The Hindu Business Line : Glivec-impact: ‘Thumb’s up for public health’

Mumbai, Aug. 6 At the patient care department of the Cancer Patient’s Aid Association, Ms Vinaya Chacko is happy for the 1,000-odd cancer patients who visit every day.

Patients are poor and cannot afford expensive cancer drugs, she says. That is why the Madras High Court’s (HC) judgment earlier in the day with regard to Novartis’ cancer drug Glivec makes her happy. The impact, she believes, is that critical drugs will not be monopolised by big companies, as frivolous patents are kept at bay.

Price caused much of the heart burn over Glivec, with Novartis’ Glivec priced at over Rs 1 lakh per month, compared to the generic copies that sold at Rs 10,000 per month. Even the less priced generic copy is not affordable, she says, illustrating how patients were getting priced out of healthcare.

Joining Ms Chacko in giving the judgment a thumb’s up from a public health perspective are several cancer and HIV/AIDS patient-related organsiations from across the world.

Medecins Sans Frontieres’ Ms Leena Menghaney is “hugely relieved”, as the global humanitarian organisation supports over a lakh HIV/AIDS patients across 30 countries. The medicines for these patients are sourced from India, and the judgment upholding the law disallowing incremental innovations on medicines is a great safeguard with far-reaching impact, she points out.

Aid agencies CARE International and Oxfam International too were happy that India protected her right as ‘pharmacy of the developing world’. More than two-thirds of generic medicines exported from India are sold in developing countries at a fraction of the cost of patented brand medicines, they pointed out.

Mail-box questions

Domestic drug-company representatives say that India’s over two-year-old product patent regime was put to test and has come good. The judgment is good when evaluated regarding its impact on public health, industry and the implementation of trade related laws, said Mr D.G.Shah of the Indian Pharmaceutical Alliance.

By disallowing incremental innovations, about 80 per cent of the estimated 7,000 pharma patent applications pending in the mail-box will be under a cloud, he said. The mail-box was a provision to help companies put in patent applications during the 10-year transitory build-up to India respecting product patents in January 2005.

Ranbaxy spokesperson Mr Ramesh Adige pointed out that they were for incremental innovation that resulted in significant efficacy. And Section 3 (d) in the Indian Patent Law in fact put the rigour into the evaluation process. Ranbaxy is one of the parties to the Glivec case.

Nicholas Piramal’s Dr Swati Piramal pointed out that criteria need to be laid out to define how much efficacy is good enough to deserve a patent. For a tuberculosis medicine five per cent efficacy may be good, for malaria it may be one per cent efficacy and for allergy it may be 30 per cent, she said, illustrating the subjective nature of the problem.

But for CPAA’s Mr Y.K.Sapru, today’s judgment will keep frivolous patenting out and that means keeping medicines affordable to patients in India and abroad, he says. CPAA was the patient organisation that locked horns with Novartis on Glivec under the full view of a global audience.

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