Proposed new rules on access to sales data on medicines for human use

In February, the Swedish Government’s official report on pharmaceutical statistics was published: Access to sales data on medicinal products for human use. This report is the result of the Government’s decision in 2021 to appoint a special investigator to examine what measures need to be taken to create a long-term, sustainable legal framework for the disclosure of sales statistics relating to medicines for human use.

The report was commissioned following the conclusion by the E-Health Authority (Sw. E-hälsomyndigheten) and the National Board of Health and Welfare (Sw. Socialstyrelsen) that the disclosure of sales data on individual medicines was contrary to the Public Access to Information and Secrecy Act (2009:400) (Sw. Offentlighets- och sekretesslagen, OSL), as it was protected by the confidentiality of the financial circumstances of individuals. It was therefore no longer possible to request this information unless the pharmaceutical companies consented. Since then, the Government inquiry has been working to find a solution that would make the statistics public again.

This work has resulted in several proposals, including the introduction of an exemption from statistical confidentiality, which has been welcomed by market participants. A brief description of the proposals is provided below.

Editorial amendment to the Act (2009:366) on Trade in Medicinal Products
The report proposes an editorial amendment to Chapter 4 § 2 of the Act on Trade in Medicinal Products (Sw. Lag om handel med läkemedel), which would divide into two paragraphs the provision requiring wholesalers and retailers engaged in the retail sale of medicinal products to the healthcare sector to provide information to the E-Health Authority, and for the Authority to keep statistics on retail trade.

Introduction of an exemption from statistical confidentiality for certain sales data on medicinal products for human use
The report proposes the introduction of exemptions from confidentiality for certain sales data in Chapters 24 & 25 OSL if a number of conditions are met, for which the data must:

1. relate to the financial circumstances of an individual legal person;
2. have been provided to the E-Health Authority in accordance with a statutory obligation to provide information necessary for the retention of statistics on retail sales in the Act on Trade in Medicinal Products; and
3. relate to a medicinal product that is included in the medicinal product benefits pursuant to the Act (2002:160) on Medicinal Product Benefits etc. (Sw. Lag om läkemedelsförmåner m.m.), constitutes a free medicinal product, or has been sold to a region, municipality or legal person carrying out publicly funded activities.

The new confidentiality exception allows the E-Health Authority to disclose data on sales statistics for medicinal products for human use, which has advantages for both individuals and authorities, which currently lack this possibility.

The current protection, which is relatively strong in this regard, is based on the conflict of interest between, on the one hand, the desire for publicity and, on the other hand, the respect for the privacy of the individual. However, the report considers that, unlike, for example, statistics held by Statistics Sweden (Sw. Statistiska Centralbyrån), with regard to which the preliminary work to the OSL emphasised that the privacy interest is significant, the balance is different in the case of sales statistics for medicinal products.

In this respect, the interest in public access is considerable, as there is a need for both individuals and authorities to be able to access medicinal sales data. Furthermore, the report considers that the issue of the individual’s personal privacy does not arise, as legal persons do not have any personal relationships or personal privacy worthy of protection. The assessment is that the data to which the report refers is not of such a nature that it entails the protection of the individual’s personal privacy, so the arguments put forth in the preparatory work for the current strong protection are not relevant in relation to sales statistics for medicinal products for human use.

It should, in this regard, be emphasised that the proposal does not constitute an exception to statistical confidentiality of information on personal circumstances of individuals.

Several amendments relating to the E-Health Authority’s obligation to disclose data to other authorities
The report proposes to extend the obligation of the E-Health Authority to disclose certain data to the National Board of Health and Welfare, the National Agency for Dental Care and Medical Benefits (Sw. Tandvårds- och Läkemedelsförmånsverket, TLV) and the National Agency for Medical Products (Sw. Läkemedelsverket).

In relation to the National Board of Health and Welfare, the proposal is that the current obligation in Chapter 6 § 5 of the Act (2018:1212) on the National List of Medicines (Sw. Lag om nationell läkemedelslista) should also include information on the active substance, pharmaceutical form, strength, distributing pharmacy, and information on whether the pharmacist has objected to the exchange and the reasons for this. The report argues that such information gives the Board valuable information that enables accurate follow-up of medicines and greater patient safety. Furthermore, information about the distributing pharmacy allows the Board to acquire knowledge about a patient’s geographical patterns, and information about objections of exchange provides insight into the difference between the retrieved and potentially retrieved amount of generic medicines.

The obligation to provide information to the TLV is proposed to include information on the reason for prescription and to be extended to cover the whole of the TLV’s supervision under the Medicinal Product Benefits Act etc. and for the follow-up and evaluation of subsidy decisions. This is proposed to ensure effective supervision and to effectively follow up and evaluate the agency’s subsidy decisions.

Finally, with regard to the Medical Products Agency, the obligation is proposed to cover the Agency’s entire supervision under the Act on Trade in Medicinal Products. This information will also be provided upon request in the future. In short, this means an extension of the obligations in Chapter 2 § 10b para. 2 and Chapter 3 § 4a to cover the agency’s entire supervision under Chapter 7 § 1 of the Act. In practice, this would result in the Medical Products Agency being able to use information retrieved from the E-Health Authority not only for the express purposes in Chapter 2 § 10b para. 2 and Chapter 3 § 4a, but for the agency’s entire supervision under the Act.

The report considers that these changes will give the relevant authorities greater opportunities to exercise effective supervision and monitor the use of medicinal products. It should be noted that the proposals should not be construed as meaning that the E-health Authority must disclose personal data of individuals to any of the abovementioned authorities.

In summary, the proposal restores public access to sales statistics for medicinal products for human use and facilitates the disclosure of certain data by the E-Health Authority to other authorities to ensure effective supervision of the market for medicinal products for human use.

We look forward to seeing how this develops and will monitor the situation.