TENDER FILE / TERMS OF REFERENCE

(Competitive bidding procedure / Framework Contract)

Purchase of consultancy services (international consultants) in the area of falsification of medical products

Contract N° 2020/AO/…

The Council of Europe (CoE) is currently implementing the project “Needs assessment - Falsified medical products (NA-FAMED)”. The Action is composed of three components (1. “Promotion of the MEDICRIME Convention and path towards ratifications”; 2. “Gap analysis aiming to improve and strengthen legal, regulatory and policy frameworks in State Parties” and 3. “Needs assessment that will lead to the identification of the main beneficiaries and the legal and procedural issues leading to the criminalisation of the production and trade of falsified medical products in the beneficiaries of the main project”) and will last until 31 March 2021.

A.    TENDER RULES

This tender procedure is a competitive bidding procedure. In accordance with Rule 1395 of the Secretary General of the Council of Europe on the procurement procedures of the Council of Europe[1], the Organisation shall invite to tender at least three potential providers for any purchase between €2,000 (or €5,000 for intellectual services) and €55,000 tax exclusive.

This specific tender procedure aims at concluding a framework contract for the provision of deliverables described in the Act of Engagement (See attached). A tender is considered valid for 120 calendar days as from the closing date for submission. The selection of tenderers will be made in light of the criteria indicated below. All tenderers will be informed in writing of the outcome of the procedure.

The tenderer must be either a natural person, or a duly registered company under sole proprietorship of a natural person, or equivalent, provided that the signatory of the Act of Engagement is individually liable for all obligations undertaken by the entity, and is the owner of the moral rights in any creations of the entity. If contracted by the Council of Europe, the signatory of the Act of Engagement shall provide the deliverables personally, in accordance with the terms as provided in the current Tender File, Act of Engagement and future Order Forms.

Tenders shall be submitted by email only (with attachments) to the email address indicated in the Table below, with the following reference in subject: “NA FAMED– International Consultants”. Tenders addressed to another email address will be rejected.

The general information and contact details for this procedure are indicated on this page. You are invited to use the CoE Contact details indicated below for any question you may have.All questions shall be submitted at least 5 (five) working days before the deadline for submission of the tenders and shall be exclusively addressed to the email address indicated below with the following reference in subject: “QUESTIONS - NA FAMED– International Consultants”

Type of contract ►	Framework contract
Duration ►	Until 31 March 2021
Deadline for submission of tenders/offers ►	25 October 2020
Email for submission of tenders/offers ►	[email protected]
Email for questions ►	[email protected]
Expected starting date of execution ►	02 November 2020

B.    EXPECTED DELIVERABLES

Background of the Project

The Council of Europe (CoE) is currently implementing the project “Needs assessment - Falsified medical products (NA-FAMED)”. The Action is composed of three components (1. “Promotion of the MEDICRIME Convention and path towards ratifications”; 2. “Gap analysis aiming to improve and strengthen legal, regulatory and policy frameworks in State Parties” and 3. “Needs assessment that will lead to the identification of the main beneficiaries and the legal and procedural issues leading to the criminalisation of the production and trade of falsified medical products in the beneficiaries of the main project”) and will last until 31 March 2021.

The NA-FAMED project is designed to provide technical assistance and support the State parties and other countries to fight against the falsification of medical products and similar crimes.

The multiregional, multi-country project provides a legal and procedural gap analysis in order to enhance international cooperation among countries. The gap analysis and needs assessment will be able to provide sufficient data to form a baseline for a full-fledged project in terms of the main beneficiaries and the legal and procedural issues leading to the criminalisation of the production and trade of falsified medical products and will assess the need in terms of harmonisation of the legislation and in order to put in place dissuasive penalties proportional to the harm suffered by patients, and thus successfully prosecute and prevent production and trade with falsified and substandard medical products.  

The geographic scope of the project is the following: CoE member and observer States, countries that have been invited by the Committee of Ministers of the CoE to sign and ratify the MEDICRIME Convention and countries that are in a very advanced situation to send an application to the Committee of Ministers of the CoE to be invited to join the MEDICRIME Convention. 

The NA-FAMED project is also expected to provide needs assessment and recommendations on how to address these needs in a strategic manner.  

The CoE is looking for 20 Providers (provided enough tenders meet the criteria indicated below) in order to support the implementation of the project concerning the falsification of medical products and similar crimes.

This Contract is currently estimated to cover up to 15 activities, to be held by 31  March  2021. This estimate is for information only and shall not constitute any sort of contractual commitment on the part of the CoE. The Contract may potentially represent a higher or lower number of activities, depending on the evolving needs of the Organisation.

For information purposes only, the total budget of the project amounts to 200 000 Euros. The total amount of the object of the present tender should not exceed 28 000 Euros for the whole duration of the Framework Contract and received bids above this limit shall be excluded from the tender.

Lots

The present tendering procedure aims to select Providers to support the implementation of the Project and is divided into the following lots:

Lots	Maximum number of Providers to be selected
Lot 1: Consultancy services in one or more of the following areas: strengthening internal, national regulations in State Parties in line with the MEDICRIME Convention, prevention and combat the trafficking of falsified medical products and similar crimes (fmpsc); initial and continuous training of the legal professionals, raise awareness of the MEDICRIME Convention, legal and case-law analysis in the fmpsc.	15
Lot 2:   Consultancy services in one or more of the following areas: International cooperation in criminal matters, criminal investigations, network data collection in relation to the MEDICRIME Convention, prevention and combat the trafficking of falsified medical products and similar crimes (fmpsc).	5

The Council will select the abovementioned number of Provider(s) per lot, provided enough tenders meet the criteria indicated below. Tenderers are invited to indicate which lot(s) they are tendering for (see Section A of the Act of Engagement).

Scope of the Framework Contract

Throughout the duration of the Framework Contract, pre-selected Providers may be asked to provide the deliverables listed in the Act of Engagement (See Section A – Terms of reference). This list is not considered exhaustive.

Under Lot 1:

The indicative list of expected deliverables under Lot 1 is as follows (not exhaustive): -       Provide expert advice on the issue of falsification of medical products and similar crimes in connection with other topics such as victims, gender; children; Internet and the Social media;  particular attention will be provided to COVID-19 pandemic situation. -       Provide data collection and expert advice of relevant national jurisprudence; -       Prepare needs assessment reports concerning the national legal framework and its developments in the areas covered by the project based on questionnaires answered by national consultants; -       Provide a baseline study on the use of different types of punishments (criminal or administrative) in the areas covered by the project; -       Prepare baseline studies, needs assessment reports, legal opinions, legal expertise, guidelines, regulations, comments, recommendations, reports on legal acts, by-laws, institutional internal rules and regulations and policy documents (drafts and in force) in the project’s area of action and/or good knowledge on the development of networks of national contact points; -       Participate and deliver presentations in the project’s area of action in  conferences, round-tables, seminars, training sessions, workshops, consultation meetings and other relevant events with national stakeholders, including through moderating/facilitating discussions; -       Deliver training to legal professionals on the project’s area of action and develop training materials.

Under Lot 2:

The indicative list of expected deliverables under Lot 2 is as follows (not exhaustive): -       Provide expert advice on international cooperation in criminal matters (covering but not exclusively limited to areas of extradition, mutual legal assistance, transfer of sentenced persons, search, seizure and confiscation of the proceeds from crime, financing of terrorism, ex-officio investigations, etc.) to combat the falsification and trafficking of falsified medical products and similar crimes; -       Participate in working groups and expert meetings and provide written contributions in the areas covered by the project;       -       Mapping the main national beneficiaries in the areas covered by the project; -       Provide expert advice on the development of a 24/7 Network of national contact points for international co-operation in criminal matters and possible terms of reference.

The above list is not considered exhaustive. The Council reserves the right to request deliverables not explicitly mentioned in the above list of expected services but related to the field of expertise object of the present Framework Contract for the lot concerned.

In terms of quality requirements, the pre-selected Service Providers must ensure, inter alia, that:

·         The services are provided to the highest professional/academic standard;

·         Any specific instructions given by the Council – whenever this is the case – are followed.

If contracted by the Council of Europe, the deliverables shall be provided personally by the persons identified in the offer of the Provider whose CVs have been presented to the Council of Europe (See section E. below), in accordance with the terms as provided in the present Tender File and Act of Engagement.

In addition to the orders requested on an as needed basis, the Provider shall keep regular communication with the Council to ensure continuing exchange of information relevant to the project implementation. This involves, among others, to inform the Council as soon as it becomes aware, during the execution of the Contract, of any initiatives and/or adopted laws and regulations, policies, strategies or action plans or any other development related to the object of the Contract (see more on general obligations of the Provider in Article 3.1.2 of the Legal Conditions in the Act of Engagement).

Unless otherwise agreed with the Council, written documents produced by the Provider shall be in English (see more on requirements for written documents in Articles 3.2.2 and 3.2.3 of the Legal Conditions in the Act of Engagement).

C.    FEES

Tenderers are invited to indicate their fees, by completing and sending the Table of fees, as attached in Section A to the Act of Engagement. These fees are final and not subject to review.

Tenders proposing fees above the exclusion level indicated in the Table of fees will be entirely and automatically excluded from the tender procedure.

The Council will indicate on each Order Form (see Section D below) the global fee corresponding to each deliverable, calculated on the basis of the unit fees, as agreed by this Contract.

D.    HOW WILL THIS FRAMEWORK CONTRACT WORK? (Ordering PROCEDURE)

Once the selection procedure is completed, you will be informed accordingly. Deliverables will then be delivered on the basis of Order Forms submitted by the Council to the selected Provider (s), by post or electronically, on an as needed basis (there is, therefore, no obligation to order on the part of the Council).

Pooling

For each Order, the Council will choose from the pool of pre-selected tenderers for the relevant lot the Provider who demonstrably offers best value for money for its requirement when assessed – for the Order concerned – against the criteria of: 

-          quality (including as appropriate: capability, expertise, past performance, availability of resources and proposed methods of undertaking the work);

-          availability (including, without limitation, capacity to meet required deadlines and, where relevant, geographical location); and

-          price.

Each time an Order Form is sent, the selected Provider undertakes to take all the necessary measures to send it signed to the Council within 2 (two) working days after its reception. If a Provider is unable to take an Order or if no reply is given on his behalf within that deadline, the Council may call on another Provider using the same criteria, and so on until a suitable Provider is contracted.

Providers subject to VAT

The Provider, if subject to VAT, shall also send, together with each signed Form, a quote[2] (Pro Forma invoice) in line with the indications specified on each Order Form, and including:

-     the Service Provider’s name and address;

-     its VAT number;

-     the full list of services;

-     the fee per type of deliverables (in the currency indicated on the Act of Engagement, tax exclusive);

-     the total amount per type of deliverables (in the currency indicated on the Act of Engagement, tax exclusive);

-     the total amount (in the currency indicated on the Act of Engagement), tax-exclusive, the applicable VAT rate, the amount of VAT and the amount VAT inclusive.

Signature of orders

An Order Form is considered to be legally binding when the Order, signed by the Provider, is approved by the Council, by displaying a Council’s Purchase Order number on the Order, as well as by signing and stamping the Order concerned. Copy of each approved Order Form shall be sent to the Provider, to the extent possible on the day of its signature.

E.     ASSESSMENT

Exclusion criteria and absence of conflict of interests

(by signing the Act of Engagement, you declare on your honour not being in any of the below situations)^[3]

Tenderers shall be excluded from participating in the tender procedure if they:

• have been sentenced by a final judgment on one or more of the following charges: participation in a criminal organisation, corruption, fraud, money laundering;
• are in a situation of bankruptcy, liquidation, termination of activity, insolvency or arrangement with creditors or any like situation arising from a procedure of the same kind, or are subject to a procedure of the same kind;
• have received a judgment with res judicata force, finding an offence that affects their professional integrity or serious professional misconduct;
• do not comply with their obligations as regards payment of social security contributions, taxes and dues, according to the statutory provisions of their country of incorporation, establishment or residence;

·         are or are likely to be in a situation of conflict of interests.

Eligibility criteria

 For lot 1:

-          University degree in the relevant field (criminal law/law enforcement/pharmacy/political studies and other related fields related to falsification of medical products and similar crimes);

-          At least 5 (five) years of professional experience in one or more of the following areas: criminal law; criminal law enforcement; falsification of medical products and similar crimes;

-          Excellent oral and written English or French at the level C1-C2 of the Common European Framework of Reference for Languages.

For lot 2:

-          University degree in the relevant field (criminal law/law enforcement /political studies and other related fields related to falsification of medical products and similar crimes);

-          At least 5 (five) years of professional experience in one or more of the following areas: criminal law; criminal law enforcement; falsification of medical products and similar crimes; Extensive professional experience with networks of national contact points of any CoE Convention or international co-operation in criminal matters;

-          Excellent oral and written English or French at the level C1-C2 of the Common European Framework of Reference for Languages.

Award criteria

• Quality of the offer (90%), including:

-           Criterion 1:         Thematic expertise in the relevant area, including the knowledge of the MEDICRIME Convention and standards and recommendations of the Council of Europe in the areas covered by this call (50%);

-           Criterion 2:         Previous similar assignments with international organisations (30%);

-           Criterion 3:         Knowledge of the falsification of medical products or in a particular focus on the following areas: victims, gender, children, Internet and Social media (10%);

• Financial offer (10%).

The Council reserves the right to hold interviews with eligible tenderers.

Multiple tendering is not authorised.

F.     NEGOTIATIONS

The Council reserves the right to hold negotiations with the bidders in accordance with Article 20 of Rule 1395.

G.    DOCUMENTS TO BE PROVIDED

·         A completed and signed copy of the Act of Engagement[4] (See attached);

·         A detailed CV, preferably in Europass Format, demonstrating clearly that the tenderer fulfils the eligibility criteria;

• A Motivation letter demonstrating the tenderer’s understanding of the Council of Europe needs and describing how the tenderer meets the eligibility and award criteria above (1 page maximum);
• At least two examples of the previous work/deliverables reference/links to publications, legal assessments/analyses, reports, studies, etc. relevant to the experience the tenderer claims (in English);
• Three relevant references, from previous employers or clients (name, surname, phone number or e-mail)

All documents shall be submitted in English, failure to do so will result in the exclusion of the tender.

If any of the documents listed above are missing, the Council of Europe reserves the right to reject the tender.

The Council reserves the right to reject a tender if the scanned documents are of such a quality that the documents cannot be read once printed.

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