[Ip-health] Op-ed by Dr. Jorge Bermudez and Dr. Viroj Tangcharoensathien in Medium: Heading off Global Action on Access to Medicines in 2018
thiru at keionline.org
Thu Jan 18 13:02:50 PST 2018
Heading off Global Action on Access to Medicines in 2018
By Dr. Jorge Bermudez and Dr. Viroj Tangcharoensathien
At the dawn of 2018, political and health leaders must seize the growing
momentum and opportunities to tackle the protracted challenges of access to
medicines that undermines efforts to save lives and improve health as
committed under the Agenda 2030 SDG by all UN member states.
Over half of the world’s population does not have access to essential
health services, 3.5 billion people are excluded from getting essential
medicines; they are neither available nor affordable. The misaligned
incentives are the root causes hampering access as well as research and
development (R&D) of new molecules which address priority diseases.
Soaring prices of EpiPens for severe allergies, cancer and Hepatitis C
treatments dominated headlines in recent years and left millions behind
unable to access the treatments and vaccines they need, even among high
income countries. Death tolls of preventable or treatable diseases due to
lack of access to vaccines or medicines licensed in the market is ethically
and politically unacceptable. Or the cost of access results in unbearable
financial hardships to patients and families and impoverishes them because
of large medical bills [i]. High priced medical products is a major
financial burden to health insurance funds.
The scientific communities and vaccine industry had failed to develop an
effective vaccine for diseases preferentially affect the poor; this was
reflected by 11 thousand death tolls from Ebola epidemic in Western African
countries. Despite Ebola was diagnosed since 1976; no vaccine was
developed. Moreover, there have been just two new classes of antibiotics
developed after 1962; though analogue development had kept pace with the
emergence of resistant bacteria [ii]. The stagnation of R&D of new classes
of antibiotic threatens both global human security and the human right to
health; AMR will kill an estimate 10 million people every year by 2050.
Not only people in low- and middle-income countries do not have access, the
treatment cost of Hepatitis C, up to US$84,000–for a three-month course, is
unaffordable even by American citizens or insurance funds[iii]. Companies’
pricing decisions serve their own financial interests at the expense of
patients’ wellbeing [iv].
The monopoly status of patented products incentivized by the intellectual
property regime is the root cause of limited access to medicines. Where
there is no expectation of high profit margins or sales, such as Ebola,
neglected tropical diseases or antibiotics despite public health
significance, there is no R&D. In contrast where there is a lucrative
market such as for treatments of hepatitis, cancer and other NCDs, the
soaring price is the main barrier [v].
Implementing TRIPS flexibilities, a legal right by all WTO members to
safeguard public health interests of their population, also faces
challenges such as the use of compulsory licensing of Efavirenz for HIV by
Thailand [[vi]], and imatinib for treatment of leukemia in Colombia.
Implementing compulsory licensing, especially for countries considered
Upper Middle Income economies, faces considerable retaliation and political
pressures from government in certain high-income countries and industry. As
a result, a study predicts a low probability of continued implementing
compulsory licensing [vii]. Hence, further systematic assessment of global
health governance on the current patent regime including TRIPS
flexibilities, is required.
With growing recognition of both the challenge and the need for reform,
many governments around the world agree in key ways to tackle access and
biomedical innovation challenges. This includes the importance of promotion
of competition, transparency and new models of innovation. For example,
Malaysia promotes competition to increase access to high priced hepatitis C
treatments. In 2017, Malaysia was the first country to issue a TRIPS
compliant compulsory license to allow both innovation and generic
competition [viii]. Generic competition has reduced prices, a three-month
course of treatment in Egypt dropped from US$ 900 in 2015 to less than US$
200 in 2016, and in Pakistan the same course today costs as little as US$
There is also growing consensus on the need for increased transparency in
medicines prices, research and development costs and clinical trials. Many
WHO Member States agreed [x], [xi] to the need to pursue new models for
innovation for urgently needed new antibiotics that ensure a return on the
public investment by delinking the cost of research and development from
prices and sales to improve access to medicines.
To head off this ‘perfect storm’ of global health challenges, the World
Health Organization’s Executive Board in January 22–27, 2018 as well as the
World Health Assembly in May 2018 will consider for the first time the
recommendations of the 2016 UN Secretary-General’s High-Level Panel on
Access to Medicines [[xii]]. Based on recommendations of the Panel, the two
platforms should find strategic solutions and concrete actions for improved
access to medicines and leaving no one behind.
Dr. Jorge Bermudez; Oswaldo Cruz Foundation, Ministry of Health, Brazil and
Member of UN Secretary General High Level Panel on Access to Medicines,
email:jorge.bermudez at fiocruz.br
Dr. Viroj Tangcharoensathien; International Health Policy Program, Ministry
of Public Health, Thailand, email viroj at ihpp.thaigov.net
[i] WHO and World Bank. Tracking Universal Health Coverage: 2017 Global
Monitoring Report. 2017.
(accessed January 3, 2018
[ii] Coates AR, Halls G, Hu Y. Novel classes of antibiotics or more of the
same? British Journal of Pharmacology. 2011;163(1):184–194.
[iii] United States Senate Committee on Finance: Wyden-Grassley Sovaldi
Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000
Hepatitis Drug. 2017
(acceeded January 8,2019)
[iv] Edlin B. Access to treatment for hepatitis C virus infection: time to
put patients first. Lancet Infect Dis 2016; Published Online July 12, 2016.
[v] Bermudez J. Contemporary challenges on access to medicines: beyond the
UNSG High-Level Panel. Ciênc. saúde coletiva vol.22 no.8.
[vi] Wibulpolprasert S, Chokevivat V, Oh C, Yamabhai I. Government use
licenses in Thailand: The power of evidence, civil movement and political
leadership. Globalization and Health. 2011;7:32. doi:10.1186/1744–8603–7–32.
[vii] Beall R, Kuhn R (2012) Trends in Compulsory Licensing of
Pharmaceuticals Since the Doha Declaration: A Database Analysis. PLoS Med
9(1): e1001154. https://doi.org/10.1371/journal.pmed.1001154
[viii]. IP Watch: Malaysia Grants Compulsory License
(accessed January 8, 2018).
[ix] WHO 2017. WHO prequalifies first generic active ingredient for
hepatitis C medicines; available from
[access 8 January 2018]
[x]. United Nations General Assembly 2016. Political Declaration of the
high-level meeting of the General Assembly on antimicrobial resistance;
Resolution A/71/L.2; available from
https://digitallibrary.un.org/record/842813/files/A_71_L-2-EN.pdf [access 8
[xi] Chan-O-Cha P, 2016. Statement on Behalf of the Group of 77 and China.
High-Level Meeting on Antimicrobial Resistance. Available from
http://www.g77.org/statement/getstatement.php?id=160921 [access 8 January
[xii]. United Nations Secretary-General’s High-Level Panel on Access to
Medicines. Report: Promoting innovation and access to health technologies.
2016. http://www.unsgaccessmeds.org (accessed January 8, 2018).
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