Act No. 338 / 2024 Coll.
Act amending Act No. 48 / 1997 Coll., on Public Health Insurance, and amending and supplementing certain related laws, as amended, Act No. 592 / 1992 Coll., on Insurance against Public Health Insurance, as amended, and Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended
Valid
Law
Effective from 01.01.2025
Text versions:
01.01.2025
19.11.2024
338
THE LAW
of 22 October 2024
amending Act No. 48 / 1997 Coll., on Public Health Insurance, and amending and supplementing certain related laws, as amended, Act No. 592 / 1992 Coll., on Public Health Insurance Insurance, as amended, and Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended
Parliament has decided on this law of the Czech Republic:
Amendment to the Public Health Insurance Act
Act No. 1 / 2006, Act No. 1 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 6 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5, Act No. 5, Act No. 5, Act No. 2006, Act No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No Act No. 47 / 2016 Coll., Act No. 66 / 2017 Coll., Act No. 150 / 2017 Coll., Act No. 183 / 2017 Coll., Act No. 200 / 2017 Coll., Act No. 111 / 2019 Coll., Act No. 262 / 2019 Coll., Act No. 214 / 2017 Coll., Act No. 20 / 2017 Coll., Act No. 165 / 2020 Coll., Act No. 205 / 2020 Coll., Act No. 538 / 2020 Coll., Act No. 221 / 2022 Coll., Act No. 322 / 2017 Coll., Act No. 200 / 2016 Coll.
1. At the end of footnote 51, the sentence "Regulation (EU) 2021 / 2282 of the European Parliament and of the Council of 15 December 2021 on the evaluation of health technologies and amending Directive 2011 / 24 / EU shall be added to the separate line. '
2. in Paragraph 1 (1) (d), the words "and in vitro diagnostic medical devices (" medical devices ")" shall be inserted after the words "devices."
3. The following Section 14d is inserted after Section 14c:
(1) The members of the coordination group of Member States for the assessment of health technologies established under Regulation (EU) 2021 / 2282 of the European Parliament and of the Council of 15 December 2021 on the evaluation of health technologies and amending Directive 2011 / 24 / EU (hereinafter referred to as the "Health Assessment Regulation") are the Ministry of Health and the Institute.
(2) Reports on the application of the Regulation on the Evaluation of Health Technologies and on whether they have been taken into account for the purposes of national assessments shall be submitted by the Ministry of Health to the European Commission under the Regulation on the Evaluation of Health Technologies, prepared under Article 31 (2) of the Regulation on the Evaluation of Health Technologies.
(3) The Institute shall, without undue delay, provide the coordination group of Member States for the assessment of health technologies through the Information Technology Platform established pursuant to Article 30 of the Health Technology Assessment Regulation with all information which it receives when carrying out the evaluation of a medicinal product for human use from the applicant for the determination of the level and conditions of reimbursement of the medicinal product for human use under Part Six and which is the subject of a request for the submission of a dossier pursuant to Article 10 (1) of the Health Technology Assessment Regulation.
(4) The Institute shall, within 30 days of the date of the decision in the procedure for setting the level and conditions of reimbursement in accordance with Part Six, taking into account reports on the joint clinical evaluation of health technologies, provide information on the national evaluation of medicinal products for human use referred to in Article 7 (1) (a) and (b) of the Health Technology Assessment Regulation, in particular on how the reports on the joint clinical evaluation of health technologies have been taken into account in this proceeding. The obligation to inform the coordination group within the period specified in the first sentence shall also apply to national clinical trials of such medicinal products referred to in Article 7 (1) (a) and (b) of the Regulation on the evaluation of health technologies for which a joint clinical trial report has not yet been issued or joint clinical evaluation has not yet been initiated.
(5) The Ministry of Health may entrust the conduct of the evaluation of medical devices to a person who is competent and competent for such evaluation. The Ministry of Health shall, by means of implementing legislation, determine the extent of the information to be transmitted by that person to the Ministry of Health and the manner in which that information is transmitted. The person referred to in the first sentence shall proceed with the evaluation of medical devices under Article 13 (1) (b) to (d) of the Health Technology Assessment Regulation. To this end, the Ministry of Health shall transmit to it information already submitted at European Union level pursuant to Article 10 (1) or (5) of the Health Technology Evaluation Regulation. The Ministry of Health shall provide a report on the evaluation of health technologies referred to in Article 7 (1) (c) and (d) and the information referred to in Article 13 (1) (e) and Article 13 (2) of the Health Technology Evaluation Regulation no later than 30 days from the date of its issue to the coordination group of Member States for the assessment of health technologies through the Information Technology Platform established under Article 30 of the Health Technology Assessment Regulation. ';
4. The heading of Section 16b reads: "Limits on medicinal products and foodstuffs for special medical purposes."
5. In Article 16b (1), the words "and have documented this fact in a copy of the third-degree invalidity pension decision 'are deleted; the words" they have documented this fact in a copy of the health assessment' shall be replaced by the words "from the first day of the calendar month following the month in which the invalidity pension or invalidity claim has been registered in the electronic recipe information system under the drug law (hereinafter referred to as" eRecept ')' and the words "the health insurance undertaking must 'shall be inserted after the words" the procedure referred to in paragraph 2'.
6. Paragraph 16b (2) reads as follows:
"(2) The health insurance undertaking shall, at the request of the insured person or his legal representative, pay the amount by which the sum of the insured person or his legal representative exceeds the amount by which he or she has proven to have paid up to the limit, the limit referred to in paragraph 1, within 90 calendar days of the date of application. The application may be lodged not earlier than the first day of the calendar year following the calendar year in which the limit was exceeded but not later than the last day of the sixth calendar month following the calendar year in which the limit was exceeded. ';
7. In Article 16b (3), "the calculation of the amount 'is replaced by" the examination of the application' and the third and fourth sentences are deleted.
8. In Article 16b (4), the word "paid 'is deleted and after the word" supplement' the words "and the information on whether and to what extent the insured person has paid it 'are inserted.
9. In Article 16b (5), the words "the payment of a supplement for a partially paid medicinal product or food for special medical purposes' are replaced by the words" the issue of a partially paid medicinal product or food for special medical purposes, including the indication of the amount of the supplement 'and the words "the amount of the supplement to which the supplement is linked'; the words" the amount of the supplement paid shall be inserted; and
10. In Article 16b, paragraphs 6 to 9 are added:
"(6) The medical care provider shall verify the state of the limit referred to in paragraph 1 for the insured person to whom the medicinal product or food for special medical purposes has been prescribed by the eRecept service prior to the delivery of the medicinal product or food for special medical purposes.
(7) If the health care provider finds that the limit referred to in paragraph 1 has been reached by the insured person, when dispensing a medicinal product or food for special medical purposes partly covered by the health insurance, it shall be entitled to require only that part of the supplement which exceeds the amount to be credited to the limit referred to in paragraph 1 at the time of issue. If, at the time of issue, the limit for the insured person is exceeded, the healthcare provider shall be entitled, in addition to the first sentence, to require also that part of the deductible supplement corresponding to the amount remaining before the issue until the limit is reached.
(8) The medical care provider shall not be entitled to increase the price of the medicinal product or food for special medical purposes on the issue of the insured person with the limit referred to in paragraph 1 compared to the price for the final consumer at which the medicinal product or food for special medical purposes offers the insured person without the limit referred to in paragraph 1.
(9) The health insurance undertaking shall pay the health care provider for its insured person a supplement to the medicinal product or special medical food, which was not required by the medical care provider in accordance with paragraph 7 at the time of issue, within the limit referred to in paragraph 1. The deductible supplement according to the first sentence shall be paid by the health insurance undertaking at the same time as the payment of the medicinal product or food in question for special medical purposes. ';
11. in Article 17 (7) (a) (1), the words "food for special medical purposes" shall be inserted after the words "medicinal products."
12. in Paragraph 39b, the dot is replaced by a comma at the end of paragraph 2 and the following point (l) is added:
"(l) a published report on the joint clinical evaluation of health technology pursuant to Article 9 of the Health Technology Evaluation Regulation.";
13. in Paragraph 39f (5), the words "if they have not already been submitted in the framework of the European Union health technology evaluation and have not been updated since the joint clinical evaluation report was issued" shall be added at the end of the text in point (f).
14. in Article 39f (6), the words "if they have not already been submitted in the framework of the European Union evaluation of health technologies and have not been updated since the joint clinical evaluation report was issued" shall be added at the end of the text of point (a).
15. In Article 39f (11) of the Introductory Part of the provision, the words "in the application or in the annexes to the application" shall be replaced by the words "in the application, in the annexes to the application or in the documentation submitted pursuant to Article 10 (2) of the Health Technology Evaluation Regulation, which the Institute shall establish pursuant to Article 13 of the Health Technology Evaluation Regulation in the relevant file," and the phrase "In the proceedings initiated at the request of a participant other than the marketing authorisation holder or from the authority of the Institute prior to the establishment of the dossier referred to in Article 13 of the Health Technology Evaluation Regulation shall be inserted after the first sentence of the said Article 39f (2) or (b) to indicate a part of the dossier submitted as a commercial secret subject, including a justification of that designation."
16. in Paragraph 39r (2), the word "electronically" is replaced by "through the Information System of Medical Devices established under the Law on Medical Devices and Diagnostic Medical Devices in Vitro73."
Footnote 73 reads as follows:
"73) Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices. '.
17. in Article 39r (6), the words "through the Information System of Medical Devices established under the Law on Medical Devices and Diagnostic Medical Devices in Vitro73" shall be inserted after the words "these particulars."
18. The following Section 43a is inserted after Section 43:
(1) The Institute shall supervise the performance of:
(a) obligations under Articles 16b (6) to (8) and 32 (4),
(b) obligations arising from written arrangements pursuant to § 39c (2) (c) and (d);
(c) obligations to provide the medicinal product free of charge pursuant to § 39d (7),
(d) the obligation to compensate for costs incurred for a highly innovative medicinal product or medicinal product intended for the treatment of rare diseases in accordance with a contract concluded pursuant to Article 39d (6) or (7) or Article 39da (8);
(e) the obligation to pay for the competition pursuant to § 39e;
(f) the obligation to supply medical devices pursuant to Paragraph 39v (1);
(g) the obligations imposed in the decision of the Institute pursuant to Paragraph 39v (3); and
(h) the obligations laid down in the decision pursuant to Paragraph 39x (7).
(2) The Institute shall proceed with the inspection under this Act according to the rules of control. The mandates of the staff of the Institute shall be demonstrated in the performance of the inspection activity under this Act by a certificate issued by the Institute, which shall be evidence of their delegation to control or by written authority to control them. ';
19. in Paragraph 44, the following paragraph 7 is inserted after paragraph 6:
"(7) A medical care provider commits an offence by issuing a medicinal product or a food for special medical purposes
(a) they shall not verify the limit of arrears pursuant to Article 16b (6);
(b) requires a supplement contrary to Article 16b (7); or
(c) increase their price in breach of Paragraph 16b (8). "
Paragraph 7 shall become paragraph 8.
20. in Paragraph 44 (8) (c), "paragraph 6 (f) or paragraph 4" is replaced by "paragraph 4, paragraph 6 (f) or paragraph 7."
21. the words "and 7" shall be added at the end of Article 44a (1).
Transitional provisions
1. Until the establishment of the Information System of Medical Devices set up under Act No. 375 / 2022 Coll., on Medical Devices and in vitro diagnostic medical devices, the provisions of § 39r (2) of Act No. 48 / 1997 Coll., as effective before the date of entry into force of this Act, shall apply to the submission of the declaration of the inclusion, disposal or change of the inclusion of a medical device in the reimbursement group, or to the group according to the functional characteristics and intended purpose of the use of essentially interchangeable medical devices within the reimbursement group, if it was created by the State Institute for Drug Control.
2. Until the start of the information system referred to in point 1, Article 39r (6) of Act No. 48 / 1997 Coll., as effective from the date of entry into force of this Act, shall apply to the notification of changes to the reported data affecting the data published pursuant to § 39t (1) of Act No. 48 / 1997 Coll., as effective before the date of entry into force of this Act.
3. In the event of payment of the amount by which the sum of the arrears payable up to the limit is exceeded, the insured person or his legal representative shall, for the period of the calendar quarter immediately preceding the date of entry into force of this Act, proceed with the health insurance undertaking in accordance with Act No. 48 / 1998 Coll., as effective before the date of entry into force of this Act.
Amendment to the Public Health Insurance Insurance Act
Act No. 10 / 1993 Coll., Act No. 15 / 1993 Coll., Act No. 53 / 2004 Coll., Act No. 127 / 2002 Coll., Act No. 61 / 2004 Coll., Act No. 49 / 2002 Coll.
1. In Paragraph 27 (4), the words "in a way that allows remote access' shall be inserted after the words" provided by insured persons' and the words "and the State Institute for Drug Control (hereinafter referred to as" the Institute ') shall be inserted at the end of the text of the paragraph.'
2. In Annex No 2, Part Two, Section H, in point 1, the words "State Institute for Drug Control (" the Institute ')' are replaced by the words "Institute '.
Amendment to the Drug Act
Act No. 378 / 2007 Coll., Act No. 141 / 2009 Coll., Act No. 281 / 2009 Coll., Act No. 291 / 2009 Coll., Act No. 2023 / 2011 Coll., Act No. 375 / 2011 Coll., Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 250 / 2014 Coll., Act No. 251 / 2017 Coll., Act No. 36 / 2018 Coll., Act No. 44 / 2019 Coll., Act No. 65 / 2017 Coll., Act No. 66 / 2017 Coll., Act No. 183 / 2017 Coll., Act No. 251 / 2017 Coll.
1.
(1) For the control activity in the field of medicinal products for human use, the professional precondition for senior staff is the termination of studies
(a) in an accredited medical master's study programme which acquired or acquired professional qualifications for the pursuit of the profession of pharmacist, doctor or dental practitioner;
(b) in an accredited master's study programme which acquired or acquired competence to pursue the profession of veterinarian;
(c) in an accredited master's programme of veterinary hygiene and ecology,
(d) in an accredited master's study programme of chemical or biological orientation; or
(e) in a similar field abroad of at least 5 years of regular study;
and at least 5 years of professional experience in the field of matters related to the requirements of educational attainment referred to in points (a) to (e) in the last 10 years.
(2) For staff of the Institute and of the Veterinary Institute carrying out a control activity (hereinafter referred to as "inspectors'), if not for the control referred to in paragraph 4, checks on manufacturers, operators conducting non-clinical studies on the safety of medicinal products, persons involved in the clinical evaluation of veterinary medicinal products, marketing authorisation holders, health service providers, operators referred to in Article 6 (1) (d) and veterinary surgeons shall be a technical condition for the termination of the studies.
(a) in an accredited medical master's study programme which acquired or acquired professional qualifications for the pursuit of the profession of pharmacist, doctor or dental practitioner;
(b) in an accredited master's programme of study which acquired or acquired competence for the pursuit of the profession of veterinarian (32);
(c) in an accredited master's programme of veterinary hygiene and ecology,
(d) in a master's study programme of chemical or biological orientation; or
(e) in a field similar to that referred to in points (a) to (c), of at least 4 years of full study abroad;
and 2 years of professional experience in the last 10 years in an activity related to the area in which the inspector carries out the inspection activity.
(3) Further completion of the study is a technical condition for carrying out the work of the inspector
(a) in an accredited Master's study programme of science;
(b) in an accredited master's programme of study giving rise to the competence of the profession; or
(c) in a similar study programme abroad of at least 4 years of full study;
and 5 years of professional experience in the last 10 years in an activity which has a bearing on the area in which the inspector carries out the inspection activity.
(4) The professional condition for carrying out the inspection of the performance of obligations under Articles 33 (2), 33 (3) (g) (3) and (4), 33 (3) (j), 33a, 33b (4), 77 (1) (f), (h), (q), (s), 77e (3), 82 (3) (d), 82 (3) (h) and (l), 82 (3) (k) and (l) is to be completed at least in an accredited Master's study programme or in a similar study abroad for at least four years of full study.
(5) In the case of other checks, at least full secondary education33) and 1 year of vocational experience in an activity that is related to the area in which the inspector carries out the inspection activity shall be a technical condition.
(6) Persons carrying out evaluations, checks and decisions under this law or taking part in professional activities in the framework of such evaluations, checks and decisions,
(a) submit to the Institute on request once a year, or prior to the performance of the activity, a declaration of financial, commercial or other relations with operators, marketing authorisation holders or applicants under this Act which could affect their impartiality in the performance of those activities; the declaration shall cover a period of at least 5 years before the declaration is lodged; any changes to the declaration shall be notified without delay; Such declarations shall be made available to the public and to the Agency on request; the details of this declaration shall be taken into account by the Institute in delegating persons to specific tasks in carrying out activities under this Act;
(b) are obliged to maintain confidentiality regarding the information they have become aware of in their activities, in accordance with the requirements of the European Union, the legislation in force and international agreements;
(c) in the case of controls abroad, they must be familiar with the principles of organisation and management of supervised activities in the Member State or third country concerned. "
2. in Paragraph 81 (1) (a), the following point 3 is inserted after point 2:
"3rd margin limit,"
3. in Article 81 (3) (f), the words "to the service referred to in Article 81fd (1) (b) 'shall be inserted after the words" to the service referred to in Article 81fd (1) (b)';
4. In Article 81 (3) (h), the words "the data held in the central repository of the margin limits in relation to its insured persons shall be inserted after the words" covered by public health insurance, "'.
5. The following Section 81fd, including the title and footnote 127, is inserted after § 81fc:
Central storage of margin limits
(1) The central repository of the margin limits is set up within the eRecept system
(a) the collection and storage of data on the amount of the premium payable up to the limit under the Public Health Insurance Act for the prescribed health insurance of partially paid medicinal products for human use or food for special medical purposes issued in the Czech Republic (hereinafter referred to as the "deductible supplement"); and
(b) the provision of a pharmaceutical information service on the state of the limit of deductible surcharges of the insured person on the issue of a partially paid medicinal product or food for special medical purposes.
(2) The Czech Social Security Administration provides the Institute with all up-to-date data on third-degree disability recipients and insured persons who have been recognised as disabled persons in second or third stages but are not beneficiaries of the invalidity pension at its disposal, including the identification details of those persons required to identify them in the basic registers, in order to maintain the central repository of the margin limits in a way that allows remote access. The change of the data according to the first sentence or the data on the newly registered pensioner or insured person according to the first sentence shall be provided by the Czech Social Security Administration of the Institute without undue delay after the creation or amendment of such data; by analogy, the Czech Social Security Administration shall provide such information if the Institute so requests.
(3) The health insurance company provides the Institute with all current data on its insured persons in the range of data held in the Central Register of Insurers pursuant to the Public Health Insurance Act 127 for the purpose of maintaining the central repository of arrears. The information referred to in the first sentence or changes thereto shall be provided by the health insurance undertaking to the Institute without undue delay; by analogy, the health insurance undertaking shall provide these data to the Institute if requested by the Institute.
(4) The Institute shall keep the information held in the central repository of the margin limits for a period of 5 years from the date of expiry of the electronic recipe or from the date of creation of the electronic record of the receipt issued in paper form in accordance with § 81f, on the basis of which the record was made in the central repository of the margin limits. At the end of this period, information from the central repository of the margin limits shall be permanently removed.
(5) The information systems used by the Czech Social Security Administration and the health insurance company to provide the data referred to in paragraph 2 or 3 must be fully compatible with eRecept and correspond to its operational documentation.
127) § 27 (1) of Act No. 592 / 1992 Coll., on the Insurance of Public Health Insurance, as amended. '
6. In Article 81g (5), the words "communicate to the central authority 'are replaced by the words" record in electronic form'.
7. In Paragraph 81g, the following paragraph 7 is added:
"(7) The pharmacy operator shall, when issuing an electronic prescription and transferring data to the electronic form referred to in paragraph 6, immediately record the amount of the deductible supplement, including information on whether and to what extent the supplement has been paid by the patient. ';
8. In Article 103 (10), the word "or 'shall be deleted at the end of point (i).
9. In Paragraph 103 (10), the dot at the end of point (j) is replaced by "or 'and the following point (k) is added:
"(k) has not made an entry in the eRecept system pursuant to § 81g (7) on the amount of the deductible supplement."
10. in Article 107 (1) (b), the words "or (g)" are replaced by the words "or (k)";
Transitional provisions
1. Information on insured persons who have been recognised as disabled in the second or third stages pursuant to Section 81fd (2) of Act No. 378 / 2007 Coll., as effective from the date of entry into force of this Act, the Czech Social Security Administration provides from the first day of the calendar month following the publication of the Communication on the launch of application aid for eRecept. Communication by first sentence will be published by the Ministry of Labour and Social Affairs in the Collection of Laws and International Treaties.
2. Until the first day of the calendar month following the date of publication of the notice referred to in point 1, data on insured persons who have been recognised as disabled in the second or third stages pursuant to Section 81fd (2) of Act No 378 / 2007 Coll., as effective from the date of entry into force of this Act, shall be provided by the State Institute for Drug Control by a health insurance company in relation to its insured persons.
3. The insurer or his legal representative shall, in the period from the date of entry into force of this Act to the first calendar day following the date of publication of the notification referred to in point 1 to the health insurance undertaking in respect of which he is insured, document the recognition of invalidity by copies of the health assessment.
EFFECTIVE
This Act shall take effect on 1 January 2025.
Pekarová Adamová v. r.
Pavel v. r.
Fiala v. r.
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Regulation Information
| Citation | Act No. 338 / 2024 Coll., amending Act No. 48 / 1997 Coll., on Public Health Insurance, and amending and supplementing certain related laws, as amended, Act No. 592 / 1992 Coll., on Public Health Insurance Insurance, as amended, and Act No. 378 / 2007 Coll., on Medicines and Amendments to Certain Related Acts (Law on Medicines), as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 19.11.2024 |
|---|---|
| Effective from | 01.01.2025 |
| Effective until | - |
| Status | Valid |
Parliamentary Paper:
Paper No. 669
The regulation text is for informational purposes only.
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