E-DRUG: Regulate pharmacy and medicines in one or separate laws? (3)
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Dear E-druggers and Dr. W.O. Wanyanga,
I offer these suggestions for how to create good
legislation. First my soap box: unfortunately there is not a
large body of published best practices for legislation for
the health or pharmaceutical sector nor much empirical
evidence - if any. By legislation I mean all levels
legislation - international, constitutional, national, sub
national and other standards, policies or non-legal
documents that can operate like legislation. But having
said this we know some from the process of law reform and
drafting from other sectors and some based on anecdotal
evidence in the health and drug sector.
I think a focus on the question of whether to have a single
legislation or have it be part of a larger body of law will
take you a bit out of the direction you want to go. So here
are some ideas from some lectures and consulting I have
recently done that may help you refocus your approach.
It is a good idea to think of the law as a framework for a
functioning DRA/health system. There is already a legal
system in place that may limit what you can do in terms of
creating a single body of law or otherwise - but that is not
the problem if fundamentally the law supports the national
medicines plan and system. To some extent it does not matter
where the law sits - as long as it does what is needed. So
start by thinking about the ideas in this email which you
can reframe as questions and please engage the lawyers in
the MOH, the DRA and every other agency involved in the
sector.
Law as a framework for a functioning DRA
1. Ministry of Health and DRA functions - does the law help
these basic functions?
Policy development - stewardship
Funding - resource generation
Program and/or service delivery
Regulation of others
Coordination of its own functions and with others
2. Law establishes the agency
Vests it with legal mandates
Creates the infrastructure, processes, and
capabilities to perform its functions
3. Common problems result from insufficient legislation
The drafting is best done when both the process and content
are considered. Below is an outline of some material I
recently presented to SIAPS and the Asia Pacific National
Medicines Policy Conference this past May. If you are
interested I can share the full presentations and there is
an audio of one.
The Process:
1. Stakeholder consultation - there are more stakeholders
than in just the health sector!
Identify
Engage
Listen to what they are saying or not saying.....
2. Importance of the right team
Use pharmaceutical and legal experts
Add MOJ, law enforcement, legislators, champions,
MOH lawyer
But do involve people from service delivery level
3. Assessment - determine relationship and linkages between
pieces of legislation in place or under review
4. Advocacy - walk the draft through channels, obtain
political buy-in
The Content:
1. Be clear on policy principles
2. Law is hierarchical - follow from the top
Use an enabling approach in the Acts - details in
regulations, rules, schedules, by- laws
3. Legislation must be practical - it must support the
national medicines policy and plan!
4. Challenges in a small country
Differences between different settings - urban/rural
5. Knock on effect e.g. regulation of medicine for
human/veterinary use - are the differences and similarities
understood and accounted for?
6. Use regulatory underpinnings- ask are you authorized to
do it?
7. Think systematically and draft same way
Some general principles:
1. Legislation is open to interpretation
2. Must support and enable service delivery
3. Importance of building capacity in
drafting
implementing
interpreting and understanding
monitoring impact of legislation
4. Legislation is not as scary as it looks!
Best of luck - Yours,
Michele
Michele Forzley, JD, MPH
O'Neil Institute on Global Health Law at Georgetown School
of Law
USA
Tel +1-301-565-0680
mforzley@comcast.net