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Ecuador reaches milestone in test data protection | Learn about our role throughout the years

 

In a significant achievement following two years of dedicated work, Ecuador's National Service of Intellectual Rights (SENADI) issued several administrative acts that solidified data protection in the country, marking a crucial advancement in intellectual property and innovation. This article highlights the accomplishments made in 2020 in data protection in Ecuador and its relevance to the pharmaceutical and agrochemical industries.


I. Legal and Regulatory Progress:

After two years of dedication, SENADI issued administrative acts affirming the full validity of data protection in Ecuador. Furthermore, it instructed the country's regulatory authorities to implement the necessary mechanisms to ensure the confidentiality of this crucial information for new medicines and agrochemical products. This achievement was supported by a mandatory opinion issued by the Office of the Attorney General, confirming SENADI's stance.


II. Contribution of Meythaler & Zambrano Law Firm:

Over the past two years, our Legal Firm played an active role in promoting and defending data protection through the organization of academic events and the publication of specialized material in Quito and Guayaquil. Several of our attorneys participated in international forums and contributed articles that received awards in specialized journals.


III. Acknowledgment of Authorities:

The courage and consistency displayed by SENADI and the Office of the Attorney General deserve special recognition. Regulatory authorities such as ARCSA and AGROCALIDAD have also demonstrated a strong commitment to legality and have initiated processes to ensure the proper execution of Ecuador's commitments.


IV. Data Protection before 2020:

Before 2020, data protection in Ecuador was based on trade secrets, which proved insufficient to prevent its indiscriminate use. Despite certain court rulings in support of fair competition, the legal protection was considered inadequate.


V. Progress towards Exclusivity:

The 2016 INGENIOS Code already stipulated that data protection should be provided under an exclusivity system, but its implementation posed a challenge. Industry associations IFI and INNOVAGRO worked to harmonize Ecuadorian legislation with international standards and promote data protection through exclusivity periods of 5 and 10 years for new medicines and agrochemical products.


VI. Concrete Results in 2020:

In August 2020, ARCSA issued an administrative act recognizing automatic data protection when granting a sanitary registration that required the submission of data. This ensures the validity of data protection exclusivity for medicines.


For agrochemical products, the Office of the Attorney General confirmed that AGROCALIDAD is the competent authority to approve marketing and grant exclusivity periods when undisclosed data is submitted.


VII. Conclusions

Data protection in Ecuador represents a milestone in intellectual property and fosters innovation. These legal advancements provide security to innovators and ensure that unauthorized competitors do not misuse data. If you need guidance on data protection for your pharmaceutical and agrochemical products, please do not hesitate to contact us: info@lmzabogados.com


VIII. ASIPI WEBINAR

📊 Our panelists include our partner and life science lawyer expert, Karina Loza Santillán, Maritza Reátegui Valdiviezo, and the moderator, Natalia Castro Velez. Register for the event by clicking on the following link:


MZ - PROTECCION DE DATOS DE PRUEBA EN EC
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Legal disclaimer

The content of this blog is provided for informational and educational purposes only and should not be considered legal advice. Regulations in Ecuador are subject to changes and updates that may affect the applicability and accuracy of the content published here. We do not guarantee that the information presented is accurate, complete or current at the time of reading. Therefore, past postings should not be construed as necessarily reflecting current regulations. We strongly recommend that you consult with our qualified attorneys for specific and personalized advice.

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