CORPORATE REVERSE DRUGS BIDDING FREQUENT QUESTIONS/FAQ LEGAL SCOPE

1. What is the Second Phase of the Corporate Reverse Drugs Bidding?

It is the procedure by which national and foreign bidders are identified and selected for the provision of drugs for human consumption and use for the Public Integral Health Network (RPIS), made up of the establishments of the Ecuadorian Social Security Institute (IESS) The Social Security Institute of the Armed Forces (ISSFA), the Social Security Institute of the Police (ISSPOL) and the Ministry of Public Health of Ecuador (MSP).
In this Second Phase of the Reverse Corporate Drugs Bidding, the Ecuadorian State plans to acquire a portfolio of approximately 133 types of drugs for orphan, rare and catastrophic diseases that are part of the National Table of Basic Drugs (9th Review) for a total amount which exceeds USD 170 million.
In addition, 80 drugs from the First Phase of the Reverse Corporate Drugs Bidding are added to this portfolio.

2. How can the bidders who are willing to participate in the Second Phase of the Reverse Corporate Drugs Bidding register?

In order to participate in the Second Phase of the Reverse Corporate Drugs Bidding, national and foreign companies shall register in the Registry of Suppliers (RUP).
This is free procedure that is carried out on line through:

• National bidders:
https://www.compraspublicas.gob.ec/ProcesoContratacion/compras/RS/registroMed.cpe

• Foreign bidders:
https://www.compraspublicas.gob.ec/ProcesoContratacion/compras/RPE/rppaso1.cpe

To enter the company information is done easily and quickly in five steps.

1. The foreign drug provider adheres to the terms and conditions for the use of the National Public Procurement Service of Ecuador and declares that all documents that will be uploaded in this platform are legitimate, truthful and are in force.
2. Enter the information in each of the requested fields related to the company, country of location, data of the legal representative domiciled in Ecuador.
3. Choose the medicines that the foreign bidder is able to offer to the Ecuadorian State.
4. Enter the requested information about the exact location of the bidder; main street and surrounding area; postal code and telephone numbers.
5. Load the existence documentation of the pharmaceutical laboratory, in PDF format:

a. Document certified by the competent authority that establishes the legal existence of the company in the country of origin.
b. Certified document that endorses the legal representative of the company in the country of origin.
c. Certified document that endorses the legal representative or legal representative of the company domiciled in Ecuador.
d. Any other documents deemed necessary to support the legal existence and activities carried out by the company.
e. In the CRDB website and its English version, interested parties will find the respective tutorial video to register in the Registry of Bidders

3. Do foreign companies require to be domiciled in Ecuador in order to participate in the Second Phase of the Corporate Reverse Drugs Bidding?

Foreign bidders participating in the Second Phase of the Corporate Reverse Drugs Bidding must have a legal representative or legal representative with fiscal domicile in Ecuador; or have fiscal domicile in Ecuador. This is an indispensable requirement for the award and signing of General Agreements with the Ecuadorian State.
The website of the Second Phase of the Corporate Reverse Drugs Bidding contains the information regarding logistic operators and customs agents in Ecuador.

4. What determines a drug bidder to be awarded?

In order for a bidder to be awarded, it is necessary that he wins a bid or a successful negotiation and that he complies with all the qualifying documentation, as established in the specifications or terms of reference of each procedure for contracting the Second Phase of the Corporate Reverse Drugs Bidding.

5. Which are the qualifying documents that must be submitted by the bidders to be awarded?

The indispensable documents that must be entered electronically by the awarded bidders of the successful bid or negotiation are:

• Certificate of in force drug´s Health Registry issued by the National Agency of Regulation, Control and Health Surveillance (ARCSA).
• Handling Qualification for drugs containing substances subject to auditing issued by the competent authority (in case the drug requires it).
• Detailed description of the offered drug through the Institutional Portal of SERCOP.
• On-line declaration of the legal representative of the bidder whose shares are traded on national or foreign stock exchanges.
• Clear identification of the identity of shareholders, participants or partners (for legal entities), and so on, until transparency is proved of the ownership structure of all companies at the level of natural persons. Online declaration that they are not disqualified from contracting with the State for any of the grounds provided for in articles 62 and 63 of the Organic Law of the National Public Procurement System; and articles 110 and 111 of itsGeneral Regulations. Otherwise SERCOP will disqualify the bidder.

6. How to obtain the Health Registration in Ecuador?

The process of obtaining the Health Registration in Ecuador issued by the ARCSA is done through the Ecuadorian Single Window, which allows the process to be carried out online.
The requirements and detail of this process are published in the following links:

• http://www.controlsanitario.gob.ec/inscripcion-de-registro-sanitario-de-medicamentos-fabricacion-nacional/
• http://www.controlsanitario.gob.ec/inscripcion-de-registro-sanitario-de-medicamentos-fabricacion-extranjera/

You should take into account that, according to Ministerial Agreement No. 586/4711 of the Ministry of Public Health of Ecuador, when companies already have health registrations issued by relevant foreign authorities which can be homologated in Ecuador, the process of obtaining a health registration will be submitted to a homologation process for this certification previously delivered in the following countries: Colombia, Brazil, Argentina, Mexico, Cuba, United States, Canada, Australia, Japan, Republic of South Korea. In the case of European countries, only certifications issued by the European Medicines Agency (EMA) will be accepted.

For further details please go to the following link:
http://www.controlsanitario.gob.ec/medicamentos-en-general/

7. Why is a General Agreement signed with the awarded bidders?

Article 43 of the Organic Law of the National Public Procurement System of Ecuador provides that SERCOP will sign General Agreements with those bidders of standardized goods and / or services that have been selected, in accordance with the Law, in order that such goods be offered in the Electronic Catalog enabled in the portal of public procurement.
The signing of these general agreements gives the contracted providers the exclusivity to provide drugs to the establishments of the Public Integral Health Network for a period of 2 years from the subscription of the said legal instrument.
The National Public Procurement System in Ecuador is deconcentrated, so that each health establishment can obtain drugs through the use of the Electronic Catalog and according to a schedule of needs. For this, each establishment has previously the fiscal resources to pay for such acquisitions, and it is the same establishment that is responsible for making the corresponding payments.

8. How long will the contractual relationship with the awarded bidders be?

The General Agreement has a duration of 2 years, counted from its subscription, notwithstanding that the period may be extended until SERCOP publishes a new Drugs e-Inventory, or until the Public Integral Health Network deems it convenient, as determined by the Regulation of the Organic Law of the National Public Procurement System.
This term of duration of the General Agreement allows national and international bidders to receive from the Ecuadorian State the certainty that drugs will be purchased from the awarded bidder during the term of the agreement.
In this way, the Ecuadorian State offers legal security and a transparent commercial relationship, promoting foreign investment in the country.

9. Can a drug bidder be disqualified during the process?

The bidder is responsible for ensuring the accuracy and veracity of the information provided to SERCOP through the electronic system.
The Technical Committee of the Corporate Reverse Drugs Bidding is capable of making inquiries to verify or obtain clarifications and additional information on the technical, economic and legal conditions of the bidder.
In case of administrative verification that the bidder or contractor altered or lacked the truth about the documentation or information that forms its offer, it will be sufficient cause to be disqualified from the procurement procedure and to declare him to be a failed adjudicator or unfulfilled contractor, as the case may be, without prejudice to any legal action that may have taken place.
In the event that the winning bidder is disqualified for failure to deliver the qualifying documentation, the Technical Commission will call the bidder who ranked second in the order of priority of the bid, who must comply with the established requirements to be awarded, including the obligation to maintain the winning bid for the subscription to the General Agreement. If the bidder called as a second option does not immediately comply with the requirements of the bidding documents, the highest authority of SERCOP, or its delegate, will declare the hiring process void.

10. Can a single drug supplier bid the whole required portfolio?

This is not possible according to what establishes the Organic Law of Regulation and Control of Market Power and the Manual of Good Practices in Public Procurement.

11. How through the Corporate Reverse Drugs Bidding can SERCOP and the Public Integral Health Network contribute to the assurance of the right to health and access to medicines by the population?

The Corporate Reverse Drugs Bidding aims to cover in a timely manner, the drug needs of the establishments belonging to the Public Integral Health Network.
In this way, it is constituted as a mechanism that assures the access of the population to a public and social good such as medicines, prevailing the interests of public health over the economic and commercial interests.

12. Will Ecuador's national industry have any preference in the Second Phase of the Corporate Reverse Drugs Bidding?

In the Second Phase of the Corporate Reverse Drugs Bidding, the national pharmaceutical industry will enjoy a margin of preference with the aim of boosting the local production of medicines and allowing the national industry to be more competitive in this procedure.
To this purpose, the Ministry of Industry and Productivity (MIPRO) will define the margins of preference that correspond to each national producer and in the corresponding portfolio of medicines, in which this margin is applicable.
This methodology will ensure and guarantee fair technical measures and conditions for bidders.

OPERATIVE SCOPE

What are the stages and timing of the Second Phase of the Corporate Reverse Drugs Bidding?

The Second Phase of the Corporate Reverse Drugs Bidding is structured around four fundamental stages:

1) Preparatory
2) Pre-contractual
3) Contractual
4) Evaluative or post-contractual

The Preparatory stage is currently being finalized, in which different activities are carried out such as preparation of specifications or terms of reference, socialization of the process at national and international level, registration of national and foreign bidders, updating of information from registered bidders, spaces development of participatory dialogue and social control, receipt of comments on drug technical data, among other activities.
It is expected that drugs purchased through the Second Phase of the Corporate Reverse Drugs Bidding will be available in the health facilities from the second semester of 2017.

14. Where can I find the information corresponding to tender specifications and reference drugs prices?

This information is available on the website of the Corporate Reverse Drugs Bidding https://subastademedicamentos.compraspublicas.gob.ec/ and in the National Public Procurement System https://sicm.compraspublicas.gob.ec/

15. Why are not all drugs required by the Public Integral Health Network procured through the Corporate Reverse Drug Bidding?

The Public Integral Health Network is the body in charge of defining the mechanisms through which drugs are purchased for its establishments. Therefore, it has been defined that through the Second Phase of the Corporate Reverse Drugs Bidding around 133 types of essential drugs for orphan, rare and catastrophic diseases that are part of the National Table of Basic Drugs are acquired. (9th Review).
The details of these drugs are available on the website of the Corporate Reverse Drugs Bidding. The procurement of this part of the drugs portfolio will be carried out in groups, depending on the characteristics of the drugs.

16. How do the Public Integral Health Network and SERCOP assure that the drugs to be purchased have the required quality?

In the tender specifications of the procedure, verification mechanisms are established ex-ante and ex-post the signing of general agreements. Thus, ex-ante, the bidder must have the Health Registration issued by the National Agency for Regulation, Control and Health Surveillance (ARCSA) to be awarded. Pharmacy surveillance and the subsequent control of medicines is also the responsibility of ARCSA in three levels, according to the technical parameters issued for this purpose.
An Early Warning System has been established to ensure that medicines dispensed in health facilities comply with the necessary parameters and quality standards.

17. What information should drugs bidders take into account when preparing the economic offer?

Drug prices will be quoted in US Dollars. The offer must contemplate that the drugs will be delivered in the establishments of the Public Integral Health Network located throughout the Ecuadorian territory according to the quantities determined in the respective purchase order, and according to the delivery deadlines established in the General Agreement.
Accordingly, a document with the drugs purchase orders is published on the website of the Second Phase of the Corporate Reverse Drugs Bidding, which covers the period 2012-2014, and which includes the purchases of medicines made by the health establishments of the RPIS, through the Drugs e-Inventory (electronic catalog), product of the 2011 Corporate Reverse Bidding. With this information suppliers can know, in a detailed way, the purchasing dynamics of the health establishments.
The contracted bidders will be responsible for having a stable stock of drugs, prior to their cataloging is such a way as to ensure the adequate supply to health facilities.

18. Do the awarded companies have to present an equity guarantee?

To request for an equity guarantee percentage is not considered within the specifications that are being prepared for the Second Phase of the Corporate Reverse Drugs Bidding. Instead, an economic guarantee of faithful compliance with the contract will be requested, which will be 5% of the total referenced budget awarded stipulated in the General Agreement, as well as a certification that establishes the existence of pre-approved lines of credit issued by a national or international financial institution, equivalent to 15% of the total awarded value.

19. Will bids be submitted with documentation in physical or electronic form?

The Corporate Reverse Drugs Bidding will be implemented with a system that guarantees the transparency of the process and allows each phase to be carried out electronically. For this reason, the information of the bidders will be entered virtually. The registered bidders will have a period to make the necessary simulations in the system, in order to become familiar with it.

20. How many products can a bidder offer in the Corporate Reverse Drugs Bidding?

The number of products offered by a bidder that participates in the Second Phase of the Corporate Reverse Drugs Bidding will depend on his capacity to supply the demand of the establishments of the Public Integral Health Network. The bidder can present its offer both in a product and in the entire product portfolio of this phase.
It should be taken into account that once the bidder adheres to the terms and conditions of a contractual procedure, he is immediately responsible for the actions performed during the development of said procedure, as stipulated in the specifications or terms of reference of the Second Phase of the Corporate Reverse Drugs Bidding.
Prior to the award, and in the event that a bidder has won more than one procurement procedure, the Technical Committee of the Corporate Reverse Drugs Bidding will send to the SERCOP´S General Director the list of bidders who meet the conditions established in the tender specifications, with the purpose that he may refer the Agency of Regulation, Control and Health Surveillance (ARCSA) the issuance of a production simultaneity certificate that guarantees that in all the drugs won by that bidder there are good practices of manufacture, simultaneously in the productive environment of this company.
Once ARCSA submits the referred certification to SERCOP, the Inter-institutional Committee of the Corporate Reverse Drugs Bidding will be convened, which is conformed by the higher authorities of the Public Integral Health Network, to grant the respective guidelines to the Technical Commission of the Corporate Reverse Drugs Bidding and to send the award recommendation or the void process declaration to the SERCOP´s General Director.
The governing body of the health sector, representing the Public Integral Health Network, may make technical visits to the winning providers in order to verify compliance with the conditions offered and determine their suitability.

21. Can multiple drug bidders have the same legal representative?

This is possible to the extent that bidders with the same legal representative do not participate in the same contracting procedure of the Second Phase of the Corporate Reverse Drugs Bidding. That is, they cannot participate in the same procurement procedure for the same type of drug. In case of non-fulfillment of the above, bidders with similar legal representative or conflict of interests will be disqualified.

22. Where are the drugs datasheets published?

The drug datasheets that are part of the Second Phase of the Corporate Reverse Drugs Bidding are available on the bidding website.
The definitive sheets with which the tender specifications or terms of reference will be published are the result of the consolidation and incorporation of the observations submitted by suppliers, citizens and academy during the preparatory stage of the Second Phase of the Corporate Reverse Drugs Bidding.

23. What labeling requirements will be required for the awarded drugs?

The labeling requirements to be met by the drugs awarded in the Second Phase of the Corporate Reverse Drugs Bidding are set forth in the drugs datasheets published on the following link:

• https://subastademedicamentos.compraspublicas.gob.ec/ ( Spanish version)
• https://medbid.sercop.gob.ec/ (English version)

24. Once registered, how do I access the Corporate Reverse Drugs Bidding Module (SICM)?

To access the Corporate Reverse Drugs Bidding Module you must enter the following link:

https://sicm.compraspublicas.gob.ec/

In this module national and foreign bidders registered in the Registry of Suppliers (RUP) will enter the company identification number, user and password to interact in procedures for contracting the Corporate Reverse Drugs Bidding.