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[e-drug] Law, taxation and harmonization - need course

E-DRUG: Law, taxation and harmonization - need course 
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Dear E-Druggers,

re:  Suggestions for Pharmaceutical Policy and Management Course at UWC

I would like to chime in on the topic of legislative frameworks,
harmonization and import duties.

I start with import duties as I did an article for Global Health Council on
this issue a while ago. 
Here is a link to it:
http://micheleforzley.com/uploads/3/5/4/9/35498635/tarrif_brief_final.pdf

It is a common misinterpretation that if tariffs go down profits for
importers/wholesalers/pharmacists go up. Import tariffs are imposed by
governments and governments are solely responsible and authorized to remove
them. If there are any markups to the import price along the supply chain
and we know there are, then the total final cost is higher because the base
price is higher due to the tariff.  By removing the tariff, the total price
should go down and the markups will go down as well  along the way thus the
profit margins will be reduced.  Governments are also responsible to manage
markups but that is not generally done. 

Second on legislation: there are minimum elements for the contents of
medicines and pharmacy legislation. These in effect authorize the regulatory
body - the MRA or the pharmacy council - to limit behavior of the actors in
the system, permit behaviors and also to define the scope of the authority
of the regulator within the legal system. While, it is a challenging process
to draft new or amended legislation for the sector, nothing else will
clarify gaps in the regulatory processes essential to ensure a quality
medicines supply. Studies by WHO indicate clearly that many countries have
inadequate or no legislation in this area, thus regulators are effectively
working with one hand tied behind their backs. This need not be. 

Related to legislation is the subject of harmonization - the process by
which regulatory functions are co-managed in effect by a group of
regulators.  This process to requires that there are minimum powers, duties
and authorities to regulate and that empower the regulator to recognize or
rely upon the decisions of other regulators to fulfill their duties.  It
cannot happen as hoped without a complimentary legal relationship. 

Since there are no programs to teach the topic of law to lawyers working in
this area and to regulators who need to have a facility with the subject of
law, I have made it my business to develop such courses and will be
announcing these shortly. The courses will not be just about medicines law
but also about the health system, UHC - thus a wider range of subjects on
which lawyers working in and around the MRA and MOH need greater expertise.
I hope programs such as this one at UWC add this topic. 

Thank you.

Michele Forzley, JD, MPH
Forzley & Associates
Global Public Health Lawyers
Email michele@forzley.associates 
"Michele Forzley" <mforzley@comcast.net>

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