R U L E S
on determining the prices of medicinal products for human use

I. GENERAL PROVISIONS
Article 1
(1) Pursuant to Council Directive 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 (OJ L 40 11. 2. 1989, p. 8), these Rules regulate:
- Criteria, methods and procedures for pricing and determining the maximum allowed price and extraordinary allowed higher price of medicinal products for human use, financed from public funds (hereinafter: the prices of medicinal products);
- Criteria, procedure and method for changing the maximum allowed price and extraordinary higher allowed price of medicinal products;
- Mandatory components of the application for determining the highest allowed price and extraordinary allowed higher prices of medicinal products;
- Marketing volume at which the prices of medicinal products are determined or changed;
- Manner of publishing and forwarding the prices of medicinal products;
- Period of validity of the maximum allowed price and extraordinary allowed higher price of medicinal products.
(2) The competent authority for the prices of medicinal products in accordance herewith shall be the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (hereinafter: the JAZMP).
 

Article 2
In addition to definitions and terms defined in Article 6, of the Medicinal Products Act (Official Gazette of the RS, no 31/06 and 45/08; hereinafter referred to as: the Act), the following terms shall also be used in these Rules:
1. The person subject to pricing of medicinal products (hereinafter: the subject) shall be:
- Marketing authorisation holder or its representative,
- Authorisation holder for import and entry of medicinal products without authorisation and included on the list of urgently needed medicinal products pursuant to the Act;
- Holder of authorisation for parallel import of medicinal products;
- Holder of a favourable opinion from the European Medicines Agency for parallel distribution of medicinal products.
2. The maximum allowed price of a medicinal product shall be the price of the medicinal product determined in accordance herewith and may be used in wholesale marketing.
3. Extraordinary allowed maximum price of a medicinal product shall be the price of the medicinal product determined in accordance herewith and may be used in wholesale marketing, exceeding the maximum allowed price of the medicinal product.
4. Comparative price of a medicinal product shall mean information determined on the basis of:
- The prices of medicinal products in comparative countries, calculated from publicly available data; or
- The prices of medicinal products in other Member States of the European Union (hereinafter: the EU) and states signatories of the Agreement on the European Economic Area (hereinafter: EEA).
5. The producer's element of the wholesale price of a medicinal product (hereinafter: the PEP) shall mean the structural part of the maximum allowed wholesale price of a medicinal product or extraordinary allowed higher wholesale price of a medicinal product representing administratively acknowledged costs of the producer of a medicinal product calculated on the basis of the comparative price of a medicinal product.
6. The marking "CIP buyer" shall mean that the wholesale price of a medicinal product includes administratively acknowledged costs of the producer and transport and insurance of goods up to the end buyer and the share for covering the costs of wholesale trading.
7. Administratively acknowledged costs of the producer are costs of production of medicinal products acknowledged by the JAZMP under these Rules when determining the wholesale prices of medicinal products.
8. The presence of the medicinal product on the market of the Republic of Slovenia shall mean the presence of the medicinal product established in accordance with Article 44 of the Act.
9. The presence of the medicinal product on the market of comparative countries shall mean the indication of the medicinal product in the publications from the second paragraph of Article 11 hereof.
10. The presence of the medicinal product on the market of other EU Member States and the signatories of the EEA Agreement shall mean indication of the medicinal product in the web sources of the bodies competent for prices and payment of medicinal products from the public funds of such states.
11. Total annual retail turnover of medicinal product in all its pharmaceutical forms and strengths in terms of value is the total annual value of funds from the compulsory health insurance and co-payments, including pharmacy services and value added tax in a calendar year.
12. Total annual turnover of medicinal product is the total annual number of packagings of the medicinal product in all pharmaceutical forms and strengths of the medicinal product wholesaled by the subject in a calendar year.
13. Total annual turnover of medicinal product at the level of manufacturer in terms of value is the total annual turnover value in all pharmaceutical forms and strengths of the medicinal product in the calendar year aligned with the data reported by the subject to the JAZMP pursuant to Article 44 of the Act.
14. Original medicinal product is:
- A medicinal product that was issued the marketing authorisation, regardless of the type of procedure, pursuant to:
– Article 23 of the Act or the third paragraph of Article 8 of the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L no. 311 of 28 November 2001, p. 67) as amended by Directive 2009/58/EC of the European Parliament and of the Council of 18 June 2009 on the amendment of Directive 2001/82/EC and Directive 2001/83/EC relating to amended conditions of marketing authorisations (OJ L no. 168 of 30 June 2009, p. 33) (hereinafter: Directive 2001/83/EC);
- Article 29 of the Act or Article 10a of the Directive 2001/83/EC, if the subject proves the rights of original manufacturer;
- Article 33 of the Act or Article 10b of the Directive 2001/83/EC; or
- Article 34 of the Act or Article 10c of the Directive 2001/83/EC prior to the expiry of data protection.
15. The form in the electronic form shall mean the form in electronic template downloaded from the JAZMP website.
 

Article 3
(1) Regardless of the expressions defined in Article 6 of the Act, the following two terms shall be used in these Rules:
1. Generic medicinal product is a medicinal product which, regardless of the type of procedure:
- obtained the marketing authorisation in accordance with:
- Article 25 of the Act or the first paragraph of Article 10 of the Directive 2001/83/EC; or
- Article 36 of the Act or Article 16a of the Directive 2001/83/EC; or
- obtained the marketing authorisation in accordance with:
- Article 27 of the Act or the third paragraph of Article 10 of the Directive 2001/83/EC;
- Article 29 of the Act or Article 10a of the Directive 2001/83/EC; or
- Article 34 of the Act or Article 10c of the Directive 2001/83/EC after the expiry of data protection of the original medicinal product, in which case the subject does not provide evidence in the primary origin of the medicinal product in terms of the provisions of the previous item hereunder.
2. Similar biological medicinal product shall mean a medicinal product that obtained the marketing authorisation in accordance with Article 28 of the Act or the fourth paragraph of Directive 2001/83/EC.
(2) The terms from the previous paragraph shall apply mutatis mutandis also to medicinal products financed from public funds, which do not have the marketing authorisation in the Republic of Slovenia but do have:
- The authorisation for entry or import of a medicinal product included in the list of urgent medicinal products;
- The authorisation for parallel import of medicinal product; or
- A favourable opinion from the European Medicines Agency for parallel distribution of medicinal products.
 

Article 4
These Rules determine wholesale prices of medicinal products excluding value added tax, CIP buyer.
 

II. PRICING AND DETERMINING OF MAXIMUM ALLOWED AND EXTRAORDINARY ALLOWED HIGHER PRICES OF MEDICINAL PRODUCTS
Article 5
(1) Maximum allowed prices of medicinal products are priced and determined on the basis of:
1. Comparison of the prices of medicinal products in comparative countries; or
2. Comparison of the prices in other EU Member States and signatories of the EEA Agreement if the medicinal product is not present on the markets of comparative countries; or
3. Comparison of the prices of medicinal products in other European countries if the medicinal product is not available on the market of the countries from Items 1 and 2 of this paragraph.
(2) Extraordinary allowed higher prices of medicinal products are determined on the basis of the criteria, procedures and method specified herein.
 

Article 6
(1) The date of enforcement of the maximum allowed price of a medicinal product is determined by a decision and may not exceed 90 days of the receipt of complete application. If no decision is issued in such period, the date of enforcement of such price is the day following the expiry of the deadline.
(2) The date of enforcement of the extraordinary allowed higher price of a medicinal product is determined by a decision. If no decision is made within 90 days from receiving a complete application, or in the extended 60-day deadline, on the proposed extraordinary allowed higher wholesale price of the medicinal product, the date of entry into force of such price shall be the day following the expiry of the deadline.
(3) If the JAZMP foresees extension of the procedure, due to large amount of applications for determining extraordinary allowed higher prices within the 60-day deadline from the previous paragraph, it shall issue a decision prior to the expiry of the 90-day deadline from the previous paragraph.
(4) If no decision from the first or the second paragraph hereunder is issued within the deadlines specified hereunder, the medicinal product can be marketed at the price proposed in the application but no later than until the issue of a new decision on the basis of the application submitted within the deadlines from the first paragraph of Article 23 hereof.
 

Article 7
(1) The specified maximum allowed price shall apply until the enforcement of the new determined maximum allowed price of the medicinal product.
(2) The determined extraordinary allowed higher price may apply for up to one year. The validity of the price may be extended on the basis of a new application.
 

Article 8
(1) If the authorisation for marketing of the medicinal product is transferred to another subject, the price used for the relevant medicinal product shall be that already determined and no new application shall be needed to determine the maximum allowed price or the extraordinary allowed higher price if it remains unchanged.
(2) The subject shall report to the JAZMP data on transfer of the authorisation within 15 days from receiving the decision on transfer.
1. Criteria, procedures and method of pricing and determining maximum allowed prices of medicinal products
 

Article 9
(1) The subjects shall submit to the JAZMP the application for determining the maximum allowed prices of medicinal products for medicinal products in written and electronic form determined in the first paragraph of Article 97 of the Act, intended for financing from public funds.
(2) Completed form B1 from Annex 1 hereto in the electronic form in .pdf and .xls formats is the constituent part of the application from the previous paragraph. Evidence of data stated in the application must be attached to it.
 

Article 10
Pricing and determining of maximum allowed prices of medicinal products is based on the PEP value, which shall not exceed the maximum allowed PEP value, and the additional share or a fixed amount intended to cover costs of wholesale (hereinafter: the wholesale margin), which shall not exceed the maximum allowed value from Annex 3 hereto.
 

Article 11
(1) The PEP value shall be calculated on the basis of the comparative price of a medicinal product.
(2) The calculation base for comparative prices of medicinal products shall be the prices of medicinal products, financed from public funds, in comparative countries Austria, France and Germany (hereinafter: the comparative countries). PEP value of medicinal products shall be determined on the basis of the latest printed or electronic publications or the pertaining websites specifying the comparative medicinal products and the date of data capture:
– Austria: Erstattungskodex (publication or website); calculation from retail prices of medicinal products,
– France: Vidal (electronic issue); calculation from retail prices of medicinal products,
– Germany: Lauer-Taxe (electronic issue or website) calculation from wholesale prices of medicinal products.
(3) Notwithstanding the provisions of the previous paragraph hereunder, as regards the comparative country Austria, the publication Warenverzeichnis shall be used for medicinal products not listed in the publication Erstattungskodex (web source, calculation from retail prices of medicinal products financed from public funds, excluding value added tax).
(4) Prices from publications of comparative countries hereunder shall be calculated by applying factors from Annex 2 hereto (hereinafter: calculated prices).
(5) Regardless of the provisions of the previous paragraph, the subjects may use, as comparative prices the prices of medicinal products sold in comparative countries directly to healthcare providers, bypassing Wholesalers, the prices stated in the publication of a comparative country.
(6) In such case, stated in the previous paragraph, the subjects shall submit:
- A statement on the existence of such method of selling medicinal products;
- A calculation of the price in accordance with these Rules, taking into account the actual selling wholesale price and explanation for each of these countries, and
- Evidence on the actual selling wholesale price which, in case it is a payment document, may not be older than three months.
 

Article 12
(1) The PEP value of an original medicinal product shall be determined on the basis of the comparative price of a medicinal product, which is for original medicinal products the lowest calculated price of the same medicinal product in any of the comparative countries. If a medicinal product is marketed only in one or two of the comparative countries, the calculated prices in those countries shall apply. The PEP value of an original medicinal product shall not exceed 100% of the comparative price of a medicinal product.
(2) The PEP value of a generic medicinal product shall be determined on the basis of prices of generic medicinal products in comparative countries, as follows:
– If a generic medicinal product is marketed in all three comparative countries, the comparative price of a medicinal product shall be the average of mean values of the calculated prices in those countries. The mean value of the calculated prices in individual comparative country shall be the arithmetic mean value of the lowest and highest calculated price. If only one generic medicinal product is marketed in a country, only that shall be taken into account. The PEP value of the generic medicinal product shall not exceed 78% of the comparative price of a medicinal product until 31 December 2011 and 74% of the comparative price as of 1 January 2012;
– If a generic medicinal product is marketed in two comparative countries, the comparative price shall be the average of mean values of the calculated prices of a medicinal product in those two comparative countries. The mean value of the calculated prices in individual country shall be the arithmetic mean value of the lowest and highest calculated price. If only one generic medicinal product is marketed in a country, only the price of that medicinal product shall be taken into account. The PEP value of the generic medicinal product shall not exceed 78% of the comparative price of a medicinal product until 31 December 2011 and 74% of the comparative price as of 1 January 2012;
– If a generic medicinal product is marketed in only one country, the PEP value of a generic medicinal product shall not exceed 70% of the comparative price of an original medicinal product referred to in first paragraph hereunder;
– If a generic medicinal product is marketed only in one comparative country in which no original medicinal product is available, the comparative price shall be the average of the highest and the lowest values of the calculated price in such country. If only one generic medicinal product is marketed in such country, only the price of that medicinal product shall be taken into account. The PEP value of the generic medicinal product shall not exceed 78% of the comparative price of a medicinal product until 31 December 2011 and 74% of the comparative price as of 1 January 2012.
(3) The PEP value of a similar biological medicinal product not complying with the definition of generic medicinal product shall be determined on the basis of the comparative price of a medicinal product, as follows:
- When the equivalent similar biological medicinal product is present in the markets of comparative countries, this value shall be the lowest calculated price of the equivalent medicinal product in any of the comparative countries. If a medicinal product is marketed only in one or two of the comparative countries, the calculated prices in those countries shall apply. The PEP value of a similar biological medicinal product shall not exceed 100% of the comparative price of a medicinal product.
- When equivalent similar biological medicinal product is not available on the markets of comparative countries, this value shall be the median of producer prices of such similar biological medicinal product in all other EU Member States or signatories of the EEA Agreement in which the medicinal product is marketed. If the number of these countries is even, the comparative price of a medicinal product is determined as the mean value of producer prices in two comparative countries in the middle of the range. The PEP value of a similar biological medicinal product shall not exceed 100% of the comparative price of a medicinal product.
- When equivalent similar biological medicinal product is not present on the markets of comparative countries or the markets of other EU Member States or signatories of the EEA Agreement, the comparative price of a medicinal product shall be determined as the comparative price of the original biological medicinal product to which the relevant biological medicinal product is similar. The PEP value of a similar biological medicinal product shall not exceed 72% of the comparative price of a medicinal product. If there are differences in the efficacy of a medicinal product, the data on the difference in the efficiency of such medicinal product shall also be taken into account, as indicated in the European Public Assessment Report (EPAR) or in the documents of the bodies in charge of evaluating health technologies in the EU Member States, calculated according to the following formula:
PEP (SBMP) = PEP (OBMP)*0.72*(share of efficacy SBMP acc. to EPAR),
where:
PEP (SBMP) - PEP of similar biological medicinal product
PEP (OBMP) - PEP of original biological medicinal product.
Article 13
(1) In the case of a different number of the medicinal product's prescription in packaging, packaging containing comparable number of units shall be used. The comparative price of the medicinal product shall then be calculated per number of prescription units for the subject's medicinal product.
(2) The comparative price of a medicinal product is defined for every pharmaceutical form separately. If there is no comparable pharmaceutical form in compared countries, a similar pharmaceutical form may be compared (e.g. tablet – sugar-coated pill) whereby the pharmaceutical forms with controlled release of active ingredients cannot be put on equal footing with pharmaceutical forms with fast release.
(3) The comparative price of a medicinal product is defined for each strength separately. If there is no identical strength in comparative countries, calculation of prices from other strengths shall apply mutatis mutandis.
 

Article 14
The PEP value of parallel imported or parallel distributed medicinal product shall be determined by comparing the calculated prices of the medicinal product to the authorisation of which the authorisation holder for parallel import of medicinal products or holder of an opinion of the European Medicines Agency on the parallel distributed medicinal product referred; the comparative price of a parallel imported or parallel distributed medicinal product shall equal the calculated price of the medicinal product to which the reference is made. The PEP value shall not exceed 100% of the comparative price of a medicinal product.
 

Article 15
(1) Notwithstanding the provision of the second paragraph of Article 9 hereof, the application, in case there is no generic or original medicinal product in the comparative country, must contain the following components:
- Substantiated proposal for the maximum allowed wholesale price of the medicinal product;
- Data on the previously applicable wholesale price of the medicinal product or the maximum allowed wholesale price of medicinal product and its structure (the share covering production costs, including those arising from the requirements of the competent bodies based on the provisions regulating medicinal products, prices of medicinal products, coverage from health insurance and wholesale costs), if it was determined;
- Data on producer prices and wholesale prices of medicinal products without value added tax CIP buyer in other EU Member States or in the signatories of the EEA Agreement or, if the medicinal product is not present on the market of these countries, adequate data for other European countries in which the medicinal product is present on the market, according to the subject’s data, indicating the source on the form B3 from Annex 1 hereof in the electronic form in pdf and xls format;
- Data on the financing of a medicinal product from public sources in other EU Member States or signatories of the EEA Agreement in which the medicinal product is present on the market, to the best knowledge of the subject;
- Evidence on data in the application.
(2) The PEP value is determined as the median of producer prices based on the subject’s data in other EU Member States or signatories of the EEA Agreement in which the medicinal product is marketed, to the best knowledge of the subject, and financed from public funds. If the medicinal product is not present on the markets of the EU Member states and the signatories of the EEA Agreement, the PEP value is determined as the median of producer prices in other European countries in which the medicinal product is present on the market.
(3) The maximum allowed price of the medicinal product shall equal the PEP value referred to in the previous paragraph hereunder topped by the maximum wholesale margin, in accordance with the table in Annex 3 which is attached hereto as a constituent part.
2. Criteria and elements for deciding on the extraordinary allowed higher wholesale price of medicinal products
 

Article 16
(1) The subject may submit an application for determining the extraordinary allowed higher price of the medicinal product, if:
- The maximum allowed price has been determined for a medicinal product or the subject simultaneously submitted to the JAZMP the application for determining the maximum allowed price and the extraordinary allowed higher price;
- The medicinal product does not have a valid price, agreed between the Health Insurance Institute of Slovenia (hereinafter: the Institute) and the subject or no procedure for concluding an agreement on such price is underway;
- There is no medicinal product on the market of the Republic of Slovenia with the same active substance, pharmaceutical form and strength whose valid price was lower than the proposed extraordinary allowed higher price;
- There is no medicinal product on the market of the Republic of Slovenia with the same therapeutic indication and the same pharmacological mechanism whose valid price was lower than the proposed extraordinary allowed higher price;
- The value of the total annual turnover of the medicinal product in all its pharmaceutical forms and strengths, taking into account their price, valid on the day of application, does not exceed 400,000 euros for the previous calendar year or the value of the total annual turnover does not exceed 100,000 euros for the previous calendar year, provided that the value of the total annual turnover for the previous calendar year did not exceed the growth index of 150 at the annual level.
(2) Notwithstanding the provision of the fifth indent of the previous paragraph, the subject can submit the application for determining the extraordinary allowed higher price if the total annual turnover of the medicinal product for the last calendar year exceeded 400,000 euros and if there is no adequate substitute medicinal product on the market.
(3) The application shall be submitted to the JAZMP in two hard copies and in electronic form.
(4) The application for determining the extraordinary allowed higher price of the medicinal products not listed according to Article 15 hereof must contain:
- Grounds of the submitted proposal, namely that the maximum allowed price based on the criteria hereof does not enable the subject to adequately supply the market of the Republic of Slovenia, including the data on actual costs additionally encumbering the medicinal product and serving as the base for the request for extraordinary allowed higher price of the medicinal product;
- Informative calculation of the maximum allowed wholesale price of the medicinal product based on criteria specified herein; on Form B1 from Annex 1 hereof in .pdf and .xls formats;
- Calculation of the proposed extraordinary allowed higher wholesale price of the medicinal product, on Form B2 from Annex 1 hereof in .pdf and .xls formats;
- Data on the volume of sales of this medicinal product in the Republic of Slovenia for the period of the last three years since the submission of the application, stating the anticipated volume of sales for the medicinal products that have been on the market for a period shorter than the required one, or that are only coming on the market;
- Data on producer prices and wholesale prices of the same medicinal product financed from public funds and data on quantity turnover of this same medicinal product in other EU Member States or in the signatories of the EEA Agreement in which the medicinal product is marketed, according to the subject’s data, indicating the source, or data on the medicinal products not marketed in the EU Member States or in the signatories of the EEA Agreement, for other European countries on the form B3 from Annex 1 hereof in xls format;
- Pharmacoeconomic analysis and analysis of effect on public funds, compiled on the basis of relevant data for the Republic of Slovenia, or analyses from the EU Member States with adequate methodological and data conversion on the basis of data for the Republic of Slovenia;
- Assessment of the relative therapeutic value of the medicinal product or appropriate pharmacoepidemiological data including relevant data for the Republic of Slovenia;
- Proof of paid fees.
(5) For medicinal products the wholesale turnover of which, in all pharmaceutical forms and strengths present on the market in the Republic of Slovenia, does not exceed 50,000 euros at the annual level in the previous calendar year no analyses and data from the sixth and the seventh indent of the previous paragraph need to be attached to the application.
(6) For medicinal products without marketing authorisation but with authorisation for import or entry which are included in the list stipulated by Article 15 of the Act no data from the fifth, sixth and the seventh indent of the previous paragraph need to be attached to the application.
 

Article 17
When deciding on the extraordinary allowed higher price of a medicinal product, the JAZMP shall take into account:
- Opinion of the Committee for determining exceptionally allowed higher prices (hereinafter: the Committee);
- The established public interest in the area of health;
- Economic substantiated assessment of risk arising from any disturbances in supply of the medicinal product.
 

Article 18
(1) In its opinion based on data from the complete application, data on medicinal product and other data reflecting the situation in science and the expert field the Committee shall adopt a position regarding:
- The significance of the medicinal product within the national health care priorities, taking into account the urgency, significance and indispensability;
- Public health risk arising from potential disturbed supply of the medicinal product including the economic aspect;
- Impact on public finance because of approved extraordinary allowed higher price.
(2) The Committee shall evaluate the date from the complete application submitted hereunder and prepare an opinion containing its findings in the form of awarding of points by applying the following criteria:
- Relative therapeutic value, which means additional efficacy by improving medical outcomes (it it assessed as the level of the Committee’s agreement with the grounds of the request for determining extraordinary allowed higher price at the interval of 1-5 points);
- Cost efficiency of the medicinal product or statement of adequate financial and economic grounds compared to other possible ways of treatment (it it assessed as the level of the Committee’s agreement with the grounds of the request for determining extraordinary allowed higher price at the interval of 1-5 points);
- The balance of the proposed extraordinary allowed higher price with the prices of the medicinal product concerned in other EU Member States or signatories of the EEA Agreement, taking into account the essential characteristics of the compared markets, namely:
- 5 points – proposal of more than 10 percent under the median price of the medicinal product on comparative markets;
- 4 points – proposal of 5 to 10 percent under the median price of the medicinal product on comparative markets;
- 3 points – proposal of 0 to 5 percent under the median price on comparative markets;
- 3 points – within 5 percent above the median price on comparative markets;
- 1 point – more than 5 percent above the median price on comparative markets;
- Existence of specific factors, important for placing the medicinal product concerned into national healthcare products in accordance with the issued priorities and ethical aspects (it it assessed as the level of the Committee’s agreement with the grounds of the request for determining extraordinary allowed higher price at the interval of 1-5 points).
 

Article 19
(1) In its opinion, the Committee shall give, in addition to the statements specified in the previous Article, its position on the proposed extraordinary allowed higher price of medicinal products in one of the following manners:
- With a favourable opinion, extraordinary allowed higher price shall be proposed, compared to the one proposed in the application, when the sum of points from the second paragraph of the previous article herein equals or exceeds 18 for the medicinal products with marketing authorisation or authorisation for parallel import of medicinal products or equals or exceeds 10 for medicinal products without marketing authorisation but with entry or import authorisation which are included in the list stipulated by Article 15 of the Act; or
- With a favourable opinion, extraordinary allowed higher price shall be determined, which is lower than proposed in the application, calculated according to the following formula:
PEP(DEAHP) = PEP(MAP) + AP/PP * (PEP(PEAHP)-PEP(MAP)) * (min(PEP(median(ER)) / PEP(PEAHP); (PEP(PEAHP) – PEP(MAP)) / max(PEP(median(ER)); PEP(MAP))),
where:
PEP(DEAHP) – determined PEP of extraordinary allowed higher price
PEP(PEAHP) – proposed PEP of extraordinary allowed higher price
PEP(MAP) – PEP of maximum allowed price
DT – achieved points
MT – possible points
(PEP(median(ER)) – median of producer prices in the EU Member States or countries signatories of the EEA Agreement, where the medicinal product is marketed, namely:
- If data are available from only two countries, the arithmetic mean of the prices in these two countries shall be considered;
- If data are available from only one country, the data for this country shall be considered;
- If this country is the Republic of Slovenia, the maximum allowed price shall be considered;
- With a favourable opinion, extraordinary allowed higher price of the medicinal product shall be proposed, namely in the amount established and justified by the Committee, proportionally taking into account the outcome of the assessment from the second paragraph of the previous Article;
- With a negative opinion, it shall be proposed that no extraordinary allowed higher price be determined.
(2) If the Committee issues a negative opinion, such opinion must be grounded, stating the definitions from the first paragraph of the previous Article and the number of achieved points from the evaluation of data from the application referred to in the second paragraph of the previous Article.
 

Article 20
(1) The JAZMP establishes the presence of public interest in the area of health, considering the presence of medicinal product on the market in the scope of national health priorities and taking into account the data on the medicinal products, its use, costs of treatment in comparison with the costs of treatment with the medicinal products for the same indication area in the scope of the same therapeutic group of medicinal products obtained on the basis of protocols on data exchange between the Institute of Public Health of the Republic of Slovenia (hereinafter: the IVZ) and the Institute.
(2) It may also obtain a second opinion on the presence of public interest in the medicinal product concerned in the scope of health care programmes financed from the regional expanded expert committee or a clinical department or three statements of specialists practicing medicine in the area of the relevant pharmacotherapy.
 

Article 21
Prior to deciding on the maximum allowed price of a medicinal product and extraordinary allowed higher price of a medicinal product, the JAZMP may request from the Institute the data on the effect of the proposed price on public expenditure at the level of the therapeutic group and pharmacotherapy.
 

III. AMENDING THE MAXIMUM ALLOWED PRICES OF MEDICINAL PRODUCTS AND EXTRAORDINARY ALLOWED HIGHER PRICES OF MEDICINAL PRODUCTS
Article 22
The maximum allowed prices of medicinal products are changed twice a year for medicinal products where:
- A change in the price of the medicinal product occurred in at least one of the comparative countries, resulting in a change in the comparative price of the medicinal product used as the basis for determining the maximum allowed price of the medicinal product;
- A change occurred in the price of medicinal products not present on markets of compared countries and with the maximum allowed price determined on the basis of prices on the markets of other EU Member States or signatories to the EEA Agreement or if the range of compared countries has changed.
 

Article 23
(1) The subjects shall re-establish the maximum allowed prices of medicinal products for medicinal products referred to in the previous Article in accordance with the criteria specified herein and submit an application for change of maximum allowed prices to the JAZMP, from:
- 1 March to 1 April; and
- 1 September to 1 October, including.
(2) The application for change of maximum allowed prices shall contain:
- Proposed maximum allowed prices of medicinal products with calculation given on Form B1 from Annex 1, in written and electronic form;
- Calculation of maximum allowed prices of the subject’s other medicinal products, which shall not be changed, on Form B1 from Annex 1, in written and electronic form;
- All evidence on data, stated in the application, in written form.
(3) The following issues of the prescribed publications shall be used in the application for amending the maximum allowed prices of medicinal products:
a) In the period referred to in the first indent of the first paragraph hereunder:
– Austria: Erstattungskodex: The issue of 1 January of the current year or Warenverzeichnis: data from a web source with the date of acquisition in February of the current year;
– France: Vidal: The issue no. 3/3 of the previous year or 1/3 of the current year; or
– Germany: Lauer-Taxe: The issue of 15 February of the current year;
b) In the period referred to in the second indent of the first paragraph hereunder:
– Austria: Erstattungskodex: the issue of 1 January of the current year with the supplement of 1 July of the current year or Warenverzeichnis: data from the web source with date of acquisition in August of the current year;
– France: Vidal: the issue no. 2/3 of the current year;
– Germany: Lauer-Taxe: The issue of 15 August of the current year.
(4) The maximum allowed prices of medicinal products shall be changed in the manner specified hereunder also in the period when the marketing authorisation for a medicinal product has already expired and the medicinal product can be marketed, pursuant to the Act, until its expiry date but not longer than 18 months.
(5) The JAZMP may reduce the extraordinary allowed higher prices of medicinal products prior to the expiry of their validity on the basis of the application submitted by the subject in electronic form in pdf and xls format, in which only the proposed reduced price of medicinal product is stated on Form B2 from Annex 1 hereof and the date of enforcement of the proposed reduced price.
 

V. PUBLISHING AND FORWARDING PRICES
Article 24
(1) The JAZMP shall at least once a month publish the maximum allowed prices of medicinal products and extraordinary allowed higher prices of medicinal products which it has determined in accordance herewith on its website in the catalogue of information of public character, by specifying the following:
- Identification marking of the medicinal product;
- Name and presentation of the medicinal product;
- General name of the medicinal product;
- Classification marking of the medicinal product;
- Name of the subject;
- Maximum allowed price of a medicinal product or extraordinary allowed price of a medicinal product;
- Date of entry into force of the price of the medicinal product;
- Medicinal product dispensing regime;
- Status of original medicinal product or generic product;
- Other relevant data.
(2) The JAZMP shall once a year report to the European Commission the applicable maximum allowed prices and extraordinary allowed higher prices of the medicinal products.
(3) At least once a month, the JAZMP shall submit to the Institute, the ministry responsible for health (hereinafter: the Ministry) and the IVZ the maximum allowed prices of medicinal products and extraordinary allowed higher prices of medicinal products together with PEP values and percentages of comparative price in the electronic form. Notwithstanding the provision of the first paragraph of this Article, the maximum allowed price shall not be published without the subject’s consent in the case of the first indent of Article 16 hereof and when the extraordinary allowed higher price had not been determined.
(4) At least once a month, the Institute shall submit to the JAZMP, the Ministry and the IVZ the wholesale prices of medicinal products agreed on the basis of the first paragraph of Article 97a of the Act together with agreed PEP values in the electronic form and data on valid classifications of medicinal products to the lists.
(5) At least once a year, the IVZ shall submit to the JAZMP, the Ministry and the Institute data on the use of medicinal products and costs for them.
 

Article 25
The subjects shall inform on the maximum allowed prices and extraordinary allowed higher prices of the medicinal products formed in accordance herewith the natural persons and legal entities with authorisation for wholesale trade in medicinal products or authorisation for production of medicinal products and concluded agreements on cooperation with them, immediately or not later than within eight days after determining the maximum allowed prices and extraordinary allowed higher prices of the medicinal products and at least three business days prior to their first use on the market.
 

VI. TRANSITIONAL AND FINAL PROVISIONS
Article 26
(1) Notwithstanding the provision of the first paragraph of Article the subjects shall re-establish the maximum allowed prices of medicinal products for medicinal products referred to in Article 22 hereof in accordance with the criteria specified herein and submit to the JAZMP an application for change of maximum allowed prices within 15 days of the enforcement hereof. The JAZMP shall complete the procedures of changing the maximum allowed prices within 30 days of the complete application.
(2) Pursuant to the previous paragraph, the maximum allowed prices are formed in accordance with the criteria hereof also for medicinal products with valid extraordinary allowed higher prices on the day of enforcement hereof. Such determined maximum allowed prices are not published on the JAZMP website in the catalogue of public information before the expiry dates of the validity of extraordinary allowed higher prices; expiry dates of the validity of extraordinary allowed higher prices, they are only published on the basis of the subject’s written consent.
(3) The provisions of the first indent of the first paragraph of Article 23 hereof shall not apply in 2011.
(4) The following issues of the prescribed publications shall be used for determining the maximum allowed prices from the first paragraph hereunder:
– Austria: Erstattungskodex: issue 1 January 2010 with the supplement of 1 July 2010 or Warenverzeichnis: issue November of the current year or web source, indicating the date of acquisition November 2010;
– France: Vidal: issue no. 3/3 2010;
– Germany: Lauer-Taxe: issue that is not older than 15 days of the date of publication of these Rules.
(5) Applications for determining the extraordinary allowed higher price received until the day of enforcement hereof, for which no price had been determined before that date shall be treated under the provisions hereof. The subjects obliged to submit these applications shall supplement them with the data for determining the maximum allowed price no later than within 5 days of entry into force hereof.
(6) With the day of enforcement of these Rules, the Rules on the prices of medicinal products for human use (Official Gazette of the Republic of Slovenia no. 97/08, 99/08 – amend. and 8/09) shall cease to apply.
(7) Notwithstanding the provisions of the sixth paragraph hereunder, the applications for determining the maximum allowed price which have not been resolved until the beginning of validity hereof shall be resolved according to the Rules on the prices of medicinal products for human use (Official Gazette of the Republic of Slovenia no. 97/08, 99/08 – amend. and 8/09).
 

Article 27
These Rules shall enter into force on the next day after their publication in the Official Gazette of the Republic of Slovenia.
Number 0070-44/2010-22
Ljubljana, 9 December 2010
EVA 2010-2711-0039
Dorijan Marušič
Minister of Health
 

Form B1: Calculation of the maximum allowed wholesale price of a medicinal product

Form B2: Calculation of the extraordinary allowed higher wholesale price of a medicinal product
Form B3: Indication of the prices of medicinal product in the EU Member States / EEA or other European countries
Annex 2: Tables for the calculation of comparative prices
Annex 3: Table 1 – calculation of the wholesale price of medicinal product