Gilead Sciences agreement with seven drug firms – CIPLA, Ranbaxy, Cadila Healthcare, Hetero Labs, Mylan Laboratories, Sequent Scientific and Stride Arcolab – has lowered the cost of treatment dramatically, from at $1000 per pill in the U.S. to $900 for the whole treatment in India – resulting in hepatitis C patients in developing countries paying 1% of the price that patients in the developed world are charged.
Is Gilead’s entering into this agreement motivated by altruism? Or is it an attempt to institute a monopoly on Hepatitis C medication? Gateway House’s Saumya Pant spoke to Gregg H. Alton, Gilead’s Executive Vice President, for corporate and medical affairs about this and about his company’s plans in India and other developing countries.
Q. Republicans have consolidated their share in the House of Representatives by gaining 14 seats. What is the future of Obamacare given these new developments?
The future of Obama care doesn’t look too bright given the new numbers in the U.S. Congress. However, I don’t think the Republicans will gun for a full repeal of Obamacare, but might ask for a partial repeal. Now that the Republicans have gained control of the Congress, they will be less confrontational because they will not want to be blamed for further gridlock. The electorate doesn’t want to see squabbling between political parties, and therefore there is likely to be a concentrated effort not to tear into each other.
Q. What has been Gilead’s India strategy?
For Gilead, a California-based company, we first entered the Indian market in 2006, when we established technology transfer and licensing partnerships with a number of India-based manufacturers for one of our HIV medicines, tenofovir disoproxil fumarate (TDF), to be sold in India and least developed countries. TDF is a component in several HIV regimens, which are now among the most-prescribed HIV therapies. Today more than 6 million patients around the world are benefiting from these partnerships.
This achievement could not have been realised without the collaboration between Gilead and its 17 Indian manufacturing partners. We have seen the production and distribution of our compounds increase exponentially since 2006, and we fully expect our collaboration with Indian manufacturers will continue to strengthen over many years.
Q. What is the next step for Gilead if the Hepatitis C patent isn’t granted in India?
As a research-based pharmaceutical company, we strongly defend our patents. We believe that the responsible use of IP is the best way to simultaneously drive therapeutic innovations, such as Sovaldi (sofosbuvir) for chronic hepatitis C, and ensure access to treatment for all patients in need. We will continue to work to enable generic production of our medicines in India with multiple manufacturers to ensure patients most in need receive access to HCV treatment.
We recently announced licensing agreements with seven Indian manufacturers to produce Gilead’s HCV medicines for distribution in 91 countries including India and we will work with our regional partners to obtain key regulatory approvals in these countries in order to expedite entry for generic manufacturers.
Q. How do you see the role of Indian pharma in global healthcare?
From our experience in HIV therapy, we firmly believe that India has the capacity to meet global needs and bring down the cost of hepatitis C treatment.
Q. What are your parameters of classification of LDCs, moderately developed countries (MDCs), highly developed countries (HDCs) – is India classified as an LDC? Why are countries like Brazil and Ukraine included in MDCs?
For hepatitis C, Gilead categorises countries in three pricing tiers (low-income, lower-middle income and upper-middle income) according to per-capita gross national income and hepatitis C prevalence. These tiers provide a starting point for price negotiations with individual governments.
Because Gilead takes into account the disease burden, more than 50 countries included in the company’s hepatitis C access program are categorized by Gilead in income tiers lower than their World Bank classifications. For example, Gilead categorizes India in its low-income tier, despite its World Bank classification as lower-middle income. Similarly, Egypt is considered by the World Bank to be a lower-middle income country, but because the country has the world’s highest prevalence of hepatitis C, Gilead has placed the country in its lowest pricing tier, and Egypt will receive Sovaldi at a 99% discount to the U.S. price.
Q. What is the next big battle after the IPR issue?
Gilead does not consider intellectual property rights to be the main battle. We are much more focused on overcoming the challenges associated with global treatment expansion, including strengthening health systems so they can support screening and treatment programs, raising policymaker awareness of important yet underfunded health issues and broadening the base of epidemiological data that will inform public health initiatives. Gilead continues to focus on bringing life-saving drugs to those who need them most, regardless of their ability to pay. The goal of our access initiatives is to see patients benefit from our innovation.
We believe the responsible use of IP can help expand access to our medicines. Gilead was the first innovator pharmaceutical company to join the Medicines Patent Pool (MPP), a United Nations-backed initiative that facilitates the sharing of drug patents for use in low-income countries. Through the MPP-Gilead agreements signed in 2011 and 2014, the MPP can sub-license Gilead’s IP to manufacturers so they can produce generic versions of our HIV and hepatitis B medicines and sell them in about 100 developing countries.
It’s time that we move beyond seeing IP and expanded treatment access as mutually exclusive. We know from our experience that IP encourages innovation and ultimately expands the reach of life-saving medicines to patients. The Modi government understands this, and we are pleased to be working in close partnership with India to further strengthen what is already a great relationship.
Gregg H. Alton, Executive Vice President, Gilead Sciences.
Saumya Pant is Senior Content Manager, Gateway House.
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