terça-feira, março 07, 2006
Carta MSF à Gilead
MSF 02.03.06
March 2, 2006
John C. Martin, PhD
President and Chief Executive Officer
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Sent via facsimile to +1-650-578-9264
Dear Dr. Martin,
I am writing to you to respond to information made available after MSF’s public communication on February 7, 2006 regarding the lack of availability in developing countries of tenofovir disoproxil fumarate (TDF), marketed as Viread, and tenofovir/emtricitabine (TDF/FTC), marketed as Truvada. MSF would like to be able to provide TDF or TDF/FTC to some of its patients, but accessing these drugs in the countries in which MSF operates has proven very difficult and sometimes impossible more than three years after Gilead first announced its Access Program in December 2002.
As you know, MSF has repeatedly outlined our concerns regarding the lack of access to TDF and TDF/FTC in written communication and meetings, in which we have asked Gilead to reduce the price of these drugs to affordable levels, register the drugs in access countries, and provide transparency related to filing for registration. Our public communication on February 7, 2006 reflected the continued lack of access to these drugs in our field projects as well as the lack of information regarding the status of registration filings.
On February 16, 2006, a document (enclosed) dated February 15, 2006, circulated by Ms. Susan Hubbard, Vice President of Investor Relations for Gilead Sciences, which provides updated information on the registration status of TDF and TDF/FTC was forwarded to MSF. According to this document, TDF is now registered in 10 of the 97 countries that are eligible for preferential prices in the Access Program and registration has now been filed in 47 additional countries. However, there are still 40 countries listed that are eligible for preferential prices but where marketing authorization has still not been requested.
Based on this source, TDF/FTC has been registered in one additional Access country (Zambia), registration has been filed in 43 additional countries, but there are 50 countries eligible for reduced prices in which no registration request has been made. The ongoing delay on the part of Gilead to make TDF and TDF/FTC available in developing countries has concrete effects on MSF programs. We do not have ready access to these products for our projects in Cambodia, Ethiopia, Honduras, Indonesia, Laos, Malawi, Myanmar, Nigeria, South Africa, and Tanzania where registration requests are pending. Access to these products is even further away in Angola, Benin, Burkina Faso, Cameroon, Congo-Brazzaville, the Democratic Republic of Congo Guatemala, Guinea, Mozambique, and Zimbabwe where the filing process has not yet begun.
For Access countries in which Gilead has filed for registration: MSF asks that Gilead provide the date when the filing dossiers were completed so that MSF teams and health advocates in these countries can work with their regulatory authorities to overcome delays.
For Access countries in which Gilead has not yet filed for registration: We are concerned that Gilead is relying on Aspen Pharmacare to register these products in the 40-50 countries eligible for reduced prices but where the registration process has not yet begun, per the agreement announced in April 2005. MSF asks that Gilead file immediately instead of waiting for Aspen to complete their product dossiers. More than three years have passed since preferential prices were first announced and further delays directly affect patient care.
For countries not included in Gilead’s Access Program: There are several middle-income countries in which MSF operates HIV/AIDS treatment projects that are not included in Gilead’s Access Program: China, Ecuador, Peru, Thailand, and Ukraine. We know registration is pending in Thailand, but do not know the status in other countries. We ask Gilead to offer equitable prices, file for registration in these and other developing countries not included in Gilead’s Access Program, where Gilead has not already done so, and provide regular updates regarding registration status.
Although Gilead has created a procedure to supply its products directly from California in the absence of registration, this process is extremely burdensome and has caused delays in delivery and risk of stock-outs and treatment interruption in MSF’s project in South Africa, Zimbabwe and Malawi. This supply chain is too complex and not practical. We strongly urge you to develop a more reliable and easy-to-use procedure to distribute these drugs in African countries while registration is pending.
For patients that need TDF because they no longer tolerate other compounds the situation is acute. In order to ensure wide availability of TDF and TDF/FTC in developing countries, we ask that Gilead urgently:
-Provide the date of submission of the dossiers in the countries in which registration is pending in order for MSF teams and health advocates to track the review process and overcome any delays at the country level;
-File for registration in all of the countries eligible for the reduced price;
-Offer equitable prices and file for registration in developing countries not included in Gilead’s Access Program; and
-Work with countries to make TDF and TDF/FTC easily available while registration applications are being considered.
Thank you for your timely response to this request, and I look forward to hearing from you at your earliest convenience.
Sincerely,
Karim Laouabdia,
MD Director Campaign for Access to Essential Medicines
March 2, 2006
John C. Martin, PhD
President and Chief Executive Officer
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Sent via facsimile to +1-650-578-9264
Dear Dr. Martin,
I am writing to you to respond to information made available after MSF’s public communication on February 7, 2006 regarding the lack of availability in developing countries of tenofovir disoproxil fumarate (TDF), marketed as Viread, and tenofovir/emtricitabine (TDF/FTC), marketed as Truvada. MSF would like to be able to provide TDF or TDF/FTC to some of its patients, but accessing these drugs in the countries in which MSF operates has proven very difficult and sometimes impossible more than three years after Gilead first announced its Access Program in December 2002.
As you know, MSF has repeatedly outlined our concerns regarding the lack of access to TDF and TDF/FTC in written communication and meetings, in which we have asked Gilead to reduce the price of these drugs to affordable levels, register the drugs in access countries, and provide transparency related to filing for registration. Our public communication on February 7, 2006 reflected the continued lack of access to these drugs in our field projects as well as the lack of information regarding the status of registration filings.
On February 16, 2006, a document (enclosed) dated February 15, 2006, circulated by Ms. Susan Hubbard, Vice President of Investor Relations for Gilead Sciences, which provides updated information on the registration status of TDF and TDF/FTC was forwarded to MSF. According to this document, TDF is now registered in 10 of the 97 countries that are eligible for preferential prices in the Access Program and registration has now been filed in 47 additional countries. However, there are still 40 countries listed that are eligible for preferential prices but where marketing authorization has still not been requested.
Based on this source, TDF/FTC has been registered in one additional Access country (Zambia), registration has been filed in 43 additional countries, but there are 50 countries eligible for reduced prices in which no registration request has been made. The ongoing delay on the part of Gilead to make TDF and TDF/FTC available in developing countries has concrete effects on MSF programs. We do not have ready access to these products for our projects in Cambodia, Ethiopia, Honduras, Indonesia, Laos, Malawi, Myanmar, Nigeria, South Africa, and Tanzania where registration requests are pending. Access to these products is even further away in Angola, Benin, Burkina Faso, Cameroon, Congo-Brazzaville, the Democratic Republic of Congo Guatemala, Guinea, Mozambique, and Zimbabwe where the filing process has not yet begun.
For Access countries in which Gilead has filed for registration: MSF asks that Gilead provide the date when the filing dossiers were completed so that MSF teams and health advocates in these countries can work with their regulatory authorities to overcome delays.
For Access countries in which Gilead has not yet filed for registration: We are concerned that Gilead is relying on Aspen Pharmacare to register these products in the 40-50 countries eligible for reduced prices but where the registration process has not yet begun, per the agreement announced in April 2005. MSF asks that Gilead file immediately instead of waiting for Aspen to complete their product dossiers. More than three years have passed since preferential prices were first announced and further delays directly affect patient care.
For countries not included in Gilead’s Access Program: There are several middle-income countries in which MSF operates HIV/AIDS treatment projects that are not included in Gilead’s Access Program: China, Ecuador, Peru, Thailand, and Ukraine. We know registration is pending in Thailand, but do not know the status in other countries. We ask Gilead to offer equitable prices, file for registration in these and other developing countries not included in Gilead’s Access Program, where Gilead has not already done so, and provide regular updates regarding registration status.
Although Gilead has created a procedure to supply its products directly from California in the absence of registration, this process is extremely burdensome and has caused delays in delivery and risk of stock-outs and treatment interruption in MSF’s project in South Africa, Zimbabwe and Malawi. This supply chain is too complex and not practical. We strongly urge you to develop a more reliable and easy-to-use procedure to distribute these drugs in African countries while registration is pending.
For patients that need TDF because they no longer tolerate other compounds the situation is acute. In order to ensure wide availability of TDF and TDF/FTC in developing countries, we ask that Gilead urgently:
-Provide the date of submission of the dossiers in the countries in which registration is pending in order for MSF teams and health advocates to track the review process and overcome any delays at the country level;
-File for registration in all of the countries eligible for the reduced price;
-Offer equitable prices and file for registration in developing countries not included in Gilead’s Access Program; and
-Work with countries to make TDF and TDF/FTC easily available while registration applications are being considered.
Thank you for your timely response to this request, and I look forward to hearing from you at your earliest convenience.
Sincerely,
Karim Laouabdia,
MD Director Campaign for Access to Essential Medicines
