(MDT-2020-220)
(MDT-2020-221)
(MDT-2020-222)
(MDT-2020-223)
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On November 4, 2020 the National Court of Justice issued a ruling within the judicial process 17751-2020-00001 by which it declared that the Regulation SENAE-SENAE-2019-0049-RE (Regulation) issued on June 26, 2019 by the General Director of the Customs Authority was void.
The Regulation established that importers were not able to file customs import declarations if they had any unpaid obligations with the Tax or Customs Authorities. The National Court of Justice resolved that this condition could not be established by a regulation, since it exceeds the legal power of the general director of the Customs Authority.
Once the Regulation has been declared void, importers may file customs import declarations even if they have outstanding obligations with the Tax or Customs Authorities.
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By Regulation No. RE-SERCOP-2020-0111 of September 23, 2020, the Regulation No. RE- SERCOP-2016-0000072 was amended (hereinafter, the “Regulation”), replacing Chapter II of Title VIII, relative to the “ACQUISITION OF DRUGS OR STRATEGIC GOODS IN HEALTH THROUGH A SPECIAL REGIME”. The main aspects of this reform are the following:
1. The Corporate Reverse Auction procedure is regulated for the selection of suppliers of drugs or strategic health goods (hereinafter and collectively, the “Products”) for the acquisition of the Products.
2. The Corporate Tender procedure is regulated for the selection of service providers for the storage, distribution and delivery or dispensing of drugs or strategic health goods (hereinafter, the “Services”) for contracting the Services.
3. It is established that the suppliers that participate in corporate purchase procedures must declare that they have no connection with other participants.
4. The attributions of the Inter-Institutional Committee are regulated, mainly in the preparatory and contractual execution stage of the procedures for the acquisition of the Products and the contracting of the Services. This Committee is different from the Technical Commission, which will act in the pre-contractual stage.
5. As a result of the Corporate Reverse Auction and Corporate Tender procedures, the respective corporate framework agreements will be signed and the Products and Services will be included in the virtual directory of SERCOP´s Portal of PUBLIC PROCUREMENT (hereinafter, the “Directory”), for their acquisition or contracting, respectively, through purchase orders.
6. It is established that the termination of a corporate framework agreement will not necessarily generate the sanction of a non-compliant contractor.
7. The obligations of the suppliers of the Products or Services are regulated, without prejudice to those established in the specifications of the selection procedure, the corporate framework agreement and the purchase orders. In the case of Service providers, the following obligations stand out:
7.1. The provision of a “continuity of service guarantee” that ensures the Services’ provision, even in the event of early and unilateral termination of the respective corporate framework agreement.
7.2. The implementation of a technological solution to monitor the Products’ route in real-time.
7.3. The implementation of a technological solution for the registration, administration, and control of stock and inventories in collection centers, warehouses, pharmacies, medicine cabinets, and other units or areas necessary to comply with the Services.
7.4. The creation of tickets for Products not delivered in health establishments for causes attributable to the supplier. Through the tickets, the patient will be able to withdraw the Products in the private pharmacies network associated with the supplier at a national level or with those subject to a previously signed agreement.
8. It is mandatory for the contracting entities that make up the Integrated Public Health Network (“IPHN”) to acquire the Products and contract the Services through the Directory. Only when the Product does not appear in the Directory, these entities may avail themselves of other contracting procedures.
9. It is established that the contracting entities of the IPHN will centralize the acquisition of the Products. Each IPHN health subsystem must define the entity or administrative body (contracting entity) that will be responsible for the centralized generation of purchase orders, in accordance with its planning.
10. It is the obligation of the contracting entities of the IPHN to contract the Services before the acquisition of the Products, except in cases of contracts related to small amount and emergencies, or when the Products are received by donation.
11. Contracting entities that do not belong to the IPHN will not be obliged to verify and acquire the Product or contract the Services through the Directory. These entities may directly use other procedures provided by law.
12. The public contracting entities that are not part of the IPHN will preferably use the Institutional Reverse Auction procedure for the selection of suppliers and acquisition of the Products. The contracting entities that are part of the IPHN may use this procedure as long as the amount exceeds the one established for a small amount procedure, and the Products are not available in the Directory for direct purchases.
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By Resolution No. SCVS-INC-DNCDN-2020-0015 issued on September 14, 2020, and published in the Special Edition Number 1071 of the Official Registry of September 25, 2020, the Superintendency of Companies, Securities and Insurance issued the Regulation of the Simplified Stock Corporations (S.A.S.)
The main aspects of the Regulations include
1. The determination of the legal existence of a S.A.S. starts with its registration in the Registry of Companies of the Superintendency of Companies, Securities and Insurance.
2. The shareholders of a S. A. S. will only be responsible for the amount of their respective shares, unless they expressly waive it in writing.
3. The impossibility of negotiating it´s own shares in the stock market. Notwithstanding being able to negotiate shares issued by other mercantile societies or other negotiable securities, according to the law of the matter.
4. The incorporation of the Simplified Stock Corporations will be done through private documents unless the assets contributed require a public deed. In this case, the public deed must be registered in the corresponding Registry Office.
5. The process of electronic incorporation of the S.A.S. is hereby established, and the SCVS is required to keep its online system open so that all users can access consultations, certifications, and access all the relevant corporate information of the S.A.S.
6. Foreign companies that are founders and shareholders of a S. A. S. must present a certificate of incorporation and legal existence issued by the authority of the corresponding country. The capital of the foreign company must be represented in shares, participations or nominative papers.
7. The document of incorporation of the S.A.S. will have a presumption of stability, enforceability, and execution. Consequently, it may not be revoked, cancelled or annulled, unless expressly provided by competent Judge.
8. It shall establish the rules of the capital and shares of the S.A.S., their organization, statutory reforms, reorganization, dissolution, liquidation, reinstatement and cancellation.
The Regulations of the Simplified Stock Corporations also govern, among other things, the procedure for the resolution of corporate conflicts, causes of voluntary removal of shareholders, payment of dividends, presentation of corporate/financial documentation, management reports, and balance sheets, removal of shareholders, digital corporate books, and the liability of the shareholder before the company for the abuse of his voting rights, when seeking his own benefit or that of a third party.
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Test data is the necessary information required by the health Authority to approve the marketing of a medicine or agricultural chemical product in order to guarantee its safety and efficacy. This information is protected by intellectual property regulations to avoid possible unfair commercial use. Ecuador has signed several international instruments that impose the obligation to guarantee the protection of this data. Internal regulations have developed this protection.
When we talk about intellectual property, we usually think exclusively about patents, trademarks and copyrights, however, there are some other modalities that are also part of intellectual property, such as, for example, test data. The importance of its protection lies in avoiding the use, by unauthorized third parties, of valuable information about the research and development process of a novel product, activities that demand a considerable economic and human effort on the part of its creators.
Test data is often associated with patents; however, these are figures that, although both are closely related to the development of drugs and agrochemicals, the test data has independent protection.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) established a minimum standard of protection to prevent unfair commercial use of test data[1]. Similarly, Decision 486 of the Andean Community provides for this special protection “against any disclosure, except when necessary to protect the public, or unless measures are adopted to guarantee data protection, against any unfair commercial use.[2]”
In the Trade Agreement between the European Union and its Members on one hand and Colombia, Peru and Ecuador on the other, the protection of undisclosed information is included within the intellectual property rights.[3]
In the aforementioned international instruments, although the protection of test data is established as an obligation for the Members, a specific period of time is not foreseen for its material protection, which is therefore regulated by each State. However, in the case of Ecuador, the Organic Code of the Social Economy of Knowledge, Creativity and Innovation establishes:
“Article 508.- Test Data.- Test data or other undisclosed data on safety and efficacy of pharmaceutical products and agricultural chemical products, in accordance with the provisions of Article 27 number 7 of the Organic Law of Market Power Control, when the information contained in the data meets the following conditions:
Article 509.- Exclusivity of test data.- When the competent authority requires as a condition to approve the commercialization of pharmaceutical or agricultural chemical products that contain new chemical entities, the presentation of test data or other undisclosed information on safety and efficacy, whose elaboration demands a considerable effort, will be granted an exclusivity period of five years from the date of marketing approval for pharmaceutical products, and ten years for agricultural chemical products. “
Thus, Ecuador has provided a period of five and ten years of exclusivity for the protection of test data on drugs and agricultural chemicals, respectively.
The National Service for Intellectual Rights -SENADI- has reiterated that, although the Agency for Regulation and Control of Phytosanitary and Zoosanitary and the Agency for Regulation, Control and Sanitary Surveillance are the entities in charge of defining the requirement to submit test data prior to granting a marketing authorization and to define its deposit and safeguard procedures, the test data protection system remains in force and that said protection is without a doubt a modality of Intellectual Property.[4]
On August 21, 2020, the State Attorney General’s Office issued a statement regarding agrochemical products expressly stating that, since the Agency for the Regulation and Control of Phytosanitary and Animal Health – AGROCALIDAD- is the competent Authority to approve the commercialization of agricultural chemical products, it is also responsible for granting the period of exclusivity when it has required the submission of test data on their safety and efficacy.[5]
This protection system and the corresponding establishment of a period of time for the exclusivity of the test data guarantees that, at least during that period, any interested party who intends to market a medicine or agrochemical product with a new chemical entity, must carry out their own studies and trials that prove its effectiveness and efficacy. Thus, avoiding the use of test data that have already been developed by a third party. Hence, it is vitally important that the public entities called upon to intervene in this protection system work in an integrated manner to ensure compliance with these international and national provisions.
[1] “Article 39 (…) 3. Members, when they require, as a condition for approving the marketing of pharmaceutical products or agricultural chemical products that use new chemical entities, the submission of undisclosed tests or other data, the preparation of which requires considerable effort , will protect that data against any unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure the protection of data against unfair commercial use. ”
[2] “Article 266.- The Member Countries, when they require, as a condition to approve the commercialization of pharmaceutical products or agricultural chemical products that use new chemical entities, the presentation of undisclosed test data or other, whose elaboration involves a considerable effort, will protect those data against any unfair commercial use. In addition, Member Countries will protect this data against any disclosure, except when necessary to protect the public, or unless measures are adopted to guarantee the protection of the data, against any unfair commercial use. The Member Countries may take the measures to guarantee the protection enshrined in this article. ”
[3] “5. For the purposes of this Agreement, intellectual property rights include: (…)
[4] Official Letter No. SENADI-DG-2019-0402-OFLetter
[5] Official Letter No. OF-PGE-09818
Katherine González H.
Associate at CorralRosales
katherine@corralrosales.com

Why can having a secondment lawyer be advantageous for a company? The needs in the field of business have changed over time; having quality legal advice at the right time has become essential. Not all companies have an in-house legal team and, if they do, it is usually a small team that is very busy with the core business of their company; therefore, they usually look for one or more external firms to provide the necessary support when needed.
Sometimes unexpected needs arise, such as large projects or new lines of business that require specialized attention and special advice. It is then when a lawyer in secondment can be an excellent solution for the company.
This service consists of assigning the company a lawyer from a trusted firm to temporarily form part of the in-house legal team allowing said in-house team to focus on the core business and its internal client. Thus the qualified reinforcement, who also has all the usual support of the firm, can take on any special project; it could be M&A, a new line of business, any complex labor or intellectual property issues, among other options.
The decision to have an external lawyer within the team can result in great benefits for all types of companies, from start-ups, through medium-sized companies, or large multinationals that need quality legal solutions. In addition to having a full-time external lawyer dedicated to their matters, they will continue to have the support and experience of their own legal team.
In this way, the company receives a personalized, continuous service adapted to the specific situation and industry. The immediacy and development of the relationship with the lawyer from the trusted firm will redound to benefits for both parties.
What are the benefits of choosing an in-house service?
In addition to being advantageous for the client company, this will provide greater tools to the lawyer who will become part of the in-house team temporarily. In this way, he will be at the center of the client’s business, deepening into the knowledge of the client’s day-to-day life and learning about their policies and ways of doing business. Once this period is over, the lawyer will get to know his client in depth and will bring this experience back to his usual team, generating benefits for all the parties involved.
Rafael Rosales
Partner at CorralRosales
rrosales@corralrosales.com

By legal provision, previously, acts and contracts had to be performed and granted before a Notary Public as a single act. Thus, all the deeds and some proceedings conclude with the famous phrase “before me, in my presence as a single act, to which I attest.-”
Ecuador had to wait for a pandemic that paralyzed a large part of the sectors to realize that technological-telematic means are useful and allied tools in all areas, which energize productive activities, including those who provide legal services.
Now, it is possible to hold mediation hearings by any technological means through the centers authorized by the Judiciary Council and to sign the corresponding minutes with electronic signatures. It is also allowed to hold judicial, arbitration and constitutional hearings by these means. However, certain regulations already did establish the appearance at proceedings and hearings through telematic means before confinement. Since the entry into force of the Organic Law of Humanitarian Support to Combat the Health Crisis Derived from Covid-19 on June 22, 2020, it is possible that certain acts, contracts and notarial proceedings be carried out by telematic, electronic or remote means . For this purpose, the Judiciary Council had to issue the corresponding regulations in which it determines the acts, contracts and proceedings that, because they require the physical intervention or the verification of the intervening parties, cannot be carried out with the appearance of the grantors or participants through the use of telematic, electronic or remote means.
Resolution 075-2020 of the Plenary of the Judiciary Council, issued on July 7, 2020, contains the Regulation for the Progressive Implementation of Acts, Contracts and Notarial Proceedings through the Use of Electronic Means and Reduction of Fees (hereinafter the “ Regulation ”). It established two phases. In the first one, article 3 of the aforementioned Regulation provides the following acts, contracts and proceedings that may be carried out electronically:
All requests for voluntary jurisdiction that are presented before a notary public by grantors who have an electronic signature may be sent electronically. Likewise, notaries may receive the corresponding minutes submitted by the attorneys who require the service, provided they have an electronic signature.
In the second phase, it was established that the Council of the Judiciary will decide on the inclusion of new acts, contracts and notarial proceedings, once the corresponding budgetary allocations are in place. It should be noted that the Judiciary Council, aware of the technological difficulties, did not provide that these acts, contracts and proceedings be compulsorily executed by these means, which implies that it will be optional for users of the notarial system.
Resolution 083-2020 of the Plenary of the Judiciary Council dated July 28, 2020, approved the Operational Instructions for the Progressive Implementation of Acts, Contracts and Notarial Proceedings through the Use of Electronic Means. which made the operational scope of the acts, contracts and proceedings feasible by electronic means, as referred to above. However, so far phase two foreseen in the Regulation has not initiated.
In conclusion, the use of electronic means for notarizations is not a novelty, but the inclusion of other acts and contracts has been a significant advance in favor of the speed of business and in judicial and arbitration activity that have been seriously affected by the pandemic. However, the legislators and the Judiciary Council remain in debt. The former because it gave the Council the power to limit the acts, contracts and proceedings that could be entered by electronic means; and, the latter, because it limited them too much. Let us hope that the Judiciary Council includes other acts, contracts and necessary procedures in the execution of the planned phase two.
Ramón Paz y Miño
Senior Associate at CorralRosales
rpazymino@corralrosales.com

MEDIA: World Trademark Review
Our associate Katherine González publishes an article in the specialized media World Trademark Review in which she comments on SENADI’s decision to reject Discovery’s opposition against the registration of the trademark DOKI MAS LOGOTIPO, based on its previous trademark DOKI. On appeal, the Intellectual Property Office ruled that the fact that two trademarks belong to different classes does not necessarily imply that there is no confusion between them and that there was a direct relationship between their goods and services.
In the text, González explains that, initially, SENADI granted the registration of the DOKI MAS LOGOTIPO brand for class 44 services; SENADI considered that there was no risk of confusion with the DOKI registered trademark, since the latter belonged to a different class. In the appeal to this registration, the Intellectual Property Office accepted the opponent’s arguments and established that the fact that two trademarks that belong to different classes is not a determining criterion to assess the risk of confusion between them.
“In the first instance, SENADI rejected the opposition and granted the registration because there was no risk of confusion or association for consumers. Despite the fact that the trademarks shared an identical word element, they covered products / services of different classes. Discovery appealed this decision presenting a clear and detailed list of the products and services in question and arguing that, despite the difference in classes, the trademarks were intended to protect the products and services that were directly related and complementary “, details our associate.
“The decision confirms the importance of carrying out a detailed and specific analysis in each case, in the event of possible trademark litigation,” adds González, who believes that this decision is very important due to the large number of products offered for sale online.
If you want to see the article (under registration), click here.

MEDIA: Teleamazonas
The project of the Organic Health Code (COS) has been vetoed by the Executive affecting several sectors of Ecuador. One of those that has not been affected has been the cannabis sector; the news channel Teleamazonas interviewed our Partner and President of the Ecuadorian Association of Cannabis Industries Felipe Samaniego to provide his expert legal vision on this situation.
“This entire industry that is developing around cannabis and hemp definitely does not stop,” Samaniego said in this interview.
The Legal Secretary of Carondele Johana Pesántez argued the veto saying that the COS “contains an extensive development of technical issues in health matters that suffers from inaccuracies, erroneous definitions and an unclear health system structure in terms of competencies and responsibilities; it lacks a true update in terms of focus and content according to the requirements of society and the world “.
Last year, the National Assembly approved reforms to the COIP that allowed the production and distribution of products made from cannabis. This reform decriminalized the use of this plant for medicinal purposes, but the legal framework that allows its commercialization is still lacking.
With reference to this, Felipe Samaniego assures that there are two “authorities that must intervene. One for cultivation and the other for what is already the finished product. What the Ministry of Agriculture is doing is regulating what contains less than 1 % THC and the Ministry of Health must regulate what has 1% or more “, explains our Partner.
After the interview with Samaniego, the news published by Teleamazonas gathers the opinion of other experts who see in this veto an opportunity for the cannabis industry to continue growing. They also hope that this industry can advance with the production and generation of resources for Ecuador with the issuance of regulations with the respective legal framework.

Resolution NAC-DGERCGC20-00000060 issued on September 29, 2020 and published in the Special Edition of the Official Registry 1100 on September 30, 2020, the Director of the Internal Revenue Service established the rules for applying the tax regime for small businesses.
The Internal Revenue Service will be able to include or exclude ex officio in the register of small businesses those taxpayers who fulfill or no longer fulfill the conditions to be considered as such. This registry will be published on the IRS website until September 30 of each year.
Taxpayers will be subject to this regime from the first day of the fiscal year following their inclusion of the registry.
The ex officio exclusion will be executed without the need for prior notice and will take effect from the first day of the fiscal year following that exclusion.
Taxpayers who have been subject to the regime for 5 years will cease to be part of it from the first day of the year following the date on which the maximum time was reached.
When taxpayers consider that their inclusion or exclusion from the regime is not appropriate, they are able to file a petition to have that decision reviewed in a term of 20 days counted from the publication of the registry.
When obtaining the tax registry (RUC), the taxpayer must inform the Tax Authority all its economic activities, the income that might be derived from such activities and the number of workers.
If the taxpayer fulfills the conditions to be considered as a small business, it will be able to start its activity under the small business regime. Otherwise, he will begin its activity subject to the general regime and the authority is able to include the taxpayer in the regime ex officio.
Taxpayers who exclusively develop one or more of the following activities will not be subject to the small business regime:
Taxpayers subject to the small business regime must comply with the formal and material obligations set forth in the law, including the following:
Taxpayers subject to the small business regime are not required to withhold income tax or VAT, except if they are qualified by the IRS as special taxpayers or withholding agents and in other cases established by law.
<p style="text-align: justify;">However, taxpayers under the regime will be subject to income tax and VAT withholding. In the case of income tax, the withholding tax percentage will be 1.75% over the income derived from the business activities subject to the regime. If the taxpayer obtains revenue from sources other than the business activity subject to the regime, such revenue will be subject to the withholding percentages provided in the current tax regulations.If taxpayers subject to the regime have made withholdings, they must declare and pay them as follows:
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