López Vila Eduardo Daniel, Buts Caroline, Jegers Marc
Department of Applied Economics, Vrije Universiteit Brussel, Pleinlaan 2, 1050, Brussels, Belgium.
J Pharm Policy Pract. 2023 Jan 30;16(1):19. doi: 10.1186/s40545-023-00522-7.
This paper reviews the regulations of over-the-counter (OTC) medicines in 30 European countries with the goal of identifying the regulatory trends and clusters as of May 2022.
To that end, we reviewed the regulation that directly or indirectly might have an impact on OTC medicines. The data were gathered from the national legislation, reports from international organizations, and the existent literature. The 12 regulatory items obtained were classified into four categories: price, pharmacy ownership, distribution modes, and dispensing restrictions. In addition, these items were also employed in the cluster analysis.
Pharmacy ownership is mainly private, and in the majority of countries, OTC medicines are not subject to any pricing system. Almost every country studied allows online selling of OTC medicines, and 16 countries allow non-pharmacy retail to sell OTC medicines as well. The dispensing restrictions applicable in pharmacy retail are similar in the countries studied: they rely on the staff, OTC medicines are placed behind the counter and the doses dispensed tend to be restricted. Concerning non-pharmacy retail, additional dispensing restrictions might be imposed, such as the establishment of buyers' minimum age, the requirement of a pharmacist to supervise the operations, a regulation on the location in the store, and further restrictions on the package sizes, strength, or pharmaceutical form. The cluster analysis resulted in an initial division between countries that widely allow the sale of OTC medicines in non-pharmacy retail and countries, where pharmacy retail has an OTC monopoly. Based on the regulations, 7 subsequent groups were identified evidencing wide regulatory heterogeneity within the countries studied.
Our findings point out that OTC medicines are in general not subject to pricing systems, selling is allowed online, and ownership of pharmacies is mostly private. However, regarding dispensing restrictions, pharmacy chains, and establishment restrictions of pharmacies, we found heterogeneity that is also visible in our cluster analysis, since we identified 7 clusters.
本文回顾了30个欧洲国家的非处方药（OTC）法规，目的是确定截至2022年5月的监管趋势和类别。
为此，我们审查了可能直接或间接影响非处方药的法规。数据收集自国家立法、国际组织报告和现有文献。获得的12项监管项目分为四类：价格、药店所有权、分销模式和配药限制。此外，这些项目也用于聚类分析。
药店所有权主要为私有，在大多数国家，非处方药不受任何定价系统的约束。几乎每个被研究的国家都允许在线销售非处方药，16个国家也允许非药店零售销售非处方药。在所研究的国家中，适用于药店零售的配药限制类似：它们依赖工作人员，非处方药放在柜台后面，配药剂量往往受到限制。对于非药店零售，可能会施加额外的配药限制，例如设定购买者最低年龄、要求药剂师监督运营、对商店位置进行规定，以及对包装尺寸、强度或剂型进一步限制。聚类分析初步划分出广泛允许在非药店零售销售非处方药的国家和药店零售对非处方药具有垄断权的国家。根据法规，随后确定了7个组，表明在所研究的国家中存在广泛的监管异质性。
我们的研究结果指出，非处方药一般不受定价系统约束，允许在线销售，药店所有权大多为私有。然而，在配药限制、连锁药店以及药店设立限制方面，我们发现了异质性，这在我们的聚类分析中也很明显，因为我们识别出了7个类别。
