E-DRUG: RFI: Bioequivalence and generics registration (2)
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Dear Colleague,
First of all, as the problem you describe is basically of a technical
nature, it is important to, at least initially, to reduce it to from the
current level you present as "National Department of Pharmaceutical
Affairs" to one of the responsible "technical officer(s)" in the
department. This way, you will separate technical from political. The
latter can easily become the proverbial elephant and be managed depending
on which side you touch! Even if you are not able at this stage to agree
with the technical officer(s), it may be helpful to at least use the
background information you will get, when you do, to prepare and present an
advocacy document.
Secondly, I suggest that you encourage and give an opportunity to the
technical counterpart to also present a technical rationale of the
Regulatory Authority's position. The point I make is that this problem is
better managed from a point of view of conflict resolution and advocacy
than from confrontation. As a third world citizen, and having worked with
regulatory authorities in that milieu for over two decades, I know that the
argument of "third world", though very relevant, is quite secondary, and is
usually looked at by the authorities with understandable suspicion. So, it
is a good move to look for supportive technical information to prepare you
for advocacy, but use it well.
Finally, like in many change endeavours in life, you need allies and
champions to help you. I think the WHO country office is the major ally. If
they cannot resolve the problem locally, they can enlist support from the
regional or headquarters office. The local professional associations may
also be able to help.
Best of luck in an important task!
Murtada M. Sesay
Past President
Commonwealth Pharmaceutical Association.
Telephone: +45 28232807
Copenhagen, Denmark
msesay@unicef.org
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