WHO to Colombia Minister of Health: Unaffordable drug prices are a legitimate reason for issuing a compulsory license

For more information, contact:
(U.S.) Andrew Goldman, KEI: andrew.goldman@keionline.org or +1 (202) 332-2670
(Colombia) Andrea Carolina Reyes Rojas, Misión Salud: subdireccion@mision-salud.org
(Colombia) Dr. Francisco Rossi, IFARMA: francisco_rossi@hotmail.com

(More on Colombia here: /colombia)

On May 25, 2016, the World Health Organization (WHO) wrote a letter to Colombia’s Minister of Health, Alejandro Gaviria, responding to a request, on May 23, 2016, for “specific advice with respect to the current procedure of issuing a compulsory license for the cancer treatment imatinib.”

The two page letter (Copy available here), was signed by Dr. Marie-Paule Kieny, the Assistant Director-General for Health Systems and Innovation for the World Health Organization. Dr. Kieny reports directly to the WHO Director-General Margaret Chan.

The letter refers to prior examples of compulsory licenses on medicines, references the authority granted through international agreements, and states plainly that “Unaffordable high prices of essential medicines, including for non-communicable diseases, are a legitimate reason for issuing a compulsory license.”

Kieny notes that “unfortunately” the patent holder of imatinib has “so far” not agreed to negotiate a lower price for imatinib, and expresses “hope such negotiations can take place at the soonest.” But Kieny also makes it clear that the WHO “remain at your disposal to assist you in line with the Mandate conferred to WHO by the Global strategy and plan of action on public health, innovation and intellectual property” to provide “technical support to countries that intend to make use of the flexibilities contained in the WTO TRIPS Agreement as recognized by the Doha Declaration”. Kieny ends the letter by saying “I wish you success in providing access to essential medicines to the people of Colombia.”

The WHO cc’d the letter to four other key officials in the government of Colombia, plus Eduardo Pisani, the Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

Andrew S. Goldman, Counsel for Legal and Policy Affairs, Knowledge Ecology International.

“The WHO advised Colombia that under the WTO agreement on intellectual property rights, Colombia has ‘the freedom to determine the grounds upon which such licenses are granted.’ The letter addresses the most important issue – can countries use compulsory licenses to permit competition when cancer drug prices are too high? The answer is yes.”

James Love, Director, Knowledge Ecology International

“The World Health Organization has a mandate to provide technical assistance countries that want to use compulsory licensing on drug patents. For many countries, this is a new legal procedure, and they face pressure from big companies and from the United States and other governments. The WHO response was timely, clear, and demonstrated the WHO will support countries that use compulsory licensing when drug prices are too high.”