General sale of non-prescription medicinal products: Comparing legislation in two European countries

Background: The number of non-prescription medicines (NPMs) available for self-medication is increasing within the European Union (EU). This can enhance the autonomy of individuals but is also connected with risks. Under an existing EU Directive, Sweden has only recently deregulated and made NPMs available in non-pharmacy outlets; The United Kingdom (UK) is a more established NPM market; both are guided by the same EU directives. Objective: The aim of this study was to compare specific requirements under the legislation, rationales and outcomes regarding the sale of NPMs through non-pharmacy outlets between Sweden and the UK. Method: The main method was analysis of legislative text and policy documents, conducted in 2012. Results: Both countries had specified medicines available to the public in non-pharmacy outlets, but with restrictions on different factors, e.g. placement and package size of the NPMs. The main rationales for legislation were quality and patient safety. NPMs for 51 ailments were available in the UK, compared to 35 in Sweden. Conclusion: Sweden had more extensive requirements, probably due to the market being more recently deregulated, while the UK represented a more mature market. There is a difference in the balance between confidence and control, as well as availability and safety when it comes to NPMs in non-pharmacy settings that needs to be further discussed. (C) 2016 Elsevier Inc. All rights reserved.