FMD plus Brexit equals potential supply chain disruption

The double whammy of the Falsified Medicines Directive and Brexit in quick succession risks a Europe-wide shortage of medicines, according to a European industry body.

The concern was voiced at the European Industrial Pharmacists Group’s (EIPG) general assembly this month, where two working groups reviewed the implications on European industrial pharmacists of Britain leaving the EU and the introduction of supply chain track and trace regulations.

The Falsified Medicines Directive (FMD), which requires pharmaceutical manufacturers to apply a 2D serialisation barcode to medicines packs to ensure authenticity and supply chain traceability, is due to come into force on 9 February 2019, while Britain is due to leave the EU on 29 March 2019.

According to EIPG president Claude Farrugia: “Since the Falsified Medicines Directive deadline coincides with Brexit, this exacerbates the potential risk to the availability of medicines.”

There have been several reports that note a lack of readiness within the pharmaceutical industry, and even within healthcare systems, in regards to the FMD, which could cause problems. In addition, the uncertainty around Brexit has muddied how the FMD will be implemented in the UK even though it is now part of UK legislation.

Of particular concern for EIPG is the impending deadlines and increased serialisation activities, and the pressure this will place on Qualified Persons in pharma companies, those people responsible in certifying the quality assurance of medicines before their release onto the market.

Because companies are required to adapt their supply chain process and quality systems in order to be compliant with FMD, this will produce challenges and directly impact the roles and responsibilities of Qualified Persons.

Speaking exclusively to SecuringIndustry.com, Giorgos Panoutsopoulos, vice-president for communications at EIPG, said the new serialisation regulations meant there was “a greater need for Qualified Persons to have the knowledge and skillset to assume the responsibilities of their position” for releasing products to the market, which will have to be acquired in a short time because of the impending deadline.

“Industrial pharmacists are of course doing their best to prepare themselves, but the learning curve is going to be a steep one, and implementation timelines very tight, especially in those countries that are lagging behind in their preparations,” he said.

However, weaknesses in the supply chain should be anticipated, he added.

“The provisions of the FMD stipulate that the safety features are to be applied to prescription-only medicines, and therefore it is natural that the supply chain is going to experience greater challenges for these types of products,” Panoutsopoulos said. “From the point of view of Brexit, older products, particularly those belonging to SME’s are also at greater risk. Every product has to be assessed on a case-by-case basis, but what is important is that in identifying solutions, one must consider simultaneously the needs for compliance of the FMD and the solutions in view of Brexit.”

 One of the most obvious complications of Brexit and FMD noted by Panoutsopoulos was where there would be shared packs between countries, including the UK. He said relatively small markets such as Ireland and Malta were particularly at risk.

“The fact that this complication in issues of shared packs comes at the same time when slightly different coding requirements, arising due to differences in national healthcare systems, are probably going to challenge supply chains in some European countries, notwithstanding flexibility in regards to the readiness to accept both single-market and multimarket packs, is a matter for concern,” he said.

EIPG was working in collaboration with national associations and other stakeholders to best support industrial pharmacists ahead of the challenges the industry will face next year, Panoutsopoulos added.

A guidance document is due to be published shortly, which will provide clarity and help Qualified Persons to assume their roles and responsibilities with a sounder background knowledge in view of the challenges arising from the FMD serialisation requirements.