic human right and the pharmaceutical industry’s focus on market-driven profits. The economics of this profit-driven model is aided and abetted by unjust global trade on intellectual property rights. For a large number of countries, especially in Africa, there is a more serious problem: even older, essential generic medicines are out of reach because of the lack of production compounded the lack of regulation.
India, however, is on much better ground. A flourishing generics industry is able to supply most of the requirements of essential medicines, even if the companies have largely become contractors for Big Pharma. Besides, it has one of the best patent regimes worldwide with clearly balanced laws that protect patient rights as well patents. Not only does the Patent Act, mandated by the World Trade Organization (WTO), allow pre-grant and post-grant opposition, there is also provision for the issuance of a compulsory licence (CL) by the government to override patents on drugs that are required for the greater public good.
Yet, patients suffering from life threatening cancers, tuberculosis, HIV-AIDS and other deadly diseases have been left high and dry by the government which, armed with the right laws, should have battled on behalf of poor patients. Instead, it has consistently shied away from using the CL, held back by the fear of trade reprisals from the rich countries that host Big Pharma. India’s tryst with the CL was brief. In 2012 it issued the first and to date the only CL when it allowed generics company Natco Pharma to manufacture Bayer’s drug for kidney cancer, Nexavar. This brought down the cost of the treatment from Rs 2.8 lakh a month to just Rs 8,800. Despite two challenges at the Patent Office, in the Bombay High Court and even through a special leave petition in the Supreme Court, Bayer did not win its appeal against the CL. This landmark decision by the Congress-led United Progressive Alliance (UPA) should have set a precedent but it did not. Before the courts gave their verdicts, UPA had been voted out, and the Bharatiya Janata Party (BJP) government took power. The latter has since then been caving into the unreasonable demands made by Big Pharma for changes in the patent law’s rules. Sadly, the timorousness of officialdom has been matched by the dilatory tactics of courts, which patients see as their last hope. But here, too, the mood has changed. There is marked reluctance to issue injunctions in favour of patients except in rare instances.
The writ petition filed in the Kerala High Court in June 2022 by a breast cancer patient in Ernakulam illustrates the good and the bad in the judicial labyrinth. The unnamed patient, a retired bank employee with a meagre pension, was suffering from a virulent form of breast cancer and had sought access to the life-saving medicine Ribociclib, made by Swiss drug giant Novartis, which was priced at Rs 78,468.75 for a month’s treatment and was out of her reach. She urged the government to issue a licence under Section 92 and Section 100 of the Patents Act to allow the manufacture of an affordable generic version of the drug as in the Nexavar case. Tragically, the petitioner passed away during the early stage of litigation, but Justice VG Arun of the High Court continued the case suo motu, recognising the larger public interest involved, and appointed an amicus curiae. The harrowing quest of the petitioner was detailed in “Desperate writ petitions of dying patients” (Down To Earth, 1-15 October, 2022).
While the Union government acknowledged the effectiveness of Ribociclib, it refused to issue a licence on the grounds that breast cancer did not constitute a matter of national urgency. In a country where breast cancer is the most common cancer among women and the leading cause of cancer-related deaths, this was an insensitive claim to make. In 2022, India reported over 190,000 new cases and nearly 98,337 deaths from breast cancer. The numbers have been growing since then. The cases are now projected to be in the region of 240,000.
The petition has brought in practically every stakeholder into the proceedings. The Union of India and other authorities were directed to file detailed responses. A detailed Final Report was submitted, and the matter was posted for final hearing with a special sitting scheduled for January 21, 2023. That did not take place. Thereafter, manufacturers of the patented medicines were impleaded. The Union Ministry of Health and Family Welfare was directed to obtain data from the Indian Council of Medical Research, and the Union government was asked to examine the availability of alternative therapies and patient assistance mechanisms.
The government subsequently came up with an alternative drug on which the patent had expired but the amicus curiae showed that it was not a suitable drug. Upset by the stasis, the convenors of the Working Group on Access to Medicines and Treatment, a non-profit, wrote a letter to the Chief Justice of Kerala High Court on July 10, seeking an urgent resolution of the matter that it said involved “the collective health and dignity of women” severely impacted by breast cancer. They pointed out that the petition had been listed at least 57 times, and that the matter was repeatedly listed for disposal in 2025.
That letter, also marked to the Chief Justice of India, had an effect. On July 19, the Supreme Court urged the High Court to expedite the matter while the larger question of access to medicines would be taken up by the apex court itself. We live in hope.