In the US mandatory serialisation of prescription drugs will enter into force a year later than planned. Photo: pixabay.com/pexel.com
To provide effective protection against counterfeit drugs, the European Union has adopted the so-called Falsified Medicines Directive. The new regulation includes the introduction of a European-wide verification system with standardised safety features on pharmaceutical packaging. From February 2019 each package must have a unique serial number that will make it fully traceable. Also, original closures must ensure that the risk of counterfeiting is reduced to a minimum along the entire the supply chain.
The on-time implementation of the Falsified Medicines Directive is posing a major challenge to pharmaceutical companies. All processes along the supply chain will need to be adjusted, and more money will have to be invested in IT, machinery, equipment, packaging and human resources. According to a survey conducted by the consultancy firm Inverto, the affected companies are to expecting pay millions and want to be well prepared for the new regulations.
Up to now 82 per cent have started taking the necessary measures, and 18 per cent have implemented the new rules. Just over half of all respondents reckon that investment costs are between one and five million euros, while 12.5 per cent are expecting to invest between ten and 100 million euros. 25 per cent are anticipating even higher expenses. A large proportion of respondents (68 per cent) said they found it difficult to estimate the costs. Will it be necessary to invest more in machinery, IT, software, the process chain or perhaps production or logistics?
Another sticking point is the time frame, as it would apparently take one or two years to implement company-wide serialisation solutions. This is due to complicated IT interfaces, capacity bottlenecks among software suppliers and long delivery periods for machinery. In addition, there is a scarcity of human resources within the affected companies themselves. One important step, according to experts, is to engage the assistance of the purchasing department as an interface and to do so well in advance.
A bitter pill for the pharmaceutical industry: the Falsified Medicines Directive requires major investment costs. Photo: pixabay.com/pexel.com
The American way
The level of complexity that is involved in serialising prescription drugs recently showed itself in the decision of the US Food and Drug Administration (FDA), when it postponed the original launch of the US regulation (27 November 2017) by one year. This is because so many pharmaceutical and contract manufacturers (CMOs) are not sufficiently well prepared to implement the new law on the originally specified launch date.
The software supplier Advents, however, reminds companies that the postponement urgently needs to be used not merely to meet short-term compliance requirements but also to check the feasibility of long-term options. This should include, for instance, a move towards more flexible serialisation solutions that are not dependent on hardware and which will eventually allow adjustments, so that track & trace requirements can be accommodated.