[Pharm-policy] Mechanics of looking for Generic Producers

[James Love]

---------- Forwarded message ----------
Date: Mon, 27 Mar 2000 19:38:36 -0500 (EST)
From: rastern@sol.racsa.co.cr
Reply-To: healthgap@CritPath.Org
To: Multiple recipients of list <healthgap@CritPath.Org>
Subject: Mechanics of looking for Generic Producers

We are doing a "mass mailing" in our region looking for companies that
might be interested in producing generics.  Any corrections, suggestions
are welcome. Also, this can be copied and used by other organizations
interested in doing the same thing. Thanks to David Balsam for getting
all the info together and drafting the letter. Richard Stern
___________________________________________________


(For Independent Laboratories Producing Generic Medications)


Directors of manufacturing and marketing:

We represent "Agua Buena Pro Defensa de los Derechos Humanos", a legally
chartered organization based in Costa Rica.  Amongst other ongoing
projects, we are currently organizing an initiative to create a
centralized distribution system for generic equivalents to existing
anti-retroviral and other medications for people living with HIV/AIDS.

We are sure you are aware, that the current cost of these agents can be
quite prohibitive to governments which might otherwise choose to make
them available through their Social Services systems, and is prohibitive
as well to Insurance Plans and individuals who might wish to purchase
them on their own.  In addition, Central American governments that are
currently supplying these medications are finding themselves more and
more financially strapped as the numbers of HIV+ individuals in their
countries continue to rise.

We have researched the international patent rights on these medications,
and have concluded that practically none are patented in any Central
American country (with the possible exception of Costa Rica where there
is a new Intellectual Property law).  Rather than try and develop
manufacturing resources in each individual Central American country, we
feel a regional distribution approach makes more sense.  It will also
provide the manufacturer with larger incentives to manufacture a wider
variety of medications.  We estimate that at this time there is a market
for medications to serve more than 10,000 individuals on an ongoing
basis.

To this goal, we are in the process of seeking out manufacturing
resources for these medications. Below is a list of medications that we
would be interested in having manufactured.  We understand that some of
the class of drugs known as "protease inhibitors" might require more
complicated manufacturing resources than are readily available, but
since we're not sure which laboratoy is qualified to manufacture which
drug, we have listed many of them. Obviously, quality control is of
utmost importance in this situation, and we would require that
participating laboratories agree to a rigorous quality assurance
program.

Medications we are seeking to have manufactured:

indinavir (Crixivan)
ritonavir (Norvir)
nelfinavir (Viracept)
saquinavir (Fortovase)
amprenavir (Agenerase)
abacavir (Ziagen)
zidovudina (Retrovir) AZT
lamivudina (Epivir) 3TC
zidovudina/lamivudina (Combivir) AZT/3TC
didanosina (Videx) ddI
zalcitabina (Hivid) ddC
stavudina (Zerit) d4T
efivarenz (Sustiva or Stocrin)
delavirdina (Rescriptor)
nevirapina (Viramune)
fluconazole (Diflucan)
itraconazole pellets (Sporanox)

Should you feel that your laboratory might be interested in
participating in this program, please give us an estimate of the cost of
manufacture for each medication you feel you would be qualified to
manufacture, as well as the quantity you would be able to produce.

Thank you very much for any interest you may have in our program.  
Please let us know if you have and questions, or suggestions for us.

Sincerely,


David Balsam/Richard Stern
Tel/Fax 506-283-0469 or (506) 234-2411  e-mail: rastern@sol.racsa.co.cr
Agua Buena Pro Defensa de Los Derechos Humanos
______________________________________________________