E-drug: Generic substitution (cont'd)
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Dear friends:
I think I need to clarify the Colombian situation. Maybe there is a
misunderstanding. Colombia is implementing a very strong
generics policy. Government support the patient's right to choice
between some products with the same active ingredient. Our
generics market grew from 15% in 1995 to 37% in 2000, according
to marketing data.
In the other hand, is possible that internationally, the Colombian
picture looks like underdevelopment, narcotics democracy. Our
reality is quite more complex, with important advances in many
fronts. Quality control of medicines is one to them. We are proud of
our regulatory agency of drugs INVIMA, who until now has been
able to certify with GMP (WHO) 100% of our manufacturing sites.
Our quality control laboratory has been qualified as excellent, by
the PAHO-USP external control program.
All this is not only patriotism. It is to make clear that our decision of
not carrying out tests of bio bio in all the generic products is not due
to technical or financial inadequacies. It is a technical convincing of
their irrelevancy (uselessness) in most products. As I explained in
my previous message, their technical and sanitary utility is
restricted to the products of narrow window. A 0.5 to 1% of the
market? Obviously they are mandatory in such a products. And we
have in Colombia the capacity to do it.
About the possibility of regional regulatory agencies, patriotism
again. In "unilateralism" and globalization times the reaction to such
a proposal can be explosive. Especially if the proposal is to extend
the area of influence of existent national agencies, with evident
national interests, different to creating regional agencies, property
of several countries. Unilateralism is far away to United Nations.
Thanks,
Francisco A. Rossi. B.
Advisor
Ministerio de Proteccion Social, Colombia
Carrera 13 No 32-76
Tel 57-1-3365066 ext 2229
fax 57-1-3360165
e-mail: francisco_rossi@hotmail.com
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