[e-drug] Boehringer blocks access to AIDS syrup for children

E-DRUG: Boehringer blocks access to AIDS syrup for children
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Dear E-druggers,

Nevirapine syrup is vital for the treatment of HIV-infected children. The
German manufacturer, Boehringer Ingelheim, had agreed on not interfering
with nevirapine production for poor countries. However, words and deeds are
poles apart. The company is applying for a patent for the vital children's
medicine in India. Since India is the major supplier of low-priced AIDS
medicines, many poor countries are facing the threat of price increases.
BUKO Pharma-Campaign, a German non-profit health organization and member of
Health Action International puts pressure on the company.

"We always act for the good of our patients" - that is what the
representative of Boehringer Ingelheim underlined in a discussion with BUKO
Pharma-Campaign, on the occasion of the World Aids Conference in Toronto in
2006. The company assured BUKO Pharma-Campaign in writing that they had not
submitted a patent application for the vital AIDS syrup nevirapine in India:
"As far as nevirapine (VIRAMUNE® tablets and suspension) is concerned, no
patent has been applied for in India at any time, nor is it planned to do
so".(1) It was only after Indian patent lawyers forwarded the patent
application to us(2) that the company admitted to having submitted the
application: "However, patent protection for VIRAMUNE® suspension [...] was
applied for in India in 1998". Nevirapine syrup is produced at low cost by
generic companies and exported to many poor countries. It costs only a
quarter of the price Boehringer charges for its original preparation. The
South African company Aspen produces nevirapine syrup under a license of
Boehringer. However, the children's medicine produced by Aspen still comes
twice as expensive as the Indian product, which contains the same active
substance. It should be mentioned that the production license for Aspen was
only obtained thanks to the high pressure applied by the South African
authorities and the public - even if Boehringer Ingelheim likes to boast of
its generous handling of such licenses.

Camouflage

Boehringer insists that only a patent could guarantee the quality of a drug
and prevent the export of the inexpensive Indian generic preparation to
Europe.(3) These arguments are sheer fabrication. The export of such drugs
to Europe is illegal and no case of such illegal export has become known to
date. The quality of drugs is assured by independent control bodies like
registration authorities and the World Health Organization (WHO) rather than
by patents. While the WHO has repeatedly confirmed the high quality of
low-priced Indian generics, Boehringer seems to aim at a public discrediting
of the quality of the Indian generics to secure a higher profit for
themselves.

Threats in Kenya

Boehringer Ingelheim does not only play a double game in India. The company
threatened Kenyan drug retailers and pharmacists with legal measures in case
they continued importing far less expensive Indian products.(4) Boehringer
point out that nevirapine is patented in Nigeria, Kenya, Zambia, Uganda and
Zimbabwe. This is why the drug orders for East Africa may only be placed
with Aspen in South Africa as nevirapine has only been licensed to this
company by Boehringer. After the public outcry following this threat in
Germany the company had to back-pedal stating that it had not been the
central message of their letter to mention possible lawsuits against
non-licensed suppliers of Nevirapine. The company tried to justify
themselves by the weird argument that they wanted to assert their patent
rights only to protect the Kenyan market against counterfeit drugs.(5) This
remark deliberately connects Indian generics of immaculate quality with drug
counterfeits and can therefore be considered slander.

Those who live in glasshouses ...

A scientific study performed by BUKO Pharma-Campaign reveals that the range
of drugs of Boehringer Ingelheim is not doing too well: 57% of the medicines
marketed in the Third World had to be assessed as irrational, the share of
such nonsensical and partly even harmful products has even slightly
increased since 1998.(6)

Profit or human lives?

The reasons for Boehringer's patent application in India are difficult to
read. The Indian law provides for a compulsory license, which may be granted
in the event of a patent granted for a medicine, which is already being
produced in India. In this case, the drug can be continued to be
manufactured in India and also be exported. So why does Boehringer then
apply for a patent? The company obviously wants to set a precedent in India.
Laurence Liang of the Alternative Law Forum in Bangalore comments: "We
reckon the company wants to test whether it is able to prevent the granting
of a compulsory license." ( 7 ) However, the Indian patent law also
provides that the patent can be objected by those affected by it. Two
networks of HIV-positive groups have already done so.8 Should Boehringer
Ingelheim succeed with its patent application for nevirapine syrup, the
company would be able to completely or partially prevent the export of the
cheap generics to other poor countries. Even if Boehringer granted licenses
(as in the case of Aspen) or if the Indian companies had to pay royalties in
case of a compulsory license, the prices would increase. With dramatic
effects: already today, children fall more often victim to AIDS than adults,
because they are discriminated when it comes to treatment and because the
disease breaks out faster among them. According to the United Nations
Children's Fund UNICEF, two million HIV-positive children are affected in
sub-Saharan Africa alone. Less than ten per cent of these small patients
receive the drugs they need to survive.9 If prices for AIDS medicines
continue to rise, even more children would miss out. Their survival must not
become a question of money! BUKO Pharma-Kampagne started a campaign in
Germany and is heading the talks with the company. Together with other
organizations they want to make the company withdraw its patent application
in response to public pressure.

1 Letter of Boehringer Ingelheim to BUKO Pharma-Kampagne, 6 September 2006
2 Pharmaceutical Suspension Comprising Nevirapine Hemihydrate, Application
2485/DEL/1998 3 Interview, Report Mainz, 27 November 2006 4 Letter to
Boehringer Ingelheim to Philips Pharmaceuticals Ltd, Nairobi, Kenya 8 June
2006 5 Letter of Boehringer Ingelheim to MEDS, Nairobi, Kenya 17 August
2006 6 Jörg Schaaber et al. , Data and facts 2004: German drugs in the
Third World, BUKO Pharma-Kampagne, Bielefeld, 2004, p.11 7 Telephone
conversation with Laurence Liang on 27 November 2006 8 Indian Network for
People Living with HIV /AIDS, Positive Women`s network, Statement of
opposition in the matter of Application 2485/DEL/1998, 9 May 2006 9
www.unicef.de/index.php?id=3917

Dr. Christiane Fischer
BUKO Pharma-Kampagne
August-Bebel-Str. 62
D-33602 Bielefeld
Germany
Tel +49-(0)521-60550
Fax +49-(0)521-63789
info@bukopharma.de
www.bukopharma.de