Dear Ms Bewley,

Thank you for the Regulation 28 report of 16 December 2024, sent to the Secretary of State for Health and Social Care, regarding the death of Ms Susan Marie Karakoc. I am replying as the Minister with responsibility for medicine regulation and prescribing.

Firstly, I would like to say how saddened I was to read of the circumstances of Ms Karakoc’s death. I offer my sincere condolences to her family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention.

You raised the following concerns:
• there is evidence of search engines readily returning websites which sell prescription medications, including those that sell highly addictive sleeping tablets and painkillers which can and do cause fatalities. I am concerned how readily search engines return websites such as these;
• the current system for monitoring the legitimacy of supply chains for medications available in England and Wales via prescription is not preventing the ready supply of such medications online;
• there is evidence that banks form a legitimate part of the supply chain, and that this is crucial to the functioning of these criminal enterprises. I am concerned that the current system for detecting such criminal enterprises and alerting the relevant authorities is not effective. Having reviewed these concerns, it is my view that the other departments and agencies with which you have shared the report are best placed to respond directly to the issues you have raised, which are relevant to their respective areas. However, I would like to offer the following information from a Departmental perspective, regarding the safe use of online pharmacies.

When used appropriately, online prescribing provides a valuable route for patient access which takes pressure off GP practices. Prescribers, whether working for the NHS or privately, in-person or remotely, are accountable for their prescribing decisions. They are expected to take account of appropriate national guidance. Prescribers should work with their patient and decide on the best course of treatment, with the provision of the most clinically appropriate care for the patient always being the primary consideration.

In addition to the duty of the prescriber, patients themselves must be honest when providing information to an online prescriber so that they receive advice and medicines which are appropriate for them and so that risks can be managed. Prescribers need full information to be able to prescribe safely. The General Pharmaceutical Council has published guidance introducing new and strengthened safeguards and checks that online pharmacies must put in place when supplying high-risk medicines. This guidance will also strengthen areas including consultation and communication with the person seeking a medicine/treatment. The updated guidance can be found here: Online pharmacies to strengthen safeguards to prevent unsafe supply of medicines | General Pharmaceutical Council The General Pharmaceutical Council (GPhC) and other professional regulators, Care Quality Commission (CQC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have the powers to investigate and take action against prescribers, products and suppliers who do not comply with legislation and national guidance. In preparing this response, my officials have made enquiries with the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure we adequately address your concerns. MHRA has shared their response with us and I am pleased to note that the website accessed by the deceased was subject to a MHRA investigation, prior to the issuing of the Regulation 28 Report, and a domain suspension request was issued in March 2024 resulting in the website being taken down.

The MHRA’s response also includes a list of future criminal countermeasures, which is set to include:

• Enhanced collaboration with search engine and UK internet service providers (ISPs) aimed at blocking harmful content through targeted ISP-filtering;
• Collaboration the Office of Communications (Ofcom) to explore fresh preventative opportunities presented by the Online Safety Act, which will create new rules for social media companies and search engine providers;
• Boosted collaboration with UK Border Force, allowing the MHRA to grow its operational footprint at the border and increase the seizure rates of illegally trafficked medicines;
• The use of cutting-edge technology to identify, track and seize the proceeds of crime, including cryptocurrency;
• Rollout of a web-based online pharmacy checker that will allow users to search if a website or social media listing has been deemed fraudulent by the MHRA.
• Implementation of a web-based reporting scheme allowing users to report suspicious websites, online marketplaces and social media listings to the MHRA;

• Continued commitment to enhancing collegiate working across internet infrastructure community, including private sector and international law enforcement partners.

The MHRA also seeks to identify individuals involved in unlawful activity and where appropriate, prosecute those who put public health at risk.

I hope this response is helpful. Thank you for bringing these concerns to my attention.

Dear Ms Bewley,

Thank you for the opportunity to respond to this Report to Prevent Future Deaths, regarding the death of Susan Marie Karakoc. I was incredibly saddened to read about the circumstances surrounding Susan’s tragic death and would like to extend my deepest condolences to her family and friends for their loss. I would like to thank you for bringing this to my attention.

Some of the key issues of concern that you raise in your report are within the remit of The Medicines and Healthcare Products Regulatory Agency, and I understand that they have provided a separate response. As the Secretary of State for Science, Innovation and Technology I am responsible for the Online Safety Act 2023 (‘the Act’) and will respond to the issues raised in this report as per my department’s remit. My department has been taking steps to tackle criminal activity online through the Act, which received Royal Assent in October 2023.

A service is in-scope of the Act if it allows user-generated content (for example, it has been uploaded or shared by a user of a service as opposed to uploaded or published by the site or service owner). The Act gives online platforms duties to tackle illegal content and activity on their services. Within these duties, the Act establishes certain ‘priority offences’. Priority offences reflect the most serious and prevalent illegal content and activity, against which companies must take proactive measures, as well as ensuring their services are not used to facilitate or commit a priority offence.

The illegal sale or supply of controlled drugs is a priority offence under the Act. This offence may be committed where a user unlawfully produces, supplies or offers to supply controlled drugs, or where a user supplies items used for administering or preparing controlled drugs. It is also a priority offence for a person to do anything which incites another to commit these drugs offences, and any content present on a service which does so is ‘illegal content’ under the Act. Platforms, and also search services such as Google, will therefore need to put in place systems and processes to ensure users do not encounter this illegal content via their services. They will also need to take steps relating to the design and operation of their service to reduce the risk that services facilitate these offences.

The strongest protections in the Act are for children. In-scope services that are likely to be accessed by children will have a duty to take steps to prevent children from encountering legal but nonetheless harmful content that has been designated as ‘primary priority’ content. This includes content that encourages, promotes, or provides instructions for self-harm, eating disorders or suicide. Search services must also minimise the risk of children encountering this content in search results or on the pages they land on when they click on them. We expect the illegal content duties to be fully in effect from Spring 2025, and the child safety duties from Summer 2025.

Ofcom is the independent regulator for the Online Safety Act. It will set out the specific steps providers can take to fulfil their duties in codes of practice. Ofcom has published the final drafts of its first codes for the illegal content duties and we anticipate these will take effect next month. The codes set out a range of cross-cutting steps that providers can take to tackle illegal drugs-related content and activity on their services. Ofcom is working with the government to implement the Act as quickly and effectively as possible.

Dear Ms Bewley,

Re: Prevention of Future Deaths report

The Financial Conduct Authority (FCA) response in relation to Susan Karakoc: Prevention of future deaths report, published on 27 December 2024:

prevention-of-future-deaths-report/

Under section 5 of the online report, the following concern was raised:

“There is evidence that banks form a legitimate part of the supply chain, and that this is crucial to the functioning of these criminal enterprises. I am concerned that the current system for detecting such criminal enterprises and alerting the relevant authorities is not effective”.

We received a copy of the report on 26 February 2025, where you requested that the FCA respond to the points raised in the report.

The Money Laundering, Terrorist Financing and Transfer of Funds (Information on the Payer) Regulations 2017 require firms to complete checks as part of the supply chain. This includes where they hold evidence of suspicious activity. In

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support of this legislation, where FCA regulated firms do identify suspicious activity, our expectations are for those firms to take action. This may include blocking particular transactions.

Firms use merchant details to understand where customer payments are being made to, and firms use these to prevent transactions where they identify suspicious activity or fraud. Suspicious activity can be identified by firms through receipt of intelligence, including from law enforcement, through receipt of serious complaints, unusual frequency and values of payments, and other similar sources. Absent of such intelligence, it would be practically difficult for a firm to identify and prevent payments to a particular merchant.

We sympathise with the death of Ms Karakoc. We have considered this matter, and based on the published report we do not consider the circumstances of Ms Karakoc’s passing require additional actions for the FCA. We will share this response with HMT, who lead policy in regards to the AML regulations. We constantly keep our rules and guidance under review. I hope this response is helpful in clarifying our approach.

Dear Ms Bewley, Regulation 28 report relating to the death of Susan Marie Karakoc Thank you for your Regulation 28 report relating to the death of Ms Susan Marie Karakoc which was received on 16 December 2024. I would like to offer my sincere condolences to Ms Karakoc’s family on their tragic loss. Please accept my sincere apologies for the delay in responding which was due to misunderstanding as to whether we should be replying to you directly. We had provided a contribution to the response by the Department of Health and Social Care (DHSC).

The Medicines and Healthcare products Regulatory Agency (MHRA), acting on behalf of the Secretary of State for Health, is responsible for the regulation of all medicines and medical devices marketed in the UK by ensuring they are effective and are acceptably safe. This includes applying the legal controls on the retail sale, supply and advertising of medicines which are set out in the Human Medicines Regulations 2012. These regulations apply equally to medicines advertised, sold or supplied via the internet.

The sale and supply of unregulated medicinal products is a global problem. Online portals play a significant role in transnational medicines crime and many websites proliferate across the internet. Currently, there is no legal mechanism for UK law enforcement to seize control of illicit domains or compel registrars to suspend them. Gaining regulatory compliance can be a difficult and sometimes impossible process, especially when domains are registered beyond the reach of UK jurisdiction.

We can confirm that the website accessed by the deceased was subject to an MHRA investigation prior to the issuing of the Regulation 28 Report and a domain suspension request was issued in March 2024 resulting in the website being taken down.

Public safety is the top priority for the MHRA, and its Criminal Enforcement Unit works hard to prevent, detect and investigate illegal activity involving medicines and medical devices. In 2024, the MHRA and its partners seized millions of doses of illegally traded medicines. These products included prescription-only anti-anxiety medicines, opioids and sleeping pills, and falsified and unlicensed lifestyle products used in the treatment of erectile dysfunction, hair loss and weight loss. It also disrupted thousands of links to websites and social media pages selling medical products to the public illegally.

We work closely with web-based sales platforms and the internet industry to identify and remove non-compliant medicines and medical devices where possible. Collaboration with one well-known online marketplace allowed the use of technology to identify and block more than a million unregulated medicines and medical devices before they could be advertised to the public.

Through a combination of public empowerment, technological innovation, traditional methods of law enforcement and close collaboration with partners, we are constantly working to develop new and innovative ways to tackle the online trade in illegal medicines.

Some of these future criminal countermeasures will include:

• Enhanced collaboration with search engine and UK internet service providers aimed at blocking harmful content through targeted ISP-filtering.
• Collaboration the Office of Communications to explore fresh preventative opportunities presented by the Online Safety Act, which will create new rules for social media companies and search engine providers.
• Boosted collaboration with UK Border Force, allowing the MHRA to grow its operational footprint at the border and increase the seizure rates of illegally trafficked medicines.
• The use of cutting-edge technology to identify, track and seize the proceeds of crime, including cryptocurrency.
• Continued commitment to enhancing collegiate working across internet infrastructure community, including private sector and international law enforcement partners.
• Collaboration with UK banking and payment providers to disrupt the payment mechanisms used by websites illegally supplying prescription only medicines. We seek to identify individuals involved in unlawful activity and, where appropriate, prosecute those who put public health at risk.

As the illegal sale of medicines can pose a serious risk to public health, our Fake Medicines campaign https://fakemeds.campaign.gov.uk/ aims to encourage people in the UK who choose to buy medication online to take steps to ensure they use safe and legitimate sources. It also encourages people to report suspicious medicinal products and adverse side effects via our Yellow Card scheme https://yellowcard.mhra.gov.uk/.

The efforts of the MHRA and its partners have led to more medicines being seized than ever before, significant custodial sentences for offenders, the forfeiture of criminal profits and considerable success in disrupting the illegal trade online.

In this response I have commented on the areas of your recommendations which fall within our remit, and we have also contributed to the DHSC response. The DHSC is appropriately placed to advise on prescribing and dispensing matters.

Should you have any further questions, please do not hesitate to contact: