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ECUADOR, ANDEAN COMMUNITY | Intellectual Property, Patents | Domestic Intellectual Property Bill –Código INGENIOS– has reached second debate
Further to the OM Weekly Digest of 5 August 2016 regarding to the Ecuadorian pending bill titled Código INGENIOS, (Spanish only) on 10 August 2016, the Commission for Education, Culture, Science and Technology to the National Assembly approved the report to the second and last debate in the legislative process. To become a Law, the bill has to go through the second debate, the approval of the plenary of the National Assembly, and presidential approval.
As to the content, the final draft kept the controversial provisions related to the intellectual property rights being conditioned to the role and social responsibility of the Ecuadorian state (now in Article 86) and the exclusion of new forms of a substance, polymorphs, etc., as patentable subject matter (now Article 268).
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BRAZIL | Regulatory | New criteria for pricing Biosimilars
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On 11 August 2016, the Executive Office of the Brazilian Pharmaceutical Market Regulation Chamber published the new criteria (Portuguese only) to be applied in the pricing of non-innovative biological products, which are those containing a molecule similar to another biological on the market in Brazil.
The criteria establishes: i) for medicines with proven therapy improvement, the factory price cannot be higher than the lowest factory price fixed for the same products in determined countries; ii) for medicines with no proven therapy improvement, and therefore new to the list of drugs marketed by a company, the factory price is based on the average treatment cost of the products with similar molecules and cannot be higher than the lowest factory price for the same products in determined countries; and iii) for drugs with no proven therapy improvement, but where a company has a similar marketed product, the factory price shall be based on the average cost of the treatment for the product marketed by the same company.
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BRAZIL | International Law | Apostille Convention entered into force in Brazil
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The Apostille Convention finally entered into force in Brazil on 14 August 2016. This means that documents, such as Powers of Attorney, no longer need to be legalized through complex consular procedure.
All documents legalized before 14 August 2016 will continue to be accepted in Brazil until 14 February 2017. Furthermore, Brazilian consular missions will continue to provide legalization services for those countries that have not yet adhered to the Apostille Convention.
COLOMBIA | Regulatory | Cancellation of the Suspension of the Mandatory Sanity Notification (NSO) as a precautionary measure
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On 17 August 2016, The Direction of Cosmetic, Cleaning, Pesticide and Domestic Hygiene Products of the INVIMA (Colombian Regulatory Health Authority), published in its website certain tips in order to lift the NSO suspension.
The suspension of the NSO is an administrative sanction, imposed by the INVIMA when the NSO does not comply with legal requirements (e.g. when the applicant fails to provide product instructions). This sanction can be cancelled upon the title holder´s request and the fulfillment of said legal requirements.
For further information, click here (Spanish only).
