[e-drug] Ceiling for drug registration (2)

e-drug
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E-DRUG: Ceiling for drug registration (2)
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Hi,

Which DRA are you talking about? The idea is commendable but I would like to know the country which is going for it. In a democracy with many powerful, vested interests operating simultaneously, such rational thinking is impossible.

Dr Vijay Thawani

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E-DRUG: Ceiling for drug registration (3)
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Balanced against the desire to reduce the burden on the drug regulatory
authority from reviewing applications on many equivalent generic products
is the desirability of fostering robust competition among multiple
producers so that countries can access lowest cost, good quality medicines.
In the U.S., the rule of thumb is that you need 8 or more competitors
before true price competition is maximized. I don't know how these numbers
translate to smaller markets and to markets with weaker competition
authorities that might not be able to monitor price fixing schemes, but it
does seem to me that as a general proposition you don't want to
artificially restrict competition. You also don't want to have so few
suppliers that drug supplies might be curtailed because of spikes in
demand, company failures, etc.

There is also some risk that restricting the number of entrants will
ultimately come to disadvantage local production. Many of the established
generic companies will be quick off the mark to register their products
even in poorer markets. Start-up local producers will be disincentivized
if they fear they will not make it through the regulatory process in time
to secure a quota position.

I think a better way to limit generic producers, and one with even better
health outcomes, is pharmacovigilance over quality both in manufacturing
and supply chain, and contract compliance with procurement orders
(timeliness, consistency, etc.). Keeping a stable of good quality
producers and rewarding companies that invest in reliability and quality
assurance throughout their distribution system is more important than
merely reducing the regulatory workload.

Brook

Professor Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115
617-373-3217 (office)
617-259-0760 (cell)