The EU Falsified Medicines Directive (EU-FMD) has been front-of-mind for pharmaceutical companies since the countdown to the legislation coming into force began in February 2016. The impact of applying the Safety Features, in particular serialisation of every pack, is wide-reaching and effects all parties in the pharmaceutical supply chain. One sector which has faced some unique challenges from the legislation are Parallel Importers (PIs).
IDENTIFYING THE CHALLENGE
We at Excellis Europe have had a close eye on what EU-FMD means for the pharmaceutical industry and have been working with various stakeholders to develop solutions and systems to ease the transformation process. Initially, we observed that the focus of EU-FMD activity was with manufacturers and their in-house assets. Later, there was a shift in focus to the manufacturers’ extended supply chain participants. More recently there has been impact on the manufacturers’ logistics service providers or 3PLs.
We observed something of a ‘scale effect’ with the larger manufacturers and their supply chain partners generally implementing first. However, many smaller and medium sized companies were later to act and now, in the final rush to compliance before 9th February 2019, many of these companies are still in the process of implementation. Under the banner of ‘manufacturers’ we not only find the originator manufacturers, but there are also Parallel Importers (PIs) who repackage pharmaceuticals.
PIs have their own obligations within the EU-FMD legislation, and these obligations are more complex than that of the mainstream originators. They typically procure product from regulated EU wholesalers, so they must first carry out the risk-based verification of the product against the European Medicines Verification System (EMVS). During the process of repacking they have to decommission the originator product for repack and update the so-called ‘repack buffer’ in the EMVS; this repack buffer is then consumed as the PI company uploads their new product pack data for their repacked product.
The British Association of European Pharmaceutical Distributors (BAEPD) are the UK trade body for PIs, and as a stakeholder in SecurMed, the UK National Medicines Verification organisation, they have a responsibility to ensure that their members meet EU-FMD compliance measures. Having recognised the challenges that PIs faced by the EU-FMD, BAEPD engaged with Excellis Europe to review the situation and suggest a strategic approach. Although the BAEPD members had no history of collaborating on a project, it was decided that the companies should work together on a serialisation project led by Excellis Europe.
From the outset, we adopted a fully collaborative approach to the project, and made sure that the interests and objectives of all parties involved were identified and addressed. We kicked off the project with an initial survey of member companies, interrogating pain points and areas of concern in terms of process. This resulted in the development of a high-level view of PI processes which could be used to form the basis of a ‘statement of requirements’. In response to this, the BAEPD created a core project team with members selected from approximately half of the member companies to further identify/refine requirements and to propose suitable solutions.
Excellis Europe put together a User Requirements Specification (URS) and, using our knowledge of the industry, generated a list of likely vendors. The URS went to the vendors and we ran a formal vendor selection exercise. After a rigorous assessment process, we found a vendor that had the components of a solution that would work, but equally importantly had the right cultural fit and excellent knowledge of the EU-FMD requirements and EMVS.
Goods batching process has been a risk for PIs – the current manual processes have worked effectively but do present a possible risk of mixing up batches of incoming product. This new serialisation solution is utilised to remove the possibility of any such mix up. Another benefit to PIs is that the companies are choosing to aggregate incoming product into their internal inventory – they have uniquely identified containers and they know which serial numbers are in which containers.
The PIs have responded enthusiastically to the project and have been keen and willing to share their operating practices, and to align on a methodology that is reflected in the new design.
As a result of this project, Excellis Europe are now in an unrivalled position with regards to our unique knowledge of the PI business, allowing us to work with other PI trade bodies in other countries.
The EU-FMD regulations undoubtedly create complications for all organisations throughout the pharmaceutical supply chain. However, by understanding the individual concerns of Parallel Importers, we have developed a collaborative solution that has simplified and eased the transition process.