[Ip-health] Gilead and request for patient information for prescription of Sofosbuvir in India,

Janis Lazdins lazdinsj at gmail.com
Fri Mar 20 04:29:29 PDT 2015

This is something very worrying, on one hand pharma companies are reluctant
to be open with the public sector to provide access on "their" clinical
trial data from their R&D activities, but on the other side they consider
perfectly acceptable that physicians/patients have to provide patient
personal information with the excuse to avoid products from being diverted
to markets where the more expensive product are sold. However, what's about
patient physician/patient confidentiality? or does the "right for profit"
takes precedence to the most basic ethical principle in medical practice? 

Janis Lazdins 

Message: 1
Date: Thu, 19 Mar 2015 14:00:06 +0530
From: "Shailly Gupta" <shailly.gupta at geneva.msf.org>
To: "Shailly Gupta" <shailly.gupta at geneva.msf.org>
Subject: [Ip-health] Economic Times: Gilead Sciences gathering details
	of	buyers of hepatitis-C drug to prevent its diversion
Message-ID: <017801d0621e$e8e188a0$baa499e0$@gupta at geneva.msf.org>
Content-Type: text/plain;	charset="us-ascii"



MUMBAI:  <http://economictimes.indiatimes.com/topic/Gilead-Sciences> 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
<http://economictimes.indiatimes.com/definition/stocks> stocks meant for
local supplies aren't diverted to other markets, has raised concerns among

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.  <http://economictimes.indiatimes.com/topic/Hepatitis-C> 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. 

cms> Natco Pharma, a Gilead partner that has launched the drug in the 
cms> 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.




Shailly Gupta

MSF Access Campaign (India)

AISF Building, First Floor

Lajpat Nagar IV

New Delhi - 110024

Ph: +91-9899976108 

Skype : shailly.17 





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