Increase in patents on essential medicines in India will jeopardise supply of affordable
treatment
, not only in the country, but also in developing nations. The
latest trigger raising concerns among public health advocates is
exorbitantly-priced hepatitis C drug sofosbuvir by Gilead, which was
recently granted a patent in India, despite opposition by civil society
and generic companies.
The issue was highlighted in a recent editorial in medical journal Lancet, while the access and affordability of hep C treatment was debated at the recently-concluded World Health Assembly.
Affordability is key in treatment for hepatitis C with the price of a 12-week sofosbuvir treatment priced at $84,000 in the US, and hence prohibitive for most health systems globally. Generic versions of the drug are available in India for as little as $335 per 12-week treatment, as Gilead has entered into licensing deals with domestic companies.
The Gilead agreement with 11 Indian generic companies allows them to supply sofosbuvir in India and export to 100 low-income and middle-income countries, potentially providing access to at least 100 million patients.
But it prohibits them from supplying it to several middle-income countries with a high burden of HCV disease, which are home to over 50 million people, and high-income countries--a market where Gilead presumably wants to be able to determine the price, the editorial says. WHO estimates that 130-150 million people worldwide have chronic HCV in fection, and if left untreated can be lethal.
Ellen 't Hoen, researcher at University of Groningen in the Netherlands, and author of the Lancet editorial says India has become "pharmacy of the developing world" -supplying quality medicines at affordable prices--because it has avoided granting such patents in the past. Indian generic antiretroviral medicines, for example, have been essential in the scale-up of HIV treatment.
However, this situation ended in 2005 when India amended its Patents Act to introduce medicine product patents to become compliant with the intellectual property rules of the World Trade Organization. "As a result, since 2005 pharmaceutical companies apply for medicines patents in India, which means that all new medicines can be subject to 20-year patents there," it says.
The editorial strongly supports the use of compulsory licenses, voluntary licenses and other flexibilities available to countries to increase access to essential me dicines. "If countries want to provide treatment for hepatitis C and the price is too high because there is a patent in their country and the patent holder refuses to lower the price or offer a voluntary license to access generic supply, they should issue a compulsory license (CL) and go ahead with buying from Indian companies at lower price," the author says.
Elaborating an effective strategy for access to key drugs, she adds, "India should be very careful in granting patent. While compulsory licensing is only needed when a patent holder refuses to grant a voluntary license, India should develop a policy for CL in case of access problems of important medicines--including for export to other countries."
Echoing a similar message, the draft adopted at the recently-concluded 69th World Health Assembly affirms the rights of developing countries in using provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) regarding flexibilities to protect public health.
The issue was highlighted in a recent editorial in medical journal Lancet, while the access and affordability of hep C treatment was debated at the recently-concluded World Health Assembly.
Affordability is key in treatment for hepatitis C with the price of a 12-week sofosbuvir treatment priced at $84,000 in the US, and hence prohibitive for most health systems globally. Generic versions of the drug are available in India for as little as $335 per 12-week treatment, as Gilead has entered into licensing deals with domestic companies.
The Gilead agreement with 11 Indian generic companies allows them to supply sofosbuvir in India and export to 100 low-income and middle-income countries, potentially providing access to at least 100 million patients.
But it prohibits them from supplying it to several middle-income countries with a high burden of HCV disease, which are home to over 50 million people, and high-income countries--a market where Gilead presumably wants to be able to determine the price, the editorial says. WHO estimates that 130-150 million people worldwide have chronic HCV in fection, and if left untreated can be lethal.
Ellen 't Hoen, researcher at University of Groningen in the Netherlands, and author of the Lancet editorial says India has become "pharmacy of the developing world" -supplying quality medicines at affordable prices--because it has avoided granting such patents in the past. Indian generic antiretroviral medicines, for example, have been essential in the scale-up of HIV treatment.
However, this situation ended in 2005 when India amended its Patents Act to introduce medicine product patents to become compliant with the intellectual property rules of the World Trade Organization. "As a result, since 2005 pharmaceutical companies apply for medicines patents in India, which means that all new medicines can be subject to 20-year patents there," it says.
The editorial strongly supports the use of compulsory licenses, voluntary licenses and other flexibilities available to countries to increase access to essential me dicines. "If countries want to provide treatment for hepatitis C and the price is too high because there is a patent in their country and the patent holder refuses to lower the price or offer a voluntary license to access generic supply, they should issue a compulsory license (CL) and go ahead with buying from Indian companies at lower price," the author says.
Elaborating an effective strategy for access to key drugs, she adds, "India should be very careful in granting patent. While compulsory licensing is only needed when a patent holder refuses to grant a voluntary license, India should develop a policy for CL in case of access problems of important medicines--including for export to other countries."
Echoing a similar message, the draft adopted at the recently-concluded 69th World Health Assembly affirms the rights of developing countries in using provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) regarding flexibilities to protect public health.
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