Questions and Answers about TAC and MSF Importing Generic Medicines from
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,
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
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
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
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
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
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.