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 September, and the MHRA has published the following document which provides their official response to the more than 50 replies received from a wide range of stakeholders.
Overall, the responses broadly supported the Government’s proposed positions regarding the level of sanctions imposed and on each national flexibility, where the UK has legal scope to make changes. Therefore, the Government intends to implement as per the positions proposed in their consultation, with the exception of Article 26(3), which exempts those within a healthcare institution from decommissioning under certain conditions. The Government did not originally see any benefit of applying this flexibility, but now understands it could be beneficial for certain healthcare institutions, in line with the criteria fixed in the Delegated Regulation.
What happens following Brexit?
FMD is the European approach to dealing with the rising global issue of falsified medicines. Like similar systems introduced in other major markets, including China and India, it involves individual serialisation of medicine packs and an associated authentication system.
The UK submitted the notification of its intention to withdraw from the European Union pursuant to Article 50 of the Treaty on European Union on 29 March 2017. Until exit negotiations are concluded, the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force. The FMD Delegated Regulation will apply automatically in all EU Member States and therefore, as of 9th February 2019, these new requirements will be directly applicable as part of UK
DHSC and MHRA have stated that the UK aims to maintain “high regulatory alignment” with the EU and that this includes FMD. In the Final consultation response: FMD features, published on 24th December 2018, Government stated:
The UK and EU negotiating teams have reached agreement on the terms of an implementation period that would start on 30 March 2019 and last until 31 December 2020, during which time the UK would continue to abide by all requirements of the FMD, including the Delegated Regulation on safety features. We firmly believe it is in the interests of both the EU and the UK to strike a deal. That remains the goal on both sides and we are confident that this will be achieved.
Looking beyond the intended implementation period, the UK’s position on medicines regulation, including identifying and removing falsified medicines from the legitimate supply chain, remains clear. We want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines.
The rejection by Parliament of the proposed Brexit deal in mid-January 2019 means it is currently uncertain whether the UK will exit the EU with or without a deal.
What happens if there is a no-deal “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.
In the Government’s Final consultation response: FMD features, published on 24th December 2018, it said:
“In the event that the UK leaves the EU in March 2019 with no deal in place, and as
stated in the Agency’s broader consultation, on which a formal response is expected
in due course, 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 confirms while in a no-deal Brexit, the legal requirement to comply with FMD would be removed, but given the global nature of falsified medicines and the fact that the UK remains a major part of the pharmaceutical sector, the UK would consider adopting its own pack serialisation system 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.