New deadlines for withdrawing medicines from the market and applying new ceiling prices

Botes de medicinas y el logo de CorralRosales

Through Resolution No. STFP-04-714-2022, published on May 3, 2022, the Board of Medicines Prices Regulatory Authority provided:

  1. Until November 17, 2022, the medicines whose secondary packaging are marked with selling prices according to Appendix B of Resolution No. 10-2015 issued on August 19, 2015 (hereinafter, “Appendix B”), which was repealed by Resolution No. STFP-07-706-2021 published on November 22, 2021, shall be withdrawn from the market.
  2. By November 18, 2022, the medicines affected by the repeal of Appendix B must be sold at the new ceiling prices.

Mario Fernández - Boletín CorralRosales - Derecho Corporativo - Contratación Pública - Sector Eléctrico - Ecuador

Specialist in Corporate Law
Mario Fernández, senior associate at CorralRosales
mfernandez@corralrosales.com
+593 2 2544144

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NOTE: The above text has been prepared for informational purposes. CorralRosales is not responsible for any loss or damage caused as a consequence of acting or not acting on the basis of the information contained in this document. Any additional determined situation requires the specific opinion and concept of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Extension for the submission of financial statements

Edificio circular blanco más el logo de CorralRosales

By Decision No. SCVS-INPAI-2022-00003228 dated on April 22, 2022, the Superintendent of Companies, Securities and Insurance resolved to extend the deadline for the submission of financial statements and corresponding reports for fiscal year 2021 to May 31, 2022.

Foto cuadrada de Milton Carrera, asociado senior de CorralRosales

Specialist in Corporate Law
Milton Carrera, senior associate at CorralRosales
mcarrera@corralrosales.com
+593 2 2544144

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NOTE: The above text has been prepared for informational purposes. CorralRosales is not responsible for any loss or damage caused as a consequence of acting or not acting on the basis of the information contained in this document. Any additional determined situation requires the specific opinion and concept of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Job security for alternate union leaders

Edificio de cristal con el logo de CorralRosales

In Resolution 02-2022 -published in Official Gazette 40 on April 11, 2022- the National Court of Justice invoked the principles of equality, freedom of association/trade union freedom, and progressive development of rights, issuing a mandatory jurisprudential precedent:
 
The alternate leaders of workers’ associations have the same guarantees as the [workers’ associations’] official leaders, in accordance with Article 187 of the Labor Code” (emphasis added).
 
This means that alternate union leaders enjoy job security that prevents them from being fired by their employers. In the event that they were to be fired, such matter would be considered ineffective dismissal, with the consequences that this entails. Specifically, the employer in question would be obliged to reinstate the individual to their job and pay them any unpaid wages plus a 10% surcharge; or alternatively, pay additional compensation equivalent to 12 months of remuneration to effectively terminate the employment relationship.

Edmundo Ramos

Specialist in Labor Law
Edmundo Ramos, partner at CorralRosales
eramos@corralrosales.com
+593 2 2544144

Marta Villagómez

Specialist in Labor Law
Marta Villagómez, associate at  CorralRosales
mvillagomez@corralrosales.com
+593 2 2544144

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NOTE: The above text has been prepared for informational purposes. CorralRosales is not responsible for any loss or damage caused as a consequence of acting or not acting on the basis of the information contained in this document. Any additional determined situation requires the specific opinion and concept of the firm in Quito / Guayaquil, Ecuador.

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Payment facilities for the tourism sector due to COVID-19

Edificio de cristal con el logo de CorralRosales
Trough Resolution C.D. 645 -published in the Official Gazette of April 13, 2022- the Board of Directors of the Ecuadorian Social Security Institute (hereinafter, “IESS” or “Social Authority”) issued the “Regulation of Payment Facilities for the Tourism Sector, in application of the Organic Law for Economic Development and Fiscal Sustainability after the COVID-19 Pandemic” (hereinafter, the “Regulation“).
  1. Scope of application

Employers registered in the National Tourism Registry shall be eligible for the benefits contemplated in the Regulation.

  1. Payment facilities

Employers that comply with the requirements and have not paid the obligations hold with the Social Authority during the period between January 2020 and December 2021, may submit to the Social Authority a request to pay the outstanding obligations within a term of up to 48 months. 

IESS will eliminated interest, fines and surcharges that were generated during the aforementioned period, provided that the employer complies on time with the payment of the installments. In case of non-compliance, interest, fines and surcharges will be paid in accordance with applicable regulations.

The debtor may request early payment of the debt to the Portfolio Management Units of  the Social Authority.

  1. Payment default

Breach on the payment agreement will be reflected on the certificate of compliance of the Social Authority.

  1. Documents that must be attached to the request
  • Inscription in the National Registry of Tourism.
  • The updated Single Annual License of Operation, granted by the Municipality in which the tourist establishment operates.
  • Titles of credit of the periods from January 2020 to December 2021 are unpaid.

Edmundo Ramos

Specialist in Labor Law
Edmundo Ramos, partner at CorralRosales
eramos@corralrosales.com
+593 2 2544144

Marta Villagómez

Specialist in Labor Law
Marta Villagómez, associate at  CorralRosales
mvillagomez@corralrosales.com
+593 2 2544144

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NOTE: The above text has been prepared for informational purposes. CorralRosales is not responsible for any loss or damage caused as a consequence of acting or not acting on the basis of the information contained in this document. Any additional determined situation requires the specific opinion and concept of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

The price of a barrel of crude oil continues above USD 100 – Teleamazonas

Rafael Serrano, asociado senior de CorralRosales, entrevistado por una periodista de Teleamazonas para hablar sobre el precio del barril de crudo en Ecuador - Vídeo subido a YouTube

DETAILS

DATE: 12-04-2022

PROFESSIONALS IN THE NEWS:

-Rafael Serrano

MEDIA:

Teleamazonas

In Ecuador, the increase in the price of oil leads to the fact that the income of resources to the Ecuadorian State remains in positive terms. The media Teleamazonas asks about this to our senior associate, Rafael Serrano, an expert lawyer in Energy issues, who considers that the trend of the international oil price will be maintained. Therefore, he believes it is important to consider other costs.

According to the Minister of Energy, Juan Carlos Bermeo, this does not mean that everything is income for the country, “because the increase in the price of oil means, in parallel, the increase in the price of fuels and what is required to import fuels, whether gasoline or diesel, is a greater amount of resources”.

Rafael Serrano, when asked about this matter, answers that “this for the country, obviously, will generate greater benefits, greater income, because a lower value was budgeted, but we also have to consider the increase in production costs in many areas: transportation costs, among others, which will make certain products more expensive”.

As a consequence of the above, the Government plans, among its future projects, a process of delegation to the private sector of the Esmeraldas Refinery. This is aimed at reducing the amount of waste and producing Euro 5 grade fuels. For this, the opinion of our expert is based on the fact that “seeking the help of the private sector through public-private alliances” is, in his opinion, “a very good mechanism to develop the Esmeraldas Refinery and to see alternatives that can be developed within the country to produce these derivatives here in Ecuador and thus make them cheaper”.

A greater use of associated gas is also expected for its use in electricity generation and industry, “cleaner and at a much lower cost”, adds the Minister.

If you want to see the full video, click here.

Living wage 2021

Edificio de cristal con un montón de ventanas + el logo de CorralRosales

On March 18th, the Ministry of Labor – by Ministerial Agreement MDT-2021-087- set the living wage for 2021 and established the payment procedure.

  • Living wage

The value of the monthly living wage for 2021 was set at US$447.41.

  • Economic compensation calculation period

To calculate the economic compensation of the living wage, employer shall consider income received by the employee from January 1st to December 31st, 2021.

If employees worked for a shorter period than the aforementioned, calculation will be proportional to the time worked.

  • Procedure to calculate economic compensation

The economic compensation to which workers whose monthly income is not less than the living wage are entitled, is the difference between the living wage for the year 2021 and the monthly income that the worker received during 2021.

To calculate employee´s monthly income, the following amounts received during the calculation period must be added and divided by 12:

  • Salary
  • Thirteenth remuneration
  • Fourteenth remuneration
  • Commissions or incentives paid by the employer.
  • Profit sharing
  • Additional benefits paid in cash by the employer
  • Reserve funds

In the case of part-time employees, economic compensation will be calculated proportionally to the hours worked. The ordinary workday is 240 hours per month.

  • Payment deadline

The economic compensation shall be paid until March 31, 2022.

  • Registration before the Ministry of Labor

Once the employer registers the labor profit sharing form of year 2021, the Ministry of Labor’s platform will generate the payroll of the employees entitled to the economic compensation to reach the living wage.

Edmundo Ramos

Specialist in Labor Law
Edmundo Ramos, partner at CorralRosales
eramos@corralrosales.com
+593 2 2544144

Marta Villagómez

Specialist in Labor Law
Marta Villagómez, associate at  CorralRosales
mvillagomez@corralrosales.com
+593 2 2544144

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NOTE: The above text has been prepared for informational purposes. CorralRosales is not responsible for any loss or damage caused as a consequence of acting or not acting on the basis of the information contained in this document. Any additional determined situation requires the specific opinion and concept of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Controversial SENADI proceedings highlight need to fight corruption within the authority

Bandera de Ecuador ondeando como foto principal del artículo publicado por la asociada de CorralRosales Katherine González en el medio online WTR

DETAILS

DATE: 24-02-2022

PROFESSIONALS IN THE NEWS:

-Katherine González

MEDIA:

WTR

The National Intellectual Rights Service (SENADI hereinafter) in Ecuador is in the news for the questionable decision made when registering a trademark. Our associate Katherine González has written about this specific case for WTR, an article that we summarize below.

 On 10 June 2020, Quirovara Tax Company SA applied for the mark DON BENJA (and logo) in Class 31, specifically “bananas and Musaceae.” On the other hand, Arbelaez Valencia Hermanos Coffee Roaster Mejía SA filed an Andean opposition based on the trademark DON BENJA, which covers the following goods of Class 31: “agricultural, horticultural, forestry products and grains not included in other classes; live animals; fresh fruits and vegetables; natural plant and flower seeds; animal feed; malt.”

 In November, SENADI began its unusual registrability study: rejected the Andean opposition, and granted, to everyone’s surprise, the registration of DON BENJA trademark for class 31, in favor of Quirovara company. In its resolution, SENADI:

  • Accepted that the marks were similar;
  • Accepted that the marks protected the same goods;
  • Acting ex officio, and against the applicable Andean law, reviewed a webpage and used this information to determine the main economic activity of the opponent, ignoring the goods listed in the registration certificate that was the basis of the opposition; and
  • Accused the opponent of trying to arbitrarily extend the protection of its trademark in relation to its commercial activity, again ignoring the basis of the opposition and the protection granted by the trademark.

Regarding the registrability of trademarks, Article 136 of Decision 486 of the Andean Community establishes as follows:

“Those signs whose use in commerce unduly affects a third party’s right may not be registered as trademarks, in particular where:

  • They are identical or similar to a trademark previously applied for registration or registered by a third party, for the same products or services, or for products or services in respect of which the use of the trademark may cause a risk of confusion or association (…)

SENADI´s resolution

On 8 December 2021, SENADI issued a resolution stating that an adequate trademark comparison had not been carried out, and requested the highest administrative Authority, through an ex officio review procedure, to decide whether the applied-for mark should be granted. This request implies that the parties were denied appeal rights, as the appeal authority would already have issued a decision.” Katherine states.

Seven days later, SENADI annulled the office action as being “inadmissible”. It found that it contravened Article 76 of the Constitution. The next day, on December 16, 2021, through Resolution No SENADI-2021-RS-14973accepted the voluntary cancellation of the trademark DON BENJA by Quirovara. The cancellation request had been filed only the day before

This situation is surprising, since, as mentioned by our associate, “Usually, the voluntary cancellation process takes between six and 12 months; however, in this case, this request was submitted and accepted within 24 hours.” She also adds that “It is noteworthy that the agent who filed the mark in dispute was the SENADI director deciding on the matter, who immediately resigned after the resolution became public.”

Conclusion

For González, this case highlights the urgent need for SENADI to:

  • Train its officials so that all actions are carried out in accordance with national and Andean regulations;
  • Strictly apply the legal norm requiring the processing of cases in a chronological order; and
  • Fight strongly against corruption.

“If these recommendations are applied, it is expected that the negative impact on users will decrease considerably, the quality of SENADI’s decisions will improve, and its reputation will recover”, she concludes.

If you want to read the complete news (under registration), click here

Investments in Ecuador: implications of Law of Economic Development and Fiscal Sustainability

Inversiones en Ecuador - Implicaciones de la Ley de Desarrollo Económico y Sostenibilidad Fiscal - CorralRosales

DETAILS

DATE: 07-02-2022

PROFESSIONALS IN THE NEWS:

-Andrea Moya

MEDIA:

LexLatin

The new article published by LexLatin, where you can read the interview to Andrea Moya, our partner and leader of the tax area of the firm, discusses investments in Ecuador: implications of the Law of Economic Development and Fiscal Sustainability.

Objective of the Law of Economic Development and Fiscal Sustainability

Moya explains that the main objective of this Law, which is the only project of the Lasso administration that is in force, is to provide the State with additional resources with which to reduce the fiscal deficit and organize public finances. She adds that “temporary wealth taxes were established, a tax regime was created to regularize assets abroad, the income tax that will affect the highest income earners was increased (…) and certain elements of the same tax were simplified. These elements include the elimination of tax incentives for investments in basic industries, prioritized sectors and public-private alliances that had been created in previous years”.

What are the main challenges of the Law of Economic Development and Fiscal Sustainability, considering that we still have to deal with the pandemic?

Our partner answers this question by placing special emphasis on the fact that “it is important to distinguish the medium- and long-term objectives proposed by the Law, such as the organization of public finances in the face of current issues such as the pandemic”. To this she adds that the reduction of the fiscal deficit, ”is expected to boost the economy with the creation of quality employment, which is the greatest need of Ecuador”.

What are the main regulatory changes in customs and foreign trade that are implemented with this Law?

For Moya, the key is the exclusion of the value of freight for the calculation of customs duties. This was done to reduce its impact on the cost of imported goods and to curb the effect of the significant increase in freight rates in the world market. In addition, this Law, “includes reforms to reduce the time of administrative processes in charge of the Customs Authority, implement technological systems for customs control and the implementation of advance consultations to provide security to the importer on the treatment that will be given to the goods.

In this same area, the Government is negotiating several trade agreements with the objective of facilitating access to international markets for exports.

If you want to read the full article, click here

Acquisition of pharmaceuticals and strategic health goods

Boletín de CorralRosales sobre fármacos y bienes estratégicos de salud - Foto de medicamentos, laboratorio

Through Executive Decree No. 337 issued on January 27, 2022, published in the Official Register (Fourth Supplement) No. 630 of February 1st, 2022, the Law of the National Public Procurement System Regulations (hereinafter the “Regulation”) were amended replacing the Section related to the “ACQUISITION OF PHARMACEUTICALS AND STRATEGIC HEALTH GOODS”. The purpose of this reform is to achieve greater controls, have adequate planning, guarantee the quality of public expenditure, and avoid shortages of health units that are part of the Integral Public Health Network (IPHN).
The main aspects of this reform are:

1.    In order to select and incorporate the supplier of pharmaceuticals or strategic health goods (hereinafter the “Supplier”) in the electronic catalog of the public procurement portal (hereinafter the “Portal”), the corporate reverse auction procedure will be used.

2.    The entities of the IPHN, together with SERCOP, will select the Supplier that will be included in the Portal. The purchase orders will be generated in the Portal for the acquisition of the health goods they require on an independent and periodical manner.

3.    Once the selection procedure is completed, SERCOP will award the selected suppliers, with whom it will enter into a framework agreement that gives the supplier the right and obligation to be included in the Portal’s electronic catalog. If the framework agreement is not signed, the selected supplier will be declared as a failed awardee.

4.    Once the Supplier is enabled in the Portal, the entities will be able to make direct public purchases by generating the corresponding purchase orders.

5.    For the acquisition of pharmaceuticals, it will be necessary that such goods are included in the current National Plan for Basic Medicines, or their acquisition must be authorized according with the provisions issued by the National Health Authority.

6.    Procedures for the acquisition of pharmaceuticals and strategic health goods:

6.1.    Electronic Catalog: IPHN contracting entities will acquire pharmaceuticals and strategic health goods through this procedure.

6.2.    Exceptionally and in accordance with the provisions of the Regulation, acquisitions may be done through the following procedures:

6.2.1.    Institutional Reverse Auction, as long as the pharmaceuticals or strategic health goods are not available in the electronic catalog under centralized acquisition models.

6.2.2.    Single Supplier of Pharmaceuticals when the manufacturer or supplier is unique in the market and provided that it is not available in the electronic catalog. This will be verified through a market study.

6.2.3.    Acquisition through international organizations or agreements as long as their acquisition optimizes public procurement, guaranteeing the quality, safety and efficacy of pharmaceuticals and strategic health goods to be acquired.

6.2.4.    Direct import when special medications are required for specialized treatments that are not included in the Portal’s electronic catalog.

6.2.5.    For the cases foreseen above, if there are no established procedures for the acquisition, it will proceed in accordance with the legal regulations of the country in which the pharmaceuticals or strategic health goods are contracted, or the commercial practices or business models of international application; or, failing that, respective procedural agreements will be previously subscribed under centralized procurement models.

7.    IPHN procuring entities should perform adequate planning processes for the acquisitions.

8.    Acquisitions will be subject to quality, safety, efficacy, technical data sheets, random post-registration controls, in the places of manufacture, storage, transportation, distribution and traceability. The traceability system will consist of the individual and unequivocal identification of each unit of pharmaceuticals or strategic health goods to be delivered, which will allow monitoring throughout the entire distribution chain.

9.    In order to carry out selection procedures for corporate purchase, an Inter-institutional Committee will be formed composed of the highest authorities or delegates of the SERCOP, Ministry of Public Health, IESS, ISSFA and ISSPN.

10.    All entities, public or private, that participate in the execution of the Decree must ensure the protection and confidentiality of patient data.

11.    When the Supplier does not comply with the purchase orders for pharmaceuticals and strategic health goods generated in the electronic catalog tool by the IPHN entities, the values derived from the execution of the guarantees will be deposited in the SERCOP account to be distributed among the health subsystems of the IPHN.

12.    All medical devices, supplies or goods that currently appear in the catalogs of standardized goods and services, and that could be declared strategic health goods, must maintain this category until the termination of the respective framework agreements.

13.    Until the SERCOP signs the framework agreements with the Suppliers for the acquisition of medicines and strategic health goods whose reference budget does not exceed the coefficient of 0.0000002 of the initial State budget (US$7,099.68), the contracting entities of the IPHN may carry out low value procedures if it is not possible to use any of the procedures established in the Law of the National Public Procurement System on a timely manner. 

14.    Until SERCOP, together with the Interinstitutional Committee, carries out the process of cataloguing medicines and strategic health goods, the IPHN contracting entities may acquire them through the exceptional processes established in the Regulation through centralized or decentralized acquisitions, guaranteeing the supply of these products.

Ricardo Mancheno - Foto en blanco y negro

Specialist in Government Procurement
Ricardo Mancheno, partner at CorralRosales
rmancheno@corralrosales.com
+593 2 2544144

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NOTE: The above text has been prepared for informational purposes. CorralRosales is not liable for any loss or damage incurred as a result of acting or failing to act on the basis of the information contained in this document. Any additional determined situation requires the specific opinion and concept of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES

Compliance plan regarding the implementation of the Data Protection law in controlled entities

Imagen para boletín legal de CorralRosales, firma de abogados de Ecuador. Aparece una imagen oscura con destellos más claros

Through resolution SB-2021-2126 subscribed on December 2, 2021, and published on the Official Gazette 604 of December 23, 2021, the Superintendence of Banks (hereinafter the “Superintendence”) reformed the “Regulations on managing operating risk” (hereinafter the “Regulations”) applicable to “banks, financial service entities and ancillary service entities.”

This reform updated the Regulations to consider the risks arising from the entry into force of the Data Protection Law on May 26, 2021.

Article 23 of the Regulations establishes that controlled entities must “(…) generate plans and programs that allow them to comply with provisions of the Data Protection Law.”

It is relevant to note that in the first transitory provision of the Regulations, the Superintendence states that “(…) it is the controlled entities responsibility to present to the Superintendence of Banks, until March 31, 2022, a compliance plan in relation to all obligations recognized on the Data Protection Law.”

Rafael Serrano, asociado de CorralRosales, con traje y corbata. En el fondo, una parte de Guayaquil (Ecuador)

Specialist in Data Protection
Rafael Serrano, associate at CorralRosales
amoya@corralrosales.com
+593 2 2544144

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NOTE: The above text has been prepared for informational purposes. CorralRosales is not liable for any loss or damage incurred as a result of acting or failing to act on the basis of the information contained in this document. Any additional determined situation requires the specific opinion and concept of the firm in Quito / Guayaquil, Ecuador.

CORRALROSALES