[Ip-health] MSF intervention on regulatory system strengthening at WHO EB

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Fri Jan 24 01:42:52 PST 2014

WHO Executive Board 134 – January 2014
Agenda item 9.5 – Regulatory system strengthening
Intervention by Rohit Malpani, Médecins Sans Frontières International


Médecins Sans Frontières welcomes the report of the Secretariat on
regulatory system strengthening, particularly its confirmation of WHO’s
leadership in setting independent norms for quality control, and its call
for collaborative solutions to fill the vacuum of regulatory oversight for
many health products.

We wish to bring the following four points to Member States’ attention:

• Firstly, the report suggests transitioning some activities of the WHO
prequalification programme to strengthened regional regulatory systems.
Although MSF encourages Member States to align with this vision, we are
concerned about the potential risks, should the activities of
Prequalification be transitioned too prematurely. The WHO Prequalification
programme has been pivotal in ensuring that affordable generic
antiretrovirals meet quality standards. Close to one third of countries
have very limited regulatory capacity, and they, as well as UN agencies and
humanitarian organisations like MSF, will still need a strong WHO
prequalification programme in the medium term.

• Secondly, Member States should allow for a potential expansion of the
remit of the WHO prequalification programme, to other critical life-saving
products, including biological therapeutics such as immunoglobulin serums
and biosimilars, complex products like liposomal formulations, and critical
anti-infectives at high risk of resistance.

• Thirdly, Member States should encourage recognition of WHO-prequalified
products by national and regional regulatory authorities and networks, to
avoid duplication and ensure prompt registration of life-saving products.

• Finally, as new models of financing, including a new fee-for-service
structure, are considered for the Prequalification programme, fees should
be set reasonably so they do not discourage small-sized companies to submit
dossiers. Donor support to the programme will need to continue, ideally in
a non-earmarked manner to ensure the sufficient flexibility for
Prequalification to determine and address priority issues.

MSF urges Member States to support both the strengthening of regional
regulatory systems long-term, and the expansion of the WHO Prequalification
programme to fill the many regulatory gaps that remain.

Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: @joanna_keenan


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