With the EU’s Falsified Medicines Directive (FMD) now in effect, pharmaceutical manufacturers must comply with strict regulations designed to ensure counterfeit medicines don’t enter any stage of the supply chain. Here EPM speaks to a number of pharmaceutical manufacturers to get their thoughts on what FMD means for the sector.
On track
Q: What’s the next steps for manufacturers?
Daniel Tedham, managing director at The Wasdell Group
“The next major step for manufacturers is to start exploring is full aggregation capabilities. While it increases the complexity of your supply chain, there are numerous benefits to aggregation and implementation will allow companies to fully realise the benefits of serialisation and full track and trace abilities. Ultimately aggregation allows for faster passage of products through the supply chain.”
Jean-Marie Aulnette, vice president of EMEA sales at TraceLink
“Eventually, the industry will move to a state where serialisation is ‘business as usual’ and companies will start searching for supply chain efficiencies and opportunities to deliver better services by improving communications with partners and patients. CMOs and serialisation vendors specifically will have to deliver additional value and use serialisation to create competitive services, otherwise their customers will look elsewhere.”
Q: What about Brexit?
Staffan Widengren, director corporate projects at Recipharm
“When the United Kingdom (UK) leaves the European Union (EU), it could be that the UK market does not require serialised products, whereas the EU will uphold the regulations. This means that when drug products are transferred from the UK to the EU market, they will still need to comply with FMD requirements.
Ultimately, the operational approach of pharmaceutical firms will depend on whether the UK remains part of the current European Medicines Verification Organization (EMVO) or European Medicines Verification Systems (EMVS), like many of the European Election Studies (EES) countries, or if they decide to adopt a new and separate system.”
Dexter Tjoa, director corporate strategy at Tjoapack
“The FMD deadline also fell just before the UK’s exit date from the EU, which has created an additional level of complexity for the pharmaceutical industry. The UK will legally have to comply with the EU FMD requirements until it leaves, however, there remains some uncertainty around what the impact will be on the UK once it leaves the EU.
The Medicines and Healthcare products Regulatory Agency (MHRA), has outlined its commitment to remaining aligned with the EU regulations. To honour this commitment, access to the European Medicines Verification Systems (EMVS) will have to be negotiated to ensure a seamless working relationship between the UK and the EU.”
Q: Is this a stepping point for new technologies?
Alberto Negri - sales and marketing director - SEAVision
“As compliance becomes widespread and the industry feels the full force of the new regulations, the technologies and systems that companies have implemented for serialisation will start to bring additional benefits that have the potential to reshape the industry.
Once new systems are in place and fully operational, the regulatory pressure is off and there is an opportunity to review processes and begin exploring some of the added value that can be realised from the data collected from new systems.
This can lead to improved processes for inventory management, product recall management, secure distribution and product authentication. It could even be utilised in preparation for the advent of smart factories.”
Jean-Marie Aulnette, vice president of EMEA sales at TraceLink
“To date, the collective pharma industry has been very focused on the costs associated with serialisation and is yet to see its potential. Ultimately, having all the additional data being created by serialisation in data lakes will enable a number of opportunities, for example the digital transformation of recalls to derive crucial business intelligence. Better supply chain visibility and providing more information to patients are just the first steps – within the next two-three years we’ll see truly revolutionary technology such as Artificial Intelligence being used to deliver predictive analytics for supply and demand forecasting.”