artikel | 16 maj 2019

Restricted access to statistics – a threat to the pharmaceutical market in Sweden?

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Following a court decision in the summer, the National Board of Health and Welfare and the Swedish eHealth Agency have stated that they will restrict access to statistics relating to sales volumes of individual pharmaceuticals. The judgement and statement have been met with wide criticism among market players.

The judgement, decided by the Administrative Court of Appeal in Stockholm in June 2018, concerned a request for access to statistics of sales volumes of pharmaceuticals, with reference to the principle of public access to official records. More specifically, it concerned the sales volumes of dose dispensing pharmaceuticals of each county council in Sweden (Sw. Landsting). 

First, a little background may be appropriate. The principle of public access to official records is a fundamental principle that safeguards a democratic society and is regulated in Swedish constitutional law. Simplified, it can be defined as the right of all citizens to take part of official records. Limiting access to official records requires support in the law. The previously mentioned judgement concerned the interpretation of a provision providing for access to statistical data in the Public Access to Information and Secrecy Act (Sw. Offentlighets- och Sekretesslagen), including, for example, statistical data relating to pharmaceutical sales and prescription of pharmaceuticals.

The provision stipulates the conditions for handing out statistical data that may be traced to an individual or individual company. As a main rule, such statistics may not be handed out at all, e.g. it is protected by absolute secrecy. However, the third paragraph of the provision provides for the conditions for handing out data that only indirectly may be traced to the individual or company concerned by the data. For those types of statistical data a so-called reversed damage requisite is applied. This means it is only possible to provide access to the statistics if it is unambiguous that the individual concerned in the statistics would not suffer any form of damage from the disclosure.

Going back to the specific circumstances in the judgement, it should be mentioned that dose dispensing pharmaceuticals are publicly procured in each individual county council. In the judgement, the requesting party was one of few providers of dose dispensing pharmaceuticals in Sweden. The court reasoned, since each county council has just one provider of dose dispensing pharmaceuticals, it would be possible for a person or company with access to the sales volume statistics to identify the specific company concerned in the statistics. Since sales records of individual companies may be sensitive information, it was not unambiguous that the individual would not suffer any damage. The court found that it was therefore not possible to provide access to the requested statistics.

Following the judgement, the National Board of Health and Welfare (Sw. Socialstyrelsen) and the Swedish eHealth Agency (Sw. eHälsomyndigheten), which publish statistics in the areas of health and medical care, assembled a committee to decide what to do to comply with the judgement. The committee presented new guidelines regarding what statistics relating to sales volumes may be handed out. 

The guidelines state that the following data may no longer be handed out in combination with statistics regarding sales volumes:

– Product ID
– Name of the pharmaceutical (product name)
– ATC code (when there is only one manufacturer)

Statistics regarding sales volumes refers to number of expedited packages and/or total costs. The changes do not, however, affect statistics regarding the number of patients that have purchased different pharmaceuticals, data for research purposes and statistics relating to a company’s own products.

The National Board of Health and Welfare has implemented the new guidelines, but the eHealth Agency will not implement them until 10 June, as a result of criticism raised when the guidelines were announced.

The criticism has included, for instance, that the interpretation may lead to difficulties with the monitoring and prognosis work by the Dental and Pharmaceutical Benefits Agency (Sw. Tandvårds- och läkemedelsförmånsverket). It may also complicate the three-party negotiations that are a fundamental part of the Swedish reimbursement system. The negotiations rely on the parties to the negotiations all having access to the same material.

It has also been pointed out that the implementation of the guidelines may lead to decreased competition in generic markets. For example, restricted access to statistical data could make it more difficult for a company to decide if, when and how to enter the Swedish market. This may in turn lead to fewer competitors within the “product of the period-system”. The guidelines may, according to the criticism, also be interpreted as extending beyond the court’s reasoning and decision, and a more pragmatic view on these issues is desired.

Moreover, the trade association for the research-based pharmaceutical industry in Sweden (LIF) has questioned the legal support for the eHealth Agency’s interpretation that they may continue to offer access to the data to other governmental organisations such as government agencies and county councils, as well as the Swedish Association of Local Authorities and Regions (SKL), but not to companies.

Furthermore, in a recent proposal from a government committee (SOU 2018:89), transparency in the pharmaceutical market is one of the keywords. The government committee emphasized that the governmental organisations are normally too strict in their assessments of secrecy, and transparency and the principle of access to public records are thus (wrongfully) pushed aside. The government committee suggests that more material and data in general should be publicly available.

Even though the guidelines may be in accordance with the current legislation, one might ask in whose interest the secrecy is upheld – the pharmaceutical companies are both the subject of the secrecy as well as the party interested in access to the same statistical data. It will be interesting to see how and if the National Board of Health and Welfare and the eHealth Agency’s interpretation of the court case, and subsequently adopted guidelines, will find their place in the current and future system suggested by the government committee.

Setterwalls Life Sciences team is monitoring the debate and is ready to assist in any related matters.



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