Info Service on Health Issues (Jul15/03)
Commentary: Making middle income countries pay full price for drugs is a big mistake
BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h3757 (Published
10 July 2015)
Radhakrishnan, cofounder and director of treatment access,Initiative
for Medicines, Access and Knowledge (I-MAK), USA.
Middle income countries are home to nearly three quarters of the global population, 73% of the world’s impoverished people, and most of the world’s sick.(1) Most cases of tuberculosis and vaccine preventable diseases occur there.(2) As of 2012, about 60% of people living with HIV resided in middle income countries; by 2020, that proportion is expected to jump to 70%.(3) Of the roughly 15 million people with HIV who do not have access to antiretrovirals, about two thirds live in middle income countries.(4)
Yet despite these statistics middle income countries are neglected by the international community. Many major donors and international aid programmes focus primarily on low income countries,(5) a trend that is increasing.(6) The same is true of drug companies, which routinely exclude middle income countries from “access programmes” that provide drugs free or at counted prices,(7) as well as voluntary licences, which allow for generic production of otherwise patented products.(8) The World Health Organization notes that although the “vast majority” of people living with HIV reside in middle income countries, “international aid and assistance . . . still focuses on low income countries.”(9)
Middle income countries are also limited in their ability to use policy levers that could help them usher in affordable medicine. The World Trade Organization’s intellectual property agreement (TRIPS) requires these countries to grant patents on drugs, whereas low income countries are not yet legally required to do so.(10) More patents mean more expensive medicines, as generics can be 99% cheaper than originator products.(11)
The cumulative result is that, despite battling a bigger burden of disease and housing more poor people, middle income countries pay much more for medicines than their low income counterparts, while receiving little international help to foot an increasingly large bill. Take the case of two antiretrovirals used in combination for third line HIV therapy, etravirine and raltegravir. Brazil pays over $5000 (£3200; €4500) per person a year for each drug (12) whereas each is available for $800 or less in sub-Saharan African ountries.(11)
Higher medicine prices mean constrained access to medicines. Thailand, for example, restricts patient access to patented second and third line antiretrovirals because it cannot foot the bill, according to Chalermsak Kittitrakul, from the AIDS Access Foundation. As a result of the high costs and limited support from the international community, antiretroviral coverage rates are lower in middle income countries than in low income countries, at 42% and 44%, respectively.(4)
Faced with rising medicine costs and decreasing international support, middle income countries need to enact policies that promote affordable medicines. One way they can do this is to use flexibilities outlined in the TRIPS agreement, which allows countries to determine what is patentable, permits the public to oppose patents that may be unmerited, and permits generic production even if patents exist, among other things.(13)
India has made most use of these flexibilities. It doesn’t issue patents on new versions of old compounds unless they significantly enhance therapeutic efficacy, allows anyone to oppose patents, and has created an enabling climate to usher in generic production of otherwise prohibitively expensive medicines.(14) In just one example, India rejected a patent for the antiretroviral tenofovir (15) and made generic versions of the medicine that are up to (14) times cheaper.(16)
India isn’t the only country to benefit from its use of TRIPS flexibilities. Famous for being the “pharmacy of the developing world,” India sells generic drugs to many low and middle income countries. The Initiative for Medicines, Access and Knowledge (I-MAK) estimates that their use of Indian generics of three antiretrovirals alone —abacavir, nevirapine, and lopinavir/ritonavir—has saved $100m annually over the past five years. If reinvested in antiretroviral programmes, these cost savings could put an extra 700 000 people on first line medicines worldwide.
India is using the same tools to foster generic production of direct acting antivirals used to treat hepatitis C virus. The most famous of these is sofosbuvir, which is patented by Gilead Sciences and sells for $1000 a pill in the United States.(17) Recognising how unaffordable high prices like these are for all countries, as well as the weak nature of Gilead’s patent, I-MAK teamed up with the Delhi Network of Positive People to oppose the company’s sofosbuvir patent. The Indian Patent Controller rejected it in January,18 but after objections from Gilead, the patent is being examined again. If generics are allowed to be made, they could cost as little as $101 for a three month course.(18) As was the case with HIV, Indian made generics could fuel the global response to hepatitis C: 73% of people with hepatitis C infection live in middle income countries, many of which were left out of Gilead’s licence with generic companies8 and therefore need another source of affordable versions.
I-MAK and local partners also challenged Gilead’s sofosbuvir patents in four other middle income countries: Argentina, Brazil, China, and Ukraine. China rejected Gilead’s patent application in June.(19) If oppositions in the other countries are also successful, and if every person with hepatitis C was to receive treatment, we estimate that $270bn could be saved. Access to generic versions of sofosbuvir in these countries could allow 53 million people more people to get the medicines they need.
global community should support such efforts. Instead, many middle
income countries, including India, have faced intense pressure from
rich countries to ramp up intellectual property protection and erode
TRIPS flexibilities.(20) It is time that we woke up to the realities
of middle income countries and supported patent laws and policies
that will promote more affordable medicine and safeguard the health
of millions of people.
1. “World Bank. Middle income countries. www.worldbank.org/en/country/mic.
2. Glassman A. New data, same story: disease still concentrated in middle-income countries. Center for Global Development, 2013.www.cgdev.org/blog/new-data-same-story-disease-still-concentrated-mid dle-income-countries
3. Schwartländer B. What will it take to turn the tide? UNAIDS, 2012.www.cegaa.org/resources/docs/IAC/What_will_it_take_to_turn_the_tide.pdf.
4. AIDSinfo database. 2015. www.aidsinfoonline.org.
5. Global Fund To Fight AIDS, Tuberculosis and Malaria. Eligibility list 2014.www.theglobalfund.org/en/fundingmodel/updates/2014-02-04_Eligibility_List_ for_2014_now_available/
Provost C. OECD donors consider pulling plug on aid to richer developing
countries. Guardian2014 Mar 12.
7. Médecins Sans Frontières Access Campaign. Proposed shake-up on drug-pricing at global fund risks higher costs for middle income countries and donors. 2013. www.doctorswithoutborders.org/news-stories/press-release/proposed-shake-drug-pricing-global-fund-risks-higher-costs-middle-income
8. Amin T. The dirty motivation behind Gilead’s hepatitis C agreement. Al Jazeera America2014 Nov 21.http://america.aljazeera.com/opinions/2014/11/pharmaceuticals-gileadhepc.html
9. WHO. Increasing access to HIV treatment in middle-income countries: key data on prices, regulatory status, tariffs, and the intellectual property situation. 2014.www.who.int/phi/publications/hiv_increase_access/en/.
10. WHO. WTO and the TRIPS agreement. www.who.int/medicines/areas/policy/wto_trips/en/.
11. Médecins Sans Frontières Access Campaign. Untangling the web of antiretroviral price reductions. 16th ed. 2013. www.msfaccess.org/sites/default/files/AIDS_Report_UTW16_ENG_2013.pdf.
WHO. Increasing access to HIV treatment in middle-income countries:
key data on prices, regulatory status, tariffs and the intellectual
property situation. 2014.www.who.int/phi/publications/WHO_Increasing_access_to_HIV_
13. World Intellectual Property Organization. Advice on flexibilities under the TRIPS agreement.www.wipo.int/ip-development/en/legislative_assistance/advice_trips.html.
14. World Intellectual Property Organization. India: the Patents Act, 1970 (as amended up to Patents (Amendment) Act, 2005). 2013. www.wipo.int/wipolex/en/details.jsp?id=13104.
India rejects ARV patent applications, saving “countless lives.” IRIN
2009 Sep 3.
MSF Access Campaign.Untangling the web of antiretroviral price reductions.
17th ed. 2014.
Walker J. Gilead’s $1000 pill is hard for states to swallow. Wall
Street Journal2015 Apr 8.
18. I-MAK. Gilead denied patent for hepatitis C drug sofosbuvir in India. Press release, 14 Jan 2015.www.i-mak.org/news-releases.
Pierson B, Jourdan A. China rejects patent linked to Gilead hepatitis
C drug. Reuters2015 Jun 19.
20. Ludwig M. Big pharma lobbies hard to end India’s distribution of generic drugs. TruthOut2014 Oct.www.truth-out.org/news/item/26721-big-pharma-lobbies-hard-to-end-india-s-distribution-of-affordable-generic-drugs#