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.