Leping

Partnership Agreement between the Ministry of Health of the Republic of Latvia, the Ministry of Social Affairs of the Republic of Estonia and the Ministry of Health of Lithuania on Joint Procurements of Medicinal Products and Medical Devices and Lending of Medicinal Products and Medical Devices Procurable Centrally The Ministry of Health of the Republic of Latvia, the Ministry of Social Affairs of the Republic of Estonia and the Ministry of Health of the Republic of Lithuania (hereinafter referred to as - Partners), recalling the decision of the Prime Ministers of the Baltic States of 24.09.2010 aimed at facilitating more efficient provision of health care services in the Baltic States and establishing a joint Task Force on Health Issues, as well as the adoption of the Terms of Reference for the Task Force on Health Issues; taking into account the need to update the Partnership Agreement signed on 2 May 2012 between the responsible Ministries of the Baltic States; being aware that eventual accession to this Partnership Agreement of the partners of other European Union Member States or of the European Economic Area States could be valuable for both - the present and the new partners; recognising that it will facilitate more efficient provision of health care services in the Baltic States; recognizing that performance of joint procurements will ensure the rationalization of procurements and reduce the time and administrative resources required; committed to work together in this field in the future; have agreed on the following: Article 1 Definitions The following terms and definitions are used in this Partnership Agreement: 1) Centralised purchasing activities – activities conducted on a permanent basis, in one of the following forms: (a) the acquisition of supplies and/or services intended for contracting authorities, (b) the award of public contracts or the conclusion of framework agreements for works, supplies or services intended for contracting authorities (according to Directive 2014/24/EU, Article 2 (1) (1) and Article 2 (1) (14)); 2) Centrally procured – public procurement performed by using joint procurement or centralised purchasing activities; 3) Competent Authority – state agency or person in public law conducting public procurement procedures according to the Partnership Agreement; 4) Delegation Letter – written authorisation of the Competent Authority in favour of the Lead Contracting Authority to perform the procurement on its behalf; 5) Framework Agreement — an agreement among the competent authorities of the Partners involved in the procurement and the successful bidders established in the procurement  2 procedure in which the contracts to be entered into in the scheduled time period and the provisions included therein are determined and described (especially as regards the prices and, if necessary, the estimated amount). 6) Lead Contracting Authority – the Competent Authority who according to the consent of the other competent authorities is responsible for the application of the public procurement procedure, signing of the Public Contract and development of the whole relevant documentation and the co-ordination thereof with other competent authorities involved in the public procurement procedure. 7) Medical device and Medicinal Products – as provided in respective European Union regulation or directive currently in force. 8) Public Contract – contract (incl. Framework Agreement) for financial interest, the subject-matter of which is supplies or services and which is awarded to an economic operator by a contracting authority or entity. 9) Working Group – desicion-making body of the representatives of the Competent Authorities. Article 2 Purpose of the Agreement The purpose of this Partnership Agreement is to facilitate joint procurements of medicinal products and medical devices with the overall aim to reduce the expenditure of the State regarding public procurements of medicinal products and medical devices, as well as to ensure the continuity of the access to the medicinal products and medical devices procurable centrally. Article 3 Scope of the Agreement This Partnership Agreement is applicable to the cooperation among the competent authorities in joint procurements of medicinal products and medical devices and the cooperation in ensuring medicinal products and medical devices procurable centrally for a Partner. Article 4 Competent Authorities In accordance with this Partnership Agreement the following competent authorities have the right to maintain direct contacts and enter into Public Contract: (1) in the Republic of Latvia: National Health Service of the Republic of Latvia – responsible for procurements of the State financed medicinal products and medical devices which are performed centrally. (2) in the Republic of Estonia: Estonian Health Insurance Fund – responsible for the procurement procedure and the procurements of the State financed medicinal products and medical devices which are performed centrally. (3) in the Republic of Lithuania: National Health Insurance Fund of the Republic of Lithuania – responsible for the procurement procedure and procurements of the State financed medicinal products and medical devices which are performed centrally.  3 Article 5 Management, Organization and Responsibility (1) For the purpose of the implementation of this Partnership Agreement a working group shall be established (hereinafter referred to as the Working Group). Each Competent Authority shall nominate its representatives for the Working Group not later than within a month following the entering into force this Partnership Agreement by informing the other Competent Authorities in writing. If the nominated representatives are subject to changes, the Competent Authorities shall inform each other thereof in written format. (2) The Working Group shall meet not less than once a year, including electronical meetings. The meeting of the Working Group may be initiated by any of the Competent Authority or members of the Working Group. The Working Group shall agree on the working procedure that shall be approved by a written consent of the Competent Authorities. (3) During the meetings of the Working Group the members shall identify the necessity to perform a specific joint procurement and agree on the Lead Contracting Authority who will perform the relevant public procurement. Detailed priority list of tasks is set out in the working procedure of the Working Group. (4) The competent authority of the Lead Contracting Authority shall, on the basis of the decision taken by the Working Group, send an invitation to the relevant competent authorities to submit a Delegation Letter for the relevant procurement to the competent authority of the Lead Contracting Authority. By this Delegation Letter the competent authorities shall, by indicating the subject-matter of the procurement, the amount and the time of the procurement, request the competent authority of the Lead Contracting Authority to perform the procurement on their behalf and to sign Public Contract on behalf of the competent authority (if applicable). The competent authority shall authorise this representative to co-ordinate the public procurement procedure, the Public Contract and other documents related to the public procurement procedure. (5) If the Delegation Letter referred to in Paragraph 4 of this Article is not received within 14 days following the receipt of the invitation from the competent authority of the Lead Contracting Authority, it shall be considered that the invited Competent Authority does not participate in the relevant procurement. (6) A joint procurement may be performed if all Competent Authorities participate or only two Competent Authorities participate which shall be agreed for each public procurement separately. In a case of admission of new partners to this Partnership Agreement according to Article 10 of this Partnership Agreement, a joint procurement may be performed if all or several Competent Authorities participate. In this case no limitations regarding the number of the Competent Authorities in organizing the joint procurement apply. (7) The Competent authorities may, if necessary, use their national central purchasing bodies to carry out the procurement procedures. (8) This Partnership Agreement in no circumstances limits the procurements performed by each Competent Authority individually.  4 Article 6 Joint Procurement Procedure (1) The competent authority of the Lead Contracting Authority shall be responsible for the organization of the procurement procedure and signing of the Public Contract (if applicable). The involved Competent Authorities shall facilitate this process and be responsible for the fulfilment of the obligations undertaken. (2) The public procurement shall be performed in accordance with the national laws and regulations of the Lead Contracting Authority. (3) Detailed procurement procedure and the issues related thereto, including the payment conditions of the procurement, shall be determined in the documents of the procurement procedure and the Public Contract. (4) Following the entering into effect of the decision of the Lead Contracting Authority the competent authorities participating in the procurement shall sign the Public Contract. If the competent authorities have authorized the Lead Contracting Authority to sign the Public Contract on behalf of the competent authorities, the Lead Contracting Authority will sign the Public Contract and will send the copy of it to the competent authorities within 2 working days after signing. Article 7 Payments (1) The Competent Authorities having decided to perform a joint procurement of medicinal products or medical devices, undertake to settle the payment for the part of the medicinal products or medical devices procured on the bases of the specified in the Delegation Letter of the competent authority referred to in Article 5, Paragraph 4 of this Partnership Agreement. (2) The Competent Authorities shall not pay each other for the appliance of the procurement procedure and for undertaking the role of the Lead Contracting Authority, except for the cases if the Competent Authorities have agreed thereof in advance. (3) In case of technically complicated procurements, the Competent Authorities may agree on a procurement of the development of technical specifications. In such a case the Competent Authorities shall separately agree on the payment conditions. Article 8 Lending of Medicinal Products and Medical Devices (1) The Competent Authorities agree, in a case of necessity, to lend to each other medicinal products or medical devices procurable by the State or by institutions represented by the State. (2) For the implementation of the provision of this Article, the Competent Authorities shall, within a month following the entering into force of this Partnership Agreement, inform the other Competent Authorities in writing about the institutions and persons responsible for the coordination of the process referred to in the Paragraph 1 of this Article. (3) If the information referred to in Paragraph 2 of this Article changes, the Competent Authorities shall inform each other thereof.  5 Article 9 Liabilities If any Partner during the procurement procedure withdraws from the joint procurement or in any other way infringes provisions of this Partnership Agreement or the Framework Agreement, this Partner shall compensate all the direct losses of other Partners incurred due to such an infringement. Article 10 Admission of New Partners (1) Any Member State of the European Union and the European Economic Area may express its wish to join this Partnership Agreement by informing in writing any Partner thereof. (2) The Partner referred to in Paragraph 1 of this Article shall, within 10 days following the receipt of the letter in which the wish to join this Partnership Agreement is expressed, inform the other Partners of this Partnership Agreement thereof. (3) If all the Partners agree on the admission of a new Partner to this Partnership Agreement, the Partner referred to in Paragraph 1 of this Article shall be responsible for preparation of the relevant amendments to the Partnership Agreement and following their entering into effect, for the transfer of the information referred to in Paragraph 2 of Article 5 and the Paragraph 3 of Article 8 to the new Partner. Article 11 Procedure for the Settlement of Disputes All the disputes arising during the execution of this Partnership Agreement shall be settled by the Partners in the form of negotiation between their competent authorities or through diplomatic channels. Article 12 Final provisions (1) This Partnership Agreement has been entered into for an indefinite period of time and shall come into force on the day when the last Partner signs it. (2) Either Partner may withdraw from this Partnership Agreement by informing in writing the other Partners thereof. In such a case, the withdrawal of the relevant Partner shall take effect six (6) months following the date when the written notification on the withdrawal has been sent to the other Partners but not earlier than when all the initiated procurement procedures, where the relevant Partner is involved, have been completed. (3) This Partnership Agreement may be amended and supplemented by mutual written agreement of the Partners. The amendments and supplements shall enter into effect in accordance with Paragraph 1 of this Article and they shall become an integral part of the Partnership Agreement. (4) The Partnership Agreement between the Ministry of Social Affairs of the Republic of Estonia, the Ministry of Health of the Republic of Latvia and the Ministry of Health of Lithuania on Joint Procurements of Medicinal Products and Medical Devices and  6 Lending of Medicinal Products and Medical Devices Procurable Centrally signed by the Partners in 2012 shall terminate upon the date of entry into force of this Partnership Agreement. Appendices Appendix 1 Template of the Delegation letter Appendix 2 Template of the Lending Agreement The Partnership Agreement is signed digitally Ministry of Health Ministry of Social Affairs Ministry of Health Republic of Latvia Republic of Estonia Republic of Lithuania Daniels Pavļuts Tanel Kiik Arūnas Dulkys Minister for Health Minister of Health and Labour Minister of Health  ANNEX 1 [on the Partner’s template of letters] Delegation Letter I, [name, surname], [head of the Competent Authority] of the [name of the Authorizing country], HEREBY AUTHORISE [name of the Lead Contracting Authority] to conduct on behalf of [name of the Authorizing country] the public procurement activities [until/ and] signing of the Framework Agreement(s) of [name of the product / name of the active substance] in amount of [the amount] for [the period of time when the product is needed – if relevant]. With this letter I nominate [name, surname, job title, contact details (phone, e-mail) of the nominated person] to be our representative in Working Group and to approve public procurement documentation and public procurement procedures, if relevant. IN WITNESS THEREOF, I have signed this Delegation Letter. [name, surname] [title] [country]  ANNEX 2 LENDING AGREEMENT on lending of centrally procured medicinal products and medical devices [Name of Competent Authority]) (hereinafter Lender), represented by [name, surname and job title of representative], which acts according to [......................] and [Name of Competent Authority] (hereinafter Borrower), represented by [name, surname and job title of representative], which acts according to [......................] (hereinafter referred to as Party or Parties), according to the Point 1 of the Article 8 of “Partnership Agreement between the Ministry of Health of the Republic of Latvia, the Ministry of Social Affairs of the Republic of Estonia and the Ministry of Health of Lithuania on Joint Procurements of Medicinal Products and Medical Devices and Lending of Medicinal Products and Medical Devices Procurable Centrally” entered into in 2021 (hereinafter Partnership Agreement), contains the following Template of the Lending Agreement (hereinafter Agreement): 1. Subject of the Agreement 1.1 The Lender shall lend to the Borrower without charge centrally procured medicinal products / medical devices [name, number of packages, and description of medicinal product / medical devices] (hereinafter Lending Subject). 1.2. The Borrower commits to use the Lending Subject to ensure the health care of people. 1.3. The Lending Subject can’t be used for further resale. 2. Liabilities of the Parties 2.1. Parties agree on delivery of the Lending Subject to the state territory of the Borrower as follows: 2.1.1. Date of delivery: ___; 2.2.2. Address of delivery: ___. 2.2. All expenses related to the delivery of the Lending Subject are covered by the Borrower according to the documents submitted by the Lender, which proves lending expenses. 2.3. The Lender guarantees the quality of the Lending Subject in accordance with [......................] and expiry date, which is [......................]./ not shorter that [......................]. 2.4. The Lender ensures the replacement of the Lending Subject if possible when it is determined after delivery that the Lending Subject or its package is damaged. The nominated representatives of the Parties shall sign the determination certificate of defect, in prior agreeing on the time when the Lending Subject will be replaced. 2.5. The Borrower commits to return the Lending Subject to the Lender not later than by ____._____________, 20___ If agreed between parties accordingly, the equivalent medicinal products / medical devices, in the same amount and quality, which is suitable for use and its expiry date is not shorter than [......................] shall be returned. The Borrower ensures the delivery of the Lending Subject to the state territory of the Lender [address] and cover all expenses related to delivery.  2 2.6. The instrument of delivery and receipt shall be signed after every delivery. 3. Settlement of disputes and reports 3.1. Any disputes that may occur in the process of the execution of this Agreement, Parties shall resolve by means of negotiations of written communication. 3.2. Failing an agreement, the dispute shall be settled in the courts of plaintiffs’ location pursuant to the procedure laid down in the legislation of the plaintiffs’ state territory. 3.3. If any of the Parties cannot fulfil the commitments taken under this Agreement, it reports that to the other Party without any delay and agrees of the future actions. 4. Other provisions 4.1. As soon as the instrument of delivery and receipt is signed, losses that may occur by damaging the Lending Subject, are covered by the Party that has accepted the Lending Subject. 4.2. Any amendment to this agreement enters into force only after their formatting in writing and signing by both Parties. 5. Period of validity of Agreement The Agreement enters into force on the day of the last signatory and remains in force until both Parties have completed their obligations in full. 6. Details of the Parties The Lender: The Borrower: [Name of institution] [Name of institution] Reg.No. [......................] Reg.No. [......................] Address: [......................] Address: [......................] The Agreement is signed digitally