The Swedish Government sent a proposed Bill regarding changes in the pharmacy market to the Council of Legislation for comments last week. The proposed Bill includes the following suggestions: The monopoly of the State owned company Apoteket AB to carry on retail business with certain drugs and goods shall be replaced by a system in which those who have permission from the Swedish Medical Products Agency shall be allowed to carry on retail business with the drugs and goods that are currently covered by the monopoly. In applying for permission, the applicant must meet certain suitability requirements and illustrate that it will be able to meet certain business requirements, for example, that pharmacists are present during opening hours, that all prescribed drugs and goods can be supplied, that counselling can be provided and that the business is conducted within appropriate premises. Drug manufacturers, holders of marketing authorisations and persons eligible to prescribe drugs shall, as a matter of principle, not be permitted to carry on retail business with certain drugs and goods. The regulation of retail and wholesale businesses is to be included in a new Act on Trade with Drugs, which is to replace the old act of the same name. The Medical Products Agency is to be the supervisory authority responsible for ensuring that the new law is observed.
Furthermore, the proposed Bill includes suggestions regarding new laws to deal with the IT-systems of Apoteket AB to which all new participants within the pharmaceutical market will need to have access and the personal data and registers that they will be obliged to handle.
Moreover, it is suggested that the Dental and Pharmaceutical Benefits Agency shall decide the new pharmacies’ purchase price and selling price for drugs that are included in the pharmaceutical benefits and it is recommended that the Agency becomes the supervisory authority responsible for ensuring that the Act on Pharmaceutical Benefits etc is observed.