E-DRUG: Independent or integrated Drug Regulatory Authority?
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Dear E-druggers,
A practical question for debate!
A small developing country with only a few pharmacists in the public sector
(the majority are in the private sector), wants to start implementing its
National medicines Policy, set up a National Drug Regulatory Authority, and
also control the professional activities of pharmacists and pharmaceutical
assistants/technologists.
Following traditional WHO recommendations, the country would need to
establish:
- a coordination unit for NMP implementation (secretariat normally held by
the Directorate of Pharmcy / Chief Pharmacist)
- a (small) Drug Regulatory Authority (with regional collaboration /
harmonisation)
- a Pharmacy Council (or seek integration with the dentists and doctors in a joint Health Professions Council?)
However, the human and financial resources of the country do not allow to
set up all these institutions separately.
The question arises whether one could set up one small, integrated unit that incorporates all these 3 functions?
NDA Uganda and DACA Ethiopia have tried to merge these functions: what were
their experiences?
Anyone knows of other countries that have tried this integrated approach?
What about conflict of Interests between regulators and policy implementers?
Should the new organisation be autonomous from MOH or can it be part of MOH
or government structures?
E-DRUG: Independent or integrated Drug Regulatory Authority? (2)
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dear E-druggers,
The question should first in my opinion, be one of competency and capability. [accepted! WB]
The autonomy debate comes after assuming that whoever carrys out the function, they are 'willing and able' to do so in the interests of the public the patient and the health proffesion.
E-DRUG: Independent or integrated Drug Regulatory Authority? (3)
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Dear E- druggers,
Sierra Leone is a typical example of this situation. We have a small regulatory authority that regulates both the profession and practice of pharmacy and yes we are part of the ministry of health. At the same time we do have a degree of autonomy in terms of our regulatory function.
Unfortunately I can not elaborate this morning because the entire country is at a stand still this morning awaiting the final results of the run off presidential election. Who ever is interested in knowing what and how we do it can contact me later.
Regards
Wiltshire Johnson
Head of the Drug Information and Pharmacovigilance Department
Pharmacy Board of Sierra Leone
Ministry of Health and Sanitation
Sierra Leone
infopharm_pbsl@yahoo.com
E-DRUG: Independent or integrated Drug Regulatory Authority? (5)
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dear E-druggers,
Kenya too has a taste of both.!
We are a state corporate under the Ministry of Health... supposed to be
autonomous... however not entirely separated.
The Director of Medical Services is the Chairman and the Chief Pharmacist is the Registrar of our Pharmacy and Poisons Board.
Hence, there remains an 'eyes on and hands on' element currently and the
Board is working towards an autonomy where there may be a 'eyes on' but
at least a 'hands off' understanding.
I believe that way we can implement and regulate policies far better.
regards
Jayesh Pandit
Head- Dept of Pharmacovigilance
Pharmacy and Poisons Board.
Kenya
jayesh_pandit@hotmail.com
E-DRUG: Independent or integrated Drug Regulatory Authority? (5)
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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.
E-DRUG: Independent or integrated Drug Regulatory Authority? (7)
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Dear all
Australian situation:
Australia has a federal system. Pharmacy is regulated at a State level. In my State - Victoria - the Pharmacy Board of Victoria is the Regulatory Authority. It is empowered under the Act to Regulate all aspects of the Pharmacy profession. It regulates standards of admission to the profession, controls registration and all professional behaviour of pharmacy professionals, standards for premises and all aspects of working in the pharmacy profession. It has inspectors and the power to impose penalties for misconducts. It can act like a sort of court and people accused of breaches of professional conduct are brought before the Pharmacy Board for 'trial' and the imposition of penalties as needed. Penalties range from warnings, imposition of conditions of practice, to suspensions and de-registration.
The Pharmacy Board has (10?) elected members from the pharmacy profession as well as the necessary administrative personnel.
So it is a legal body as well as being an independent representative body of the Victorian pharmacy profession.
If anyone is interested I can send a more detailed description of the role of such a Board thaqt has been prepared for students.
regards
Beverley Snell
Centre for International Health
Macfarlane Burnet Institute for Medical Research and Public Health
P O Box 2284 Melbourne 8001, Australia
Telephone 61 3 9282 2115
Fax 61 3 9282 2144
email <bev@burnet.edu.au>
Site address: 85 Commercial Road, Melbourne, 3004