28 July 2015
WIPO Standing Committee on the Law of Patents (SCP)
Written Statement of Knowledge Ecology International on Patents and Health
As the Trans-Pacific Partnership (TPP) is currently reported to be in the final stages of negotiation, it is both appropriate and urgent that this Committee is addressing the topic of patents and health.
Bilateral and plurilateral trade agreements such as the TPP, continue to be a cause of great concern over the death inducing effects of TRIPS+ measures, when they are designed to make drugs, vaccines, diagnostic tests and other medical technologies more expensive, often by broadening and extending the intellectual property right monopolies. The harmful impacts will be present in all countries, and in some countries, reach lead to absurd rationing and limits on access to known efficacious treatments for diseases.
According to leaked drafts of the still secret TPP intellectual property chapter, the United States and some other countries are seeking to requirements to expand the scope of patentability, for example, to include more patents on more new uses, formulations and combinations of drugs, making it certain that older drug monopolies will live longer, while patients lives involve more suffering and shorter lives. This is a failure of imagination, a failure of the heart, and a failure of the political process.
The TPP also threatens to ban the effective implementation of liability rules, by create norms for the payment of damages that exceed current national laws and WTO TRIPS norms. We have published an article about this today in IP-Watch, highlighting the practical negative impact on this on the U.S. law to induce transparency of patents on biologic drugs, and the efforts in the US Senate to expand access to hepatitis C virus (HCV) treatments for Veterans.
The US also wants to TPP to mandate linkage between patent status and drug registration, even as this Committee reviews the extensive evidence that low patent quality is a huge problem and the one that requires high levels of expertise to manage, something no country, let alone developing countries, seems to have mastered.
On a more positive note, we support the joint proposal in document SCP/16/7 by the African Group and the Development Agenda Group on a work program on patents and health, in particular, paragraphs 11 and 14:
11. Organize a technical workshop on state practice involving the compulsory licensing of medical technologies, including the application of TRIPS Articles 30, 31 and 44
14. Develop a technical assistance module that explicitly demonstrate the difference between compulsory licenses that are granted under the procedures of Part II of the TRIPS Agreement, concerning patent rights, and those granted under Part III of the Agreement, concerning the remedies for infringement of those rights. These technical assistance programs would explain both approaches, and focus on the flexibilities afforded to both systems, noting that under the structure of the TRIPS Agreement, Article 44 compulsory licenses are not subject to the restrictions that exist for Article 30 and 31 of the Agreement. These targeted technical assistance programs would proceed from the study identified in paragraph 8 above.
In developing modules on state practice, the WIPO secretariat should examine how certain countries, such as the United States, implement limitations and exceptions to remedies associated with the exclusive rights of patents, with a focus on the flexibilities found in Articles 44.1 and 44.2 of the TRIPS, including cases where non-voluntary authorizations to use patents replace injunctions to enforce exclusive rights.
In Brazil’s submission on exceptions and limitations (SCP/14/7) which compliments the proposed work program on patents and health, Brazil called attention to the lack of policy coherence in a world where at one moment countries endorse the use of compulsory licensing to promote access to medicines for all, and in separate fora criticize developing countries for actually considering or issuing such compulsory licenses. If the compulsory licensing of medicines is truly supported, it should not be subject to bilateral and unilateral trade pressures. What role if any can WIPO play in addressing this lack of policy coherence? Perhaps the countries most committed to bilateral and unilateral trade pressures could be asked to elaborate the rationale and criteria they use to punish countries that simply try to carry out the mandate of the Doha Declaration on TRIPS and Public Health, and to explain why they believe such pressures are in fact consistent with the Doha Declaration.
On a final note, I would draw the Committee’s attention to the revised WHO Model List of Essential Medicines which announced the inclusion of 16 cancer drugs including such costly treatments as trastuzumab and imatinib in addition to costly TB (delamanid and bedaquiline) and hepatitis C drugs (including sofosbuvir and daclatasvir). WHO’s policy shift signals a change in thinking about access to essential medicines — WHO has re-defined essentiality based on clinical need. Now, essentiality is not limited by cost or cost-effectiveness considerations, an approach WIPO should consider in its work on patents and health, where WIPO can address the issue of how one promotes access to an essential drug that is too expensive, when controlled as a patent enforced monopoly.