The EU has provided much of the scientific, regulatory and trade infrastructure for the pharmaceutical industry in the UK through the European Medicines Agency (EMA). This ensures all medicines available on the EU market are safe, effective and of high quality.
Securing co-operation between the EU and UK on the regulation of medicines will be critical to providing certainty to the pharmaceutical industry in the UK and ensuring EU and UK patients are able to continue to access the medicines they need from day 1 of the UK leaving the EU.
'No deal' Brexit
The pharmaceutical industry is doing everything in its power to prepare for every Brexit outcome, including 'no deal'. Find out more about what 'no deal' means for medicines.
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.
Our sector has worked together with government since 24 June 2016 to establish consensus on the following issues:
For the mutual benefit of patients and industry in the UK and the EU, the UK should seek to negotiate alignment and commonality with the EU for the regulation of medicines, through:
The UK should seek to negotiate continued access to long-term European funding and collaboration programmes for science, through:
The UK should seek to negotiate an agreement with the EU that facilitates the ease of movement for highly-skilled talent in Life Sciences, through:
Due to the complexity of import/export declarations and inspections, and the existing integrated nature of supply chains, the UK should seek to negotiate the ability to trade and move goods and capital across borders with the EU for pharmaceuticals and medical supplies, through:
Given the integrated nature the research, regulation and supply of medicines across Europe, The ABPI is working closely with the European Federation of Pharmaceutical Industries and Associations (EFPIA), who have established a Brexit Taskforce.
The ABPI are pleased to be a member of the NHS Confederation Brexit Health Alliance.