[Ip-health] Fifa Rahman in Intellectual Property Watch (Inside View) Malaysia Inclusion In Gilead Voluntary Licence – A Product Of Compulsory Licence Pressure

Thiru Balasubramaniam thiru at keionline.org
Thu Aug 24 07:43:37 PDT 2017


Malaysia Inclusion In Gilead Voluntary Licence – A Product Of Compulsory
Licence Pressure


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By Fifa Rahman

Gilead’s announcement today that they would include four middle-income
countries (Malaysia, Thailand, Belarus, Ukraine) in their sofosbuvir
voluntary licence was a welcome surprise, and will enable millions access
to their highly effective, but exorbitantly priced, drug.

The decision to include these countries, however, no doubt is a response to
increasing pressure from within these countries to either issue a
compulsory licence (CL) or a government use licence (GUL), invalidate the
sofosbuvir patents, or block data exclusivity for the drug.

The threat of a GUL in Malaysia may have been particularly instrumental.
Sources state that the Malaysian Cabinet has only recently given approval
for the GUL application, and Gilead may have decided to circumvent this, in
the nick of time, to prevent the possible mushrooming of other GULs/CLs in
neighbouring countries or countries in the same income bracket who were
excluded from the Gilead voluntary licence.

The issuance of a GUL, which enables a patent to be overridden, and the
generic version to be manufactured or imported for use in government
facilities, is a completely legal mechanism provided for in the TRIPS
agreement. Unfortunately, they have not been used as extensively as they
should be due to fears that they result in trade retaliation, a myth that
is quite easily disproven.

In Malaysia, the Ministry of Health began price negotiations with Gilead in
2016. Price negotiations with the patent holder are not required for GULs,
but in practice, they often occur. The news emerged around this time that
Gilead was unwilling to go below $12,000 for a complete course of 12-weeks
treatment. Given that average Malaysian household incomes are a little over
$1200 per month, and HCV affected populations often earn much less than
this, there was no way that the proposed price would be an acceptable price

In the meantime, in my capacity as Manager – HCV Access & Affordability for
the Malaysian AIDS Council, and in partnership with Third World Network and
MTAAG+, I met with the Pharmacy Practice & Development Department, Ministry
of Health on 17 August 2016 to enlist our support, lobby for the GUL or CL,
and provide data on Brazilian, Ukrainian, and Chinese progress on TRIPS
flexibilities to access sofosbuvir. Earlier that month, we had met with
Gilead’s representative in Malaysia to discuss their proposal to the MOH.

We then planned for a bipartisan parliamentary roundtable discussion on the
use of GULs/CLs for access to medicines. On the 24th of November 2016, this
roundtable discussion was held in the Parliament building, and was chaired
by the Deputy Minister of Health, Dato’ Seri Hilmi Yahya. The MOH
pharmaceutical pricing negotiating team attended this meeting, and it was
then that we learned that procedures for a GUL were underway and were at
that time with the Ministry of Domestic Trade for their further action.

Meanwhile, in the fourth quarter of 2016, Drugs for Neglected Diseases
initiative (DNDi) had begun a feasibility trial with generic sofosbuvir and
ravidasvir as a pan-genotypic regimen in Malaysia, with the objective of
demonstrating that a public health approach in resource-limited settings
was possible. There is no doubt that as anecdotal results emerged from
this, there was increasing pressure on Gilead to respond with a price

In the first quarter of 2017, the Cabinet paper for the government use
licence was tabled, and as aforementioned, this was only recently approved.
Gilead’s response, as aforementioned, was the inclusion of Malaysia in
their voluntary licence.

Countries have been loath to issue GULs or CLs because of perceived trade
repercussions that might occur after a GUL/CL is issued, and this concern
circulated because of the US withdrawal of Generalised System of
Preferences (GSP) status for 2 Thai products in the year following the
issuance of compulsory licences in Thailand for HIV and cancer drugs. Less
publicised is the fact that in the same year, the US granted GSP status for
8 more products.

Fear of American trade sanctions post-GULs/CLs is also unjustified given
that the US themselves considered using a CL to respond to anthrax scares
in 2001, and more recently in 2017 in Louisiana, where patients were unable
to access HCV direct-acting antivirals due to the high price point.
Furthermore, in a 5 August 2016 letter to DC-based non-profit Knowledge
Ecology International, the US Department of State stated that they
‘respect(s) our trading partners’ rights to protect public health and, in
particular, to promote access to medicines for all… The TRIPS Agreement
affords countries sufficient flexibility to address serious public health
challenges, including the right to issue compulsory licenses for
pharmaceuticals in cases that meet all of the elements of Article 31 of

Therefore, not only are fears of trade retaliation post-CLs unfounded, but
the Malaysian actions also demonstrate that even the threat of a compulsory
license can result in the patent-holder voluntarily including countries’ in
existing licences, resulting in reduced prices and increased access to
medicines for all.

Fifa Rahman is a Postgraduate Researcher in Intellectual Property Law,
International Trade, and Access to Medicines, University of Leeds.


Johnson, C. Y. 2017. Louisiana considers radical step to counter high drug
prices. The Washington Post. [Online]. [Accessed 7 July 2017]. Available

Mullin, T. F. 2002-2003. AIDS, anthrax, and compulsory licensing: has the
United States learned anything? A comment on recent decisions on the
international intellectual property rights of pharmaceutical patents. ILSA
Journal of International & Comparative Law. pp. 185-209

Rahman, F., Chee, Y. L. 2017. Intellectual property and HCV: barriers and
solutions. In: Rahman, F. (ed). 2017. At the edge of a miracle: the
hepatitis C virus (HCV) in Malaysia. Kuala Lumpur: Malaysian AIDS Council

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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