Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medical Devices Intended for the Outpatient Medical Treatment

Issued pursuant to
Section 5, Clause 20
of the Pharmaceutical Law

I. General Provisions

1. This Regulation prescribes the procedures for the reimbursement of expenditures for the acquisition of medicinal products and medical devices intended for the outpatient medical treatment (hereinafter - the procedures for reimbursement).

2. These procedures for reimbursement are a set of measures, that provide an opportunity for a patient to acquire medicinal products and medical devices, the expenditures for the acquisition of which in accordance with this Regulation are completely or partially covered by the funds from the State budget for the current year granted for the reimbursement of expenditures for the acquisition of medicinal products (hereinafter - the funds granted for reimbursement). The purpose of measures included in these procedures for reimbursement is to ensure medicinal products and medical devices for as wide range of patients as possible within the framework of the funds granted for reimbursement, as well as to achieve the lowest possible price of reimbursable medicinal products and medical devices, and to direct the resources obtained as a result of saving for the improvement of health of patients and achievement of the medical treatment objectives.

[22 September 2009; 27 December 2011; 21 October 2014; 26 May 2015]

2.¹ Settlement for medicinal products and medical devices, which are distributed in accordance with the procedures for reimbursement, shall be performed in euros.

[25 August 2009; 10 September 2013]

II. Basic Principles of the Procedures for Reimbursement

3. Expenditures for the acquisition of medicinal products included on the list of reimbursable medicinal products (a list that includes medicinal products and medical devices, expenditures for the acquisition of which are covered from the funds granted for reimbursement in conformity with this Regulation) (hereinafter - the reimbursable medicinal products) and of medical devices included therein (hereinafter - the reimbursable medical devices) shall be covered in accordance with this Regulation for patients who have been diagnosed with any of the diseases referred to in Annex 1 to this Regulation or in the case laid down in Sub-paragraph 92.1 of this Regulation, taking into account the nature and level of seriousness of the disease and complying with reimbursement restrictions and prescription conditions.

[26 January 2010]

3.¹ Expenditures for the acquisition of medicinal products and medical devices shall be covered in full amount from the funds granted for reimbursement for a patient who has been recognised as a needy person or an asylum seeker in accordance with the procedures laid down in laws and regulations and who is entitled to receive reimbursement of expenditures for the acquisition of medicinal products or medical devices in accordance with this Regulation, except the following cases:

3.¹ 1. the non-reference medicinal products included in the List A of reimbursable medicinal products are prescribed for a patient. In such case the patient shall cover the difference between the pharmacy price of non-reference and reference medicinal products of the relevant group (with value added tax);

3.¹ 2. the expenditures for the prescribed medicinal products exceed the amount determined in Paragraph 100 of this Regulation.

[26 January 2010; 21 October 2014; 20 September 2016]

3.² [27 December 2011. See Paragraph 2 of the amendments]

3.³ [27 December 2011. See Paragraph 2 of the amendments]

3.⁴ [27 December 2011. See Paragraph 2 of the amendments]

3.⁵ The patient referred to in Paragraph 3.¹ of this Regulation shall present a statement in a pharmacy on conformity with the status of a needy family (person) issued by the social service office of the local government in accordance with the laws and regulations on recognition of a family or a person living separately as needy or a personal document of an asylum seeker issued by the State Border Guard.

[27 December 2011; 20 September 2016]

3.⁶ The expenditures for the acquisition of medicinal products and medical devices shall be covered in full amount for a patient until reaching 18 years of age who in accordance with this Regulation is due reimbursement of expenditures for the acquisition of medicinal products or medical devices, except the following cases:

3.⁶ 1. the patient has been prescribed non-reference medicinal products or medical devices included on the List A of reimbursable medicinal products. In such case the patient shall cover the difference between the pharmacy price of non-reference and reference medicinal products or medical devices of the relevant group (with value added tax);

3.⁶ 2. the patient has been prescribed medicinal products included on the List M, expenditures for the acquisition of which are covered in accordance with the procedures laid down in Sub-paragraph 9.2 of this Regulation;

3.⁶ 3. the restrictions for reimbursement specified in Sub-paragraphs 6.2.2, 8.16 and 16.1 of Annex 1 to this Regulation, exist;

3.⁶ 4. the costs of medicinal products or medical devices prescribed exceed the amount laid down in Paragraph 100 of this Regulation.

[17 December 2013; 26 May 2015]

4. Expenditures for the acquisition of reimbursable medicinal products shall be covered, applying the following reimbursement categories:

4.1. Category I - reimbursement in the amount of 100 % or in the amount of the reference price of the relevant group (in respect of medicinal products and medical devices included on List A of reimbursable medicinal products), if it has been determined that a patient has a chronic, life-threatening disease or a disease, which causes serious irreversible disability and the medical treatment of which requires the use of the respective medicinal products in order to maintain the patient's vital functions;

4.2. Category II - reimbursement in the amount of 75 % or - in respect of medicinal products and medical devices included on List A of reimbursable products - in the amount of 75 % of the reference price of the relevant group, if it has been determined that a patient has a chronic disease, in the medical treatment of which the maintenance of the patient's vital functions is made difficult or which causes serious disability without the use of the respective medicinal products;

4.3. Category III - reimbursement in the amount of 50 % or - in respect of medicinal products and medical devices included on List A of reimbursable products - in the amount of 75 % of the reference price of the relevant group, if it has been determined that a patient has a chronic or acute disease, in the medical treatment of which the use of the respective medicinal products is necessary in order to maintain or improve the patient's state of health or in case where vaccines are paid for from the funds granted for reimbursement.

[27 January 2009; 27 December 2011]

4.¹ When acquiring medicinal products or medical devices included on the list of reimbursable medicinal products within the framework of reimbursement Category I, a patient shall pay EUR 0.71 for each prescription in a pharmacy. When performing settlement of accounts with the pharmacy, the National Health Service shall reduce the sum to be repaid by the amount of payment made by the patient.

[29 March 2011; 19 October 2011; 10 September 2013]

4.² The patient's payment referred to in Paragraph 4.¹ of this Regulation shall not be applied:

4.² 1. to prescriptions written out to the patients referred to in Paragraph 3.¹ of this Regulation;

4.² 2. to prescriptions written out to children up to 18 years of age;

4.² 3. to prescriptions based on which medicinal products or medical devices, the pharmacy price determined by the National Health Service of which does not exceed EUR 4.27, are prescribed.

[29 March 2011; 19 October 2011; 27 December 2011; 10 September 2013]

5. Groups of reimbursable medical devices and the amount of reimbursement thereof shall be determined in accordance with Annex 2 to this Regulation.

6. The list of reimbursable medicinal products shall consist of three parts - List A, List B, and List C. The list of reimbursable medicinal products shall be drawn up according to the following basic principles:

6.1. List A shall include medicinal products of equal therapeutic efficacy within the scope of the common medicinal product name, which conforms to the seven-digit code of the medicinal product in the anatomical therapeutic chemical classification (hereinafter - the common medicinal product name), or the pharmaco-therapeutic group of the medicinal products and medical devices of the same type of the use in accordance with the criteria referred to in Paragraph 23 and Chapter IV of this Regulation;

6.2. List B shall include such medicinal products and medical devices, which do not comply with the criteria referred to in Chapter IV, in accordance with the criteria referred to in Paragraph 23 and Chapter V of this Regulation;

6.3. List C shall include such medicinal products and medical devices, costs of which for medical treatment of one patient exceed EUR 4 268.62 per year and to which the prescription conditions referred to in Paragraph 55 of this Regulation are not sufficient in order to limit the number of patients according to the funds granted for reimbursement, in accordance with the criteria referred to in Chapter VI of this Regulation.

[25 August 2009; 19 October 2011; 10 September 2013]

7. Medicinal products that are applied for inclusion on the list of reimbursable medicinal products shall comply with the following conditions:

7.1. they are included on the list of medicinal products authorised in the Republic of Latvia or authorised with the European Medicines Agency under a centralised authorisation procedure of medicinal products, or are distributed in parallel or parallel imported in accordance with the laws and regulations on the bringing in and distribution of medicinal products, or there is a permit to bring in and distribute the respective medicinal products in the territory of the Republic of Latvia in accordance with Section 10, Clause 7 of the Pharmaceutical Law;

7.2. the medicinal products are classified as prescription medicinal products in accordance with the laws and regulations on the classification of medicinal products;

7.3. the medicinal products are intended for the use, if there is any of the diseases referred to in Annex 1 to this Regulation.

[27 January 2009; 25 August 2009]

8. Homeopathic medicinal products shall not be included on the list of reimbursable medicinal products.

9. Medical devices that are applied for inclusion on the list of reimbursable medicinal products shall comply with the following conditions:

9.1. EC declaration of conformity has been drawn up for them and they have been labelled with CE conformity marking in accordance with the laws and regulations on the registration, conformity assessment and distribution of medical devices;

9.2. medical devices intended for use in the event of any of the diseases referred to in Annex 1 to this Regulation.

[29 March 2011]

9.¹ Medicinal products reimbursable within the scope of the reimbursement procedures, which are used by pregnant women, women during the period following childbirth up to 70 days and children up to the age of 24 months, but which are not included on the list of reimbursable medicinal products, shall form List M (hereinafter - the List M medicinal products) and they shall conform to the following conditions:

9.¹ 1. they are included on the list of medicinal products authorised in the Republic of Latvia or authorised with the European Medicines Agency under a centralised authorisation procedure of medicinal products, or are parallel distributed or parallel imported in accordance with the laws and regulations on the bringing in and distribution of medicinal products;

9.¹ 2. they are classified as prescription medicinal products, except:

9.¹ 2.1. medicinal products which conform to the designation Pr. I, Pr. II stac. or Pr. III in accordance with the laws and regulations on the procedures for classification of medicinal products;

9.¹ 2.2. medicinal products in prescribing of which, in accordance with the laws and regulations on the prescribing of prescription medicinal products, the programme for avoiding pregnancy developed by the holder (owner) of the registration certificate of the medicinal products and co-ordinated with the State Agency of Medicines is conformed to;

9.¹ 2.3. vaccines which, in accordance with the laws and regulations on vaccination, are included in the vaccination calendar and are paid for within its scope;

9.¹ 3. they have the price declared in the State Agency of Medicines in accordance with the laws and regulations on the principles of creation of prices for medicinal products.

[24 July 2012; 21 October 2014; 7 August 2018]

9.² The expenditures for the acquisition of the List M medicinal products shall be covered, applying the following reimbursement categories:

9.² 1. reimbursement in the amount of 50 % for a child up to the age of 24 months, if a diagnosis with another amount of reimbursement has not been determined for him or her;

9.² 2. reimbursement in the amount of 25 % for a pregnant woman or a woman during the period following childbirth up to 70 days, if a diagnosis with another amount of reimbursement has not been determined for her.

[24 July 2012; 7 August 2018]

10. Expenditures for the acquisition of medicinal products and medical devices shall be reimbursed in accordance with the list of reimbursable medicinal products and List M which is created and maintained by the National Health Service. The National Health Service shall indicate on the list the common medicinal product name, the medicinal product name, the code of the medicinal product in the anatomical therapeutic chemical classification, the identification number, the owner of the marketing authorisation, the pharmaceutical form, the strength, the size of the packaging, the basic price of reimbursement, the pharmacy price (with value added tax), the amount of reimbursement, the category of the list and the time period of inclusion of a medicinal product, if the medicinal product is included for a certain time period, as well as the group, the name, the identification number, the owner of the marketing authorisation, the size of the packaging, the basic price of reimbursement, the pharmacy price (with value added tax), the amount of reimbursement, the category of the list and the time period of inclusion of a medical device, if the medical device is included for a definite time period.

[25 August 2009; 22 September 2009; 19 October 2011; 24 July 2012 / Amendments to this Paragraph shall come into force on 1 September 2012. See Paragraph 3 of the amendments]

10.¹ The National Health Service shall determine the basic reimbursement price and pharmacy price for the List M medicinal products on the basis of the price declared by the manufacturer in conformity to the laws and regulations on the principles for creation of prices for medicinal products and applying the mark-up per cent, correction coefficients and correction amounts referred to in Paragraphs 26 and 28 of this Regulation. The National Health Service shall update the prices not less than twice a year - on 1 January and 1 July, using the manufacturer's prices declared in the State Agency of Medicines.

[24 July 2012 / Paragraph shall be applied on 1 August 2012. See Paragraph 2 of the amendments]

III. Inclusion of Medicinal Products and Medical Devices on the List of Reimbursable Medicinal Products

11. In order to include medicinal products and medical devices on the list of reimbursable medicinal products, the holder (owner) of the registration certificate of the medicinal products or medical devices or the authorised representative thereof, or the wholesaler of the medicinal products or medical devices or the authorised representative thereof (hereinafter - the applicant) shall submit a written application to the National Health Service. The application shall indicate:

11.1. information regarding the applicant (the name, registration number, legal address of the legal person) and the payer (settlement details);

11.2. information regarding the medicinal product or medical device (the name, the registration number, the registration date, the manufacturer's price and the anticipated basic price of reimbursement, the number of doses in a packaging (hereinafter - the size of the packaging). In addition the common medicinal product name, the code of the medicinal product in the anatomical therapeutic chemical classification with the defined daily dosage (hereinafter - the ATC/DDD classification), the pharmaceutical form and the strength of the medicinal product (amount of active substances in a dose) shall be indicated for medicinal products;

11.3. the disease, indicating the code of the diagnosis pursuant to the International Statistical Classification of Diseases and Related Health Problems (10th Revision) (hereinafter - ICD classification), and the target group of patients (group of patients with a specified diagnosis, for which the use of the relevant medicinal products or medical devices is justified), for whose medical treatment reimbursement of expenditures for the acquisition of medicinal products or medical devices should be evaluated.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

12. The applicant shall append the following documents and information to the application regarding the inclusion of medicinal products on the list of reimbursable medicinal products:

12.1. a summary of the clinical trials and the copies of publications, indicating a reference to a source that proves the therapeutic efficacy of such medicinal products and advantages in comparison with other alternative therapies available in Latvia (if an application is being submitted for the inclusion of a new common name for a medicinal product on the list of reimbursable medicinal products);

12.2. information on the sales price of the manufacturer of the medicinal products in the respective currency in the Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovakia and Hungary and in euros in conformity with the foreign currency exchange rate to be used in accounting on the day when the application is submitted;

12.3. the calculation of the anticipated consumption of funds granted for reimbursement, including the comparative therapy, target groups of patients and the number of patients, as well as the calculation regarding the probable quantity and the estimated turnover of the medicinal products to be sold in Latvia in accordance with the procedures of reimbursement;

12.4. the pharmaco-economic calculations in accordance with the economic assessment guidelines of medicinal products specified in Annex 3 to this Regulation (if an application is being submitted for inclusion of a new common name for a medicinal product on the list of reimbursable medicinal products);

12.5. a certification that the continuous presence of the reimbursable medicinal products on the market will be ensured;

12.6. an authorisation issued by the holder (owner) of the registration certificate of the medicinal products or the wholesaler of the medicinal products, if the applicant is the authorised representative of the holder (owner) of the registration certificate or the wholesaler of the medicinal products;

12.7. a document confirming that the applicant has registered in any of the European Economic Area Member States, as well as a document confirming the right of representation (copies);

12.8. information regarding the number of patients to whom the applicant intends to cover expenditures for the acquisition of the relevant medicinal products from his or her own resources if the medicinal products are to be included on List C;

12.9. [25 August 2009];

12.10. proposals on conditions of the contract referred to in Sub-paragraph 61.² 4 of this Regulation.

[25 August 2009; 9 October 2012; 10 September 2013]

13. Where medicinal products are being brought in and distributed in the territory of the Republic of Latvia in accordance with Section 10, Clause 7 of the Pharmaceutical Law, the applicant shall attach the following information to the application:

13.1. instructions on the use of the medicinal products in the official language and the original language;

13.2. the wholesale price in the currency of the state of manufacture and state of exportation and in euros in accordance with the foreign currency exchange rate to be used in accounting on the day when the application is submitted;

13.3. a certification that the continuous presence of the medicinal products on the market will be ensured;

13.4. the calculations regarding the probable amount of the medicinal products to be sold in Latvia in accordance with the procedures for reimbursement, the estimated turnover (in euros) and the number of patients per year;

13.5. an authorisation issued by the holder of the permit of the State Agency of Medicines for the bringing in of non-authorised medicinal products, where the application is being submitted by an authorised representative.

[25 August 2009; 10 September 2013]

14. Where the medicinal products are being distributed in parallel or parallel imported, an applicant shall attach the following information to the application:

14.1. the sales price of the manufacturer in the currency of the state of manufacture and state of exportation and in euros in accordance with the foreign currency exchange rate to be used in accounting on the day when the application is submitted;

14.2. a certification that the continuous presence of the medicinal products on the market will be ensured;

14.3. the calculations regarding the probable amount of the medicinal products to be sold in Latvia in accordance with the procedures for reimbursement, the estimated turnover (in euros) and the number of patients per year;

14.4. an authorisation issued by the parallel distributor or parallel importer, where the application is being submitted by the authorised representative.

[27 January 2009; 25 August 2009; 10 September 2013]

15. The applicant shall append the following documents and information to the application regarding inclusion of medical devices on the list of reimbursable medical devices:

15.1. information on the sales price of the manufacturer of the medicinal products in the respective currency in the Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovakia and Hungary and in euros in conformity with the foreign currency exchange rate to be used in accounting on the day when the application is submitted;

15.2. the calculation of the anticipated consumption of funds granted for reimbursement, including the comparative therapy, target groups of patients and the number of patients, as well as the calculation regarding the probable quantity and the estimated turnover of the medical devices to be sold in Latvia in accordance with the procedures of reimbursement;

15.3. a certification that the continuous presence of the reimbursable medical devices on the market will be ensured;

15.4. an authorisation issued by the holder (owner) of the registration certificate of the medical devices, if the application is being submitted by an authorised representative of the holder (owner) of the registration certificate;

15.5. a document confirming that the applicant has registered in any of the European Economic Area Member States, as well as a document confirming the right of representation (copies);

15.6. information on the number of patients to whom the applicant intends to cover expenditures for the acquisition of the relevant medical devices from his or her own resources if the medical devices are to be included on List C;

15.7. a description of the medical devices in Latvian;

15.8. a copy of the EC conformity declaration.

[25 August 2009; 29 March 2011; 10 September 2013; 21 October 2014]

16. The applicant shall append the following documents and information to the application on re-examination of reimbursement conditions for medicinal products:

16.1. a summary of the clinical trials and the copies of publications, indicating a reference to a source that proves the validity for re-examination of prescription conditions or inclusion of the medicinal products on another list for the particular diagnosis or target group of patients;

16.2. the calculation of the anticipated consumption of funds granted for reimbursement, including the comparative therapy, target groups of patients and the number of patients, as well as the calculation regarding the probable quantity and the estimated turnover of the medicinal products and medical devices to be sold in Latvia in accordance with the procedures of reimbursement, in changing the prescription conditions or including the medicinal products on other list;

16.3. the pharmaco-economic calculations in accordance with the economic assessment guidelines of medicinal products specified in Annex 3 to this Regulation, which justify the validity of re-examination of prescription conditions or inclusion of medicinal products on another list for the particular diagnosis or target group of patients;

16.4. information on the sales price of the manufacturer of the medicinal products in the respective currency in the Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovakia, and Hungary and in euros in conformity with the foreign currency exchange rate to be used in accounting on the day when the application is submitted.

[25 August 2009; 10 September 2013; 21 October 2014]

16.¹ The applicant shall append the following documents and information to the application regarding re-examination of reimbursement conditions for medical devices:

16.¹ 1. a justification for re-examination of reimbursement conditions for the particular diagnosis or target group of patients or inclusion of the medical device on another list;

16.¹ 2. the calculation of the anticipated consumption of funds granted for reimbursement, including target groups of patients and the number of patients, as well as the calculation regarding the probable quantity and the estimated turnover of the medical devices to be sold in Latvia in accordance with the procedures for reimbursement, in changing the prescription conditions;

16.¹ 3. information on the sales price of the manufacturer of the medicinal products in the respective currency in the Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovakia, and Hungary and in euros in conformity with the foreign currency exchange rate to be used in accounting on the day when the application is submitted.

[25 August 2009; 10 September 2013; 21 October 2014]

16.² The applicant shall append the following documents and information to an application regarding re-examination of the basic reimbursement price of medicinal products or medical devices:

16.² 1. a justification based on calculations regarding the changes in the manufacturer's price or the basic reimbursement price. A justification for increase of the basic reimbursement price may be the growth of manufacturing costs, the changes in the currency exchange rate, the application of maximum surcharge of a wholesaler;

16.² 2. the calculation of the anticipated consumption of funds granted for reimbursement after changing of the basic reimbursement price, including the comparative therapy, target groups of patients and the number of patients, as well as the calculation regarding the probable quantity and the estimated turnover of the medicinal products and medical devices to be sold in Latvia in accordance with the procedures of reimbursement;

16.² 3. information on the sales price of the manufacturer of the medicinal products in the respective currency in the Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovakia, and Hungary and in euros in conformity with the foreign currency exchange rate to be used in accounting on the day when the application is submitted.

[25 August 2009; 10 September 2013; 21 October 2014]

16.³ An applicant shall indicate the name of medicinal products or medical devices, the registration number, the common name of the medicinal product, the strength of the medicinal product, the pharmaceutical form of the medicinal product, the size of the packaging, the basic reimbursement price, the basic reimbursement price reduced temporarily and the time from which the reduced basic reimbursement price will be applied, in the application on reducing the basic reimbursement price of medicinal products or medical devices temporarily. The temporarily reduced basic reimbursement price of medicinal products and medical devices of List A may not be lower than or equivalent to the reference prince already specified in the list of reimbursable medicinal products, or lower than the lowest offered price specified in accordance with Section 62.³ of this Regulation or equivalent thereto. The reduced basic reimbursement price shall be waived on the basis of the application of the applicant regarding the waiving of the reduced basic reimbursement price. If the reference medicinal products are deleted from the list of reimbursable medicinal products, the National Health Service shall increase the reduced basic reimbursement price so that it would conform to the criteria laid down in this Paragraph.

[7 August 2018]

17. The National Health Service, in addition to the documents and information referred to in Paragraphs 11, 12, 13, 14, 15, 16, 16.¹, 16.², and 16.³ of this Regulation, has the right to request additional information necessary for the taking of a decision.

[25 August 2009; 22 September 2009; 19 October 2011; 21 October 2014]

18. An applicant shall be responsible for the veracity of the data included in documents and information appended to an application. After registration of the application with the National Health Service, the applicant is not entitled to amend the information referred to in the application upon his or her own initiative. If the applicant wants to amend the information referred to in the application, the application shall be submitted anew. The previous application shall be cancelled (payment for the new application shall not be required).

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

18.¹ An applicant shall immediately notify the National Health Service, if the name, the registration number, the holder (owner) or his or her authorised representative of the registration certificate of the medicinal products or medical devices included on the list of reimbursable medicinal products, have been changed.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

19. After registration of the application the National Health Service shall draw up an account in accordance with the pricing of the National Health Service.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

20. The National Health Service, on the basis of an application of an applicant, has the right to waive the charge for the evaluation of medicinal products or medical devices necessary for the inclusion thereof on the list of reimbursable medicinal products or the charge for the evaluation of the revision of reimbursement conditions, or the annual charge for maintaining medicinal products and medical devices in the list of reimbursable medicinal products if:

20.1. the turnover of the relevant medicinal products or medical devices within the scope of reimbursement procedures in the previous year have not exceeded EUR 2845.74, but they are substantially necessary for the provision of the treatment process;

20.2. the medicinal products are brought in and distributed in the territory of the Republic of Latvia in accordance with Section 10, Clause 7 of the Pharmaceutical Law.

[27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011; 9 October 2012; 10 September 2013; 21 October 2014; 7 August 2018]

21. An applicant is allowed to submit an application regarding waiving of the charge referred to in Paragraph 20 of this Regulation at any time. If the National Health Service takes a decision to waive the charge referred to in Paragraph 20 of this Regulation, it shall not draw up an account for the performance of the relevant payment or shall cancel the account that has already been draw up. If the applicant has already paid for examination of the application or for the maintenance of the medicinal products or medical devices on the list of reimbursable medicinal products, he or she shall not be reimbursed the expenditure.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

22. In examining an application regarding the inclusion of medicinal products or medical devices on the list of reimbursable medicinal products, the National Health Service shall perform the following activities:

22.1. a medical assessment (for an application for including a new common name of medicinal products or a new combination of common names of medicinal products on the list of reimbursable medicinal products, revising the conditions for reimbursement, including a new pharmaceutical form) and shall evaluate:

22.1.1. the results of published clinical trials on the advantages of the therapeutic efficacy of the particular medicinal products within the scope of pharmaco-therapeutic group or diagnosis in respect of the mortality indicator or time period until the progression of the disease, frequency of chronic diseases, occurring of disability, reduction of hospitalisation cases, improvement of the condition of health, in comparison with another available type of medical treatment;

22.1.2. the compliance with the schemes developed by professional physicians' associations for the treatment of specific diseases (hereinafter - treatment schemes) and international medical treatment guidelines;

22.1.3. the place of the medicinal products in the treatment scheme of the particular disease (for example, the medicinal products of first and second choice, the target groups of patients);

22.1.4. the correspondence of the pharmaceutical form and strength with the treatment scheme;

22.1.5. the correspondence of the size of the packaging with the course of treatment;

22.2. economic assessment and shall evaluate:

22.2.1. the treatment expenses, in using the relevant medicinal products or medical devices, and the effects thereof upon the funds granted for the health care including reimbursement (including the effects of possible adverse reactions caused by the use of the medicinal products or medical devices upon the course of treatment and the treatment costs);

22.2.2. therapeutic efficacy and costs of the new common medicinal product names in comparison with another type of available treatment in accordance with the economic assessment guidelines of medicinal products approved in Annex 3 to this Regulation;

22.2.3. the prices of medicinal products and medical devices in comparison with prices of the respective medicinal products and medical devices in the Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovakia, and Hungary.

[27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011; 9 October 2012; 21 October 2014]

23. Medicinal products shall be included on List A and List B, if they comply with the following criteria in addition to the requirements referred to in Sub-paragraphs 6.1 and 6.2 and Paragraph 7 of this Regulation:

23.1. the therapeutic efficacy and advantages in the treatment of any of the diseases referred to in Annex 1 to this Regulation have been proved to the medicinal product;

23.2. the use of the medicinal product complies with the treatment scheme or international treatment guidelines of the particular disease;

23.3. the pharmaceutical form and strength complies with the treatment scheme;

23.4. the size of the packaging corresponds with the course of treatment;

23.5. the costs of use of the medicinal product can be foreseen and commensurable with the anticipated therapeutic efficacy and with the funding granted for reimbursement in the respective year.

24. Medical devices shall be included on Lists A and B, if they comply with the following criteria in addition to the requirements referred to in Sub-paragraphs 6.1 and 6.2 and Paragraph 9 of this Regulation:

24.1. the therapeutic efficacy and advantages in the treatment of any of the diseases referred to in Annex 1 to this Regulation have been proved to the medical device;

24.2. the costs of use of the medical device can be foreseen and commensurable with the anticipated therapeutic efficacy and with the funds granted for the reimbursement in the respective year.

25. Medicinal products, the efficacy of which is higher, in comparison with another type of efficient treatment of available costs, but the inclusion of which on the list of reimbursable medicinal products might cause additional expenses from the funds granted for reimbursement, shall be included on the list of reimbursable medicinal products, applying the prescription conditions, as well as if it is allowed by the amount of the funds granted for the reimbursement.

26. The basic price of reimbursement (sales price of the wholesaler) for reimbursable medicinal products and medical devices and any medicinal products and medical devices partially or completely reimbursable from the funds of the State budget shall not exceed the price that is obtained by utilising the following formula:

KBC = KMRC + LP, where

KBC - the basic reimbursement price of the reimbursable medicinal products or medical devices in euros;

KMRC - the manufacturer's price in euros of the reimbursable medicinal products or medical devices;

LP - the wholesaler's mark-up in per cent (Annex 4).

[10 September 2013]

27. [15 May 2012]

28. The pharmacy price of reimbursable medicinal products and medical devices and any medicinal products and medical devices partially or completely reimbursable from the funds of the State budget shall be calculated by utilising the following formula:

KMAC = KBC x k + X + PVN, where

KMAC - the pharmacy price in euros of the reimbursable medicinal products or medical devices;

KBC - the basic price of reimbursement in euros;

K - the correction coefficient (Annex 5);

X - the correction amount in euros (Annex 5);

PVN - the calculated value added tax.

[10 September 2013]

29. A patient shall cover the difference between the pharmacy price of medicinal products or medical devices and the reimbursement sum or the third party or applicant - in the cases referred to in Paragraph 100.¹ of this Regulation.

[9 October 2012]

29.¹ Medicinal products and medical devices included on the list of reimbursable medicinal products shall be distributed in pharmacies only for the pharmacy price determined by the National Health Service, taking into account the procedures referred to in this Regulation.

[26 May 2015]

29.² The National Health Service in conformity with the information provided by a pharmacy shall pay EUR 0.71 for each prescription (except those prescriptions against which non-reference medicinal products or medical devices included on the List A have been issued) within the framework of reimbursement procedures to the pharmacy which is operating as an individual pharmacy outside town and the turnover of which did not exceed EUR 71 143.59 in the previous year within 12 months. In order to receive a payment the owner of the pharmacy shall lodge a submission to the National Health Service attaching a document attesting the amount of the turnover.

[28 December 2010; 19 October 2011; 10 September 2013; 21 October 2014]

30. The price of reimbursable medicinal products or medical devices shall not be higher than the third lowest sales price of the manufacturer and the price of the wholesale trade of the medicinal products or medical devices in the Czech Republic, Denmark, Romania, Slovakia, and Hungary and shall not exceed the sales price of the manufacturer and the price of the wholesale trade of the medicinal products or medical devices in Estonia and Lithuania. The applicant shall, each year by 1 February, submit electronically to the National Health Service the information on the current prices of medicinal products (EUR) in the abovementioned countries and indicate them also in the currency of the relevant country, if necessary.

[9 October 2012; 7 August 2018]

30.¹ The price of parallel distributed and parallel imported medicinal products shall be lower than the price of such reimbursable medicinal products, in relation to which parallel distribution or parallel importation has been carried out. The prices of other reimbursable medicinal products and medicinal products to be included on the list of reimbursable products shall not be compared to the prices of parallel distributed or parallel imported medicinal products.

[26 May 2015]

31. In carrying out non-interventional trials of medicinal products, the manufacturer of the medicinal products shall cover the expenditures related to the acquisition of the respective medicinal products and the surveillance of the use thereof.

IV. Inclusion of Medicinal Products and Medical Devices on List A and the Determination of the Reference Price

32. The medicinal products shall be included on List A:

32.1. within the scope of one common medicinal product name with the same type of administration and medical devices with the same type of use (medicinal products within the scope of one common name are considered as medicinal products of equal therapeutic efficacy, except in cases when as a result of clinic researches submitted by the applicant clinically significant differences in terms of therapeutic efficacy or adverse effects are proven compared to other medicinal products of the same common name included on the list of reimbursable medicinal products);

32.2. within the scope of pharmaco-therapeutic groups of the medicinal products (three to seven symbols in the ATC/DDD classification) if:

32.2.1. therapeutic efficacy of the medicinal products has been proved for the treatment of the same disease referred to in Annex 1 to this Regulation;

32.2.2. there are no clinically significant differences, taking into account the data of the clinical trials, therapeutic efficacy and adverse effects;

32.3. they are medicinal products of combined composition, the composition of which includes common medicinal product names or common medicinal product names of equal therapeutic efficacy included on the list of reimbursable medicinal products and advantages of the medicinal products of combined composition have not been proved in the clinical trials of the medicinal products within the meaning of therapeutic efficacy and adverse effects, in comparison with medicinal products to be used individually included in the composition thereof.

[27 March 2007; 25 August 2009; 9 October 2012; 7 August 2018]

33. Medicinal products on List A shall be classified in groups of equal therapeutic efficacy medicinal products, taking into account the pharmaceutical form, the strength of the medicinal products. The medicinal products which are intended for the commencement of therapy or for dosage titration (gradual diminishing or amplification of dosage of medicinal products) shall be classified in one group with the medicinal products of the nearest strength.

[25 August 2009; 20 September 2016 / Amendment to the first sentence of this Paragraph with regard to the deletion of words "as well as the compliance of the size of packaging with the treatment course" shall come into force on 1 April 2017. See Paragraph 2 of the amendments]

34. Medical devices on List A shall be classified in groups, taking into account their type of use.

[25 August 2009]

35. For each group of medicinal products or medical devices included on List A shall be calculated a reference price, which is the pharmacy price of the cheapest medicinal product or the cheapest medical device of an equal therapeutic efficacy group. The reference price shall be the ground for the calculation of the reimbursement sum.

[25 August 2009; 19 October 2011; 27 December 2011; 9 October 2012; 26 May 2015]

36. In order to calculate the reference price for the medicinal product and medical device included on List A, the following principles shall be applied:

36.1. the reference price shall be calculated for each medicinal product name, including the pharmaceutical form, strength, and for each medical device name;

36.2. the reference price shall be calculated for each medicinal product name on the basis of the treatment costs of the reference medicinal product name of equal therapeutic efficacy group in accordance with the daily dosage defined in the ATC/DDD classification, taking into account the pharmaceutical form, strength and size of the packaging;

36.3. if in accordance with the submitted clinical documentation the therapeutic daily dosage of medicinal products does not comply with the defined daily dosage in the ATC/DDD classification, the reference price shall be calculated on the basis of the therapeutic daily dosages;

36.4. the costs of one unit of different forms of medicinal products may differ from the costs of the tablet and capsule form of the medicinal products in accordance with the maximum admissible difference in costs indicated in Annex 6 to this Regulation;

36.5. the unit price of the one common name medicinal product with the stronger active substance shall be less than the unit price of the nearest medicinal product with the active substance of less strength;

36.6. [20 September 2016. See Paragraph 2 of the amendments]

36.7. the costs of medicinal products of combined composition may not exceed the amount of the cost of the cheapest medicinal product under the same common medicinal product name or common medicinal name of equal therapeutic efficacy included on the list of reimbursable medicinal products to be utilised separately.

[27 January 2009; 25 August 2009; 20 September 2016 / Amendment to Sub-paragraph 36.1 with regard to the deletion of words "and size of packaging" and amendment regarding deletion of Sub-paragraph 36.6 shall come into force on 1 April 2017. See Paragraph 2 of the amendments]

36.¹ Within the scope of one reimbursement group the reimbursement price may be determined for several medicinal products or medical devices.

[26 May 2015]

37. The reimbursement sum for the medicinal products and medical devices included on List A shall form by applying the reimbursement sum specified in Annex 1 to this Regulation to the reference price.

37.¹ In reviewing the reference price of the medicinal products or medical devices included on List A in accordance with the justification indicated in Paragraph 38 of this Regulation, the National Health Service shall indicate the relevant changes in the list of reimbursable medicinal products in the decision on such medicinal products or medical devices which cause changes to the reference price, without making amendments to decisions on other medicinal products or medical devices included in the relevant reference group (hereinafter - the non-reference medicinal products or medical devices).

[29 March 2011; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

38. The National Health Service shall revise the reference price of medicinal products and medical devices included on List A or the basic reimbursement price on the basis of:

38.1. the applicant's application, to which the documents and information referred to in Paragraph 16.2 of this Regulation are appended;

38.2. a decision to include such medicinal products or medical devices on the list of reimbursable medicinal products, by using which the treatment costs are lower than the costs of medicinal products or medical devices already included on the list of reimbursable medicinal products;

38.3. the report of the Health Inspectorate or the information from the information system of the State Agency of Medicines that the reference medicinal products or reference medical devices are not permanently available on the market. In such case the reference price shall be re-calculated taking into account the following cheapest medicinal product or medical device price of the relevant group of medicinal products or medical devices of an equal therapeutic efficacy;

38.4. a decision to delete reference medicinal products and reference medical devices from the list of reimbursable medicinal products;

38.5. the classification in groups performed for the calculation of the reference price.

[1 April 2008; 27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011 / The new wording of Sub-paragraph 38.3 shall come into force on 1 January 2019. See Paragraph 2 of the amendments]

38.¹ The National Health Service shall take a decision not to increase the basic reimbursement price of medicinal products and medical devices included on List A if:

38.¹ 1. the applicant has not provided a justification based on calculations for the increase of price;

38.¹ 2. due to revision of the price the foreseeable increase of costs is not commensurable with the funds granted for reimbursement;

38.¹ 3. the sales amounts of the respective medicinal products or medical devices within the scope of reimbursement procedures have increased by more than 10 % in the preceding year and reimbursement of such medicinal products and medical devices to patients with other diagnoses has not been started or the prescription conditions have been changed;

38.¹ 4. the manufacturer's price or the reimbursement basic price of medicinal products or medical devices is higher than the third lowest sales price of the manufacturer or the price of the wholesale trade of the medicinal products or medical devices in the Czech Republic, Denmark, Romania, Slovakia, and Hungary or exceeds the sales price of the manufacturer and the price of the wholesale trade of these medicinal products or medical devices in Estonia and Lithuania.

[27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011; 21 October 2014]

38.² If the applicant applies to reduce the basic reimbursement price of the medicinal products or medical devices included on List A, determining it lower than the basic reimbursement price of the reference medicinal products and medical devices present in the relevant reference group, the basic reimbursement price of these medicinal products or medical devices shall be at least 5 % lower than the basic reimbursement price of the reference medicinal products or medical devices present in the relevant reference group on List A.

[27 December 2011; 7 August 2018]

38.³ If the applicant applies to include new medicinal products on List A and the National Health Service takes the decision referred to in Paragraph 45 of this Regulation to include the medicinal products present on List B into List A, the basic reimbursement price for the new reference medicinal products within the scope of one common medicinal product name shall be at least 30 % lower than the basic reimbursement price of the medicinal products present on List B. The basic reimbursement price of the subsequent two medicinal products to be included on List A within the scope of one common medicinal product name shall be at least 10 % lower than the basic reimbursement price of the reference medicinal products or the cheaper medicinal products present on the relevant reference group on List A. Hereinafter the basic reimbursement price of the medicinal products to be included on List A within the scope of one common medicinal product name shall be at least 5 % lower than the basic reimbursement price of the reference medicinal products or the cheaper medicinal products present on the relevant reference group on List A.

[7 August 2018]

38.⁴ If the applicant submits a justified application to the National Health Service, at least one month prior to interruption of the supplies of reference medicinal products or medical devices, regarding interruption of the supplies for a time period from one month to three months, the relevant medicinal products or medical devices shall not be deleted from the list of reimbursable medicinal products, but the subsequent cheapest reimbursable medicinal products or medical devices of the relevant group available in Latvia shall be determined as the reference medicinal products or medical devices for this period of time. If the applicant fails to ensure continuous and uninterrupted availability of the reference medicinal products or medical devices on the market of Latvia without submitting a justified application regarding foreseeable interruption of supplies, the relevant medicinal products or medical devices shall be deleted from the list of reimbursable medicinal products.

[21 October 2014]

38.⁵ [27 December 2011]

38.⁶ If the applicant applies inclusion of a new medical device on List A of reimbursable medicinal products, the basic reimbursement price of such medical device must be at least 5 % lower than the basic reimbursement price of the reference medical devices present in the relevant reference group of List A.

[21 October 2014]

V. Inclusion of Medicinal Products and Medical Devices on List B

39. Medicinal products shall be included on List B if in addition to the criteria referred to in Paragraph 23 of this Regulation the price of the medicinal products is justified by calculations performed in accordance with the guidelines for the economic assessment of medicinal products included in Annex 3 to this Regulation. The calculations include the costs for one unit of an additionally obtained result of therapeutic efficacy (incremental cost-effectiveness ratio) - for a life-year gained, a life-year without progression of the disease or, if the abovementioned indicators are not available, for acquired quality-adjusted life year. The cost-effectiveness of the medicinal products shall be proved in relation to the health care system at large or a specific group of patients. The incremental cost-effectiveness ratio for an additionally gained life-year, a life-year without progression of the disease or quality-adjusted life year shall not exceed triple gross domestic product per capita in the previous year or in the last year for which the data is available (the data available on the website of the Central Statistical Bureau regarding the gross domestic product in current prices).

[7 August 2018]

40. The reimbursement sum for the medicinal products and medical devices included on List B shall form by applying the reimbursement sum specified in Annex 1 to this Regulation to the pharmacy price.

41. In determining the basic reimbursement price of medicinal products to be included on List B, costs of medicinal products within the scope of one common medicinal product name shall be assessed and the following conditions shall be taken into account:

41.1. the costs of different forms of medicinal products may differ from the costs of the tablet and capsule form of the medicinal products in accordance with the maximum difference of costs indicated in Annex 6 to this Regulation, calculating according to the daily therapeutic dosage of the medicinal products as defined in the ATC/DDD classification. If according to the submitted clinical documentation the therapeutic daily dosage does not comply with the defined daily dosage in the ATC/DDD classification, the price shall be calculated on the basis of dosages referred to in the submitted clinical documentation;

41.2. the unit price of a medicinal product with a stronger active substance shall be lower than the unit price of the nearest medicinal product with the active substance of less strength;

41.3. the unit price of a medicinal product of equal strength with a larger number of units in a packaging shall be less than the unit price of the nearest smaller packaging medicinal product;

41.4. [27 March 2007].

42. [7 August 2018]

43. The National Health Service has the right to revise the approved basic reimbursement price of medicinal products and medical devices included on List B in the following cases:

43.1. the applicant's application, to which the documents and information referred to in Paragraph 16.2 of this Regulation are appended, has been received;

43.2. the increase of the sales amount exceeds more than 10 % a year, except in cases where reimbursement of such medicinal products and medical devices to patients with other diagnoses has been started or the prescription conditions have been changed in the indicated period of time;

43.3. medicinal products or medical devices of therapeutic or superior efficacy with lower costs have been included on the list of reimbursable medicinal products.

[27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

44. The National Health Service shall take a decision not to increase the basic reimbursement price of medicinal products and medical devices included on List B if:

44.1. the applicant has not submitted a corresponding justification based on calculations for the increase of the price;

44.2. the sales amounts of the respective medicinal products or medical devices within the scope of reimbursement procedures have increased by more than 10 % in the preceding year and reimbursement of such medicinal products and medical devices to patients with other diagnoses has not been started or the prescription conditions have been changed;

44.3. medicinal products or medical devices of of equal therapeutic efficacy with lower costs are on the list of reimbursable medicinal products;

44.4. due to revision of the price the foreseeable increase of costs is not commensurable with the funds granted for reimbursement;

44.5. the manufacturer's price or the basic reimbursement price of medicinal products or medical devices is higher than the third lowest sales price of the manufacturer or the price of the wholesale trade of the medicinal products or medical devices in the Czech Republic, Denmark, Romania, Slovakia, and Hungary or exceeds the sales price of the manufacturer or the price of the wholesale trade of these medicinal products or medical devices in Estonia and Lithuania.

[27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011; 21 October 2014]

44.¹ If the applicant applies to reduce the basic reimbursable price of medicinal products included on List B within two years before expiry of the patent protection, the reduction of the price shall be at least by 20 %.

[28 December 2010; 19 October 2011; 21 October 2014; 26 May 2015]

44.² If the basic reimbursement price of medicinal products or medical devices is reduced for a definite time period on the basis of the application referred to in Paragraph 16.³ of this Regulation, the requirements of Paragraph 44.¹ of this Regulation shall not be applied.

[29 March 2011]

45. The National Health Service shall take a decision to include the medicinal products and medical devices, which are on List B, on List A, if a decision to include a new medicinal product name of equal therapeutic efficacy, common medicinal product name or new medical devices with the same indication of the use and type of the use on the list of reimbursable medicinal products has been taken. If in re-assessing the conformity of the medicinal products and medical devices included on the list of reimbursable medicinal products with the requirements and criteria referred to in this Regulation, the National Health Service establishes that the common name of a medicinal product of equal therapeutic efficacy or a medical device with the same type of the use is on the list of reimbursable medicinal products, the National Health Service shall take a decision to include the medicinal products or medical devices currently on List B into List A.

[25 August 2009; 22 September 2009; 8 June 2010; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

45.¹ If, in performing an annual data analysis, the National Health Service detects that the increase in the sales volume of the particular medicinal products or medical devices included on the List B, reimbursement of the acquisition expenditures of which has been commenced before at least three years, exceeds 10 % from the relevant indicator of the previous year, except cases if the contract referred to in Sub-paragraph 61.2.4 of this Regulation or a sales volume contract has been entered into or reimbursement of the acquisition expenditures of such medicinal products or medical devices with other diagnosis has been commenced, or the prescription conditions have been changed, the National Health Service shall inform the applicant regarding excess of the increase in sales volume. If the applicant does not enter into the contract referred to in Sub-paragraph 61.2.4 of this Regulation or a sales volume contract within two months from receipt of information from the National Health Service, but the increase in the sales volume exceeds 10 % the National Health Service shall take a decision and write out an invoice regarding the payment to be made. The amount of the payment shall be determined, using the following formula:

P = PA_x - (Pa_y + 10 %) - PVN - AU - LU, where

P - the amount of the payment;

PA_x - the sales volume in the previous year;

PA_y - the sales volume prior to the previous year;

PVN - the calculated value added tax;

AU - the amount of the added price of pharmacies, which has been calculated in accordance with Paragraph 28 of this Regulation;

LU - the amount of the added price of pharmacies, which has been calculated in accordance with Paragraph 26 of this Regulation.

[21 October 2014 / Paragraph shall come into force on 1 January 2016. See Paragraph 128]

VI. Inclusion of Medicinal Products and Medical Devices on List C

46. Medicinal products and medical devices shall be included on List C, if an applicant undertakes to cover the expenditures towards reimbursement of medicinal products for a definite number of patients from his or her own resources in amount of not less than 10 % of the number of patients specified in Sub-paragraph 47.1 of this Regulation or of the estimated turnover of medicinal products or medical devices within the scope of reimbursement system of expenditures for the acquisition of the medicinal products and if they comply with the conditions referred to in Sub-paragraph 6.3, Paragraphs 39 and 41 of this Regulation and the following criteria:

46.1. the medicinal products or medical devices have proven therapeutic efficacy in the reduction of mortality or consequences of life-threatening diseases or diseases causing irreversible disability;

46.2. the incremental cost-effectiveness ratio for an additionally gained life-year, a life-year without progression of the disease or quality-adjusted life year shall not exceed triple gross domestic product per capita in the previous year or in the last year for which the data is available (the data available on the website of the Central Statistical Bureau regarding the gross domestic product in current prices);

46.3. the number of patients who need reimbursement of expenses towards the purchase of the relevant medicinal products or medical devices can be foreseen.

[25 August 2009; 9 October 2012]

47. In including medicinal products and medical devices on List C, the National Health Service shall determine:

47.1. the number of patients to whom the expenditures for the acquisition of the relevant medicinal products or medical devices will be reimbursed from the reimbursement funds granted for the relevant year, including patients for whom the medical treatment started in the previous year must be completed in the subsequent year;

47.2. the number of patients to whom the expenditures for the acquisition of the relevant medicinal products or medical devices will be covered by the applicant from its own resources, including patients for whom the medical treatment started in the previous year must be completed in the subsequent year;

47.3. the percentage of the reimbursement funds granted for the relevant year and intended for reimbursement and of the resources of the applicant.

[28 December 2010; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

48. The National Health Service has the right to review the number of patients, if the data of analysis performed thereby provides for the possibilities for reimbursement of expenditures for the acquisition of the particular medicinal products or medical devices within the scope of the planned resources for a larger number of patients.

[19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

49. If applications of several applicants have been received regarding one common medicinal product name, the National Health Service shall take a favourable decision regarding the economically more profitable offer, taking into account the treatment costs of one patient, on the basis of the pharmacy price and the total number of patients, to whom it is possible to ensure reimbursement of medicinal products within the framework of a calendar year.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

50. The National Health Service has the right to take a decision on the inclusion of medicinal products and medical devices from List C on List B in one of the following cases:

50.1. if an application regarding the reduction of the basic reimbursement price has been received and the prescription conditions referred to in Paragraph 55 of this Regulation are sufficient in order to restrict the number of patients according to the funds granted for reimbursement;

50.2. the offer of an applicant referred to in Sub-paragraph 61.² 4 of this Regulation to enter into a contract regarding financial participation in provision of reimbursement has been entered into, providing for covering of the increase in the utilisation of the funds granted for reimbursement in comparison to the relevant period, in which the medicinal products were on List C.

[21 October 2014]

50.¹ The National Health Service has the right to take on the inclusion of medicinal products and medical devices from List C on List A in one of the following cases:

50.¹ 1. an application regarding the inclusion of medicinal products of equal therapeutic efficacy or medical devices with the same type of the use on the list of reimbursable medicinal products has been received and the prescription conditions referred to in Paragraph 55 of this Regulation are sufficient in order to restrict the number of patients according to the funds granted for reimbursement;

50.¹ 2. an application regarding the inclusion of medicinal products of equal therapeutic efficacy or medical devices with the same type of use on the list of reimbursable medicinal products with an offer of the applicant to enter into a contract regarding financial participation in the provision of reimbursement in accordance with the procedures referred to in Sub-paragraph 61.² 4 of this Regulation has been received and the prescription conditions referred to in Paragraph 55 of this Regulation are sufficient in order to restrict the number of patients according to the funds granted for reimbursement.

[21 October 2014]

51. The National Health Service has the right to review the basic reimbursement price and reimbursement conditions of medicinal products and medical devices included on List C, if the information regarding changes in prices for these medicinal products and medical devices in other states is at the disposal of the National Health Service.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

52. The reimbursement sum for the medicinal products and medical devices included on List C shall be formed by applying the reimbursement sum specified in Annex 1 to this Regulation to the pharmacy price.

VII. Taking and Announcement of Decisions

53. The National Health Service shall examine an application for inclusion of medicinal products or medical devices on the list of reimbursable medicinal products, revision of reimbursement conditions or inclusion of medicinal products on another list and take a decision within 180 days after registration of the application, not including the period of time that was necessary for the receipt of the supplementary information referred to in Paragraph 17 of this Regulation and the period of time from drawing up of a bill until payment thereof (if the applicant has not paid for examination of the application within three months after sending of the bill, the National Health Service shall not examine the application and shall inform the applicant thereof). While examining the application the belonging of medicinal products and medical devices to List A, B or C, the basic reimbursement price and the pharmacy price for all medicinal products and medical devices to be included shall be determined, as well as the reference price for medicinal products and medical devices to be included on List A shall be calculated.

[25 August 2009; 22 September 2009; 29 March 2011; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

54. The National Health Service shall examine an application for the revision of the basic reimbursement price of medicinal products and medical devices and take a decision within 90 days after registration of the application, excluding the time period that is necessary for receipt of additional information.

[25 August 2009; 22 September 2009; 19 October 2011; 21 October 2014]

55. The National Health Service shall take a decision regarding the diseases referred to in Annex 1 to this Regulation, for treatment of which expenditures for the acquisition of medicinal products or medical devices will be reimbursed from the funds granted for reimbursement. Limitations for prescribing or prescription conditions of reimbursable medicinal products or medical devices shall be determined in the following cases:

55.1. the reimbursement of medicinal products or medical devices is clinically justified and costs are efficient only to a specific target group of patients;

55.2. the advantages of such medicinal products have been proved to a specific group of patients in the clinical trials of the medicinal products, but costs of the medicinal products are higher than the costs of other medicinal products in the respective pharmaco-therapeutic group of medicinal products (three-five symbols in the ATC/DDD classification);

55.3. supervision of a specific expert is required for the use of the medicinal products, thus administration thereof is within the competence of an expert of the relevant treatment field (the expert determines the treatment, but henceforth the medicinal products may be prescribed and use thereof may be monitored by a family doctor) or only an expert is entitled to prescribe the medicinal products;

55.4. the anticipated costs of reimbursement of medicinal products or medical devices increase the funding granted for reimbursement for the acquisition of medicinal products in the respective year.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

56. A decision to revise reimbursement conditions shall be taken in accordance with the requirements and criteria specified in this Regulation, as well as on the basis of:

56.1. the analysis of the results of the clinical trials on the medicinal products;

56.2. the evaluation of the impact on the funds granted for reimbursement;

56.3. the results of evaluation of pharmaco-economic calculations obtained in accordance with the guidelines for the economic assessment of medicinal products included in Annex 3 to this Regulation and that include the calculation of the costs for one unit of an additionally obtained result of therapeutic efficacy (incremental cost-effectiveness ratio) - for a life-year gained, a life-year without progression of the disease or, if the abovementioned indicators are not available, for acquired quality-adjusted life year, as well as proved cost-effectiveness of the medicinal products for the treatment of a particular disease or a target group of patients.

[25 August 2009; 7 August 2018]

56.¹ A decision to revise reimbursement conditions of medical devices shall be taken in accordance with the requirements and criteria specified in this Regulation, as well as taking into account the submitted justification for the revision of reimbursement conditions and by evaluating the impact on the funds granted for reimbursement.

[25 August 2009]

57. In addition to the information specified in the Administrative Procedure Law the following information shall be indicated in the decision to include medicinal products and medical devices on the list of reimbursable medicinal products:

57.1. the time period of inclusion of the medicinal products or medical devices (the time period, during which the medicinal products or medical devices are on the list of reimbursable medicinal products), if the medicinal products or medical devices are included for a specified time period;

57.2. the basic reimbursement price and the pharmacy price of the medicinal products or medical devices, also the reference price - for List A;

57.3. the diseases, for the treatment of which expenditures for the acquisition of the particular medicinal products and medical devices will be reimbursed;

57.4. the prescription conditions of the particular medicinal products or medical devices (if required in accordance with Paragraph 55 of this Regulation);

57.5. the time of coming into force of the decision.

[25 August 2009]

58. In the decision to include medicinal products and medical devices on List C, in addition to the information referred to in Paragraph 57 of this Regulation, the National Health Service shall indicate the information referred to in Paragraph 47 of this Regulation, as well as the maximum permissible number of patients which is determined on the basis of the average expenditures for medical treatment of patients of the relevant diagnosis treated with particular medicinal products in the previous year in conformity with the funds provided for in Sub-paragraph 71.2 of this Regulation.

[28 December 2010; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

59. The National Health Service, within 30 days after taking of the decision to include medicinal products or medical devices on List C, shall prepare and enter into a contract with the applicant regarding the supply of the quantity of the particular medicinal products or medical devices to a medical treatment institution free of charge, with which the National Health Service has entered into a contract regarding the provision of health care services.

[19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of amendments]

60. The National Health Service shall publish a decision to include medicinal products or medical devices on List C in the newspaper Latvijas Vēstnesis [the official Gazette of the Government of Latvia]. The decision of the National Health Service to include medicinal products or medical devices on List C shall enter into effect on the day of publication thereof in the newspaper Latvijas Vēstnesis.

[19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of amendments]

61. Medicinal products and medical devices for the treatment of particular diseases shall be included on the list of reimbursable medicinal products for an indefinite period of time (except the cases when the time period for inclusion is determined initially) until taking of a decision to delete medicinal products or medical devices from the list of reimbursable medicinal products.

[25 August 2009]

61.¹ The National Health Service shall evaluate the conditions for reimbursement of medicinal products and medical devices included on the list of reimbursable medicinal products and take a decision to revise conditions for reimbursement of medicinal products and medical devices on the basis of the clinical and economic efficiency assessment of medicinal products or medical devices, as well as the evaluation of the impact on the funds granted for reimbursement.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

61.² The National Health Service has the right:

61.² 1. to repeatedly assess the compliance of medicinal products and medical devices included on the list of reimbursable products with the requirements and criteria specified in this Regulation. If the National Health Service determines non-compliance of medicinal products or medical devices with this Regulation, it shall send a notification to an applicant. If, in repeatedly assessing the compliance of medicinal products or medical devices included on the list of reimbursable products with the requirements referred to in Paragraph 30 of this Regulation, the National Health Service detects a non-compliance, the National Health Service has the right to determine the price of such medicinal products or medical devices for a time period up to two years, unless the applicant has proved that the indicated prices comply with the actual prices at the time of assessment in the countries referred to in Paragraph 30 of this Regulation. The price shall be reduced to the third lowest sales price of the manufacturer or wholesale price in the Czech Republic, Denmark, Romania, Slovakia, and Hungary or to the sales price of the manufacturer or wholesale price of such medicinal products or medical devices in Estonia and Lithuania depending on the lowest price;

61.² 2. to include medicinal products and medical devices on the list of reimbursable medicinal products for a definite time period;

61.² 3. on the basis of the application referred to in Paragraph 16.³ of this Regulation, take a decision to reduce the basic reimbursement price and the pharmacy price of reimbursable medicinal products or medical devices for a definite time period;

61.² 4. after evaluation of proposals by the applicant to enter into a contract with the applicant regarding financial participation in the ensuring of reimbursement of medicinal products included on the list of reimbursable medicinal products, as well as in the ensuring of reimbursement for individual persons.

[25 August 2009; 22 September 2009; 29 March 2011; 19 October 2011; 27 December 2011; 9 October 2012; 21 October 2014]

62. The National Health Service shall not include medicinal products and medical devices on the list of reimbursable medicinal products and revise reimbursement conditions upon initiative of the applicant if:

62.1. the inclusion of medicinal products or medical devices on the list of reimbursable medicinal products or revision of reimbursement conditions does not comply with the requirements and criteria referred to in this Regulation;

62.2. the supplementary resources of the State budget are required for inclusion of the medicinal products or medical devices on the list of reimbursable medicinal products, but they are not commensurable with the funds granted for the reimbursement in the relevant year;

62.3. the use of the medicinal products or medical devices fails to comply with the outpatient medical treatment.

[27 January 2009; 25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

62.¹ The National Health Service shall introduce the changes in the list of reimbursable medicinal products resulting in the change in the reference price of the medicinal products and medical devices included on List A of reimbursable products four times a year - on 1 January, 1 April, 1 July, and 1 October. Other changes in the list of reimbursable medicinal products shall be introduced by the National Health Service once a month - on the first date of each month.

[7 August 2018]

62.² To revise the basic reimbursement price in accordance with Paragraph 38.² of this Regulation, the application for revision of the basic reimbursement price shall be submitted until 30 September (if changes are intended from 1 January), until 30 December (if changes are intended from 1 April), until 31 March (if changes are intended from 1 July), and until 30 June (if changes are intended from 1 October).

[7 August 2018]

62.³ The application for the revision of the basic reimbursement price of medicinal products and medical devices included in the List A of reimbursable medicinal products to the lowest price offered shall be submitted at least 45 days prior to the first date of the month on which the changes are intended to come into effect.

[7 August 2018]

62.⁴ The procedure referred to in Paragraph 62.² of this Regulation shall not be applied for the revision of the basic reimbursement price with reduction for a definite time period.

[26 June 2012]

62.⁵ Information regarding the received applications for the inclusion of medicinal products and medical devices into the list of reimbursable medicinal products, and also for the revision of the basic reimbursement price shall be posted by the National Health Service, within three working days after the receipt of application, on its website under the section "Reimbursable medicinal products".

[7 August 2018]

63. The National Health Service shall take a decision to delete medicinal products and medical devices from the list of reimbursable medicinal products if:

63.1. the medicinal products and medical devices have been withdrawn from the market or the distribution thereof has been prohibited in accordance with the procedures laid down in laws and regulations on the distribution of medicinal products;

63.2. the basic price of reimbursement is not complied with, which is confirmed by a report of the Health Inspectorate;

63.3. the applicant does not ensure the continuous presence of the reimbursable medicinal products and medical devices on the market, which is confirmed by a report of the Health Inspectorate or the information from the information system of the State Agency of Medicines;

63.4. the applicant has not paid the account for the maintenance of the medicinal products and medical devices on the list of reimbursable medicinal products within two months after the receipt of the account;

63.5. the applicant has submitted an application regarding deletion of the medicinal products or medical devices from the list of reimbursable medicinal products;

63.6. the applicant does not fulfil the conditions referred to in Sub-paragraphs 47.2 and 47.3 and Paragraph 57 of this Regulation, the conditions of the decision referred to in Paragraph 57 of this Regulation, or the conditions of the contract entered into with the National Health Service and referred to in Paragraph 59 or Sub-paragraph 61.² 4 of this Regulation;

63.7. the applicant does not submit an application for elimination of non-compliance within a month after sending of the warning of the National Health Service referred to in Sub-paragraph 61.² 1 of this Regulation;

63.8. the increase in the sales volume of particular medicinal products or medical devices included on List B of the applicant exceeds 10 % from the sales volume of the previous period and the applicant has not entered into the contract referred to in Sub-paragraph 61.² 4 of this Regulation or has not performed the payment referred to in Paragraph 45.1 of this Regulation.

[1 April 2008; 25 August 2009; 22 September 2009; 28 December 2010; 19 October 2011; 21 October 2014; 7 August 2018 / The new wording of Sub-paragraph 63.3 shall come into force on 1 January 2019. See Paragraph 2 of the amendments]

64. The National Health Service shall inform the applicant in writing regarding the decision taken and post the relevant information on the Internet site thereof within 10 days after taking of the decision, as well as inform the Ministry of Health thereof 15 days before the entering into effect of the decision. The National Health Service shall publish the changes in the list of reimbursable medicinal products, as well as the part of the decision to include medicinal products on List C in the newspaper Latvijas Vēstnesis.

[19 October 2011 / The new wording of this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

64.¹ The National Health Service shall notify electronically the decision on the medicinal products or medical devices which caused changes in the reference price to the applicants of non-reference medicinal products or medical devices.

[29 March 2011; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

64.² The National Health Service shall notify the decision referred to in Sub-paragraph 61.² 3 of this Regulation to reduce the basic reimbursement price and the pharmacy price for a definite time period to the applicant, the Ministry of Health, the Health Inspectorate, pharmacies, which are in contractual relations with the National Health Service, and medicinal product wholesalers electronically not later than 15 days before the application of reduced price, without making any changes in the list of reimbursable medicinal products.

[19 October 2011; 27 December 2011; 26 May 2015]

64.³ The National Health Service shall, 15 days prior to the day of entering into effect of the updated list of reimbursable medicinal products, post the new list of reimbursable medicinal products on the website with an indication as to the date of entry into effect thereof, without indicating the basic reimbursement price temporarily reduced in accordance with Paragraph 16.³ of this Regulation.

[26 May 2015]

65. The applicant has the right to contest the decision of the National Health Service to the Ministry of Health in accordance with the procedures laid down in the Administrative Procedure Law. A decision of the Ministry of Health may be appealed to a court.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

66. The State Pharmacy Inspection shall control the compliance with the procedures for reimbursement by the undertakings of pharmaceutical activity and shall inform the National Health Service in writing regarding any violations determined.

[1 April 2008; 25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

VIII. Reimbursement of Medicinal Products Included on List C

67. After entering into effect of the decision to include medicinal products or medical devices on List C, the National Health Service shall take a decision to reimburse medicinal products and medical devices included on List C, if a letter signed by the head of medical treatment institution - the limited liability company Riga Eastern Clinical University Hospital, the State limited liability company Pauls Stradiņš Clinical University Hospital, the State limited liability company Children's Clinical University Hospital, the limited liability company Daugavpils Regional Hospital, the limited liability company Liepājas reģionālā slimnīca [Liepāja Regional Hospital], or the State limited liability company Piejūras slimnīca [Maritime Hospital] - to which a decision by the council of experts of the relevant field of medical treatment is appended on necessity of using the particular medicinal products or medical devices for a particular patient, indicating in the decision the diagnosis, the code of the diagnosis according to the ICD classification, the medicinal product name, the pharmaceutical form, the strength, dose, or the type of the medical device, the justification of using the medicinal products or medical devices, the recommended duration of the treatment course, and required amount of medicinal products. The National Health Service shall send the decision to the patient and inform the particular medical treatment institution.

[28 December 2010; 19 October 2011; 15 May 2012; 20 September 2016]

67.¹ The National Health Service shall refuse reimbursement of medicinal products and medical devices included on List C, if:

67.¹ 1. the particular case does not conform to the requirements referred to in Paragraph 67 of this Regulation;

67.¹ 2. the particular case does not conform to the conditions for prescribing medicinal products or medical devices laid down in the decision to include medicinal products and medical devices on List C;

67.¹ 3. the number of patients laid down in the decision to include medicinal products and medical devices on List C has been reached.

[28 December 2010; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

67.² If the number of patients specified in the decision to include medicinal products or medical devices on List C has been reached, however, the particular case conforms to the conditions for prescribing medicinal products or medical devices specified in the abovementioned decision and the requirements referred to in Paragraph 67 of this Regulation, the National Health Service shall extend the time period for taking of a decision on reimbursement of medicinal products or medical devices included on List C until the time when the number of patients specified in the decision to include medicinal products and medical devices on List C is extended.

[26 May 2015]

68. The applicant shall cover no less than 10 % from the amount of medicinal products necessary for every patient at the beginning of medical treatment process or the expenditures for every other patient from its own resources until the number of patients indicated in the decision of the National Health Service is reached, to whom expenditures for the acquisition of the relevant medicinal products or medical devices are covered by the applicant from its own resources in accordance with Sub-paragraph 47.2 and Paragraph 58 of this Regulation. After taking of a positive decision to reimburse medicinal products and medical devices included on List C, the National Health Service shall inform the applicant in writing, indicating the medical treatment institution, to which the applicant supplies medicinal products or medical devices according to the contract entered into. The applicant shall reimburse the expenditures for the acquisition of medicinal products or medical devices until the end of the time period indicated in the decision by the council of the medical treatment institution referred to in Paragraph 67 of this Regulation.

[28 December 2010; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

68.¹ Delivery of and payment for the medicinal products of List C for parenteral administration intended for treatment of diseases referred to in Annex 1, Paragraph 5 shall be carried out in accordance with the following procedures:

68.¹ 1. according to the decision of the National Health Service on the reimbursement of medicinal products included on List C the medical treatment institution shall request the medicinal products for the specific patient from the medicinal product wholesaler;

68.¹ 2. the medicinal product wholesaler, upon the request of the medical treatment institution, shall deliver the medicinal products to the relevant medical treatment institution according to the determined basic reimbursement price;

68.¹ 3. the medical treatment institution shall submit to the National Health Service the invoice and the report on the use of medicinal products, indicating in the report the information regarding the amount of medicinal products used for the specific patient;

68.¹ 4. following the receipt of the invoice and the report, the National Health Service shall perform the settlement with the medical treatment institution;

68.¹ 5. the medical treatment institution shall settle with the medicinal product wholesaler for the delivered amount of medicinal products.

[19 December 2017 / Paragraph shall come into force on 1 July 2018. See Paragraph 3 of the amendments]

69. The National Health Service shall register all decisions of the doctors' councils, which are received regarding the necessity of utilisation of medicinal products and medical devices included on List C, and shall indicate:

69.1. the patients for whose medicinal products or medical devices used the payment is performed from the funds granted for reimbursement;

69.2. the patients for whose medicinal products or medical devices used the payment is performed from the resources of the applicant;

69.3. the medical practitioner (the medical treatment institution) who prescribes the relevant medicinal products or medical devices;

69.4. the duration and costs of the treatment course.

[25 August 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

70. If a patient has discontinued the utilisation of the relevant medicinal products or medical devices or has received a complete treatment course, the particular medical treatment institution shall inform the National Health Service thereof within 10 days after discontinuing of utilisation of the medicinal products or medical devices. The National Health Service shall inform the particular medical treatment institution about the possibilities to start the use of medicinal products or the utilisation of medical devices to the next patient pursuant to the registered decision of the council.

[25 August 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

IX. Supervision of Financial Resources

71. The National Health Service shall administer the funds granted for the reimbursement. In planning the distribution of the financial resources granted, the following conditions shall be taken into account:

71.1. resources for the reimbursement of expenditures for the acquisition of medicinal products and medical devices to individual patients shall be provided for in accordance with Paragraph 99 of this Regulation;

71.2. resources for the reimbursement of expenditures for the acquisition of medicinal products and medical devices included on List C shall be provided for;

71.3. resources for patients to whom, according to the prescription conditions, the medicinal products may be prescribed only by specialists of the particular medical treatment institution, shall be provided for;

71.4. a 5 % reserve shall be planned, deducting the resources referred to in Sub-paragraphs 71.1, 71.2, 71.3, 71.6, and 71.7 of this Regulation from the total financial resources;

71.5. financial resources for the prescribing of reimbursable medicinal products and medical devices, which is performed by the doctors referred to in Paragraph 84 of this Regulation, shall be planned, deducting the resources referred to in Sub-paragraphs 71.1, 71.2, 71.3, 71.4, and 71.7 of this Regulation from the total financial resources;

71.6. resources shall be provided for persons in imprisonment;

71.7. resources shall be provided for the reimbursement of expenditures for the acquisition of the List M medicinal products.

[25 August 2009; 19 October 2011; 24 July 2012 / Amendments to this Paragraph shall come into force from 1 September 2012. See Paragraph 3 of the amendments]

72. The National Health Service shall obtain information regarding the amount of the necessary financial resources:

72.1. in the case referred to in Sub-paragraph 71.3 of this Regulation - by multiplying the anticipated number of patients (taking into account the management information system data regarding the previous period) by the amount of financial resources provided for one patient in the subsequent calendar year;

72.2. in the case referred to in Sub-paragraph 71.6 of this Regulation - by multiplying the anticipated number of patients laid down by the Prison Administration in diagnoses and groups of diagnoses by the amount of financial resources utilised in the State for one patient in the relevant diagnosis or group of diagnosis.

[19 October 2011 / The new wording of this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

73. The resources referred to in Sub-paragraph 71.5 of this Regulation shall be calculated on the basis of the following indicators:

73.1. the expenses of the previous period for the covering of expenditures for the acquisition of the relevant medicinal products or medical devices (if a time period shorter than 12 months is used for calculations, the obtained data shall be re-calculated in proportion, related to 12 months);

73.2. the assessment regarding treatment costs and the impact thereof on the funds granted for reimbursement performed by the National Health Service according to Sub-paragraph 22.2.1 of this Regulation, if it is intended to include new medicinal products or medical devices on the list of reimbursable medicinal products or it is intended to make any changes in the list of reimbursable medicinal products.

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

74. The medicinal products and medical devices referred to in Sub-paragraph 71.5 of this Regulation and the amount of financial resources planned for the reimbursement of expenditures for the acquisition thereof shall form a speciality group of reimbursable medicinal products - medicinal products or medical devices that are prescribed by a medical practitioner of the respective speciality or a family doctor.

75. The National Health Service shall revise the list of the medicinal products and medical devices included in the speciality group of reimbursable medicinal products and the financial resources intended for the relevant group, if a decision is taken on changes in the list of reimbursable medicinal products.

[19 October 2011 / The new wording of this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of amendments]

76. The National Health Service shall indicate in the contracts with medical treatment institutions the amount of the planned financial resources for the prescription of reimbursable medicinal products and medical devices in the medical treatment institution and the medical treatment institution shall, in signing the contract, undertake to observe it. Once per quarter the National Health Service shall compile the information regarding the amount in euros for the prescription of reimbursable medicinal products and medical devices per one patient broken down by specialities and diagnosis. If the amount of medicinal products in euros prescribed by a doctor for one patient with a certain diagnosis exceeds the average indicator in the relevant speciality or diagnosis more than 30%, the National Health Service shall inform the medical treatment institution and the Health Inspectorate thereof.

[27 January 2009; 25 August 2009; 19 October 2011; 10 September 2013]

77. The amount of finances referred to in Paragraph 76 of this Regulation for the prescription of reimbursable medicinal products and medical devices in a particular speciality of doctors shall be calculated, using the following formula:

L = I x A, where

L - the planned amount of finances for the prescription of reimbursable medicinal products and medical devices in the respective speciality of doctors;

I - the planned amount of finances for the prescription of reimbursable medicinal products and medical devices per outpatient visit in the respective speciality of doctors;

A - the anticipated number of outpatient visits in the medical treatment institution in the respective speciality of doctors.

78. The planned amount of finances for the prescription of reimbursable medicinal products and medical devices per outpatient visit in the respective speciality of doctors shall be calculated, using the following formula:

I = P : AA, where

P - the anticipated amount of finances for the speciality group of reimbursable medicinal products;

AA - the anticipated number of outpatient visits in the relevant speciality of doctors.

79. The National Health Service shall calculate the anticipated number of outpatient visits in the relevant speciality of doctors on the basis of the number of outpatient visits registered in the management information system of the National Health Service in the previous period.

[25 August 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

79.¹ When calculating the number of outpatient visits in the speciality of family doctors, the visits to nurses of family doctors or physician assistants falling within the voluntary quality assessment system shall be added to the visits to family doctors in order to receive a prescription of reimbursable medicinal products or medical devices without a visit to a family doctor.

[19 October 2011 / Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

80. [19 October 2011 / See Paragraph 2 of the amendments]

81. If the amount of finances referred to in Paragraph 76 of this Regulation is larger than the amount of finances referred to in Sub-paragraph 71.5 of this Regulation, the reserve planned in Sub-paragraph 71.4 of this Regulation shall be reduced accordingly.

82. The National Health Service has the right to revise the amount of finances specified for a medical treatment institution in a contract for the prescription of reimbursable medicinal products and medical devices in the respective speciality of doctors and to use the planned reserve in the following cases:

82.1. the National Health Service has taken a decision on changes in the list of reimbursable medicinal products (for example, the change in supplementation of the list of reimbursable medicinal products or the prescription conditions);

82.2. the structure of reimbursable medicinal products and medical devices prescribed by doctors of a medical treatment institution and actual costs thereof do not comply with the speciality group (the National Health Service shall change the amount of financial resources for medical practitioners and medical treatment institutions after the assessment of data of not less than six months (on 1 September of the current year) and nine months (on 1 November of the current year).

[25 August 2009; 22 September 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

83. The National Health Service shall, once a month, submit a report to the Ministry of Health on the utilisation of the funds granted for reimbursement, indicating also all such cases where the expenditures for the acquisition of medicinal products and medical devices have been covered in accordance with Chapter XII of this Regulation.

[21 October 2014]

X. Duties of Medical Practitioners

84. The reimbursable medicinal products and medical devices, as well as medicinal products of List M shall be prescribed using a specific form of prescription in accordance with the laws and regulations on the issue of prescriptions by an attending doctor to whom such rights have been laid down in the contract entered into by and between the medical treatment institution and the National Health Service on provision of health care services or on the amount of funding for prescribing reimbursable medicinal products and medical devices in the relevant speciality of a doctor.

[25 August 2009; 19 October 2011; 24 July 2012 / Amendments to this Paragraph shall come into force on 1 September 2012. See Paragraph 3 of the amendments]

84.¹ If a patient has not previously received medicinal products or medical devices included on List A of reimbursable medicinal products intended for the particular diagnosis within the framework of reimbursement procedures, a doctor shall prescribe the common name of medicinal products or the common name of medical device intended for such diagnosis using the specific form of prescription.

[19 October 2011 / Paragraph shall come into force on 1 January 2012. See Paragraph 3 of the amendments]

84.² If in conformity with Paragraph 89 of this Regulation the use of medicinal products or medical devices ensures the desirable therapeutic effect, medical treatment shall be continued using them. If they fail to provide the desirable therapeutic effect, a doctor shall prescribe other medicinal products or medical devices instead of them starting with the lowest price within the scope of the common name. The doctor shall indicate the justification for changing the medicinal products or medical devices in the patient's medical file. The doctor shall notify the State Agency of Medicines on adverse effects observed in conformity with the laws and regulations on supervision of adverse effects caused by the use of medicinal products and medical devices.

[19 October 2011 / Paragraph shall come into force on 1 January 2012. See Paragraph 3 of the amendments]

84.³ If a doctor has prescribed the name of medicinal products or medical devices of a particular manufacturer in the case referred to in Paragraph 84.¹ of this Regulation, the National Health Service shall inform the Health Inspectorate thereof.

[19 October 2011 / Paragraph shall come into force on 1 January 2012. See Paragraph 3 of the amendments]

85. In prescribing the medicinal products and medical devices included on List A, the pharmacy price of which is higher than the reference price, the physician shall inform the patient thereof.

86. In prescribing insulin preparations, the physician shall make an entry in the insulin card of the patient of diabetes mellitus.

86.¹ In prescribing medicinal products for a pregnant woman in the case referred to in Sub-paragraph 9.²2 of this Regulation, the physician shall indicate additionally the diagnosis code "Z33" on the prescription, but in prescribing medicinal products for a woman during the period following the childbirth up to 70 days, the physician shall indicate additionally the diagnosis code "Z39.2" on the prescription.

[24 July 2012; 7 August 2018]

XI. Duties of Pharmacies

87. A pharmacy, which has a contractual relationship with the National Health Service, shall dispense medicinal products and medical devices to a patient, the acquisition expenses of which are partially or completely covered from the funds granted for the reimbursement of expenses, except a case where the patient wishes to vaccinate with a vaccine included on the list of reimbursable medicinal products or List M. In such case the pharmacy and the medical treatment institution shall comply with the following procedures:

87.1. vaccination with the vaccine included on the list of reimbursable medicinal products or List M shall be performed at the medical treatment institution, which has entered in the respective contract with the National Health Service;

87.2. the medical treatment institution shall plan the number of persons to be vaccinated, taking into account the restrictions laid down in Annex 1 to this Regulation;

87.3. the medical treatment institution shall submit to the pharmacy a written request regarding the supply of the necessary number of vaccine doses. A medical practitioner shall draw up the specific prescription for each case of vaccination and each vaccine used in accordance with the laws and regulations on the issue of prescriptions, and the medical treatment institution shall deliver it to the pharmacy by the end of the current month;

87.4. the pharmacy, in supplying the necessary number of vaccine doses to the medical treatment institution, shall draw up a bill of lading. On the basis of the prescriptions received, the pharmacy shall enter data regarding the dispensed vaccines in the management information system of the National Health Service;

87.5. the medical treatment institution, within 30 days after the supply of the vaccines, shall cover to the pharmacy the costs of the supply of vaccines in the amount of 50 % from the pharmacy price of the supplied vaccines included on the list of reimbursable medicinal products. The other part of the pharmacy price shall be covered by the National Health Service from the funds granted for reimbursement. Expenses, which the medical treatment institution has paid in the amount of 50 % from the pharmacy price of the reimbursable vaccine, shall be covered by the person vaccinated.

[25 August 2009; 19 October 2011; 21 October 2014]

88. [7 August 2018]

89. If a physician, in writing a prescription for reimbursable medicinal products, has used the common name of a medicinal product, the pharmacy has a duty to dispense the cheapest reimbursable medicinal products, which conform to this name, the prescribed pharmaceutical form and strength, but if there are two or more medicinal products on the list of reimbursable medicinal products with the cheapest basic reimbursement price the pharmacist shall offer the patient to choose any of them. If a physician, in writing a prescription for reimbursable medical devices, has used their common name, the pharmacy has a duty to dispense the cheapest reimbursable medical devices, which conform to this name and type of use, but if there are two or more medical devices on the list of reimbursable medical devices with the cheapest basic reimbursement price the pharmacist shall offer the patient to choose any of them. If a pharmacy has provided the State Agency of Medicines with the information referred to in Paragraph 91 of this Regulation on unavailability of the reference medicinal products or the cheapest reimbursable medical products within the scope of the common name and the State Agency of Medicines has posted information on its website regarding the shortage of the medicinal products, the pharmacist may dispense the next cheapest medicinal product to the patient.

[26 May 2015; 7 August 2018 / The amendments of the Paragraph shall come into force on 1 January 2019. See Paragraph 2 of the amendments]

90. If a physician, in prescribing the reimbursable medicinal products, has not indicated on the prescription that the prescribed medicinal products may not be substituted, a pharmacist shall inform the patient regarding the possibilities of the substitution of medicinal products by offering the cheapest complying reimbursable medicinal products, taking into account the following provisions:

90.1. the active substances of the medicinal products prescribed and dispensed are identical;

90.2. the pharmaceutical form and strength of the medicinal products offered is the same as the form and dosage of the medicinal products prescribed.

91. If the pharmacy had no possibility to purchase medicinal products included in the list of reimbursable medicinal products within 24 hours, the pharmacy shall inform the State Agency of Medicines thereof using the report form on the website of the State Agency of Medicines. The State Agency of Medicines shall contact the relevant marketing authorisation owner or the distributor of parallel imported, parallel distributed or unregistered medicinal products and, if a confirmation has been received that the medicinal product is not available in Latvia, it shall publish information on its website regarding the shortage of medicinal products.

[7 August 2018 / New wording of the Paragraph shall come into force on 1 January 2019. See Paragraph 2 of the amendments]

XII. Reimbursement of Medicinal Products and Medical Devices for Individual Persons

92. The National Health Service, on the basis of the submission of a person, to which a decision of the doctors' council of the relevant treatment field has been appended, is entitled to take a decision to reimburse expenditures for the acquisition of medicinal products and medical devices for individual patients. The abovementioned expenditures shall be reimbursed within the scope of the funds granted for the reimbursement of expenditures for the acquisition of medicinal products in the following cases:

92.1. the diagnosis is not included in Annex 1 to this Regulation, and in treatment of the respective disease it is not possible to maintain the vital functions of the patient without the use of the respective medicinal products (medical devices are not paid for in the specific case referred to in this Sub-paragraph);

92.2. the diagnosis is included in Annex 1 to this Regulation, but no medicinal products and medical devices are included on the list of reimbursable medicinal products for medical treatment of the relevant diagnosis.

[25 August 2009; 19 October 2011; 9 October 2012 / The new wording of Sub-paragraph 92.2 shall come into force on 1 January 2013. See Paragraph 2 of the amendments]

93. The following information shall be indicated in the council's decision (if a person has several diseases, for the treatment of which reimbursement of medicinal products or medical devices is being requested, one decision of the council may be submitted, if the composition of the council includes experts of all the respective fields and information referred to in this Paragraph regarding each diagnosis has been indicated):

93.1. the given name, surname, personal identity number (except the asylum seeker referred to in Paragraph 3.¹ of this Regulation), address of the patient;

93.2. the diagnosis (code of the diagnosis in accordance with the ICD classification);

93.3. the medicinal products previously used for the treatment of the patient (the common name, medicinal product name, dosage, length of usage) and medical devices, including reimbursable medicinal products and medical devices. If medicinal products that are not included on the list of medicinal products authorised in the Republic of Latvia are selected for the further treatment, it shall be indicated whether the patient has been treated using analogical authorised medicinal products;

93.4. the result of the use of the medicinal products and medical devices referred to in Sub-paragraph 93.3 of this Regulation (justifying with the results of examinations);

93.5. the medicinal products (the common name of the medicinal product, medicinal product name, pharmaceutical form, required daily dosage, duration of course) or medical devices (name of the medical device, the required quantity), the reimbursement of expenditures for the acquisition of which is necessary to the patient;

93.6. the justification of the selection of the medicinal products and medical devices referred to in Sub-paragraph 93.5 of this Regulation (in comparison to other medicinal products, medical devices and treatment methods, if available, provided for the treatment of the relevant disease), also the justification of the selection of the particular name of medicinal product or medical device if several medicinal product names or medical devices comply with the common name;

93.7. the compliance of the medicinal products and medical devices with the schemes or international guidelines for the treatment of particular diseases, the place of the medicinal product in the scheme of the treatment of the particular disease;

93.8. the term of validity of the decision;

93.9. or it is possible to support the life functions of the patient in medical treatment of the relevant disease without the use of the particular medicinal products (if the diagnosis is not included in Annex 1 to this Regulation).

[21 October 2014; 20 September 2016]

93.¹ If there are substantiated doubts, the National Health Service has the right to transfer the council's decision referred to in Paragraph 93 of this Regulation for additional evaluation to the doctors' council of the same treatment field in other composition.

[27 January 2009; 25 August 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

94. In the case referred to in Sub-paragraph 92.1 of this Regulation the National Health Service shall take a decision to reimburse expenditures for the acquisition of medicinal products in the amount of 100 %, except the case referred to in Paragraph 100.¹ of this Regulation.

[27 March 2007; 25 August 2009; 19 October 2011; 20 September 2016]

95. In the case referred to in Sub-paragraph 92.2 of this Regulation the National Health Service shall take a decision to reimburse expenditures for the acquisition of medicinal products or medical devices within the amount laid down in Annex 1 to this Regulation, except for the case referred to in Sub-paragraph 100.¹ of this Regulation.

[27 March 2007; 25 August 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

96. The National Health Service shall perform the calculation of the price of medicinal products or medical device pursuant to the principle of the reference price, if the respective medicinal products or medical devices are included on List A and in case of the particular disease the medicinal products or medical devices comply with the principles of making List A referred to in Paragraph 32 of this Regulation.

[25 August 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

97. [19 October 2011 / See Paragraph 2 of the amendments]

98. Until 10 January and 10 July of the current year the National Health Service shall compile information regarding the applications received within previous six months as regards the reimbursement of expenditures for the acquisition of medicinal products and medical devices in the cases provided in this Chapter (also if reimbursement of medicinal products and medical devices is refused), assess it and, where necessary, lodge proposals to the Ministry of Health on the necessary amendments to Annex 1 to this Regulation.

[19 October 2011 / The new wording of this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

99. Not more than 2 % of the funds granted for the reimbursement of expenditures for the acquisition of medicinal products shall be used in the cases of the reimbursement of expenditures for the acquisition of medicinal products and medical devices provided in this Chapter.

100. The National Health Service shall reimburse the expenditures for the acquisition of medicinal products and medical devices in the cases provided in this Chapter in the amount of not more than EUR 14 228.72 for one patient within 12 months.

[25 August 2009; 19 October 2011; 10 September 2013]

100.¹ If the intended expenditures exceed the expenditures referred to in Paragraph 100 of this Regulation, the National Health Service shall indicate the reimbursement expenditures for one packaging of medicinal products in the decision to reimburse medicinal products, as well as the difference between the total expenditures for the course of medicinal products and expenditures referred to in Paragraph 100 of this Regulation. The patient shall receive medicinal products, if one of the following conditions exists:

100.¹ 1. the patient covers the difference between the price of one packaging of the medicinal products and the reimbursement amount indicated in the decision of the National Health Service;

100.¹ 2. the third party has entered into a contract with the National Health Service regarding financial participation for ensuring the reimbursement for a particular patient;

100.¹ 3. the applicant has entered into the contract referred to in Sub-paragraph 61.² 4 of this Regulation with the National Health Service which provides for the supply of the medicinal products to the pharmacy or medical treatment institution for a particular patient.

[9 October 2012]

101. The National Health Service shall grant the medicinal products and medical devices to a patient for a treatment course, duration of which does not exceed 12 months. If the utilisation of the medicinal products or medical devices must be continued after this period of time, the patient shall submit the necessary documents in accordance with Paragraph 92 of this Regulation.

[25 August 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

102. The National Health Service shall refuse the reimbursement of expenditures for the acquisition of medicinal products if:

102.1. the National Health service has taken a negative decision to include the relevant medicinal products or medical devices on the list of reimbursable medicinal products for medical treatment of the particular diagnosis;

102.2. the annual funds granted for the reimbursement of expenditures for the acquisition of medicinal products and medical devices in individual cases have been utilised;

102.3. the council's decision does not comply with the requirements referred to in Paragraph 93 of this Regulation;

102.4. other medicinal products included on the list of reimbursable medicinal products with the same common medicinal product name or medical devices of the same name are available for the patient in accordance with the diagnosis referred to in Annex 1 to this Regulation;

102.5. the National Health Service has recognised that selection of the medicinal products or medical devices is not justified;

102.6. the medicinal products are classified as non-prescription medicinal products in accordance with the laws and regulations on the procedures for classification of medicinal products, except those which are necessary for the maintenance of vital functions to patients with cystic fibrosis;

102.7. the use of the particular medicinal products or medical devices in medical treatment and their payment procedures are governed by other laws and regulations.

[19 October 2011; 9 October 2012; 21 October 2014]

103. The National Health Service shall request from the State Agency of Medicines information regarding the sales price of such medicinal products in Latvia, which are not included on the list of reimbursable medicinal products and regarding which the manufacturer of the medicinal products or his or her authorised representative provides information to the State Agency of Medicines in accordance with laws and regulations on the principles of the formation of the price of the medicinal products. The State Agency of Medicines shall send the referred to information within five days after the receipt of the request. The National Health Service shall calculate the costs of the reimbursement of expenditures for the acquisition of medicinal products in accordance with Paragraphs 26 and 28 of this Regulation.

[25 August 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

104. If the manufacturer of the medicinal products or his or her authorised representative has not submitted information regarding the sales price of medicinal products in Latvia to the State Agency of Medicines, as well as in determining the price of medical devices, the National Health Service shall survey three pharmacies selected by the patient. A contract regarding the reimbursement of expenditures for the acquisition of medicinal products and medical devices shall be entered into with a pharmacy, which offers the lowest price per unit.

[25 August 2009; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

XIII. Closing Provisions

104.¹ The supervision of conformity with this Regulation shall be performed by the National Health Service and the Health Inspectorate in accordance with their remits.

[19 October 2011 / The new wording of this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

105. Cabinet Regulation No. 418 of 14 June 2005, Procedures for the Reimbursement of Expenses Towards the Purchase of Medicinal Products and Medical Devices for Ambulatory Care (Latvijas Vēstnesis, 2005, No. 99, 210; 2006, No. 50), is repealed.

106. [25 August 2009]

107. The medicinal products included on the list of reimbursable medicinal products, costs of which exceed LVL 3 000 and regarding the reimbursement for the acquisition of which the Health Payment Centre has entered into a contract with the applicant, shall be included on List C without a supplementary application beginning with 1 January 2007.

[25 August 2009]

108. This Regulation shall come into force on 15 November 2006. Chapter IX of this Regulation shall come into force on 1 January 2007.

109. The expenditures for the acquisition of medicinal products and medical devices shall be covered in full amount from the funds intended for implementation of the Social Security Network Strategy in 2009 for a patient who has been recognised as needy in accordance with the procedures laid down in laws and regulations and who has the right to reimbursement of the expenditures for the acquisition of medicinal products and medical devices in accordance with this Regulation, if the expenditures for the acquisition of medicinal products and medical devices of such person have exceeded LVL 12.5 within the scope of reimbursement procedures from 1 October 2009 until 31 December 2009.

[22 September 2009]

110. On the basis of a patient's submission the Health Payment Centre shall cover the expenditures for the acquisition of medicinal products and medical devices to be covered in full amount acquired in January 2010 during the status of a person in need for a patient who in January 2010 had a valid statement of the social service office of the local government on conformity with the status of a person in need drawn up in accordance with the procedures laid down in laws and regulations and who is entitled to reimbursement of expenditures for the acquisition of medicinal products or medical devices in accordance with this Regulation, taking into account the exceptions referred to in Sub-paragraphs 3.¹ 1 and 3.¹ 2 of this Regulation.

[26 January 2010]

111. [21 October 2014]

112. [21 October 2014]

113. [1 April 2013 / See Paragraph 116]

113.¹ [21 October 2014]

114. [21 October 2014]

115. [1 April 2013 / See Paragraph 116]

115.¹ The National Health Service shall make amendments related to changes in the reference price in the decision to include non-reference medicinal products or medical devices on List A only concurrently with other amendments to the decision.

[29 March 2011; 19 October 2011 / Amendments to this Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

115.² If the applicant wishes to start the reduce of the basic reimbursement price for a definite time period until 1 July 2011, the time limits for the lodging referred to in Paragraph 16.³ of this Regulation shall not be applicable to the lodging of the application referred to in Paragraph 16.³ of this Regulation.

[29 March 2011]

116. Paragraphs 113, 115 and 122 of this Regulation shall be in force until 31 March 2013.

[27 December 2011]

117. [1 January 2012 / See Paragraph 2 of the amendments]

118. The requirements referred to in Paragraph 62.² of this Regulation shall be applied in 2011 starting from 1 November and a new application on reducing the basic reimbursement price below the lowest offered price of the relevant reference group in conformity with the amount laid down in Paragraph 38.² of this Regulation may be lodged within seven working days starting from the next day after 1 November.

[19 October 2011 / Paragraph shall come into force on 1 November 2011. See Paragraph 2 of the amendments]

119. Applications regarding reducing the basic reimbursement price below the basic reimbursement price of the reference medicinal products or medical devices present in the relevant reference group or below the lowest price offered in the relevant reference group, if they have been lodged after 15 October 2011 until the end of the deadline laid down in Paragraph 118 of this Regulation and reduction of the price conforms to the amount referred to in Paragraph 38.² of this Regulation below the lowest price offered in the relevant reference group (according to the applications lodged until 15 October 2011), or below the basic reimbursement price of the reference medicinal products or medical devices present in the relevant reference group (if no application regarding reducing the basic reimbursement price in the relevant reference group has been submitted until 15 October 2011), shall be examined in accordance with the legal order which existed at the time of lodging the applications without applying limitation depending on the fact whether the application regarding reducing the basic reimbursement price was submitted until 15 October 2011.

[27 December 2011]

120. The National Health Service shall examine an application regarding reducing the basic reimbursement price of medicinal products or medical devices included on List A for a definite time period, which in accordance with Paragraph 16.³ of this Regulation has been lodged until 15 January 2012 and take a decision thereon until 1 February 2012 by determining the reduction of the basic reimbursement price for a time period until 30 June 2012. In the case laid down in this Paragraph, in taking a decision to reduce the basic reimbursement price for a definite time period, the time limit for notification of the decision referred to in Paragraph 64.² of this Regulation shall not be applied.

[27 December 2011]

121. In 2012 the National Health Service shall make changes in the list of reimbursable medicinal products on 1 February and 1 July in accordance with the procedures referred to in Paragraph 62.¹ of this Regulation.

[27 December 2011]

122. [1 April 2013 / See Paragraph 116]

123. In accordance with the requirements referred to in Paragraph 120 of this Regulation the reduced basic reimbursement price of medicinal products and medical devices included on List A reduced for a time period until 30 June 2012 shall be in effect until 31 December 2012, if an application of the applicant for retaining the reduced price is received until 31 December 2012.

[26 June 2012]

124. The rate laid down in Paragraph 99 of this Regulation shall be applied in the amount of 3 % in 2012.

[24 July 2012 / Paragraph shall be applied from 1 August 2012. See Paragraph 2 of the amendments]

125. The National Health Service shall establish the List M referred to in Paragraph 9.¹ of this Regulation until 15 August 2012 and maintain it on the Internet site thereof.

[24 July 2012 / Paragraph shall be applied from 1 August 2012. See Paragraph 2 of the amendments]

126. The National Health Service shall lay down the basic reimbursement price and pharmacy price for the List M medicinal products referred to in Paragraph 10.¹ of this Regulation on the basis of the manufacturer's price declared in conformity to the laws and regulation on the principles for creation of prices for medicinal products in the State Agency of Medicines on 1 July 2012.

[24 July 2012 / Paragraph shall be applied from 1 August 2012. See Paragraph 2 of the amendments]

127. If reimbursement of medicinal products and medical devices has been started in accordance with the procedures laid down in Chapter XII of this Regulation until 31 December 2012 for a person whose diagnosis has been included in Annex to this Regulation and for the maintaining of whose life functions none of the reimbursable medicinal products and medical devices are suitable (the use of the medicinal products and medical devices that are not included on the list of reimbursable medicinal products is necessary), it shall be continued until the end of the term of the validity of the council's decision. The National Health Service is entitled, on the basis of an application of the person to which the council's decision referred to in Paragraph 93 of this Regulation is attached, to take a decision to continue the reimbursement of expenditures for the acquisition of the relevant medicinal products and medical devices in conformity with the conditions referred to in Paragraphs 99, 100, 100.¹ and 101 of this Regulation.

[9 October 2012]

128. Paragraph 45.¹ of this Regulation shall come into force on 1 January 2016.

[21 October 2014]

129. Paragraph 45.¹ of this Regulation shall not be applied, if the budget base for reimbursement procedures in the law on the State budget for the current year has been increased by at least 5 %.

[21 October 2014]

130. If the medical treatment course with the medicinal products referred to in Sub-paragraph 9.¹ 2 of this Regulation was commenced until 1 November 2014, the expenditures for acquisition of such medicinal products until the end of the medical treatment course, but not longer than until 1 November 2015 shall be reimbursed in accordance with the procedures for covering of the expenditures for acquisition of the medicinal products included on List M.

[21 October 2014]

131. Medicinal products shall be dispensed for prescriptions which have been written out until 31 October 2014, until 31 January 2015 according to the codes of diagnosis which were in effect until 31 October 2014.

[21 October 2014]

132. If the diagnosis referred to in Sub-paragraphs 1.2 and 2.1 of Annex 1 to this Regulation has been determined, the reimbursement shall be applied to children up to 3 years of age until 30 June 2015.

[26 May 2015]

133. If the diagnosis referred to in Sub-paragraphs 6.3.1, 9.2.1, and 9.2.2 of Annex 1 to this Regulation has been determined, the reimbursement in the amount of 50 % shall be applied until 30 June 2015.

[26 May 2015]

134. The National Health Service shall take a decision to delete the medicinal products corresponding to the common names of medicinal products included in the list of medicinal products to be administered parenterially (approved in accordance with the laws and regulations regarding the health care and procedures for financing) from the list of reimbursable medicinal products as of 1 January 2019. Upon deleting the medicinal products from the list of reimbursable medicinal products, the National Health Service shall refund to the applicant the remaining part of the annual charge paid. If the medicinal products to be administered parenterially have been included in the list of reimbursable medicinal products both for the treatment of diseases referred to in Annex 1, Paragraph 5 of this Regulation and for the treatment of other diseases, the National Health Service shall take the decision to delete such medicinal products only for the treatment of diseases referred to in Annex 1, Paragraph 5 of this Regulation.

[19 December 2017]

135. For medicinal products and medical devices for which, according to Paragraph 16.³ of this Regulation, the basic reimbursement price has been temporarily reduced by determining a time period in which the reduced reimbursement price is applied, the term for application of the temporarily reduced price shall be revoked as of 1 September 2018.

[7 August 2018]

136. As regards the medicinal products of one common medicinal product name or medical devices with the same type of use included on List A whose pharmacy price exceeds the lowest pharmacy price of the medicinal products or medical devices of the relevant group by more than 100 % by calculating in accordance with the daily dosage defined in the ATC/DDD classification or, if such has not been determined, in accordance with the therapeutic daily dosage, the applicant shall, by 1 September 2018, and also repeatedly by 1 September 2019, submit the application to the National Health Service on the reduction of the basic reimbursement price until the determined 100 % price spread threshold or by 20 %, taking into account the current pharmacy prices of the reimbursable medicinal products.

[7 August 2018]

137. The doctor referred to in Sub-paragraph 69.3 of this Regulation may write out the prescription for the receipt of medicinal products of the List C to be administered parenterially and intended for the treatment of diseases referred to in Annex 1, Paragraph 5 of this Regulation, and the patient may receive medicinal products on the prescription by 31 December 2018. The receipt of medicinal products of the List C to be administered parenterially and intended for the treatment of diseases referred to in Annex 1, Paragraph 5 of this Regulation shall, in accordance with Paragraph 68.¹ of this Regulation, be commenced from 1 January 2019.

[7 August 2018]

138. The applicant shall, in accordance with this Regulation, submit the application for the inclusion of the medicinal products in the list of reimbursable medicinal products in which the price of medicinal products is justified by calculations for an acquired quality-adjusted life year and the National Health Service shall evaluate such application from 1 July 2019.

[7 August 2018]

Informative Reference to the European Union Directives

This Regulation includes legal norms arising from Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems.

Prime Minister A. Kalvītis

Minister for Health G. Bērziņš

Annex 1
Cabinet Regulation No. 899
31 October 2006

Diseases for the Treatment of which Expenditures for the Acquisition of Medicinal Products and Medical Devices are Reimbursed

[21 October 2014; 26 May 2015; 8 December 2015; 20 September 2016; 4 January 2018; 7 August 2018 / The Sub-paragraphs 3.13, 3.14, 3.15, 6.4, and 10.5 shall come into force on 1 January 2019. See Paragraph 2 of the amendments]

Annex 2
Cabinet Regulation No. 899
31 October 2006

Groups of Medical Devices for Inclusion on the List of Reimbursable Medicinal Products, and the Level of Reimbursement of Expenditures for the Acquisition Thereof

[17 December 2013]

Minister for Health G. Bērziņš

Annex 3
Cabinet Regulation No. 899
31 October 2006

Guidelines for Economic Evaluation of Medicinal Products

[25 August 2009; 22 September 2009; 19 October 2011; 10 September 2013; 7 August 2018]

1. The Guidelines for Economic Evaluation of Medicinal Products (hereinafter - the Guidelines) are a combination of methods used for pharmaco-economic analysis to support decision-making in listing medicinal products and medical devices on the list of reimbursable medicinal products or deletion thereof from the list.

2. Upon submitting an application for inclusion of medicinal products or medical devices on the list of reimbursable medicinal products, the applicant shall perform pharmaco-economic calculations in accordance with the Guidelines.

3. Upon assessing the application for inclusion of medicinal products or medical devices on the list of reimbursable medicinal products, the National Health Service shall determine administration costs of medicinal products or medical devices and assess the effect on the health care system parameters and costs in accordance with the Guidelines.

4. The following requirements shall be considered in the pharmaco-economic analysis:

4.1. clearly defined research subject;

4.2. performer of the analysis, his or her qualification and relation with the entity contracting analysis is indicated;

4.3. analysis is based on published clinical trial data which attest to the therapeutic equivalence or therapeutic added value of the medicinal product and in which the primary and secondary benefits are defined and research results are shown;

4.4. analysis may be based on unpublished clinical trial data, if they have been submitted for registration of medicinal products;

4.5. conformity with the indications of medicinal products approved in the relevant states is observed. The number of patients included in analysis shall conform to the number of patients contained in the clinical trial and all additional information applying to the research subject is included in the analysis;

4.6. clinical trial subgroup data is presented additionally in case of significant differences in therapeutic effectiveness or costs;

4.7. the costs and benefits of using the new medicinal product are compared with the costs and benefits of using another alternative therapy (standard treatment or the usual treatment in daily practice in the relevant state):

4.7.1. if the new medicinal product belongs to an existing pharmaco-therapeutic group, the comparator shall be the most commonly used alternative medicinal product in this group;

4.7.2. if the new medicinal product belongs to a new pharmaco-therapeutic group, the comparator shall be the most commonly used alternative drug for the indication;

4.7.3. non-medicinal treatments or no treatment principle may be used as a comparator if they are the most commonly used practice;

4.7.4. doses and duration of comparative treatments shall correspond to those recommended in the summary of product characteristics and treatment guidelines and doses used in the clinical trial. If different doses from those used in the clinical trial are used, such differences shall be justified;

4.7.5. alternative choices shall be justified.

5. The following types of pharmaco-economic analysis shall be distinguished (choice of the specific type shall be justified):

5.1. cost minimisation analysis (CMA). This method shall be applied if the therapeutic value of the new medicinal product is equal to that of the comparator, assuming that if the outcomes of the both treatments are equal, only costs shall be compared;

5.2. cost effectiveness analysis (CEA). This method shall be applied to compare costs and obtained results of two or more alternative treatments each with a common objective. The obtained results shall be measured in physical units. The objective of analysis is to calculate the cost per unit result achieved using the incremental cost-effectiveness ratio;

5.3. cost utility analysis (CUA). The cost utility analysis is a more comprehensive form of cost effectiveness analysis used to calculate the costs for one year-life additionally gained, including the expedience or evaluation of the quality of life. The origin of expedience value shall be explained in the analysis and the method (general or disease-specific) applied to evaluate the quality of life shall be validated.

6. The therapeutic value of the medicinal product shall be determined by the result of use thereof (either for an individual patient or the entire health care system):

6.1. reduced mortality;

6.2. reduced incidence of disease complications;

6.3. reduced incidence of adverse effects caused by the disease;

6.4. incidence of well-controlled therapy symptoms;

6.5. reduced incidence of hospitalisations and recurrence.

7. If the pharmaco-economic analysis has been performed in another state, the results of the study shall be adapted to the conditions of the health care system in Latvia. The following essential criteria shall be considered:

7.1. choice and frequency of adjunctive therapy;

7.2. ratio of patient age and gender;

7.3. evaluation of patient disease severity;

7.4. choice of comparator therapy.

8. The criteria for selecting the applied clinical trials:

8.1. explicitly stated study design;

8.2. randomised, double-blind and controlled trials (non-blinded studies, if the choice is justified);

8.3. clearly defined research subject;

8.4. comparable patient groups at baseline;

8.5. clinically relevant endpoint and study duration based on an "intention to treat" analysis;

8.6. the clinical and statistical significance of the achieved results.

9. The clinical trial analysis may be based on a single clinical trial or meta-analysis (combination of several clinical trials). Meta-analysis increases the precision of the estimates of differences between the new medicinal product and comparative therapy. If calculations are based upon a meta-analysis, selection criteria of trials and the performed statistical tests shall be specified.

10. The results of clinical trials shall be presented as a summary of results for the new medicinal product and comparative therapies. The following data shall be specified for each comparison:

10.1. the number of patients assigned to treatment;

10.2. the number of withdrawals;

10.3. the number of successes and failures presented as the risk of event onset or the ratio between the number of cases per group and the total number of patients in the group (indicating confidence intervals);

10.4. changes in the mean values for the group (indicating confidence intervals).

11. In order to identify the differences in the clinical effectiveness of the new medicinal product and comparative treatments, the absolute risk difference (the difference between the risk of the incidence of events in the studied group and the risk of the incidence of events in the control group) shall be calculated and used for pharmaco-economic analysis. Simultaneously, relative performance measures shall also be calculated (ratio of the risk of the incidence of events in the studied group and the risk of the incidence of events in the control group).

12. The pharmaco-economic analysis shall be performed based on the direct health care costs. Direct health care costs shall include the following:

12.1. costs of medicinal products (including costs of adjunctive therapies and the treatment of adverse effects);

12.2. costs of medical services;

12.3. costs of hospital services;

12.4. costs of diagnostic and laboratory investigation services;

12.5. any other direct health care costs.

13. If additional pharmaco-economic analysis is aimed at the public in general, also other costs shall be included therein (both direct and indirect costs outside the health care system): costs of social services, costs related to the patient transfer and other costs to the patient or his or her family.

14. If the pharmaco-economic analysis is performed based on economic studies performed abroad, all costs shall be adapted to the conditions of the local health care and also sources of data used to estimate costs shall be provided. Costs shall be adjusted according to the following principles:

14.1. pharmaco-economic study costs positions corresponding to the practice in the relevant state shall be established;

14.2. number of costs units (for example, number of consultations, number of bed days);

14.3. changes in the cost per unit of costs;

14.4. all costs shall be specified in euro.

15. If any direct or indirect costs outside the health care system are included, they shall be indicated separately and calculations shall be conducted separately, including the following:

15.1. direct costs within the health care system;

15.2. direct costs outside the health care system;

15.3. indirect costs outside the health care system.

16. Summary data analysis shall include the following comparison parameters of administration of the relevant alternatives:

16.1. treatment costs per acquired result unit for each alternative shall be indicated - costs for a life-year gained, a life-year without progression of the disease or, if the abovementioned indicators are not available, for acquired quality-adjusted life year;

16.2. the incremental cost-effectiveness ratio shall be calculated in the cost-effectiveness analysis or cost utility analysis for a life-year additionally gained, a life-year without progression of the disease or, if the abovementioned indicators are not available, for acquired quality-adjusted life year to show the difference for one additional result reached with the new medicinal product;

16.3. total costs of both comparable treatments and total benefit for the health care system shall be calculated. Total cost savings in the health care system shall be presented, if relevant.

17. The pharmaco-economic analysis shall include discounting of costs and benefits that is a standard feature of economic evaluations. Future costs and benefits shall be discounted at an annual rate of 5 %. If another discounting rate is used, justification shall be provided.

18. The sensitivity analysis shall be applied to measure the extent of the effect of factorial (for example, time of the onset of therapeutic result, disease prevalence (patient number in the population), disease incidence (number of new cases per year)) changes upon the results of analysis. The sensitivity analysis shall specify statistical tests performed and the confidence intervals around the main variables.

19. If the pharmaco-economic analysis cannot be performed according to the methods described above, economical modelling techniques can be applied (for example, to model a sufficient analysis period when trial data provide too short time frame, or when the data originate from a study which was carried out in settings of a different system). The economic model shall be presented in a manner that will enable the replication of the analysis, concurrently submitting electronic copy of the spreadsheets or the software used. The indicators of effectiveness and costs used in the model must be substantiated. The economic model shall be based upon scientific evidence.

Minister for Health G. Bērziņš

Annex 4
Cabinet Regulation No. 899
31 October 2006

Wholesaler's Mark-up Applicable to Basic Price of Reimbursement for Medicinal Products and Medical Devices included in the List of Reimbursable Medicinal Products

[10 September 2013]

Annex 5
Cabinet Regulation No. 899
31 October 2006

Correction Coefficients and Correction Sums Applicable for Pharmacy Price Calculation for Medicinal Products and Medical Devices Included in the List of Reimbursable Medicinal Products

[10 September 2013]

Annex 6
Cabinet Regulation No. 899
31 October 2006

Maximum Permissible Difference in Costs of Medicinal Products for Different Pharmaceutical Forms of the Same General Name

Minister for Health G. Bērziņš

Annex 7
Cabinet Regulation No. 899
31 October 2006

Plan to Introduce the Procedures for Reimbursing Expenditures for the Acquisition of Medicinal Products and Medical Devices Intended for the Outpatient Medical Treatment

[25 August 2009]

Translation © 2018 Valsts valodas centrs (State Language Centre)