TAC Electronic Newsletter

29 September 2003

GARPP and TAC Treatment Project Request Voluntary License from Boehringer Ingelheim:
- Refusal will result in compulsory license application
Letter to Boehringer Ingelheim byAIDS Law Project on Behalf of GARPP and TAC Treatment Project
800 Rally for Treatment at Gugulethu - Memo handed over to Western Cape Department of Health and Addressed to National Minister of Health

Generic Antiretroviral Procurement Project (GARPP) and TAC Treatment Project Request Permission to Import Generic Nevirapine

28 September 2003

On Friday September 26th 2003, the Generic Anti-Retroviral Procurement
Project and the TAC Treatment Project asked multinational pharmaceutical
company Boehringer Ingelheim for permission to import generic nevirapine
for use in combination antiretroviral therapy, failing which they will
seek compulsory licenses in court. This new request follows previous
attempts by the Treatment Action Campaign (TAC) and Médecins Sans
Frontières South Africa to obtain voluntary licenses for nevirapine
since 1999 and 2001 respectively.

Nevirapine is used as one of three drugs in the treatment of HIV/AIDS in
adults and children. A single dose of the drug is also used extensively
in poor countries and communities to reduce the risk of mother-to-child
HIV transmission. It is an essential component of triple drug therapy
for pregnant women with HIV/AIDS.

Why the need for licenses?

As patentees and licensees of nevirapine, the Boehringer Ingelheim group
of companies has the exclusive right to sell nevirapine in South Africa,
which it markets as Viramune® and sells at R410.40 for an adult's
monthly supply. A quality generic equivalent, already registered for
use in South Africa by the Medicines Control Council, can be bought for
just over R70.00 per month. In other words, five times as many people
could be treated at the generic price compared to Boehringer's
Ingelheim's price. But without Boehringer Ingelheim's permission, the
Generic Anti-Retroviral Procurement Project and the TAC Treatment
Project cannot access the cheaper generic without exposing themselves to
legal action.

Excessive prices reduce government's ability to pay for medicines in
poor communities and place an undue burden on medical schemes. The
scale of the HIV/AIDS epidemic requires that the most affordable price
be available in both private and public sectors. This can only be
achieved with generic competition.

While the issue of price is paramount, Boehringer Ingelheim's exclusive
right also prevents access to new innovative products that help to make
antiretroviral therapy as simple as taking two pills a day. Many
generic companies have combined nevirapine with two other
antiretrovirals in a single pill that is taken twice daily. Boehringer
Ingelheim cannot produce this combination pill itself because it does
not hold the patent to the other two antiretrovirals. But it can ensure
that it does not stand in the way of people with HIV/AIDS accessing
these products.

What if the request for voluntary licenses is refused?

If Boehringer Ingelheim does not grant the Generic Anti-Retroviral
Procurement Project and the TAC Treatment Project the right to import
generic nevirapine (on its own and as part of combination products), the
projects will apply to the Commissioner of Patents for compulsory
licenses that will entitle them to import generic nevirapine. In terms
of the Patents Act, the Commissioner (a judge of the Pretoria High
Court) can grant such licenses if it is shown that Boehringer Ingelheim
has abused its rights in the nevirapine patent. South African patent
law already recognises that the rights in a patent are being abused by
charging an excessive price that results in limited access.

Who is the Generic Anti-Retroviral Procurement Project?

As a not-for-profit association, the Generic Anti-Retroviral Procurement
Project's main business and object is to improve access to highly active
antiretroviral therapy (HAART) through the promotion of generic ARV
medicines of good quality and at the lowest possible cost for use in
HAART projects in South Africa. To achieve this aim the Generic
Anti-Retroviral Procurement Project intends to import ARVs on behalf of,
and distribute them to, a wide range of community-based not-for-profit
HAART treatment projects that collectively plan to treat approximately
five thousand (5000) people living with HIV/AIDS within the next two
years.

Who is the TAC Treatment Project?

Like the Generic Anti-Retroviral Procurement Project, the TAC Treatment
Project is also a not-for-profit association, with its main business and
object to provide access to HAART for people living with HIV/AIDS. The
TAC Treatment Project aims to provide access to generic ARVs to
individuals (including beneficiaries of medical schemes), as well as
provide counselling, training and support to patients who receive
treatment funded by the TAC Treatment Project.

The TAC Treatment Project envisages that it will provide and fund HAART
for 50 patients within the first phase of the project, that is, by the
end of December 2003. In addition to providing and funding HAART for TAC
members and activists, the TAC Treatment Project will also provide and
fund HAART for persons living with HIV/AIDS who are not members of the
TAC. The TAC Treatment Project aims to provide and fund HAART for at
least one thousand (1000) people across South Africa by the end of
2004. Apart from satisfying certain clinical criteria, such persons
will not, in all likelihood, be able to afford to purchase ARVs
themselves.

For further information, contact:

Generic Anti-Retroviral Procurement Project
Dr Wilbert Bannenberg (Managing Director): +31.497.540-965 or
+31.6.2087-3123

TAC Treatment Project
Vuyiseka Dubula (Chairperson): (021) 364-9514 or
Eduard Grebe (Co-ordinator): (021) 788-3507 or 083.384-0600

AIDS Law Project (legal representatives of the Generic Anti-Retroviral
Procurement Project and the TAC Treatment Project)
Fatima Hassan (Attorney): (021) 422-2186 or 083.279-9962
Jonathan Berger (Researcher): (011) 717-8627 or 083.419-5779

[END OF REPORT ON LICENSE FOR NEVIRAPINE APPLICATION]

Letter from AIDS Law Project to Boehringer Ingelheim on Behalf of GARPP and TAC Treatment Project

26 September 2003

By hand

To:
Boehringer Ingelheim Pharmaceuticals Inc;
Boehringer Ingelheim Pharma KG;
Boehringer Ingelheim International GmbH; and
Ingelheim Pharmaceuticals (Pty) Limited

Care of:
D M Kisch Inc
Building No. 5, Inanda Greens Business Park
54 Wierda Road West,
Wierda Valley SANDTON 2146

Re: REQUEST FOR VOLUNTARY LICENSES FOR NEVIRAPINE UNDER SOUTH AFRICAN
PATENT NO 90/9246

1.We act on behalf of the Generic Anti-Retroviral Procurement Project
and the TAC Treatment Project.

2.Our clients have instructed us to write to you as patentees and
licensees of South African Patent No 90/9246 to request voluntary
licenses on reasonable terms and conditions for the antiretroviral (ARV)
drug nevirapine, which is the subject of South African Patent No 90/9246.

3.This request follows previous unsuccessful attempts by the Treatment
Action Campaign (TAC) and Médecins Sans Frontières South Africa (MSF
South Africa) to obtain voluntary licenses for nevirapine since 1999 and
2001 respectively. MSF South Africa is a founder member of the Generic
Anti-Retroviral Procurement Project.

PART I
4.The Generic Anti-Retroviral Procurement Project is an association
incorporated under section 21 of the Companies Act, No. 61 of 1973, with
registration number 2003/013155/08.

4.1.The Generic Anti-Retroviral Procurement Project's main business and
object is to improve access to highly active antiretroviral therapy
(HAART) through the promotion of generic ARV medicines of good quality
and at the lowest possible cost for use in HAART projects in South Africa.

4.2.To achieve this aim the Generic Anti-Retroviral Procurement Project
intends to import ARVs on behalf of, and distribute them to, a wide
range of community-based not-for-profit HAART treatment projects that
collectively plan to treat approximately five thousand (5000) people
living with HIV/AIDS within the next two years.

4.3.A list of the members of the Generic Anti-Retroviral Procurement
Project is attached hereto marked Annexure 1.

4.4.A list of the names of the duly elected members of the board of
directors of the Generic Anti-Retroviral Procurement Project is attached
hereto marked Annexure 2.

4.5.HAART projects that intend procuring medicines through the Generic
Anti-Retroviral Procurement Project may only do so through formal
membership of the project. At present there are twenty (20) members of
the Generic Anti-Retroviral Procurement Project.

4.6.The Generic Anti-Retroviral Procurement Project has resolved that
members who prescribe ARVs should respect the obligations of being a
member of the Generic Anti-Retroviral Procurement Project in so far as
the standard of quality of care in the use of ARVs is concerned. A copy
of the document that refers to member's obligations is attached hereto
marked Annexure 3.

4.7.In terms of its Memorandum of Association read with its Articles of
Association, the Generic Anti-Retroviral Procurement Project is duly
authorised to act on behalf of its members. Copies of the Memorandum of
Association (and relevant registration documents) and Articles of
Association are attached hereto marked Annexure 4 and Annexure 5
respectively.

4.8.In terms of a resolution taken by the Generic Anti-Retroviral
Procurement Project's board of directors dated 3 August 2003 and signed
on 4 August 2003, it is duly authorised to seek voluntary licenses for
the importation of generic ARVs. A copy of the resolution is attached
hereto marked Annexure 6.

4.9.The Generic Anti-Retroviral Procurement Project has submitted its
application for registration as a pharmacy in terms of relevant
legislation and regulations. The person designated as a pharmacist for
purposes of the registration is Mr Renier Botha, an adult male South
African, with identity number 6403205142086. Mr Botha is duly registered
with the Pharmacy Council of South Africa with registration number 10343.

PART II
5.The TAC Treatment Project is an association incorporated under section
21 of the Companies Act, with registration no. 2003/009927/08.

5.1.The TAC Treatment Project's main business and object is to provide
access to HAART for people living with HIV/AIDS.

5.2.It is a founding member of the Generic Anti-Retroviral Procurement
Project.

5.3.A list of the duly elected directors of the TAC Treatment Project is
attached hereto marked Annexure 7.

5.4.A list of the names of the registered directors of the TAC Treatment
Project is attached hereto marked Annexure 8.

5.5.The TAC Treatment Project aims to provide access to generic ARVs to
individuals (including beneficiaries of medical schemes), as well as
provide counselling, training and support to patients who receive
treatment funded by the TAC Treatment Project. Clinical guidelines
dealing with selection criteria, drug regimens, informed consent,
treatment support strategies, data management, visits and laboratory
monitoring schedules, adverse event management, reporting procedures and
evaluation procedures have been developed by the TAC Treatment Project
for this purpose. A copy of the guidelines is attached hereto marked
Annexure 9.

5.6.The TAC Treatment Project envisages that it will provide and fund
HAART for 50 patients within the first phase of the project, that is, by
the end of December 2003. In addition to providing and funding HAART for
TAC members and activists, the TAC Treatment Project will also provide
and fund HAART for persons living with HIV/AIDS who are not members of
the TAC.

5.7.The TAC Treatment Project aims to provide and fund HAART for at
least one thousand (1000) people across South Africa by the end of
2004. Apart from satisfying certain clinical criteria, such persons
will not, in all likelihood, be able to afford to purchase ARVs
themselves.

5.8.In terms of its Memorandum of Association read with its Articles of
Association, the TAC Treatment Project is duly authorised to act on
behalf of its members. Copies of the Memorandum of Association (and
relevant registration documents) and Articles of Association are
attached hereto marked Annexure 10 and Annexure 11 respectively.

5.9.In terms of a resolution taken by the TAC Treatment Project board of
directors dated and signed on 1 August 2003, it is duly authorised to
seek voluntary licenses for the importation of generic ARVs. A copy of
the resolution is attached hereto marked Annexure 12.

5.10.The TAC Treatment Project has submitted its application for
registration as a pharmacy in terms of relevant legislation and
regulations. The person designated as the responsible pharmacist for
purposes of such registration is Gavin Robert Brown, an adult male South
African, with identity number 6711145709081. As is required by
legislation, Mr Brown is duly registered with the South African Pharmacy
Council with registration number 11526.

PART III
6.The Generic Anti-retroviral Procurement Project and the TAC Treatment
Project have resolved only to procure ARVs that are either registered
for use in South Africa by the Medicines Control Council (MCC) or in
respect of which the MCC has granted authorisation for use in terms of
section 21 of the Medicines and Related Substances Control Act, No.101
of 1965 (the Medicines Act).

7.Our clients have therefore instructed us to request from Boehringer
Ingelheim Pharmaceuticals Inc and Boehringer Ingelheim Pharma KG as
co-patentees of South African patent number 90/9246, with the consent of
Boehringer Ingelheim International GmbH and Ingelheim Pharmaceuticals
(Pty) Limited as licensees under South African Patent No. 90/9246,
non-exclusive voluntary licences to import into South Africa, and to
use, offer to dispose of and dispose of in South Africa, and to export
from South Africa, nevirapine, including but not limited to the
following forms of nevirapine and combination products that include
nevirapine:

7.1.200mg tablets;
7.2.10mg/ml oral solution;
7.3.150mg/30mg/200mg tablets of lamivudine/stavudine/nevirapine;
7.4.150mg/40mg/200mg tablets of lamivudine/stavudine/nevirapine; and
7.5.300mg/150mg/200mg tablets of zidovudine/lamivudine/nevirapine.

8.In the event that voluntary licenses are granted, our clients also
request the right to sub-license to associations and projects that have
the same objectives and aims as them, and who are similarly constituted
as not-for-profit bodies.

9.Our clients therefore propose that the non-exclusive voluntary
licences that they request be granted on the following terms and conditions:

9.1.The right to import generic nevirapine products into South Africa
for the use of, or for offer to dispose of, or for the disposal of,
nevirapine products in South Africa by the Generic Anti-Retroviral
Procurement Project and its current and future members, including the
TAC Treatment Project, for the remainder of the term of patent
protection of South African Patent No. 90/9246.

9.2.The right of the Generic Anti-Retroviral Procurement Project and the
TAC Treatment Project to sub-license the rights licensed to them to
organisations in South Africa with similar aims and objectives and who
are similarly constituted (in South Africa) as not-for-profit bodies.

9.3.The licences shall address the payment of a reasonable royalty to
the patentees. Our clients propose a royalty rate of four (4)% of the
ex-manufacturer price for products containing only nevirapine as the
active ingredient, and a similar royalty for nevirapine contained in
combination products.

9.4.The licences shall also extend to new nevirapine products as and
when these new products become available.

9.5.The rights under the licences shall be transferable by the Generic
Anti-Retroviral Procurement Project and the TAC Treatment Project to a
successor in title to either of the organisations.

9.6.The licences shall extend to the export from South Africa of the
licensed products by the licensees to organisations in other parts of
the developing world with similar aims and objectives.

9.7.Any other terms and conditions that are usually stipulated in
non-exclusive voluntary licences of this type.

10.We look forward to your response by no later than one calendar month
from the date of this letter, failing which our clients have instructed
us to proceed with an application for compulsory licences in terms of
Section 56 of the Patents Act, No. 57 of 1978.

Yours faithfully

Ms Fatima Hassan
Attorney: Law and Treatment Access Unit
AIDS Law Project
(021) 422-2186 (t); (021) 424-0875 (f)
083 279-9962 (cell)
fatima@tac.org.za

[END OF LETTER TO BOEHRINGER INGELHEIM]

800 Rally for Treatment at Gugulethu

On Saturday 27 September 2003, despite pouring rain more than 800 people packed out the Gugulethu Sports Complex in Cape Town to support the roll-out of anti-retroviral therapy for all. The TAC rally was supported by trade unions, faith leaders, the New Women's Movement, the Network Against Violence Against Women. MSF and many other organisations. Congratulations to the Western Cape office for organising this event. Below is the memorandum handed over to an official from the Western Cape Department of Health.

To: National Minister of Health, Dr. Manto Tshabalala-Msimang, Western Cape MEC for Health, Mr. Piet Meyer

Memorandum Delivered at Gugulethu Rally, September 27, 2003

We are Ready for the Treatment Plan

It is with great hope that we are here today. On most of TAC's previous demonstrations, we pleaded for our lives and the lives of millions of our fellow citizens. In the meanwhile we have lost many of our comrades, hundreds in the last few months. We think of Siphiwo Mtolo and Bulelani Taroto both from the Western Cape who died in the last few weeks. But today we have hope because finally government has committed to the development of a treatment plan.

A well-implemented treatment plan will save many lives. It will ensure that many children who would have otherwise been orphaned will live to adulthood with their parents. It will ensure that our workers, including nurses, police officers and teachers continue to contribute to society. It will bring much needed resources to the public health system and it will strengthen prevention efforts. It will also give meaning to the Constitutional rights to life, dignity and health-care.

We say to you today that the TAC and our friends in civil society are ready for the treatment plan. We know that we have a tremendous responsibility to make this plan work. Therefore we offer the following important interventions:

Treatment literacy for communities, unions, businesses, NGOs and nurses, covering the science of HIV, preventing transmission of HIV, nutrition, treatment of opportunistic infections and antiretroviral therapy.
Building and maintaining support groups for people with HIV/AIDS.
Through TAC branches, ensuring that clinics in our areas have access to the resources they need to provide decent health-care, including medicines and counselors.

However, we are also warning you today that your responsibility is immense and that you have a lot to do to earn our trust. We have handed over a submission to the task team developing the operational treatment. We attach a copy to this memorandum. The key demands of this submission are:

Antiretroviral treatment must begin as soon as possible. Dates and targets for rolling out treatment must be published.
500,000 people need treatment now. Let's aim to treat 200,000 people by March 2005.
The selection of sites for rollout must consider factors such as increasing capacity where treatment is available, self-selection by sites for antiretroviral treatment and choosing key rural sites at which to rollout to address inequity between urban and rural areas.
Government must implement measures to make medicines more affordable, such as seeking voluntary licenses and failing this, obtaining compulsory licenses.
Clinics must actively encourage voluntary HIV counselling and testing, CD4 measurements and more effectively treat opportunistic infections.
Communities must be involved in all aspects of treatment rollout.

We urge the task team to deliver their final report to Cabinet by the end of this month.

Furthermore, we say to the National Minister of Health that it is the responsibility of every Cabinet minister to send clear messages to the public on HIV/AIDS and not to indulge in pseudo-science and false hopes. We say that any member of Cabinet who does not know someone who is living with HIV or who has died of AIDS is failing to confront the tragedy of this disease.

Let us work together to make the treatment plan a reality.

Signed on Behalf of the TAC NEC by:

Thembeka Majali (Western Cape Co-ordinator) Nombasa Rune (TAC Volunteer)

[END OF GUGULETHU REPORT]

[END OF NEWSLETTER]