SCP24: KEI statement on Patents and Health
29 June 2016
World Intellectual Property Organization (WIPO)
Standing Committee on the Law of Patents (24th session)
Statement of Knowledge Ecology International: Patents and Health
Since the African Group and Development Agenda Group tabled their proposal on a work program on patents and health in May 2011, much has happened. Ebola and Zika have made a resurgence, and governments and health systems all over the world are struggling to cope with the high cost of medicines for cancer, hepatitis C, HIV and rare diseases, as well as the challenge of growing antimicrobial resistance.
For example, on October 1st, 2015, the Coalition for Affordable T-DM1, a group of cancer patients, doctors, and access to medicines advocates, sent a letter to the UK Secretary of State for Health, Jeremy Hunt, requesting the Government of the United Kingdom of Great Britain and Northern Ireland to authorize the manufacture or importation of generic versions of the expensive breast cancer treatment T-DM1.
T-DM1 is used to treat late-stage breast cancer patients who test positive for a protein that causes an aggressive form of breast cancer. Roche holds the patents on T-DM1, and charges extraordinarily high prices. A year of treatment for the average patient costs £102,405, roughly 3.9 times the UK’s income per capita in 2014. [£26,350]
On 8 August 2014, the National Institute for Health and Care Excellence (NICE) decided that T-DM1 should not be made available on the National Health Service (NHS), citing its extraordinarily high cost. NHS patients in England continued to get access to T-DM1 through the Cancer Drug Fund (CDF). The Cancer Drug Fund, however, does not extend to patients living in Northern Ireland, Scotland and Wales, demonstrating the disparity in access to high-cost medicines that exists even within one nation.
Turning now to Colombia, in November 2014, civil society groups in Colombia petitioned the Colombian government to issue a compulsory license on the expensive anti-leukemia medicine, imatinib (marketed as Gleevec by the Swiss company, Novartis). The process for a compulsory license is specified in Colombian law, and the right is preserved through numerous well-known international trade agreements, including the TRIPS Agreement, the Doha Declaration on the TRIPS Agreement and Public Health, and the U.S.-Colombia Free Trade Agreement. In spite of this, there has been well-documented pressure on the Colombian government not to use TRIPS flexibilities by the Swiss government, the pharmaceutical industry, the USTR, the United States Senate Finance Committee, and the United States Chamber of Commerce. The Minister of Health recently did take the commendable step of issuing a public interest declaration-a prerequisite under Colombian law before a compulsory license may be issued.
In terms of the Committee’s work program on patents and health, we urge the WIPO SCP to commission a framework study by leading independent experts to examine the implications of international trade agreements on access to medicines including norms on the evergreening of patents, mandatory patent extension, sui generis exclusivity, damages and the investor state dispute system (ISDS).
The study should examine the impact of patent monopolies on the prices of, inter alia, hepatitis C medicines and cancer medicines.
The study should also examine limitations and exceptions to remedies for infringement contained in Part III of the TRIPS Agreement, the very area that is facing new challenges from the new norms on remedies for infringement included in the TPP.
If the patent system is going to survive and thrive, it will have to be seen as an instrument to benefit society, and not as a weapon of mass destruction. Reforms that moderate the abuses of the patent system would protect the patent system’s legitimacy and its role in promoting social welfare.