E-DRUG: WHO Medicines Strategy 2008-2013 Consultation (5)
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[MSF sent the following comments on WHO Medicines Strategy 2008-2013 to Dr Hans Hogerzeil. WB]
Dr Hans V. Hogerzeil
Director
Medicines Policy and Standards
World Health Organization
CH-1211 Geneva 27
October 1, 2008
Re: WHO Medicines Strategy 2008 2013
Dear Hans,
Thank you for sending us the draft WHO Medicines Strategy 2008 2013 for
comments. Please find below some comments and suggestions by MSF.
The concept of essential medicines as a guiding principle is not confined
to developing countries only. While the immediate impact may be most
significant there, the concept as such is a global one. It would be good if
the document in the achievement section reflects that. (see for example
Laing & al, 25 years of the WHO essential medicines list : Progress and
challenges, The Lancet, Vol. 361, 1723-29, May 2003)
Under the heading access we would suggest adding as one of the achievements
making information about patent status available (see for example WHO,
UNAIDS & MSF Campaign for Access to Essential Medicines, Determining the
patent status of essential medicines in developing countries, Health
Economics and Drugs, EDM series No. 17, 2004)
In the introduction you contrast vertical programmes against horizontal
health systems. While we appreciate the debate, it is also important to
recognise that the emphasis on vertical interventions in particular in the
area of HIV/AIDS has driven a lot of the change in medicines pricing, pro
health patent policies, increased financing for health and support for the
Prequalification project. It is important to not pitch vertical programmes
against more comprehensive health care systems but rather regard them as a
driver of change towards more emphasis on health.
Under Trends, challenges and gaps in the global pharmaceutical situation
second paragraph it would be important to specifically mention the
implementation of the Doha Declaration on TRIPS and public health instead
of the vague wording existing provision and recommendations. At the time
Dr Bruntland called the Doha declaration a victory of public health. The
WHO medicines programme needs to play a key role in the implementation of
the Doha Declaration and we found it surprising to not find one reference
to it in the strategy document.
The continued support and recognition of the value of the WHO
Prequalification Project (PQP) is very much appreciated and supported by
MSF. However we feel that the PQP would benefit from priority setting it
is not just a matter of prequalifying as many products as possible but
rather to focus on where the needs are. The PQP can also play a key role in
innovation by identifying products that do not exist in particular
formulations and proactively work with companies to get quality assured
production. One has to be careful with widening the scope of the PQP in
areas where it may not be needed and become a barrier.
MSF experiences increasingly difficulties in identifying manufacturers for
basic essential drugs that fulfil the required quality criteria. The PQP
should play a role in encouraging and improving quality standards in
production of essential medicines. Measures to address the deficits in
manufacturing quality and monitoring of production practices in many
countries should be strengthened and clearly the WHO medicines programme
needs to continue to play a strong role in that.
Although we recognise the risks of counterfeit medicines to patients, the
experience from our projects and evaluations of the pharmaceutical markets
in over 50 countries indicate very clearly the extend of the problem with
substandard drugs. [JM Caudron & al, Substandard medicines in resource-poor
settings : a problem that can no longer be ignored, Tropical Medicine and
International Health, Vol. 13, No. 8, 1062-1072, August 2008] The emphasis
on counterfeit in the Strategy may therefore seem out of balance.
We would like to suggest to add in the section on counterfeit as one of the
reasons for counterfeiting absence of affordable quality medicines in
adequate quantities. Furthermore it would be important for the WHO
medicines programme to explicitly state in its strategy the following
action: to guard against attempts to use anti-counterfeit measures to
discredit legitimate generic products. We would like to warn against
rewriting the WHO definition of counterfeit drugs. The clarity that exists
today will help to combat attempts to create inappropriate barriers against
generic pharmaceutical production and import, for example the draft anti
counterfeit legislation in Kenya which leaves room to interpret a generic
drug as a counterfeit. Those who are working on countering such provisions
in draft legislation benefit from the clarity of the WHO definition of
counterfeit drugs.
We recognize the value of encouraging a harmonisation of procurement
policies between different donors and procurement agencies. However, we
would like to underline the importance that such an initiative places
sufficient weight on appropriate quality standards to be applied for
selection and validation of products.
The strategy should be clearer on WHO Medicines Programmes role in
intellectual property. For example on page 16 speaks of guiding
harmonisation of intellectual property rights. This is not a role for WHO
to play. It is precisely the lack of harmonisation that allows for the
current flexibilities for example Section 3D of the Indian Patents act that
awards only real innovations with patents. Elsewhere (page 20) the strategy
speaks of promoting the link between innovation, IPR and access while the
recent WHO reports (CIPIH) and WHA resolutions have indicated that the
link between IP and health needs driven innovation is weak if existing at
all. WHO resolution 60.30 recommends looking into proposals that de-link
payment of cost of R&D from the price. We suggest to replace that action
with language that reflects WHOs understanding for the need to manage IP
in such a manner that it allows the protection of public health and in
particular access to medicines for all (Doha Declaration par 4.).
We suggest that the strategy specifies how it wants to contribute to a
pro-health implementation of IP requirements through the implementation of
the Doha Declaration on TRIPS and Public Health, make a reference to the
Medicines Programmes role in the implementation of the recently adopted
Global Strategy and Plan of Action on Innovation, Public Health and
Intellectual Property (for example overcoming IP barriers to local
production of quality generics). We would specifically like to see a
reference to WHOs support to the UNITAID plans to set up a patent pool.
We would be more than happy to discuss these points with you. Again thank
you for this opportunity to comment.
Kind regards,
Carine Werder
International Pharmaceutical Coordinator
Tido von Schoen-Angerer
Executive Director
Myriam Henkens
International Medical
Coordinator
Ellen 't Hoen
Director Policy Advocacy
Campaign for Access to Essential Medicines
Medecins Sans Frontieres International
ellen.t.hoen@paris.msf.org