[e-drug] Independent or integrated Drug Regulatory Authority? (5)

["Bonface Fundafunda" <bcfunda@hotmail.com>]

E-DRUG: Independent or integrated Drug Regulatory Authority? (5)
----------------------------------------------------------------

Hi Wilbert,

I will address the last question: I believe a Regulatory Authority needs to be autonomous. However, a few NRAs are closely linked with their MOH either for purpose of administratiion or oversight, or other (eg, paying part of the NRA operational costs). But that arrangement is subject to biasness and conflict of interest. How can NRA regulate the Ministry of Health, if the NRA is 'sponsored' by the MOH? You can imagine cases where an MOH might 'instruct' the NRA to act on certain issues, simply because the MOH is under pressure to show a result. The NRA that is part of such a structure will be duty bound to act accordingly, against its better judgement. I am not sure how the two countries you have indicated have worked out this potential problem, but it would be good to learn from them.
 
The NRA needs to be an autnomous government body, because public safety is primarily a government responsibility. The example you give of this country with limited human resources, etc, of course would suggest that housing all activities under one roof may be economic. However, public safety considerations should be paramount and a separation of duty, as much as possible ought to be in place.
 
Regards,

Bonnie
Bonface Fundafunda
Zambia
bcfunda@hotmail.com