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Injecting purpose into pharma R&D | The Hindu | Business Line | 4 April 2013

The Glivec ruling is a watershed, but we also need to spur local research and ensure access through insurance.

Some of the attention on the legal battle involving Novartis’ blood cancer drug Glivec can be explained by the David-versus-Goliath nature of the fight. In India, it was the Cancer Patients’ Aid Association that stood with those legally opposing multinational drug-major Novartis’ claim for a patent on Glivec. And at the Novartis headquarters in Basel, a shareholder spoke up for Indian patients at the Swiss company’s annual shareholders’ meeting.

But when the dust settles and the breathless commentary on the Supreme Court’s landmark judgment wanes, it would be time to introspect and face some disconcerting realities on why patients in the country bear the brunt of mounting medical bills. And reality is — an unhealthy mix of abysmal healthcare spends by the Government, patchy health-insurance coverage and the absence of an environment that sparks bright minds to research products to tackle diseases of the local population.

Earlier this week, when the Supreme Court dismissed Novartis’ plea on Glivec, it did not just put a lid on a seven-year long, high-profile case. The watershed judgement stood for innovation, as defined by the Indian Patents Act, and its touchstone to measure efficacy — the law’s Section 3 (d).

After technically evaluating the merits of the patent claim, the Court had ruled that imatinib mesylate (sold under the Glivec brandname) did not show an inventive step or improved efficacy (from its already known version) to merit patent protection. In fact, there are a handful of drugs locked in patent battles, at various stages of progress across the country (see table compiled by Gopakumar Nair Associates). Last year, the Patent Controller took the unprecedented step of issuing the country’s first compulsory licence to drug-maker Natco, allowing it to make its less expensive version of Bayer’s advanced kidney cancer drug Nexavar, on the payment of a 7 per cent royalty. The decision was seen to be in the interest of public health.

But patent battles are a moment in time in the country’s changing landscape of protecting intellectual property — the data and knowledge generated while undertaking research. India amended its Patents Act (1970) to respect product patents in 2005. And this made the environment difficult for companies that reverse-engineered new products to make similar versions.

With this crutch being removed came a new concern — who would shoulder the responsibility of treating diseases in the country? Would it be the domestic industry, still getting its act together on research; the multinationals and their high-priced innovative products; the slow-moving public sector institutions; or the low-spending Government?

No social security net

Unfortunately, while the Courts step in to protect the interest of the patient, the Government and industry fall short in their efforts. The Government’s spending on healthcare is a shameful 1 per cent odd of GDP. Not a patch on other developed nations that spend over 10 per cent.

Health insurance continues to be patchy and riddled with mistrust between insurance companies (wary of false claims) and patients, who feel companies are tight-fisted when it comes to reimbursing their legitimate medical bills.

The country is not even close to bringing in a social security net, where people pay when they are young and earning, to get a State cover when they are older.

Doctors treating cancer patients acknowledge, in private conversations, the situation that patients find themselves in — something that’s lost in the present jingoism over medicine prices.

If Glivec is beyond reach at Rs 1 lakh a month, even the reduced price of Rs 10,000 per month is steep, as a life-long expense for salaried people, says a doctor.

While the patent-life of the drug may be debated, what is not in question is that it is improves the quality of life for a patient — from the earlier five years to about 17 years now, he points out.

Tempering jubilation over the Glivec ruling with realism, the doctor wryly says if there is no original research, there would be no medicine to be copied. This is not to say that medicine prices should not be affordable. But the Government has to step in and support massive healthcare programmes, even as it facilitates an environment to encourage research.

It needs to bring in a transparent procurement system to buy drugs at subsidised cost and give it free to patients. Companies would be willing to participate in Government programmes if they were transparent, did not have an L-1 fixation (where the drug with the lowest price is chosen, even if it is not the most effective one) and did not threaten to blow up into the next big scam in the country — is the measured observation in some medical circles.

Step up research

A section of the scientific community is also uneasy about the state of affairs in research. Unlike overseas, there isn’t a system where research from government institutions and labs gets picked up and commercialised by industry. Whether this is because innovative work does not come out of labs here, or because industry is not supportive, is something that needs to be figured out.

But research is a shot in the dark, a pathway fraught with risk. And some of the biggest names in the domestic pharma space have sold out entirely, because they lacked their predecessor’s vision to power ahead .

All the more reason for research alliances between local companies, government labs and foreign companies — to push for new drugs to be brought into India, and at reasonable prices.

Companies and policymakers will have to figure out better ways to fund healthcare innovation, and not make patients pay a huge price for falling sick. In the last 60 years, the country has built its rock-solid base of generic drug makers. They have played, and will continue to play a key role in providing inexpensive drugs in India and across the world. But there is huge opportunity to be tapped — from scientific capabilities to the scope of traditional knowledge available in the country.

As the doctor says, it is in the interest of local researchers and companies to get out of the “photo-copier” mindset and take that leap into meaningful research to bring out affordable medicine.