Tuesday, April 8, 2008

India Cancer Patients Seek To Use Courts For Access To Patented Drugs

Posted by William New @ 1:37 pm

By Tatum Anderson for Intellectual Property Watch

One of the most vocal voices for the interests of cancer patients in Indiasays it will use the courts to force the Indian government to declare cancera national emergency, in an attempt to make cancer drugs affordable tosufferers.The Cancer Patients Aid Association (CPAA) wants the Indian government toissue permits, called compulsory licences, for a number of drugs it hasdeemed unaffordable. Such permits would allow generic pharmaceuticalcompanies to manufacture the drugs instead of the patent holders.

It believes that the prices would then drop considerably.Under Indian patent law, no one can apply for a compulsory licence for thefirst three years after a patent has been granted, unless the governmentdeclares one of four emergency criteria: a national emergency, extremeurgency, a case for public non-commercial use or a patentee has employedanti-competitive practices. (After three years anyone can apply for alicence under much broader set of criteria.)

The idea, said Y K Sapru, CEO and founder of the 38-year-old organisation,is to establish the exact meaning of a national emergency. "The act says acompulsory licence can be given when there is a national emergency, then theissue of what that national emergency is can be debated."

The CPAA thinks cancer is a national emergency because cancer drugs are soexpensive that Indian cancer sufferers die because they cannot afford them.Some drugs can cost several thousand or even hundreds of thousands of rupeesper month, while many sufferers live on less than 40 rupees (about $1) perday, it said."Our contention is that the manufacturers are pricing the products at aninternational price," said Sapru. "And as 98 percent of India's populationis not covered by any form of health insurance, many who suffer from thecancer will die because they won't have access to the life-saving drugs."

The association has compiled a list of 20 medicines it feels are vital butprohibitively expensive for most cancer patients . Theyinclude drugs made by international companies like Pfizer and Novartis.Interestingly, the list also includes drugs made by some domestic genericscompanies.First, CPAA plans to send a letter shortly to the country's Ministry forHealth and Family Welfare requesting that it declare such an emergency.Later it will turn to the courts if no action is taken.

The CPAA's actions are taken seriously in India. It has filed formaloppositions against countless patent applications at the Indian patentoffice, negotiated cheaper prices for some drugs and was a key member of theopposition in a court case brought by Swiss manufacturer Novartis last year( <http://www.ip-watch.org/weblog/wp-trackback.php?p=712> IPW, PublicHealth, 7 August 2008).

The strategy is a considerable departure from CPAA's traditional role offighting individual patents - like the one filed by Novartis - on the basisof frivolous patenting.That method is used throughout the industry. India's generic manufacturerCipla is currently arguing that it should be able to manufacture copies ofSwiss manufacturer Roche's Tarceva on this basis. Cipla last week won theright to continue manufacturing the drug until the case is settled. Calling for price controls and compulsory licences is essentially afast-track way of trying to reduce prices of several drug prices en masse,rather than the lengthy process of opposing patent applications one at atime.

The plan is to take this particular compulsory licence initiative as far asit will go, to the Supreme Court if necessary, said Sapru. "If they [thehealth ministry] don't think that it is a national emergency then we willtalk about the constitutional rights of a human being above any other rightthat the constitution will give because he owns the patent," he said.

Tahir Amin, a lawyer from I-MAK specialising in Indian public health, saidhe believes that CPAA could mount a challenge under the constitution,specifically under Article 21 - the right to life.The criteria under which compulsory licences can be issued are being hotlydebated. World Trade Organization rules on intellectual property rights havebuilt-in flexibilities in public health situations.

Nevertheless, Thailand's decision to grant compulsory licences for cancer drugs on the basis ofpublic non-commercial use within the country's public sector health systemhas drawn huge criticism from those who believe compulsory licences shouldonly be used as a last resort.At home, India may be heading for more controversy as its patent officeconsiders whether to grant a compulsory licence to Indian generic companyNatco that would allow it to export a copy of Roche's cancer drug Tarceva,to Nepal.

Opponents say although compulsory licences were designed for use in nationalemergencies, cancer should not be classed as one.Guy Willis, a spokesman for the International Federation of PharmaceuticalManufacturers and Associations (IFPMA) which represents originatorcompanies, told Intellectual Property Watch that cancer patients do not haveaccess to adequate drugs because the Indian government has not investedenough in its public healthcare infrastructure. This is not a problem that emergency compulsory licences can fix, he said."

It is the systematic failure of the Indian government to give enoughresources and I don't think you can classify a systemic failure as anemergency," he said. "It implies something that is very deep-seated and isnot going to be addressed by emergency measures."In addition, Willis adds that enabling generic manufacturing does notnecessarily lead to more affordable prices. "The generic versions of cancerdrugs are cheaper perhaps than the originator versions but the cost of ayear's treatment is still several multiples of the average Indian salary.They don't improve access," he said.

CPAA's list of unaffordable drugs contains medicines made by genericcompanies including, ironically, Natco, which has applied for a compulsorylicence under another provision within the Indian law.CPAA's Sapru said the association also will be trying to convince the Indiangovernment to apply existing pricing control regulations to drugmakersproducing cancer drugs (such controls have already been imposed on Cipla foranother drug). "We are not even making a distinction between themultinationals and the generics because there are some generic drugs whichare also expensive," he said.

Tatum Anderson may be reached at info@ip-watch.ch.The Cancer Patients Aid Association's List of 20 Vital but ProhibitivelyExpensive Cancer Medications

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