E-DRUG: Call for information about law enforcement for OTC sales of prescription-only antibiotics (2)
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[Thanks Michele - It is not only WHO that needs to step up its action (see last par) member countries need to formally include inspection and enforcement of laws as part of their regulatory activities BS]
Dear colleagues,
In response to this query, I offer the following observation. The challenges
and solutions to enforcing any and every medicines regulation will also
apply to the enforcement of prohibition of OTC sales of prescription only
antibiotics.
These are having a sufficient legal basis to take action
against those who sell medicines in any manner that is contrary to
requirements. Some of the elements of the legal basis are; having an
authorized regulator, legal prohibitions against offers for sale,
dispensing, or otherwise making available products in any manner that is
contrary to the rules ( such as what can be sold/offered over the counter,
prescription only, etc.), rules that obligate those who deal in medicines to
comply with rules, and having a qualified, funded and legally empowered team
of inspectors of sufficient quantity to "police" the market taking advantage
of community support, and a legal system that will act against wrong doers.
The legal requirements include administrative actions such as license suspension or
retraction, fines and of course remediation so that dealers are
knowledgeable about the right courses of action and a criminal justice
system that names the crimes and there are penalties with big enough teeth
to hurt those who willfully put patients at risk.
In addition, the professional cadre and those that own and operate
pharmacies and other outlets must be clear about what they can and cannot
do. This again is a regulatory matter and here regulatory means legal
actions of standard setting, licensing, inspection and law enforcement.
This includes professional associations assisting in or leading in the
training of those involved medicines dealings.
Case studies in various countries show that in some countries, there are
many if not thousands of dealers and just there are too few inspectors. A
ratio of 20 inspectors to 2000 dealers won't work and if inspectors don't
have requisite authority and a program of inspections it does not matter
how many there are.
Much has been done to raise the technical capacity of regulators but there
are still significant gaps in the "law enforcement aspect" which I call the
last mile of quality. This need not be. I have just read the medicines
road map and am dismayed to note the lack of specific activities related to
the establishment of an appropriate legislative framework and attention to
the law enforcement aspects of medicines regulation.
The road map refers to regulatory strengthening but in my experience in this field for the past 20 years, this does not mean the same thing.
We can have all the technical skills needed to identify a substandard or falsified product or to determine the fitness of a dealer in medicines but it is the legal framework and appropriate law enforcement mechanisms and systems that provide the exoskeleton to medicines safety.
The WHO needs to step up its work in this area as an explicit component of the road map. Otherwise criminals and those who would knowingly or inadvertently evade the good rules we know ensure the safety efficacy and quality of medicines will continue putting patients at risk.
Michele Forzley, JD, MPH
Forzley & Associates
Global Public Health Lawyers
Email michele@forzley.associates