The Falsified Medicines Directive – Preparing for Change

The sale of counterfeit or falsified medicines pose a serious threat to patient health. The Falsified Medicines Directive (FMD), requires complete compliance by February 2019 and mandates the systematic authentication (scanning) of medicines at the point of supply to the patient, in an effort to identify counterfeit, falsified, recalled or expired drugs. At Evolve Clarity, we understand the changes and realise where implications lay and problems may arise – we offer innovative solutions in order for compliance to be met by those companies affected.

Pharmaceutical medicine
Pharmaceutical medicine

The Falsified Medicines Directive (FMD) introduces tough rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled.

Falsified medicines are a major threat to public health and safety. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year. Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level.

What are falsified medicines?

Falsified medicines, put simply are fake medicines that pass themselves off as real, authorised medicines. They might contain ingredients, including active ingredients, which are of bad quality or in the wrong dose – either too high, or too low. As they have not been properly evaluated to check their quality, safety and efficacy – as required by strict EU authorisation procedures – this could be detrimental to patient health. Following adoption by the Council and the European Parliament, the Falsified Medicines Directive was published and has been applied since 2 January 2013.

The World Health Organization (WHO) advise that up to an estimated 1% of medicines available in the developed world are likely to be counterfeit – increasing to 10% globally. With the Pharmaceutical market being worth Billions, it is an attractive place for criminals to intersect supply chains in order to put illegal and potentially dangerous medicines into circulation. With an increasing number of patients now using medicines that are manufactured around the world, the risk of medicines being used with a lower amount of active ingredient or even containing a toxic substance is increasing. Not only does this pose the risk of increased levels of patient harm, but this ‘black market’ of medicines also undermines innovation of exclusive products on the market and carries damaging effects to the economy.

In order to make it easier for all those involved in obtaining and distributing medicines, the FMD has introduced new rules and regulations to help prevent any unclassified, counterfeit or falsified coming into the market.

In line with the new rules, all medicines will be required to hold a unique serial number which will be applied at the point of manufacture, and this will almost certainly be displayed on the pack via a 2D barcode.  All prescription-only medicines will be included unless a risk assessment excludes them – a ‘white list’ has been created to include prescription-only medicines that are exempt from the serialisation. All over-the-counter medicines will be excluded apart from those considered to be a vulnerable product – these products will appear on the ‘black list’. The unique serial number for each item will then be placed on to a database.

Falsified medicines are a major threat to public health and safety. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year.

Prior to patient supply, the product can then be scanned to ensure the unique number is registered on the database. This serial number will be marked on the database so that it cannot be used to authenticate any other products. Products must also have a tamper-proof seal.

The delegated act Commission Delegated Regulation (EU) 2016 details the characteristics of the safety features, how medicine authenticity should be verified, and by whom. It was adopted on 2nd October 2015 and published, after some scrutiny by the European Parliament and the Council, on 9th February 2016.

Many stakeholders within the Supply Chain have already adopted strategies on how to work alongside the new directive. Brand manufacturers, Pharma wholesalers, traders and Pharmacies who will use the system on a daily basis, argue that they should take lead on this important IT project – rather than it be controlled centrally by the EU Commission. In response to the opposition, the leading bodies within the supply chain (including the Pharmaceutical Group of the European Union, on which the National Pharmacy Association, the Royal Pharmaceutical Society and the Pharmaceutical Society of Northern Ireland) are developing a stakeholder-led model for the authentication process.

By using this model, it has been suggested that manufacturers will input unique serial numbers into an EU Hub Main database. This will then supply the numbers to a stakeholder-led database in the local market –  thus accommodating parallel trade and manage multi-country packs of medicines. Stakeholders have agreed that ownership of commercial data held is retained by those who put it there in the first place – data such as pharmacy dispensing data.

Other new measures include:

  • Obligatory safety features on the outer packaging of the medicines, to be detailed via a delegated act;
  • A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union;
  • Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and
  • Strengthened record-keeping requirements for wholesale distributors

The Delegated Regulation, and the new medicine verification system it lays down detailing the characteristics of the safety features, how medicine authenticity should be verified, and by whom, was published on 9thFebruary 2016.  The Delegated Regulation, sets in motion the Europe wide implementation of the Falsified Medicines Directive legislation. The new regulation introduces both digital and physical safety features to the packaging of medicinal products for human consumption.

Experts agree that The FMD is a ‘win’ for government, the pharmaceutical industry and for patients, but they warn that it remains to be seen how the change will affect the secondary care environment.  Medicine authentication is not a novel concept in all European countries; Belgium, Greece and Italy have been scanning individual medicine packs in primary care for a number of years. In secondary care however, this process is new and implementation may prove to be a greater challenge.

Some UK hospitals are acutely aware of the importance to act, and have already been working on a national level to prepare for compliance. A large UK NHS Trust for example, has already implemented authentication technology in an effort to learn and influence ahead of the 2019 deadline.

Overall, the Regulation is being seen by many as the most significant change to the pharmaceutical industry impacting on patient safety in decades. The publication of the Delegated Regulation means that each EU Member State will have 3 years to implement the necessary changes and protocols and is acknowledged as a big step forward for the safety of EU medicines and the protection of public health in the EU.

Tony Mottram, Managing Director of Evolve Clarity said:

“We hold a great amount of experience and knowledge in the Pharmaceutical industry. Our experience tells us that the impending legislation will create many challenges for those organisation’s that haven’t already started to consider the impact of FMD in their business”.



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