article / 17 May 2016

Appropriate Regulation Important for Pharmacy Customers

Just a few months ago, Sweden’s New Pharmacy Inquiry began conducting a review of the country’s pharmacy market. Åsa Kullgren has been appointed as the Inquiry’s special investigator. Her commission includes analysing the availability of pharmacy services and medicinal products throughout Sweden. Another important aspect of the Inquiry concerns reviewing how pharmacies’ role in promoting better use of medicinal products can be developed.

When the Inquiry was announced, the national media dubbed it “Sweden’s most pointless inquiry”. In many respects, this criticism was easy to understand. A large number of the facts that the Inquiry has been tasked with analysing have already been compiled and are well-established. What’s more, in addition to such data as the Swedish Pharmacy Association can provide, since its re-regulation in 2009, Sweden’s pharmacy market has already been reviewed in no less than four major reports issued by the Pharmaceutical and Pharmacy Inquiry, and in a comprehensive evaluation by the Swedish Agency for Public Management. Moreover, a number of other public authorities have also analysed various aspects of the pharmacy market’s re-regulation. The market is also subject to continuous oversight by three public authorities and by the Swedish Data Protection Authority. As such, the re-regulated pharmacy market is hardly lacking in scrutinizers. If you add to that the stable and very high level of satisfaction reported by Swedish pharmacies’ customers since such measurement began just after the re-regulation, it is understandable that yet another inquiry might seem unwarranted.

Nonetheless, the Swedish Pharmacy Association has chosen to welcome this new inquiry nonetheless, given that we recognise that there are a number of areas where pharmacies’ service to their customers could be further improved, if the rules, regulations and other conditions
governing pharmacies were amended. At the same time, we would like to emphasise that we see no need for a more comprehensive regulation of pharmacies’ activities overall. The prospective improvements that we envision can rather be achieved through a modest loosening of the current regulation, or through a better, more appropriate regulation.

The concept of “better regulation” is discussed in legislative circles within the EU, meaning that laws and policies should be designed so as to achieve their objectives at minimum expense. At times, this is a matter of reducing the total number of regulations in force, although it is just as often a case of achieving the same aims through an improved or different regulation that is less costly from an economic standpoint. New or amended regulations must also be preceded by a thorough impact analysis and gain the support of interested parties through their involvement in the process. We hope that the New Pharmacy Inquiry will adopt this same approach to regulation. In Sweden, circumstances viewed as problematic have too often been “resolved” by adding yet more rules to an already unwieldy body of regulations. This type of “solution” is rarely helpful and most often creates new problems.

One case in point where better regulation is needed concerns the “24-hour rule”, which will be a particular focus of the Inquiry. In short, the rule entails that a pharmacy customer must be able to receive their medication within 24 hours, if it cannot be provided immediately. However, the possibility for a customer to have their ordered medication (customer reservation) delivered to a pharmacy within 24 hours is wholly beyond the pharmacies’ power to control. Ordering deadlines and delivery times to pharmacies are determined solely by the two pharmaceutical distributors (“wholesalers”). Consequently, the 24-hour rule, which formally imposes obligations on pharmacies, is subject to a host of distributor-related exceptions that, in reality, mean that if the distributors consider themselves unable to deliver within 24 hours, then no 24-hour limit applies. Obviously, this circumstance is difficult for pharmacy customers, who expect delivery within 24 hours, to understand: pharmacies must be able to deliver within 24 hours, but because their distributor is not bound by the same obligation, delivery time often exceeds 24 hours. Also from a regulatory standpoint, it is very peculiar that a duty to supply within 24 hours has been imposed on only one part of the pharmaceutical supply chain, namely on that part that has no power to influence the delivery of ordered medication to pharmacies. In this respect, pharmacy customers can hope that the regulation’s practicality will be improved.

The pharmacy market is subject to extensive and, at times, highly complex regulation. Any review or analysis of this regulation must take customers and the regulation’s impact on them into account. Customers want to be able to obtain their medications in a safe and efficient way and, at the same time, receive reliable information on how to use them. Pharmacies have an important public function to fill in this respect, and thus, their ability to execute this function needs to be as well-supported as possible. In the end, it is pharmacy customers who provide a true indication of the health of the market.