Keynote abstract
Facts about Croatia
Croatia is a Central European country, which gained its independence and sovereignty in May 1991. It covers an area of 56,600 sq. km and has about 4.4 million inhabitants. Proprietary structure comprises private and state ownership. In 2006 the gross domestic product per capita was 7,706 €, with a growth rate of 4.8%, and the total health expenditure amounted to 8% of GDP. Croatia opened negotiations for the accession to the EU in autumn of 2005.
Health care and medicines
The health care system has been mainly regulated by the Health Care Act (revised in 2003) and Health Insurance Act (revised in 2004). The legislation was supplemented in 2003 with the following new Acts: Act on Drugs and Medical Devices, Act on Pharmacy, Act on Medical Practice, Act on Dental Practice, Act on Medical Biochemistry (Laboratory) Practice, and Act on Nursing Practice, as well as a number of by-laws.
This legislation enabled establishment of privately owned institutions in the area of health care and pharmacy services.
Act on Drugs and Medical Devicesdefines the demands on drugs, medicaldevices, and homeopathic products, defines the domain of the Agency for Medicinal Products and Medical Devices, which was founded in 2003.
Preparation of a new Act on Drugs, harmonised with the EU legislation, is just in course.
Act on Pharmacy (first in recent history) defines pharmaceutical activities in community and hospital pharmacies, galenic laboratories and quality control laboratories, defines pharmaceutical profession, rights and obligation of pharmacists and pharmaceutical technicians and defines the domain of the Chamber of Pharmacists.
The health legislation has not been completed yet, what causes some current problems in the health care and especially in the pharmaceutical sector. As the reform of the health care system is currently in progress, positive changes are expected.
Life expectancy in Croatia is 74.73 years for both sexes (women 78.23 years, men 71.17 years). About 15 % of the population are older than 65 years. The death rate is equal to the birth rate, and the cerebro-vascular diseases and malignancies are the leading causes of death.
Besides prolongation of life expectancy, major goals of health policy also include improvement of the quality of living. Along with further improvement and development of health services, this involves promotion of healthier ways of living, reduction or elimination of preventable health risks, and improvement of the quality of living of chronic patients and disabled persons.
Health care is provided through state- or county-owned health institutions as well as private health institutions. Croatia has 75 hospital institutions: 2 university hospitals, 14 clinical hospitals and clinics, 23 general hospitals, 29 special hospitals and 7 health resorts.
Average per capita spending on health care is ~ 550 €, while average per capita expenditure on medicines is ~150 €.
Every citizen in Croatia is entitled to basic health care insurance. The Croatian Institute for Health Insurance (CIHI) is the main health insurance institution and is entirely state-owned.
15.5% of each employee’s salary is allocated to basic health insurance. The private initiative through supplementary and extra insurance is foreseen, but only the first steps have been made in this area to date.
There are two positive lists of drugs that may be dispensed with remuneration by CIHI to pharmacies. The drugs on the Basic list are completely remunerated, and for those on the Additional list patients´ co-payment is needed.
There is also a hospital list of drugs that may be dispensed to in-patients and are remunerated by CIHI to hospitals.
The Ministry of Health and CIHI determines prices of reimbursed medicines.
The total number of registered medicines in Croatia, including all formulations and presentations, comes up to 3700. Dispensing of non-registered drugs is possible only through import based on individual prescriptions.
The market share of the national pharmaceutical industry is about 35% in value and about 50% in packages. There are about 20 drug wholesalers, among which the 4 biggest ones hold above 90% of the market.
As fundamental problems in the health care system the following can be identified:
the financial insolvency of CIHI and the debt of the health system, inappropriate system of planning and management, irrational and ineffective use of health care services, unrealistic expectations of insured persons and health professionals concerning level and span of care that can be financed by the economy, undeveloped system of quality control, the lack of maintenance and investments, too many nonmedical stuff, informal payments.
PHARMACY
Community pharmacy
At the end of 1990 the first legislative act on private ownership within the health care system entered into force, while the first private community pharmacy was founded in January 1991. The Act of 1993 enabled establishment of pharmacy chains and the owner of such chains need not be a pharmacist. In 1996, legislation on gradual privatization of the existing state-owned pharmacies was passed, involving leasing a pharmacy to all employed pharmacists who had continually worked in that pharmacy for at least three years (group practice). It was planned for this model of privatization to be implemented by 1999; however, there was a gap between the foreseen schedule and implementation. The whole process has been prolonged and privatization of state-owned pharmacies has not been completed to date.
The total number of community pharmacies today is 970 (1-pharmacy/4550 inhabitants) with the following proprietary structure: private 63%, private-leased 14%, and state-owned 23%.More than 60% of pharmacies operate in pharmacy chains.
Pharmacy network is demographically and geographically regulated.
The demographic criterion is 1 pharmacy per 3000 insurants of CIHI, every following pharmacy per 5000 insurants of CIHI.
Geographic criteria are: minimal distance between pharmacies in cities >500,000 inhabitants = 200 m, in cities 100,000-500,000 inhabitants = 300 m, in cities <100,000 inhabitants = 500 m).
Applicable regulation now prescribes 80-sq. m as the minimal area for a pharmacy. On average, a pharmacy employs two pharmacists and 1 pharmacy technician.
From 2300 pharmacists permanently employed in health care, 44% are working in state
owned institutions (community and hospital pharmacies), 27% in private pharmacy institutions, and 29% in private pharmacies (including leased-pharmacies).
About 65% of pharmacy turnover refer to dispensing prescription medicines to the debit of CIHI. In 1994, the Croatian Health Insurance Institute introduced a points-system (service fee), rather than a margin for reimbursing pharmacy services (recalculated to margin it amounts to 6-7%). A degressive margin system is applied for non-reimbursable drugs and OTC medicines and may amount to 35%. VAT on reimbursable medicines is 0%, and for other drugs 22%.
Contracted reimbursement time is 120 days, but in reality it may take up to 280 days.
Drug dispensing is restricted to pharmacies. OTC medicines are dispensed mainly through pharmacies, but some OTC medicines can be dispensed in specialised retail shops (under permission of health authorities). Only pharmacists can dispense prescription medicines, while dispensing of OTC can be also done by pharmaceutical technicians.
Hospital pharmacy
There are 52 hospital pharmacies in Croatia administering only in-patient services, and they are not foreseen for privatization. Development of hospital pharmacies does not comply with the needs of modern health care and they are increasingly turning into warehouses and distribution services for hospital wards. Staff structure is also rather poor, due to shortage of pharmacists and low salaries, and no prospects of advancement.
Basic and continuing pharmacy education
Until 2004/05 academic year, university studies of pharmacy were organized in 8 terms (4 years) at the Faculty of Pharmacy and Biochemistry, University of Zagreb, which is the only Faculty of Pharmacy in Croatia. Starting with 2005/06 academic year, the new five-year curriculum, harmonized with the Bologna Declaration, is applied.
Number of pharmacists graduating each year is about 130.
Until now, after completing the 4-year long course of pharmaceutical studies at this faculty and the one-year practice in a pharmacy, the pharmacist has to pass the state exam to obtain the first licence - approval for independent practice, granted by the Croatian Chamber of Pharmacists. The said one-year practice in a pharmacy has a strictly defined program of work and skills acquisition (8 months - drug dispensing practice in a community pharmacy, 2 months - preparation of extemporaneous and galenic medicines, 1 month - hospital pharmacy practice, and 1 month - analytical laboratory practice). The state exam comprises a professional and a legal part and is taken before the Examining Board of the Ministry of Health.
Pursuant to the Health Care Act, the licence for independent work of pharmacists (issued by the Croatian Chamber of Pharmacists) has been obligatory since 1996/1997, and the licence has to be renewed every 6 years. During that period the pharmacist has to take part in continuing education, and in case he fails to fulfil this obligation, the level of his professional knowledge is evaluated by a special exam. The following forms of continuing education are foreseen: training courses, workshops, seminars, symposia, conferences, congresses, lectures, projects, as well as publishing scientific and professional papers. A points-system has been introduced for systematic monitoring of participation in education. A special Board for Continuing Education of the Pharmaceutical Chamber assigns points to the offered programs and forms of continuing education, mainly organized by the Croatian Pharmaceutical Society and Faculty of Pharmacy, and sometimes by medical associations and pharmaceutical companies. Points are also granted for attendance at educational or training events abroad. Pharmacists have to collect at least 30 points, or 5 points per year, during a 6-year period.
Education of pharmaceutical technicians lasts 4 years at the Secondary Pharmaceutical School. After finishing school, technicians who want to work in community or hospital pharmacies must complete one-year practice in a pharmacy and pass the relevant state exam.
Pharmacists’ workplaces
Today there are about 2900 pharmacists in the workforce, employed in: community pharmacies - 75%, hospital pharmacies - 4%, domestic industry and representative offices of foreign pharmaceutical industry - 10%, wholesalers - 5%, education - 2%, health institutions - 2%, other - 2%.
National pharmaceutical associations
There are two professional organizations. The Croatian Pharmaceutical Society (founded in 1858, under this name until 1946) is responsible for professional development, including continuous education of pharmacists (voluntary membership). Main tasks of the Croatian Chamber of Pharmacists (founded in 1995) are to represent the pharmacy profession, negotiate with health and insurance authorities about the pharmacists’ working conditions and to monitor the pharmacists’ adherence to ethical principles (mandatory membership for community and hospital pharmacists).
Concluding remarks
The problems that adversely affect the operation of community and hospital pharmacies in Croatia today are the insolvency and delayed reimbursement by the National Health Insurance, along with other economic difficulties in the last few years. There is also incompleteness or imprecision in a part of the legislative framework pertaining to pharmacy and an inadequately low service fee for dispensing prescription medications. All that, including lack of monitoring and inspection, puts to test the ethical principles of the profession.
Overall predominance of private ownership in the public pharmacy sector should be only a question of time. The leasing model was accepted as a necessity in the initial privatization stage but it is expected that a comprehensive model of full privatization of state property in the pharmacy sector will be put forward soon. The authorities should also accept the requirement of the profession that only a pharmacist may be the owner of a pharmacy.
Stabilization of economy, health reform and further democratization, as well as amendments to pharmacy legislation, should rapidly bring Croatian pharmacy practice closer to the model and standards of pharmacy organization and operation in the European Union.
