[Ip-health] KEI statement on GSK's announcement of policies to expand access to patented medicines.

Danny Edwards dedwards at atmindex.org
Thu Mar 31 06:57:07 PDT 2016

My 2 cents - this was welcome news from GSK.  The public statement and clarity of the approach is particularly notable.

The most interesting development from my point of view is the expanded commitment to engage in licensing within the LMICs for products outside of HIV (I completely agree with KEI that the proof of public health value here will have to be that any licenses agreed ought to be publicly available, and adhere to the same or greater levels of flexibility as the ones we see from the Medicines Patent Pool engagement).  The statement on oncology lays down an interesting challenge to other companies on whether or how they will respond to GSK’s call to collaborate.

The publishing of patent statuses is very welcome, and helpfully confirms (a) the importance and value of companies taking their share of responsibility for clarity in this area (given the ambiguity of getting this data in a confident, clear way from other possible sources)  I hope that GSK publishes complete, useful, accessible, comprehensible patent information: (for eg product patent, process patent, filing date, expiry date - I’m sure other IP-health subscribers can think of other aspects they’d like to see).  Merck KgaA made this type of disclosure for a set of products back in late 2014.

On the patent non-filing/non-enforcement side - its a good, clear public statement - Roche did something similar in the last few years (commitment not to file/enforce in LDCs+LICs + HIV in SSA) and Merck KgaA’s similar action covered all LDCs, all LICs, all LMICs and a handful of UMICs.  

Of course the actual impact of these activities depends on the relevant patented portfolio of the company in question.

Interested to follow and hear others reactions.

On 31 Mar 2016, at 14:30, Zack Struver <zack.struver at keionline.org> wrote:


KEI statement on GSK's announcement of policies to expand access to
patented medicines.

GSK has made a major announcement of new polices to expand access to its
patented medicines. A copy of the press statement is here
In a nutshell, GSK promises to file fewer patents or license patents in low
income countries, lower prices in lower income countries, make its patent
landscape more transparent, and to license patents to its oncology drugs to
the Medicines Patent Pool (MPP), in a number of (but not all) low and
middle income countries. Knowledge Ecology International issued the
following statement today:

The decision by GSK to license patents on cancer drugs to the Medicines
Patent Pool (MPP) is welcome and impressive news. At present, the
disparities in access to cancer drugs are incredibly harsh, and much more
unequal than one sees for HIV and HCV drugs, the two areas where the MPP is
now active.

The details will be important. For both HIV and HCV drugs, the MPP has used
open licenses that are transparent. Companies can sign on to MPP licenses
and still maintain independence from the patent holder on other issues, and
these features are important, and we assume that GSK’s decision to use the
MPP is a decision to embrace these policies.

All of the MPP licenses apply to a limited number of countries, and do not
address all of the important access challenges. For this reason, it has
been important that the MPP licenses have also allowed products
manufactured under an MPP license to be exported to countries outside of
the licensed territory, where there is no patent or where compulsory
licenses have been issued. We also expect the GSK licenses for cancer drugs
to permit exports outside of the territory, where the exports are otherwise
lawful in the importing country.

The GSK decisions on filing and licensing patents on other products in
lower income countries, and the commitments on pricing and transparency,
are all welcome initiatives.

Other companies, such as Roche, Novartis, Bayer, Astellas, and BMS, with
important oncology drugs should begin to engage on expanding access to
their patented medicines, beyond just HIV and HCV drugs.

Sir Andrew Witty has shown exceptional leadership, and we look forward to
the implementation of this ambitious set of initiatives. In our view, even
these welcome measures are not enough, and we continue to press for global
delinkage of R&D costs from drug prices, and open licenses on all products.
But people live and die in both the short and the long term, and the GSK
announcement means more cancer patients will live longer and better lives
in the near term, and that is good news."

Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428
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