982.     Rules Amending the Rules Determining the Prices of Medicinal Products For Human Use

Pursuant to Paragraph three of Article 158 of the Medicinal Products Act (Official Gazette of RS, no. 17/14 and 66/19), the Minister of Health hereby issues the following 

R U L E S
Amending the Rules Determining the Prices of Medicinal Products For Human Use

Article 1

The Rules Determining the Prices of Medicinal Products For Human Use (Official Gazette of the Republic of Slovenia, No. 32/15, 15/16, 19/18, 11/19 and 26/20) shall be amended in Article 2 as follows:
- The initial sentence shall be amended in the brackets following the text “17/14” by adding “and 66/19”;
- The second, third and fourth indent of Item 1 is hereby amended to read as follows:
“- The holder of authorisation for entry or import of a medicinal product that is without marketing authorisation and is classified into the list of essential or indispensable medicinal products pursuant to the Act;
- The holder of temporary marketing authorisation for a medicinal product that is not authorised for marketing;
- The holder of marketing authorisation for parallel imported medicinal product;”.

In Item 13 the text “in a calendar year” shall be supplemented by “which is sold by the Holder listed under Item 1 to another legal person and is”.

In indent one of Item 14 the text “Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299 of 27 October 2012, p. 1)” shall be substituted by the text “Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (OJ L no. 198 of 25 July 2019, p. 241)”, and the second indent shall be deleted.

Article 2

The text of Article 3 is hereby amended to read as follows:
“(1) The expressions used herein shall have the following meaning:
1.    A generic medicinal product is a medicinal product that has, regardless of the type of procedure, acquired marketing authorisation pursuant to:
- Paragraph one of Article 45 of the Act or paragraph one of Article 10 of Directive 2001/83/EC;
- Article 52 of the Act or Article 16a of Directive 2001/83/EC;
- Paragraph six of Article 45 of the Act or Paragraph three of Article 10 of Directive 2001/83/EC;
- Article 47 of the Act or Article 10a of Directive 2001/83/EC; or
- Article 50 of the Act or Article 10c of Directive 2001/83/EC after expiry of data protection of the original medicinal product, whereby the subject does not possess evidence on the primary origin of the medicinal product.
2.    A similar biological medicinal product is a medicinal product that has acquired marketing authorisation pursuant to paragraph 7 of Article 45 of the Act or paragraph four of Article 10 of Directive 2001/83/EC and corresponds to the definition under item 58 of Article 6 of the Act.
(2) Terms set out in the above paragraph shall apply mutatis mutandis to medicinal product that are financed by public funds or are intended to be financed by public funds and do not have marketing authorisation in the Republic of Slovenia, but do have:

- Temporary marketing authorisation or authorisation for entry or import of a medicinal product that is without marketing authorisation and is classified into the list of essential or indispensable medicinal products pursuant to the Act; 
- Marketing authorisation for parallel imported medicinal product; or 
- Certificate of received notification on parallel distribution of medicinal product based on the provisions of Article 118 of the Act.”. 
Article 3Indent two of paragraph five of Article 11 shall be amended to read as follows: “- Prices for France shall be recalculated using Equation 2 and Table 1 which are enclosed in Appendix 2 hereof, except in case of applying the UCD pricing standard which is a directly comparable price;”.

Article 3

Indent two of paragraph five of Article 11 shall be amended to read as follows: “- Prices for France shall be recalculated using Equation 2 and Table 1 which are enclosed in Appendix 2 hereof, except in case of applying the UCD pricing standard which is a directly comparable price;”.

Article 4

Paragraph three of Article 12 is hereby amended to read as follows: 
    “(3) PEP value of biosimilar medicinal products shall be determined on the basis of all biosimilar medicinal products in comparative countries in the following manner: 
    - if biosimilar medicinal products are present on markets of comparative countries, the comparative price of a medicinal product shall be the lowest recalculated price of the biosimilar medicinal product in any of the comparative countries. If the biosimilar medicinal product is marketed in only one or two comparative countries, recalculated prices from such countries shall be considered. The PEP value of a biosimilar medicinal product shall not exceed 100 percent of the comparative price. 
    - If biosimilars are not marketed in comparative countries, the comparative price of such a medicinal product shall be established as the comparative price of the reference biological medicinal product the medicinal product in question is similar to. The PEP value of a biosimilar medicinal product shall not exceed 68 percent of the comparative price of the original biological medicinal product stated in paragraph 1 of this Article. If there are differences in the effectiveness of the medicinal product, data on differences in medicinal product effectiveness listed in the European public assessment reports (EPAR) or documents of bodies competent for assessment of healthcare technologies in EU member states shall also be considered and calculated using the following equation: 

PEP (BSM) = PEP (RBM)*0,68* (share of BSM efficiency according to EPAR),

whereby the following elements shall have the following meanings: PEP (BSM) - PEP of similar biological medicinal product  PEP (RBM) - PEP of reference biological medicinal product”. 

Article 5

In paragraph one of Article 15 the initial sentence shall be amended to read as follows:
    "(1) Notwithstanding the provision of the second paragraph of Article 9 hereof, the application, in case there is no original or generic or biosimilar medicinal product in the comparative country, shall contain the following components:”.
     A new fourth paragraph is hereby added after the third paragraph to read as follows: 
    “(4) If a medicinal product is not available in other EU member countries, EEA signatories or other European countries and the above referenced median cannot be determined, the PEP shall be determined with regard to the expert substantiation as per indent one of paragraph one of this Article.”. 
In the current fourth paragraph that shall become the fifth paragraph, the text “previous paragraph” shall be substituted to read “third or fourth paragraph of this Article”. 

Article 6

Paragraph four of Article 16 is hereby amended to read as follows: 
    “(4) The application for determining the extraordinary allowed higher price of a medicinal product must contain: 
 
1. Cover letter with a listing of reasons and substantiation of why the maximum allowed price does not allow market supply in the Republic of Slovenia;
2. Administrative section (Section A of Appendix 4 which is an integral part hereof):
- A.1: Basic information about the medicinal product for which the subject is filing an application for the determination of an exceptional higher allowed price;
- A.2: Data on overall annual turnover of the medicinal product at manufacturer level by individual medicinal product furnished with a national identifier, for all pharmaceutical forms, strengths and packaging variants, for the last three calendar years and anticipated volume of sales in the following calendar year;
- A.3: Proposed maximum allowed price or proposed exceptional higher allowed price of a medicinal product. If the market price of the medicinal product is lower than the maximum allowed price or exceptional higher allowed price, the agreement concluded based on Article 159 of the Act requires substantiation.
3. Clinical section (Section B of Appendix 4 hereof):
- B.1: Listing of therapeutic indications
- B.2: Listing of medicinal products marketed in the Republic of Slovenia and used in the same therapeutic area;
- B.3: Comparison of efficiency and safety or determination of relative therapeutic value of medicinal product that constitutes additional efficiency by improving health outcomes in comparison to medicines listed under B.2;
- B.4: Assessment of risk to public health that may arise from unavailability or impaired supply of the relevant medicinal product;
4. Economic section (Section C of Appendix 4 hereof) for medicinal products with marketing authorisation, marketing authorisation for a parallel imported medicinal product or certificate of notification of parallel distribution:
- C.1: Analysis of impact on public funds after approval of exceptional higher allowed price, with listing of market share and assessment of entire population of treated individuals;
- C.2: Comparison of medicinal product prices for individual patients for monthly therapy in case of chronic treatment or for the entire duration of treatment in case of acute treatment with other medicinal products listed under item B.2;
- C.3: Data on manufacturer prices and wholesale prices for a medicinal product in equal or comparable packaging (per packaging unit) in other EU member countries or signatories of the EEA Agreement and other European countries on form B3 from Appendix 1 hereto in xls format;
5. Cost section (Section D of Appendix 4 hereof) for medicinal products with temporary marketing authorisation or authorisation for entry or import of a medicinal product that is classified onto the list of essential or indispensable medicinal products pursuant to the Act;
- D.1: Statement of medicinal product purchase price with included discounts and rebates and evidence of purchase price in the form of an invoice for previously delivered products or, in case of first delivery, a pro-forma invoice or offer;
- D.2: Calculation and evidence of costs of transporting the medicinal product from the source country to the Republic of Slovenia;
- D.3: Calculation and evidence of the costs of medicinal product storage and associated services;
- D.4: Calculation and evidence of costs of potential additional packaging or labeling of the medicinal product;
- D.5: Statement of administrative costs incurred upon entry or import of the medicinal product;
- D.6: Statement of paid fees and other dues incurred upon entry or import of the medicinal product.”.
Paragraph five is hereby amended to read as follows:
“(5) Medicinal products with marketing authorisation, marketing authorisation for a parallel imported medicinal product or certificate of notification of parallel distribution, the annual turnover of which at manufacturer level does not exceed the value of EUR 30,000 as evidenced by the applicant in the application, do not require the submission of data under section B, part B.3  and section C, parts C.1 and C.2 of Appendix 4 hereto.”.

Paragraph six is hereby amended to read as follows:
 “(6) Medicinal products with temporary marketing authorisation or authorisation for entry or import of medicinal products classified on the list of essential or indispensable medicinal products in accordance with the Act, the annual turnover of which at manufacturer level does not exceed the value of EUR 30,000 as evidenced by the applicant in the application, and the proposed exceptionally allowed higher price of which does not exceed 120 % of the purchase price of the medicinal product under section D, part D.1 of Appendix 4 hereto, do not require the submission of data under section B, part B.3 of Appendix 2 and section D, parts D.2, D.3, D.4, D.5 and D.6 of Appendix 4 hereto.”.

Article 7

Paragraph three of Article 18 is hereby amended to read as follows:
 “(3) Notwithstanding paragraphs one and two of this Article, the Commission shall in applications consistent with paragraphs five and six of Article 16 hereof issue an opinion on the economic or costs related aspects and potential risk to public health that may arise from unavailability or impaired supply of the relevant medicinal product.”.

Article 8
Item 1 of paragraph one of Article 19 is hereby amended to read as follows:
 “1. By a positive opinion the Committee proposes the exceptionally allowed higher price of medicinal product as proposed in the application,”.

Article 9

Form B3 of Appendix 1 shall be substituted by a new form B3 that shall constitute an integral part hereof.


Article 10
Heading B in Appendix 2 shall be substituted by a new heading B, which constitutes an integral part hereof as Appendix 2.


Article 11

A new Appendix 4 shall be added after Appendix 3 hereof that shall constitute a constituent part hereof.

TRANSITIONAL AND FINAL PROVISION

Article 12

Applications for determining the maximum allowed price and extraordinary allowed higher price of medicinal products, received up to the day of enforcement hereof, for which no price had been determined before that date, shall be subject to the provisions hereof.

Article 13

These Rules shall enter into force on the next day after their publication in the Official Gazette of the Republic of Slovenia.

No. 0070-30/2021
Ljubljana, 29 March 2021
EVA 2021-2711-0024

Janez Poklukar
Minister of Health

Attachments to the rules(.pdf)