Contract development and manufacturing organization (CDMO) Recipharm has unveiled plans to improve the affordability of serialization with the introduction of a novel pricing model aimed at keeping 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 CDMO’s serialization 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 serialized product will be compliant with the pending US and EU regulations, with any customization of the pack offered separately.
The announcement comes as the pharmaceutical industry faces the daunting task of meeting new legal requirements for the serialization 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), something that is expected to require significant financial investment.
As part of its commitment to actively help pharmaceutical companies prepare for the regulatory changes, Recipharm recently announced plans to invest €40 million during the next 3 years to ensure state-of-the-art solutions for serialization processes. As soon as the service is operational, the company will provide serialization 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 serialization 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 serialization. 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 serialization across each customer’s ongoing supply agreement as opposed to them needing to make a major upfront investment. From 2023, we will extend this further, ensuring that serialization is included as standard as part of our product manufacturing costs. Having provided serialized products in Asia for a number of years, we understand the scale of the investment involved so are utilizing our experience, technologies and capabilities to reduce costs for companies in Europe and the US,” he added.
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 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 customize packs to individual requirements. There will also be no volume commitment needed from customers wishing to access our serialization services. We have also considered the financial implications of aggregation and can include this service from 2017 on customer request. The ability to minimize upfront investment will enable compliance with the new regulations, while reducing financial burden.”
Recipharm is preparing a range of educational papers aimed at training staff internally across its global network and supporting customers with the challenges of serialisation, verification and complying with new regulatory requirements.