This piece is authored by Rupali Samuel, Analyst, SpicyIP.
WIPO published a report on 11th April 2016 titled “Patent-based Analysis of the World Health Organization’s 2013 Model List of Essential Medicines” authored by Reed F. Beall and Amir Attaran of the University of Ottawa that aims to empirically test the effect of patents on access to medicines. Their conclusion is that only 2% of the medicines on the WHO Essential Medicines List are covered by patents so as to block generic production of those drugs and therefore, there are now “more opportunities to choose new collaborations over conflict (whether in the form of licensing agreements or more creative solutions not yet envisaged) and to avoid repeating past friction between advocates for essential medicines access and advocates for patent protection during the HIV/AIDS crisis”. Understandably, the report has public health advocates up in arms over its wide ranging policy implications and the methodology employed in reaching there. A careful analysis of the report shows that some of the flaws highlighted by these groups are quite serious and render the conclusions highly suspect.
(Both Beall and Attaran, together with Randall Kuhn, have also authored another controversial article, published in March 2015, on the failure of compulsory licensing to result in lower prices of antiretrovirals. Critiques of the findings of, and methodology employed by, Beall, Attaran and Kuhn, can be found here.)
The report takes the 375 drugs on the 18th edition of the WHO Model list of Essential Medicines as a base indication of the drugs vital for realising access to medicines and attempts to identify which of these are covered by patent. It does this by testing which of these feature on lists in earlier studies classifying medicines whose patents had by now exceeded 21 years from the application filing date and for the remaining, the patent status of these drugs disclosed in the United States Food and Drug Administration’s Orange Book (2015) and the Health Canada’s Patent Register (2015) and then additionally filtering out those drugs covered by a patent but with generic competition in those markets. Thus, the threefold criteria they rely on distil out only those drugs that (i) have patents listed in the United States or Canada; (ii) are available only in the originator form in the respective jurisdiction; and (iii) had not yet been determined to be post-patent by a previous study. Based on these criteria it selects 20 drugs from the list as covered by a patent. With the assistance of the INPADOC and Derwent databases and the Merck Index (Royal Society of Chemistry 2015) and two independent reviewers, the study next identifies which of these 20 were patented in developing countries. The final results were cross checked with the pharmaceutical companies producing the drugs.
A number of objections can be taken to this process. First, it fails to capture equivalent patents or adequately correlate secondary patents on drugs (matching secondary patents to drugs is only attempted in the second phase when cross testing the patent status of these drugs in developing countries). Medicines Sans Frontiers (MSF) in their statement responding to this report highlights this as a fatal flaw to the methodology of the report. Secondly, the patent status of the drugs in developing countries are identified only after they test positive for patent in either the US or Canada. The reason for this is not highlighted in the report. It is clearly possible for an originator to file for patent in a jurisdiction after a patent has been granted in another jurisdiction. Therefore, the filtering out of drugs past the 21 year mark in the US or Canada means that those drugs that were filed only later in the developing world could continue to be under patent in those jurisdictions. In fact, the patent terms of even these 20 drugs as described in Table 4 at page 21 of the report, patent expiries across jurisdictions are as far apart as ten years. For example, tenofir, an important HIV drug has its earliest expiry in 2015 and its latest expiry in 2029. Thirdly, the exclusion of drugs with a generic participant equates the presence of a generic manufacturer with access to the drug, which, in the case of generic manufacture under voluntary licenses may not always be true. If negotiated under a strong patent regime, high royalties could force up generic prices. More importantly, voluntary licensing has often excluded important middle income countries such as China leaving a gaping hole in the access to these drugs.
A more fundamental objection to the entire methodology, however, is the reliance solely on patent holding as a test for market exclusivity. The controversy around the TPP has demonstrated the emerging shift to data exclusivity and patent linkage as means to exclude generic entry even without active patents on drugs. Public health advocates like MSF and KEI have also raised objections to the reliance on the WHO list which has been controversial for excluding drugs covered by patent. They have also pointed out that the use of the 2013 (18th edition) list and not the 2015 (19th edition) also means that four important cancer drugs recently added to the list that are central to access debates in the developing world (for example, imatinib which has been the focus of much discussion in India) were not part of the study. KEI has also raised questions of conflict of interest vis-a-vis the authorship of the report and the earlier studies it relies on.
Finally, it is unclear why the authors consider voluntary licensing arrangements as an alternative to compulsory licensing, since the latter captures those circumstances where voluntary arrangements are unable to be concluded and other peculiar public health triggers. For example, Indian law looks at whether the patent holder is meeting the reasonable requirement of the public or if the drug is available at a reasonably affordable price. These provisions, apart from safeguarding the right to health of the public, also set the stage for how patent holders utilise their patents and form the background to negotiations over voluntary licensing. The report overall, while attempting to introduce strong empirical analysis into the access debates, seems to suffer from a lack of broader perspective and loses much of its bite in asking the wrong questions.. or skirting the right ones.