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[e-drug] WHO: Members agree to list of behaviours linked to compromised medical products

E-DRUG: WHO: Members agree to list of behaviours linked to compromised medical 
products
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TWN Info Service on Intellectual Property Issues (Jul13/08)
30 July 2013
Third World Network 
http://www.twn.my/title2/intellectual_property/info.service/2013/ipr.info.130708.htm

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 behaviours 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) medical products in November 2012. The OEWG is
a first activity of the MSM tasked to identify actions, activities and
behaviours 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 behaviours 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 that only 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 behaviours 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 (1)  by a national and/or regional regulatory authority; 
- 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 and
conflict of interest; and lack of effective labelling of medical products". 

Further the Report recognized the need for discussions to be held on "What
activities and behaviours are irrelevant for the purposes of this
discussion?"

While the meeting reached consensus on the listing of actions, activities
and behaviours, 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.

(1) Products or manufacturers, importers, distributors, suppliers, or
sellers of medical products. 

  


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