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§ 45. Entry into price agreement

(1)        The interests of insured persons in obtaining necessary medicinal products at a reasonable price, the budgetary funds of the health insurance fund which are prescribed for the assumption of obligations to pay for medicinal products, and the principle provided for in subsection 25 (3) of this Act shall be taken into account upon entry into a price agreement.

(2)        The following conditions shall be agreed upon in a price agreement:

1)         the wholesale purchase price of a medicinal product in kroons by each pharmaceutical form, active substance content and package subject to a 100 or 75 per cent discount rate;

(28.06.2004 entered into force 01.08.2004 - RT I 2004, 56, 400)

2)         the estimated retail sale volume of the medicinal product during the term of validity of the price agreement if the medicinal product is the only medicinal product with a given active ingredient and route of administration entered in the list of medicinal products with a discount rate of 100 or 75 per cent;

(28.06.2004 entered into force 01.08.2004 - RT I 2004, 56, 400)

3)         the term during which amendment of the price agreement by the parties is prohibited;

4)         the conditions under which a party has the right to demand that the price agreement be amended;

5)         the due date by which the parties are required to submit requests for amendment of the price agreement in order to prevent automatic extension of the term of validity of the price agreement;

6)         the term during which the manufacturer of a medicinal product is required to sell the medicinal product on the Estonian market and the health insurance fund is required to assume the obligations of insured persons to pay for the medicinal product under the currently applicable conditions if the parties do not reach an agreement concerning amendment of the price;

7)         other conditions and obligations necessary for ensuring the efficient and purposeful use of health insurance funds and compliance with the conditions of the price agreement.

(3)        A proposal for a price agreement to be entered into shall be made to the Ministry of Social Affairs by a manufacturer of a medicinal product or a person holding marketing authorisation for a medicinal product.

(4)        The Ministry of Social Affairs may issue a precept demanding that a price agreement be entered into to a manufacturer of a medicinal product or a person holding marketing authorisation for a medicinal product if the medicinal product concerned has been entered in the list of medicinal products with a 100 or 75 per cent discount rate.

(28.06.2004 entered into force 01.08.2004 - RT I 2004, 56, 400)

(5)        In the event of failure to comply in a timely manner with a precept demanding that a price agreement be entered into, the Ministry of Social Affairs has the right to impose a penalty payment pursuant to the procedure provided for in the Substitutive Enforcement and Penalty Payment Act. The upper limit for a penalty payment is 100 000 kroons.

(51)      If no agreement is reached on the conditions for entry into or amendment of a price agreement during a reasonable period of time, the Ministry of Social Affairs may initiate proceedings for the reduction of the discount rate for the medicinal product pursuant to the procedure established pursuant to subsection 43 (3) of this Act.

(28.06.2004 entered into force 01.08.2004 - RT I 2004, 56, 400)

(6)        The procedure for entry into price agreements shall be established by a regulation of the Minister of Social Affairs.