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Slovenian Complementary Health Insurance Reform – Dichotomy between the Internal Market and the Social Dimension

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Nikolić B.

DANUBE: Law and Economics Review

2015

vol. 6

issue 4

205-216

Complementary health insurance is divided between the internal market (market principles) and social dimension, wherein the state has an extremely difficult task, as it must create the conditions necessary for the fair and efficient functioning of the health care financing system. Slovenia has failed to successfully accomplish this task, which consists of both ensuring the social dimension and also facilitating the operation of market principles. The aim of this article is not on the functioning of market principles, which are covered by the field of economics, but is instead on analyzing the dichotomy between the internal market (the rules that govern the functioning of the internal market) and the social dimension (the rules that enable the exercise of the social function), and, in this light, analyzes the legal regulation of the Slovenian complementary health insurance. Analysis of the legal regulation highlights the shortcomings in ensuring the social dimension, shortcomings which are, with the help of the measures proposed in the concluding section of the article, remedied by the author.

EU Medical Device Regulation – The Level of Convergence and Impact on Regulatory Complexity

63%

Gavrilović Jankovič N., Nikolić B.

Review of European and Comparative Law

2024

vol. 57

issue 2

249-268

Medical Device Regulation (MDR) entered into force in 2017 and became applicable in 2021. In the context of Europeanization and the European Union (EU) multilevel governance system, regulations are used as a means of unification. EU has gradually increased the degree of convergence in medical devices, even though medical devices pertain to the health sector, which is within the Member States’ competence. Despite MDR being a regulation, its preamble states that its aim is to harmonize rules for the placing on the market and use of medical devices on the EU market. This article analyzes the level of convergence introduced by the MDR and its impact on regulatory complexity. Our findings demonstrate that many relevant elements, such as mandatory CE marking, reached the level of unification, whereas some that are still to become legally effective, such as the European database on medical devices (EUDAMED), went further and reached the highest level – supranational and integral joint administrative capacities. Unlike the expected inverse correlation between EU convergence and regulatory complexity, our findings revealed that due to delays in bringing into effect certain unifying elements, de facto, MDR introduced additional constraints compared to the previous Medical Device Directive (MDD) framework. This leads to the main finding of this research, which is that the MDR convergence increase has led to a conflicting outcome – an increase in regulatory complexity.

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1 DANUBE: Law and Economics Review

1 Review of European and Comparative Law

2 Nikolić B.

1 Gavrilović Jankovič N.

1 2024

1 2015

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Slovenian Complementary Health Insurance Reform – Dichotomy between the Internal Market and the Social Dimension

EU Medical Device Regulation – The Level of Convergence and Impact on Regulatory Complexity