While currently, the UK is a full and active member of the EU, after the withdrawal of the UK from the EU, the focus of the Medicines and Healthcare products Regulatory Agency (MHRA) remains in protecting and improving lives. Currently, the MHRA is working with the government to ensure that there will continue to be effective regulation for medicines and medical devices after Brexit.
So, what will be the role of the MHRA after Brexit?
The Government Objective For MHRA After Brexit
A statement, published in the Financial Times, said there were three main principles they would like the MHRA to uphold after Brexit which are;
- No patient will be disadvantaged
- The UK will play a leading role in the promotion of public health
- Innovators will be able to access the UK market quickly.
MHRA Response To Brexit
The European Council has expressed that the UK and EU retain a close partnership, with this in mind, the MHRA’s response to Brexit is one where there are still links and strong relationships across the EU.
- Regulate medicines
The MHRA will maintain a relationship with EU members as a new role as a reference member state. The MHRA plans to continue with current programmes that involve implementing EU legislation. Furthermore, the MHRA will continue with EU inspection duties.
- Protect patients with market surveillance
The role of the MHRA will be to continue conducting vigilant market surveillance that can help to protect patients and public health. After Brexit, MHRA will continue to coordinate responses across Europe and internationally with Competent Authorities to ensure market surveillance is upheld and direct action can be taken when needed.
- Regulate devices
The MHRA will continue to oversee the work of the five UK Notified Bodies who all assess devices on the EU market. Furthermore, there will be the implementation on new Regulations for Medical Devices and IVDs, MHRA will continue to support this.
MHRA Guidance For A No-Deal Brexit
In the event that the UK leaves the EU without a deal in place, several technical notices were published which affect the work of the MHRA.
These technical notices include;
How medicines, medical devices and clinical trials would be regulated –
Currently, medicines in the UK are regulated by the EU Medicines Regulatory Network (EMRN). A no-deal scenario would mean these functions would be taken on by the MHRA. The legislation surrounding medicine regulation will change slightly too. It is currently an offence to offer, sell or supply unauthorised medicine to a person in the European Economic Area. This will change the offence to the sale and supply to a person in the United Kingdom and the EU/EEA.
The MHRA will also be responsible for assess post-authorisation safety studies and periodic safety update reports. Manufacturers will have to submit these directly to the MHRA.
The UK will no longer be a part of the EMA. However, the UK will accept batch testing of medicines if it is carried out in a country that is on the approved MHRA list. The list will include EU countries, EEA countries and countries outside of the EU which has an MRA.
The will be no change to the current arrangements for batch testing Investigational Medicinal Products.
Regulatory information on medicinal products –
After a no-deal Brexit, the UK will no longer be a member of the EU medicines and medical devices regulatory network. Instead of sharing information as previously conducted, the UK will have to create their own processes and systems for regulatory activities.
For MHRA stakeholders, they would have to submit regulatory information directly to the MHRA who will create national portals so stakeholders can submit information such as paediatric investigation plans and device registration.
Advice For Marketing Authorisation Holders
It has been recommended that Marketing Authorisation Holders may want to prepare for changes for marketing authorisation by following the advice from HMA and EMA. However, it is stressed that the MHRA will continue working at the same speed to process authorisations and that the MHRA will continue to collaborate so that public health is safeguarded and protection is uninterrupted.
The MHRA strives to ensure that the public will be able to access new and innovative medicines and that the safety, quality and efficacy is checked and ensured.
For Marketing Authorisation Holders, further advice has been issued in the event of a no-deal Brexit. This information, created by the Department of Health and Social Care can be found at the Medicines Supply Contingency Planning Programme Guidance here.
Contingency legislation in place
At the moment, there is still no deal in place for the UK’s withdrawal from the EU on the 29th March 2019. As a result, the government has published contingency legislation that covers the regulations of medicines, medical devices and clinical trials, should a no-deal occur.
The three pieces of contingency legislation that can ensure to continuing access and sale of medicines, devices and clinical trials are;
- The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019
- The Medical Devices (amendment) (EU exit) Regulations 2019
- Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.
The MHRA is available through your usual contact points if you have any questions, and you can find links to helpful guidance relating to the topics discussed here.