TAC Electronic Newsletter

19 May 2005

Contents

TAC, AIDS Law Project and Southern African HIV Clinicans Society successfully campaign for Bristol-Myers Squibb (BMS) to reduce the cost of amphotericin B. From 1 July, BMS will sell this medicine for R22.60 excl. VAT per vial.

Today, TAC will lead a march for better health-care in Limpopo Province. The march takes place in Polokwane and starts at 11h00 at Mimosa Park next to SABC. The Department of Health receives the memorandum at 13h00.

TAC tells Minister of Health it will litigate against her to issue a compulsory license for efavirenz, unless she takes action to do so. This follows a number of unanswered attempts to get the Minister to act on this issue. It also follows unsuccessful correspondence and discussions with MSD (patent-holder of efavirenz in South Africa) in which we requested that the company issues voluntary licenses.

Community stories about clinics:

Athlone Park in Kwazulu-Natal needs accreditation to rollout antiretrovirals. Story by Themba Maphumulo.

A river, a lack of ambulances and staff hamper patient care at De Hope Clinic, Limpopo. Story by Joel Ntimbani.

TAC, AIDS Law Project and Southern African HIV Clinicians Society successfully campaign for Bristol-Myers Squibb to reduce the cost of amphotericin B

Life-saving medicine to be sold for less than R30 per vial from 1 July 2005

Amphotericin B is an essential medicine used to treat cryptococcal meningitis, a common and frequently fatal opportunistic infection in people with HIV. The only amphotericin B sold in South Africa is by Bristol-Myers Squibb (BMS). The BMS product is marketed as Fungizone.

Following a series of letters written by the AIDS Law Project (ALP) on behalf of TAC to BMS, BMS has agreed to drop the price of fungizone to R22.60 per vial in both the private and public sectors, effective 1 July 2005. This price excludes VAT (14%) and logistical costs in the private sector (at most 10%). When correspondence began with BMS on 15 February 2005, the private sector price was R192 per vial and the public sector price was R145 per vial. By comparison, the UK government pays R41 per vial. Amphotericin B is cheaper in the United States than it is in South Africa (until 1 July).

The ALP, acting on behalf of TAC and the Southern African HIV Clinicans Society, threatened legal action including filing a complaint with the Competition Commission for excessive pricing if BMS failed to reduce their price.

Currently many public hospitals treat cryptococcal meningitis using only fluconazole. But optimal treatment generally requires a course of amphotericin B for two weeks followed by fluconazole maintenance therapy. The price reduction means there should be no excuse for public facilities not to use amphotericin B after 1 July. It also makes the medicine more affordable for medical schemes and people using their own funds to pay for private medical treatment.

The correspondence between the ALP and BMS will be placed in the Documents section of the TAC website (www.tac.org.za) shortly.

[END OF AMPHOTERICIN B ARTICLE]

March for Better Health-Care in Limpopo

Today, Thursday 19 May 2005, TAC will lead a march in Limpopo for better health-care. Here is the text of the memorandum to be handed over to the Limpopo Provincial Department:

Memorandum to Premier Sello Moloto and MEC for Health and Social Development Seaparo Charles Sekoati

Deliver Health-Care in Limpopo!

Polokwane, 19 May 2005

We come here today to say that the health care system in Limpopo Province is inadequate. The Medical Research Council estimates that in 2000, life-expectancy in our province was a mere 57 years. It is almost definitely much less in 2005 because of the worsening AIDS epidemic. The latest antenatal clinic survey showed that 17.5% of women pregnant women are HIV positive. Many people are dying from AIDS while their families watch hopelessly. Urgent action is needed to address this epidemic which is made worse by a poor health care system.

In the past year TAC has tried every means possible to communicate with the provincial department of health about our concerns. But our efforts have mostly fallen on deaf ears. We held our People's Health Summit on the 13 November 2004 in Polokwane. The department was invited but did not come. In March and August 2004 we had another meeting where the department was also invited, but an apology was sent at the last minute. Countless letters were sent to the MEC and other programme managers in the department. Yet there has never been any effort to engage with TAC except for a thirty minute meeting we had with the HIV/AIDS Manager Mr Ledwaba and the antiretroviral manager Dr Pinini. Following this meeting we received a letter from the department which failed to address any of our concerns.

In November 2004 we picketed outside this department and we promised that we would come back if our concerns were not addressed. Today we are fulfilling that promise.

There are several issues that we wish you to address.

Antiretroviral (ARV) treatment

This province was the last one to start rolling out ARVs it still lags behind the other provinces. Our latest statistics show less than 1 000 people on treatment. Hopsitals like Khensani, Botlokwa, Sheshego and Tintswalo are ready to start treating people, but they remain unaccredited or without medicines. There is no visible political leadership to make sure the programme is a success. We are tired of waiting and say that the following must be implemented:

The number of people on antiretrovirals must be increased from 20 000 by March 2006.

The accreditation process must be sped up. Hospitals that are ready should be able to apply for accreditation and receive it immediately. There are people waiting to go onto treatment in Tintswalo. Some of them are here today.

Hospitals that are already rolling out, such as Polokwane, Mankweng, Mapulaneng and Tshilidzini should be given the resources they need to put more people onto treatment.

Limpopo needs to invest more money in laboratory services so that blood tests are accessible quickly. This will assist the monitoring of patients on treatment.

More health professionals should be trained to prescribe antiretrovirals for treatment, post exposure prophylaxis and mother-to-child transmission prevention.

Where possible the single-dose nevirapine regimen used for mother-to-child transmission should be upgraded to a more effective regimen, as has been done in the Western Cape.

The Provincial AIDS Council must be revived and made to function accountably and effectively.

Government must be more vocal on the need for people to get counselled, tested and treated.

Human Resources

There is a desperate shortage of health care workers in the province and the department is aware of this. The province's strategic plan highlights the need for a human resource plan. Yet still no such plan has been delivered. 34% of health care positions remain unfilled. and these vacancies must be filled. This is unacceptable. We call on government to:

Meet urgently with unions and civil society to develop a provincial human resources plan.

Make it a priority to fill unfilled posts.

Implement better conditions of service for health-care workers by examining salaries, overtime, leave and career development opportunities.

There should be debriefing sessions offered to health-care workers working with HIV patients, because they are exposed to a high degree of unnecessary mortality.

Health-care workers with HIV must be given treatment when required.

Service Delivery

Service in the Limpopo public health system is poor. We call on government to:

Investigate the lack of equipment and supplies in many hospitals and put measures in place to reduce the likelihood of this happening.

Improve communication between tertiary hospitals, primary health care centres and community health centres.

Increase the number of ambulances.

Initiate and complete a tender process for mobile clinics.

Build more clinics in areas such as Hlanganani, which only receive a mobile clinic once a month.

Demonstrate a greater willingness to work with civil society and to accept constructive criticism.

We acknowledge that Limpopo Province is underfunded. This needs to be rectified and we call on the provincial government to put pressure on the national Treasury for more funds. However this does not mean that we do not have the resources to start with programmes and resolve health problems in the province immediately.

Let us work together to build a better health-care system.

[END OF MEMO TO LIMPOPO GOVERNMENT]

Letter to Minister of Health threatening to litigate for a compulsory license on efavirenz

The AIDS Law Project, on behalf of TAC, has written to the Minister of Health threatening to compel her through litigation to issue a compulsory license for efavirenz. This follows a number of unanswered attempts to get the minister to act. It also follows lengthy, but unsatisfactory, correspondence and discussions with MSD, the patent-holder of efavirenz in South Africa.

Here is the letter:

16 May 2005

Dr ME Tshabalala-Msimang

Minister of Health

Private Bag X328

PRETORIA 0001

Per fax: (012) 325-5526 and (021) 465-1575

Dear Dr Tshabalala-Msimang

RE: DRUG PROCUREMENT – OPERATIONAL PLAN FOR COMPREHENSIVE HIV AND AIDS CARE, MANAGEMENT AND TREATMENT FOR SOUTH AFRICA

1.We act on behalf of the Treatment Action Campaign ("the TAC") and refer to our previous letters dated 14 February 2005, 9 March 2005 and 1 April 2005. Copies of these letters, which were faxed to your offices on the above dates, are attached marked "MTM1", "MTM2" and "MTM3" respectively. To date, we have yet to receive a response to any of our letters from either the Department of Health ("the department") or the Ministry of Health ("the Ministry").

2.In our letter dated 9 March 2005, we drew to the department’s and Ministry’s attention that "despite the award of the tender, access to a sustainable supply of affordable ARV medicines still remains under threat." We explained as follows:

"This is largely because of the de facto monopoly held by MSD (Pty) Ltd ("MSD") in respect of efavirenz, and the de jure monopoly held by Abbott Laboratories South Africa (Pty) Ltd ("Abbott") in respect of ritonavir and lopinavir/ritonavir. As you know, these ARV medicines are currently marketed in South Africa as Stocrin®, Norvir® and Kaletra® respectively."

3.In the same letter, we further drew to the department’s and Ministry’s attention that "[w]hile the award of the tender deals with some of the questions raised in our letter dated 14 February 2005, the remaining questions relating to the issue of sustainability of supply still require an answer." The remaining two questions were set out as follows:

"4.1 What steps, if any, has the Department of Health ("the department") taken to ensure that generic pharmaceutical companies are in a position to supply efavirenz, ritonavir and lopinavir/ritonavir to both public and private sectors?

4.2 If the department has been unable to convince MSD and/or Abbott to issue multiple voluntary licences for the local production and/or importation of generic efavirenz, ritonavir and lopinavir products, what steps – if any – has it taken to advise the Minister of Health ("the Minister") to use her power in terms of the Patents Act, 57 of 1978 to issue compulsory licences to generic companies for the public purpose of ensuring access to a sustainable supply of ARV medicines?"

4.Since then, we have had the opportunity to meet with Abbott representatives to discuss our concerns. We are still in discussions with Abbott and are hopeful that our concerns will be adequately addressed in the near future.

5.However, we are less hopeful in respect of MSD. To date, we have yet to receive any substantive response to our letter dated 9 March 2005 in which we informed MSD that the "TAC has instructed us that if MSD fails to accede to its demands by 31 March 2005, it will have no option but to begin taking the necessary legal steps to ensure that such demands are met." A copy of that letter is attached marked "MTM4".

6.In addition, a copy of another letter to MSD dated 15 November 2004 is attached marked "MTM5". This letter makes it plain that MSD has repeatedly been unable to satisfy demand for efavirenz. A copy of the letter was faxed to your offices on 15 November 2004.

7.In our letter to the department (copied to the Ministry and others) dated 9 March 2005, we stated that "[i]n the event that we do not receive a response [‘by no later than Friday, 1 April 2005’] that adequately addresses our concerns, we will have no option but to advise our client to begin taking legal steps to compel the Minister to comply with her constitutional obligations by issuing compulsory licences in terms of section 4 of the Patents Act."

8.As already indicated, we have yet to receive any response from either the department or the Ministry to our letters dated 14 February 2005, 9 March 2005 and 1 April 2005. In addition, MSD has failed to comply with our demands regarding the issuing of multiple voluntary licences for the local production and/or importation of generic efavirenz products. We are therefore left with no option but to request the following:

a.If the department and/or the Ministry have failed to demand that MSD issue multiple licences for the local production and/or importation of generic efavirenz products, or have been unable to convince MSD to issue such licences, what steps, if any, have you taken to exercise your power in terms of section 4 of the Patents Act, 57 of 1978 to issue compulsory licences to generic companies for the public purpose of ensuring access to a sustainable supply of efavirenz?

b.If you have not done so, on what basis do you justify your failure to act? In our view, your failure – in the circumstances – to take such action is in breach of your constitutional obligation to "take reasonable … measures, within … available resources, to achieve the progressive realisation" of the right of access to health care services, as entrenched in section 27 of the Constitution of the Republic of South Africa, 1996.

9.In the event that we do not receive a response that adequately addresses our concerns, we will have no option but to launch application proceedings in the High Court to compel you to issue compulsory licences in terms of section 4 of the Patents Act for the local production and/or importation of generic efavirenz products.

10.Such an application would cite you:

a.In your official capacity as a Minister of State empowered to act in terms of section 4 of the Patents Act, 57 of 1978;

b.As the member of the national executive responsible for developing and implementing national policy with regard to health services;

c.As the political head of the department responsible for the implementation of the Operational Plan on Comprehensive HIV and AIDS Care, Management and Treatment for South Africa; and

d.In your official capacity as a representative of the Government of the Republic of South Africa.

4.Whilst not necessarily seeking mandatory relief against any other party, such as application would also cite:

a.The Minister of Trade and Industry in his official capacity as a Minister of State empowered to act in terms of section 4 of the Patents Act, 57 of 1978 and as the member of the national executive responsible for developing and implementing national policy with regard to intellectual property; and

b.MSD and/or any affiliated company in each company’s capacity as a holder of the exclusive rights in the Stocrin® patent in South Africa.

We look forward to hearing from by no later than Friday, 17 June 2005.

Yours faithfully

 

 

 

 

____________

Fatima Hassan

Attorney: Law & Treatment Access Unit

(021) 467-5673 (tel)

(021) 461-2814 (fax)

083-279-9962 (mobile)

cc: Mr MBM Mpahlwa: Minister of Trade and Industry (per fax: (012) 394-0337 and (021) 465-1291)

Ms NC Madlala-Routledge: Deputy Minister of Health (per fax: (012) 325-5526) and (021) 461-9203)

Mr TD Mseleku: Director-General, Health (per fax: (012) 323-0093)

Mr T Matona: Acting Director-General, Trade & Industry (per fax: (012) 322-0617)

Ms M Hela: Acting Chief Director: Pharmaceutical Policy and Planning, National Department of Health (per fax: (012) 312-3166)

Dr N Xundu: Chief Director: HIV/AIDS & TB Directorate, National Department of Health (per fax: (012) 312-3122)

Mr Chirfi Guindo: CEO, MSD (per fax: (011) 655-3187)

Mr Angelo Kondes: CEO, Abbott (per fax: (011) 858-2002)

[END OF LETTER TO MINISTER OF HEALTH]

 

Community Story: Athlone Park Clinic, Kwazulu-Natal

Athlone Park needs accreditation as an antiretroviral site

by Themba Maphumulo

Athlone park clinic is situated in Umbongintwini suburb on the south coast of Durban. It serves people from Ezimbokodweni and Athlone Park. This clinic takes about 50 people a day, especially on Mondays and Thursdays when it is very busy.

The clinic offers voluntary counselling and testing (VCT), mother-to-child transmission prevention (MTCTP) and antenatal care. On VCT, the lay counsellor, Noxolo Luthuli, tests about twenty people a day and usually about ten of them test positive. Patients are referred to Prince Mshiyeni hospital for CD4 count testing and antiretroviral treatment. They have two registered nurses, one staff nurse, a clerk, one lay counsellor and two cleaners employed by the municipality. There is not much over-crowding as most people use the Kwamakhutha clinic because they have to walk more than twenty kilometres to get here.

The challenge faced by this clinic is that of not being accredited as a rollout site for antiretroviral treatment whereas there is a great need of antiretrovirals for the community. They also need a volunteer to come and do treatment literacy education for the community on Mondays and Thursdays. The community has a good relationship with the health care workers on the primary level because of the good work they do in direct observed treatment service (DOTS) for TB. The nurses have asked the TAC Athlone branch to help them with education on HIV/AIDS and antiretroviral treatment (ARVs).

[END OF STORY ON ATHLONE PARK CLINIC]

Community Story: De Hope Clinic, Limpopo Province

A river, too few staff and a lack of ambulances hamper patient care

by Joel Ntimbani

De Hope is a disadvantaged area in Limpopo Province. Goods are available from tuck shops and there is no transport. The town clinic covers six villages: Nhanganani, Njhakanjhaka, Doli, Matsele, Nkunzana and De Hope. Some patients have to travel more than three kilometres to the clinic and on some parts of the road you have to take off your shoes to cross the river.

The clinic does not have a telephone and there is a shortage of staff. Staff use their mobile phones for emergencies to communicate with the doctors at Elim Hospital. There is only one nurse for voluntary counselling and testing. When she is upset she does not come to work, therefore no VCT is done until she comes back. If there is a patient that is in a critical condition they have to wait for the ambulance and it takes time to come because it travels for more than 70 kilometres to the clinic.

Mr. Shikwambani (the senior professional nurse) uses his Toyota conquest car to transport patients to Elim hospital. It is a risk because if a patient dies in his car he could be held accountable. But what choice does he have?

[END OF DE HOPE CLINIC STORY]