Pf Magazine asked four industry experts for their views.
In your view, how far did industry progress in 2018 in terms of readiness for FMD?
The European Medicines Verification Organisation (EMVO) provides an update on the readiness of the pharma industry in Europe – and still, less than three months out, not all pharmaceutical companies have completed the EMVO on-boarding process and developed their connection to the EU Hub production environment. This process can take up to six months and any businesses that aren’t well underway face a significant risk of not being ready in time.
The reality is that there are still some companies that will not meet the regulatory deadline. This is particularly the case for smaller organisations that were unable to invest the necessary time and resources into preparing for the FMD. For these companies, outsourcing their serialisation requirements will be the only option.
What have the greatest challenges been in meeting the FMD requirements?
For contract manufacturers and packagers, one of the main challenges of implementing serialisation was installing and validating the sophisticated coding and detection equipment required. It was also vital to ensure that the software systems put
in place are capable of supporting
multiple client and country serialisation coding requirements.
Companies have also had to consider a number of necessary changes to packaging components. Artwork templates had to be reworked and redesigned to incorporate these requirements, which added a layer of cost and complexity that some businesses hadn’t factored into their preparations.
The most obvious FMD challenge is the varying market demands that one solution must cater for. Many companies supply products to a global marketplace and each country’s legislation differs slightly. There is not a one-size-fits-all solution to serialisation requirements, so companies have had to develop adaptable solutions that can be customised when necessary.
Cost has also been a barrier for some companies. The upfront investment required to equip lines and to introduce the necessary IT infrastructure to manage and exchange the data that will be generated is huge. This, added to the cost of training staff and the time required to adequately try and test lines, means for many small and mid-sized players, implementing a solution in-house has simply not been a viable option.
What’s your advice to marketing authorisation holders unprepared for the requirements?
Any company that is not close to validating a solution must look to outsource serialisation requirements to third-party contract partners. Some manufacturers that do not count packaging as a core competency took this route at an early stage to offset some of the costs of buying and installing new hardware, as well as ensuring the right IT infrastructure was in place and training staff. Ultimately, this has allowed them to negate the production downtime required to equip lines.
These factors make the outsourcing approach an appealing option, and as the deadline looms, this is likely to become more prevalent.
For those companies that are further away from finalising a solution, the sensible decision at this stage is to look to third party providers who can support them with a compliant solution. However, the onboarding process also takes time, so the sooner companies approach contract providers the better.
“The end goal for the industry should be the implementation of full track and trace systems that work collaboratively across the global marketplace”
What does the future hold for serialisation in the EU?
Once a compliant solution is in place, businesses should begin thinking about how to leverage the new information created by serialisation and the master data produced to achieve greater business value. This, combined with the ability to seamlessly exchange information with direct and indirect trade partners through a digital network platform, is what is driving the digitalisation of the pharmaceutical supply chain.
Processes that will transform because of this include product recalls, the enablement of secure, distributed product verification for supply chain partners, and the launch of patient-centric programs that enable the ultimate consumers of medicines to interact with real-time product information based on the uniquely identifiable products.
It is likely that we will see regulations continue to evolve, which will ideally result in a degree of standardisation across the global market. For example, although aggregation is not a legislative requirement in Europe, it can enable more efficient passage of drugs through the supply chain, resulting in cost and resource savings. As these benefits are recognised, aggregation will likely become a more standard requirement.
The end goal for the industry should be the implementation of full track and trace systems that work collaboratively across the global marketplace. This will not only help to eradicate counterfeit medicines but also help companies realise the operational and logistical efficiencies offered by increased visibility and access to legacy data.
How has Brexit affected preparations?
While the Brexit negotiations muddied the waters and little clarity was offered as to how the UK pharma industry would countinue its operations within Europe, the UK’s regulatory bodies have always been committed to the implementation of the FMD regulations.
Companies have adopted different approaches to create contingency plans that would ensure continuous operations in Europe. Some have developed joint ventures and co-location of premises in the EU. At Wasdell, we have invested in a new facility and legal entity in Ireland to provide continuity for our customers and maintain access to global markets.
Theoretically, Brexit should have little impact on preparation for serialisation. However, analysis and release activity may be impacted by Brexit. If we have a hard Brexit, for example, all pharmaceutical products that are manufactured, packed, analysed and released in the UK will need to be retested in an EU country before release to this market. Unfortunately, this will have a significant impact on the supply chain because it will restrict timings and resources.
Daniel Tedham, Managing Director, Wasdell Manufacturing, a division of the Wasdell Group
Jean-Marie Aulnette, Vice President EMEA Sales, TraceLink
Pieter Vercruysse, Commercial Director, Tjoapack
Staffan Widengren, Director Corporate Projects, Recipharm