[e-drug] Generic substitution (cont'd)

[Patrice Trouiller <pat.trouiller@netclub.mg>]

E-drug: Generic substitution (cont'd)
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Pursuing the discussion, in particular with the suggestion made by
Bonnie Fundafunda to call for "regional drug regulatory offices", I
would be more prudent, in order not to put the cart before the horse.

Medicines registration, one of the missions of any drug regulatory
authority (DRA) is complex work. Even for generics and not only new
chemical entities, which is beyond its technical aspects, it is above all
embedded in the social, cultural and epidemiological context of a
country. Let's only observe all the difficulties and length of time
needed for the European region to set-up a regional DRA, the EMEA,
and then to extend it step by step to the countries of Eastern and
Central Europe through the CADREAC framework.

Many and lengthy preliminary steps are needed, first by beginning to
work together through for instance networking (to share and
exchange between DRAs mutual experiences and all the difficulties of
the work). We observe that even within an integrated economic zone
- because pharmaceutical products are goods supposed to circulate
abroad, from one exporting country to another importing one -
pharmaceuticals circulate with many regulatory obstacles. Quite
often, by lack of mutual confidence and understanding, lack of
harmonised regulations, one country will prefer to import a drug from
a remote but Western country (supposed to be the gold standard)
rather than "shopping" in a neighbouring country.

The second step, once there is a mutual trust between two or more
DRAs of a given region (formalized through an official agreement, it
all depends), is to try to work on specific registration dossier, and little
by little to come to a mutual recognition. A mutual recognition means
that when a registration dossier has been appraised and a marketing
authorization given by a A country, the B country will recognize it de
facto, and will not have to perform its own process. That means as
well that you trust the DRA system of a foreign country, its expertise
capacity, its pharmaceutical inspection system... etc. Clearly you
accept, for various reasons (e.g., your own lack of adequate tools
and/or skilled staff, or financing means) that a given DRA will review
and assess for you a drug dossier, and vice versa, recognizing its
capacity to do so. However you must also and in parallel take into
account the necessity of harmonizing the regulatory framework
between the country A and B, in order to sweep aside any other
hurdles (harmonizing meaning "producing harmony" but without
necessarily identity). Most of the time it is a huge endeavour.

Then you can start beginning of thinking and working on a regional
DRA project. 

Such a regional project ought to be a priority for many countries, it
could indeed save time, money, and definitely will improve public
health by facilitating the availability of needed medicines. 

Patrice Trouiller
Madagascar
pat.trouiller@netclub.mg

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