International Coalition to Address Access to Glivec

An international effort is now being organized to address the difficulties of many cancer patients in developing and transitional countries in receiving the Novartis drug glivec (imatinib mesylate or IM). Glivec, considered to be a ground-breaking targeted therapy drug without therapeutic equivalents, was approved in 2001 in the USA to treat a specific form of chronic myelogenous leukemia (CML) and subsequently for gastrointestinal stromal tumors (GIST). It is now being investigated for use against ovarian and prostate cancers, glioblastoma, Kaposi’s sarcoma, and as part of combination chemotherapy regimens for other forms of cancer.

Another unique feature of Glivec is its global price, estimated at $30,000 USD annually for the most typical dosage. It is presumed that while Glivec as a targeted therapy halts disease progression, it is not curative, and patients will need to take it for their entire lives.

When Glivec was first introduced in the USA, Novartis’ CEO Daniel Vasella declared that no patient would be deprived of access to this novel therapy for financial reasons, and announced the creation of Patient Assistance programs (PAPs) both in the USA and internationally.

The reality for patients, however, has been quite different. While there is a global price for Glivec, there are no global criteria to qualify for assistance. The donation program, called GIPAP or Glivec International patient Assistance program, is handled on a country-by-country basis, and many inconsistencies have been reported.(Strom & Fleischer-Black, 2003). In the USA, the annual income ceiling for receiving  free Glivec was set at $43,000 USD (the US median income) for uninsured patients, asset adjusted. ( Tavis, 2001).  Just as one example, in China, at the present time, only those patients who are in the bottom 10% income bracket, earning less than approximately $240 USD per year, qualify for  receiving donation of Glivec. ( GIPAP, 2004)  This is despite the vast differences in the economies of the two countries, as well as the fact that Chinese patients in the lowest income group rarely have access to the oncology specialists and high-tech diagnostic tests needed to detect the unique CML marker targeted by Glivec and necessary to qualify for GIPAP. The principle means of promoting the donation program and the application process are web-based, requiring not only ready Internet access but command of the English language, although  host  country auxiliary organizations are designated. The layers of administration, from Novartis , to its NGO program facilitator, to the local interfaces, all add to its cost and access barriers.

Because of the ongoing difficulties faced by patients in low and medium–income  countries to access this wonder drug (and not withstanding access problems in high-income countries where the price is also exorbitant), advocates in a number of countries are uniting to address the issue. The effort is being spearheaded by activists in Asian countries, who wish to invite their counterparts worldwide to become involved. They intend to study the cost of, and access to Glivec, in  each country and region, and to propose solutions to enable patients to receive this promising therapy, as well as to include access to cancer drugs into broader access to medicines initiatives.

Theoretically countries that belong to the World Trade Organization will be able to  use the provisions that were incorporated though activist efforts into the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, that allow countries to manufacture and import/export of generic forms of on-patent drugs, when necessary for public health reasons, via the mechanism of a  compulsory license.

However, recent events in India that occurred after several generic forms of imatinib mesylate were launched, have created a pall over prospects for genuine health relief under the terms of Para 6 of the Doha Declaration. Novartis promptly took action to shut down generic IM production, after the Indian government granted EMR (Exclusive Marketing Rights) to them for Glivec in 2003. Only Natco, the largest IM generic producer, has been able to continue production and enter into a legal challenge. The case was recently bolstered by the entry of the Cancer Patients Aid Association, a major Indian patient group with a PIL or Public Interest Litigation, on the grounds that the EMR violates the right to health and equality of CML patients. The case has wounds its way through the courts, and is on the docket for the Supreme Court of India.  (A chronology of events, news releases, and other documents can be found on the Imatinib Mesylate page on the Consumer Project on Technology website at

http://www.cptech.org/ip/health/gleevec/

and also  via a subject search in the archives of CP-Tech’s IP-Health listserv at  http://lists.essential.org/pipermail/ip-health/ .)

The case of Glivec and IM generics is a critical public health issue, as it represents a test case of global pricing, as well as a portent for the future of, as medical innovations will  be meaningless if access to them is governed by personal income.

For further information about the access campaign and how to join the effort, please contact Hee Seob Nam  and Hi Jin Yang at patientnetwork@list.jinbo.net