Medicines falsification is a growing concern on the agenda of governments, regulators/authorities and industry. The World Health Organization (WHO) estimates a market share of up to 1% for falsified medicines in industrialized countries, while the European Commission has estimated that approximately 1.5 million falsified packs make it in the legal supply chain every year. To strengthen anti-counterfeiting measures in the pharmaceutical supply chain, the European Commission has issued new regulations on product traceability known as the Falsified Medicines Directive (FMD), which requires the implementation of product serialisation together with a common European medicines product verification system used by the whole sector and implemented in February 2019 which involves more than 150.000 players in the supply chain (SC). Such a setting has enabled the conduct of timely and relevant research into a contemporary phenomenon, product traceability implementation, which is the topic of this executive PhD thesis. Based on a systematic literature review, a research framework is developed which relates the benefits of traceability to its successful implementation. Such implementation is related to how the players involved respond, through the implementation process, to contingent factors, enablers & barriers, while the implementation process itself is impacted by the multi-stakeholder collaboration enacted by the working mechanisms of the specific governance structure defined by the legislation. This is the first research on digital transformation at the level of an entire sector and is also the first to consider multi-stakeholder collaboration as a key element in the implementation process. Both a multiple case study, involving three European countries, and an Insider Action Research (IAR) are performed to answer the research questions arising from the application of the research framework to this new and specific context, investigating which are the key factors impacting the implementation of traceability in such context and the expected benefits and risks, how stakeholders position themselves and respond to these factors during implementation and how multi-stakeholder collaboration is enacted through governance. The research provides several findings on the key factors impacting the implementation of traceability across an entire sector, such as high customer service levels, regulation, level of visibility, and provides the main areas of response to these factors by the SC players, such as process re-design, IT integration and visibility improvements. Also the critical role of the new SC stakeholders, legitimised by their role in the governance, is identified and explained as they achieve common stakeholder orientation across the SC stakeholders; furthermore, the elements for ensuring constant stakeholder alignment through the process are discussed in details and operationalised during the research. The research identifies the key benefits from the implementation, such as SC digitalisation, operational efficiency, increased levels of trust, patient safety together with emerging risks such as cybersecurity. Finally this research adds to current knowledge by having extended at a sector level elements of contingency theory and stakeholder theory, having operationalised the contingency model provided by (Sousa, Voss, 2008) and contributed to the work of (Soundararajan, Brown & Wicks, 2019) and (Co, Barro, 2009) through the findings on stakeholder interaction and alignment. It also provides a new approach to improve relational governance, while on practical contribution this study has developed key business processes during the IAR and provides relevant insights to business leaders implementing traceability at sector level.
La falsificazione dei medicinali è una preoccupazione crescente nell'agenda di governi, autorità di regolamentazione e industria. L'Organizzazione Mondiale della Sanità (OMS) stima una quota di mercato fino all'1% per i medicinali falsificati nei paesi industrializzati, mentre la Commissione Europea ha stimato che circa 1,5 milioni di confezioni falsificate entrano nella catena di fornitura legale ogni anno. Per rafforzare le misure di anticontraffazione nella filiera farmaceutica, la Commissione Europea ha emanato nuove normative sulla tracciabilità dei prodotti note come Direttiva sui medicinali falsificati (FMD), che richiede la serializzazione del prodotto, insieme a un sistema comune europeo di verifica dei medicinali utilizzato dall’intero settore e implementato nel febbraio 2019. Questo sistema coinvolge più di 150.000 attori della catena di fornitura (Supply Chian). Tale contesto ha consentito lo svolgimento di ricerche tempestive e pertinenti su un fenomeno contemporaneo, l'implementazione della tracciabilità del prodotto, che è l'argomento di questa tesi di dottorato. Sulla base di una revisione sistematica della letteratura, viene sviluppato un quadro di ricerca che collega i vantaggi della tracciabilità alla sua corretta implementazione. Tale implementazione è correlata al modo in cui gli attori coinvolti rispondono, attraverso il processo di implementazione, ai fattori contingenti, fattori abilitanti e barriere, mentre il processo di implementazione stesso è influenzato dalla collaborazione multi-stakeholder resa possibile dai meccanismi di lavoro specifici della struttura di governance definita dalla legge Europea. Questa è la prima ricerca sulla trasformazione digitale a livello di un intero settore ed è anche la prima a considerare la collaborazione multi-stakeholder come un elemento chiave nel processo di implementazione. In questa tesi vengono eseguiti sia un caso di studio multiplo, che coinvolge tre paesi europei, che un Insider Action Research (IAR); per rispondere alle domande di ricerca derivanti dall'applicazione del quadro di ricerca a questo nuovo e specifico contesto, indagando i fattori chiave che influenzano l'implementazione della tracciabilità in tale contesto ed i benefici ed i rischi attesi, il modo in cui gli stakeholder si posizionano e rispondono a questi fattori durante l'implementazione e il modo in cui la collaborazione multi-stakeholder viene attuata attraverso la governance. La ricerca fornisce diversi risultati sui fattori chiave che influenzano l'implementazione della tracciabilità in un intero settore, come gli elevati livelli di servizio al cliente, la regolamentazione, il livello di visibilità, queste generano inoltre le principali strategie di risposta a questi fattori da parte degli attori della Supply Chain (SC), come la riprogettazione, l’integrazione IT e i miglioramenti della visibilità. Anche il ruolo critico dei nuovi stakeholder di SC, legittimati dal loro ruolo nella governance, viene definito e spiegato man mano che viene raggiunto un orientamento comune tra gli stakeholder; inoltre, gli elementi per garantire il costante allineamento degli stakeholder durante il processo, sono discussi in dettaglio e resi operativi durante la ricerca. La ricerca identifica anche i principali vantaggi derivanti dall'implementazione, come la digitalizzazione delle SC, l'efficienza operativa, l'aumento dei livelli di fiducia e la sicurezza dei pazienti insieme ad alcuni rischi emergenti come la sicurezza informatica. Infine questa ricerca contribuisce alle attuali conoscenze avendo esteso a livello settoriale elementi della teoria delle contingenze e della teoria degli stakeholder, inoltre ha reso operativo il modello di contingenze fornito da (Sousa, Voss, 2008) e contribuito al lavoro di (Soundararajan, Brown & Wicks, 2019 ) e (Co, Barro, 2009) attraverso i risultati sull'interazione e l'allineamento degli stakeholder. Questa ricerca fornisce inoltre un nuovo approccio per migliorare la governance relazionale, mentre, da un punto di vista di contributo pratico, questa ricerca ha sviluppato processi aziendali chiave durante l’IAR e fornisce nuovi elementi rilevanti ai leader aziendali che devono implementare la tracciabilità a livello di settore.
Product traceability in the pharmaceutical sector. A contingency and multi-stakeholder collaboration approach to implementation: the case of the EU Falsified Medicines Directive (FMD)
FARINELLI, MARCO
2020/2021
Abstract
Medicines falsification is a growing concern on the agenda of governments, regulators/authorities and industry. The World Health Organization (WHO) estimates a market share of up to 1% for falsified medicines in industrialized countries, while the European Commission has estimated that approximately 1.5 million falsified packs make it in the legal supply chain every year. To strengthen anti-counterfeiting measures in the pharmaceutical supply chain, the European Commission has issued new regulations on product traceability known as the Falsified Medicines Directive (FMD), which requires the implementation of product serialisation together with a common European medicines product verification system used by the whole sector and implemented in February 2019 which involves more than 150.000 players in the supply chain (SC). Such a setting has enabled the conduct of timely and relevant research into a contemporary phenomenon, product traceability implementation, which is the topic of this executive PhD thesis. Based on a systematic literature review, a research framework is developed which relates the benefits of traceability to its successful implementation. Such implementation is related to how the players involved respond, through the implementation process, to contingent factors, enablers & barriers, while the implementation process itself is impacted by the multi-stakeholder collaboration enacted by the working mechanisms of the specific governance structure defined by the legislation. This is the first research on digital transformation at the level of an entire sector and is also the first to consider multi-stakeholder collaboration as a key element in the implementation process. Both a multiple case study, involving three European countries, and an Insider Action Research (IAR) are performed to answer the research questions arising from the application of the research framework to this new and specific context, investigating which are the key factors impacting the implementation of traceability in such context and the expected benefits and risks, how stakeholders position themselves and respond to these factors during implementation and how multi-stakeholder collaboration is enacted through governance. The research provides several findings on the key factors impacting the implementation of traceability across an entire sector, such as high customer service levels, regulation, level of visibility, and provides the main areas of response to these factors by the SC players, such as process re-design, IT integration and visibility improvements. Also the critical role of the new SC stakeholders, legitimised by their role in the governance, is identified and explained as they achieve common stakeholder orientation across the SC stakeholders; furthermore, the elements for ensuring constant stakeholder alignment through the process are discussed in details and operationalised during the research. The research identifies the key benefits from the implementation, such as SC digitalisation, operational efficiency, increased levels of trust, patient safety together with emerging risks such as cybersecurity. Finally this research adds to current knowledge by having extended at a sector level elements of contingency theory and stakeholder theory, having operationalised the contingency model provided by (Sousa, Voss, 2008) and contributed to the work of (Soundararajan, Brown & Wicks, 2019) and (Co, Barro, 2009) through the findings on stakeholder interaction and alignment. It also provides a new approach to improve relational governance, while on practical contribution this study has developed key business processes during the IAR and provides relevant insights to business leaders implementing traceability at sector level.| File | Dimensione | Formato | |
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https://hdl.handle.net/10589/171135