There is considerable uncertainty about the process of Brexit and the form of the UK’s new relationship with the EU. At least six different models are possible:
Joining the European Economic Area (EEA) – the Norwegian model The UK remains bound by most EU legislation (excluding common agricultural and fisheries policies and customs union), but is no longer involved in the EU law-making process.
Joining the European Free Trade Association (EFTA) – the Swiss model The UK enters bilateral trade agreements with the EU which do not include full access to services. Free movement rules adopted by the UK so it can access the single market.
Joining the EU Customs Union – the Turkish model The UK retains access to the internal market for certain goods (no customs duties payable) and needs to comply with EU product standards for exports to the EU, to which tariffs are applied.
A comprehensive trade agreement – the Canadian model The UK is free to set its own national rules outside of the EFTA.
Trading under World Trade Organisation rules The UK loses access to the single market but does not need to permit the free movement of people.
A bespoke model
Depending on the relationship between the UK and the EU, there may be implications for pharmacy in the following areas:
Medicines regulation European law underpins much UK medicines legislation, particularly our laws on wholesaling and manufacturing. UK law is unlikely to change radically, with manufacturers and wholesalers that operate internationally resisting changes. But small beneficial changes may be possible. For example, section 10(7) of the Medicines Act 1968 (known at the 5 per cent rule, which restricted pharmacies’ ability to trade between themselves) was repealed to meet EU regulations. It may be possible to reverse this change after Brexit.
The European Medicines Agency is located in London, and is likely to have to relocate. The EMA is staffed by a lot of MHRA staff sympathetic to the British approach to issues such as POM-to-P switches, but Brexit is likely to cause staff changes within the EMA. If the UK were to leave the EMA, this could lead to delays in new medicines being licensed in the UK.
Parallel trading of medicines Free movement of goods within the EU allows medicines to be traded across national borders. UK pharmacies have benefited by sourcing medicines from countries where prices are lower. And UK taxpayers has benefited through the invoice inquiry process. But attempts by manufacturers to block parallel trade using quotas has caused medicine shortages. Access to parallel trade may be stopped as a result of Brexit.
Further areas of potential Brexit impact will be considered next month.