Gilead Sciences is collecting details of patients who buy generic versions of hepatitis-C medicine Sofosbuvir to ensure that stocks aren’t diverted to other markets.
DIVYA RAJAGOPAL | 20 March 2015, 11:30 AM IST
MUMBAI: Gilead Sciences is collecting details of patients who buy generic versions of its blockbuster hepatitis-C medicine Sofosbuvir, on which it had signed voluntary licensing deals with several Indian companies, people with knowledge of the matter said. The move, aimed at ensuring that the stocks meant for local supplies aren't diverted to other markets, has raised concerns among activists.
Under the licensing agreements, US company had asked local partners to put in place an anti-diversion strategy and, as part of that, they are collecting each patient's phone number and the name of the doctor who prescribed the drug through chemists, the people said. The drug's distributors have been told to keep a record of the sales.
Gilead's overcautious move is a result of dual pricing that it has introduced for the drug. In India, the generic versions of the drug are priced at $900 (Rs 56,400) for a 12-week treatment, compared with $84,000 in the western markets for Sofosbuvir. And, with several generic makers in the fray, the drug might cost lower than $900 in some 90 countries.
Gilead didn't respond to an email seeking comment. One of its generic partners confirmed, on the condition of anonymity, that it has been instructed to maintain records on the contact details of Indian patients.
"With this pre-condition of revealing one's details, patients have no choice but to give in, if they want to access this drug," said Shiba Phurailatpam of the Asia Pacific Network, an organisation that works with HIV-positive people. Hepatitis C and B are common among people who are living with HIV.
Leena Menghaney, regional head of MSF South Asia, said companies aren't authorised to collect the identities (name and phone numbers) of hepatitis-C positive patients who procure medicines in India. "As HIV activists we fought hard for confidentiality rights for people living with HIV to ensure that patients were not faced with discrimination and misuse of their medical data," she said, while warning that the conditions to sell the drug could lead to serious human rights violations, if the data were abused.
Last year, Gilead gave voluntary licenses to seven Indian drug companies to manufacture and sell generic versions of Sofosbuvir in 91 countries, excluding western markets and a few countries in Asia. It fears that the drug, made available in these markets at a fraction of the branded version's selling price, could find its way to developed markets. So, it is looking to account for every dosage sold.
Gilead asked partners to put in place the antidiversion strategy to help prevent the drug being routed to western markets, the sources said. In countries like Pakistan and Egypt, Gilead has instructed its distributors to sell new stocks only after patients return the empty bottles of previously purchased drugs.
Natco Pharma, a Gilead partner that has launched the drug in the local market last week, refused to comment. Zydus Cadila, which announced the launch of the drug, couldn't be reached for comment, despite repeated phone call to a senior executive.
In India, only companies that sell drugs that come under Schedule X have to keep such stringent records of distribution.
"Companies and chemists have no business collecting patients' details; personal information about a patient stays with doctors alone," said Anand Grover, senior advocate with Lawyers Collective.
Under the licensing agreements, US company had asked local partners to put in place an anti-diversion strategy and, as part of that, they are collecting each patient's phone number and the name of the doctor who prescribed the drug through chemists, the people said. The drug's distributors have been told to keep a record of the sales.
Gilead's overcautious move is a result of dual pricing that it has introduced for the drug. In India, the generic versions of the drug are priced at $900 (Rs 56,400) for a 12-week treatment, compared with $84,000 in the western markets for Sofosbuvir. And, with several generic makers in the fray, the drug might cost lower than $900 in some 90 countries.
Gilead didn't respond to an email seeking comment. One of its generic partners confirmed, on the condition of anonymity, that it has been instructed to maintain records on the contact details of Indian patients.
"With this pre-condition of revealing one's details, patients have no choice but to give in, if they want to access this drug," said Shiba Phurailatpam of the Asia Pacific Network, an organisation that works with HIV-positive people. Hepatitis C and B are common among people who are living with HIV.
Leena Menghaney, regional head of MSF South Asia, said companies aren't authorised to collect the identities (name and phone numbers) of hepatitis-C positive patients who procure medicines in India. "As HIV activists we fought hard for confidentiality rights for people living with HIV to ensure that patients were not faced with discrimination and misuse of their medical data," she said, while warning that the conditions to sell the drug could lead to serious human rights violations, if the data were abused.
Last year, Gilead gave voluntary licenses to seven Indian drug companies to manufacture and sell generic versions of Sofosbuvir in 91 countries, excluding western markets and a few countries in Asia. It fears that the drug, made available in these markets at a fraction of the branded version's selling price, could find its way to developed markets. So, it is looking to account for every dosage sold.
Gilead asked partners to put in place the antidiversion strategy to help prevent the drug being routed to western markets, the sources said. In countries like Pakistan and Egypt, Gilead has instructed its distributors to sell new stocks only after patients return the empty bottles of previously purchased drugs.
Natco Pharma, a Gilead partner that has launched the drug in the local market last week, refused to comment. Zydus Cadila, which announced the launch of the drug, couldn't be reached for comment, despite repeated phone call to a senior executive.
In India, only companies that sell drugs that come under Schedule X have to keep such stringent records of distribution.
"Companies and chemists have no business collecting patients' details; personal information about a patient stays with doctors alone," said Anand Grover, senior advocate with Lawyers Collective.
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