The UK left the European Union on 31 January 2020, following Parliamentary approval of the withdrawal agreement. There will be a transition period until the end of 2020, while the UK and EU negotiate additional arrangements.

The UK’s exit from the EU could have wide-ranging implications for medicine supply, science and research and the health and care workforce.

Whatever happens in the coming months, we know that pharmacists will be working tirelessly to put patients first and help ensure they receive the best possible care.

We are continuing to talk to the Government about how Brexit might affect the pharmacy profession, including looking at measures to enable pharmacists to provide the best access to medicines in the event of potential shortages.

A range of information has been published by the Government and NHS relating to Brexit and we’ve collated some of the key topics below. 

If you have other questions, contact our One-to-one Support Service.

Our answers to common Brexit questions

I am an EEA-qualified pharmacist, what does Brexit mean for me if I want to work/continue working in the UK?

The Government has said EU or Swiss qualified persons entering the UK after Brexit may have their qualifications recognised, whether we leave the EU with or without a deal.

Legislation introduced on 7 March 2019 means pharmacists with professional qualifications from EU and Swiss institutions will continue to be recognised by the General Pharmaceutical Council, meaning those who are currently registered can continue to practise in the UK as they do now.

Employment contracts will not need to be changed if the UK leaves the EU without a deal, and staff won’t have to reapply for their current positions after exit day.

If you’re an EU citizen, the government encourages you and your family to apply to the EU Settlement Scheme to continue living in the UK. Find out more about the EU Settlement Scheme.

How do I deal with a prescription issued in an EEA member state or Switzerland?

The Government has issued guidance for pharmacists that will take effect if the UK leaves the EU with no deal. In this event, a prescription issued in an EEA member state or Switzerland can be dispensed in the UK if the prescriber is from a profession recognised by this guidance that is legally entitled to issue a prescription of that kind in the country in which the prescription is issued.

We also have a pharmacy guide on dealing with EEA prescriptions.

Am I still legally required to comply with FMD requirements post Brexit?

The Falsified Medicines Directive (FMD) aims to create a system that ensures medicines supplied in the UK are safe. This will include new security features on individual packs and a new electronic scanning authentication process.

If the UK leaves the EU as part of a negotiated agreement (with ‘a deal’) then it is expected that FMD will continue to apply during any transition period.

In the event that the UK leaves the EU with no deal in place, the legal obligation to comply with FMD would no longer apply. In this event it is possible that 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. 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 has stated it would evaluate the options around a future national falsified medicines framework, which would inform the detail of any short or longer-term modifications. Further information is available on the FMD Source website.

You can also read more about FMD in our FMD pharmacy guide.

What is a Serious Shortage Protocol?

Medicines shortages can have a huge impact on patients and healthcare professionals involved in their care.

A Serious Shortage Protocol is intended to speed up patient access to appropriate treatment and reduce pressure on the prescriber, most likely GPs, in the event of the prescribed medicine being in serious shortage.

Currently, if a pharmacy cannot obtain a medicine that is on a prescription, it will either send the patient back to the prescriber or contact the prescriber to discuss an alternative and get the prescription changed.

Legislation has been passed that would enable Ministers to issue protocols that would enable community pharmacies to dispense against a protocol instead of a prescription without going back to the prescriber first.

Each protocol would clearly set out what action can be taken by the pharmacist, under what circumstances, for which patients and during which period. In cases where a substitution might not be appropriate, or where the patient does not consent to a change, patients would be referred back to the prescriber.

You can read more about the Serious Shortage Protocol in this NHS FAQ

The NHS Business Authority publishes details of any SSPs currently issued, along with Operational Guidance and a detailed Q&A.

PSNC have published a briefing for community pharmacy contractors.

There is also a feature in the Pharmaceutical Journal: Everything you need to know about serious shortage protocols.

You can also read explanatory notes about The Human Medicines (Amendment) Regulations 2019 and The National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019

Will the Serious Shortage Protocol apply to any medicine that is in shortage or difficult to obtain post Brexit?

Serious Shortage Protocols would only be issued for specific medicines in the event of a serious shortage, developed on a case-by-case basis with input from senior clinicians.

Who should I speak to if I feel the Serious Shortage Protocol should apply to a particular medicine in short supply?

A Serious Shortage Protocol would only be introduced in case of a serious shortage and is only one of the tools that can be used to manage shortages. The Government has well-established processes for managing shortages in collaboration with manufacturers and suppliers, clinicians, the NHS and the Medicines and Healthcare Products Regulatory Agency.

Any medicines supply issues (regardless of whether or not they are considered to be related to EU Exit) should continue to be reported through your usual process:

Community pharmacists should continue to report supply issues via the PSNC.

Pharmacists in secondary care should continue to report supply issues via your Pharmacy Department to the specialist Regional Procurement Leads.

Where can I signpost patients with questions about Brexit and their medicines?

NHS England has published information for the public on how they will continue to receive medicines and treatment if the UK leaves the EU without a deal. 

What is being done to ensure continuity of supply?

The Department of Health and Social Care (DHSC) has been working closely with the NHS, pharmaceutical companies, suppliers of medical devices, and supply chains to make sure medicines and medical products continue to be available in the event of a no deal EU exit.

Since 2018, DHSC has been working with all pharmaceutical companies that supply prescription-only medicines and pharmacy medicines to the UK that come from, or through, the EU or European Economic Area (EEA). DHSC has been asking companies to ensure they have extra stocks available in the UK by 12 April 2019.

Where these medicines have a short shelf life, DHSC has asked companies to ensure that they can fly these medicines in from the EU in the event of no deal. The Government is procuring an ‘Express Freight Service’ – access to freight services that are able to deliver small consignments on a 24-hour basis and a two-to-four-day pallet delivery service. The NHS Supply Chain organisation is holding extra stocks of medical products.

To ensure that there will be enough space available for extra stocks of medicines and medical products, the Government has secured extra warehouse space including refrigerated and controlled drug storage that companies can use to store products.

The Government has also put in place extra shipping for suppliers to use on a variety of routes to ease pressure on the short straits crossings to Dover and Folkestone. This includes capacity on ferries to Poole, Portsmouth, Plymouth, Immingham and Felixstowe. The Government has agreed that medicines and medical products will be prioritised on these alternative routes.

Where can we go for the most up to date information on pharmacy post-Brexit?

We have published a joint statement, along with other pharmacy organisations, on the potential impact of Brexit on medicines supply.

Updated FAQs on medicines supply were published on the NHS website on 17 September 2019.

A number of other updates have been issued by Government and the NHS about Brexit over the past year, available from the NHS England website.

The PSNC website has a range of information, including guidance for community pharmacy contractors.

The MHRA has a range of guidance and publications about a possible 'no-deal' Brexit.

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