Ruben Bousquet

Our Ref: 

Dr Andrew Harris 
HM Senior Coroner, London Inner South 
HM Coroners Court 
1 Tennis Street 
Southwark 
London SE1 1YD 

From the Lord Bethell 
Parliamentary Under Secretary of State for Innovation 

39 Victoria Street 
London 
SW1H 0EU 

16 April 2021 

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.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 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.  

LORD BETHELL

Chief Executive 

Mr Andrew Harris 
Senior Coroner 
Southwark Coroner’s Court,  
1 Tennis Street,  
SE1 1YD 

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS – RUBEN BOUSQUET:  
RESPONSE BY THE FOOD STANDARDS AGENCY 

Date:  09 February 2021 

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, 

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 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. 

Yours sincerely,

HM Senior Coroner Dr Andrew Harris 
Southwark Coroner’s Court 
1 Tennis Street 
London 
SE1 1YD   

Date 15th April 2021  

Dear Dr Harris 

Medicines and Healthcare products 
Regulatory Agency 

10 South Colonnade  
Canary Wharf  
London  
E14 4PU 
United Kingdom 

+44 (0) 20 3080 6000 

gov.uk/mhra 

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 

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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. 

Yours sincerely 

Chief Executive Officer 
Medicines and Healthcare products Regulatory Agency  

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