2.7. Regulation

The legislative and regulatory framework for the health care system in Slovenia begins with the Constitution of the Republic of Slovenia (1991) which defines fundamental rights related to health: the right to health care, freedom of choice in family planning and the right to a healthy living environment. Slovene legislation is harmonized with that of the EU and applies nationally.

Two acts, the Healthcare and Health Insurance Act (1992) and the Health Services Act (1992), further define the health care system, and are supported by the Medical Services Act (1999), Pharmacy Practice Act (2016), Patients’ Rights Act (2008), and Healthcare Databases Act (2000). Other health-related areas are also regulated by legislation, but will not be discussed here.

2.7.1. Regulation and governance of third-party payers

Third-party payers are the ZZZS and VHI companies (see section 2.2). ZZZS is regulated by the Government and Parliament and monitored by the MoH. VHI activity is regulated by the Ministry of Finance and monitored by the Insurance Supervisory Agency (see section 3.5).

2.7.2. Regulation and governance of provision

Table2.2 provides an overview of the regulation of providers.

Table2.2

Health care providers are categorized as individual (e.g. medical doctors, nurses, dentists, physiotherapists, pharmacists and other) or institutional providers (e.g. CPHCs, hospitals and rehabilitative centres). Individual providers are regulated by professional chambers, while institutional providers are regulated through legislation adopted according to the policies of the MoH. The Medical and the Pharmaceutical Chambers have high levels of self-regulation and autonomy. They have control over professional advancements, including professional auditing and licensing of physicians, dentists and pharmacists, and are responsible for supervising, monitoring and ensuring quality of care as defined by relevant legislation (e.g. Medical Services Act (1999) and the Pharmacy Practice Act (2016)). Other professional associations (see section 2.2) play an important role in organizing professional (postgraduate) training, adopting and monitoring implementation of professional instructions.

CPHCs and hospitals are managed by directors under supervision of the council of the respective institution. Councils consist of representatives from the MoH or the municipalities, patient representatives and a representative from ZZZS.

Annual partnership negotiations between providers, represented by the Association of Health Institutions of Slovenia, and the payer (ZZZS) define and specify national guidelines and priorities, culminating in a General Agreement (and its annexes) (see section 3.3.4). Individual contracts between ZZZS and providers follow the General Agreement and specify the type and volume of services to be provided, the cost and/or prices of services, methods of payment, quality requirements and conditions for monitoring contract implementation, and the individual rights and responsibilities of the contracting parties. Some services (e.g. magnetic resonance imaging (MRI) and computed tomography (CT) scans, dialyses, transplantation and some outpatient services; see section 3.7) are paid with no caps; however, payments for most health services are prospectively defined and capped; those provided above the determined threshold are not reimbursed by ZZZS (see section 3.3.4). If ZZZS and a provider do not reach a consensus within the framework of the General Agreement, both parties may initiate an arbitration process. The MoH is the key arbiter in this case and has final decision-making power.

Most private providers are contracted by ZZZS based on a concession for inclusion in the network of publicly financed health care providers (with certain restrictions). Once a concession is granted, providers approach ZZZS to define the terms of the contract regarding provision, extent and reimbursement. The contract with ZZZS endows the same rights and obligations as public providers, except that private providers cannot apply for public funds for capital investments. Concessions are for practitioners seeking reimbursement for their services by SHI and/or VHI and only apply to the specific services. Non-concessionaires may offer services to patients who purchase supplementary VHI (e.g. for specialist visits outside the public network or to circumvent waiting times) or pay out of pocket.

Municipalities are responsible for regulating primary health care services. Most providers are contracted by ZZZS and are employed in CPHCs, with a small number working in private practice as concessionaires. The system of concessions and relevant legislation was updated in 2017 in line with the National Health Care Plan 2016–2025 (Government of the Republic of Slovenia, 2016), particularly around transparency and better regulation and supervision by the MoH.

2.7.3. Regulation of services and goods

Basic benefit package

All residents of Slovenia are entitled to essential and other medical and care services, medication and devices, as codified in the Health Care and Health Insurance Act (1992). There is a list of services fully covered by the statutory system (section 3.3). The benefits package is determined annually through the determination of the General Agreement between stakeholders (see section 3.3).

Health technology assessment

No formal health technology assessment (HTA) has been established yet in Slovenia. To date, the introduction of new technologies into the SHI system has been ad hoc and, as a result, providers have considerable leeway in terms of which services they can provide for reimbursement by insurance. Despite the initiatives put forward mainly by the NIJZ, JAZMP and other stakeholders in recent years, only elements of HTA are considered in pricing and reimbursement decisions.

ZZZS as a purchaser is consistently involved with the evaluation of pharmaceutical products. Once marketing authorization has been granted (see section 2.7.4), pharmaceuticals are systematically evaluated for placement on one of three lists of medicinal products – the positive, intermediate or negative reimbursement list (see sections 2.7.4 and 5.6).

Recent attempts have been made to introduce parts of HTA systematically, which reflect a general intention of Slovenia to integrate the European endorsement of HTA (Directive 2011/24/EU) into policy. For example, the MoH has introduced standards for medical premises and equipment and measures for assessing new treatment methods. Additionally, in 2015, a protocol to evaluate proposals for the funding of new diagnostics, treatments, procedures and therapies was adopted. Here, the Health Council appraises proposals using a questionnaire informed by HTA principles. Approved proposals are discussed by the MoH, ZZZS and providers, with reimbursement of the new intervention negotiated on a yearly basis. These processes, however, have not yet been fully implemented and are mostly ad hoc.

NIJZ and the Institute for Economic Research are involved in the European EUnetHTA Joint Actions 1 (2010–2012), which put into practice effective and sustainable cooperation on HTA in Europe, and Joint Action 2 (2012–2015), which strengthened the practical application of tools and approaches to cross-border HTA cooperation. From 2016–2020, the MoH together with NIJZ and JAZMP also collaborated and contributed to EUnetHTA Joint Action 3 to build on the lessons, successes and products of the previous actions.

2.7.4. Regulation and governance of medicinal products

The Medicinal Products Act (2014) and Medical Devices Act (2009) regulate all products used for the diagnosis, prevention, monitoring, treatment and alleviation of diseases, disorders, disabilities, anatomical functions or physiological processes, while the Pharmacies Act (1992) regulates the provision and organization of pharmacy services and activities. The MoH acts as the regulator of medicinal products, medical devices and pharmacy services in Slovenia. JAZMP is the competent authority for medicinal products and medical devices, overseeing tasks pertaining to marketing authorization, distribution, post-marketing evaluation and vigilance for pharmaceuticals (and medical devices). It also has an inspection function for clinical trials and pharmacy services and cooperates with other EU Member States and the European Medicines Agency (EMA).

In accordance with European legislation, medicinal products must obtain marketing authorization prior to their placement on the market, with some exceptions. Generally, there are four procedures to apply for marketing authorization: the national procedure; mutual recognition procedure; and the two methods via the EMA, the decentralized procedure and the centralized procedure. In the national procedure, JAZMP checks whether the quality, safety and efficacy of the medicinal product in question have been proven, and whether the risk–benefit ratio for use is favourable. JAZMP also decides on the prescription status (available over the counter (OTC)/by prescription/by restricted prescription) and the terms of supply (pharmacies only/non-pharmacy outlets and pharmacies) of the product. Medicinal products with marketing authorization are registered in the online database of medicinal products (www.cbz.si).

After market access has been granted by national procedure, the applicant may apply, through the mutual recognition procedure, to be recognized in other EU/European Economic Area (EEA) Member States. The applicant may also choose to seek authorization separately from all Member States (decentralized procedure) or apply directly to the EMA for a single authorization, evaluation and authorization throughout the EU (centralized procedure).

Marketing authorization is generally issued for five years, after which a renewal must be applied for. Authorization can also cease to be valid when the product is no longer on the market or at the request of the marketing authorization holder. For reference products, patent protection is granted lasts 10 years, with a possible one-year extension for new indications.

Pharmacovigilance is governed by the Medicinal Products Act (2014) and the “Rules on pharmacovigilance of medicinal products for human use”. A product’s marketing authorization can be suspended or withdrawn by JAZMP or the EMA following negative pharmacovigilance findings. JAZMP is responsible for the monitoring and acting on issues of quality and safety related to all medicinal products used in Slovenia. It evaluates and reports on adverse reactions, performs risk assessments, adopts and implements measures for the safe use of medicinal products, and encourages reporting of adverse events by medical professionals. The Inspection Department of NLZOH samples medicinal products for quality control, pharmacovigilance and good clinical practice inspection, performs on-site inspections of marketing authorization holders, wholesalers, pharmacies and other retailers and is responsible for the management of measures in cases of inadequate quality, suspected counterfeits and other emergencies. Further, JAZMP participates in activities within the international pharmacovigilance system.

Distribution of medicinal products

JAZMP grants authorizations for the wholesale trade of medicinal products. There are 85 authorized wholesalers currently. The mark-up for wholesalers is not fixed; the same applies to retail stores selling OTC products. The price margin of OTC products sold in a retail setting is determined by the pharmacies themselves; prices of prescribed drugs reimbursed by ZZZS are defined by negotiation between ZZZS and manufacturers.

OTC products can also be obtained at online retailers, though the online sale of medicinal products is only allowed with JAZMP or EU authorization.

For acute diseases, physicians may prescribe medicines for up to 10 days. When longer-term treatment is necessary, a prescription can go for a maximum of 30 days; however, in exceptional cases and for specific indications, medicinal products can be prescribed for up to three months. Physicians may choose to prescribe pharmaceutical products either by their trade names or their generic equivalents.

EU Directive 2011/62/EU established an obligation to affix security features to all prescription-only medicinal products to prevent entry of falsified medicinal products into the legal supply chain. Security features comprise, for example, unique labelling and anti-tampering measures. A European-wide archive system, including an EU Hub and national and transnational archives, stores security information and enables the verification of authenticity of medicinal products. In Slovenia, the Institute for the Authentication of Medicinal Products was established in 2016 for this purpose.

Pricing

Parameters of pharmaceutical pricing and reimbursement are outlined in the Medicinal Products Act (1992) and the Health Care and Health Insurance Act (1992) and their implementing regulations. These were amended in 2008 to comply with the EU Directive 89/105/EEC, though the pricing model and relevant policy-making remain within Slovenia’s jurisdiction.

For medicinal products not financed from public funds, prices are set freely based on market mechanisms. Price setting for products reimbursed in the public system is regulated by JAZMP, which determines maximum prices. An external price referencing system, with Austria, France and Germany as reference countries, is used. Actual prices may be lower than the maximum-set price following agreements between the manufacturer and/or wholesaler and public payers (e.g. ZZZS, pharmacies, hospitals), or because of public tendering procedures. Only in exceptional cases can a price be set higher than the maximum price.

Since 2003, a system of maximum attributed value (MAV) for mutually interchangeable medicinal products (MIMPs) has been in place in Slovenia for products that no longer hold market exclusivity. JAZMP officially lists pharmaceutical products as mutually interchangeable based on their essential similarity in accordance with the Medicinal Products Act (1992). ZZZS creates MIMP clusters and defines MAVs (updated every 6 months) based on the lowest wholesale price among the mutually interchangeable products.

In 2013, the MAV system was extended to “therapeutic groups of medicinal products” – clusters of pharmaceuticals composed of different molecules but having the same effect. For each group, an MAV is determined according to the most favourable ratio of treatment costs and effects. All pharmaceuticals in a group are reimbursed by SHI only up to a level corresponding to the price of the cheapest molecule. When the manufacturer’s price exceeds the MAV set for each MIMP cluster or therapeutic group, the difference must be paid by patients out of pocket.

Substitution

Both physicians and pharmacists are required to inform patients appropriately about generic prescribing and substitution. Patients for whom a product with a price higher than the relevant MAV has been prescribed may choose to either pay the difference out of pocket or to receive a generic product without co-insurance (in the form of co-payment). For all chemical entities, there is at least one medical product available without additional co-payment. Pharmacists are permitted to dispense a cheaper product from the MIMPs system and are required to offer patients a choice among the pharmaceuticals available for substitution. Prescribers may explicitly exclude pharmacy-level substitution on the prescription but should be able to present justification for this decision. Records of dispensed substitutions at pharmacy level enable tracking for prescribers, payers and regulators.

Reimbursement

Reimbursement of medicinal products from public funds falls within the competence of ZZZS. A Pharmaceutical Reimbursement Commission provides recommendations on reimbursement level. Criteria include effectiveness, costs and cost–effectiveness. ZZZS ultimately places products on a positive or negative list. SHI covers all medicinal products on the positive list fully (medicines prescribed for children and specific conditions, such as diabetes, cancer, multiple sclerosis and epilepsy) or with a 30% co-payment; 10% of the price of products on the intermediate list is covered. Co-payments are covered by complementary VHI or paid out of pocket. War veterans, prisoners and socially vulnerable people are covered by the state budget. A negative list includes products completely excluded from public reimbursement; patients must pay for these products in full and out of pocket. Physicians working in the public network use a system of green and white prescriptions when prescribing from the positive/ intermediate list or the negative list, respectively. Private physicians without a concession may only issue white prescriptions.

2.7.5. Regulation of medical devices and aids

To enter the market, medical devices must obtain a CE (conformité Européenne) mark from a notified body, in line with national quality and safety requirements of regulations and EU Council Directive 93/42/EEC. The Medicinal Products Act (2014), which corresponds to Council Directive 93/42/EEC, regulates the field of medicinal products. As the relevant competent authority, JAZMP has regulatory and supervisory functions over the Slovene medical device market, including activities related to the classification of products, the verification of essential requirements for marketing authorization, clinical investigations of medical devices and the medical device vigilance system. JAZMP supervises manufacturers or their authorized representatives as well as wholesale and retail suppliers to ensure that they adhere to national and EU legislation. It maintains several public registers on medical devices production and trade, such as the Register of Medical Device Manufacturers and of Business Entities Carrying out Wholesale Trade in Medical Devices.

For information on the investment in and procurement of medical devices see sections 2.4 and 4.1.2.