Dear Sir Brian Bicat (Deceased) am writing in response to your letter sent on 02 August 2018 regarding the Report to Prevent Future deaths in relation to Mr Bicat. Bradford District Care NHS Foundation Trust has taken the following actions: 1_ The Trust has produced safety information leaflet for patients in relation to using paraffin-based products, in particular regarding the laundering of clothing and bedding: This leaflet has been disseminated locally across all Bradford Clinical Commissioning Groups and Acute Trust providers and Leeds Community Services. 2 The Trust has produced a fire hazard poster in relation to using paraffin-based products, which has been disseminated for display throughout clinical services areas and this has also been communicated electronically across the organisation: 3 The leaflet and poster been uploaded onto the NHSI improvement hub website under the heading of patient safety. Communication has been undertaken with the Trust's lead for CCG and NHSI: Work has been undertaken to disseminate this information nationally through NHSI; 4 Awareness has been raised with all staff within Bradiord District Care Foundation Trust and this issue is included in all fire training:
5. An alert has been created on our clinical records system, SystmOne. This is an electronic icon indicating that a patient is at risk when emollient is entered into the clinical record. 6 The Trust has undertaken a survey of staffs awareness of the hazards of emollients. This survey will be undertaken six monthly and any areas of concem will be addressed following the results W: www.bdct nhsuk @BDCFT You & Your Care New have

7 A yearly audit will be undertaken within all community nursing services within BDCFT to demonstrate that staff distribute the safety leaflets on initial contact of patients who are prescribed emollients The audit will also demonstrate that there is documented evidence of discussion by staff with patients regarding the hazards of emollients. 8_ A piece of work has been completed by the community nursing services to ensure that all existing patients have relevant patient infomation leaflet and advice has been given by staff to patients regarding the risks of using emollients.
9. The message regarding the risks of using emollients have been shown on the Trusts computer screens on Screen savers This will be repeated on a bi-annual basis within BDCFT to ensure that the risk of emollients remain paramount:
10. The fire officer for BDCFT will continue to liaise with the Fire service t0 ensure all teams are updated on the most recent evidence regarding the laundering of clothes and ongoing hazards of emollients: hope that this evidence on the above will demonstrate to yourself and the family that learning has been taken forward across the wider NHS organisation following this tragic incident to raise awareness of the risks of using emollient creams.

Dear Mr Fleming Re: Brian Leonard Bicat, deceased Report to Prevent Future Deaths Paragraph 7 , Schedule 5 of the Coroners and Justice Act 2009 and Regulations 28 and 29 of the Coroners (investigations) Regulations 2013 Thank you for your letter of 2 August 2018. The safety of our products is something we take extremely seriously, and we are committed to ensuring safety information is prominent; clear and readable We have identified the following areas where action can and will be taken: Warnings of such risk displayed on all product packaging 2 Consider more prominent labels and alerts re fire hazard on product containers
3. Consider fire warning labelling on all emollients including those below 50% content; making clear the mechanisms of the risk Warnings of such risk displayed on all product packaging We have completed a product labelling review to improve prominence; clarity and content as well as ensuring consistency across the Hydromol range; regardless of paraffin content The revised product labelling, website and promotional materials is expected to be available throughout the remainder of 2018 and 2019. The labelling now states: "If this product comes into contact with dressings, clothing and bedding the fabric can be easily ignited with a naked flame: You should keep away from fire when using this product:' Registered Office: Avonbridge House; Bath Road, Chippenham; Wiltshire SN15 ZBB Registered in England No. 3250064 rec

Alliance Pharmaceuticals Limited CALLIANCE Avonbridge House; Bath Road; Chippenham, Wiltshire SN1S 2BB Telephone: +44 (0) 1249 466966. Fax: +44(0) 1249 466977 Breathing lite into medicines e-mail: info@alliancepharmaceuticalscom wwwalliancepharmaceuticals.com We continue to work with the MHRA and PAGB to input into the labelling review: If changes are recommended by the MHRA, we commit to further updates, in addition to the changes we have already implemented
2. Consider more prominent labels and alerts re fire hazard on product containers We will undertake an assessment of the labelling throughout the remainder of this year; this activity will review all information from this event to determine any further opportunities for improvement of the current labelling: The assessment will be performed by a cross functional group of experts who have knowledge and experience of Hydromol and its use. We will implement any required changes to the product; product labelling or promotional materials which the risk assessment identifies We will also apply required labelling amendments to marketed paraffin containing products, regardless of paraffin content: Furthermore; any proposed changes to the labelling will be reviewed by user groups who will support us in ensuring the intended message is understandable We are also engaging with West Yorkshire Fire Service to ensure the mechanisms of risk are clearly stated on our labelling: Any and all personnel in contact with healthcare professionals and the general public will be updated appropriately to ensure communications are in line with; and convey, the correct message which communicates the outcome of the assessment and any subsequent labelling changes
3. Consider fire warning labelling on all emollients including those below 50% content, making clear the mechanisms of the risk We are proactively working with the MHRA and PAGB to ensure a consolidated warning is displayed on all product packaging, across industry: And we further commit to revisiting warnings on the product packaging; or any supporting processes, if additional information from the MHRA, trade bodies or any other expert groups becomes available Alliance takes this issue extremely seriously and is working proactively to address the issues raised by the coroner: Clearly this is a tragic incident and we hope that these actions will help to prevent future incidents from occurring: Yours sincerely Peter Butterfield Chief Executive Officer Registered Office: Avonbridge House; Bath Road; Chippenham, Wiltshire SNIS 2BB istered in England No. 3250064 Regi

(C B 4 BAYER 2 7 SEP 2018 E R Mr M.D. Fleming HM Senior Coroner for West Yorkshire (Western) Courts The Tyrls Bradford BD1 1LA Dear Mr Flemming 25th September 2018 Brian Leonard Bicat (deceased): report to prevent further deaths Bayer plc issued under Regulation 28 Coroners (Investigations) Rules 2013 400 South Oak Way Green Park Reading We refer to the report to prevent further deaths dated 18 July 2018 ("the RG2 6AD Report") , issued following the inquest into the death of Mr Bicat and sent United Idom to Bayer under cover of a letter dated 2 August 2018. Tel; +44 0118 206 3000 The Report indicates that; at the time of his death; Mr Bicat suffered from lars bruening@bayer com leg ulcers for which he was under the care of district nurse and WWW bayer co.uk receiving daily applications of Diprobase Cream and Hydromol Ointment On 22 September 2017, Mr Bicat experienced severe burns as a result of a fire inadvertently started when a flame from his cigarette lighter came Bayer plc is registered into contact with his dressing gown. Evidence given at the inquest by In England No.935048 Registered office: West Yorkshire Fire and Rescue Service stated that the speed and 400 South Oak Way intensity of the fire had been increased by the presence of the cream and Green Park ointment on Mr Bicats dressing gown and pyjamas. Reading RG2 6AD We are seriously concerned to learn of the death of Mr Bicat and the fact that his use of Diprobase Cream, together with Hydromol Ointment; may have contributed to the intensity of the fire which caused his injuries The Report to Prevent Further Deaths The Report raises various concerns in relation to the risk of fire associated with use of paraffin based ointments and emollient creams, including those with a paraffin content below 50%. It has been sent to number of Government; NHS and industry persons and bodies, including Bayer as the manufacturer of Diprobase Cream Bayer was not asked to provide evidence for the purposes of the inquest and has no knowledge of the circumstances of Mr Bicat's death save for the information set out in the Report City Kingc

B A BAYER 8 2 of 6 The specific concerns raised in the Report are as follows: 1 . Paraffin based ointments and emollient creams which contain a low level of paraffin pose a potential fire hazard risk; 2 Warnings of such risks are not displayed on all product packaging; 3 Consider more prominent labels and alerts re fire hazard on product containers; 4 . Health care professionals in both hospital and community setting may not be aware of the potential fire hazard poised by emollient creams which contain a low level of paraffin;
5. To consider fire warning labelling on all emollients including those below 50% content; making clear the mechanisms of the risk;
6. Health care professionals including pharmacists to verbalize product warnings at the point of prescription, dispensing or of sale;
7. Members of the public are able to purchase such products in retail outlets and online where verbal warnings from healthcare professionals are not given; 8_ Review patients with repeat prescriptions for emollients and cross reference those that smoke. Give safety advice retrospectively and review prescriptions; 9 Raise awareness with health care professionals and include paraffin based skin products in annual continuing fire safety training;
10.Review information sharing of burns data between hospitals, YAS and fire service so that incidents that didn't receive a fire service attendance can be investigated fully;
11.The NHS prescribing systems (system One and Optimise) appear to be updated by individual CCG's resulting inconsistent alerts and warnings;
12.Consider a review of the current effectiveness of obtaining fire incident reports involving paraffin based skin products since there is currently a lack of accurate national data involving paraffin based skin products_ Bayer's response to items 1-5 is provided below: understand that other recipients of the Report will address items 6-12 Page point We

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1 Paraffin based ointments and emollient creams which contain a low Ievel of paraffin pose potential fire hazard risk Paraffin based skin products represent first line treatments for patients with dry or scaly skin conditions, including psoriasis and eczema: are highly effective, well tolerated and easily and conveniently by both patients and carers_ therefore provide important therapies for conditions which can; when severe, be both disabling and distressing: Paraffin based ointments and emollient creams are not themselves flammable_ However use of products containing paraffin which results in an accumulation of paraffin from the ointment or cream on clothing or bedding, increases the flammability of such fabrics in the context of environmental hazards, such as cigarettes and cigarette lighters_ Diprobase Cream, manufactured by Bayer, contains 15% white soft paraffin and 6% liquid paraffin: It is currently regulated as a medicinal product Bayer is committed to ensuring the highest standards of safety of all of its products and, where appropriate, providing relevant warnings about the use of such products_ The Medicines and Healthcare products Regulatory Agency (MHRA) and other bodies have issued general warning statements informing patients , carers and healthcare professionals of the risks posed by naked flames to persons using emollients and we are currently, as described below; working with the MHRA and with the Proprietary Association of Great Britain (PAGB) , the industry association representing the consumer healthcare industry, in order to reinforce this information_ We support the development of common warnings and information to be applied to relevant paraffin containing ointments and emollient creams across the industry: They applied They'

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Warnings of such risks are not displayed on all product packaging While warnings regarding the possibility that paraffin containing products may accumulate on clothing and bedding increasing their flammability, have been issued by the MHRA NHS bodies and fire services, Bayer supports the inclusion of warnings on product packaging in order to strengthen the existing warnings and to provide an immediate reminder of the risks to users of emollients In 2017 , the MHRA commenced a review of the labelling of paraffin-containing emollients and the instructions for use provided in relation to such products, with a view to determining consistent warnings to apply to all such products, where appropriate. Bayer has co-operated fully with this review, but understands that it has not yet been completed The labelling and patient information provided in relation to all medicinal products forms part of the product's marketing authorization and must be approved by the competent regulatory authority (the MHRA in the UK) before it is put into circulation MHRA has advised Bayer that it will not approve labelling changes to emollients regulated as medicinal products until it has completed the review referred to above However , Bayer is in the process of re-classifying Diprobase Cream as a Class medical device under the Medical Devices Regulations 2002 and has conducted conformity assessment in accordance with such Regulations In compliance with the Regulations, Bayer may apply warnings to the labelling of medical devices without external regulatory approval When the re-classified product is launched in the UK (anticipated around February 2019) Diprobase Cream will include the warning fabric which has been in contact with this product away from sources of fire including lit cigarettes" The warning will be visible on the external labelling/packaging of the product as well Keep

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as being included in the patient information leaflet supplied with it_ 3 Consider more prominent labels and alerts re fire hazard on product containers As indicated above, Bayer supports the effective provision of warnings to patients , carers and healthcare professionals regarding the risk of flammability following accumulation of paraffin containing emollients on bedding and clothing However , it is important that such warnings should convey consistent message when applied to relevant products. We are therefore co-operating fully with the MHRA review; as described above, in order to ensure that effective and appropriate information can be provided with Bayer products and other emollients, as soon as this has received regulatory approval. Health care professionals in both hospital and community setting may not be aware of the potential fire hazard poised by emollient creams which contain a low level of paraffin We refer to our responses above_ In addition to the measures described, Bayer operates consumer-facing website for Diprobase products, which includes warning in respect of the risk of flammability associated with the use of Diprobase Cream: Following receipt of your letter in relation to Mr Bicat, Bayer is in process of updating the content of the website to include the same warning as that which will be included on the labelling for Diprobase Cream as medical device, namely Keep fabric which has been in contact with this product away from sources of including lit cigarettes"_ The updating of the website will be completed no later than the end of October 2018. the fire

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5. To consider fire warning labelling on all emollients including those below 50% content; making clear the mechanisms of the risk We refer to our responses above_ We hope that the information provided in this letter addresses your concerns and reiterate our commitment to ensuring that appropriate warnings and information are provided with all Bayer products to ensure safe usage by patients, carers and healthcare professionals.

Dear Mr Regulation 28 Report concerning Brian Leonard Bicat Your Ref;_ Thank you for your letter %f August 2018 in which you asked the MHRA to provide a response to the Regulation 28 Report to Prevent Future Deaths following the inquest into the tragic death of Brian Leonard Bicat In the UK an emollient may be regulated as a medicine, a medical device or a cosmetic. One of emollient products referred to in your Regulation 28 Report is regulated as a medical device Hydromol Ointment; the other; Diprobase Cream is a medicine. This response deals with the aspects of your report which relate to medical devices and device regulation. A response dealing with the medicine aspects wili be provided separately, in line with your request for two separate responses report listed seven matters of concern which fall within the remit of MHRA & medical device regulation. Paraffin based ointments and emollient creams which contain low level of paraffin pose potential fire hazard risk 2 Wamings of such risks are not displayed on all product packaging 3 Consider more prominent labels and alerts re hazard on product containers Healthcare professionals in both hospital and community setting may not be aware of the potential for fire hazard posed by emollient creams which contain a low level of paraffin_
5. To consider fire warning labelling on all emollients including those below 50% content; making clear the mechanism of the risk 6_ Healthcare professionals including pharmacists to verbalise product warnings at point of prescription, dispensing or point of sale. 7 Members of the public are able to purchase such products in retail outlets and online where verbal warnings from healthcare professionals are not given. Medical devices must be CE marked before are placed on the market in the UK and throughout the EU: MHRA's expectation is that, when CE marking and placing medical device on the market, manufacturers will have evaluated the potential risks that could occur, including that of fire. [5 ~z ZQre HM Fleming the Your fire the they

The CE mark demonstrates that the medical device is fit for its stated intended purpose and meets legislation relating to satety: This requires the manutacturer to demonstrate their medicai device meets the requirements in the Medical Devices Directive (MDD) by carrying out conformity assessment. Additionally, higher risk medical devices require certification from a third party conformity assessment body ("Notified Body") located in the EU prior to being placed on the market: MHRA is responsible for the oversight of UK Notified Bodies and has a post-market role in investigating reported safety issues. Emollients may fall into any of the risk classes according to their constituents and mode of action: The paraffin content of these products varies over a wide range , also, from as Iittle as 5% in some cases, and has no bearing on whether the product is classed as device or as medicine. The classification difference is due to their mode of action_ In March 2008 MHRA Devices issued a reminder to healthcare professionals of the potential risks associated with paraffin based emollients, as highlighted by the work of the National Patient Safety Agency (NPSA) in 2007 _ This reminder was in the form of a "One Liner" which was published in issue 56. Since_ at that time, as no adverse incident reports had been received, it was not considered necessary to issue any further communication. However, in addition, we have written to manufacturers to raise awareness of this potential risk This highlighted the need for the risk of to be included in their product risk analysis and ensuring warnings of the potential risk were placed either on packaging or included in device's instructions for use_ We have previously issued warnings regarding the dangers around smoking and bed fires (MDA2013/073). No reports of adverse events, injuries or fatalities were reported to MHRA regarding devices until 2017_ At this point it was noted that there are differences in labelling between products regulated as devices and medicines: Working in collaboration with colleagues in the medicines regulatory part of the Agency in Spring 2017 MHRA Devices wrote to UK manufacturers of Class medical devices (the lowest risk category) directly and asked them to undertake a review of their products. In addition, we asked the UK Notified Bodies to ensure that a review and risk assessment was undertaken by manufacturers of higher risk classification medical devices_ We also brought the issue to notice of European regulatory colleagues to highlight the dangers internationally. All European Competent Authorities were asked to share the letter mentioned above to with Notified Bodies they oversee t0 ensure coverage of all manufacturers with products in the European market; The issue has been raised with NHS Improvement and Medical Device Safety Officers (MDSOs): The latter are individuals in each NHS Trust in England who ensure safety information is made available to relevant staff. MHRA is also liaising with the Care Quality Commission to highlight the potential dangers to users within the care community In response to more recent evidence regarding the risk with emollient products paraffin, including a number of fatalities reported since 2017 (many of which were historical), MHRA is reviewing the available evidence regarding the risk for a wider range of paraffin-containing medicines and devices and has convened an ad hoc Expert Group to advise on the appropriate regulatory action for both medicines and medical devices_ The Expert Group met for the first time on 7th September 2018 and will meet again on Friday 30th November 2018 when it is expected to deliver its final recommendations for regulatory action to protect health: Each of the seven matters of concern raised in your report within MHRA's remit is put to the group for consideration and advice. In making its recommendations, the ad hoc Group will consider evidence from five Coroners Regulation 28 reports including those for Pauline Taylor (Regulation 28 Report by Assistant Coroner Burke, West Yorkshire Western District; Ref: HK/1067-2015) and Brian Bicat; data on additional possible cases reported by ten Fire and Rescue Services across the UK; the results of fire the the the public being Mary

flammability tests conducted by West Yorkshire Fire and Rescue Service and Anglia Ruskin University; data iiUiti tne international Burn Injury Database, as well as data provided by the companies which market emollients in the UK: will write to you following the ad hoc Expert Group's meeting on 30th November 2018, to inform you of its recommendations and the regulatory action we will take to protect public health.