OM Weekly Digest (21-04-2016)
April 21 2016

PERU | Regulatory | Health Minister approved Policy Guidelines on Access to Biotechnological Products

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On 15 April 2016, the Peruvian Health Minister issued Resolution No. 259-2016/MINSA by means of which the “Technical Document: Guidelines on Access to Biotechnological Products” was approved. The approved Technical Document purportedly seeks to improve access to safe and efficient biotechnological products, through a rational use, and ensuring financial sustainability for health institutions.

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COLOMBIA | Patents | Compulsory Licensing: The Ministry of Health and Social Protection makes a formal price offer in the imatinib (Glivec®) case

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On 12 April 2016, the Ministry of Health and Social Protection issued a communication to Novartis, by means of which it made a formal price offer on the current Administrative Process for the Declaration of Public Interest (DPI) seeking a Compulsory License for a patent covering the β polymorph of imatinib (Glivec®).The offer was made following the recommendation issued by the Technical Committee in the DPI procedure. The price offered by the Ministry was COP 140/mg of imatinib, which constitutes a 60% price reduction.

Imatinib is already offered by two other non-infringing suppliers in the Colombian market, and additionally Glivec® has been subject to government price control since 2011.

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COLOMBIA | Regulatory | The Colombian Regulatory Authority (INVIMA) reduced the clinical protocol evaluation from 4.5 to 2 months

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On 12 April 2016, the Colombian Regulatory Authority (INVIMA) announced a time reduction, from 4.5 to 2 months, of clinical protocol evaluations for human drugs approval. This reduction was achieved through 2 main changes aimed at improving evaluation efficiency: i) the simultaneous performance of the technical evaluation of the clinical protocol and the drug quality evaluation; and ii) the Clinical Research Team, from the Drugs and Biological Products Office, will now perform the technical evaluation of clinical protocols, instead of the Special Team for Drugs and Biological Products. For further information, click here. (Only in Spanish)

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COLOMBIA | Consumer Law | The government sanctioned a Decree that allows consumers to revert an online purchase

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On 11 April 2016, the Government sanctioned Decree 587 of 2016 which allows consumers to revert any purchase made through an e-commerce mechanism, such as internet, PSE, call center or any other instrument of teleshopping or virtual store, if and when: (i) the payment mechanism used is a debit or credit card, or any other electronic payment system;(ii) the provider of the product and the issuing company of the payment mechanism must be notified within 5 business days counted from the reversion request; and (iii) both the provider and the issuing company of the payment mechanism must be domiciled in Colombia.

This right can be exercised in any of the following scenarios: (i) when the consumer has been a victim of fraud; (ii) when the purchase has not been requested; (iii) when the product has not been received; (iv) when the delivered product is different from the requested one, or does not match the characteristics offered by the provider; and (v) when the product is defective.

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