[Ip-health] Making middle income countries pay full price for drugs is a big mistake

Tahir Amin tahir at i-mak.org
Wed Jul 15 15:56:30 PDT 2015


http://www.bmj.com/content/bmj/351/bmj.h3757.full.pdf


*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)

Cite this as: *BMJ* 2015;351:h3757



*Priti Radhakrishnan, cofounder and director of treatment access,
Initiative for Medicines, Access and Knowledge (I-MAK), USA.
priti at i-mak.org <priti at i-mak.org>.*



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 discounted
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 drug12 whereas each is available for $800 or less in sub-Saharan
African countries.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 tenofovir15 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.



The 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.



References

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-middle-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/
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6. Provost C. OECD donors consider pulling plug on aid to richer developing
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7. Médecins Sans Frontières Access Campaign. Proposed shake-up on
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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.
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9. WHO. Increasing access to HIV treatment in middle-income countries: key
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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.

12. 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_treatment.pdf?ua=1
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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.

15. India rejects ARV patent applications, saving “countless lives.” IRIN
2009 Sep 3.
www.irinnews.org/report/85995/global-india-rejects-arv-patent-applications-saving-countless-lives
.

16. MSF Access Campaign.Untangling the web of antiretroviral price
reductions. 17th ed. 2014.
www.msfaccess.org/sites/default/files/MSF_UTW_17th_Edition_4_b.pdf.

17. Walker J. Gilead’s $1000 pill is hard for states to swallow. Wall
Street Journal2015 Apr 8.
www.wsj.com/articles/gileads-1-000-hep-c-pill-is-hard-for-states-to-swallow-1428525426
.

18. I-MAK. Gilead denied patent for hepatitis C drug sofosbuvir in India.
Press release, 14 Jan 2015. www.i-mak.org/news-releases.

19. Pierson B, Jourdan A. China rejects patent linked to Gilead hepatitis C
drug. Reuters2015 Jun 19.
www.reuters.com/article/2015/06/19/us-gilead-sciences-sovaldi-patents-idUSKBN0OZ0A620150619
.

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#
.



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