[Ip-health] Ellen 't Hoen, IP-Watch-Inside Views: Why The Request By Least Developed Countries For An Extension Of The Transitional Period For Granting And Enforcing Medicines Patents Needs To Be Supported

Elizabeth Rajasingh elizabeth.rajasingh at keionline.org
Fri Feb 27 06:55:04 PST 2015

*Why The Request By Least Developed Countries For An Extension Of The
Transitional Period For Granting And Enforcing Medicines Patents Needs To
Be Supported*
February 27, 2015
By Ellen ‘t Hoen, LLM


On 24 February 2015 Bangladesh on behalf of the 34 Least Developed Country
members (LDCs) of the World Trade Organization (WTO) submitted a request
for an extension of the transitional period under article 66.1 TRIPS with
respect to pharmaceutical products until the country is no longer
classified as LDC.[1] [2] The original extension, set to expire on 1st
January 2016, specifically removes the obligation for LDCs to comply with
Section 5 (Patents) and Section 7 (Protection of Undisclosed Information)
of Part II of TRIPS, including any obligation to enforce rights under these

It is a little known fact that since the adoption of the 2001 Doha
Declaration on TRIPS and Public Health, LDCs have frequently used the
extension in day-to-day procurement of low cost generic medicines, in
particular to access medicines needed for the treatment of HIV.

[Editor’s note: TRIPS refers to the 1994 WTO Agreement on Trade-Related
Aspects of Intellectual Property Rights]

The Present Situation

While LDCs have not been obliged to implement the TRIPS Agreement thus far,
the reality is that most of them have had patent law on the books for many
years. LDCs inherited their patent laws in the post-colonial era when they
gained independence from high-income countries. At the time of the adoption
of the Doha Declaration in 2001 out of thirty African LDCs only two, Angola
and Eritrea[2] [3], did not grant patents for pharmaceuticals.[3] [4]

Medicines, including those needed for the treatment of HIV, are widely
patented throughout the developing world including in low-income
countries.[4] [5]  In sub-Saharan Africa, the regional patent offices – the
Organisation Africaine de la Propriété Intellectuelle (OAPI) and African
Regional Industrial Property Organization (ARIPO) – offer easy routes for
companies to obtain patents. Twelve of the 17 OAPI members are WTO LDC
members and 10 of the 19 ARIPO members are WTO LDC members.

While today patent licensing and non-assert declarations by companies that
hold patents on HIV medicines are common, this was not the case in the
early and mid 2000s. Even when companies had made public announcements not
to enforce their patents in LDCs, procurement agents would seek assurances
of government officials. In general, procurement agencies are reluctant to
supply medicines that are patented or of which the patent status is unknown
in the absence of assurances by the government.

Therefore the ability of LDCs to not enforce patents through simple
declarations is of key importance. It provides much needed legal certainty
for suppliers and procurement agencies – including non-profit actors – who
seek to minimize the risk of patent infringement suits.

Preliminary results of a study of the use of TRIPS flexibilities in
procurement after the adoption of the 2001 Doha Declaration show that
during 2001 -2009 at least 31 LDCs authorised the importation of generic
antiretroviral medicines (ARVs) to treat HIV/AIDS with a reference to the
LDC extension[5] [6]. 25 were WTO members and six of them were WTO
observers at the time of the purchase. The WTO has 34 LDC members. (There
are currently 48 least-developed countries on the UN list [7])

So How Relevant is the Extension Today?

Some may argue that the extension is no longer necessary because ARVs are
made available through licensing and several companies have indicated they
will not assert their patents in LDCs. LDCs are systematically included in
the scope of the Medicines Patent Pool licenses. However not all companies
provide licenses for products that are needed in the treatment of HIV/AIDS.

Licensing may seem to have become the norm for HIV-related products but
this is not the case for all ARVs and it is not the case for most other
diseases increasingly affecting LDCs. The LDC request cites
non-communicable diseases and in particular the rising incidence of cancer
in their countries. The World Health Organization is expected to amend its
Essential Medicines List this year to include essential medicines for
cancer, of which some are still protected by patents in many countries. The
LDC extension is not confined to a particular disease and can be used to
purchase or produce any generic medicine.

Another argument against the extension of the specific pharmaceutical
waiver is that LDCs are not obliged to implement the TRIPS Agreement as
whole (with the exception of some articles) until 1 July 2021. This
implementation deadline may also be further extended upon request of the
LDC members. [6] [8] Therefore, some will argue, the specific
pharmaceutical waiver is redundant. However, to date very few LDCs have
rewritten their laws to undo previous implementation of TRIPS obligations.
The ability to use the specific pharmaceutical extension and in particular
the non-enforcement declarations remain essential tools for LDCs and their
suppliers of low cost medicines. These tools do not require legislative
changes and have proven to be practical and effective.

Some LDCs have important production capacity. Bangladesh, for example, is
today the only source of generic sofosbuvir[7] [9], a direct-acting
antiviral needed for the treatment of hepatitis C and a medicine the entire
world is struggling to access at affordable prices. One could imagine such
manufacturing capacity being developed in the African region including in

LDCs that do not make use of the transition options can of course use the
TRIPS flexibilities including the “WTO paragraph 6 system” (aka 30 August
2003 decision). Under the paragraph 6 of the ‘WTO paragraph 6 system”
certain regional economic communities can use compulsory licensing to
produce, import and export generic medicines to address a common health
problem.[8] [10] This is the case for trade groups of which at least half
of the membership is made up of LDCs such as Southern African Development
Community (SADC), East African Community (EAC), Common Market for Eastern
and Southern Africa (COMESA) and the African Union (AU).

The extension of the specific pharmaceutical waiver for LDCs is still very
relevant today. It is one of the WTO mechanisms for increasing access to
medicines that work effectively and have been used on a large scale. It
would be a huge mistake not to honour the request by LDCs to leave it in
place for as long as it is needed.

Elizabeth Rajasingh
Perls Research and Policy Fellow, Knowledge Ecology International
1621 Connecticut Ave. NW, Suite 500
Washington, DC 20009
*elizabeth.rajasingh at keionline.org <elizabeth.rajasingh at keionline.org>* |

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