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.
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
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.