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 the Republic 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),

taking into account the decision of the Prime Ministers of the Baltic States of 24 September 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,

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 future,

have agreed on the following:

Article 1
Definitions

The following terms and definitions are used in this Partnership Agreement:

Procurement Commission - Commission established by the Lead Partner for application of the procurement procedure.

Lead Partner - a partner who according to the consent of the Partners is responsible for the application of the procurement procedure and development of the whole relevant documentation and the co-ordination thereof with other Partners involved in the procurement procedure.

Framework Agreement - an agreement among the competent authorities of the Partners involved in the procurement and the winners established in the procurement 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).

Medical device - a medical device as defined by the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.

Medicinal products - medicinal products as defined by the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

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 the State 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 Framework Agreements:

(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:

Ministry of Social Affairs of the Republic of Estonia - 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 under the Ministry of Health - responsible for the procurement procedure and procurements of the State financed medicinal products and medical devices which are performed centrally.

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 - Working Group). The Working Group shall meet not less than once a year. The meeting of the Working Group may be initiated by any of the Partners. The Working Group shall agree on the working procedure that shall be approved by a written consent of the Partners.

(2) During the meetings of the Working Group the Partners shall identify the necessity to perform a specific joint procurement and agree on the Lead Partner who will perform the relevant procurement.

(3) Each Partner shall nominate its representatives for the Working Group referred to in Paragraph 1 of this Article not later than within a month following the coming into force this Partnership Agreement by informing the other Partners of the Partnership Agreement in writing thereof.

(4) The competent authority of the Lead Partner shall, on the bases of the decision taken by the Working Group, send an invitation to the competent authorities of the relevant Partners to submit a Delegation Letter for the relevant procurement to the competent authority of the Lead Partner. By this Delegation Letter the competent authorities of the Partners shall, by indicating the subject-matter of the procurement, the amount and the time of the procurement, request the competent authority of the Lead Partner to perform the procurement on their behalf, as well as shall nominate a representative for the relevant Procurement Commission. The competent authority of the Partner shall authorise this representative to co-ordinate the procurement procedure, the Framework Agreement, procurement contract and other documents related to the procurement procedure. If the competent authority of the Partner does not wish to nominate its representative for the Procurement Commission, it shall inform the competent authority of the Lead Partner in writing on the person who is authorised to participate in the coordination of the procurement procedure, the Framework Agreement, the procurement contract and other documents related to the procurement procedure.

(5) If the Delegation Letter referred to in Paragraph 4 of this Article is not received within 30 days following the receipt of the invitation from the competent authority of the Lead Partner, it shall be considered that the invited Partner does not participate in the relevant procurement.

(6) The Partners shall agree on the template of the Delegation Letter as soon as possible but not later than within 2 (two) months following the coming into force of this Partnership Agreement. The confirmed template of the Delegation Letter shall become an integral part of this Partnership Agreement.

(7) A joint procurement may be performed if all Partners participate or only two Partners participate which shall be agreed for each 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 partners participate or several partners participate. In this case no limitations regarding the number of the partners in organizing the joint procurement are applied.

(8) This Partnership Agreement in no circumstances limits the procurements performed by each Partner separately.

Article 6
Joint Procurement Procedure

(1) The competent authority of the Lead Partner shall be responsible for the organization of the procurement procedure and for the establishment of the Procurement Commission for initiating the procurement procedure. The involved Partners shall facilitate this process and be responsible for the fulfilment of the obligations undertaken.

(2) The procurement shall be performed in accordance with the national laws and regulations of the Lead Partner.

(3) The Procurement Commission shall be responsible for the development of the documents of the procurement procedure, the course of the procurement and the evaluation of the proposals submitted. The Procurement Commission shall terminate its activities when the Framework Agreement is signed.

(4) 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, the Framework Agreement and the procurement contract.

(5) The competent authorities of the Partners which participate in the procurement shall sign the Framework Agreement taking into account the standstill period and procedure for entering into the Framework Agreement determined in the national laws and regulations of the Lead Partner.

Article 7
Payments

(1) The Partners having decided to perform a joint procurement of medicinal products or medical devices, undertake to make 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 of the relevant partner referred to in Article 5, Paragraph 4 of this Partnership Agreement and according to the decision of the Procurement Commission.

(2) The Partners shall not pay each other for the appliance of the procurement procedure and for undertaking the role of the Lead Partner, except for the cases if the Partners have agreed thereof in advance.

(3) In case of technically complicated procurements, the Partners may agree on a procurement of the development of technical specifications. In such a case the Partners shall separately agree on the payment conditions.

Article 8
Lending of Medicinal Products and Medical Devices

(1) The Partners agree, in a case of necessity, to lend to each other medicinal products or medical devices procurable centrally by the State.

(2) For the implementation of the provision of this Article, the Partners shall, within a month following the entering into force of this Partnership Agreement, inform the other Partners 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 Partners shall inform each other thereof.

(4) The Partners shall agree on the template of the Lending Agreement as soon as possible but not later than within 2 (two) months following the coming into force of this Partnership Agreement. The confirmed template of the Lending Agreement shall become an integral part of this Partnership Agreement.

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 2 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.

Signed in Riga, Latvia, 2 May 2012, in three original copies each in Latvian, Estonian, Lithuanian and English language, all texts being equally authentic. In case of any divergence of interpretation, the English text shall prevail.