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Interim Partners, a provider of interim managers, claims that pharmaceutical companies in the Europe are racing to comply with new EU regulations which will mean that they will need to completely overhaul the packaging, distribution systems, and tracking of all of their drugs.
Similar regulations are also being introduced in the US and China, which means that drugs sold by UK pharmaceutical companies in these countries will also need to meet the new standards.
All pharmaceutical companies selling drugs in the US need to be partially compliant with the FDA serialisation regulations by January 1 2015.
Global demand
By the beginning of 2017 all drugs sold in the EU must comply with the EU ‘Falsified Medicines Directive’, with the aim of helping pharmaceutical companies better identify defective drugs as well as counterfeit pharmaceuticals that pose a serious danger to public health.
According to Interim Partners, pharmaceutical companies are bringing in senior compliance staff, or 'Serialisation Project Managers', to help them meet the tough new regulations.
They report that a serialisation role can earn from £500 to £1,000 per day - depending on the scale of the project, and their rates are rising steadily as global demand outstrips the supply of experienced talent.
The World Health Organisation estimates that 10 per cent of drugs sold globally are counterfeit. Eli Lilly projects that the cost of its own serialisation programme will be $110m.
Norma Warwick-Smith, Senior Consultant at Interim Partners, said: “Pharmaceutical companies are in a race against time to ensure they comply with the new regulations. Many are finding compliance is taking longer and is far harder than previously thought which means that highly skilled interim serialisation experts are now a necessity for most firms.
“The sheer scale of many pharmaceutical companies means that the process of overhauling drug packaging systems, establishing new distribution processes and putting new tracking processes in place is a daunting task.
“When you consider that the pharmaceutical giants have production lines across many countries around the world, and then process and sell millions of packages across thousands of product lines globally – and then add in the complexity of managing all of this under one robust system – pharmaceutical companies really are facing a daunting challenge."
Burden
There is growing concern that the new regulatory burden may force many smaller pharmaceutical companies to the wall, especially if they haven’t yet started to take the serialisation regulations seriously. Those businesses have to start their serialisation programmes now or it is felt that there will be insufficient time to comply with the EU deadline in 2017.
Norma Warwick-Smith said: “Serialisation experts will be the driving force behind creating and putting in place the right systems that will help to fight against counterfeit pharmaceuticals and shore up the safety of drugs being consumed globally.
“Serialisation is going to have a major impact on the industry, which means experienced and talented professionals that can take this work on a project basis and have the experience needed to bring the company into line with the new regulations are highly sought after.”
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Susie Hughes © Shout99 2015
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