[e-drug] TRIPS LDC 2021 extension and 2016 pharmaceutical waiver

E-DRUG: TRIPS LDC 2021 extension and 2016 pharmaceutical waiver
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[The 8 years extension of not having to comply with most TRIPS obligations until 2021 is good news for Least Developed Countries. E-drug received some questions whether this affects the current 2016 waiver for specific pharmaceutical patents. Here is the answer. This allows at least another 5 years for LDCs (and regions with a majority of LDCs in their economic community) to try and produce generic versions of otherwise patented and often unaffordable medicines. WB]

Dear E-drug readers,

There seems to be some confusion about how the recent draft decision of the WTO Council for TRIPS to extend the Least Developing Country Members obligation to comply with TRIPS until at least 1st July 2021 relates to the 2002 TRIPS Council decision which specifically removed any 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 provisions, until 1st January 2016.

The extension agreed upon last week concerns the entire TRIPS Agreement (with the exception of articles 3, 4 and 5 related to national treatment and most-favored nation treatment) and thus removes also LDCs obligations with regards to pharmaceutical patents and data protection until at least 1st July 2021.

It is also important to note that the decision does not include any more the ‘no roll back’ language of the earlier extension decision of 2005, which read: “Least-developed country Members will ensure that any changes in their laws, regulations and practice made during the additional transitional period do not result in a lesser degree of consistency with the provisions of the TRIPS Agreement.”

This means that LDCs are now free to make legislative changes that fit their own policy and technological development objectives, including developing the types of IP provisions that fit their specific needs in the health field for example.

The specific pharmaceutical waiver of 2002 which runs until 1st January 2016, could however be subject to a different extension request regardless –– such an extension could go well beyond 2021 and survive - for example in the case 2021 no further general extension is requested or granted. I assume LDCs will make such a request.

Kind regards,

Ellen 't Hoen
ellenthoen.ip@gmail.com
twitter:@ellenthoen

E-DRUG: TRIPS LDC 2021 extension and 2016 pharmaceutical waiver Q&A
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Question:
Thanks to Ellen for her explanation but I’m still a bit confused based on the MSF press release about the extension.

The specific point that I’m unclear about is whether the recent exemption did cover intellectual property rights for pharmaceuticals. If it did then what, if anything, will change come January 1, 2016 when the exemption for IPRs for pharmaceuticals expires?

Joel Lexchin MD
121 Walmer Rd.
Toronto ON
Canada M5R 2X8
E mail: joel.lexchin@utoronto.ca

Answer:
This new agreement, which expires in 2021, is a general extension which
applies to all subject matters, including pharmaceuticals. However, it is
without prejudice to the separate extension agreement on pharmaceuticals
which expires in 2016. The pharmaceuticals agreement is currently
unconditional.

What it means is that if the pharmaceuticals agreement runs out in 2016
without a new agreement being signed, then the 2021 agreement takes over,
but with all of the conditions in that agreement now attached to
pharmaceutical as well.

We hope, however, that LDCs will negotiate a much better, unconditional
agreement in 2015 on pharmaceuticals.

Joanna Keenan
Press Officer
Medecins Sans Frontieres - Access Campaign
E: joanna.keenan[at]geneva.msf.org