Legal & Regulatory > Croatia > Regulatory, Pricing and Reimbursement

An intro to the legal situation for regulatory, pricing and reimbursement of drugs in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in Croatia is the Agency for Medicinal products and Medical devices of Croatia (HALMED or Agency).

The legal aspects of the Agency‘s operations are supervised by the Ministry of Health. The Agency submits annual reports on its work to the Minister of Heath and to the Government of Croatia.

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The primary national legislation for the authorization and pricing of medicinal products and biologicals is the Medicinal Products Act (Official Gazette Nos. 76/13, 90/2014, 100/2018), Medical Devices Act (Official Gazette No. 76/13) and its regulations (bylaws).

Authorization of medical devices is not necessary to market a medical device. Requirements that have to be fulfilled in order for the medical device to be placed on the market and administered are set by Medical Devices Act (Official Gazette No. 76/13).

(The criteria for the pricing of medical devices are regulated by the Minister of Health in Ordinance on determination of prices of orthopedic and other aids. Reimbursement of medicinal products and medical devices is mainly regulated by Health Insurance Act and its regulations.)

3. What are the steps to obtain authorization to develop, test, and market a product?

A) MEDICINAL PRODUCT

The Agency or the European Commission grants marketing authorisations for medicinal products in Croatia. For the purpose of placing a medicinal product on the market, its quality, safety and efficacy have to be determined.

The Agency grants marketing authorisations for medicinal products through the national procedure, the mutual recognition procedure and the decentralised procedure by means of the decision which marks the completion of the authorisation procedure carried out in accordance with Medicinal Products Act and ensuing regulations. Croatia can be either the reference state or the concerned state in the mutual recognition procedure and decentralised procedure.

The European Commission grants marketing authorisations based on the centralized procedure in accordance with the provisions of the Regulation (EC) No 726/2004.

Marketing authorisation is also granted for radionuclide generators, radionuclide kits, radiopharmaceuticals, radionuclide precursors and industrially produced radiopharmaceuticals.
When a medicinal product has been granted an initial authorisation for marketing in the European Union, any additional strengths, pharmaceutical, administration routes, types and sizes of packaging, as well as any variations and extensions have to also be granted an authorisation or have to be included in the initial marketing authorisation. All refered authorisations are considered as belonging to the same global marketing authorisation.

Please see chapter about Marketing, Manufacturing, Packaging and Labeling Advertising, question 1 for details on different procedures for obtaining a marketing authorization in Croatia.

Private individuals and business entities seated in Croatia may manufacture intermediate products, medicinal products and/or investigational medicinal products only in accordance with a manufacturing authorization. The manufacturing authorisation is compulsory for:

• a factory where a pharmaceutical and/or a group of medicinal products will be manufactured;
• the entire manufacturing process or certain parts of the manufacturing process, and
• manufacture of medicinal products intended only for exports and/or exit.

Importers of medicinal products from third countries have to obtain a manufacturing authorisation.

For marketing authorization, private individuals or business entities engaged in manufacturing, have to comply with the following requirements:

• given the scope and complexity of manufacture of a medicinal product or a group of medicinal products, an adequate number of qualified persons in the field of pharmacy, chemistry, biology, biochemistry, biotechnology, chemical technology, medicine, dental medicine, veterinary medicine or other corresponding professions are required;
• a qualified person for the release of a medicinal product batch who should be permanently available has to be emoployed;
• key personnel for the manufacture, quality checks and distribution of medicinal products have to be employed;
• suitable premises and equipment requisite for the manufacture, quality control, storage and delivery of medicinal products are required, and
• observation of principles and guidelines of Good Manufacturing Practice is neccessary.

For the purpose of obtaining a manufacturing authorisation, a private individual or a business entity seated in Croatia has to submit a motion to the Agency.

Along with the motion and the evidence about the compliance with the requirements of the Good Manufacturing Practice the applicant has to enclose a file containing the following data and documents:

1. name and head office of the business entity or private individual;
2. evidence of registration within a companies registry;
3. evidence of entry of the activity in the companies registry;
4. evidence of professional competencies and employment contract with a person responsible for the release of a medicinal product batch;
5. evidence of professional competencies and employment contract with the key personnel corresponding to the scope of manufacture;
6. personal data of the person responsible for the release of a medicinal product batch and for the key personnel;
7. data on the premises and equipment for manufacture, quality control and storage of medicinal products;
8. description of the manufacturing process or a part of the manufacturing process of a medicinal product for which the authorisation is applied for, or for other parts of the manufacturing process, such as sterilisation of active substances or excipients;
9. a list of medicinal products and pharmaceutical for which the authorisation is applied for, and
10. master file of the manufacturing site.

In the procedure of granting the manufacturing authorisation, an Agency inspector delivers an opinion on the compliance with the requirements of Good Manufacturing Practice.

The Agency grants or refuses the manufacturing authorisation for a medicinal product within 90 days from the date of receipt of a duly filed motion. If the applicant complies with all the requirements laid down by provisions of Medicinal Products Act and the ensuing ordinances, the Agency grants the manufacturing authorisation for an indefinite period of time.

Clinical trials of medicinal products, including non-profit clinical trials, in Croatia may not commence without a favourable opinion of the Central Ethics Committee and the authorisation of the Ministry of Health. If the Ministry does not authorise or refuses to authorise a clinical trial within the referred period, the authorisation is deemed issued, unless a written approval of the Ministry is required before the commencement of a clinical trial in the case of clinical trials intended for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms, and xenogenic cell therapy.

Clinical trials involving persons with mental disorders cannot start without obtaining a positive opinion from the Commission for the Protection of Persons with Mental Disorders of the Ministry of Justice.

The applicant, who has been approved by the Ministry for conducting clinical trials on the basis of a positive opinion of the Central Ethics Commission and seeking approval for conducting clinical trials in additional legal entities, is obliged to obtain the consent of the Central Ethics Committee for each of the following business entity to be included in the clinical testing, as well as obtaining approval from the Ministry of Health.

The Central Ethics Committee has a period of up to 30 days from the date of receipt of a valid request prescribed in Ordinance on Clinical Trials on Medicinal Products and on Good Clinical Practice to give its written opinion concerning the acceptability of the proposed clinical trial. The Central Ethics Committee has to deliver the opinion to the applicant and to the Ministry of Health in written form. The applicant, after a positive opinion of the Central Ethics Committee is obtained, has to submit a request to the Ministry for the implementation of a clinical trial in Croatia. The Ministry either authorises or refuses to authorise a clinical trial within 30 days of the day of receipt of a duly submitted request. The deadline may be extended by a further period of 90 days where consultations with experts or committees are necessary. In the case of xenogenic cell therapy, there is no time limit for the issuing of an opinion on the acceptability of implementing the clinical trial.

A duly submitted request within the meaning of the above mentiones Ordinance means the submission of a complete set of documents prescribed by this Ordinance.

The Ministry notifies the applicant within 5 days of the receipt of the request, in writing (by electronic means or telefax), if it establishes that the set of documents submitted is not complete. If no notification is given, the request is deemed to have been duly submitted.

The applicant may supplement the request, and the referred period begins on the day of receipt of a duly submitted request. Within this period, the applicant may amend its request before the issuing of a decision of the Ministry of Health. The period may be extended in the case of a clinical trial intended for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms, and xenogenic cell therapy.

If the Ministry does not authorise or refuses to authorise a clinical trial within the referred period, the authorisation is deemed issued, unless a written approval of the Ministry of Health is required before the commencement of a clinical trial in the case of clinical trials intended for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms, and xenogenic cell therapy.

The Ministry shall refuse to authorise a clinical trial for gene therapy if there is risk of changes in the reproductive cell genome of the subject.

The Ministry notifies the applicant about defects in the request and request the documentation to be supplemented. The applicant may make a single amendment to the request.

If the applicant does not submit supplementary documents or a written explanation stating the period of delivery of supplementary documents (by electronic means or telefax) within 5 days of the receipt of the conclusion, the Ministry issues a decision rejecting the request.

The applicant notifies the Ministry of the intention to withdraw a request that was submitted for the authorisation of a clinical/non-profit trial as soon as possible following the issuing of a decision. The notification submitted by electronic means or telefax has to be delivered to the Ministry within the shortest term possible, in writing, with a brief description of the grounds for withdrawing the request.

Where the applicant intends to re-submit a request for authorisation that was withdrawn, the applicant has to state on the request to the Ministry and on the EudraCT Clinical Trial Request Form (hereinafter: EudraCT Form) that the request is being re-submitted in accordance with the Communication from the Commission 2010/C 82/01 — Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1).

The authorisation to conduct a clinical trial, including a non-profit clinical trial, is issued or denied by the Ministry in a decision against which no appeal is allowed, but an administrative dispute may be initiated.

The Ministry has to deliver the authorisation to conduct a clinical trial to the applicant, the Central Ethics Committee, the Agency, the Croatian Institute for Health Insurance, and the pharmaceutical inspection of the Ministry.

B) MEDICAL DEVICES

Specific authorization for manufacture of medical devices is not required.

The manufacturer of a medical device has to, within the period not exceeding 15 days from the start of performing its economic activity, file a motion for entry into the register of medical devices manufacturers kept by the Agency.

Motion for entry into the register of manufacturers of medical devices has to be submitted by:

• the manufacturers of medical devices with their place of establishment in Croatia, and
• the authorised representatives of manufacturers from third countries, who have their seat in
  Croatia.

The decision of the Agency on the entry of a manufacturer of a medical device into the registry of manufacturers of medical devices has to be adopted within the time period of 60 days from the day of the receipt of the complete request.
The authorisation for the clinical investigation of a medical device is issued by the Minister of Health on the basis of the complete documentation and the positive opinion of the Central Ethics Committee.

The authorisation for the clinical investigation of a medical device is given or rejected within a time period of 60 days from the day of the receipt of the complete motion.

Where the minister does not give or reject the authorisation for the conduct of a clinical trial within the time period of 60 days, the authorization is deemed granted.

Medical devices may be made available on the market in other words placed on the market and administered if they meet the essential requirements, if they have been issued a certification of conformity and if they have been affixed the CE marking. The essential requirements for medical devices are regulated by the Minister of Health in an ordinance.

The conformity assessment procedure relating to a medical device is a procedure on the basis of which it is established and assessed whether the medical device or the manufacturing of the medical device meets the requirements laid down by Medical Devices Act and the bylaws adopted pursuant to this Act.
The conformity assessment procedure relating to a medical device establishing its conformity with the essential requirements is conducted in accordance with the classification of the medical product concerned.

Before placing on the market of a medical device the manufacturer draws up a declaration on conformity in respect with the medical device in question and affix the CE marking of conformity.

Business entity or private individual who place on the market of Croatia medical devices classified as Class IIa, IIb and III, in vitro diagnostic medical devices and active implantable medical devices have to notify the Agency thereof within a time period not exceeding 15 days from the day on which these products are placed on the market.

Medical devices may be made available on the market of Croatia only if they do not compromise the safety and health of patients, users and other persons and only if they have been properly manufactured, correctly installed, maintained and used in accordance with their intended purpose.

4. What are the approximate fees for each authorization?

A) MEDICINAL PRODUCTS

The expenses incurred in the process of granting, renewing, amending, transferring and repealing of an authorisation are determined by the Agency, with the consent of the Minister, and have to be covered by the applicant.

An administrative fee of HRK 225 (approx. EUR 30) has to be paid for each pharmaceutical and strength of the drug.

B) MEDICAL DEVICES

Specific authorization for manufacture of medical devices and marketing authorization is not required.

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

The Agency grants marketing authorisations for medicinal products for the period of five years. Not later than nine months before the marketing authorisation ceases to be valid, a motion for its renewal may be submitted to the Agency.

Risk and benefit ratio of the approved drug is once again assessed in the renewal procedure five years after first granting approval. Depending on the outcome of this assessment, the approval may be renewed for an unlimited period or the renewal process has to be carried out again after five years.

Once renewed, the marketing authorisation is valid for an unlimited period, unless the Agency decides, on justified grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, to proceed with one additional five-year renewal.

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

Without prejudice to the regulations relating to the protection of industrial and intellectual property, the applicant for the authorization of generic products is not required to provide the results of pre-clinical tests and of clinical trials, if he can demonstrate that the medicinal product is a generic which is or has been authorised for not less than eight years in an EU Member State based on the centralised marketing authorisation procedure.

Please see chapter about Marketing, Manufacturing, Packaging and Labeling Advertising, question 2 for more information on authorization process of generic products.

There are no differences for local manufactures versus foreign-owned manufactures.

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

Combination products are not particulary regulated.

The provisions of Medical Devices Act apply to any medical device intended for administration of a medicinal product. Where a medical device incorporates a medicinal product as an integral part and where this integral product is intended exclusively for use in the given combination and which is not reusable, the Act on Medicinal Products applies. As far as the safety and performance relate device features of the medical device are concerned, they have to comply with the essential requirements under Medical Devices Act.

Where a medical device make up an integral part an ancillary medicinal substance which may be used separately and acts upon the body with action that is ancillary to that of the device, this medical device has to be assessed under the provisions of Medical Devices Act, whereas the medicinal substance has to be assessed under the Act on Medicinal Products and the relevant bylaws adopted on the basis of the latter.

The provisions of Medical Devices Act apply also to in vitro diagnostic medical devices manufactured from tissues, cells or substances of human origin.

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

A) MEDICINAL PRODUCTS

The supervision of the implementation of the provisions of Medicinal Products Act in respect of medicinal products, investigational medicinal products, active substances and excipients, and especially the supervision of testing, production and manufacture, distribution, brokering, quality control, pharmacovigilance and advertising of medicinal products is carried out by the pharmaceutical inspectorate of the Ministry.

The supervision of the implementation of the provisions of this Act in regard of the production of medicinal products, investigational medicinal products, active substances and excipients, and the supervision of pharmacovigilance is performed by the Agency.

When conducting an inspection, the pharmaceutical inspector and the Agency inspector may:

• inspect business premises, facilities, installations, devices, equipment;
• inspect raw materials, active substances, excipients, intermediate products, medicinal products;
• inspect agreements, records and any other quality system documents or other business documents; if documents are supplied electronically, he may require seeing them and have their printout;
• take copies of documents, subject to making the relevant note in the inspection report;
• take free samples of medicinal products and raw materials for quality control purposes;
• take and use free data from official records and other databases related to persons, if necessary, for inspection;
• remove medicinal products from the market if they do not comply with the provisions of Medicinal Products Act;
• inspect personal documents for the purpose of identification, and
• take photographs or record data on other visual media about persons, premises, facilities, installations, equipment for the purpose of presentation of evidence.

In addition to the above listed rights, the pharmaceutical inspector has the right to exclude from trade medicinal products which do not comply with the provisions of Medicinal Products Act.

The pharmaceutical inspector and the Agency inspector have the right to conduct unannounced inspections.

B) MEDICAL DEVICES

Supervision of the implementation of provisions of Medical Devices Act and the bylaws adopted on the basis of this Act is carried out by the Ministry of Health. The pharmaceutical inspections regarding the implementation of the provisions of this Act and the bylaws adopted on the basis of this Act is performed by pharmaceutical inspectors of the Ministry of Health.

In carrying out the inspection the pharmaceutical inspector inspects the business premises, facilities, devices, equipment and documentation.

The regulatory regime of the European Medicines Agency is generally applicable in Croatia.

9. What is the potential range of penalties for noncompliance?

The potential range of penalties are regulated by the Medicinal products Act and Medical devices Act and depend on the misdemenaour and the perpetrator.

A) MEDICINAL PRODUCTS

In the performance of the inspection, the pharmaceutical inspector has both the right and duty to:

1. order the performance of activities in accordance with the conditions laid down by this Act and other regulations;
2. order the removal of identified irregularities and deficiencies within a specified time limit;
3. prohibit the performance of activities which are contrary to this Act and other regulations;
4. temporarily prohibit the work to any legal or natural person who does not satisfy the conditions in respect of employees, equipment, instruments and rooms;
5. prohibit the work to any private individual or business entity engaged in testing, production and manufacture distribution, brokering and quality control of medicinal products without the Agency’s authorisation or licence;
6. order the ban on placing of the medicinal product on the market:
   – if the medicinal product is falsified;
   – if the shelf life of the medicinal product has expired;
   – if it has been established that the medicinal product is kept or handled contrary to regulations;
   – in the cases where Medicinal Products Act stipulates product suspension and recall, and
   – prohibit the performance of a clinical trial of a medicinal product or the performance of a clinical trial at any individual investigation site if it is not performed in accordance with the provisions of Medicinal Products Act, the ensuing regulations and good clinical practice.
7. file a motion with the Agency for the suspension or recall of the batches which do not comply with the conditions laid down by Medicinal Products Act and other regulations;
8. declare the product which is found defective as waste and order its handing over to the person authorised in accordance with the rules and regulations governing waste management;
9. prohibit the work and submit a proposal to the Agency for the revocation of the authorisation if noncompliance with the conditions laid down by Medicinal Products Act or any other regulation may jeopardise the life and health of people;
10. prohibit the sale of the product if therapeutic indications are given on its immediate or outer packaging and the product is not authorised as the medicinal product or as the homeopathic medicinal product;
11. prohibit the advertising of the product which is attributed medical indications and which is not a medicinal product within the meaning of Medicinal Products Act;
12. prohibit the distribution of the product if it is established that it contains an active substance or a substance related to the active substance and it is not a medicinal product within the meaning of Medicinal Products Act;
13. temporarily suspend the execution of the decision on the marketing authorisation for a medicinal product due to a violation of the provisions of Medicinal Products Act, and
14. order other measures to be taken as authorised by this Act and other regulations.

In the performance of the inspection, the Agency inspector has both the right and duty to:

1. prohibit the work to any private individual or legal entity engaged in the production without the authorisation or the Agency‘s licence;
2. order the performance of activities in accordance with the conditions laid down by Medicinal Products Act and other regulations;
3. order the removal of identified irregularities and deficiencies within a specified time limit;
4. prohibit performance of activities that are contrary to this Act and other regulations;
5. temporarily prohibit working to any private individual or legal entity who does not satisfy the conditions in respect of employees, equipment, instruments and premises;
6. submit a proposal for revocation of the marketing authorisation if the marketing authorisation holder does not operate a pharmacovigilance system, have a person qualified for pharmacovigilance or fulfil other pharmacovigilance tasks laid down by the provisions of Medicinal Products Act, and
7. order other measures to be taken as authorised by this Act and other regulations.

According to Medicinal products Act private individual or business entity is liable to a fine of between HRK 100,000.00 (approx. EUR 13,500.00) and HRK 150,000.00 (approx. EUR 20,200.00) for the misdemeanours prescribed by this Act. For the same misdemeanours responsible persons of business entity are also be liable to a fine of between HRK 10,000.00 (approx. EUR 1,300.00) and HRK 15,000.00 (approx. EUR 2,000.00).

According to Medicinal Products Act private individual or business entity can also liable to a fine of between HRK 70,000.00 (approx. EUR 9,400.00) and HRK 100,000.00 (approx. EUR 13,500.00) for the misdemeanours regulated by the provisions of this Act. For these misdemeanours, responsible persons of business are also be liable to a fine of between HRK 7,000.00 (approx. EUR 900.00) and HRK 10,000.00 (approx. EUR 1,300.00).

Any business entity or private individual who provides incorrect data during the procedure for issuance of the authorisation for entry or import of a medicinal product which has not obtained the marketing authorisation in Croatia is liable to a fine of between HRK 50,000.00 (approx. EUR 6,700.00) and HRK 70,000.00 (approx. EUR 9,400.00). For above-mentioned misdemeanor the responsible person of the business entity is also liable to a fine of between HRK 5,000.00 (approx. EUR 670.00) and HRK 7,000.00 (approx. EUR 900.00).

A medical doctor or a dental medicine doctor who prescribes a medicinal product in respect of which the marketing authorisation has not been granted in Croatia, contrary to Medicinal Products Act and the ordinance, is be liable to a fine of between HRK 5,000.00 (approx. EUR 670.00) and HRK 7,000.00 (approx. EUR 900.00).

Private individual or business entity is liable to a fine of between HRK 30,000.00 (approx. EUR 4,000.00) and HRK 50,000.00 (approx. EUR 6,700.00) in cases regulated by the Medicinal Products Act. The responsible person of the legal person is also be liable to a fine of between HRK 3,000.00 (approx. EUR 400.00) and HRK 5,000.00 (approx. EUR 670.00) for these misdemeanours.

B) MEDICAL DEVICES

In carrying out the inspections the pharmaceutical inspector has the following rights and duties:

• to order particular inspections and investigations relating to the medical device after it has been placed on the market or put into service;
• to order the recall of the medical device from the market or from the service;
• to order proper labelling of the medical device;
• to order the medical device which does not meet the statutory requirements to be properly disposed where this is necessary for the protection of health of humans;
• to order private individual or legal entity the performance of the activity in conformity with the criteria set out by Medical Devices Act and other rules;
• to order rectification of established irregularities and deficiencies with a set time period,
• to order the implementation of other measures in accordance with the powers stipulated under Medical Devices Act and other rules;
• to order suspension or termination of a clinical trial where the latter has not been carried out in conformity with the provisions of this Act and the ordinance adopted pursuant to Medical Devices Act;
• to restrict or suspend placing on the market or putting into service, in other words prohibit the use of a medical device which is not in conformity with the requirements stipulated by the provisions of this Act and other rules adopted pursuant to Medical Devices Act;
• to temporarily prohibit placing on the market, putting into service or advertising of the medical device where there is reasonable doubt regarding the conformity of the medical device with statutory requirements;
• to prohibit placing on the market and putting into service of a medical device where there has been suspected that the medical device or the documentation has been counterfeited;
• to prohibit distance sale for private individual or legal entity of the medical devices via the Internet where it does not meet the requirements stipulated under Medical Devices Act;
• to temporarily prohibit the operation of a private individual or legal entity where they do not meet the requirements stipulated under Medical Devices Act and the rules adopted pursuant to this Act;
• to prohibit the operation of private individual or legal entity where they are engaged in conformity assessment, manufacturing, designing and placing on the market without the authorisation of the Minister of Health, in other words, without having been licenced to do so by the Agency;
• to prohibit advertising of a medical device which is in contravention of the provisions of Medical Devices Act, and
• to prohibit the carrying out of the activities which are in contravention of Medical Devices Act and other rules.

The potential range of penalties is regulated by the Medical Devices Act. A fine in the amount ranging from HRK 70.000.00 (approx. EUR 9,400.00) to HRK 100.000.00 (approx. EUR 13,500.00) is imposed on a business entity and private individual if they commit misdemenours prescribed on the list in the provisions of Medical devices Act. For these minor offences the responsible person in the business entity is also fined the amount ranging from HRK 7.000.00 (approx. EUR 900.00) to 10.000.00 (approx. EUR 1,300.00).

A fine in the amount ranging from HRK 50.000.00 (approx. EUR 6,700.00) to HRK 80.000.00 (approx. EUR 10,700.00) is also imposed on a business entity and private individual if they commit minor offences on the list regulated in provisions of Medical devices Act. For these minor offence the responsible person in the business entity is also fined the amount ranging from HRK 5.000.00 (approx. EUR 600.00) to HRK 8.000.00 (approx. EUR 1,000.00).

10. Is there a national healthcare system? If so, how is it administered and funded?

The national healthcare system is run by the Croatian Health Insurance Fund (HZZO – abbreviation commonly used localy is the Fund’s acronym, or the Fund). The Fund is a public institution. Fund’s rights, obligations and responsibilities are established by the Law on Compulsory Health Insurance and the Statute of the Croatian Health Insurance Fund.

Supervision of the legality of the work of the Fund is performed by the Ministry of Health. The Office is managed by a Governing Board of nine members appointed by the Government of Croatia. The Administrative Council makes decisions and general acts of the Fund.

The work of the Fund is managed by the director The Director of the Fund is responsible for the financial operations of the Fund. The Office conducts the tasks through 7 departments headed by Assistant Directors.

The Fund is established through the Directorate and four regional offices (Zagreb, Osijek, Split, Rijeka), has 16 regional branches and 134 municipal locations. Since 2012 the total number of employees in the Fund was 2,422.

Within the mandatory health insurance, there are about 4,300.000 insured persons (99.7% of the Croatia’s population). Within the supplementary health insurance (also being provided by private insurerres along with the HZZO supplementary health insurance scheme), around 2,500.000 persons are insured.

(The health system of Croatia does not function solely according to a single financing model but is a combination of the so-called Bismarck’s model (based on social security, or contributions that citizens stand out from salaries) and the so-called Beveridge model based on budget revenues, all due to a revenue shortage based solely on Beveridge- this model of financing.)

11. How does the government (or public) healthcare system function with private sector healthcare?

HZZO covers 80% of healthcare costs within the “basket of services” (commonly used reference for a list of services) covered by compulsory health insurance, which includes the right to primary healthcare, specialist-healthcare, hospital healthcare, the use of drugs listed on the HZZO list, healthcare abroad, dental-prosthetic services, surgeries, and orthopedic and other aids. The remainder of the service cost (20%) is compulsory for the insured person to pay. If the amount that the personal insured person pays exceeds HRK 2,000.00 (approx. EUR 175) per hospital account personal insured person pays only up to that amount.

Insured persons may carry out their right to healthcare in health institutions or with private healthcare professionals with whom the Fund has concluded a contract on the implementation of healthcare in the manner and under conditions determined by Compulsory Insurance Act (Official Gazette Nos. 80/2013, 137/2013) and by the general acts of the Fund.

12. Are prices of drugs and devices regulated and, if so, how?

A) MEDICINAL PRODUCTS

The Croatian Health Insurance Fund publishes an annual calculation of the cost of medicines on its website.

The procedure for determining the prices of medicinal products is carried out according to the Ordinance on standards and the manner of determining the prices of wholesale medicinal products and the manner of reporting on wholesale prices (Official Gazette Nos. 83/2013, 12/2014, 69/2014, 22/2015, 84/2015).

HZZO is obliged to conduct the procedure of the public procurement for the determination of the prices of medicines that are already on the valid basic and supplementary list of HZZO medicinal products in accordance with the provisions and according to the prescribed procedure established by the said Ordinance if medicines are found in the current lists of HZZO drugs different prices within the reference groups.

HZZO sets out the medicines in the defined groups and subgroups. The level of drug cost for the HZZO is established depending on which drug has 5% of turnover for the last 3 months.

After the publication of the public bid on the HZZO website, there is a possibility of appeal. Approval holders has to submit their responses on the published prices.

After the decisions are made on the complaints filed and based on the submitted responses of the Approval Holder to accept / not accept the reference price for each medicine, HZZO begins the preparation of a full list of pricelist prescription drugs.

The medicines are classified into the basic and supplementary list of medicines and as such, HZZO immediately instructs the HZZO Governing Board to make final decisions on the acceptance of medication prices (then the proposals for the adoption of the Decision on the establishment of the basic list of medicines and the Decision on the establishment of supplementary lists of medicines are prepared).

The basic list of medicines includes medicines which prices are at the reference price level or lower; the supplementary list includes medicines whose price level is higher than the reference price. No drug price needs to be “unalterable” if there is some justification for the deviation from the said Ordinance, because it is permissible for the approval holders to propose, with detailed explanation, a higher cost price for which the consent of the Minister of Health is necessary.

The entire bidding procedure for the basic and supplementary list of medicines usually lasts several months from the first decision to the decision on the final price in the lists, to over a year.

B) MEDICAL DEVICES

The criteria for the pricing of medical devices are regulated by the Minister of Health in Ordinance for the determination of prices of orthopedic and other aids.

The prices are determined by legal entities or private individuals with a registered office in Croatia who are licensed for the marketing of medical devices and who are the holders of the entry in the medical device and the medical device manufacturer’s records at the Agency.

Measures for determining prices are as follows:

• the existing price of aids in Croatia;
• comparative prices in other countries, and
• health and economic analysis.

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

The Croatian Health Insurance Fund covers 80% of healthcare costs within the “basket of services” covered by compulsory health insurance, which includes the right to primary healthcare, specialist-healthcare, hospital healthcare, the use of drugs listed on the HZZO list, healthcare abroad, dental-prosthetic services, surgeries, and orthopedic and other aids. The remainder of the service cost (20%) is compulsory for the insured person to pay. If the amount that the personal insured person pays exceeds HRK 2,000.00 (approx. EUR 175) per hospital account personal insured person pays only up to that amount.

Additional health insurance is intended to provide for a higher standard of healthcare than that provided under the mandatory health insurance scheme, and for broader rights than those provided under the mandatory health insurance scheme.

The medicines are divided into two lists: the basic for which the costs for medicines are fully covered by HZZO and the supplementary for which part of the cost is covered by the HZZO, and the remainder of the cost the insured person or supplementary insurance of the insured person.

The Croatian Chamber of Pharmacists regulates pricelists and compulsive margins for medicines and for most over the counter medicines and medical devices.

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Retail sale of medicinal products or medical devices can be carried out by private individual and business entity authorised to engage in pharmacist activity in accordance with a special act as well as by specialised retail stores authorised by the Agency to engage in retail sale of medicinal products or medical devices. (If the patient is insured by the Croatian Health Insurance Fund and the product is included in the list of products of the Fund, the product is compensated by the Fund in the extent enacted by the applicable legislation.)

Decision on the method of calculating the retail prices of medicinal products and other medicines that are not part of the treatment with HZZO, which sets out how to shape retail prices of medicines, regulates that the lowest number of margins is 10% and the highest is 35%.

Particular medical devices may be sold outside the pharmacy stores and specialised retail stores selling medical devices. The list of the reffered medical devices has to be drawn up by the Agency and made available of the web site of the Agency.

Medicinal products subject to medical prescription can be dispensed exclusively in pharmacies, while medicinal products not subject to medical prescription can also be dispensed in specialized retail sale outlets for medicinal products in line with the marketing authorisation granted by the Agency. If the medicinal product can be dispensed in specialized retail sale outlets for medicinal products, the Agency may determine restrictions in respect of its strengths and pack sizes.

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

A specialized shop has to employ a responsible person of the appropriate professional qualifications.

The responsible person in specialized shops for retail of medical devices performs the following tasks:

• procurement, receipt, warehousing and keeping of medical devices;
• sale of medical devices;
• informing, advising and familiarising customers with the proper use of medical devices, and
• keeping records on the quantities and types of medical devices.

The responsible person in specialized shops for retail of medicinal products is a pharmacist holding a master’s degree.

The responsible person is responsible for:

• procurement, takeover, warehousing and storage of medicinal products;
• issuance of medicinal products to the end user;
• notification of users on the manner of use of the medicinal product, precautionary measures
  and possible adverse reactions;
• keeping records on the type and quantity of medicinal products;
• keeping records on the storage of medicinal products that require special storage conditions;
• reporting of adverse reactions of medicinal products, and
• drafting the annual report on consumption of medicinal products.

A pharmacist holding a master’s degree is obliged to apply his knowledge to all patients in accordance with Code of Pharmacy Ethics and Deontology. Pharmacist has to be fully involved with other health professionals in training and providing guidelines for safe and rational use of medicines. The activity of pharmacist is public, their relation toward all patients has to be the same.

A pharmacist holding a master’s degree is obliged to apply its knowledge and art to all patients in accordance with Code of Pharmacy Ethics and Deontology. He has to perform his work conscientiously, with respect for man and his life.

Pharmacists are sometimes obliged, in the interest of the health of the patient, to refuse to issue the medicine. If such medicine is issued on prescription, it is mandatory for the pharmacists to seek for a medical advice. Pharmacists issue over the counter medicine at their own risk.

Pharmacists are obliged to:

• treat all patients with the same sense of responsibility;
• recommend such methods of treatment, medicines and other preparations whose use is ethical and professionally advocated;
• to advise all patients on the most appropriate way within his knowledge and if necessary, timely refer them to the physician’s care;
• to deny the issue of medicines in the event of a legitimate suspicion that the patient will use the medicine in a manner which would harm his or her health, or
• to make unlawful gain.

All that a pharmacist, performing his pharmacy duty, learned about a patient is considered a professional secret.

The Chamber of pharmacists will institute disciplinary proceedings against each pharmacist that violates the provisions of the Code through the Disciplinary Chamber.