The focus for our members for many months has been to ensure uninterrupted medicines supply for all patients, whatever Brexit we end up with, including ‘no deal’.
This includes increasing stocks of medicines where possible, duplicating processes here and in the EU, planning alternative routes and reviewing supply chains. Manufacturing plants are running for extra hours and into the weekend.
Not everything is in the control of pharmaceutical companies. To ensure all medicines reach all patients we need to be able to get medicines across borders as quickly as possible, especially those with special requirements, like cold storage, short shelf lives or personalized medicines containing DNA.
However, despite all of the preparations that have been made by pharmaceutical companies, there a range of things outside of our control. This means that we remain concerned that should the UK leave the EU without a deal, there could be some disruption to the supply of some medicines. It is therefore crucial that a 'no deal' Brexit is avoided.
The ABPI has called on the UK Government to implement a temporary restriction on parallel exports from the UK to the EU in advance of a possible ‘no deal’.
What is parallel trade?
Parallel trade is the legal cross-border sale of goods within the EU by traders outside of the manufacturer’s distribution system, without the manufacturer’s consent. Parallel traders buy goods in one EU Member State at a relatively low price and subsequently resell them in another Member State where the price is higher.
In the case of pharmaceuticals, such arbitrage is incentivised by variations in drug prices between EU/EEA Member States.
Why are we calling for a restriction?
We need to make sure that, in the event of significant currency fluctuation in advance of the UK leaving the EU without a deal, middle men don't sell medicine stockpiles into the EU for profit. We believe it's important the Government puts a restriction out on parallel exports of medicines to make sure that those we've got for British patients can stay and be used for British patents.
The restriction would cover parallel exports – not all pharmaceutical exports – only up to the date of a possible ‘no deal’. The EU has made clear that, if the UK leaves the EU without a deal, parallel exports into the EU would not be possible as the UK would be outside of the single market.
The UK Government has provided a range of guidance to support companies to make all necessary preparations.
The Government has published an online tool to support businesses prepare for the UK leaving the EU. The tool aims to guide businesses to the most appropriate advice via a series of 7 questions.
The Border Delivery Group has also published a ‘Partnership Pack’ to support businesses to plan around importing and exporting goods.
If your business will need to process your own customs declarations and/or need to change your IT systems to comply with customs processes, you may wish to apply for funding to help train staff or update your systems. More information about this can be found here.
Businesses may also need to take action where personal data is transferred from the EU to the UK. The Information Commissioners Office has published further guidance.
The Department of Health and Social Care published Planning for a no-deal Brexit: information for the health and care sector.
The Government has also published the following:
The ABPI continues to work closely with the Government as part of this programme. The programme team can be contacted at email@example.com.
Any questions regarding clinical trial and clinical investigation supplies should be sent to firstname.lastname@example.org.
Government has detailed process maps outlining all necessary steps for importing and exporting goods in a ‘no deal’ Brexit. Instructions are given for hauliers, carriers and UK Government representatives.
The Government have published a number of ‘technical notices’ to support companies on how to prepare for Brexit if there's no deal. These technical notices provide information on issues including:
For more information on ‘no deal’ Brexit and medicines, contact the Department of Health and Social Care (DHSC).
The Government is working with organisations who sponsor clinical trials, including industry. The Government has published this guidance on the Supply of Investigational Medicinal Products for clinical trials in the event of a no-deal. In case of questions, please contact email@example.com
The MHRA has published a range of guidance to support companies to prepare for the UK to leave the EU.
The European Medicines Agency has published a range of guidance to support companies to prepare for the UK to leave the EU.
The Department of Health has issued information and guidance for patients and healthcare professionals referring to getting medication in the event of a ‘no deal’ Brexit. See below for:
The Department of Health has issued to the following guidance for the NHS referring to “Brexit operational readiness guidance for the health and care system in England” in the event of a “no deal” Brexit.