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Cheap medicine, costly treatment

A single issue in India’s high court will affect the availability of reliable drugs in the world’s poorest countries and the future development of India’s pharmaceutical industry.

Activists claim patent protection will restrict the supply of cheap drugs, particularly in Africa — one can only hope that it will indeed restrict the supply of poorly-copied drugs that have worsened the plight of the poor.

Swiss drug company Novartis is challenging an Indian law that refuses patents on drugs when they are modifications of some existing drugs. This allows Indian firms to produce copies.

Novartis says this clause is unconstitutional because it violates WTO agreements implemented in India in 2005. Under this clause, India refused a patent on Novartis’s Glivec, patented in more than 40 countries — but the issue is not Glivec, it is patent protection itself.

This Section 3(d) of the Patent Law applies only to medicines and it imposes especially severe criteria: both of these exceptions appear to infringe the WTO’s TRIPS agreement on intellectual property.

The case has mobilised activists worldwide, ranging from Midecins Sans Frontihres (MSF) to the chairperson of the World Health Organisation’s Commission on Intellectual Property Rights, Innovation and Public Health.

Their joint open letter says, “the changes sought by Novartis in the Indian Patents Act could negatively affect access to essential generic medicines (in particular HIV/AIDS medicines) not only in India but also in all the developing countries that import Indian generic medicines.”

Their emotional allegations confuse a variety of terms. Generics are copies of medicines whose patents have expired, with the same active ingredients and the same proven effects (“bio-equivalent”): there are few quality problems because they are approved by exacting regulatory authorities. “Copycat” drugs, in contrast, are unregulated copies of patented drugs: they are usually untested and cannot be sold where patent law is respected.

The activists have not cited a single effective generic medicine that would be curbed by respecting patents. The Section 3(d) conditions were introduced to protect Indian “copycat” makers who would suffer most if patents became fully enforced inside India.

The companies that the open letter signatories wish to protect are not makers of true generics but copiers of products patented outside India. Many of these copies are exported to countries that do not require proof of bio-equivalence.

Some of these copies are merely ineffective, while others accelerate drug-resistance: the WHO removed temporary approval (“pre-qualification”) from 18 Indian AIDS drugs in 2004 and it confirmed this January that “drugs which are not pre-qualified could foster resistance to AIDS drugs.”

In Thailand, a government-manufactured antiretroviral copycat called GPO-Vir has made many HIV patients resistant to treatment, raising costs from $24 to $239 per person per month — although open letter signatories MSF and Oxfam continue to promote it in Laos and Cambodia. Resistance among Brazilian users of one Indian copy drug now runs at 44% after two years.

The issue for patients is safety and availability but the activists claim it is all about price. As for the price of Glivec, the Novartis cancer therapy is provided free of charge to 99% of Indian patients needing it.

On the other hand, the open letter fails to criticise the Indian government’s inability to distribute ARVs to AIDS patients in need: only 6% of its 785,000 HIV/AIDS patients receive treatment, although Indian firms, supposedly under threat from Novartis, have been pumping out cheap and effective ARVs for years.

As for money, the Global Fund for HIV/ AIDS has $6.4 billion available but has spent only $2.6 billion over the past four years, because the problem is not price but delivery, infrastructure and personnel. Behind the talk of prices and access to medicines, the avowed aim is to remove patent protection, bring down pharma companies and put research and production under government control.

A decision against Novartis would be a major setback to India’s growing competitive pharmaceutical industry which, in addition to bringing in foreign investment and creating skilled jobs, is quickening the pace of global medical innovation. There is every chance that the next generation of AIDS medicines could come from the labs of Mumbai — perhaps even a lifeline for patients suffering drug resistance as a result of taking copy drugs.

AIDS patients will suffer further if India continues to export unregulated copies to poor countries, accelerating drug resistance and the mutation of HIV. The massive extra cost of treating drug-resistant patients far outweighs the little saved by using copy drugs.

India can best serve the poorest AIDS patients by researching new medicines and manufacturing proven generics under international patent treaties. Or it can take the activist route and jeopardise its economy and patients’ health around the world. The populist decision is rarely the right one.

Jeremiah Norris is Director of the Centre for Science in Public Policy, Hudson Institute, USA.

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