Treatment Action Campaign Electronic Newsletter
17 November 2004
Brief Note: ANC Today Attack on TAC and AIDS Law Project
The ANC Today of Friday 5 November 2004 attacked the TAC and the AIDS Law Project for its litigation against the Minister of Health. The article contained many inaccuracies. A TAC response is being prepared. It will be included in a future electronic newletter (soon) alongside the original ANC Today article.
Brief Note: TAC demonstrations for access to information on 4 November
On 4 November, thousands of TAC members marched and demonstrated in six cities around South Africa (Polokwane, Nelspruit, Pretoria, Cape Town, Bisho, Pietermaritzburg) to demand access to information. At the same time, the Pretoria High Court heard the TAC's application for punitive costs against the Minister of Health (see our previousnewsletter for a full explanation of the court case). Judgment has been reserved.
[END OF BRIEF NOTES]
Letter from the AIDS Law Project on behalf of the TAC to MSD calling for more generic licenses for Efavirenz
15 November 2004
Mr Chirfi Guindo
CEO: MSD (Pty) Ltd
Private Bag 3
Halfway House 1685
Per fax: (011) 655-3187
Dear Mr Guindo
ENSURING A SUSTAINABLE SUPPLY OF AFFORDABLE ANTIRETROVIRAL MEDICINES
1.We act on behalf of the Treatment Action Campaign ("the TAC").
2.We refer to previous correspondence between the TAC and the AIDS Law Project ("the ALP") on the one hand and MSD (Pty) Ltd ("MSD") on the other. Much of this correspondence, which dates back to 14 May 2002 and deals with access to MSD’s essential antiretroviral (ARV) medicines efavirenz and indinavir (marketed in South Africa as Stocrin® and Crixivan® respectively), is referred to in a letter from our offices dated 13 February 2004. A copy of that letter is attached hereto marked "A". Copies of the correspondence between our offices since that date are attached hereto marked "B", "C", "D" and "E" respectively.
3.It has come to our client’s attention that MSD is currently unable to satisfy public sector demand for efavirenz. As you know, efavirenz is one of the key ARV drugs used in the treatment of HIV infection and is used by public sector health facilities as part of the first-line ARV treatment regimen. While we acknowledge that many patients can be and in fact are placed on nevirapine-based regimens that exclude the use of efavirenz, we nevertheless recognise that in many cases – such as concomitant treatment for tuberculosis, certain liver conditions and alcohol dependence – the use of nevirapine may lead to serious life-threatening adverse events. In such cases, access to efavirenz is essential.
4.According to information that we have received, MSD has been unable to deliver sufficient stocks of efavirenz to satisfy the October and November 2004 orders placed by the Gauteng Central Medicines Depot in Auckland Park. As a direct result, Chris Hani Baragwanath Hospital has only received partial delivery of its orders. As recently as 8 November 2004, MSD was only able to deliver 300 bottles of 600mg efavirenz capsules, which we have been advised amounts to about 35% of a month’s supply at the hospital’s current dispensing rate and significantly less stock than is outstanding on previous and current orders.
5.This has resulted in extreme caution in the initiation of treatment for new patients. With growing public demand for treatment and lengthy waiting queues, this is something that the public sector can ill afford. It places the lives of many people living with HIV/AIDS at risk.
6.This is not the first time that stock shortages of efavirenz have been brought to the ALP’s and TAC’s attention. Our client and we were advised in January of this year that a shortage of efavirenz 50mg (used in the treatment of HIV infection in children over the age of three years) resulted in at least one patient defaulting on treatment for four days.
7.At the time, the TAC brought to your attention the serious consequences of patients defaulting on their treatment. In particular, our client drew attention to the potential for the development of resistance, most notably in the case of a non-nucleoside reverse transcriptase inhibitor such as efavirenz where resistance is not only limited to the particular drug in question but all other drugs in the same class, such as nevirapine.
8.In his letter dated 19 January 2004, a copy of which is attached hereto marked "F", the chairperson of the TAC explained how this "has the potential to limit severely the future treatment options of children currently using an efavirenz-based regimen", recognising that "the treatment options of children, relative to those of adults with HIV-infection, are already somewhat limited."
9.In the same letter, Mr Zackie Achmat explained as follows:
"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."
10.It has been our client’s view for some time that the most effective and efficient way to ensure a sustainable supply of affordable efavirenz is for MSD to grant multiple non-exclusive voluntary licences on reasonable terms to importers and manufacturers of generic efavirenz products.
11.In fact, our client has consistently called for your company to publicly commit to the grant of such licences. Instead, MSD has indicated in a letter to our offices that it "is open to evaluating further bona fide applications [for voluntary licences], provided that they meet the required standards for quality and sustainability." A copy of that letter, already referred to above as "C", is attached hereto.
12.We record that to date, however, MSD has:
(a) Granted a single "non-exclusive patent license for the manufacture and sale of a generic version of Efavirenz to Thembalami Pharmaceuticals (Pty) Ltd. ("Thembalami"), the joint venture partner of Adcock Ingram, for South Africa and other countries in the Southern African Development Community (SADC)";
(b) Has expressly informed at least one generic manufacturer that it has no intention whatsoever of licensing anyone else at this point because "[i]n view of the forecast numbers … received from the ministry of health in regard to treatment of patients in the provinces, … [MSD does] not believe that more than two suppliers of Stocrin and Crixivan are reasonable"; and
(c) Has informed the generic manufacturer referred to in paragraph 12.b above of its intention "to reconsider multiple suppliers as the patient numbers increase and warrant more capacity in supply of these drugs."
13.However, not only has Thembalami failed to bring any efavirenz products to market, but also all its ARV products have been recalled from the market by parent company Ranbaxy (SA) (Pty) Ltd. In addition, Ranbaxy Laboratories Limited India has voluntarily withdrawn all its ARV products from the World Health Organization (WHO) list of pre-qualified medicines. As you know, WHO pre-qualification means that the product has been found to be acceptable, in principle, for procurement by United Nations agencies.
14.We once again submit that MSD’s failure to meet the demand for a life-saving medicine constitutes the abuse of rights in a patent, being a well-recognised ground for the granting of compulsory licences under section 56 of the Patents Act, 57 of 1978. In addition, the same conduct constitutes abuse of market dominance, as contemplated in section 8 of the Competition Act, 89 of 1998, as does MSD’s refusal to license additional generic drug manufacturers.
15.In our previous correspondence dated 13 February 2004 (already referred to above and attached hereto marked "A"), we once again drew attention to the 9 December 2003 agreements entered into between the complainants (Hazel Tau and others) and GlaxoSmithKline and Boehringer Ingelheim respectively as the basis for the settlement of the excessive pricing complaint lodged before the Competition Commission in September 2002 (case no. 2002Sep226). In terms of these settlement agreements, the two groups of pharmaceutical companies agreed to licence four and three generic pharmaceutical companies respectively to manufacture and/or import generic zidovudine, lamivudine and nevirapine products.
16.We call on MSD to commit to doing the same, or alternatively, to follow the example of Bristol-Myers Squibb and stop enforcing its exclusive rights in ARV medicine patents in sub-Saharan Africa.
We trust that you will satisfactorily respond to this letter by no later than Friday, 26 November 2004.
Head: Law & Treatment Access Unit
cc: Dr N Xundu: Director, HIV/AIDS/STI/TB (HAST) Directorate, Gauteng Department of Health ((011) 355-3297)
Dr GM Ramokgopa: MEC for Health, Gauteng ((011) 838-4143)
Dr H Zokufa: Manager, Pharmaceutical Policy and Planning, National Department of Health ((012) 321-3103)
Mr MBM Mpahlwa: Minister of Trade and Industry ((012) 394-0337)
Dr ME Tshabalala-Msimang: Minister of Health ((012) 325-5526)
[END OF LETTER TO MSD]
World Health Organisation Establishes a Strategic and Technical Advisory Committee on HIV/AIDS:
Zackie Achmat, Milly Katana and Mark Harrington appointed -- TAC Calls on SA Government to Set 3x5 Target
A Strategic and Technical Advisory Committee (STAC) has been appointed for two years by the World Health Organisation to advise its Director-General Dr. Jong-wook Lee on HIV/AIDS policies and programmes at national and international level. The committee has 23 members and includes experts from government, civil society, scientific and clinical communities.
The 7 African members include TAC chairperson, Zackie Achmat (South Africa), Milly Katana (Uganda), Hamida Khattabi (Morroco), Rene Loewenson (Zimbabwe), Ruth N’Duati (Kenya), Eva Ombaka (Tanzania) and Papa Salif Sow (Senegal). The committee. Veteran AIDS activist and person living with HIV/AIDS Mark Harrington is also on the committee. The STAC will be chaired by Professor Michel Kaztchine and its vice-chair is Milly Katana, one of Africa’s leading activists who lives with HIV/AIDS. TAC welcomes the creation of this committee. It must play a central role in bringing urgency to WHO target to treat 3 million people by the end of 2005. This is one of the most ambitious but necessary targets to save lives and to build public health systems. Although we believe that deliberations should be confidential, we expect activists to report-back to the International Treatment Preparedness Coalition, the Pan-African Treatment Access Movement and other bodies of civil society. The first meeting takes place in Geneva from 8-10 November 2005.
The WHO plan for "Scaling up treatment and accelerating prevention" notes that South Africa has 5.3 million people living with HIV/AIDS and estimates that 370 000 people will die of AIDS-related illnesses this year. It also estimates that fewer than 3% of people who need anti-retroviral therapy have access. Angola, Botswana, Burkina Faso, Burundi, Ethiopia, Ghana, Guinea, Kenya, Lesotho, Mozambique, Nigeria, Swaziland, Uganda, Tanzania, Zambia and Zimbabwe have all declared targets to meet the WHO target of treating 3 million people globally by the end of 2005. South Africa has failed to declare its target. TAC calls on the South African government to set treatment targets and timelines. We also call on government to implement the WHO resolution "Scaling up treatment and care within a coordinated and comprehensive response to HIV/AIDS" that the minister of Health committed our country to on 22 May 2004 at the World Health Assembly.
[END OF STATEMENT ON WHO COMMITTEE]