Focus of the new phamaceutical and pharmacy investigation

Pharmacies have been the subject of continual investigation over the past ten years. Earlier this year the government announced that yet another investigation will be conducted, aimed at improving access to medicines, among other things. On November 19, 2015 the government presented a new investigation.

Ten years of investigation
About ten years ago, on May 31, 2005, the European Court of Justice gave judgment in the case Hanner (C-438/02). The Court found that the agreement that Apoteket AB then had with the Swedish state (1996 agreement), may put medicinal products from other Member States at a disadvantage compared with Swedish medicinal products. The state monopoly thus was not designed in such a way that all discrimination against medicinal preparations from other Member States was excluded. Thus the monopoly was contrary to Article 31(1) EC.

In response to this judgment, on February 16, 2006, the Government at the time decided to conduct a review of the Swedish pharmacy monopoly. The investigator was to submit proposals for necessary changes to comply with Community law requirements on state monopolies. The investigator was specifically instructed to analyze whether the sales network of what was then Apoteket AB was designed to ensure consumer access to human and veterinary medicines.

While the issue of whether to preserve the monopoly is obviously a moot point, the second question, ensuring consumer access to medicines, remains relevant. This was confirmed when the responsible cabinet minister earlier this year announced that the government intends to initiate a new pharmacy investigation.

The past ten years have been eventful in the pharmaceutical and pharmacy market. After a change of government in autumn 2006, a new pharmacy investigation was ordered (December 21, 2006) that was not aimed at adapting the monopoly to EU law, but was tasked with making it possible for other participants to engage in retail trade with medicinal products: to “re-regulate” the pharmacy market. Re-regulation was implemented in 2009 and the pharmacy business was transferred in part to a number of private operators. The remaining issues related to re-regulation were investigated from June 2011 in the Pharmaceutical and Pharmacy Inquiry, which released a final report about one year ago, in December 2014. The official period for submitting comments on the final report expired as recently as last summer.

New inquiry
The Government has now adopted terms of reference for the new inquiry, called “Increased focus on quality and safety in the pharmacy market” (dir. 2015:118).

Åsa Kullgren (S), chair of the County Council in Sörmland, will head up the inquiry. The remit of the inquiry includes:

• Analysing developments in the pharmacy market since reregulation and assessing the short-term and long-term effects of the trends.
• Reviewing the requirements for obtaining a permit to run a retail pharmacy.
• Analysing measures that could be necessary to ensure good access to pharmacy services throughout Sweden.
• Analysing whether measures are necessary to ensure compliance with the obligation to supply and dispense medicinal products.
• Analysing whether there is a need for further measures to promote a high degree of direct dispensing or to improve the service provided when direct dispensing is not possible.
• Reviewing how the role of pharmacies in improving medication use can be expanded.

The terms of reference specifically stipulate that the inquiry chair should bear in mind that proposals should leave the current generic substitution model unchanged.

The report must be submitted by 31 December 2016.