PHM-Exch> SSFFC Argentina Memberstate Mechanism meeting 19 - 21 november 2012 Counterfeit medicines

[Claudio Schuftan]

From: Roy Vancauwenberghe <roy.vancauwenberghe at telenet.be>


*First meeting of the Member State Mechanism on
Substandard/Spurious/Falsely-labeled/Falsified/Counterfeit medical products.
*

****Buenos Aires****, 19-21 November 2012****

*Call for mutual respect and understanding(*):*

Counterfeit medicines are a serious threat to public health. Development
countries suffer much more from counterfeit and illegal medicines compared
to western countries where manufacturing and distribution of medicines meet
high (and expensive!) standards. We often forget too easily that through
the third payer system embedded in our social security systems most of our
high quality medicines are financed by “the people”. Lack of legislation
and regulatory provisions besides absence of quality assurance and
authorizations in manufacturing and distribution of medicines makes
development countries very vulnerable for infiltration of medicines of
compromised quality. Moreover most development countries have no suitable
quality control laboratories surveying the market and the absence of an
authorization system (Marketing Authorization) are conductive to the spread
of counterfeit and compromised medicinal products. The actual Babel-like
confusion on the definition of counterfeit has driven the BRICs countries
right into a confrontation with Europe and **North America**. The latter
are not able to prove in clear terms their first concern not being the mere
protection of Intellectual Property Rights. BRICs countries do have serious
reasons to claim the access to quality, safe, efficacious and affordable
medicines as part of the Memberstate Mechanism discussion on substandard,
spurious, falsely-labeled, falsified, counterfeit medical products. This
upcoming meeting in **Buenos Aires** the 19th November is of utmost
importance when the scope of this Memberstate Mechanism will be set
forward. The European Union should not be allowed to push his will to
remove Access to quality medicines from the agenda. The result will be a
further paralyzing of relations where a consensus should be strived for. We
have no right to withhold development countries from access to quality and
affordable medicines. Again western countries do have access to affordable
medicines since their health systems are based on a serious contribution by
the people to the development of medicinal products. Only a serious and
in-depth discussion of all aspects of worldwide medicines manufacturing and
distribution can lead to mutual understanding and a more transparent
international trade in medicinal products. The Memberstate Mechanism gives
a unique opportunity to listen to each other and to go for solutions to the
benefit of all partners.****

SSFFC denomination is a contradictio in terminis since substandard
medicines being intentionally manufactured and distributed should be
classified as counterfeit. Unintentional substandard and counterfeit are
two parts of the same coin and cannot be solved in an isolated way since
their causes are the same: weak legislation, weak regulatory, weak quality
assurance and monitoring, weak enforcement, weak communication, absence of
authorizations and licenses...The Memberstate Mechanism will only prove its
integrity by looking for those causalities. ****

The term Counterfeit should be abandoned immediately since it has been
claimed too much by IPR and is also part of the TRIPS agreements. Confusion
has been mounted significantly by including terms like spurious and falsely
labeled. UNODC created another term “fraudulent medicines”. Also this
approach only aggravates the confusion and proves  little expertise in
medicines legislation. A simple and concise definition may be the one
depicted by the EU in their falsified medicines directive where falsified
in relation to identity, source and history might be the right term to use.
Definitions in this field should be discussed in a multidisciplinary and
multisectoral expert working group with proven experience in grey and black
markets and not in the WHO Expert Committee on Specifications for
Pharmaceutical Preparations. ****

Allowing the discussion on the prevention and control of medical products
of compromised quality, safety and efficacy at the same time with measures
to ensure the availability of quality, safe, efficacious and affordable
medical products may lead to remarkable measures and consensus between all
memberstates. IMPACT may be dredged up without the ENFORCEMENT part since
WHO has no competence and jurisdiction to investigate and prosecute. For
this, close collaboration with other UN organisms may be the solution.****

The Memberstate Mechanism (MSM) is a unique opportunity to discus,
recommend and agree on measures to approach the problem of SSFFC from a
multidisciplinary and multisectoral point of view. Mandatory
prequalification for all imported medicines and serious participation in
GGM (Good Governance for Medicines – a WHO approach) should be part of the
discussion. Cooperation of authorities and information exchange (National
and International), preventive measures, measures for protection of
victims, substantive criminal law, investigation, prosecution and
procedural law, international collaboration .. all of these may be
discussed in this MSM. And maybe … a new treaty may result and find
international agreement … just like we did with the Medicrime Convention at
the Council of Europe.****

There is simply no “one bullet” strategy!****

** **

31 october 2012****

Roy Vancauwenberghe****

Pharmacist Inspector****

Head of Special Investigation Unit ****

Belgian Federal Agency for Medicines and Health Products****

** **

roy.vancauwenberghe at telenet.be****

**Mobile**: +32 475 456476****

*This is a personal opinion of the author who is an expert in medicines
with a long career   -12 years- in manufacturing medicines in development
countries (Rwanda) and more than 20 years in combating pharmaceutical crime
in Belgium and Europe. ****
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://phm.phmovement.org/pipermail/phm-exchange-phmovement.org/attachments/20121101/3fd8b46c/attachment.html>