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Implementing “the safest medicines system in the world”

Published on 10/06/19 at 10:35am

With debates heating up over cooperation between European across the continent, Matt Fellows investigates the current state of packaging countermeasures in the region after delegated regulation to the Falsified Medicines Directive came into force earlier this year.

Europe seems to be a hot topic at the moment; well, certainly at least here in the UK. I’m sure you don’t need – or perhaps want – to be reminded why, but the ongoing debate has forced many of us across the continent to engage with the notion of our international relationships, our own national capabilities and limitations, and the benefits and drawbacks to cross-border cooperation on a wearying range of key issues.

While there are many challenges that are unique to nation states across the continent, there are also many that we all face, that are shared concerns and perhaps require shared solutions. Public health is one such immutable and ever-present concern that is unwaveringly universal, irrespective of national borders; all citizens have the right to authentic, effective, quality medicines, and all governments have a responsibility to provide this for their people. Because of this, the threat of counterfeit medicines is one that looms over us all, regardless of whether we choose to cooperate or not.

According to the European Commission (EC), counterfeit medicines “may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage – either too high or too low. Since they have not passed through the necessary quality, safety and efficacy evaluation as required by the EU authorisation procedure, they can be a major health threat.”

Because, by design, counterfeit medicines are hard to detect, it is difficult to get an accurate fix on their exact prevalence and the real extent of the problem, but the EC says it was notified by national authorities of 400 separate incidents involving fake medicines between 2013 and 2017, while Interpol, Europol and national medicines agencies seized almost €7 million-worth of such drugs at European Union borders in the latter year alone. According to the World Health Organization, it is estimated that around 10% of all medicines in low- and middle-income countries are falsified – a scary figure when you’re talking about public health – but the organisation claims that this figure is “much lower” in EU nations.

Still, given the potential damage they can cause, the threat of fake drugs is very real, especially considering the scale of medicines distribution in an increasingly globalised world: in any one year, billions of packs of medicines navigate the international supply chain network to find themselves in the hands of 500 million patients across Europe. Crime knows no borders, as the saying goes, and faced with this shared problem, the EU devised a shared solution: the Falsified Medicines Directive (FMD).

In the spirit of the notion that constituent players are stronger together than they are alone, the idea was to establish a traceable web of checkpoints stretching all across all 27 EU nations, through which pharmaceutical products navigating the system could be authenticated by referencing an EU-wide database, drastically reducing or negating the possibility that falsified products could find their way into the hands of patients.

The deadline for implementation of the system across the continent by nation states as required by the EC has come and gone; [Pharmafocus] reached out to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to get a picture of how adoption of this new system is going.

“Member States had until 9 February to implement the final aspect of the EU Falsified Medicines Directive (FMD), which requires two new ‘safety features’ (a 2D bar code and an anti-tampering device) to appear on the packaging for almost all prescription-only medicines for sale in the European Economic Area (EEA),” the agency said. “Since 9 February, manufacturers have been required to place the safety features on the packaging of medicines and upload the data into the European database prior to placing the product on the market. The 2D barcode then needs to be scanned at various points in the supply chain to verify that it is an ‘authentic’ medicine. On supply to the patient, the unique identifier must be ‘decommissioned’ by scanning the 2D barcode and removing the serial number from the FMD system (to prevent the same unique code being used elsewhere in Europe).”

A shaky start?

While directions from the EC were clear and the threat of falsified medicines even clearer, the European Medicines Verification Organisation (EMVO) warned in August last year that, of 2,291 companies required to comply with the incoming FMD by the February deadline by connecting to the EU database “Hub”, just 841 of them had completed the first stage of that process. As the process can take up to six months to complete in full, the EMVO said that, in order to achieve compliance in a timely manner, the last opportunity to begin this process and get on board by the deadline was June that year, and had already been missed. This meant, shockingly, that 63.3% of firms were in danger of missing the deadline.

Nine months since then and six months since the deadline, is adoption really as bad as that in the UK? The MHRA painted a reassuring picture, though one that was thin on comprehensive detail.

“The government has made the necessary amendment to put FMD into UK law and the UK has made good progress on implementation and much of the UK supply chain is already compliant,” the agency confirmed. “FMD codes are now appearing on packs and are being scanned through the supply chain. The UK’s progress is in line with other European member states.

“However, there is more to do, and we are continuing to work collaboratively with stakeholders to resolve issues and ensure FMD is implemented correctly in the UK. Relevant regulators in the UK and the MHRA are working together to make sure the new requirements are met and medicines are safe for the public to use.

The Government expects all stakeholders in the UK supply chain to comply with the safety features requirements,” the agency added, again reiterating that “indeed, we know much of the UK supply chain is compliant.”

Deal or no-deal?

It’s certainly a positive note and one that patients can take some solace in, but what good is all that if the UK were to just, say, pull out of the system that all these players have spent so much effort to make a reality? A chain is only as strong as its weakest link, but the ongoing ‘will they, won’t they’ Brexit fiasco in the UK is now bringing that strength into question. And the question now revolves primarily, not around whether the UK leaves or stays, but if it is to leave, whether it does so without or without a negotiated deal with the EU.

There are many reasons why a no-deal exit would be bad for the UK and has experts worried and pleading with government, and this is just another to add to the ever-growing pile. The conundrum was spelled out succinctly by the MHRA:

“If there is a deal, stakeholders in the UK supply chain will still be required to comply with the safety features requirements under the FMD. If we enter an implementation period, the UK would remain part of the EU-wide system, with arrangements beyond that subject to negotiation,” it confirmed. “In the event of no-deal, it is expected UK stakeholders would no longer be able to comply with the requirement to verify and authenticate. Therefore, the legal obligations related to this would be removed for all actors in the UK supply chain.”

This was confirmed by Dr Rick Greville, Director of Supply Chain at the Association of the British Pharmaceutical Industry (ABPI), in an interview with LBC’s Shelagh Fogarty on the eve of the FMD deadline. In response to Fogarty’s question: “Will we just fall out of [the system] in the event of a no-deal?” Dr Greville replied: “We will, that’s the disappointing part of the story. Under a no-deal Brexit, we understand that the UK Government will revoke the legislation that will come into play [on 9 February], because when we’ve left Europe, packs of medicines headed for the UK will actually be heading for a ‘third country’.

“For a transition period: different scenario,” he continued. “The pharmaceutical industry has been very strong and persistent in terms of its ask for a deal scenario, and this is the scenario we find ourselves in in this case. We are asking for a deal and at least a movement into a transition or implementation period, during which time this system will still be operable.

“It is important in terms of patient safety because it adds that extra layer of protection for patients with regards to counterfeit medicines.”

In the event of a no-deal scenario, “packs containing the FMD safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements,” the MHRA said. “In the interests of public safety, we will evaluate the options for a future UK falsified medicines regulatory framework, taking into account the investment already made by stakeholders.

“The MHRA has published further guidance following its EU exit consultation which made it clear that the UK would evaluate the options for a future UK falsified medicines regulatory framework in the event of a no-deal, taking into account the investment already made by stakeholders. We aim to give businesses and individuals as much certainty as possible; further information as required will be published as soon as we can.”

It doesn’t take an expert to see what’s at stake. Dr Greville went on record on the same day as his LBC interview on the ABPI’s website, arguing: “It would be an absolute travesty if NHS patients aren’t part of a system specifically designed to protect them. But that’s exactly what could happen in a no-dea’ Brexit. It is just another reason why we urgently need a Brexit deal.”

This sentiment was echoed by Mike Thompson, the ABPI’s Chief Executive: “‘No-deal is not in the interest of the NHS or its patients. Not being part of the safest medicines system in the world, one that the UK has helped design and build – and which provides protection against fake medicines – makes no sense. Being part of a system that keeps them safe is the minimum that UK patients should expect.”

If you weren’t perturbed already by the current political circus in the UK (and you’d be spoilt for choice on reasons why to be), damning statements like these from two of the UK’s most prominent pharmaceutical industry figures adds even more fuel to the fire. Even with the numerous ‘noble’ efforts by Prime Minister Theresa May to secure a deal prior to her resignation, no matter the concessions, and despite repeated warnings from industry experts, the Brexit debacle looks to be on the verge of a sinister turn, as political forces move to hijack the debate and steer the country towards a no-deal exit under the guise of the old ‘will of the people’ axiom. Ask even the most fervent Brexiteer and I think you would struggle to find one who would argue in good faith that withdrawal from this progressive EU-wide project would be a good idea for the people of the UK.

Still, in the end, we may just have to keep calm and carry on. Even if the worst comes to pass, we’re in safe hands: “The MHRA is working with NHS Improvement in the UK and globally with the International Medication Safety Network to deliver best practice in the area of packaging design to deliver safer packaging for all markets,” the agency said.

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