[e-drug] Pharmacy Law (3)

e-drug
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E-DRUG: Pharmacy Law (3)
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Dear colleagues

Dr Kahiga is not alone in being challenged to update very old legislation.

Most of the Pacific Island Countries have been left with legislation
that was developed during the colonial period, much of it with little
change since the 1940s. Updating the legislation is a confronting
task. We have found that pharmacy legislation is so special that it
needs pharmacists to work on it first to make it right for your setting,
and this can be done. You don't have to be a lawyer. The following
publication by Josephine Cooper, was produced to be relevant for small
countries and can be downloaded.

Here is the url and the description
http://www.wpro.who.int/publications/pub_9290610859.htm
Enhancing Health Policy Development: A practical guide to
understanding the legislative process

This publication is intended as a guide to ministries of health to
enhance their understanding of their country's legislative structure and
process. Concise descriptions are provided of the difference between
primary and secondary (or subordinate) legislation, as well as civil law
systems and common law systems. It also defines and describes a number
of legislative terms and legal concepts, such as ultra vires, legal
precedents, international conventions, and the three stages in creating
parliamentary legislation. This guide helps identify relevant materials
and informative descriptions that should be collected and compiled that
will provide a ministry of health with an essential legislative resource
available for all concerned with the development and implementation of
health policy. Compiling the information suggested in this guide will
also ensure that countries obtain maximum benefit from specialized
technical assistance that is provided to draft health legislation, and
the guide is designed to ensure that it is not necessary for preliminary
legislative work to be carried out by trained legal personnel.

The following publication by DC Jayasuriya is very old but we have found
it really helpful. I don't know whether WHO still has some copies on
their shelves. It would be good to find a copy. I can't find an electronic copy.
He wrote a later edition but we found this earlier one more helpful.

Regulation of pharmaceuticals in developing countries 1 edition 1985
By D. C. Jayasuriya

It is mentioned at
http://openlibrary.org/books/OL2284278M/Regulation_of_pharmaceuticals_in_developing_countries

DC Jayasuriya has written other publications that might be helpful. He
wrote one called The Health Legislation System of Sri Lanka (1992) that
might be useful.

Beverley Snell
Senior Fellow
Centre for International Health
Macfarlane Burnet Institute for Medical Research & Public Health
GPO Box 2284, Melbourne 8001 Australia
http://www.burnet.edu.au/home/cih
Telephone 613 9282 2115 / 9282 2275
email <bev@burnet.edu.au>

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E-DRUG: Pharmacy Laws (5)
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Dear colleagues,

I agree with Beverley Snell's response on this matter. I also believe that drafting law for Pharmacy needs to account for how to respond to developmental issues that affect healthcare delivery in developing and developed countries as well. Too often we end up preparing laws, regulations that are so set in concrete that the ability of the profession to respond to needs that arise, is limited. This approach often is based on the laws / regulations that have been set in developed countries where they may have a view that systems are in place. My suggestion would be for any new law be structured in such as a way that it would allow for the ability of the profession of pharmacy respond to circumstances that we often face; or the to ensure that there is an allowance for innovative provision of pharmaceutical services and goods in the developing setting.

[Note from Moderator: Because Acts can be very rigid and can only be changed by Parliament, it is usually best to limit the Act to cover frameworks and to reserve details that might need adjustment or modification for the Regulations. An empowered body such as a Pharmacy Board can be authorised (by an Act) to maintain and update Regulations.BS]

In this regard, I would again refer to the ADDO project in Tanzania, and how the TFDA has provided leadership in responding to a needs expressed by the public that led to setting up the 'dawa Baradis' across the country, which hopefully in time will be transformed into ADDO outlets that are regulated. It is that ability to respond to national development issues that need to be provided for in law and regulatory function.

Bonnie

Bonface Fundafunda PhD., MBA., B.Pharm
Manager, Drug Supply Budget Line
Ministry of Health,
P.O. Box 30205,
Ndeke House,
Lusaka,
Zambia
Tel: +260 211 25 41 83
Fax: +260 211 25 33 44
Mobile: + 260 979 25 29 00
Email: bcfunda@hotmail.com