E-DRUG: TAC and MSF import generic ARVs into South Africa
--------------------------------------------------------------
[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]
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
Generic AIDS Drugs Offer New Lease on 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 program 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 more than 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
exorbitant 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 generic 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.tac.org.za and www.accessmed-msf.org
--------------------------------
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
---------------------------------------------------------------
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.
[ENDS]
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