The EU's Falsified Medicines Directive (EUFMD) has been on the cards for a while. First proposed in December 2008, and approved in February 2011, the directive aims to stop counterfeit drugs from entering the supply chain and to save lives across Europe in the process.
"Falsified medicines are silent killers, either because they are devoid of effect, or because they contain toxic substances that may harm or even kill those who take them," said Marisa Matias, an MEP involved in drafting the directive at the time it was approved.
The need for such a directive is not in doubt. Counterfeit drugs, generally speaking, pose far more of a problem in the developing world than they do in Europe. The World Health Organization (WHO) estimates that in industrialised countries, fewer than 1% of the drugs in the supply chain fall into this category, largely due to effective regulatory systems and adequate market control.
Regardless of regulations, wherever there is legitimate pharmaceutical trade, there will be scammers looking to make a profit and European patients and consumers are not invulnerable.
"Pharma crime poses a major threat to public health and safety, and according to every agency - from WHO to Interpol - the counterfeiting of medicines in the EU is on the rise and accounts for the biggest hauls year on year," says Sid Dajani, chair of the Royal Pharmaceutical Society's Falsified Medicines Directive Stakeholders Group.
"These aren't just the expensive lifestyle meds like Viagra, Xenical and Cialis, but cheaper, high-turnover generics like Omeprazole, partly due to medicine shortages. And although most counterfeit medicines in Europe are acquired through illegal internet sources, as the counterfeiters become more sophisticated in their methods, the risk of a fake medicine entering the legal supply chain is a real one."
EUFMD is intended as a key line of defence against the scammers. It aims to guarantee the authenticity and safety of medicines, by ensuring that all packs include features such as a unique serial number and tamper-evident packaging. This will enable the pharmacist to verify the legitimacy of a drug before it reaches the patient. Additionally, to protect customers buying drugs online, there will be a standard EU-wide logo to identify legal online pharmacies.
Targeting weak links
The directive will target every point in the supply chain, from manufacturers to pharmacies, to ensure there are no weak links. For instance, the producers of active pharmaceutical ingredients will be subject to tougher rules and inspections, while wholesale distributors will face strengthened record-keeping requirements.
"We need to ensure what's implemented doesn't increase risk through excessive workload or bureaucracy, increase waste or introduce risk in other areas of our practice," says Dajani. "We also must ensure that what's implemented must not delay the flow of medicines into pharmacies and then out into the hands of patients. Therefore, having an efficient system is a must, not a luxury, because whatever goes wrong further up the chain will affect what pharmacists can deliver."
While this directive has been welcomed, implementation is fraught with challenges, especially given the patchwork of jurisdictions within the EU. The first step along the way, reached in January 2013, was for each member state to transpose its wording into national law, helping pharmaceutical stakeholders within each country understand what they needed to do.
Beyond this, most of the specifics were still open to question. It wasn't until August 2015 - some time behind schedule - that the European Commission released its draft rules for the implementation of safety features. When this draft is published in its final form, the pharmaceutical industry will have three years left to comply. It is thought the requirements will finally come into force in early 2019.
"What's implemented will be key in deciding whether this is a monumental, much-needed success story or another expensive failure of epic proportions, and we have no time to waste," says Dajani. "There really is much left to do in the UK, even though we have central European support. Each country is different, and we will be fined for not delivering on time so we must be up and running from the first day we are meant to be live."
The Commission is proposing the use of 2D barcodes as product identifiers, that will provide information about each unit's serial number, product code, batch number and expiry date. In general, prescription-only medicines will need this barcode, whereas over-the-counter medicines will not. There are, however, various exceptions to the rule. The document includes a whitelist of prescription drugs, that are exempted from the need for barcodes, and a blacklist of over-the-counter drugs, that are subject to greater checks.
The verification process is truly end to end. Manufacturers will need to keep scrupulous records for at least a year after the expiry date of the pack and there will be additional risk-based checks at the wholesaler level. In the final step of the process, pharmacies and hospitals will need to scan the product and check the unique serial number against a database.
"What's key to making this work is authentication software training and interoperability with all software systems," explains Dajani. "While the best protection for the way ahead is being sold as a sugar plum fairy, there will be many iron maidens in the shadows, and we want to ensure whatever is implemented works. This requires a great team effort, respect for each player and consideration of their situation in finding the best workable solution."
While three years may seem like a long time, there is plenty to do before we get there. Judging by the precedent set in different parts of the world, serialisation has a tendency to take longer than expected. And while most major pharma companies, which have operations in markets such as China, are well equipped to implement the new requirements, it may be sink or swim for smaller organisations that lack experience in setting up these kinds of systems.
Even for larger companies, there are no grounds for complacency. Speaking to In-Pharmatechnologist in February, TraceLink's vice-president, Brian Daleiden, suggested that three-quarters of the top European pharma companies were falling behind on meeting the implementation deadline.
He pointed out that with many different packaging lines to bring up to date and several facilities requiring new equipment, the transition may prove expensive and time-consuming. Moreover, should they choose to work with a contract packager, that company is still going to have its own priorities and schedules, so it is not necessarily going to jump when they say jump.
Dajani feels it is important to incorporate three key aspects: governance, operational nous and strategic capability. He feels there should be more onus on national governments to publicise "the FMD meteorite hitting planet earth", and that there should be more clarity as to how pharmacists will be resourced for the extra work and change management required.
While the EUFMD could change the face of the pharmaceutical supply chain, all stakeholders will need to pull together to ensure it comes to pass without glitches.
"The challenge is we need a system that works, can cope, is hack-proof, separates legitimate market authorisation holders from bogus ones and continues to meet the spiralling demand of ever-increasing pharma crime," says Dajani. "It may seem far away, but the time for action is now. Things are now moving at a pace - there are no pilots or dry runs and no bedding-in time. I believe in having better clarity in 2015 than confusion in 2017."
