In a world where the online trade of fake drugs is all too visible, where there is a growing incidence of counterfeit products reaching licenced distributors and pharmacies, and where a large proportion of fake medicine seizures are of 'commercial size', companies need to do all they can to secure their supply chains, Hans Bijl of Siemens tells World Pharmaceutical Frontiers.
Counterfeit drugs and diversion risk lives, undermine revenues and threaten company reputations. Supply chain security, through serialisation and the ability to authenticate the e-pedigree of a product, is an essential part of the battle against fake drugs. It is also important in combating product diversion, where legitimate products are diverted from one market to another, with implications for licensing obligations and distribution agreements, as well as for revenues.
In a world where the online trade of fake drugs is all too visible, where there is a growing incidence of fake products reaching licensed distributors and pharmacies, and where a large proportion of counterfeit medicine seizures are of 'commercial size', companies need to be sure they are doing all they can to secure their supply chains and prove product authenticity.
"The industry is looking for practical ways to respond," says Hans Bijl, senior business development manager LifeScience for Siemens. "One important way is to secure the supply chain by proving the authenticity of a drug, preferably all the way down the supply chain to the point of sale or point of care."
The failure of a company to demonstrate that it is doing all it reasonably can to secure and authenticate its products could fatally damage its brand and reputation. It is not enough to just comply with regulatory requirements - policy and regulations are generally lagging behind the problem. Companies need to make the running themselves. They cannot afford a situation where lives are at risk and they have failed to implement measures that other companies, whether inside or outside of the sector, have adopted.
Serialisation - the printing of a unique identity on product packaging linked to a central data repository - is at the heart of supply chain security. The Siemens serialisation for ePedigree solution enables pharmaceutical companies to fulfil existing and upcoming legal global requirements and to protect their brand, customers and revenue.
"It is vital to think of a comprehensive solution rather than respond in an ad-hoc manner that takes care of single local requirements only," Bijl explains. "This starts at line level, where the actual products are being packed, but also comprises the levels above, including the serial number handling and the link to a company's IT infrastructure. And this, for most multinational companies, in a consistent, globally available and supported way."
Serialisation of individual products is a very complex process for a pharma company. Billions of serial numbers have to be generated and printed, and the history of billions of medicines has to be electronically stored in ways that provide near-instant verification by pharmacies and others involved in the supply chain. It is a huge challenge for IT systems. Siemens is able to provide individual elements of the answer or an end-to-end solution depending on a company's particular requirements.
Any serialisation solution has to fit in with a range of different regulatory and technological contexts. Institutions such as the European Federation of Pharmaceutical Industries and Associations and the US FDA are calling for unique identification on every medication package. Laws to implement such measures are being introduced in many parts of the world, but progress and requirements vary from country to country.
Hans Bijl points out that the regulatory and technological landscape is fragmented. "It is currently very regionally driven with different requirements and timetables," he says. "What is not in doubt is the direction of regulation. Companies should not be tempted to wait and see. Indeed, it could be potentially very damaging, reputation and revenue-wise, for them to do so."
Siemens technology reaches upwards into the company's management and control systems, giving a track-and-trace functionality along the supply chain. Data from serialisation devices at production and distribution facilities are channelled into the Central Data Repository and, in turn, the ERP can be configured to manage data flow to and from retailers and dispensaries through an external enterprise data exchange.
This solution is fully SAP-certified, ready to integrate with SAP or non-SAP systems, and is based on the standard ISA95 architecture. Thus it can be integrated into other ERP and legacy systems to enable serialisation, not only within the company, but also within the extended supply chain, no matter what platform third parties employ.
Siemens says that the gains from its serialisation technology not only provide essential protection against counterfeiting, product diversion and danger to patients, they also deliver better supply chain transparency and better optimisation and control of the supply infrastructure, allowing for added business agility and profitability. As well as delivering the required e-pedigree information at the right place and at the right time, the solution provides a business system framework that can drive future production and supply chain efficiencies, asset utilisation, quality and other supply chain measures to higher levels of performance.
"The pharma industry is going through a major transition," says Juergen Manz, head of solutions for tracking & tracing in the pharmaceutical industry at Siemens IT Solutions and Services. "The move away from blockbuster models means that companies are facing more intense competition with the consequent need to fully optimise supply chains. Serialisation technology gives companies maximum product visibility all the way through the chain, thereby enabling them to identify bottlenecks, minimise stock and benefit from supply efficiencies."
The Siemens serialisation solution supports companies, for example, in the performance of rework activities, in-line or offline, provides pick-and-pack process warehouse support, supports promotion management and easily tracks returnable transport items.
Siemens systems and devices are widely used in the pharmaceutical industry and healthcare and life sciences sectors. The life science industry forms a priority market sector for Siemens. It works in many segments of the sector and understands the pressure and trends affecting the industry.
Drawing on our considerable experience in serialisation and track-and-trace technology, Siemens was chosen as the technology provider to the European Federation of Pharmaceutical Industries and Associations's successful Swedish pilot project, which aims to verify the identity of pharmaceuticals at the point of dispensing. Siemens was responsible for the end-to-end project management, the IT infrastructure, including the information systems, data integration, system security and design.
"When the pharmacist is scanning the product, he wants to know immediately if it is the real product," explains Manz. "The request goes from the cash system via the internet to the central database, and the feedback in 90% of cases was less than half a second. It is very fast."
Siemens supports customers in approximately 190 countries with innovative, made-to-measure solutions from a single source. It is one of the world's largest manufacturers of track-and-trace products, with experience in many industries, covering the entire supply chain from production to the end customer.
Partnering with Siemens gives the reassurance of leading edge technology, backed up with industry insight and understanding, and the geographical scale to respond to any market needs and footprint. The company's global reach means it understands the varying requirements of different production sites, regulators and markets to give customers the expertise and back-up they need.
Siemens IT Solutions and Services