The EU Falsified Medicines Directive will introduce major changes for community pharmacists across the UK when its requirements for medicines verification are introduced from 9th February 2019. This page sets out what has happened recently and considers the impact that the UK leaving the European Union might have.
Discussions have been going on in Europe for over a decade about how to deal with the rising tide of falsified medicines. This culminated in the adoption of the EU Falsified Medicines Directive [2011/62/EU] in 2011, setting out a route towards placing “safety features” on every pack of prescription medication sold in Europe.
Although unlicensed internet sites have now become the main route for trading falsified medicines directly to the public, the issue remains a real one for the legitimate medicines supply chain. Regulatory authorities across Europe continue to find and report incidents of falsification identified by pharmacies and wholesalers. With large volumes of medicines being traded across European borders under free movement rules (the parallel trade market is estimated to be worth around €6bn a year), concerns remain that falsified packs containing little or no active ingredient, or harmful ingredients, could still reach patients.
Establishing the systems
The European Hub (or European Medicines Verification System, EMVS) has already been established. It was set up under what is known as the European Stakeholder Model (ESM) under a governing body, the European Medicines Verification Organisation, EMVO), that consists of equal representation from the European associations for research-led manufacturers (EFPIA), generic manufacturers (Medicines for Europe), parallel traders (EAEPC), wholesalers (GIRP), and pharmacies (PGEU).
The EMVO has established a “blueprint model” for setting up national verification systems that is designed to ensure a degree of standardisation while also promoting competition and reducing costs. Three companies, each with experience in major IT projects and serialisation, were selected as preferred “Blueprint Service Providers” (BSPs) – they are Aegate, Arvato and Solidsoft Reply. Of these, Solidsoft Reply has been selected to provide the EMVS hub. Note: Since the start of the process Aegate has withdrawn from the market.
Progress to date in the UK
The UK has been making solid progress towards being ready for FMD. Following the publication of the Delegated Regulation, the existing cross-sector working group was formally established as the UK Medicines Verification Organisation, under the name SecurMed UK. This body has five voting directors; one each from research-led manufacturers (ABPI), generic manufacturers (BGMA), parallel traders (BAEPD), wholesalers (HDA) and “dispensing entities” – currently held under a joint agreement between the National Pharmacy Association and the Company Chemists’ Association.
SecurMed UK selected Arvato as their Blueprint Service Provider and they entered into a contract for provision of the UK FMD system in July 2018. Community pharmacies should be able to start getting connected to the system from September 2018. Once details on how this “on-boarding” process will operate are available, they will be communicated to pharmacy contractors.
What happens next in the UK?
The Delegated Regulation is binding on all Member States of the EU once it takes effect from 9th February 2019. However, there are a few areas where each country can make adjustments that are relevant to its own supply chain model. Governments also get to set out the enforcement regime and the potential penalties for not complying with FMD.
The Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) initiated a public consultation on 16th July 2018. The Community Pharmacy Working Group and pharmacy bodies will be responding and we also encourage pharmacy contractors and LPCs to be involved in the consultation process.
What happens following Brexit?
FMD is the European approach to dealing with the rising global issue of falsified medicines. Like other major markets, including China and India, it involves individual serialisation of medicine packs and an associated authentication system.
The European Directive and the Delegated Regulation are binding on all EU and EEA Member States. Switzerland is also adopting FMD and pack serialisation. As it currently stands, FMD scanning will come in to effect before the UK leaves the European Union.
DHSC and MHRA have stated that the UK will maintain “high regulatory alignment” with the EU and that this includes FMD. In a letter to SecurMed UK written in April 2018, DHSC stated:
“However, even if we do not achieve our desired future relationship with the EU, the European Union (Withdrawal) Bill will ensure that, as far as possible, the same rules and laws will apply in the UK after exit as the day before. The Bill will convert existing direct EU law, such as EU regulations, into UK law as it applies in the UK at the date of exit. It will also preserve the laws we have made in the UK to implement our EU obligations, such as laws made to implement the FMD. This means that the duties of the regulations under the FMD would continue to apply, unless specifically revoked.”
In a written answer (10th July 2018) to a Parliamentary Question asked by Baroness McIntosh of Pickering, DHSC stated:
“The United Kingdom will still be a Member State of the European Union until 29 March 2019 and, in line with our existing obligations, will therefore be required to implement the Falsified Medicines Directive (FMD) Delegated Regulation before 9 February 2019.
When the UK exits the EU, the Withdrawal Bill will convert existing EU law into UK law and preserve the laws we have made in the UK to implement our EU obligations. This means that the duties of the regulations under the FMD would continue to apply, unless specifically revoked.
Furthermore, on 19 March 2018, the Secretary of State for Exiting the European Union confirmed that the UK and EU have agreed a fixed implementation period of 21 months, lasting until December 2020. During this time, access to each other’s markets will continue on current terms, including all aspects of FMD, providing certainty for businesses and citizens across the EU and UK, and time to prepare for the future.”
DHSC and MHRA have stated that they are continuing with work to implement FMD in the UK and this is “business as usual” for them.
Given the global nature of falsified medicines and the fact that the UK remains a major part of the pharmaceutical sector, we believe that the UK would have to adopt pack serialisation in order to maintain its reputation as a safe part of the medicines supply chain. At present, it seems likely that this would be the European FMD system.
Implications for pharmacy contractors
Following its latest meeting in July 2018, the UK Community Pharmacy Falsified Medicines Directive (FMD) Working Group is advising pharmacy contractors that uncertainties related to Brexit mean that all pharmacies need to carefully consider which FMD system they choose to verify the authenticity of the medicines they supply from 9th February 2019.
The group recommends that whatever system pharmacies choose, they ensure that termination of the contract without penalties is possible, in the remote possibility there is no workable UK FMD repository following Brexit.
Continued access to the EU FMD hub will depend on the future relationship between the UK and the EU. Access is likely to continue during the transition period, and if the UK government realises its aim of a close alignment on medicines policy within the Brexit agreement, it will continue after 2020 too.