Will see the removal of any upfront investment costs for pharmaceutical firms seeking access to CDMO's serialisation capabilities
Swedish contract development and manufacturing organisation (CDMO) Recipharm aims to improve the affordability of serialisation, with the introduction of a novel pricing model that will keep investment costs down for clients.
The company has devised a pricing structure that will see the removal of any upfront investment costs for pharmaceutical companies looking to access the firm’s serialisation capabilities.
Recipharm will offer a standard solution across 14 locations in Europe and more than 70 production lines, with a fixed service fee per pack for all customers. Each serialised product will be compliant with the pending US and EU regulations, with any customisation of the pack offered separately.
The pharmaceutical industry must meet the new legal requirements for the serialisation of licensed drug products from November 2017 in the US and early 2019 in Europe.
Companies must adapt their packs, implement their tamper evidence capability and establish the systems, processes and data to comply with the EU Falsified Medicines Directive ‘Safety Features’ Commission Delegated Regulation 2016/161 and the US Drug Supply Chain Security Act (DSCSA), which is expected to require significant financial investment.
We have created a pricing model designed to spread the cost of serialisation across each customer’s on-going supply agreement as opposed to them needing to make a major upfront investment
As part of its commitment to help pharmaceutical companies prepare for the regulatory changes, Recipharm recently announced plans to invest €40m over the next three years to build state-of-the-art solutions for serialisation processes. As soon as the service is operational, the company will provide serialisation free-of-charge until the legal requirements come into effect to ensure drug developers are prepared ahead of the deadlines.
The CDMO’s company-wide serialisation project is being led by Staffan Widengren, Director Corporate Projects at Recipharm. He said: 'We have spoken to our clients and conducted extensive research to help us fully understand the main challenges associated with the looming requirement for serialisation. Many companies are behind in their preparations, not fully aware of the scale and complexity of the task ahead and concerned about the required financial investment.
'As a result of this consultation exercise, we have created a pricing model designed to spread the cost of serialisation across each customer’s on-going supply agreement as opposed to them needing to make a major upfront investment. From 2023, we will extend this further, ensuring that serialisation is included as standard as part of our product manufacturing costs.'
The industry-wide serialisation, aggregation and verification directive is expected to improve traceability of drugs, help in the fight against counterfeit products entering the supply chain and ultimately improve patient safety.
Recipharm serves more than 250 customers and expects 85% of its production to require serialisation.
Kjell Johansson, President Manufacturing Services Europe, added: 'Those companies who fail to prepare for the new regulations will face major disruption to their product supply. Recipharm aims to simplify the process by offering a standard solution with a fixed price per unit with the option to customise packs to individual requirements. There will also be no volume commitment needed from customers wishing to access our serialisation services.
'We have also considered the financial implications of aggregation and can include this service from 2017 on customer request. The ability to minimise upfront investment will enable compliance with the new regulations, while reducing financial burden.'