July 13, 2010

India's patent regime hurting across Asia-Pacific

Priyanka Golikeri / DNA
Tuesday, July 13, 2010 2:04 IST

Mumbai: Sitting in a first-floor room of a nondescript school building off Thakurdwar Road at Charni Road in south Mumbai, Eldred Tellis is a picture of frustration and agony.

As the founder director of Sankalp Rehabilitation Trust, which works with HIV/AIDS patients, Tellis is confronted with the challenge of providing affordable treatment for patients of hepatitis C, a liver disease that affects almost 95% of users of injectable drug.

Unless hepatitis C is treated, no effort to save AIDS patients would suffice.

“Hepatitis C medicines are incredibly expensive. We just can’t treat patients,” says Tellis.

Two key hepatitis C medicines—pegylated interferon alpha 2a and pegylated interferon alpha 2b — both patented in India, cost between $16,000 and $18,000 (Rs 7.5-8.4 lakh) for a 48-week course of treatment.

Same is the case with patented HIV/AIDS medicines like raltegravir, which costs Euro 2000 (Rs 1.2 lakh) per year in India, and etravirine priced internationally (no separate pricing for developing countries) at about $8000 (Rs 3.7 lakh) per year.

Other than the patent-holders, no other company can manufacture the medicines till the patents expire.

“The older medicines for HIV/AIDS are given by the government, but the newer ones, which are patented, are just unaffordable. With competition, prices come down. But that’s not possible in case of patented drugs. Hence, patients are left to God’s mercy,” says Loon Gangte, president of Delhi Network of Positive People, which works with HIV/AIDS patients.

The sentiments of Gangte and Tellis are reflected across Asia Pacific, in countries that depend on India for supply of low-cost off-patent (generic) medicines.

Estimates suggest that 200 million people around the world are infected with hepatitis C, while a report by the World Health Organisation (WHO), Unicef and UNAIDS, shows that at the end of 2008, about 5 million HIV/AIDS patients were not having access to treatment.

“We are seeing several deaths due to hepatitis C across Asia-Pacific, although no specific numbers are available. India is the pharmacy of the world. Patients look forward to cheap medicines from India, but as key HIV/AIDS and hepatitis C medicines hold patents in India, its a huge setback for patients in our region,” says Giten Khwairakpam, programme coordinator, Coalition of Asia Pacific Regional Network on HIV/AIDS, which works in Vietnam, Malaysia, Papua New Guinea, East Timor, Myanmar, etc.

Abdullah Denovan from Indonesia, who is the national coordinator of Indonesian Network of HIV Infected Persons, also echoes Khwairakpam’s views. “In 2009, there were over 15,000 hepatitis C cases in Indonesia. Estimates show that, from the 1980s to September 2009, Indonesia had about 18,442 HIV/AIDS sufferers. There may be many more unreported cases. There are no generics from India due to the patents.”

Manipur-based Deepak Leimapokpam, a user of injectable drugs who is afflicted by both HIV and hepatitis C is one of the very few who has managed to source funds from friends and relations abroad.

“99% of hepatitis C patients across India, specially in states like Manipur, Mizoram, Nagaland, are bereft of treatment. Of the more than 300 people with Hepatitis C whom I know, just two- three are on treatment,” says Leimapokpam, who is with the Manipur Network for Positive People in Imphal.

Leimapokpam says he spends about Rs 14,000-15,000 for a vial of the medicine per week. “Patients with both hepatitis C and HIV need to take the hepatitis C treatment for a year, and Rs 14,000 per week is just unimaginable.”

Five years after India adopted the product patent and 20-year patent regime, in accordance with the trade related aspects of intellectual property rights agreement (Trips) of the World Trade Organisation (WTO), the adverse effects of the regime are rubbing salt into the wounds of patients across countries.

“Local manufacturing in developing countries is not developed. Hence we have to depend on India,” says Kannikar Kijtiwatchakul, coordinator, health consumer protection programme, Chulalongkom University in Thailand.

Apart from Thailand, Indonesia, less developed countries like Lesotho, buy nearly 95% of all anti-retrovirals from India. Moreover, international humanitarian aid organisation Medecins Sans Frontieres, which provides treatment to 140,000 HIV/AIDS patients in 30 countries, buys more than 80% of its HIV/AIDS drugs from India. Also, about half the essential medicines that Unicef distributes and 75% medicines distributed by the International Dispensary Association in developing countries come from India.

Industry estimates suggest, that by 2015, when the Indian pharmaceutical market would be worth $20 billion, about 15% of total drugs would be patented molecules.

Anuradha Salhotra, managing partner at intellectual property law firm Lall, Lahiri & Salhotra, says the minute Trips came into effect, patent filings rose and will continue going up.

“That is frightening for all patients dependent on India. If key medicines are patented, it would allow patent holders to charge whatever they want and would push millions below poverty line,” says Khwairakpam.

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