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[e-drug] Fixed Dose Combination ARV for children available!

E-DRUG: Fixed dose combination ARV for children available!
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Dear fighters for Access!

We all are lobbying for better ARVs for treatment of children. It is not
acceptable that grandmothers have to give three different suspensions in
different dosages - some of them to be stored cool ? to the orphans they
care for. This terrible situation is very well known to us.

But sometimes there are little lights somewhere at the sky that gives hope:

Do you remember? One year ago Ranbaxy introduced the first ARV-FDC for
children ?Triviro-LNS-Kid? during the World Aids Conference in Toronto.
Today Triviro-LNS kid is approved in India and Nigeria! It has been filed
in:

Burkina Faso
Cameroon
Congo-Brazzaville
DRC
Ethiopia
Gabon
Ivory Cost
Kenya
Malawi
Mozambique
Senegal
Tanzania
Uganda
Zambia
Zimbabwe
 
The pricing agreement between Ranbaxy and UNITAID/CHAI is as follows:  

Triviro-LNS kid: USD 2.70 per bottle of 60 dispersible tablets
The price for a child 1 year?s age would be 32,40 USD pppa.

That?s a very big break through: Supply Organisations currently have to pay
about 330 US Dollar pppa for children.

The order servicing lead time for this product is usually 4-6 weeks. Ranbaxy
maintain a stock in India for servicing emergency orders.

WHO Prequalification is in process.

Nice pictures about that product can be requested from Ranbaxy or from me.

That?s a good development, but still a few steps to walk:

a) According WHO Prequalification website additional data have to be
provided by the manufacture. 

We as civil society have to push Ranbaxy not delay that process.

b) Every year about 500.000 children are dying on HIV/AIDS because of
no access to ART or because of bad compliance or no storage facilities to
the suspensions. Therefore we should introduce the new dispersible tablets
where ever possible even if they are not WHO prequalified.

c) We should contact the governments of the countries listed above not
to delay the process of registration. WHO-AMDS is developing a website where
the status of registration for new drugs will be noted. That will be a
helpful tool for this kind of very important activities in near future.

d) We should give clear signals to Ranbaxy to file Triviro-LNS in all
other LDC and MDC countries for registration immediately.

e) We should keep on lobbying for other similar FDCs for children,
especially for second line treatment.

This example and the DNDI-ASAQ/Coarsucam case, where we had to push Sanofi
and DNDI to present data about registration and modalities of procurement
(E-Drug 5th of July) makes me wonder about a very new situation we are
facing. Hopefully more and more new products will be developed, produced and
marketed on non profit conditions. Different from new innovations of Big
Pharma that are followed by huge and expensive promotion campaigns these
will have no or only very limited budgets for advertisement etc.

Do we need to develop totally new mechanisms of transparencies and
information sharing that guarantee immediate access for the benefit of
patients in need? 

Any ideas?

kind regards

Albert Petersen
Pharmaceutical Aid Department 
DIFAEM - German Institute for Medical Mission
P.O.Box 1307
72003 Tübingen
Fon: +49/7071/206-531
Fax: +49/7071/27-125
e-Mail: petersen.amh@difaem.de
http://www.difaem.de/

Country Focal Point and Chair of
Ecumenical Pharmaceutical Network EPN

Difaem: 100 years - health for a global community

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