On 11 July 2018, Knowledge Ecology International delivered the following statement on patents and health at the 28th session of WIPO’s Standing Committee on the Law of Patents (SCP).
Statement of Knowledge Ecology International
Agenda item 7 – Patents and health
As this Committee deliberates on a work program on patents and health, it may be worthwhile revisiting recent discussions at the World Health Organization (WHO) on this topic.
At the Executive Board in January 2018, the Netherlands underscored that “increased transparency on relevant data, such as innovation pipelines, pricing, market power, and patents” was unconditional for achieving SDG 3.8, and noted that “countries like the Netherlands” were considering the use of compulsory licensing to address the high prices of medicines.
At the World Health Assembly in May 2017, Portugal noted:
All regions of the world face, at different levels, insufficient access to medical products. In recent times, the dramatic increase of prices of new and innovative medicines made them unaffordable to large segments of the population also in rich countries, while threatening the sustainability of health care systems. In too many countries, prices of new medicines (to treat Hepatitis C and cancer, for instance) are particularly shocking.
KEI underscores our strong support for the African Group’s timely proposal contained in document SCP/24/4 as a sound basis for the Committee’s work on patents and health. We urge the SCP to schedule a presentation by experts on the legal basis and experience of states in permitting the non-voluntary use of patents on medical inventions as a limitation on the remedies available in Part 3 of TRIPS, including cases of running royalties for infringement of medical devices and diagnostic tests, and the export of those products outside of the WTO 31bis framework.
In relation to the paper submitted by Canada, Switzerland, Brazil, and Argentina, we would suggest that the proposal be expanded to address issues on transparency as they relate to the litigation over patent validity and scope, the economic aspects of drug development and commercialization, including the costs of R&D and the prices and revenues of products, as well as the utilization and gaps in access for new drugs.
The need for greater transparency of R&D outlays is quite important for several reasons. First, the only reason to grant a legal monopoly on a life saving drug is to induce private investments in R&D. If we don’t have reliable data on R&D outlays, including data on each clinical trial used to support the registration of a novel drug, we cannot evaluate the efficacy and efficiency of the patent monopoly as an incentive nor properly design or evaluate alternatives to the monopoly, such as cash market entry rewards, which can be implemented as alternatives to the monopoly, and are consistent with greater and more fair access to medical innovations.
The terms of reference of Canada’s proposed work program on assessing the role of compulsory and voluntary licensing mechanisms and patent pools in facilitating the affordability and availability of medical products and health technologies should provide information about all cases between 2005 to 2017 where non-voluntary use has been allowed as a limitation on remedies, including, for example, recent limitations on remedies for infringement of patents on medical diagnostic tests and medical devices in the United States. KEI has compiled an extensive catalogue of state practice on this, and would be happy to share this research with the Committee. The study should also examine the use and impact of compulsory licensing of medicines for HIV, cancer and heart disease in developing countries between 2001 to 2017. For that purpose we draw attention to a recent study of the use of TRIPS flexibilities published in the Bulletin of the World Health Organization in March 2018.
KEI supports the disclosure of International Nonproprietary Names (INN) in patent applications and / or patents. Such disclosure should be required when a patent application relates to a product with a designated INN or as soon as the INN has been designated by the WHO. The document SCP/28/5 prepared by the secretariat does not identify any significant obstacles for this disclosure requirement. Disclosure of INN in patent applications and patents will help increase transparency of patents related to medical products and is consistent with the current drive towards greater transparency with regard to patent status information as is evidenced by this Committee’s interest in publicly available patent status databases such as MEDSPAL (by the Medicines Patent Pool) and WIPO’s new partnership with the pharmaceutical industry: the Patent Information Initiative for Medicines (Pat-INFORMED).
In closing, KEI would like to draw the Committee’s attention to negotiations at the UN in New York on political declarations for tuberculosis (TB) and for non-communicable disease. It has come to our attention that a certain Member State is hellbent on purging all references to WTO TRIPS flexibilities and to the progressive delinkage of R&D costs from the prices of medical technologies (which is essential to reducing prices without undermining innovation). This is a sad state of affairs and undermines commitments to multilateralism to the detriment of balanced IP systems and the international trade architecture.