article / 25 Nov 2021

The Swedish National Audit Office is to audit the governing authorities’ supervision of the trade in medicinal products and the pharmacy market

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The National Audit Office is part of the parliamentary control, and ensures that the country’s governmental bodies perform their duties efficiently and in accordance with applicable rules. While a financial audit is more or less self-explanatory, a performance audit is intended to assess the efficiency of a governmental body. Thus, a performance audit is intended to assess how well the audited governmental body achieves its goals, as well as the suitability of the organisation, operations, process and fitness for function.

Since the deregulation of the pharmacy market in Sweden around a decade ago, the market for medicinal products has increased steeply. For example, the government’s costs for medicinal products, subsidised under the pharmaceutical benefits scheme, was about SEK 34.3 billion (including patient fees) in 2020.

Together with a large increase of the number of actors operating in the market over the same period of time and more complex and comprehensive rules governing the trade in medicinal products, this has caused challenges for the supervision by the authorities regarding the trade of medicinal products. The situation is further complicated by the fact that the rules pertaining to the wholesale, distribution and substitution of medicinal products are supervised by a number of different authorities. Against that background, the Swedish National Audit Office has decided to undertake an audit of the governing authorities’ supervision of pharmacies and the trade of medicinal products.

The authorities subject to the audit are those jointly responsible for the supervision, including the Swedish Medicinal Products Agency, which is responsible for approval and licensing of medicinal products, and the Dental and Pharmaceutical Benefits Agency, which is responsible for the pricing and reimbursement of medicinal products, as well as for overseeing the retail margins for pharmacies. The purpose of the audit is to examine whether the governmental supervision is efficient and able to detect not only misuse of pharmaceutical subsidies, but also financial irregularities.

The findings of the Swedish National Audit Office will be presented in a report which is to be published and made available to the general public in May 2022.

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