KEI comment on WIPO report on patents landscape for the WHO essential medicines list

This is a comment on the WIPO- commissioned report on the patent landscape for the WHO essential medicines list, published on April 11th, 2016. The report is titled: Patent-based Analysis of the World Health Organization’s 2013 Model List of Essential Medicines, by Reed F. Beall and Amir Attaran, both at the University of Ottawa, Canada. This is is the third collaboration between WIPO's Thomas (Tom) Bombelles (Head, Global Health, WIPO) and Attaran on the same topic -- the patenting of medicines in developing countries.

In December 2000, WIPO published a report by the industry and USPTO funded International Intellectual Property Institute (IIPI), titled "Patent Protection and Access to HIV/AIDS Pharmaceuticals in Sub-Saharan Africa." The report was prepared by Bruce Lehman, the former head of the USPTO and then CEO of IIPI, as well as Lee Gillespie-White, Venus Griffith, Albena Petrova, and Stetson Sanders of the IIPI staff, and Paul Salmon (then working for WIPO). This paper was subsequently re-written by Amir Attaran and Lee White, and re-published in JAMA on October 17th, 2001, a few weeks before the WTO met in Doha (November 2001) to consider the issue of TRIPS and access to medicines. The title of the JAMA version was "Do patents for antiretroviral drugs constrain access to AIDS treatment in Africa?" [JAMA. 2001 Oct 17;286(15):1886-92.] Merck gave IIPI $25,000 grant for its work on the report. At the time, Tom Bombelles was the Director of International Government Relations at Merck. Attaran was then working as a researcher for Jeff Sachs at Harvard. PhRMA, its member company lobbyists and USTR referred to the paper as the “Harvard report,” and used it to lobby against the Doha Declaration on TRIPS and Public Health, citing Attaran’s conclusions that patents were largely irrelevant to access to drugs for HIV in Africa.

After Attaran wrote the JAMA article, but before it was published, Tom Bombelles presented an August 2001 PhRMA survey on patents in Africa on September 30, 2001, at the American Society of Law, Medicine & Ethics (ASLME) conference on Law and Human Rights, which covered essentially the same points as the JAMA article, and he also presented data on the paucity of patents on the WHO essential drugs list, another favorite talking point for drug companies seeking to deflect criticism of drug patents.

Criticisms of the various Attaran, IIPI, Bombelles/PhRMA papers have covered several topics.

The October 16, 2001 "Comment on the Attaran/Gillespie-White and PhRMA surveys of patents on Antiretroviral drugs in Africa," by Consumer Project on Technology, Essential Action, Oxfam, Treatment Access Campaign, and HealthGap [http://www.cptech.org/ip/health/africa/dopatentsmatterinafrica.html] explained that the most useful drugs (from a medical and manufacturing cost basis) were fairly widely patented in Africa, nearly everything was patented in South Africa, and patents covered the most important products in the countries with most purchasing power in Africa (at a time when the Global Fund did not exist). Because economies of scale were important, extensive patents in South Africa and patents on key drugs like AZT, 3TC and Nevirapine in countries with higher than average (for Africa) incomes were harmful not only for the countries where the patents existed, but because the smaller markets were associated with less efficient manufacturing costs.

The lack of patented drugs on the WHO model list of essential drugs had been for years a standard talking point for pharmaceutical industry lobbyists, designed to persuade people who knew and cared little about access to medicine in developing countries that patents were unimportant.

In 2004, Attaran published "How Do Patents And Economic Policies Affect Access To Essential Medicines In Developing Countries?" in Health Affairs. [Health Aff May 2004 vol. 23 no. 3 155-166]. The Health Affairs article was basically an update of the paper that Bombelles had presented earlier as a PhRMA report, and it was used again, repeatedly, to argue that concerns about drug patents in developing countries were misguided.

On the issue of patents and the WHO model list, the issues were much more basic than the more nuanced debate over the HIV/AIDS drug patent patent landscape. For years, the WHO just excluded patented drugs from its EML, not because patented drugs were medically unimportant -- but because the prices were too high, and they were not “cost effective.”

The lack of patents on the WHO model list was not evidence that poor people would not benefit from patented medicines, it was evidence that patents lead to high prices, and high priced drugs were systematically excluded from the list. In other words, the WHO EML was evidence that patents block access, not that patents were unimportant.

The issue of patented drugs on the EML has been very slowly reformed, first for drugs for HIV/AIDS, and only recently for drugs for cancer, hepatitis C, tuberculosis and other illnesses.

In the current WIPO report on patents on drugs on the 2013 WHO Model List of Essential Medicines, what is lacking is an analysis of the harm that patent-related access barriers have caused.

It is a shame that for years, new cancer drugs had been systematically excluded from the EML. [See: 2011:1. KEI Research Note: Paul Miano. Cancer: Approval, ownership, market structure, and placement on WHO Model Essential Medicines List, for 100 new molecular entities (NMEs) on the NCI alpha list of cancer drugs and vaccines.]

The WIPO report focuses on the 18th edition of the WHO EML, which was issued in 2013. The newer version of the EML is the 19th edition, which was published in May 2015, and it focused on adding several new cancer drugs, including two under patent, trastuzumab and imatinib, as well as new patented drugs for HCV (daclatasvir, sofosbuvir) and TB (bedaquiline, delaminid) (See: http://keionline.org/node/2222). The WHO is now considering a much more ambitious effort to expand the number of patented medicines on the EML, but they still have to deal with the challenges associated with the very high prices for these medicines.

Tom Bombelles is now an international public servant, and spends his time working on issues of poverty. In commissioning his long time collaborator [on this issue] to publish a paper on patents and essential medicines, Bombelles picked someone who knows the topic, but who has also systematically sought to downplay patent-related access barriers, and produce what have often been used as public relations talking points to harm reforms that will benefit poor people. The current report is not as misleading or harmful as earlier papers by Attaran on the same topic, but it also is astonishingly tone deaf to the implications of few patented drugs on the WHO EML, and makes the inaccurate and puzzling comments that health groups are not concerned about the transparency of patent landscapes, particularly given the intensive efforts to address these issues over the past 15 years, all of which the authors ignore.

We hope that WIPO and Tom Bombelles will continue to focus on this issue, but in ways that show more sophistication about the relationship between patents, prices and access, and consider the important reforms to progressively delink R&D costs from drug prices so that in the future the WHO can publish lists of essential medicines that do not systematically exclude drugs that work but are too expensive to be purchased by health systems with limited resources.