Medicines & Healthcare Products Regulatory Agency (MHRA) Law - Defence Barristers
Leamington Spa Chambers
Providing expert legal representation and advice in MHRA Prosecutions
MHRA Law Defence Barristers
Leamington Spa Barristers represent and advise clients in the criminal courts, who have been charged with alleged medicines offences that are being prosecuted by Medicines and Healthcare Products Regulatory Agency (MHRA) (through the MHRA’s Criminal Enforcement Unit). The MHRA is an executive agency of the Department of Health and Social Care, which means it operates at arms length from the Department.
Our barristers cover cases in the whole of England and Wales, and can defend clients in the magistrates and crown courts, who are facing prosecutions under the Medicines Act 1968, and prosecutions under other medicines and healthcare products legislation.
To speak with a specialist MHRA law defence barrister, contact our barristers’ clerks for a without obligation chat about and how we can help to defend you or your client in a MHRA prosecution.
MHRA Law - Legal News
Our MHRA Law Expertise
Our criminal law barristers have expertise in representing clients (people and firms) who have been accused by the MHRA of breaches of the law and MHRA medicines and medicinal products regulations. Our barristers can advise and represent medicines manufacturers, pharmaceutical companies, pharmacists, responsible pharmacists, registered pharmacies, bodies corporate, partnerships, medicines importers, superintendent pharmacists, firms and lay people.
Our barristers can advise on breaches of the Medicines Act 1968, including unlawful exportation of medicines that are on the MHRA restricted medicines list, the hoarding of medicines that are on the MHRA restricted medicines list.
Our barristers can also advise clients facing allegations of prescription fraud, unlawful activities relating medicines through alleged membership of an organised crime group, a conspiracy to unlawfully sell or supply controlled drugs, supplying faulty or unapproved medical devices, unlawfully advertising Prescription Only Medicine (POM), supplying unlicensed or fake medicines, and money laundering associated with the alleged commission of medicines related offences.
Our barristers can advise on defending assets where there are proceedings for the recovery of ‘proceeds of crime’ related to drug regulation offences, as well as restraint orders. The MHRA has its own ‘officers’ to deal the identification and recovery of the proceeds of crime, called Accredited Financial Investigators (AFIs) – who are authorised by the National Crime Agency (NCA) to carry out such work, pursuant to the Proceeds of Crime Act 2002 (POCA).
The AFIs support MHRA investigations by tracing, freezing, and confiscating assets linked to crimes, including money from laundering and the illegal supply of medicines within the UK. The MHRA’s AFIs can seize cash, valuable personal or company held items, freeze bank accounts, freeze company accounts, and freeze cryptocurrency accounts that are suspected to flow from criminal conduct, including the illegal supply of medicines, or other regulatory breaches related to medicines that carry criminal penalties.
Speak with one of our specialist barristers without obligation to see how we can assist.
More About Our Defence Barristers in MHRA Law
Our MHRA law barristers have defended clients in criminal cases concerning medicines and medical regulations, including manufacturers of medicines, and wholesalers of medicines – whether human or veterinary.
Our barristers can advise in relation to MHRA inspections, MHRA enforcement, and MHRA investigations. Our barristers can advise on MHRA disclosure, client disclosure to MHRS, PACE interviews by MHRA, criminal charges laid byMHRA, prosecutions brought by MHRA.
We can advise on MHRA investigations and prosecutions relating to alleged unlawful conduct such as
- Hoarding of Medicines (where there has been a stockpiling or stock management or other breach) (breaches of regulation 43(2) the Human Medicines Regulations 2012):
- Exports of Medicines
- Contraventions of conditions imposed by an order under section 58 of the Medicines Act 1968
- selling, supplying importing medicinal products in contravention of an order made under section 62 of the Medicines Act 1968
- advanced therapy medicinal product data retention failures (due diligence defences, reasonable precuations defences)
- contraventions of regulations
- giving false information
- failing without reasonable exuse to give information
- manufacturing a medicinal product that is prohibited except in accordance with a licence
- adulteration of medicinal product; injuriously affecting it by the addition or abstraction of any substance
Prohibitions
- Regulation 293 of the Human Medicines Regulations 2012 prohibits the sale or supply of samples of medicinal products to the public for promotional purposes.
- Regulation 279 prohibits advertising of medicines for which no marketing authorisation or registration is in force
Also, in relation to MHRA powers concerning medicines, we can provide advice and advocacy (representation) services relating to:
- Suspensions of Licences
- Revoked Authorisations / Licences
- Exemptions
- Marketing Authorisations
- Licensing Refusals, Surrrenders (including Urgent Procedure), Revocations, Variations
- Making Written Representations to the licensing authority
- Breaches of the Good Manufacturing Practice Directive (Quality Assurance)
- Checks on valid licence or authorisation holders
- MHRA and the identification of safety issues
- MHRA Investigations of licence holders
We are able to advise on rebuttals of MHRA allegations, and provide gudiance on the best evidence to obtain to counter the concerns being investigated. There may in some instances be multi-jurisdictional issues and we are able to work with overseas lawyers in many instances.
Sentencing in MHRA Prosecutions
Regulation 35 Human Medicines Regulations 2012 Penalties: Fines and Imprisonment
Medicines Act 1968 Penalties: Fines and Imprisonment
Publications
MHRA Blue Guide – Advertising and Promotion of Medicines in the UK (Nov 2020)
Common Questions About Our Services
Leamington Spa Barristers Chambers can meet with clients (defendants) in Chambers, at solicitors’ offices, by videoconference, and in prisons.
What expertise do your barristers have in defending people being prosecuted for MHRA breaches??
A number of our criminal law barristers are experienced in representing defendants in MHRS prosecutions.
How can I instruct a barrister who defends defendants in MHRA prosecutions?
You can schedule an introduction or formal consultation in MHRA law by contacting our clerks.
What will the barrister need to be able advise me in a MHRA criminal law case?
For a criminal law barrister to advise, they will need to see the MHRA’s evidence. The Crown Prosecution Service (representing the MHRA/Crown) usually brings cases to trial, instructing KCs and senior juniors, supported by other barristers and lawyers. A defendant should therefore arrange for good representation to counter the MHRA’s / Crown’s case.
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