With news that the Falsified Medicines Directive (FMD) was transposed into UK legislation and came into force yesterday, it’s now time for pharmaceutical manufacturers to stop talking and start acting, says Craig Stobie, Global Life Sciences Sector Manager at Domino Printing Sciences.
Adopted in 2011 and aimed at stemming the flow of falsified medicines reaching the open market within the European Economic area, the EU Falsified Medicines Directive (FMD 2011/62/EU) will, within a few years, completely change the landscape of the European pharmaceutical business model. The scope of the Directive places new obligations on all branches of the industry – manufacturers, generics producers, contract packers, re-packers and importers – amongst which is the unique identification of products at unit of sale level.
In 2011 Domino established a European Group dedicated to helping manufacturers comply with the Directive. The Group consolidates Domino’s industry-leading expertise in pharmaceutical legislative compliance solutions and comprises specialists in all the critical disciplines, including legislative standards, validation of automated manufacturing good practice, code formats and serialisation.
Compliance with the directive has always been a race against time, says Stobie, but now UK manufacturers need to stop playing a waiting game and start working with suppliers. With there being few pilot projects that have achieved the full extent of the FMD, there are no solid examples for manufacturers to learn from; so building on trusted relationships with suppliers and industry experts will enable manufacturers to make confident decisions on how best to comply.
It is always tempting to push investment costs into the next financial year but it is key for manufacturers to realise that implementing serialisation is not a straightforward engineering job. In some respects it is similar to a regular installation but in others it’s vastly different: getting a serialisation-ready line back to ‘business as usual’ standards has proved to be a challenge in pilots, with high levels of rejects and low line speeds cited as key problems that take time to overcome.
However, it’s not all bad. Item level serialisation as a result of the FMD, if done well, will raise OEE levels and in addition to improving consumer safety it can potentially increase patient engagement, leading to improved adherence and patient experience.
My top tips when preparing for FMD, and other emerging legislation, are to get your senior colleagues involved – senior stakeholder engagement is essential as serialisation will affect most if not all business functions during implementation, with a dip in efficiency across all departments a real risk. Getting your business leaders to understand this will go a long way to getting teams working together to make compliance a company goal.
Invest too in training – make time to train engineers and operators in optimising lines and don’t be afraid to champion the idea of a pilot line for staff to work on. Furthermore, don’t be reluctant to share best practice; the directive is making an industry wide impact and it will help to take a collaborative approach with other companies.