Statement of MSF to Eighteenth Session of WIPO Standing Committee on the Law of Patents (SCP)

Speaker: Hafiz Aziz ur Rehman

Thanks Mr Chairman,

I am speaking on behalf of Médecins Sans Frontières International. MSF is an independent medical humanitarian organisation that works in over 65 countries around the world.

MSF reiterates its support to the proposal of the Africa Group and Development Agenda Group. We are however very concerned with the proposal submitted by the United States Government as we consider it is a step backward in the very promising discussions at WIPO on patents and health. The US government proposal seems to be based on several assumptions on the relationship between patents and global health, which does not reflect our experience providing medical care in many developing countries, where we are confronted with a range of access and innovation barriers including those related to patent system. Our field experience shows that accessing affordable quality drugs  can be restricted due to patents, for example in relation to treatments for HIV. This problem is increasing with the full implementation of the WTO TRIPS Agreement in countries with existing and prospective generic production capabilities. It is therefore vital that developing countries make full use of the range of flexibilities as one of the tools that allow such barriers to be overcome in order to ensure continued access to affordable medicines. The US position also contradicts Member States-agreed consensus in the WTO Doha Declaration on TRIPS and Public Health and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.

MSF would highlight three areas to the Committee and its Member States for particular consideration as part of its ongoing work.

First;

The issue of transparency and access to patent related information is critical for us and other treatment providers to make decisions about treatment options and procurement. For example, MSF has an extensive experience of treating people living with HIV/AIDS and we have been reporting continuously through our annual pricing publication, Untangling the Web, that tracking relevant patent related information about a drug and what patents are in force in a particular country is often extremely difficult. There can be multiple patents on specific drugs making it difficult in finding the relevant patents because of lack of uniformity in how patents are described. The patent situation of different drugs can be so complex that the drug procurers like MSF often do not get full information about patent status in the countries where we work. We suggest that WIPO, building on the work it has already done with the Medicines Patent Pool and patent offices to develop a patent database for certain HIV medicines, should consider the development of a database for all medicines and/or should offer on demand assistance to requests from procurers of medicines to identify with relevant patent offices all the active patents in the  country related to specific medicines and make the information public so that others can use it for further  patent searches.

Second;

Yesterday a considerable time was spent discussing different aspects of quality of patents. It is particularly important in the field of medicines that patents are only granted that meet robust patentability criteria. However, a number of developing countries do not undertake substantive patent examination. Without a substantive patent examination system developing countries cannot fully benefit from different flexibilities mentioned in the TRIPS Agreement, like the capacity to define patentability criteria that promotes public health and prevent bogus or evergreeing patents being granted. There is little information on the ways in which developing countries could implement feasible and functional examination systems suitable for their domestic needs and public health priorities. It would be useful for a study to be undertaken on the different costs and structures of examination systems in developing countries.

Third;

The important role of patent opposition system should be noted as an important mechanism to increase patent quality. The opposition system, both pre-grant and post-grant, is crucial to ensure that all information is reviewed and thoroughly scrutinized by national patent offices. In India, for example, the use of opposition system has led to the rejection of patent applications of doubtful quality on vital HIV drugs for example tenofovir, darunavir, and child friendly versions of nevirapine in syrup form, allowing generic companies manufacture, supply and export these AIDS medicines to the rest of the developing world. The incorporation of an opposition system in developing country patent laws has shown to be a key public health safeguard.

Thank you Chair