WHEREAS Pakistan missed a rare opportunity offered in 1972 to begin a new era of providing access to its people to medicines at affordable price, India made it possible by taking extraordinary measures to boost its generic drugs industry.

Over the years, Indian patent office and courts have been interpreting the 2005 patent law and World Trade Organisation’s (WTO) Trips in favour of poor patients to deny grant of patents to the western drug multinationals for their expensive life-saving medicines.

These companies have accused India of disregarding intellectual property rights. Roche’s patent application for a hepatitis C drug was rejected for it was not innovative enough. Similarly, Abbott’s application for an AIDS drug was refused on the grounds of non-inventiveness. Last year, an Indian manufacturer was allowed to produce a far cheaper version of the kidney and liver cancer drug manufactured by Bayer. Its cost was $5,600 a month while its generic version was priced at $175 a month.

The climax came on April 1 when India’s Supreme Court dismissed Novartis AG’s appeal for a patent for its cancer drug Glivec. The landmark ruling, which gives a further boost to generics industry, is seen having the potential to change global debate on patents. A generic form of Glivec, already on the Indian market, costs $175 per month. The price of its patented version is $2,600.

The six-year-old case revolves around a legal provision in India’s patent law that prevents companies from getting fresh patents for making only minor changes to their existing medicines — a practice known as ‘ever greening.’ Novartis argued that the new version was much different for it was more easily absorbed by the body. Its application was rejected for the new medicine was not sufficiently distinct from the earlier version to warrant a patent extension. The Swiss firm then turned to the Supreme Court.

In Pakistan, when the government of Z.A. Bhutto (1971-77) introduced the generic medicines scheme to replace branded medicine, it was welcomed by a broad section of the population for it meant a drastic reduction in prices. But, as was expected, it was strongly resisted by western pharmaceutical firms. What was not expected was the full support extended to these firms by the country’s medical profession and also the domestic drug firms.

The Pakistan Medical Association (PMA) took equally active part in the anti-generic campaign launched by multinationals, ignoring the fact that high prices of brand drugs were beyond reach of most of the population. However, a research article published recently in JPMA, the Journal of the PMA well respected for its opinions here and abroad, has recommended the reintroduction of generic drugs scheme of 1972 which, it said, would be a positive development. In an effort to overcome the escalating drug cost in Pakistan, it said, generic medicines could be a solution to at least 80 per cent of the population living in poverty or at subsistence level.

This is necessary because the failure of Generic Medicine Scheme introduced in 1972, due to logistical constraints in demonstrating drug quality, contributed to negative perception about generic medicines. Many doctors, it said, have admitted that they were influenced by pharmaceutical firms and commercial sources of information in their perception of the generics.

Coming back to the Glivec case, the fact remains that it has been about the interpretation of Section 3 of the Indian patent law, which explains what does not constitute ‘invention.’ Section 3(d) in particular states that, “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” cannot be called innovation. This clause is one of the patent law’s public interest safeguards and is likely to play an important role in the ongoing battle between Big Pharma and India’s generic drug manufacturers. The provision was introduced by the Indian Parliament in the country’s patent law in 2005.

The Indian patent law of 1970 enabled the local industry to manufacture generic drugs under a process patent by using a process different from the one used to make the expensive patented products. But the 2005 Patents Act is different as it seeks to strike a balance between public health needs and the obligations of India as a WTO member by giving protection to innovative patents.

Today, every fifth tablet, capsule and injectable generic drug being used in the world is manufactured in India, according to India’s health minister. He told the Lok Sabha in February that India’s pharmaceutical industry now supplies around 10 per cent of total global production, which also amounts to around 20 per cent of generics globally. India’s $26 billion generic industry, called ‘the pharmacy of the poor in the Global South’ supplies over 80 per cent of AIDS medicines to the eight million people in Africa at very low prices.

Many view the April 1 judgment as a big blow to western firms seeking to expand their sales in India. It is seen as a precedent-setter. It remains to be seen whether India is going to be isolated or will inspire others, and whether multinational companies will carry out their threat and refuse to roll out new drugs in this country.

But there is no possibility of an apocalyptic scenario in the near future. The multinational companies, says an analyst, will have to find new ways of doing business in India, suggesting they may consider licensing agreements with local firms to offer cheap versions of branded drugs as provided in the Trips.

Meanwhile, all research and development ( R&D) investments have moved to China with seven global companies having invested billions of dollars after the patent law was promulgated in India. These are Novartis, Roche, Sanofi, Pfizer, GSK, Astra Zeneca and Elli Lilly. Not a single of them invested in India.

Novartis says over 16,000 patients in India use Glivec, the vast majority of whom receive it free of charge. By contrast, generic Glivec is used by more than 300,000 patients.

Last year Novartis and the provincial government of Khyber Pakhtunkhwa had been jointly running a project in which blood cancer patients were provided Glivec, free of cost, worth Rs150,000 per month for treatment. In Khyber Pakhtunkhwa there are around 1,000 of blood cancer patients out of a total 12,000 reported across Pakistan.

It is time that Pakistan undertook compulsory licensing to obtain essential drugs in the domestic markets at affordable prices to help patients suffering from diseases like cancer, hepatitis, and AIDS.