Dear Dr Harris

Regulation 28 Report concerning Ruben Bousquet;

Thank you for your letter of 18th December 2020 in which you asked the Rt. Hon Matt Hancock, Secretary of State for Health and Social Care, to provide a response to a Regulation 28 Report to Prevent Future Deaths following the inquest into the tragic death of Master Ruben Bousquet.

Your report raised a matter of concern regarding the availability of emergency Adrenaline Auto-injector devices (AAIs) in the Retail food sector. You recorded that the court heard no substantive evidence on whether this matter has been officially investigated. You further requested that consideration should be given to the feasibility of wider access to AAIs.

The Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care (DHSC), is responsible for the regulation of medicines in the UK. In 2019 and 2020 MHRA sought advice from the UK Commission on Human Medicines (CHM), its independent scientific advisory committee, on a range of areas to support the effective and safe use of AAIs. Members of the CHM include a range of clinical and technical experts and lay representatives. CHM advice was sought after coroners’ inquests into fatalities from anaphylaxis highlighted a range of issues in relation to the prescribing and use of AAIs. The feasibility of making AAIs available in the wider community, as a means of providing emergency treatment for anaphylaxis in exceptional circumstances, was also raised.

Although potential risks in making AAIs more widely available were noted by the CHM, the potential for life-saving benefit was clearly acknowledged provided the risks could be managed. Risks which were highlighted by the CHM include the difficulty of distinguishing collapse due to anaphylaxis from collapse due to other causes where the administration of adrenaline might be harmful as in some types of cardiac or cerebrovascular event (heart attack or stroke). Challenges also lie in correct and secure storage of AAIs to ensure that the adrenaline does not deteriorate and the device remains functional, also, the need for use by a person trained in the recognition of anaphylaxis and the correct administration of AAIs. Notwithstanding these challenges, the CHM recognised the vital lifesaving benefit that wider availability of AAIs could bring and concluded this should be examined in more detail.

In March 2020 the CHM agreed to the formation, and Terms of Reference, of an Adrenaline Auto- injector Expert Working Group (AAI EWG) to examine a range of cross-cutting areas to support the HM Senior Coroner Dr Andrew Harris Southwark Coroner’s Court 1 Tennis Street London SE1 1YD

Date 15th April 2021

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effective and safe use of AAIs for the emergency treatment of anaphylaxis, including wider availability. The AAI EWG met on a number of occasions between April and July 2020 during which a number of areas were examined and a series of recommendations were made. In July 2020 CHM endorsed the conclusions and recommendations of the AAI EWG and made some additional recommendations.

Following their review, the AAI EWG recommended in principle that AAIs should be made available in public locations for use to treat anaphylaxis in unforeseen, critical circumstances, provided suitable safeguards can be implemented to ensure effective and safe use of the AAIs. Cinemas offering food for sale, and other retail food outlets, were identified by the AAI EWG as examples of key locations where emergency AAIs could be envisaged to have particular potential to save lives. This could for example be individuals presenting for the first time with food-related anaphylaxis, or those who, through error or lack of awareness, may not be carrying their personally prescribed AAIs on their person, against advice.

Legislative amendment to the Human Medicines Regulation will be needed to effect such a key change in policy to make a prescription only medicine available for use in the community in an emergency on an unnamed basis. To safely implement the change, a requirement for training to ensure responsible acquisition and deployment of AAIs in a range of settings is envisaged. There are other significant considerations and prior to any such amendment, consultation with relevant stakeholders will be necessary to inform the feasibility and a hierarchy of need given the potential impact on AAI supply if a large number of outlets were to be involved.

Alongside the recommendations on wider availability, the AAI EWG recommended a number of other measures including reinforcement of the need for all patients at risk of anaphylaxis to carry two AAIs at all times; the need for administration of an AAI at the first signs of anaphylaxis and how to recognise this; the need for patients experiencing anaphylaxis to remain lying down; and the need for patients to know how to use their particular AAI device.

A report summarising the conclusions and recommendations of the AAI EWG, endorsed by the CHM, will be published by the end of May 2021.

The MHRA hopes that this initiative will provide you and the Court with reassurance that the matter has been, and is continuing to be, officially investigated and that the MHRA views this as a matter of significant public health importance. The MHRA will continue to advance progress towards an effective and safe, legally implemented, mechanism of widening access to AAIs in order to save lives in the future. This will also need to ensure that the future supply of AAIs will be able to meet the additional demand for AAIs that wider roll-out would bring, without compromising the supply of prescribed AAIs that remain the mainstay for protecting individuals at risk.

We will keep you informed of progress.

Dear Mr Harris

Thank you for sending me the Regulation 28: Report to Prevent Future Deaths on 18th December 2020, concerning the inquest into the death of Ruben Bousquet, who died tragically from a severe anaphylactic reaction.

We were deeply saddened to hear of the death of Master Bousquet in April 2019 and extend our sympathies to his family and friends.

We have considered the matters of concern you have raised, and the action you have suggested be taken, and offer the following response.

Reporting and Registering

You recommend ‘…establishing a national reporting system which includes timely reporting to local authority and FSA and maintenance of a register of fatalities and their investigations …’.

The FSA is responsible for food safety labelling and food allergy policy in England, Wales and Northern Ireland. The FSA would welcome improved access to any source of information about fatalities where a food-related allergy is suspected. Better and earlier access to such information would help the FSA in its important work to help reduce the incidence of food-related anaphylactic reactions. We agree that access to information about fatalities where a food allergy is suspected is inadequate at present. While food businesses are required to notify competent public authorities such as a local authority and the FSA, when the food business considers or has reason to believe that a food it has placed on the market is injurious to health, there are circumstances where no, or no timely,

notification is provided. In these cases, a mechanism by which the FSA is made aware of the fatality would be very helpful. Most obviously, this might involve the sharing of information with the FSA by medical authorities, but this is not a matter in respect of which the FSA has a policy function.

However, the FSA would like to make the Senior Coroner aware of the following ongoing actions that reflect our key aims to reduce the incidence of food-related anaphylaxis:

• The FSA has started work on a project designed to collect more reported data on food-based allergic reactions that do not result in death. Work on this project is progressing despite some disruption due to the COVID-19 pandemic. We are currently undertaking discovery work with people with allergies to understand the type of information they could provide and the data that the FSA could receive on allergic reactions. This will enable us to assess expectations and the perceived usefulness of such a reporting mechanism. The result of this work would not equate to a national reporting system, but it would provide us with valuable information on emerging patterns and help us to build a better picture of the reactions experienced by allergic consumers.
• The FSA has also commissioned work that uses data to monitor trends in the occurrence of severe, food-induced allergic reactions which do not result in death and to help identify those most at risk of severe anaphylaxis. This includes the establishment of a registry to collect detailed, clinical information around the circumstances of anaphylactic reactions. This will be launched in the coming months. The project also identifies individuals who have experienced near-fatal food anaphylaxis and undertakes detailed interviews to provide information regarding the circumstances and context of the anaphylaxis event. This work will report towards the end of next year.
• Separately, whilst it is not within FSA’s remit to establish a national register of fatalities, given their medical and clinical responsibilities in this area, we are discussing with the Department for Health and Social Care (DHSC) how we could analyse and evaluate different data sources to give us a clearer picture of allergic reactions that result in fatality.

Availability of emergency Adrenaline Auto-injector devices (AAIs) in the Retail food sector

The FSA respectfully considers that action in this area is a matter best addressed by the other copy recipients, namely the DHSC, the Royal College of Paediatrics and Child Health, ROSPA and Health and Safety Executive.

FSA’s commitment to progress work on food hypersensitivity

The above comments address the action suggested in your report, but you may wish to know more about the work the FSA undertakes in this area. Food hypersensitivity is a priority for the FSA. We want to improve the quality of life for people living with food hypersensitivity and support them to make safe, informed food choices to effectively manage risk. Our Food Hypersensitivity Programme builds on the FSA’s extensive work over many years on research, recommending legislation to improving labelling, and the provision of information to customers. To date more than 60 projects have been initiated with an investment of £20 million. The FSA also regularly reviews its guidance and support to food businesses and we are developing several pieces of work to strengthen that support.

Our current work includes the following priority areas:

• Raising awareness amongst hypersensitive consumers is a key part of our work. The FSA will soon be launching a new communications campaign targeting 18-21 year olds to encourage them to speak up about their allergies when ordering from food businesses.
• We are supporting businesses, consumers and local authorities to prepare for new allergen labelling rules for ‘prepacked for direct sale’ food that come into effect on the 1st October 2021. This legislation will require that these types of products have full ingredients labelling with the allergens emphasised. This is a step forward in the provision of allergen information for allergic consumers and will help enable consumers to make safe and informed choices when eating out.
• We are considering the benefits of developing a food allergy safety scheme for allergen management within food businesses, through gathering a range of information, including the views of hypersensitive consumers. Such a scheme would help consumers in a similar way to the Food Hygiene Rating Scheme, enabling them to trust food businesses and to make choices safely.
• In September 2020 we refreshed our online allergy and intolerance training aimed at businesses and local authorities to improve the content and overall clarity. To date, we have had a significant number of users sign up to the training, including 48% (17,639) from food businesses who can learn more about how to handle allergens safely in a food business environment.
• We are planning a second Allergy Symposium this year to bring together industry, enforcement bodies, consumer groups and clinicians to explore the complexities of managing allergens, showcase good practice, while expanding awareness of food hypersensitivity and assisting food businesses to achieve compliance.

This work demonstrates the commitment that the FSA has to tackling food hypersensitivity and we will continue to work together with food businesses, consumer groups and enforcement bodies on this important issue. We would once again like to extend our deepest condolences to the family of Master Bousquet and hope that the work we are doing will help to prevent future occurrences of incidents like this.

Dear Dr Harris

Thank you for your letter of 18 December 2020, received by this Department on 6 January 2021, to Matt Hancock about the death of Ruben Bousquet. I am replying as Minister with policy responsibility for medicines and medical devices and I am grateful for the additional time in which to do so.

Firstly, I would like to say how deeply saddened I was to read of the circumstances of Ruben’s death. I can appreciate how distressing his death must be for his parents and those who knew and loved Ruben and I offer my heartfelt condolences. It is vital that we take the learnings from what happened to Ruben to prevent future deaths.

Reporting and Registering

As articulated in your report, these matters of concern refer firstly to consideration of the establishment of a national reporting system to enable local authorities and the Food Standards Agency (FSA) to access data; and secondly, the maintenance of a fatalities register to determine the circumstances of these deaths.

As you are aware, currently the FSA has no means to access data on allergic reactions. The FSA is undertaking work to establish a way for people to directly report information regarding anaphylactic reactions caused by food allergies that do not result in death. We understand that the FSA is considering how to collect more information on allergic reactions and is undertaking consumer research to gather information and insights from people with food allergies. This intelligence will help the FSA build a better picture of the emerging patterns on allergic reactions experienced by consumers.

We agree that it is essential that we learn from these tragedies. In conjunction with the FSA’s ongoing programme to collect more information on allergic reactions, the Department of Health and Social Care is working to support the FSA to increase information prevalence regarding such fatalities.

LORD BETHELL

Furthermore, officials from the Department and the FSA are together considering the existing data available from across the medical estate on food-related anaphylaxis cases, and how this might be analysed and used to prevent future incidents and deaths. The intention is to understand what more both Departments are able to do in this area.

I am aware that the FSA has provided you with a more detailed response on these matters, as well as supporting information on its strategy on food hypersensitivity, which the Department fully supports. I hope that information is helpful to you.

Availability of emergency Adrenaline Auto-injector (AAI) devices in the retail food sector

In relation to your second matter of concern regarding the availability of emergency Adrenaline Auto-injector (AAI) devices in the retail food sector, my officials have liaised with the Medicines and Healthcare products Regulatory Agency (the MHRA), which is responsible for the regulation of medicines in the UK.

I can assure you, and Ruben’s family, that making AAI devices more widely available for use in exceptional, emergency situations, is being considered carefully and thoroughly.

The MHRA is providing a detailed response to you on the work that is taking place to consider and respond to a range of issues relating to the safe and effective use of AAIs. This includes a recommendation in principle by an Expert Working Group on AAIs (EWG AAIs), endorsed by the UK Commission on Human Medicine (the MHRA’s independent scientific advisory committee), that AAIs should be made available in public locations for use to treat anaphylaxis in unforeseen, critical circumstances, provided that safeguards can be implemented to ensure effective and safe use. Cinemas offering food for sale is an example of the type of location that the EWG AAIs identified as having particular potential to save lives.

The EWG AAIs made a number of other recommendations including the reinforcement of critical safety measures to patients on the use and management of AAIs.

A report summarising the conclusions and recommendations of the AAI EWG, endorsed by the UK Commission on Human Medicine, is expected to be published by the end of May 2021.

Further work is required to consider the full implications of this recommendation, including how widening access to AAIs for emergency use can be safely implemented, as well as the need for legislative change.

I hope this response is helpful and demonstrates our continued commitment to ensure the safety of those with food-related allergies. I am grateful to you for bringing these concerns to my attention.