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Friends of the Court: Questions and Answers
Important victories in the fight for access to treatment have occurred in
the last week. The Treatment Action Campaign (TAC) was admitted as a
friend of the court (amicus curiae) on 6 March in the much publicised case
between multinational pharmaceutical companies and the South African
Government. In addition, the international day of action called by TAC for
5 March was a resounding success. Around the world people mobilised
demanding that the drug companies withdraw their legal action. The media
gave full coverage and the court case captured headlines in most major
newspapers and news broadcasts. Around the world, people hold the
multinational pharmaceutical industry responsible for a large share of the
blame for millions of unnecessary deaths. As a result of this pressure,
drug company, Merck, announced a substantial drop in the price of its two
anti-retroviral medicines. Furthermore, the Pfizer donation to the South
African government, with all the problems accompanying it, has finally
come through. This was a direct result of activist pressure.
We have put together a glossary and a list of questions and answers
regarding recent events.
Glossary
Trade Related Aspects of Intellectual Property Rights (TRIPS)
Voluntary License
Compulsory License
Friend of the Court
Parallel Import
This is when a patented medicine is bought from another country,
usually at a lower price from the same producer. This is possible because
drug companies
sell their medicines at different prices in different countries.
Note that a parallel import does not refer to buying a generic
version of a medicine, but to a lower-priced patented medicine.
Patents Act
Question and Answers
Medicines and Related Substances Control Amendment Act No 90 of 1997, or
just the Medicines Act for short.
The act introduces three important provisions.
Yes, they establish a legal framework to reduce medicine costs, not only
during a crisis, but on a long-term basis.
The generic substitution provision will curb a practice that enriches
brand-name producers and dispensers, at the patient's expense. A common
example that most people will identify with is Panado. Few people are
aware that generic versions of paracetamol are sold for 25% (or less) of
the price of Panado. The same applies to cotrimoxazole, an essential
medicine for preventing and treating opportunistic infections in people
with HIV. Most pharmacists sell patients the brand-name version of
cotrimoxazole, called bactrim. However, there are cheaper, generic
versions available such as Purbac.
There are provisions for compulsory licenses in the Patents Act of 1978.
The government should immediately request voluntary licenses from the
patent holders of opportunistic infection and anti-retroviral medicines.
This is the first step towards obtaining compulsory licenses.
The pharmaceutical companies have enormous resources. It is by no means a
formality that the government will win. By joining the court case, TAC has
presented argument against the drug companies that will show that drug
company profiteering is a major obstacle to access. TAC brings to the
court a perspective the government cannot, i.e. the testimony of ordinary
South Africans regarding the cost of medicines, with particular emphasis
on the HIV/AIDS epidemic. The government agreed to let TAC join because
together there is a greater chance of beating the pharmaceutical
companies. Furthermore, TAC's testimony has exposed the disgraceful
practices of the pharmaceutical companies at a legal level. The drug
companies are now on the defensive. It will be difficult for them to
continue the court case without divulging information that they are
usually reluctant to give out, i.e. their pricing data and practices.
The postponement is an indulgence that the judge has allowed the drug
companies. TAC warned of its intentions to join the case on 26 January.
The drug companies have had since 16 February to respond to TAC's
arguments. Arguing that TAC’s entry into the case delays the outcome of
the case and, therefore, access to medicine, is akin to the logic of
stating that the drug companies should have been presented with easier
arguments to counter, so that the case could terminate quicker.
Here is a summary of the advantages of TAC joining the case:
The pharmaceutical companies have enormous resources. They can hire the
best lawyers and spend huge amounts of money slowing down the judicial
process. There is no guarantee that the court case will be won by the
state.
TAC is an independent social movement. We oppose the government when
necessary and we support it when necessary. Our objective is the
provision of affordable and good quality medicines for people with
HIV/AIDS. Many of the government's policies, actions and inaction towards
tackling the HIV/AIDS epidemic have been disgraceful. We have -- and will
continue -- to criticise the government for this. However, the Medicines
Act is an important law that will establish a legal framework for bringing
down the prices of medicines. TAC, therefore, will support the government
in trying to get it enacted.
Yes. Under the Apartheid government, the courts, aided by racist
legislation, frustrated justice. Even then, we used the courts to expose
inequality, torture and systemic violence. The new constitution, however,
has made the courts a place where justice and equal rights can be
enforced. This is not automatic but the current legal system is
infinitely more advantageous to poor people. The fight for affordable
treatment has to be conducted both through mass mobilisation and in the
court rooms.
The WTO TRIPS agreement sets a minimum standard that laws within member
countries must follow. South African law is considered TRIPS-plus. This
means that it gives stronger protection to intellectual property rights
than TRIPS demands. The pharmaceutical companies are claiming that the
Medicines Act is not TRIPS compliant. TAC, the South African, Dutch and
German governments, the WHO, the ICFTU, the AFLCIO and many others firmly
believe that it is. A law can be disallowed if it is found that it is not
compliant with South Africa's international treaty agreements or the
Constitution.
TRIPS is a notoriously complicated, ambiguous legal document. It is a
poorly drafted compromise of various interests, but mainly those of big
business. There is clearly a need, especially by developing countries, to
push for TRIPS and the WTO to be reformed. Currently it is too favourable
to big business at the expense of consumers and start-up businesses,
particularly in poor countries. However, we believe that the needs for
people with HIV/AIDS can probably be met within the current agreement,
albeit not without enormous legal costs and wrangling.
No. The HIV/AIDS epidemic threatens South Africa's social and economic
fabric. South African Business, for ethical reasons, but also because it
is in their interests should support the Medicines Act. Furthermore, the
strengthening of the local generic pharmaceutical industry would also
benefit the economy. Nevertheless, big business has been shamefully
silent. South Africa's biggest institutions, holding companies, mining
houses and life insurance firms, as well as medical aids, have a duty to
openly support the government and to condemn the Pharmaceutical
Manufacturers Association. SACOB are usually quick to criticise government
when they perceive the slightest threat to their members. Their silence on
this critical issue is unacceptable. In contrast, the unions, Cosatu,
Nactu and Fedusa, have made a firm commitment to supporting the government
in the court case.
The US government until recently supported the pharmaceutical industry.
South Africa was placed on the US 301 Trade Watch List. Trade sanctions
were threatened and AID was suspended. As a result of activist pressure,
the US government backed down. Nevertheless it is critical for activists
to put more pressure on the US government and to demand that the
pharmaceutical companies withdraw their court action. The same applies to
European governments. The German and Dutch governments are to be commended
for openly supporting the South African government in the court case.
Shortly after the court case began the WHO issued a statement of support
for the South African government. The next day they retracted their
support. If the WHO is truly committed to improving health-care they
should not be taking a neutral stand on this issue. TAC calls on the WHO
to openly support the South African government in the court case.
Yes. The court case has highlighted the disparate situation between
treatment access in rich countries and poor countries. The international
day of action highlighted the need for countries like Brazil, India, South
Africa, Philippines and Thailand to form a strategic alliance with the
power to reform TRIPS and other international legal agreements that are
heavily weighted in favour of the United States and Western Europe.
Furthermore, the development of a strong generic pharmaceutical industry
throughout these countries will increase the chances of providing
affordable treatment to other poor countries.
TAC does not stand against patents. We are against the abuse of patents.
When millions of lives are threatened because pharmaceutical companies
charge exorbitant prices on their medicines, then patents are being
abused. Clearly there is a need for patent law, in particular TRIPS, to be
reformed.
The pharmaceutical industries often accuse activists of ignoring other
barriers to treatment. There are many, including poverty, lack of
government will -- throughout the third-world, with a few notable
exceptions -- to tackle the epidemic, lack of government finance
throughout the third-world, poor health-care infrastructure in many parts
of South Africa and throughout Africa, social stigma and ignorance
associated with the disease, poor adherence by patients to drug regimens
(throughout the world, in rich countries as well as poor) and lack of
skilled medical personnel. However, the central barrier is affordability
of medicines and testing procedures. TAC and its allies have been and
remain firmly committed to combating all of these problems.
It is true that the cost of researching and developing new drugs is very
high. However, the following points should be considered:
Generic production of essential HIV/AIDS medicines is the only way to
ensure a sustainable supply of affordable medicines in South Africa and
many other developing countries. TAC will campaign for a research and
development tax of 1% on all generics sold in South Africa.
You can ask the company or institution you work for to issue a statement
of support for the Medicines Act. Join an organisation campaigning for
affordable access to health-care in your area. Join TAC and make
donations to our organisation.
This is a World Trade Organisation (WTO) agreement to
which South Africa is a signatory. It defines the minimum
standards to which intellectual property law of the member
countries of the WTO must conform.
This is where a patent holding
drug company gives a manufacturer a license to
produce the generic version of the patented medicine.
This hardly ever happens.
This is an order by a court or an administrative body
to one or more manufacturers to produce and distribute a generic
version of a patented medicine. It is compulsory
because it takes place without the permission
of the patent holder.
TAC is a friend of the court in the case between the government
and the pharmaceutical companies. This means TAC may submit
evidence and argument before the court. Although TAC takes an
independent position, in this case we support the legislation and the
government’s desire to make all medicines affordable.
This is the South African law relating to patents. It was passed
in 1978 and amended in 1997 to make it TRIPS compliant.