[Ip-health] MSF response to WIPO report on WHO EML

Danny Edwards dedwards at atmindex.org
Tue Apr 12 07:40:20 PDT 2016


While I agree it would be good to update the study using the most recent EML (and associated patented oncology + hep C meds - and WHO had the patent landscape for the hep C drugs)  I think its important to emphasise the fact the paper makes an important call for comprehensive, clear patent transparency.  

My opinion is that the more responsibility companies take for publicly disclosing this information (clearly, regularly updated, and with the right level of detail) then the greater clarity and surety manufacturers and procurement agencies will have. 
  
On 12 Apr 2016, at 15:35, Joanna Keenan <joanna.l.keenan at gmail.com> wrote:

*MSF response to WIPO report **on WHO EML *


*http://www.msfaccess.org/about-us/media-room/press-releases/msf-response-wipo-report-who-eml
<http://www.msfaccess.org/about-us/media-room/press-releases/msf-response-wipo-report-who-eml>*



WIPO has published a study by Amir Attaran and Reed Beall on “Patent-based
Analysis of the World Health Organization’s 2013 Model List of Essential
Medicines”. This study is now available on WIPO’s website.



*Here is the link to the report: *

*http://www.wipo.int/edocs/mdocs/mdocs/en/wipo_gc_ip_ge_16/wipo_gc_ip_ge_16_www_334437.pdf*
<http://www.wipo.int/edocs/mdocs/mdocs/en/wipo_gc_ip_ge_16/wipo_gc_ip_ge_16_www_334437.pdf>



Médecins Sans Frontières responds to the report with the following
statement:



“We find WIPO’s report to be fundamentally flawed in terms of its
methodology, data and therefore its recommendations. The study is based on
an old version of WHO’s Essential Medicines List (EML) from 2013, when
there was more reluctance to include patented medicines on the list because
of their high price – in fact, today there are far more medicines that are
on the most recent EML that are indeed patented, such as bedaquiline and
linezolid, and patents are a well-known barrier to people’s access to
medicines. There is also a fundamental problem with the mandate — or lack
of mandate — under which WIPO has commissioned this study and we wonder
about the need to reconsider the relevance and future cooperation between
WIPO and WHO on the relationship between intellectual property and public
health.



“We find WIPO’s approach to data collection and analysis of patents on EML
medicines in the report to be flawed. WIPO’s report uses patent-holding
pharmaceutical companies’ sources and listings as the gold standard, and
ignores a number of up-to-date and credible public data sources and
publications.



“It should be noted that the report’s publication is taking place on the
margins of WIPO's Committee on Development and Intellectual Property
(CDIP). WIPO should redirect its resources to support countries in the full
implementation and effective use of TRIPS flexibilities to increase
people’s access to medicines.”



                            --- Yuanqiong Hu, Legal and Policy Advisor,
MSF Access Campaign.





WIPO’s report disregarded a number of important publications, advocacy
efforts and normative discussions initiated and supported by public health
communities on the issue of patent transparency for more than a decade, and
ignored the ongoing proposal of introducing mandatory disclosure of
International Non-proprietary Names (INN) of medicines in patent
applications as a critical regulatory measure to improve patent
transparency.



In 2003, Medecins Sans Frontieres (MSF) published the first database on
patents on HIV medications. The document can still be consulted here:
http://apps.who.int/medicinedocs/en/d/Js4913e/



MSF Access Campaign has, for almost two decades, compiled patent status
data on some of the most critical antibiotics, antiretroviral medicines
(ARVs) and now direct-acting antivirals (DAAs) for hepatitis C treatment in
the EML. The Access Campaign shares and publishes the information in a
simplified and accessible form as and when the critical need arises with
governments, agencies, WHO and civil society.  Many public health agencies
and organisations such as WHO, Medicines Patent Pool, UNITAID, and Open
Society Initiative have also published patent status databases on key HIV,
TB and HCV medicines.



WIPO’s report not only relies on old data and ignores a number of more
recent and reliable publicly-available sources and publications, but also
has a flawed methodology leading to inaccurate conclusions and
recommendations that appear targeted at undermining the importance of
government-driven strategies to increase access to affordable medicines.



The report also fails in simplifying the data in one very key aspect – it
does not allow governments and other stakeholders to check the status of
equivalent patent applications in different jurisdictions.



Importantly, some of the patent status of key ARVs are confusingly
presented. Firstly, there is no analysis on the strength of the patent –
i.e. claims covering the compound or secondary patent claims like
composition, fixed-dose combinations (FDCs) or process that can be overcome
with patent challenges and reverse engineering. Secondly, the database is
misleading as, even where patent challenges leading to rejections in India
and Brazil have provided freedom to operate for generics for essential ARVs
such as tenofovir, the status is shown as ‘active’ in the report.



The report’s findings overwhelmingly prefer voluntary measures for
licensing intellectual property, without addressing the burning issue of
upper-middle-income countries that are especially excluded from most
voluntary licensing measures and are facing increasing pressure to grant
unmerited patents on new EML medicines. Its recommendations also undermine
the important role of public agencies and compulsory measures that can be
used to increase access to medicines listed in the EML.




Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: @joanna_keenan

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