THE right to health is a fundamental human right enshrined in all international and human rights conventions and treaties. However, the realisation of this right requires many preconditions.
One of these is legislation and the implementation of a raft of measures to facilitate the production and supply of cheap and affordable medicines. In practice, this is easier said than done because the profit-hungry multinational pharmaceutical industry opposes this public health goal.
Multinationals maintain a monopolistic pricing of patented drugs by using mechanisms such as intellectual property rights. Fortunately, the might of big pharma is being increasingly challenged and restrained in countries like India which offers a template for other developing countries in this respect. A look at the Indian case is instructive.
The tussle between expanding access to effective and cheap medicine and the exorbitant pricing of monopolistic drug patents has been shaping up in India for decades now.
In 1970 the Indian Patent Act recognised what is known as process patent rather than product patent. This public-interest innovation allowed the local industry to manufacture generic drugs by using a process different from the one used to make expensive patented products.
The upshot was a drastic reduction in the price of drugs. More importantly, this measure led to the consolidation of the local generic industry which has come to be known as the pharmacy of the developing world. Most of the cheap HIV medicines being supplied to African countries come from Indian firms. As a result, the cost of treatment for HIV patients in the African continent has gone down appreciably. Drugs sales in India are projected to rise from $19 billion in 2010 to $49bn in 2020 according to one estimate.
India continued with the production of generic drugs until 1995 when it joined the World Trade Organisation. Admission into the WTO necessitated the modification of its Patents Act in line with the new requirements which were heavy on patent protection and intellectual property rights (IPR).
Yet India, in keeping with its policy of expanding access to cheaper drugs, modified its patent legislation by striking a fine balance between the public health needs of its population and its international obligation in relation to the patent protection regime and IPR. The 2005 Patents Act seeks to do this by offering protection to patents considered an innovative improvement on existing drugs.
But mere tinkering with existing patents in order to prolong the life of a patent for profit maximisation is considered an abuse of the system. Clearly, this has not gone down well with big pharma. Over the years a string of legal challenges have been mounted in the Indian courts to this public interest legislation.
The biggest challenge was mounted by Novartis — a challenge that found its way to the Supreme Court in 2012. Novartis was seeking to claim patent protection for its money-spinning Glivec used for treating leukemia (the drug earned $4.9bn in 2011).
Earlier this month, in a long-awaited ruling, the Indian Supreme Court threw out the legal challenge by ruling that Glivec did not qualify for patent protection because it does not represent significant innovative improvement on the original medicine.
This bold legal ruling has come as a huge relief for millions of leukemia sufferers who cannot afford to buy this exorbitantly priced medicine. Now local manufacturers can produce copycat drugs at a vastly reduced price. A generic form of Glivec, already on the Indian market costs $190 per month as compared to the Glivec patented price of up to $2,500 according to Roxana Bonnell and Els Torreele, senior advisors at the grant-making Open Society Foundations’ public health programme.
Earlier, the Indian Intellectual Property Appellate Board had also rejected Roche’s patent application for a hepatitis C drug on the ground that the process used was not innovative enough to warrant patent recognition. This opens up the possibility of converting out-of-reach drugs into affordable drugs.
Not only this, the Indian government and courts have made civic-spirited use of flexibilities inherent in the Trade Related Intellectual Property Rights which allow governments to force the pharmaceutical industry to issue compulsory licences to local manufacturers in times of national health emergencies in order to make medicines more widely, and affordably, available to patients.
In 2012 Indian courts used this flexibility to force Bayer to issue a compulsory licence for its kidney-curing medicine Nexavar to a local Indian manufacturer at one-thirtieth of its patented version.
Against this backdrop, the latest ruling caps a string of pro-people rulings handed down by the Indian courts which, cumulatively, have contributed to the realisation of the right to cheap and affordable medicines in a big way.
Pakistan faces a similar set of issues on this front. Yet no concerted efforts have been made to tackle the organised power of the industry which constrains the right to cheap and affordable medicine.
With the public health system in permanent decline, and the unregulated private medical care sector filling the gap haphazardly, the right to cheap and affordable medicine has acquired utmost importance. Already, the treatment costs for chronic diseases such as hepatitis C are out of reach for a vast majority of people.
The only way forward is by taking the route of generic drugs production. Unfortunately, there has been no movement on this front since the doomed effort at introducing a generic drugs scheme during the first PPP administration in the 1970s. Surely the time has come to revive this debate and take it forward.
The writer is an Islamabad-based development consultant and policy analyst.