TWN Info Service on Intellectual Property Issues (Jul13/08)
30 July 2013
Third World Network

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 (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 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.

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