[Ip-health] Fwd: TWN Health Info: WHO: Members agree to list of behaviors linked to compromised medical products

K.M. Gopakumar kumargopakm at gmail.com
Tue Jul 30 02:29:22 PDT 2013


*Title :* TWN Health Info: WHO: Members agree to list of behaviors linked
to compromised medical products
*Date :* 30 July 2013

*Contents:*

*TWN Info Service on Health Issues (July13/06)
30 July 2013
Third World Network*
*www.twn.my*
 *WHO: Members agree to list of behaviors linked to compromised medical
products*

 Geneva, 30th July (K M Gopakumar) – Member States in a working group of
the World Health Organization have reached agreement on a non-exhaustive
list of actions, activities and behaviors that result in medical products
with compromised quality, safety and efficacy.

 The Open-Ended Working Group (OEWG) was established by the first meeting
of the Member State Mechanism (MSM) on
Substandard/Spurious/Falsified/Falsely labelled/Counterfeit (SSFFC)
medicalproducts in November 2012. The OEWG is a first activity of the MSM
tasked to identify actions, activities and behaviors that result in SSFFC
medical products as outlined in the terms of reference of the MSM.

 The MSM is the outcome of a process started in 2008 to clean up WHO’s
engagement in so-called counterfeit medicines and to bridge differences
among WHO member states over the use of terminologies to address unsafe
medical products and how WHO should approach the matter. In recent years,
developing countries have raised concerns over WHO’s counterfeit program
due to its conflation of quality of medicines with intellectual property
protection and enforcement.

 The deliberations on 23-24 July 2013 were based on a “non-paper” provided
by Brazil entitled: “Practices of health authorities and WHO in the process
of ensuring the quality, safety and effectiveness of medical products”.

 The deliberations ended with a Report of the OEWG, with an Annex
containing the non-exhaustive list on actions, activities and behaviors
that result in SSFFC medical products.

 According to the Annex, the list is based on the “guiding principle” “to
prevent and reduce the risk to public health from SSFFC medical products,
ensuring thatonly medical products meeting the national and/or regional
regulatory authority’s requirements are manufactured, imported, distributed
and supplied”. It also states that the list “could be subject to revisions
and adjustments in the future”.

The list of agreed actions, activities, and behaviors presented in the
Annex is as follows:

   - Manufacturing medical products in establishments that are not
   authorized by the national and/or regional regulatory authority;
   - Manufacturing medical products or their packaging or their labelling
   without registration or approval by the national and/or regional regulatory
   authority;
   - Modifying accompanying information of the medical products and
   changing their packaging and extending the use-before date or expiration
   date of the products which misleads the public and/or purchasing entities;
   - Substituting the contents of the medical product using the authorized
   packaging;
   - Importing, exporting, distributing, including transporting, supplying,
   selling, including through the Internet as appropriate, and storing medical
   products without compliance to applicable national and/or regional
   regulations and requirements;
   - Manufacturing, importing, distributing, supplying or selling medical
   products: a. without registration or approval or authorization by the
   national regulatory authority; or

   b. using an authorization that does not exist; or
   c. using without permission an authorization already granted to another
   (add Add footnote todefine “another”) by a national and/or regional
   regulatory authority;
   Footnote: Products or manufacturers, importers, distributors, suppliers,
   or sellers of medical products.


   - Manufacturing medical products which replicate registered medical
   products or their packaging without authorization of the national and/or
   regional regulatory authority;
   - Failing to comply with good practices of manufacturing, distribution,
   transportation and storage of medical products, as set out by the national
   and/or regional regulatory authority;
   - Importing, exporting, distributing, including transporting, storing,
   supplying or selling medical products obtained from an unauthorized or
   unknown origin;
   - Manufacturing medical products that violate the formula or the data
   contained in the registration file as approved or accepted by the national
   and/or regional regulatory authority;
   - Modifying the packaging and/or the labelling, without complying with
   national and/or regional regulations and without authorization from the
   national and/or regional regulatory authority.

 According to the meeting Report dated 24 July, “the Working Group
recognized that issues for further discussion include, among others:
advertising that misleads the public or purchasing entities; corruption
andconflict of interest; and lack of effective labeling of medical
products”.
 Further the Report recognized the need for discussions to be held on “What
activities and behaviors are irrelevant for the purposes of this
discussion?”

 While the meeting reached consensus on the listing of actions, activities
and behaviors, there is little clarity on the next steps. Several delegates
privately stressed on the need for a common understanding of the type of
“products” that fall within the scope and meaning of “SSFFC medical
products”.

 The agreed list will be handed over to the MSM meeting in November for
further action.




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