Copyright © Françoise Herrmann
On Dec, 8 2005, an amendment to the WTO TRIPS Agreement (World Trade Organization - Trade-Related Aspects of Intellectual Property Rights) was voted by all of the members of the WTO (World Trade Organization). This amendment called for safeguards and measures to ensure legal pathways for access to generic versions of patented drugs in poorer nations via compulsory licensing agreements. Compulsory licensing occurs when a court orders the production or distribution of patented drugs at specific prices, without the patent holder’s permission. However, for the amendment to come into full force within the TRIPS agreement, a 2/3 majority of the 164 members of the WTO have to ratify the amendment in their own countries.
Recent ratification of the 2005 amendment by Burkina Faso, Nigeria, Liechtenstein, the United Arab Emirates and Viet Nam, finally created the much delayed and needed 2/3 majority. Thus, the amendment to the TRIPS agreement finally became effective on January 23, 2017 -- 12 years after it was voted (WTO News - Jan 23, 2017).
This news is heartening -- even if 12 years is far too long to wait for the victims of such diseases as AIDS, TB, malaria and other sorts of curable afflictions and epidemics.
The amendment to the TRIPS Agreement now includes provisions for the import and export of patented medicine under compulsory licensing agreements to all poor countries with limited or no local production capacities. Compulsory licensing had always been possible under the TRIPS agreement (Part II, Section 5, Article 31), but the distribution of medicine under compulsory licensing could only occur in the local markets of the member states invoking the procedure, where the drugs were being produced. This made it impossible for poor countries with limited or no production facilities to invoke compulsory licensing agreements, and consequently barred their access to needed medicines as well as any legal recourse to obtain access.
Now that the amendment is incorporated in the TRIPS Agreement, such compulsory licensing agreements are secured for poor countries, with limited or no production facilities, in order to facilitate access to medicine via third parties and the routes of imports and exports.
News of this modification of the TRIPS agreement prides itself on putting the interest of public health before the interests of patented medicine. Indeed, this amendment is seen as an alignment with the 19th-century concerns for the risks of patented medicine. Medicine actually only became patentable in the 1960s and 70s, precisely because it was feared that the monopolies created by patents would drive the price of medicine to the point of being prohibitive, and thus create unequal access to health. It turns out that the 19th-century fears of unequal access to essential medicines, and consequently to health, have already largely played out, exactly as anticipated. So, any step that restores a measure of greater fairness in access to medicines is a success – however incomplete.
Incidentally, in the aftermath of the US 9/11 events and the fear of anthrax biological warfare, the United States DHHS (Department of Health and Human Services) negotiated the purchase of a supply of 100 million tablets of Ciprofloxacin antibiotics, at a reduced price of .95 cts per tablet, under compulsory licensing agreement, from the Bayer Corporation (DHHS press release, 2001). This purchase was designed to supplement the nation’s existing emergency reserves of antibiotics. The agreement also included further price cuts in case subsequent 100 million-tablet supplies were needed.
Amendment to the TRIPS Agreement (Dec. 8, 2005)
HHS, Bayer agree to Cipro purchase (Press release)
Cipro compulsory licensing dispute
TRIPS - Trade-related aspects of IP rights
WTO IP rules amended to ease poor countries’ access to affordable medicineshttps://www.wto.org/english/news_e/news17_e/trip_23jan17_e.htm