E-DRUG: WHO Medicines Strategy 2008-2013 Consultation (4)
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Dear colleagues,
We would like to share with you the contribution that we sent to WHO,
in the framework of the consultation on the draft of WHO Medicines
Strategy 2008-2013.
Dear Director,
Firstly, we wish to thank WHO for this precious opportunity to give
inputs to the draft of WHO Medicines Strategy 2008-2013. Here are
some comments, prepared following the list of questions that you
provided.
1. Do you agree with our analysis of global trends and gaps in the
pharmaceutical sector?
The document is highly valuable and we appreciate very much the fact
that emphasis is put on the problem of quality, which constitutes a
major weakness of health systems in many middle-income and
low-income countries and which has, through the spread of
sub-standard and counterfeited medicines, underestimated
consequences for the individual and public health among vulnerable
populations. However, we would suggest that "sub-standard
medicines" are clearly mentioned as a major threat for public health
beside "counterfeit medicines": otherwise, a dangerous tendency could
appear in the general public -and also in some policy makers- to
underestimate the dangers of sub-standard medicines, whose negative
impact is huge, even more than the counterfeit medicines, especially in
the most vulnerable populations.
2. Do you agree with the strategic directions and priority activities we
have identified?
Generally, yes. However, we would like to give you some more specific
comments and remarks:
- As a very general remark, we strongly suggest that the wording
"access to essential medicines" be systematically replaced by the
wording "access to quality essential medicines". We are persuaded
that quality should be transversal topics, touching all the aspects of
pharmaceutical policies: the fact of having it systematically mentioned,
could help to build a quality-oriented approach among policy-makers.
- Concerning the need to further strengthen the regulatory systems of
many LICs (page 9), we would like to point out that, while the
reinforcement of the Drug Regulatory Authorities (DRAs) in
resource-constrained countries is a long-term task, the recognition of
the work of reference bodies could 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 could also help rationalizing the use of resources, by
avoiding unnecessary duplication of efforts. In other words, we would
like that WHO clearly encouraged a transparent exchange of technical
information not only between the WHO Pre-qualification and the DRAs
in the South, but also between the WHO Pre-qualification and the
DRAs in the North, and among the DRAs in the North and in the South.
- Concerning the third paragraph at page 10 (about analysis and
comparisons of prices, a subject retaken also in other parts of the
document), we feel that talking about prices without clearly linking
prices to quality, can be seriously misleading, and even lead to the
procurement of non pre-qualified over pre-qualified sources. Therefore,
we suggest that whenever prices of medicines are discussed as a
selection criterion for procurement, it is well clarified that you can only
compare prices "of medicines of equally verified quality".
- We also feel that any reflections on prices of medicines should
incorporate the impact of the 2005 WTO deadline on TRIPS
implementation in developing countries: for "old" essential medicines,
you can still compare the price of innovator versus the price of
pre-qualified generics, but new essential medicines could be
unavailable as quality generic competitors for a number of years. So, in
a post-2005 scenario, procurement and pricing policies will have to
incorporate intellectual property aspects and -hopefully- exceptions,
from the very early stages.
- Concerning the WHO Pre-Qualification (page 11), we wonder if it
could not be extended to the group of anti-infectious medicines as a
whole, since in our experience the procurement of anti-infectious
medicines, especially in injectable formulations, is often a major
challenge in resource-constrained contexts, due to the lack of sources
of traceable origin and of verified quality. This clearly creates great
dangers for the individuals and for public health (because of the
emergence of resistances): thus, extending the WHO Pre-Qualification
to these medicines (and gradually to other groups of essential
medicines) would be in line with a public health approach. In addition,
as previously suggested, the exchange of information between the
WHO Pre-Qualification and stringent DRAs should be encouraged and
implemented (as it already happens with the US and the Canadian
Drugs Regulatory Authorities, but concerning antiretrovirals only).
- As already mentioned, we would like that in addition to counterfeits
(IMPACT) also sub-standard medicines were specifically targeted by
WHO, in order to adopt a strong and coherent public health oriented
approach (both sub-standards and counterfeits can kill!) rather than a
counterfeit-only approach (which could end up being too much
intellectual property oriented).
- Talking about "Evidence and information for medicine policies" (page
15), we would like to underline/remind the relevance of public and
transparent information on quality assessments (manufacturing sites,
active pharmaceutical ingredients and final products), and on patents
on pharmaceuticals.
3. Is there any important activity or strategic direction missing?
- In our opinion, more emphasis could be put on the role and
responsibilities of Donors, who could and should do more, in order to
set up pharmaceutical procurement policies based on coherent and
appropriate quality evaluations. This point is mentioned at page 15, but
not, for instance, at page 5 of the document ("Threats"). We are
persuaded that there is a real risk that Donors opt for procurement
policies that give low prices priority over quality verification, which in
turn weakens the political power of very important tools like the WHO
Pre-Qualification (in addition to being directly dangerous for public
health).
- We feel that the "financial accessibility to quality essential medicines"
should be clearly stated as a strategic direction: in other words, the
right of the poor to receive essential and life saving medicines for free,
just as it happens in rich countries through social solidarity
mechanisms, should be an objective in itself ("the poor should not have
to pay for essential medicines"), and specific activities should be
developed to reach this objective.
- Concerning the cross-cutting theme of "Access to (quality)
medicines", we would like to underline the need of carefully following up
the consequences of post-2005 TRIPS implementation: with most new
essential medicines patented in countries like in India, resource-poor
countries will be "forced" to renounce to new medicines, and/or to
adopt sub-standard old protocols (e.g., stavudine-based ART),
because of the lack of access to new medicines. In line with the motion
of 2008 WHA, WHO should monitor that structural mechanisms are
enforced to ensure access to new medicines to vulnerable populations,
on a regular and not on an exceptional (case-by-case) basis. On the
same topics, we feel that specific activities should be put in place to
start to prepare LDCs to the 2016 TRIPS implementation deadline.
- As a minor remark, we would like to note that the promotion of rational
use should be more and more integrated with other topics. Actually,
context-specific factors such as the lack of financial accessibility to
medicines can also have a heavy impact on the (lack of) rational use of
medicines, and they should be corrected as a major pre-requisite for
rational use full implementation.
4. In case we have to define our priorities in view of limited resources,
which component(s) of the strategy would you consider of lowest
priority for WHO?
Actually, we found it "easier" to look at highest, rather than lowest,
priorities. In our opinion, in a public health approach, two major
priorities are constituted by:
a)The global enforcement of appropriate quality standards, so as to
avoid that a double standard keeps on existing, for vulnerable
populations; b)The achievement of full financial accessibility of quality
essential medicines to individuals and households, in low- and
middle-income countries.
Thanks in advance for your kind attention. Yours sincerely,
Raffaella Ravinetto
Pharmacist, Prince Leopold Institute of Tropical Medicine, Antwerp
Daniel Vandenbergh
Pharmacist, AEDES, Bruxelles
Jean-Michel Caudron
Pharmacist, Health cy, Paris
Jacques Pinel
Pharmacist, Bruxelles