E-DRUG: Tracing counterfeit medicines (8)
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Dear e-druggers,
In the course of her comments (below) Michele Forzley says 'there is no
reason why some aspects of drug regulation cannot be managed jointly by
countries', and this is surely true. She goes on to say that the
requirement to register drugs nationally is an impediment to access which
should be vehemently opposed. But decisions that govern which drugs are
acceptable tools for mediating the health of populations is, in principle, a
national responsibility. It is possible to make progress on the former
while respecting and enabling the latter; the two are not incompatible.
The issue of regional and sub-regional harmonisation of medicines'
regulation has been discussed for decades, but for many reasons has failed.
A new move to bring together all necessary pieces of the jigsaw to
accomplish sub-regional harmonisation of drug registration - based on 5
regional economic communities (RECs) in Africa - is now in process of
development. An African Medicines' Registration Harmonisation initiative has
been proposed, and is evolving through a number of consultations that will
set in train a plan to harmonise the registration of medicines with support
from NEPAD and WHO.
The act of streamlining registration will bring many benefits for individual
countries, and will improve overall regulatory performance against shared
standards among groups of countries. Ultimately it may allow for
continental policies and strategies, as has happened over a long period in
the European Community. The vision incorporates a commitment to equity of
access to Essential Medicines (not just medicines for 3 diseases), and -
since Africa is largely dependent on generic drugs - it focuses on generics.
Local manufacturing is to be encouraged, in line with the African Union's
policy on pharmaceutical development. Small countries' National Medicines
Regulatory Authorities (NMRAs) will receive support to allow them to exert
national sovereignty over their pharmaceutical affairs, while benefitting
from the greater resources and capacities of the more advanced countries in
their regions (and, where necessary, from overseas). Expertise will be
'grown' and pooled to the advantage of all.
The key partners are the Nepad Health Secretariat, and WHO (HQ and AFRO). It
is hoped that financial support will be forthcoming from DFID and the Gates
Foundation, and a call for proposals has been issued for each of the RECs to
prepare their plans. External cooperation has been pledged by agencies such
as the US FDA, the EMEA, the TGA.
Sub-regional organisation of medicines' registration will simplify and
streamline registration, and make it less costly.
It will facilitate local, regional and global cooperation, especially
important in the increasingly complex medicines' environment, and speed the
time it takes for medicines to be registered - which can take up to 4 years
(as was the case of tenofovir) in countries with almost no capacity.
It will allow EMs to be freely traded in a group of countries, swelling
volumes in the market, and thus encouraging competition and lower prices.
Transparency will be easier to achieve - making wrong-doing more obvious and
detectable.
It will raise the morale and profile of neglected NMRAs, opening the door to
better resources, equipment and training, and the retention of staff.
Finally, it will encourage local producers, who may feel able to enter the
market; pooled procurement could work at a regional level. And in the longer
term it will open the door to cooperation on wider aspects of regulation,
such as labelling, pharmacovigilance and clinical trials.
In view of these potential benefits the initiative should receive the
wholehearted support of all relevant stakeholders who share a mission to
provide health-promoting and life-saving essential medicines. While it will
not in itself deliver access, it is a necessary prerequisite to meet this
aim.
best wishes,
Philippa Saunders.
Philippa Saunders is a consultant on Access to Medicines to Oxfam, and
attended a consultation on AMRH in this capacity.
"Philippa Saunders" <edp@gn.apc.org>