Tag: Medicines and Healthcare products Regulatory Agency

llegal medicines worth more than £30 million seized in the UK in 2023

The Medicines and Healthcare products Regulatory Agency (MHRA), working with law enforcement partners, seized more than 15.5 million doses of illegally traded medicines with a street value of more than £30 million during 2023.

his includes more than two million doses seized during Operation Pangea, the international initiative of global enforcement partners that targets the illegal internet trade in medical products.

Last year’s seizures included prescription-only anti-anxiety medicines, opioids and sleeping pills and falsified and unlicensed lifestyle products such as erectile dysfunction and hair loss medications, as well as a small number of aesthetic products such as Botox and semaglutide-containing ‘weight loss’ products.

Working with partners, the MHRA also disrupted more than 12,000 websites illegally selling medical products to the public and shut down almost 3,000 social media profiles during the year.

The MHRA works with many online marketplaces, social media platforms and technology providers, as well as a wide range of law enforcement agencies at home and abroad to investigate and remove potentially harmful medical products that are offered illegally to the public. 

Support and advice provided by the MHRA to online marketplaces resulted in the successful removal of more than half a million unregulated prescription medicines, over-the-counter medicines and medical devices before they could even be offered for sale to the public.

Andy Morling, MHRA Deputy Director (Criminal Enforcement), said: Public safety is our number one priority. Our Criminal Enforcement Unit works hard to prevent, detect and investigate illegal activity involving medicines and medical devices, to protect people and defeat this harmful trade.

“This year, working with partners across public and private sectors, our efforts have led to more medicines seizures than ever, custodial sentences for offenders, the removal of criminal profits and considerable success in disrupting the trade online.

“We would urge everyone to think very carefully before buying medicines they see online and to take the necessary steps to assure themselves the seller is legitimate. Buying powerful medicines from illegitimate sellers poses a real and immediate danger to your health, as you have no idea what they might actually contain. 

“If you suspect that you have seen illegal products being sold online, you can help us take action by reporting your concerns through our Yellow Card scheme.

The dangers of unlicensed medicines

If a medicine is unlicensed, it will not have been assessed by the MHRA for its safety, effectiveness or the quality of its manufacturing and distribution processes. Anyone buying such a product cannot be sure what it contains or whether it will cause them harm.

In the courts

The sale of medicines and medical devices is strictly controlled in the UK, with certain products only permitted for sale through registered pharmacies or supplied on prescription from a qualified healthcare professional.

Last year, six MHRA investigations resulted in significant custodial sentences for many of those convicted.   These prosecutions followed detailed investigations, the seizure of millions of doses of medicines and the removal of hundreds of thousands of pounds of criminal profits. 

MHRA safety advice when buying medicines online

Be careful when buying medicines online

Medicines are not ordinary consumer goods and their sale and supply is tightly controlled. Websites operating outside the legal supply chain may seem tempting, for example, offering a prescription medicine without a prescription. Not only are these sites breaking the law – they are putting your health at risk. 

Criminals use a variety of techniques to sell medicines illegally online. Some are sold using websites designed to look like legitimate pharmacies or online retailers, while others might be advertised via online marketplaces or social media sites.

Visit the #FakeMeds website for tools and resources to help people purchase medicines or medical devices safely online.

Anyone who suspects that their product is fake is encouraged to report it directly to the Yellow Card scheme, through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card. 

JCVI advises use of additional bivalent vaccine for autumn booster campaign

Following on from the previous advice on which vaccines should be used in this year’s autumn booster programme, the Joint Committee on Vaccination and Immunisation (JCVI) has updated its published advice to include an additional bivalent vaccine now approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

Studies indicate the Pfizer-BioNTech bivalent vaccine produces a marginally higher immune response against some variants than the Pfizer-BioNTech mRNA Original ‘wild-type’ vaccine. The clinical relevance of these small differences is uncertain.

‘Bivalent’ vaccines have been developed by global manufacturers since the emergence and dominance of the Omicron variant. These vaccines are targeted against antigens (substances that induce an immune response) from 2 different COVID-19 strains, or variants.

All of the available booster vaccines offer very good protection against severe illness from COVID-19. As more vaccines continue to be developed, the committee will consider their use in the autumn programme.

Professor Wei Shen Lim, Chair of COVID-19 immunisation on the JCVI, said: “It is very encouraging that more vaccines continue to become available and we now have another option to add to the vaccines already advised for the autumn booster campaign.

“Winter is typically the time of greatest threat from respiratory infections. We strongly encourage everyone who is eligible to have their booster vaccine this autumn when it is offered. This is our best defence against becoming severely ill from COVID-19.”

Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator

A second, “bivalent” vaccine was yesterday approved as a booster by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.

The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. This decision has been endorsed by the Commission on Human Medicines, after a careful review of the evidence.

In each dose of the booster vaccine, ‘Comirnaty bivalent Original/Omicron’, half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1).

The MHRA’s decision is based on data from a clinical trial which showed that a booster dose with the bivalent Pfizer/BioNTech vaccine triggers a strong immune response against both Omicron and the original strain. Safety monitoring showed that the side effects observed were the same as those seen for the original Pfizer/BioNTech booster dose and were typically mild and self-resolving, and no new serious safety concerns were identified.

Dr June Raine, MHRA Chief Executive said: I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain.

“Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against COVID-19 variants.

“We have in place a comprehensive safety surveillance strategy for all UK-approved COVID-19 vaccines, and this will include the updated booster we approved today.”

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines said: “Following an independent review of the safety, quality and effectiveness of the vaccine, the Commission on Human Medicines and its COVID-19 Vaccines Expert Working Group supports the MHRA’s decision.

“As with any medicinal product, including vaccines, it is important to continually monitor effectiveness and safety when it is deployed, and we have the relevant processes and expertise in this country to do that.

“The Joint Committee on Vaccination and Immunisation (JCVI) will advise on how this vaccine should be offered as part of the deployment programme.”