E-drug: TAC and MSF import generic ARVs into South Africa
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[the struggle for more affordable Anti-retroviral treatment is
heating up: MSF-South Africa, which used to pay up to USD 5
for triple therapy from big farma, has now bought the same
combination (AZT-3TC-NVP) for USD 1.50 a day, by importing
generic ARVs from Brazil. The NGOs admitted to breaking the
patent law, but they said they were forced to do so in the interest
of the millions of Africans that are otherwise going to die.
With the recent WTO statements of Doha in mind, it will be
interesting to see the response of the drug companies involved
(GSK, Boehringer Ingelheim. Below a copy of the press release
and some supporting docs. WB]
[Apologies if this has been posted before. It is a long and really
important reference - thanks Wilbert for putting the docs together.
BS]
29 January 2002
TAC AND MSF IMPORT GENERIC ANTIRETROVIRALS FROM
BRAZIL IN DEFIANCE OF PATENT ABUSE
Joint Press Release of M�decins Sans Fronti�res (MSF), Treatment
Action
Campaign (TAC), and Oxfam
* Zackie Achmat: (27) 83 467 1152 or (27) (21) 788 5058
* Mark Heywood: (27) (11) 717 8634
JOINT PRESS RELEASE OF EDECINS SANS FRONTIERES (MSF),
TREATMENT ACTION CAMPAIGN (TAC) AND OXFAM
Generic AIDS Drugs Offer New Lease of Life to South Africans
Importation of generics cuts price in half
29 January 2002, Johannesburg - Yesterday, three members of the
Treatment Action Campaign, (TAC) returned to South Africa from Brazil
carrying generic drugs manufactured for use in an AIDS treatment
programme in Khayelitsha. At a press conference today, TAC and MSF
explained that the drugs carried from Brazil were the second shipment
of Brazilian drugs and that as of today 50 people are already taking
the Brazilian medicines in Khayelitsha.
To guarantee the quality of these drugs, an authorisation from the
Medicines Control Council (MCC), the South African drug regulatory
authority, was obtained prior to their use.
"Last week in Brazil we saw what happens when a government decides to
tackle HIV/AIDS. The Brazilians' decision to offer universal access to
antiretroviral therapy even in the poorest areas of the country is
keeping tens of thousands of people alive," said Zackie Achmat of the
Treatment Action Campaign. "Central to the success of Brazil's AIDS
programme is their willingness to do anything necessary to source the
lowest cost quality ARVs. The South African government should pursue
compulsory licensing to ensure that generic antiretrovirals can be
produced and/or imported in South Africa."
At a press conference today, the NGOs said that the court victory of
the South African government against multinational pharmaceutical
companies had opened the door to improved access to affordable
medicines. "The South African government may need international
financial help to provide treatment, but these needs will be
dramatically reduced if the government takes steps to use the most
affordable drugs available on the worldwide market, as the
multinational pharmaceutical companies are still charging high prices
for these drugs," said Dan Mullins of Oxfam.
Despite the national government's refusal to provide antiretroviral
treatment, three clinics run by M�decins Sans Fronti�res (MSF) within
the government primary health care centres offer a comprehensive
package of services to people living with HIV/AIDS, including
antiretroviral therapy. This project is part of an agreement between
MSF and the government of the Western Cape, signed two years ago with
the express intent to test the feasibility of antiretroviral therapy.
These clinics, located in Khayelitsha, a sprawling township of 500,000
people outside Cape Town, were opened in April 2000 and have provided
treatment for opportunistic infections for over 2,300 people living
with HIV/AIDS.
In May 2001, combination antiretroviral therapy was introduced for a
group of people in advanced stages of AIDS. To date, 85 people have
received antiretroviral therapy and 50 of these are receiving
Brazilian medicines. Using generic antiretrovirals offers the
possibility of treating twice the number of people with the same
amount of money.
"I have personally benefited from the MSF antiretroviral programme,
and I have gone to Brazil to bring back generics so that more people
like me can have access to these medicines," said Matthew Damane, a
person living with AIDS who is receiving antiretroviral therapy as
part of the MSF programme in Khayelitsha. "The government should
publicly accept the effectiveness of these medicines and make them
available to people with AIDS in South Africa."
"Our project shows that antiretroviral therapy is feasible in a
resource-poor setting, contrary to those who insist that poor Africans
are not able to successfully take these drugs. Patients who were
critically ill are now returning to their normal lives," said Dr. Eric
Goemaere of MSF South Africa. "We have seen firsthand that these drugs
can be used safely and effectively here in South Africa. As medical
professionals, it is our duty to offer these benefits to as many
patients as possible."
Similar initiatives are springing up elsewhere around the country as
medical staff become increasingly frustrated by the lack of action
from the national government. Nonetheless, the price of medicines
continues to be a critical problem.
MSF has signed agreements with the Brazilian Ministry of Health (MoH)
and Fiocruz, a public research body funded by the Brazilian
government. The former established a cooperative agreement involving
technical collaboration on the response to HIV/AIDS, so that MSF and
the Brazilian MoH can collaborate to improve the delivery of treatment
in resource-poor settings. The agreement with Fiocruz allows MSF to
purchase antiretroviral drugs produced by FarManguinhos, the Brazilian
national pharmaceutical producer, which is part of Fiocruz.
An innovative aspect of this arrangement is that the money MSF pays
will go directly into research and development for AIDS and neglected
diseases such as sleeping sickness, Chagas Disease and malaria (all
diseases for which current treatment options are inadequate).
MSF is currently using the antiretroviral drugs AZT, 3TC,
co-formulated AZT/3TC, and nevirapine produced by FarManguinhos. By
using these drugs the price per patient per day falls from US$3.20 to
US$1.55.
In 1996, in response to pressure from civil society, the Brazilian
government began providing free access to antiretroviral therapy to
people with HIV/AIDS. This policy has allowed more than 100,000 people
to receive antiretroviral therapy and reduced AIDS-related mortality
by more than 50%. Between 1997 and 2000, antiretroviral treatment has
saved the Brazilian government $677 million on hospitalisations
averted and treatment for opportunistic infections averted.
South Africa could launch a similar programme. To do so, the
government needs to have access to the lowest cost medicines, whether
they come from multinational pharmaceutical companies or from generic
producers. This means both taking advantage of offers from
multinational companies and being willing to seek compulsory licenses.
These licenses can be used to produce these drugs locally or import
them and are an important way to stimulate competition, which is a
powerful tool to reduce prices.
Additional background information is available on the websites of MSF
and TAC: www.accessmed-msf.org and www.tac.org.za
---------------------------------------------------
COSATU Statement on the Importation of Generic Antiretrovirals from
Brazil
The Congress of South African Trade Unions (COSATU) and
the Treatment Action Campaign (TAC) have returned from a
visit to Brazil. The delegation included Joyce Pekane, Second
Deputy President of COSATU, Zackie Achmat, Chairperson of
TAC, Nomandla Yako, and Matthew Demane, a person who is
living with AIDS and currently being treated with anti-retroviral
therapy.
The delegates, hosted by M�decins sans Fronti�res (MSF),
looked at Brazilian HIV/AIDS treatment programmes, visited
factories which manufacture generic anti-retroviral medicines and
met government officials and people living with AIDS. The
Brazilian government has formally offered the South African
government help in fighting HIV/AIDS.
On their return the delegates brought back a batch of generic
anti-retroviral medicines for use by MSF in a treatment
programme in Khayelitsha. The Medicines Control Council
(MCC), having studied the safety of these medicines, has given a
Section 21 exemption which allows for them to be imported and
used by MSF.
The equivalent drugs are in fact available in South Africa,
produced by GlaxoSmithKlein (GSK) and Boehringer
Ingelheim. But they cost approximately R1000 per month
compared to the cost of R450 for the medicines being brought
from Brazil.
The importation of these drugs for use under strict conditions by
MSF has been approved by the MCC. We are aware that it
may infringe patent rights. However, we believe that faced by an
emergency caused by AIDS, and in face of overwhelming
support for the government's view that patent rights should not
be used to deny people access to life-saving medicines that this
importation is in line with government and international policy.
COSATU, TAC and MSF stand by their belief that the
government and society as a whole must get anti-retroviral
medicines to the people who need then as quickly and
cheaply as possible and must not let the vested interests of multi-
national pharmaceutical manufacturers to prevent this.
This is why these medicines are being brought in. The MSF
programme in Khayelitsha is already improving the lives of over
80 people. With affordable medicines many more people could
be reached, not only in the Western Cape but throughout SA.
Patrick Craven and Moloto Mothapo
Acting COSATU Spokespersons
011 339 4911 0r 082 821 7456
siphiwe@cosatu.org.za
082-821-7456
339-4911
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Questions and Answers about TAC and MSF Importing Generic Medicines
from Brazil
1.What medicines have been imported from Brazil?
TAC and MSF have imported generic antiretroviral medicines from
Brazil. The scientific names for these medicines are Zidovudine (AZT),
Lamivudine and Nevirapine. For part of the imported batch, AZT and
Lamivudine are
combined together into one capsule.
2.What are these medicines used for?
They stop HIV from reproducing in the human body. This allows the
immune systems of people who have HIV/AIDS to get better (reconstitute).
These medicines have been shown to help people with HIV/AIDS to live longer,
healthier lives.
3.Have TAC and MSF broken the law?
There are patents on these medicines in South Africa. TAC and MSF have
committed an act of defiance. By importing them from Brazil, TAC and MSF
have infringed the patents. The constitution, which is the highest
law in South Africa, protects the rights to life and dignity. By
bringing in these medicines, TAC and MSF believe they are upholding
these rights. Note that patent infringement is a civil matter, not a
criminal one.
4.Why did TAC and MSF do this?
There are patents on these medicines in South Africa. This means that
there is no competition on these drugs in South Africa. They are
therefore much too expensive. By importing these drugs from Brazil in
breach of the country's patent law at much lower prices, TAC and MSF
are challenging both the South African government and the
pharmaceutical industry. The government is being challenged to pursue
voluntary and compulsory licenses (see next question) from the
patent-holding pharmaceutical companies. The pharmaceutical companies
are being challenged to offer non-exclusive voluntary licenses (see
next question) available on their essential
medicines.
5.What are compulsory licenses and voluntary licenses on medicines?
A company that holds a patent on a medicine can allow pharmaceutical
manufacturers to make this medicine. If they do this, they are giving
voluntary licenses to other pharmaceutical manufacturers. If a
pharmaceutical company refuses to give voluntary licenses to other
manufacturers, a court can order that a compulsory license be issued,
giving other manufacturers the opportunity to produce the medicine.
It is compulsory because the patent-holder does not have a choice. It
must
allow companies to manufacture the medicine in competition to it. A court will
only issue a compulsory license if there is a good legal reason to do
so. Furthermore, it is necessary to first ask the pharmaceutical
company to issue voluntary licenses. TAC and MSF want the government
to ask the pharmaceutical companies for voluntary licenses. If they
refuse to adhere to the government request, the government must then
pursue compulsory licenses using the courts.
6.What is meant by a non-exclusive voluntary license?
It is seldom that pharmaceutical companies issue voluntary licenses.
When they occasionally do, they often limit the voluntary licenses to
a few companies (usually only one) of their choice; i.e, they make
the license available on an exclusive basis. A non-exclusive license,
means that any company may manufacture them.
7.Why do TAC and MSF want non-exclusive compulsory and voluntary licenses
on essential medicines?
This will create competition among the drug companies and ensure that
their prices drop. Exclusive licenses are not good enough, because
allowing more manufacturers into the market creates more competition
and therefore lower prices.
8.What are the respective roles of TAC and MSF in this defiance
campaign?
The organisations planned this together. MSF paid for the medicines. TAC
volunteers, Zackie Achmat, Matthew Damane and Nomandla Yako, have brought
the medicines into the country. Both organisations will share any
legal liability that may arise from this action.
9.What role do Cosatu and Oxfam have in this campaign?
Cosatu and Oxfam support what TAC and MSF have done. Furthermore,
Cosatu secretariat member, Joyce Pikane, accompanied the TAC
volunteers on their mission to Brazil.
10.Which Brazilian company manufactured and sold these medicines to MSF?
Farmanguinhos, which is owned and managed by the Brazilian government,
manufactured and sold these medicines to MSF Brazil. MSF Brazil has
donated these drugs to the MSF antiretroviral pilot programme in
Khayelitsha.
11.Are these generic medicines of the same quality as the patented
versions sold in South Africa?
Tests have been conducted on them which show that from a medical
point of view, they are identical in quality and effect to the
patented versions sold in South Africa. Furthermore, the Medicine
Control Council has granted MSF what are known as section 21
exemptions to use these medicines. The section 21 exemptions would
not have been granted if the medicines were not considered to be safe
and effective. No medicine can be used in South Africa (whether
registered or exempted from the
registration procedures) without the MCC's approval. Such approval
is only granted if the MCC is satisfied that the medicines are safe
and effective.
12.President Mbeki says these drugs (generic or patented) are toxic.
What is TAC's response?
Nearly all medicines have side-effects, even paracetamol (which most
people know by the brand-name Panado). However the benefits of
antiretrovirals far outweigh the side-effects. Of course, people on
antiretrovirals must be monitored regularly by their doctor or
clinic. When this is done correctly, antiretrovirals are safe and
effective. In Brazil, these medicines have been responsible for
reducing the rate at
which people with HIV die by 50%. In rich countries in Europe and
North America, the rate at which people with HIV die has been reduced
by over 70%. People who need antiretrovirals and do not have access
to them usually die prematurely.
13.If compulsory licenses are issued on these drugs, how can South
Africans be sure that generic versions will be safe to use?
No drug can be used in South Africa without the Medicine Control Council's
permission. There role is to ensure that medicines are safe and effective.
Any generic medicine has to be registered with the Medicine Control
Council who will check that it is safe and effective.
14.Who holds the patents on AZT, Lamivudine and Nevirapine in South
Africa?
Boehringer Ingelheim holds the patent on Nevirapine. GlaxoSmithKline
holds the patents on AZT and Lamivudine.
15.What are the price differences between the medicines bought in
Brazil and the ones sold here?
GlaxoSmithKline has offered AZT and Lamivudine (in combination) to
the South African government at US$2 per day (at the current exchange
rate this is about R22.80 per day). Farmanguinhos sell it to MSF at
US$0.96 (about R10.94 ) per day. Boehringer Ingelheim sell Nevirapine
for US$1.19 (about R11.63) per day in South Africa. Farmanguinhos
sell it to MSF at US$0.59 (about R6.76) per day.
16.Why are these medicines not patented in Brazil?
Brazil's patent laws only started applying to pharmaceutical products
in 1997. Therefore, all drugs developed before then are not patented
in Brazil. This includes AZT, Lamivudine and Nevirapine. For more on
the situation on Brazil, see TAC's fact sheet on the Brazilian
response to HIV/AIDS.
17.TAC has imported medicines as part of a defiance campaign before. What
is different this time?
TAC continues to import generic fluconazole from Biolab in Thailand
in defiance of Pfizer's patent. This campaign has saved and improved
the lives of about a thousand people. However, fluconazole is a
medicine used to treat opportunistic infections that occur in people
with HIV/AIDS. The antiretrovirals imported from Brazil are used to
control HIV itself so that it is less likely for infected people to
get opportunistic
infections. Eventually, nearly everyone with HIV needs
antiretrovirals to continue living.
18.Why have these three antiretroviral medicines been chosen?
MSF is conducting a pilot treatment programme in Khayelitsha. The
standard first-line regimen for their patients is AZT, Lamivudine and
Nevirapine or AZT, Lamivudine and Efavirenz. By buying the generic
versions from Brazil, MSF can substantially increase the number of
people on this programme
(currently 85 people).
19.DDI and D4T are cheaper than AZT and Lamivudine. Why does MSF not use
these drugs instead?
Firstly, the AZT and Lamivudine from Brazil are cheaper than the
versions of ddI and d4T available in South Africa. Furthermore, for most
people, AZT and Lamivudine are a better option to begin with than ddI and d4T.
20.As with fluconazole, will these medicines be made generally
available to the public through doctors?
NO! Antiretroviral medicines are expensive and require more complex
logistics to administer and monitor than fluconazole. These drugs
are being imported only for use in the MSF programme in Khayelitsha.
Unfortunately, they cannot be offered to anyone not on the programme.
Ultimately, this enormous task must fall upon the state and the
private sector as a whole. It can only happen on a large scale once
the
government adopts a national HIV/AIDS treatment and prevention plan.
21.GlaxoSmithKline has given Aspen Phamacare a voluntary license to
produce AZT and Lamivudine. Why is this not good enough? Why did MSF
and TAC not get the drugs from Aspen?
The license is exclusive and it has draconian conditions attached to
it. Aspen may only sell their drugs to NGOs and the public sector.
TAC and MSF are demanding that non-exclusive voluntary licenses be
made available for sale to both the public and private sectors.
Furthermore, Aspen's drugs are not yet ready and they have indicated
that their price will be higher than Farmanguinhos's price.
22.Boehringer Ingelheim have offered Nevirapine for free. How can the
price possibly get lower than that?
The company has offered Nevirapine for free only for the use of
mother-to-child transmission prevention in the public sector. It is
not offered for free as part of an antiretroviral treatment
programme. TAC has calculated that Boehringer's donation of
Nevirapine amounts to approximately R1.5 million per year (using
Boehringer's price) if a country-wide mother-to-child transmission
prevention programme is
fully implemented. Putting just 355 people with AIDS on Nevirapine for a
year exceeds the donation amount in revenue. The donation is double-edged
and aimed at taking attention off the area where the real costs for South
Africa lie: treating people with HIV/AIDS.
23.The pharmaceutical companies say that compulsory licenses are
property theft and that if they are issued South Africa will be doing what
Mugabe has done in Zimbabwe. What is TAC's response?
Firstly, a compulsory license is something allowed by South African
and international law, after due process. Secondly, when a compulsory
license
is issued, the generic manufacturers have to compensate the
patent-holder. TAC has asked that generic manufacturers pay a 5%
royalty fee to the patent-holders. The analogy with Zimbabwe is
ridiculous. In Zimbabwe, the law has been ignored and perverted. Even
the forcibly evicted farmers in Zimbabwe do not deny that there is a
need for land reform. However, what is wrong in Zimbabwe is the means
that have been used to carry out Mugabe's so-called land reform
programme. While compulsory licenses on medicines will save lives,
Mugabe's actions are endangering lives.
24.Would issuing compulsory licenses put the South African government
in breach of its international obligations?
South Africa is a signatory to the World Trade Organisation Trade
Related Aspects of Intellectual Property Rights (TRIPs) agreement.
This agreement sets out the minimum standards of intellectual
property protection that countries must abide by. This agreement
makes provision for compulsory licenses. Furthermore, in a recent
meeting of the World Trade Organisation's members in Doha, Quatar, it
was agreed that TRIPs should not stand in the way of a country's
health concerns. The South African government can pursue compulsory
licenses without breaching its
international obligations and without scaring off foreign investors
(if the process is managed correctly).
25.What is TAC's position on local production of generic
antiretrovirals?
Local production is essential for a number of reasons. It will (a)
create more competition, (b) insulate, to some extent, the prices of
antiretrovirals against the depreciation of the rand and (c) create
jobs. Both local production and importation of antiretrovirals will
be essential to meet the country's (and the SADC region's) treatment
needs. Antiretrovirals need to be taken for life. It is therefore
crucial
that the supply of these medicines be sustainable. The best way of
guaranteeing this is via competition between producers, including local ones.
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