Pharmaceutical Industry Faces Huge Pressure to Invest
There are 15 000 production lines of prescription medicines in Europe, of which only 30 percent currently have the capacity to implement serialization or the traceability of the origins of prescription medicine packages. During the next three years, the pharmaceutical industry will encounter a huge pressure to invest, as the European Commission adopted a regulation in October under which the serialization of prescription medicine packages will become mandatory in all EU countries in 2019.
“So far, pharmaceutical manufacturers have waited to see how the legislation will evolve. Soon, everyone will be rushing at the same time and only the most progressive ones will make it on time, because the delivery times of equipment suppliers are becoming longer,” says serialization expert, D. Sc. (Tech) Iiro Jantunen from Servicepoint Oy in Finland.
The situation poses challenges, because the international market has only a few system vendors who can respond to the need to reform production lines according to the demands of serialization. One of these is Servicepoint Oy.
“Our strengths are our extensive know-how in automation and a rapid installation time, due to which the downtimes of production lines are as short as possible,” says Jantunen.
Serialization transforms entire pharmaceutical business
Senior Consultant Pasi Kemppainen from NNE Pharmaplan assesses that the industry has not yet even realized what an extensive and comprehensive transformation serialization involves. The change concerns pharmaceutical factories that will have to mark medicine packages with an individual, traceable 2D barcode. Pharmacies and hospitals at the end of the supply chain will verify the origins of the medicines that are sold. In the future, the consumer may also verify the authenticity of a product using the camera application of a phone.
“Serialization will alter existing operations models, systems, and markets. In addition, the EU requires the simultaneous implementation of integrity protection for medicine packages,” says Kemppainen.
According to him, it is high time for marketing authorization holders, or pharmaceutical companies, to examine their production chain and the capacity of their contract manufacturers to respond to the demands. Ultimately, it is the pharmaceutical companies’ responsibility to ensure that the traceability of medicines is carried out properly.
Forced action to prevent counterfeit medicines
The implementation of serialization is a forced additional expense from the perspective of pharmaceutical factories. Costs may rise up to several hundreds of thousands of euros per production line. Some production lines will have to be fully replaced and automated.
“The costs of the investment cannot be added to the price of prescription medicines either, because the prices are regulated. Implementation is the key: the more efficiently a solution is implemented, the less it will eat into the margin and the competitiveness of pharmaceutical companies,” states Kemppainen.
The need for serialization has come up, because counterfeit medicines pose a significant, growing global problem. The market for falsified medicinal products eats into the business of pharmaceutical companies, not to mention their consequences to individuals, which can be highly tragic at worst.
“Due to this, a similar reform is also underway in the US where serialization will be mandatory for all health technology products. Furthermore in terms of Europe, Belgium, Italy, and Greece already use country-specific serialization solutions due to which they received six years of extra time to the joint schedule given by the EU,” says Jantunen.
Servicepoint Oy is the leading serialization automation supplier in the Nordic countries. The company was founded in 2006, but the roots of its automation expertise go back 30 years. The ServiceGroup consists of a total of six industrial service companies with extensive know-how and experience from automating hundreds of production lines for the pharmaceutical industry and other fields of industry. Based in Kuopio, Finland the company specializes in industrial automation and electrification projects, maintenance, and robotic applications.
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Directive 2001/83/EC on the Community code relating to medicinal products for human use, which was amended by the Falsified Medicines Directive (FMD) 2001/62/EU. On 2nd October, the European Commission adopted a delegated regulation concerning safety mechanisms, which will be issued in Q1/2016.
CTO, Chief Technology Officer
Servicepoint Kuopio Oy