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 the current state of play on FMD and considers the impact that the UK leaving the European Union might have.
Setting up the UK system
The UK has made solid progress towards being ready for FMD. Following the publication of the Delegated Regulation, the UK Medicines Verification Organisation was formally established 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.
Each community pharmacy in the UK will need to connect to the SecurMed UK FMD system. The process of identifying legitimate pharmacies and granting them an account to connect is known as registration or “on-boarding”. This can’t be done until you have decided which FMD IT system you will be using.
Since 31st October 2018, community pharmacies have been able to register with SecurMed by visiting https://www.securmed.org.uk/register/end-user-registration/.
The DHSC/MHRA consultation
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 responded to the consultation.
The consultation closed in late September 2018 and the responses to it are currently being considered by DHSC and MHRA; a decision on the various matters consulted on, including enforcement and sanctions, will be made in due course.
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. 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 aims to 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.
What happens if there is a hard-Brexit?
In October 2018, the MHRA consulted on how legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no implementation period (“transition period”). This consultation covers no-deal proposals on medicines, clinical trials and medical devices.
On FMD, the consultation document said:
“In a no-deal, we expect the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK. Therefore, the legal obligation related to this would be removed for actors in the UK supply chain. Packs containing the FMD safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements. In the interests of public safety, we will evaluate the options around a future national falsified medicines framework, which would inform the detail of any short or longer-term modifications.”
This consultation confirms the UK Community Pharmacy FMD Working Group’s expectation that given the global nature of falsified medicines and the fact that the UK remains a major part of the pharmaceutical sector, the UK would have to consider adopting pack serialisation in order to maintain its reputation as a safe part of the medicines supply chain.
Implications for pharmacy contractors and contracts for FMD systems
The UK Community Pharmacy FMD Working Group advises 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 circumstance there is no workable UK FMD repository following Brexit.