E-DRUG: Relying on Stringent Drug Regulatory Authorities? (4)
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Dear Colleagues,
The lack of resources of Drug Regulatory Authorities in many middle-
income and low-income countries is widely acknowledged as a major
weakness of health systems, which favours the spread of sub-standard and
counterfeited medicines, with consequences for the individual and public
health among vulnerable populations that are probably underestimated.
However, in our opinion, the solution cannot be the abolition of national
DRAs, but rather a combination of strong measures aimed at upgrading the
resources and capacities of the national DRAS, and at pursuing transparent
exchange of information among DRAs in rich and resource-poor countries.
As for the first point, the reinforcement of the DRAs in resource-
constrained countries is a long-term task, which requires significant
investments, and it would be na<ve to expect short-term results. However,
as pharmacists, we consider that such investments are vital, because it is a
matter of fact that today patients in poor countries may be exposed to
medicines that are by far not compliant with the appropriate standards, as
defined by the WHO. It should always be reminded that, in addition to GMP
requirements, a number of other factors must be considered for the sake of
patients' safety, including the quality of active pharmaceutical
ingredients, the stability, the bio-availability, the quality of the
packaging, the appropriate supervision of procurement channels, etc.
As for the second point, and in light of the positive six-year experience of
the WHO Pre-Qualification, we believe that the recognition of the work of
reference bodies can considerably lighten the workload of the DRAs in
developing countries and contribute to a rapid improvement of the quality of
the medicines circulating in those countries; it may also help rationalizing
the use of resources, by avoiding unnecessary duplication of efforts. In the
same line, transparent exchange of technical information among DRAs in
the North and in the South would be of great help and should be
encouraged.
Concerning the definition of countries with a stringent DRAs, we would like
to notice that PIC/S purpose, as described in the website, is to pursue and
strengthen the cooperation established between the participating authorities
in the field of inspection and related areas; therefore, strictly speaking,
PIC/S countries should be taken as reference for inspections at
manufacturing site, rather than for products' registration.
Finally, it is interesting to note that this subject was on the agenda of
the WHO Intergovernmental Working Group on Intellectual Property, Public
Health and Innovation, whose Global Strategy and Plan of Action, adopted
by the 61st World Health Assembly in May 2008, include, at point 39 of the
Element 6, the following actions:
(6.2) Establishing and strengthening mechanisms to improve ethical review
and regulate the quality, safety and efficacy of health products and medical
devices;
(a) Develop and/or strengthen the capacity of national regulatory authorities
to monitor the quality, safety and efficacy of health products while
sustaining ethical review standards;
(c) Comply with good manufacturing practices for safety standards, efficacy
and quality of health products;
(d) Strengthen the WHO pre-qualification programme.
We hope that WHO and partners will manage to provide concrete
measures and adequate resources to implement such ambitious but vital
objectives over the next years.
Raffaella Ravinetto, Prince Leopold Institute of Tropical Medicine, Antwerp
Jean-Michel Cann, Medecins Sans Frontieres, International Pharmaceutical Coordination
Jean-Michel Caudron
Jacques Pinel
Sandrine Cloez