Britain’s exit from the EU has caused significant change but much will depend on how ministers use their powers when the Medicines and Medical Devices Act becomes law, writes David Reissner…
The UK left the EU on January 31, 2020. Just before its transition period ended, the UK and EU negotiated the UK-EU Trade and Cooperation Agreement. Now, we are left working out what Brexit means for the pharmaceutical sector.
EU law in the UK
Since 1973, most laws governing medicines and medical devices in the UK had come from Europe. The EU (as it is now known) followed a doctrine known as harmonisation. When the EU agreed on a law, all member states had to adopt it.
When the government knew we would be leaving the EU, the parliament passed the European Union (Withdrawal) Act 2018. This act stated that any law adopted in the UK as a result of membership of the EU remains the law following Brexit unless changed by a new law.
UK or Great Britain
Great Britain – England, Scotland and Wales – has left the EU Customs Union, Northern Ireland now has a dual system. It is part of the UK but recognises EU laws and processes. Among other things, this means that any sales of medicines between Great Britain and Northern Ireland involve different legal requirements to those which apply when sales are made within Great Britain.
Many medicines have a marketing authorisation that are valid throughout the EU. These marketing authorisations for centrally authorised products (CAPs) remain valid in Great Britain if they were granted before January 1, 2021 but they have automatically been converted to UK marketing authorisations.
Marketing authorisations for CAPs that are granted after January 1, 2021 are not valid in Great Britain, so the holders of such marketing authorisations must register with the MHRA and apply for a UK marketing authorisation to put the products on the market in Great Britain.
Recognition of professional qualifications
The EU has a system that allows pharmacists in one member state or in the European Economic Area or Switzerland to practise in other member states. Anyone who was already registered as a pharmacist or pharmacy technician in Great Britain by December 31, 2020 remains entitled to be included in the relevant GPhC register.
From January 1, the GPhC is required to register EU, EEA and Swiss pharmacists who were not already registered if their qualification standards are comparable to UK standards. If a qualification is not comparable, the GPhC will have the discretion as to how to proceed.
The position is different for pharmacy technicians because there is no general recognition in the EU of the profession of pharmacy technician. Instead, applications for recognition of pharmacy technicians’ qualifications will be processed via the GPhC’s international registration process.
The government will provide guidance to the GPhC about the recognition of qualifications. The UK-EU Trade and Cooperation Agreement did not rule out the possibility of a future agreement between the UK and the EU about arrangements for recognising the qualifications of pharmacists.
CE marking on a product indicates that the product has been assessed and conforms to appropriate standards. Until June 30, 2023, products that are CE-marked can still be sold in Great Britain if they were on the market at December 31, 2020.
In place of CE marking, products such as medical devices must bear a UKCA mark if they are placed on the market in Great Britain.
New EU laws governing medical devices will come into force on May 26, 2021. These laws will not apply in the UK, but the new EU rules may be relevant in Great Britain. Under the new rules, manufacturers must, among other requirements:
- ensure the device meets new risk classification criteria
- meet increased requirements for clinical evidence
- register their organisation and devices, upload relevant documentation, including post-market surveillance documentation
- have a person responsible for regulatory compliance
- have sufficient financial coverage to meet any potential liability
- meet new vigilance reporting timescales and provide an annual periodic safety update report
The Medicines and Medical Devices Bill is currently going through the parliament. When it becomes law as the Medicines and Medical Devices Act, it will give ministers powers to amend the Medical Devices Regulations. Manufacturers will have to be registered with the MHRA and will have to have a place of business in the UK.
It is expected that a register of medical devices will be set up and some of the deficiencies identified by the Cumberlege Report following the PIP breast implant scandal will be addressed. These include post-marketing surveillance of medicinal devices, as well as packaging and labelling requirements. Ministers will have the power to incorporate provisions similar to those that will come into effect throughout the EU in May.
FMD and common logo
The Falsified Medicines Directive (FMD) requires pharmacies to scan the barcode on medicines at the time of supply. Scanning involved accessing a central repository to check the authenticity of the medicinal product.
Since pharmacies in the UK can no longer access the EU repository, FMD ceased to apply in Great Britain on January 1. Following a consultation, it is expected that ministers will introduce a British equivalent of FMD. One of the things to look out for is whether the British system will give pharmacies greater flexibility in choosing when to scan medicines, for example, at the time they are taken into stock rather than at the time they are supplied.
Until December 31, 2020, British online pharmacies were required to display an EU logo, enabling website users to check that the pharmacy was registered with a regulator. This requirement lapsed at the end of the UK’s transition period because the UK can no longer access EU systems.
For some parts of the pharmaceutical sector, Brexit has already caused significant change. For others, the changes will only impact over time. Much will depend on how ministers use their powers when the Medicines and Medical Devices Act becomes law, whether they use them to avoid the one-size-fits-all approach of the EU, and the extent to which ministers consider that pharmacy and medicines law needs to be aligned with EU law to secure patient safety.
David Reissner is Chair of the Pharmacy Law & Ethics Association.