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Colombia Issues Regulations Requiring Take-Back of Expired Pharmaceuticals

Beveridge & Diamond, P.C., March 10, 2009

Colombia’s Ministry of the Environment (MinAmbiente) has issued regulations implementing its hazardous waste laws requiring take-back of expired pharmaceuticals and medications.  Colombia has had in place take-back requirements for manufacturers and importers of expired pharmaceuticals since 2005 under Decree 4741; the recently issued Resolution 371/2009 now implements those requirements.

By way of background, under the 2005 Decree, end-of-life (expired, used, or retired) pharmaceuticals and medications are deemed hazardous wastes and subject to post-consumer producer management plans. Decree 4741, Art. 20.  Manufacturers and importers of pharmaceuticals and medications are also required to develop post-consumer take-back management plans (“Management Plans”) for such products.  Decree 4741, Art 21. 

Under the new Resolution, MinAmbiente has set forth a multi-phased procedure for implementing take-back.  In the first year, responsible parties (manufacturers, importers, distributors and retailers) would be required to develop pilot plans for take-back;  in the second year, a Management Plan formalizing take-back would be required to be offered to 10% of the population in Colombia; and after year three, the Plan would be required to be expanded 10% each year until 70% of the population is covered.  See Resolution 371, Art. 6.     

The Resolution fleshes out considerably what is required for a Management Plan.  Under the Decree, a “Management Plan” is defined as a tool that contains the collection of rules, activities, procedures, and mechanisms available to facilitate  the return and take-back of post-consumer products that become hazardous wastes when disposed, with the objective that such products are sent to facilities for recycling, treatment or final disposal.  The Resolution lays out Plan content requirements but in addition, requires detailed information on how take-back will take place, how consumer communication will occur, descriptions of the security of product collection, and mechanisms for establishing that the ambitious take-back goals will be met, among other requirements.  Resolution Art. 7.  Management Plans must be submitted within 12 months from the final date of the Resolution.  The Resolution specifically contemplates that some companies will enter into collectives as a way to implement the Managment Plans. 

Distributers and retailers are also required to participate in these Plans, and perhaps most significantly, are required to accept returned end-of-life medications and pharmaceuticals free-of-charge from consumers and keep them on site and in secure containers free-of-charge to importers and manufacturers.  Resolution Art. 4.  As a consequence, it is plainly anticipated that take-back would occur free-of-charge to consumers and with costs ultimately borne mainly by manufacturers and importers.

The Resolution also sets forth minimum technical requirements for collection centers and requires that transportation of postconsumer pharmaceuticals and medications from collection centers to disposal centers be conducted under the Colombia's hazardous waste transportation rules.  Resolution Art. 8 (1).  Finally, under both the Decree and Resolution, consumers are obligated to return their end-of-life pharmaceuticals and medications according to the program instructions developed by manufacturers and importers.  Id. Art. 5.     

For a copy of the Resolution (Spanish version), please click here.

For more information, please contact Paul Hagen at phagen@bdlaw.com, (202) 789-6022, Maddie Kadas at mkadas@bdlaw.com, (512) 391-8010, or Ami Grace-Tardy at agrace@bdlaw.com, (202) 789-6076.

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