Fighting falsified medicines with paperwork – a historic review of Danish legislation governing distribution of medicines

Abstract

BackgroundMany areas of pharmaceutical legislation in the European Union (EU) are harmonised in order to promote the internal market and protect public health. Ideally, harmonisation leads to less fragmented regulation and cross-border complexities. This study, however, focuses on an increasingly harmonised legislative area that is subject to increases in requirements and complexities: the distribution of medicines. This study compared Danish legislation governing the distribution of medicines before and after Denmark joined the EU in order to assess the impact of EU harmonisation, as well as to evaluate whether the drastic increases in requirements mandated by the Falsified Medicines Directive of 2011 correspond to a new approach to governing the pharmaceutical supply chain.MethodsA review was conducted of 115 applicable Danish laws, executive orders and guidelines from 1913 to 2014. Legal requirements were organised according to the year they were published and the companies they affected. Greater changes in legislative requirements were developed through inductive content analysis.ResultsEarly legislation positioned pharmacies as gatekeepers, requiring them to identify and stop medicines of substandard quality. Legislation to regulate the supply chain was slow to materialise. After Denmark joined the EU, the scope of legislation widened to include all actors in the supply chain, and the quantity of legislation increased dramatically. Simultaneously, requirements became more specific, thereby promoting a formalistic interpretation and focusing the attention of companies and authorities on predefined areas with little room to implement innovative solutions. Over time, documentation became the focus of legislation, requiring companies to provide documentary evidence for their compliance with legislation. The Falsified Medicines Directive continues these trends by increasing requirements for documentation and promoting a formalistic interpretation.ConclusionThe legislative approach adopted since Denmark joined the EU gives companies and medicine inspectors little room to interpret legislation. The Falsified Medicines Directive does not depart from this approach. Legislation seems more focused on enforcing similar requirements than on benefiting public health. Legislation may benefit from allowing room for local interpretation of requirements.Electronic supplementary materialThe online version of this article (doi:10.1186/s40545-016-0078-2) contains supplementary material, which is available to authorized users.

Implementing pharmaceutical track-and-trace systems: a realist review

“… 9 Support may also be related to legislation and regulation; in Denmark, the legislation’s high complexity made compliance highly demanding, decreasing support. 29 44 In Germany, the PTTS was tailored to already existing processes, resulting in minimal changes and more significant support. 30 Supply chain actors appear to become more supportive by training and preparation, thus gaining awareness, knowledge, and skill , the second social contextual factor.…”

“…In the dataset, Denmark developed legislation to implement and use PTTS, but this legislation proved so complicated that supply chain actors became reluctant to comply. 29 In Hong Kong, supply chain actors’ attitude towards the implementation of PTTS mechanisms was positive due to proper training and preparation. However, supply chain actors still opposed implementation as the investment costs were high and benefits hard to visualise.…”

“…Denmark implemented coding for all BMJ Global Health prescription medicines, but the codes were not scanned, resulting in an incomplete database. 29 A barcoding pilot in Ethiopia used a mobile application and a national database with real-time validation and cross-referencing, but no further implementation was realised despite promising results. 27 A cross-country RFID-tag study was conducted in Germany, allowing all supply chain actors to communicate with a central database.…”

Hospital Audit as a Useful Tool in the Process of Introducing Falsified Medicines Directive (FMD) into Hospital Pharmacy Settings—A Pilot Study

“…These actions should be understood as an important step in ensuring the safety of European patients. Based on this regulation, hospital pharmacies in Europe have until February 2019 to launch authentication protocols and to complete successful harmonization with the new legislature [ 15 , 16 ]. One of the essential steps for the effective implementation of these regulations into routine practice subsets remains the introduction and continuous improvement of validated procedures, using Good Authentication Practice (GAP) [ 17 ].…”

The importance of visual inspection in national quality assurance systems for medicines

“…The tests found that the product contained less than 70% of the stated active ingredient, while it should be at least 90%. In other words, the visual inspection had predicted chemical poor quality, and expensive confirmatory lab test could have been avoided by a less formalistic interpretation of the legislation [5]. In addition, even if the product had passed the chemical tests, an important problem of traceability would have remained.…”