Efavirenz is Patented by World's Largest Pharmaceutical Company, Merck (MSD in South Africa)
At Least One Patient has Defaulted Taking Efavirenz Following Shortage
Demonstration Outside MSD Offices on 2 February to Demand Voluntary Licenses
Pharmaceutical Company MSD has run out of stock of the paediatric version of its antiretroviral, efavirenz (Stocrin 50mg). In response the Treatment Action Campaign (TAC) has sent the letter below to MSD. Furthermore, the TAC will hold a picket outside MSD's South African offices on 2 February 2004 demanding that the company gives non-exclusive voluntary licenses on a 5% royalty fee basis to any generic company that meets objective criteria for quality and manufacturing standards.
MSD is a subsidiary of the world's largest pharmaceutical company, Merck & Co, Inc. based in the United States.
Venue: 117 16th Avenue, Midrand
Date: 2 February 2004
Contact: Pholokgolo Ramothwala: 011 339 8421 or 082 969 8691
Mr. Chirfi Guindo
Chief Executive Officer
MSD (Pty) Ltd
Private Bag 3
Halfway House 1685
19 January 2004
By Registered Mail and Fax: 011 655 3187
Dear Mr. Guindo
RE: RUN ON STOCK OF 50MG EFAVIRENZ
It has come to the attention of the Treatment Action Campaign (TAC) that MSD (Pty) Ltd, holder of the exclusive right to market and distribute efavirenz in South Africa, has run out of stock of the 50mg tablet that is used in the treatment of HIV infection in children over the age of three years. As far as can be ascertained, very few pharmacies in the country are currently holding any stock of 50mg efavirenz.
We have been reliably informed that MSD is unable to guarantee supply of this particular formulation before 28 January 2004. In personal communication with us, MSD said that the supply would restart on Wednesday, 21 January. The logistical nightmare created by the unavailability of stock has, to the best of our knowledge, resulted in at least one patient defaulting on treatment for four days. A serious consequence of stock shortages is that resistance to the particular antiretroviral medicine can develop if patients default.
In the case of a non-nucleoside reverse transcriptase inhibitor such as efavirenz, resistance is not only limited to the particular drug in question but all other drugs in the same class, such as nevirapine. This has the potential to limit severely the future treatment options of children currently using an efavirenz-based regimen. As you are aware, the treatment options of children, relative to those of adults with HIV-infection, are already somewhat limited.
This unacceptable situation points to the need for multiple suppliers of essential medicines. With more providers there will be less likelihood of all companies running out of stock. Competition will also ensure that companies are more careful about monitoring their stock.
In this regard, we draw to your attention that MSD's failure to meet market demand of a life-saving medicine constitutes patent abuse and is a well recognised ground under South African patent law for the granting of compulsory licences so that generic companies can begin developing, producing and distributing 50mg efavirenz.
In December 2003, GlaxoSmithKline and Boehringer Ingelheim entered into agreements with the TAC and others in terms of which they agreed to licence four and three generic pharmaceutical companies respectively to manufacture and/or import generic AZT, lamivudine and nevirapine products. We call on MSD to enter negotiations with the TAC to consider entering a similar agreement which will allow multiple generic manufacturers to enter the market or to follow the example of Bristol-Myers Squibb and stop enforcing the patent on efavirenz in sub-Saharan Africa.
We ask you to respond with a detailed explanation of why MSD ran out of stock and what actions are being taken to find stock for current patients. In this regard, TAC requests a meeting with MSD as soon as is reasonably possible.
We trust that you will respond by no later than Monday, 26 January 2004.
CHAIRPERSON, TREATMENT ACTION CAMPAIGN