E-drug: Generic substitution (cont'd)
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Dear Friends:
We have discussed this topic a lot in Colombia. A very tough and
controversial discussion. Some argue that a "truly Generic" drug must
show bioequivalence, in order to be interchangeable with the original.
If not, it is a "copy" or a "similar" drug. And like it or not, the possibility
of substandard quality is always present. I'm afraid WHO's position
and documents may contribute to this point of view. In Mexico and
Brazil, it is the official position and legal situation.
Our opinion, in Colombia's MOH and the drug quality control agency
(INVIMA) is as follows: Generics are necessary and desirable to
introduce competition for same products. But interchangeability is not
a health objective. In fact any physician is interested in changing
drugs day by day, pill by pill. Just to have options when to start (and
end) a therapy. Interchangeability is a condition present in countries
with a large patent experience in the market. Generic alternatives
must show the same distribution profile to enter into the market, when
the patent finishes. But developing countries are very different.
Today, you can find two or three alternatives of one "original" drug.
Interchangeability from whom and to whom?
With narrow therapeutic margin drugs the situation is more clear.
Switching from one drug to other is not recommended. Even original
to generic, or generic to original. In fact we strongly recommend not
to change the manufacturer's drug without clinical follow up. Or we
sometimes prohibit a change. Maybe this is a good recommendation
in therapies for chronic diseases.
Bioequivalence tests, especially in vivo, just have a very short scope
of application: oral dosage forms, narrow therapeutic margin and
dissolution problems. Maybe 30 drugs?
In this context, substitution or prescription in INN are the same. In our
experience there is a very strong effort by the research based
industry to generate artificial (technical) barriers to competition. And
to suggest diferent standards of quality.
We would very much appreciate your opinions on this topic.
Thanks a lot,
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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