Provision of Epinephrine Auto-Injectors: Discussion

I welcome our viewers who are watching this meeting live on the UPC network and on the Internet. I also welcome all the people in the Visitors Gallery and Ms Caroline Sloan, Ms Yvonne Moynihan, Dr. Michael Byrne, Professor Jonathan Hourihane, Mr. Pat O'Mahony, and Ms Lorraine Nolan to our meeting today.

I remind members, witnesses and those in the Visitors Gallery that all mobile telephones should be switched off for the duration of this meeting and should be in airplane mode rather than on silent because they interfere with the broadcasting of proceedings and it is unfair to staff to have buzzing noises in their headsets.

Our meeting this evening has been convened to discuss EpiPens which are used for the treatment of allergic reactions. Severe allergic reactions can have devastating consequences for those affected and immediate access to medication can be a life-saving intervention. Today we are conscious that Ms Sloan, whose daughter Emma tragically died, is with us. We offer our sympathies to her and thank her for being here and for her courage, not just in coming here but in campaigning since Emma's death. We know it is not easy to be here but we appreciate her presence

Professor Jonathan Hourihane and Dr. Michael Byrne from University College Cork, UCC, have been very strong advocates and campaigners in this area. We are also joined by Mr Pat O'Mahony and Ms Lorraine Nolan from the Irish Medicines Board, IMB. They are very welcome this afternoon. I apologise to Deputy Ó Caoláin because this meeting unfortunately clashes with his business dealing with a Bill in the Dáil.

The purpose of our meeting is to promote awareness of the campaign run by our witnesses and to ensure that the like of the tragedy which has occurred may never happen again. I am aware that circumstances surrounding Emma's tragic death are now the subject of an inquiry by a statutory body and that this committee needs to exercise caution and should not enter into a discussion regarding these events as we do not wish to prejudice the outcome of that inquiry. This is an important meeting and I thank the many people in the Visitors Gallery for showing their support for our witnesses.

I wish to advise the witnesses that by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if a witness is directed by the committee to cease giving evidence in regard to a particular matter and continues to do so, the witness is entitled thereafter only to a qualified privilege in respect of his or her evidence. Witnesses are directed that only evidence connected with the subject matter of these proceedings is to be given and are asked to respect the parliamentary practice that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable. Members are reminded of the long-standing ruling of the Chair to the effect that they should not comment on, criticise or make charges against a person outside the House or an official either by name or in such a way as to make him or her identifiable.

I invite Mrs Sloan to make her opening remarks.

Ms Caroline Sloan

Emma is my child. She will forever be 14 years old. I loved her from the day she was born and I watched her grow into a beautiful young woman. Emma was bright, beautiful, smart, funny and kind. She was so kind to others in her short life that I am very proud to be her mother. Emma lived her life to the fullest. She was headstrong and she knew her own mind. She had many plans for her future, which included doing her junior certificate, becoming a stylist, getting loads of tattoos and having a family of her own. I was sure she would achieve all of this and more. Instead, Emma died on a cold street corner one week before Christmas while we watched helplessly. She was looking forward to Christmas, her new telephone, and her tickets. All her presents still sit wrapped in a box in a press. I only ever got to spend one Christmas with all three of my children.

Emma's death has been described many times as a tragedy but for me that is not the case because a tragedy is something unavoidable. Emma's death was avoidable. Had we had the correct information and education about her allergy, and had we had access to an EpiPen, Emma would be with us today. That is the reason for the campaign.

The first aim of the campaign is to free up the availability of EpiPens. They should be in every first aid box in the country. There is very little training required in the use of these pens. They cost 10 cent a day to keep which could make the difference between life and death, especially for people as yet undiagnosed with allergies. The second aim is to have all allergy sufferers supplied with ID cards or bracelets. This would be of benefit for two reasons, one can walk into a chemist and be given a pen and someone else can easily identify what is happening to a person who goes into anaphylactic shock and is not able to administer the pen him or herself. There is a scheme in Scotland under which pharmacists have an orange light and will administer treatment for anaphylaxis. While this is a step in the right direction it is not practical unless one has the reaction in the vicinity of a chemist. As we are all too aware since Emma's death, time is not on our side.

This country should follow in the footsteps of America where last year President Obama signed legislation to encourage all schools to stock EpiPens following the death of two children. Canada is also introducing this measure state-by-state, which has already saved lives. We are also campaigning for an allergy clinic in every county in Ireland. Until recently Professor Hourihane was the only allergy specialist in the country. He was based in Cork. Recently an allergy specialist has been appointed in Our Lady's Hospital in Crumlin. The waiting time for an appointment is one and a half years. How many children could die in that time and why are there not better services for children with allergies? Had Emma been referred to a specialist, given the results of her allergy test and given an allergy management plan she would be alive today. We knew the importance of having her asthma inhaler and carried it everywhere. Had we known the importance of the EpiPen we would have carried it everywhere. We were never told Emma's nut allergy was fatal.

Since starting this campaign a little over seven weeks ago we have collected over 60,000 signatures, including 10,000 on-line. The support from people across the country has been amazing in promoting the campaign and collecting signatures. Many of Emma's friends have been involved every week, attending various events and locations to promote the campaign, and collecting signatures. Everywhere they go people who sign the petition express shock and outrage at the circumstances of Emma's death and see the aims of our campaign as common sense.

The campaign has also received support from the Restaurants Association of Ireland, the Hotels Federation of Ireland, Dublin Fire Brigade and Ambulance Service and Deputies and councillors all over the country. Emma died because we were denied access to a life-saving injection. We will continue to fight for Emma and have her voice heard until the changes are made to ensure this never ever happens to another child or family because she gave her life for this.

I thank Ms Sloan very much for her bravery in being here today and the courage she has shown in being a campaigning voice.

I invite Ms Yvonne Moynihan to speak.

Ms Yvonne Moynihan

I thank the Chairman and members for inviting us here today. I welcome the initiative to discuss the provision of EpiPens as they provide vital life-saving injections. I met Ms Sloan through the Emma’s Voice campaign because I too suffer from anaphylaxis. I did not know that I had anaphylaxis until I went into shock in a restaurant in 2010. Fortunately for me, I was able to discuss my symptoms on the phone with a doctor and she was soon able to administer and adrenaline injection.

Since that incident I have been consistently vigilant in telling members of staff in restaurants about my shellfish allergy, despite that, however, there have been occasions on which I have suffered a reaction because of cross-contamination in food. For this reason it is my submission that it is very important to have EpiPens available in restaurants.

The fact is that people have died in restaurants in this country as a result of allergies. The law is insufficient. Proof of that has been the death of Emma Sloan.

My written submissions could be distilled into four distinct categories which I will briefly summarise. First, I identify the problems with the law. In effect, there is no real legislative platform at the moment. Second, I will suggest solutions by examining the laws in other jurisdictions, in particular the US, Canada and the United Kingdom. My submissions will focus on the provision of EpiPens specifically in restaurants and schools. Amending the regulations is insufficient in itself. A comprehensive Bill is required. In my submissions I consider the Public Health (Availability of Defibrillators) Bill and suggest that any new law should model itself on the provisions of that particular Bill.

Finally, in my submissions I consider the civil liability in the administration of epinephrine in an emergency situation. That is very important. I will illuminate the importance of setting out the scope of liability in any potential legislation so that any individual who intervenes in an emergency situation need not be afraid of the threat of the proceedings. Therefore, it is very important to remember that EpiPens exist to save lives and not to create unnecessary legal woes.

In terms of the current law, regulation 8 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003-2008 does provide that a pharmacist can supply epinephrine without prescription in an emergency. I submit that the legislation is restrictive because it fails to define an emergency and, furthermore, it fails to cater for people such as me who have undiagnosed allergies and do not have a prescription for an EpiPen. The only way to fix the issue is for the legislation to go further and to set out further exceptions for emergencies and extend accessibility to schools and restaurants in particular. There also needs to be provision to introduce a scheme to train first responders.

I submit that schools and restaurants in particular are a hot bed for anaphylactic reactions. Currently, there are no statutory protocols in being for dealing with food allergic customers. In addition, there are no formal guidelines in schools for the treatment and management of anaphylaxis. Deficiencies in the legislation will lead to exposure in terms of liability. The only way to minimise that is to introduce guidelines.

The US in particular has been very proactive in introducing legislation. As Ms Sloan said, President Obama signed federal legislation in December 2013 requiring schools to stockpile EpiPens. Individual states will enact their own laws. The Act permits trained staff to administer the injections and it requires schools to have a stockpile of epinephrine and furthermore to have a plan in place for the management of anaphylaxis. Most importantly, the Act outlines the scope of liability which protects trained individuals who administer an injection in an emergency. I set out the text of that in my written submissions.

The federal legislation was enacted as a result of the death of a student in Virginia. Amarria Johnson accidentally ate a nut in school. The school had an EpiPen belonging to another child but was not allowed to use it on Amarria and as a result, unfortunately, she died of anaphylaxis. Subsequently, Amarria’s Law was enacted. That allows schools to administer EpiPens and it indemnifies anyone who uses one on a child.

In Canada, Sabrina’s Law was enacted following the death of a child in school. The Act requires that every school board adopts an anaphylaxis plan dealing with life-threatening situations. The Act also provides that no action will be taken for a claim for damages in respect of any act that is done in good faith.

Across the water, in the UK, the Children and Families Act was enacted last month. It requires every school in England to ensure that children who suffer from health conditions such as anaphylaxis get the care they need in school. Once again, there is a requirement that staff are trained in respect of the medical condition and protection is provided should an allegation of negligence be made subsequently.

I do not think amending the regulations will resolve everything. I propose that a Bill would be more broadly welcomed, such as the Public Health (Availability of Defibrillators) Bill. The way the Bill is set out is of some relevance. Part 2 deals with the provision of defibrillators, which requires all owners of designated places to install defibrillators. Part 3 deals with training in the use of defibrillators. Part 5 deals with the scope of liability in order to protect anybody who does act in good faith. Part 6 is concerned with offences and penalties that may arise. The layout of the Bill is a good guide for any proposed heads of Bill.

Action is needed on the introduction of comprehensive legislation to impose, first, mandatory health plans in schools, a requirement to stock EpiPens in schools, restaurants and other places that may have a first aid kit, and a requirement to train staff. Most importantly, the scope of liability needs to be set out in any legislation so that individuals do not have to fear a claim for damages against them.

A policy combining all of the above would probably be one of a kind and if it were to be introduced, Ireland would lead the way in terms of accessibility to EpiPens. I thank the committee for inviting us before it, in particular those members who have helped Ms Sloan, especially Deputy Gerry Adams, who first brought the situation to the attention of the Minister for Health. I also thank the Minister for Health for suggesting that the regulations could be reviewed. I commend Ms Sloan for her strength of character. It takes a rare person to turn a very tragic situation into positive action and I applaud her for that.

I thank Ms Moynihan for her remarks and what she said about Ms Sloan. Deputy Adams was not the first person to mention the issue to the Minister as the committee has raised it on a number of occasions. Many Members of the House have also raised it with the Minister both privately and publicly. It is important to clarify the record of the House on the matter.

I welcome Amy Sloan, daughter to Caroline and sister of Emma, and her friends, to the public gallery. I thank them for being here. From University College Cork, I welcome Dr. Michael Byrne, who is the head of the student health department. He is very welcome.

Dr. Michael Byrne

Go raibh maith agat, a Chathaoirligh. Ar an gcéad dul síos, ba mhaith liom mo mhíle buíochas a ghabhaíl leatsa as ucht an obair atá déanta agat ar an ábhar tabhachtach seo.

I am Dr. Michael Byrne. I am head of the student health department in University College Cork. I am also co-co-ordinator of UCC Health Matters, an initiative that is seeking to make UCC a HSE-recognised health promoting university. I was the founding medical director of UCC’s first responder automatic external defibrillator, AED programme, that has overseen the provision of more than 40 automatic external defibrillators in multiple locations on and off campus in UCC. I am a trained health care AED provider and have previously been an AED basic life support, BLS, instructor for both health care and lay personnel. I am co-lead, along with Professor Hourihane, of UCC’s anaphylaxis initiative.

I am more than happy to defer to Professor Hourihane in terms of the research, science and the application of knowledge in the area of anaphylaxis, especially in the paediatric setting. He is acknowledged as a world expert in the field of anaphylaxis, and Ireland, and in particular Cork and the Munster region, are indeed fortunate to have the services of an expert such as he.

My passion, interest and concern in this area arises from my role as the medical practitioner on-site, responsible for protecting the health, welfare, well-being and safety of more than 18,000 students that are on campus daily. As head of the student health department, I lead a team of health care professionals, endeavouring to anticipate and provide care for the full range of the usual presenting problems that occur in the primary care setting, for a population comparable to any large rural town.

In addition, as a student health physician I am challenged with anticipating and providing for the unique health threats and risk-taking behaviours that are prominent in a third level setting and among students. To date, we have had a number of notable successes, including in the area of alcohol related harm, with the successful implementation of the university alcohol action plan, which has been recognised nationally and internationally as an example of best practice. A particular success in the area of life-threatening emergencies was the establishment of the first responder automatic external defibrillation, AED, programme on campus, with the recruitment and training of lay university personnel to act as first responders, along with the deployment of more than 40 AEDs. Within one month of having AEDs on campus in UCC we had the great fortune to manage to save the life of a parent of an attendee at a conferring ceremony by means of successful defibrillation.

All of which is cited by way of illustrating that we believe in UCC that we have an established a track record of identifying real life-threatening risks and of implementing innovative and effective solutions to mitigate those risks. It was in that context that I was delighted to be approached by Professor Hourihane to seek to establish a comparable first responder anaphylaxis autoinjector programme, which as he has indicated, we managed to design and implement in 2011. It is with some dismay therefore that we continue to be unable to activate this innovative and life-saving pilot project for the want of appropriate legislative approval.

We contend that, given the in-house expertise, the established proven track record, and the unique high-risk practices that this anaphylaxis-prone age group display, there is no better setting in which to demonstrate proof of concept and to establish such a first responder anaphylaxis autoinjector pilot programme. Thankfully, life-threatening anaphylaxis is rare. We very rarely see cases of near-death anaphylaxis in the student health premises. We have done so, however. In my eight years as head of service in UCC, we have saved at least one life in danger of anaphylaxis in our emergency treatment room through the prompt administration of adrenaline. We have had one episode of anaphylaxis on our premises in eight years. Therein lies the problem, however, because there will be many more anaphylaxis episodes which will occur outwith our premises. Anaphylaxis will occur when someone is not there but in the library, on the running track or in one of our multiple eating places on campus. It will occur at night and at weekends. It will occur when we are closed and not available.

Students are risk takers; it is in their DNA. They see themselves as invincible and even those who know themselves to be at risk often will ignore the risk. We anticipate that those who know they have anaphylaxis may not even carry their autoinjector on many occasions. Few, if any, will step forward and admit to having an issue with food allergy or anaphylaxis, not wanting to stand out in any way. In four years, despite regularly promoting and encouraging self-declaration at registration and orientation, not a single student came forward to tell me of an existing food allergy so that I could establish and compile a risk register. This is a high-risk vulnerable population. We believe we have the expertise in-house and the willingness to embrace the challenge. We have an innovative, safe and effective means of reducing the risk, and we ask for the committee's support to make that happen.

I thank Dr. Byrne. I welcome Professor Jonathan Hourihane, professor of paediatrics and child health at University College Cork, to make his presentation.

Professor Jonathan Hourihane

I am professor of paediatrics and child health in UCC. I was a member of the 2012 to 2014 food allergy and anaphylaxis task force of the European Academy of Allergy and Clinical Immunology, EAACI, whose documents were published and launched at EAACI’s annual congress in Copenhagen last week. I submitted that in PDF form as part of my written evidence. Other scientific documents were also included. I am the co-chair of EAACI's food allergy and anaphylaxis meeting, the world’s biggest food allergy meeting, which is scheduled for the National Convention Centre in Dublin in October. The committee is invited to attend, if members so wish. I am principal investigator on a prospective study of anaphylaxis, with Professor Ronan O’Sullivan and Dr. Ioana Maris, funded by the National Children’s Research Centre, Dublin. I co-lead, with Dr Michael Byrne, the anaphylaxis initiative in UCC. I am chairman of the Irish Food Allergy Network. Until last week I was secretary of the Irish Association of Allergy and Immunology, which receives unrestricted financial aid from industry, including contributions from manufacturers of autoinjectors. I declare that as a relative conflict of interest. However, the grant is unrestricted. I am a board member of the Clemens von Pirquet Foundation, an independent charity affiliated to the professional association, EAACI, which promotes the scientific study of allergy in children. I have received research funding and travel grants from other sources. I recently visited Boston to investigate the possibility of bringing oral immunotherapy practices to Ireland.

Anaphylaxis is a term coined by Clemens von Pirquet in the early 20th century to indicate the phenomenon of lack of protection. Prophylaxis is protection and anaphylaxis is lack of protection. Anaphylaxis could loosely be considered the opposite of prophylaxis. The use of the term anaphylaxis is now broadly related to allergic reactions to allergens, which can be foods, which we are mainly talking about today, pollens - we are in the middle of hay fever season at the moment, house dust mites, which cause asthmatic attacks, and medicines, which are by far the commonest cause of anaphylaxis because they are administered to people by routes that are not natural such as injection and other means. Anaphylaxis is a common problem within hospitals but we are probably more focused today on community reactions outside the hospital setting. Recent European position statements and systematic reviews recognise how difficult it is to collect data because the disease is diffuse in its presentation and it is difficult for unfamiliar physicians, nurses, other health professionals, members of the public, parents and other carers to recognise it. It is noteworthy that 20% of acute asthma deaths are probably anaphylactic in nature because the final common pathway in anaphylaxis can be wheezing and the person may be too unwell to say why the wheezing started.

Anaphylaxis is likely to become more common because we are moving into a dynamic phase of management of food allergies where we are giving the foods people have been rigorously told to avoid. In the oral immunotherapy programmes it is harder to have the treatment than the condition where one simply avoids the food rather than eating it. Allergic reactions are becoming more common. Iatrogenic anaphylaxis is going to become more common. Immunotherapy will be moving from research protocols to more routine care in other parts of the world but, as usual, Europe, and in particular Ireland, will be behind the curve due to inherent caution and uncertainty.

It appears that people at risk of anaphylaxis have a lack of protection against the outcome of the condition. People are unaware of the condition. The legislation is not in place to protect people who might be aware of it and families are uncertain as to who can help them. The situation could be addressed with simple or complicated legislative measures that would be both innovative and widely welcomed by the public.

While death from anaphylaxis is rare, the prospect of it is not. Death is a grim part of daily life for families. They feel they are being followed around by the Grim Reaper. That is a sentiment I hear every week. A more classical way to put it is that the sword of Damocles is hanging over their heads. They feel that the Grim Reaper will take their child if they make the tiniest mistake with their food. That is a hard way to live. It inhibits families sharing their child's life with other carers and adults in loco parentis and limits their child's normal integration in social groups such as after-school clubs, sports clubs and social parties. Those are all normal parts of life which are manageable allergy exposing situations if proportionate restrictions and precautions are in place. The handing over of adrenaline autoinjectors from an experienced but anxious family to an inexperienced and unfamiliar family can be very stressful and can limit such interaction for families.

In the United States, the Executive has enacted the School Access to Emergency Epinephrine Act. However, it must be recognised that President Obama had a personal interest in the issue as one of his daughters is peanut allergic. She has eaten food in Ireland, in Dalkey, and precautions must have been put in place for her in a way we do not think is worth putting in place for other children. The intention of the Act is to indemnify and encourage schools to have generic adrenaline available to administer to people who do not have their own adrenaline kits, or more likely to people who are not already aware that they are allergic to a food such as Ms Moynihan found out in adulthood.

There is no reason that this administrative effort could not take place in Ireland, which has far more limited or effectively no on-site school medical services. Nurses are employed in schools in the UK and America but it is not common in the public school system in Ireland. However, it must come with appropriate training packages and renewal mandates. It is not something that can be stuck to the wall with masking tape. We have to be familiar with the use of these devices in a way that allows us to be confident in using them in a situation where everything else has gone wrong. It is not sufficient to just put these kits into restaurants and catering outlets without the backup of training and support from public health authorities and allergy services.

We have far fewer allergists than America or European countries. Finland, with approximately the same population as Ireland, has 100 paediatric allergists. It is also difficult to access to allergy services in Ireland. The paediatric allergy clinic in Cork University Hospital is the largest in the country and I personally receive twice as many referrals per week as all the other services in the hospitals, each of which are resourced with two consultants. I am a 0.5 position because I am an academic and I receive twice as many referrals, which pro rata equates to four times as many referrals. My service’s wait times are all in breach of HSE guidelines and I have no idea how to fix that. Waiting times for the allergy clinic in Cork are at least one year for routine appointments and three years for diagnostic food challenges. These obstacles to accessing treatment suggest that the need for empowering patients and other partners in the social contract with families may be even more critical in Ireland than elsewhere.

If a person who carries prescribed adrenaline needs assistance in using his or her medicine, this assistance is covered by Good Samaritan provisions in legislation. The administration of unprescribed medication by health professionals is also covered by existing legislation. The gap in Irish legislation relates to the administration by non-medical staff of adrenaline to people for whom adrenaline is not specifically prescribed. This problem was solved in the United States and there is no reason that the Oireachtas cannot do the same. A pilot study proposed by UCC in 2009 and 2010 engaged in extensive training and recruitment of first responders for a programme of campus wide allergy stations beside existing defibrillators. The photograph I have circulated to members shows a locked black box beside a defibrillator. It is not the case that somebody can insert a €2 coin into this box to open it or that it is easily accessible. A first responder would have to be asked to access the box. The programme was voluntarily suspended in February 2011 in the context of confusion about over the counter administration of oral contraceptives by pharmacists. As it became apparent that the legislation under which we presumed protection would be available was unclear, we decided we could not take that responsibility. Since 2011, when we voluntarily suspended our programme, we have sought advice and guidance from regulatory authorities. We received no assistance sequentially from the Irish Medicines Board or the Chief Pharmacist’s Office prior to January 2013, when a Deputy facilitated a meeting with the Secretary General. Unfortunately, no material progress has occurred since then, despite multiple inquiries.

Since the death of Emma Sloan by anaphylaxis in Dublin in December 2013, our study in Cork has received details of 36 more cases of survived anaphylaxis in Irish children. The regional variance in reporting reflects the uneven medical awareness of the condition. More cases are inevitable and another avoidable death is also inevitable. Continuing legislative inaction could expose the State, its ill-equipped schools and its health care providers to liability in such an event.

If Emma Sloan had been born Emma Obama, we would not be having this discussion because she might be alive and well in the United States. The wider, regulated availability of adrenaline in the community and easier access to more clinicians who understand anaphylaxis are achievable, affordable and uncontroversial public health care innovations that meet several of the Government’s aims to improve patient autonomy and self-care.

Mr. Pat O'Mahony

I am saddened by the evidence presented by Ms Sloan, whom I have not met previously. I offer my sympathy to her and her family on their avoidable tragedy. We have prepared an introductory statement based on the committee's request to us to appear before it. I would also be happy to respond to any questions or additional comments. Many of the issues raised are unfortunately outside of the capacity of the Irish Medicines Board, IMB, to address because they pertain to policies of the Department of Health and other agencies. I am joined by my colleagues, Ms Lorraine Nolan, director of human products authorisation and registration, and Mr. John Lynch, director of compliance.

The IMB, which is shortly to be renamed as the Healthcare Products Regulatory Authority, HPRA, is the competent authority in Ireland for health product regulation. The mission of the IMB is to protect and enhance public and animal health through the regulation of medicines, medical devices and other health products. In the context of human medicines, one of the IMB’s key areas of responsibility includes the approval of medicines prior to their being placed on the market. Before a new medicine can be placed on the Irish market, it must be assessed and authorised by the IMB or by the European Medicines Agency. The assessment involves establishing that a medicine’s public health benefits outweigh its known risks based on an evaluation of the scientific data on the quality, safety and efficacy of the product. Where the benefit to risk ratio is considered positive, the product may be granted a marketing authorisation.

Adrenaline is a hormone which occurs naturally in the body but is also available as a medicine indicated in the emergency treatment of severe acute allergic reactions, or anaphylaxis. A number of medicines containing adrenaline are authorised for use in Ireland. Adrenaline products can be administered intravenously, IV, intramuscularly, IM, or subcutaneously, SC. IV administration must be performed by a health care professional.

Adrenaline auto-injectors, AAIs, consist of an adrenaline solution in a pre-filled delivery system designed for self-administration by the IM route. AAIs are used for the treatment of anaphylaxis, which is a severe and life threatening systemic allergic reaction. Such an allergic reaction can be rapid in onset, very severe in nature and can affect persons of all ages. Adrenaline administered by the IM route acts more quickly than when given by SC injection. This is an important consideration because rapid action of adrenaline is critical in reversing the symptoms of anaphylaxis. The exact incidence of anaphylaxis is not known but it is estimated that under 2% of the population per year experience anaphylaxis. Anaphylaxis can occur if someone who is allergic to a particular trigger, such as a food, insect bites and stings or a medicine, comes in contact with that trigger. Contact with the trigger results in substances such as histamine being released from certain blood cells in the body, thereby causing a clinical reaction which may involve many organs in the body, including the respiratory system, heart and kidneys.

In Ireland, three different AAI product ranges are currently authorised, namely, Anapen, Epipen and Jext. Each product range includes two different strengths, for adult and paediatric treatment, respectively. These products are all authorised under European procedures, which result in authorisations in many EU member states.

Anapen and Anapen Junior were the first auto-injector products to be authorised for the Irish market in 2003. In the past three years the range of adrenaline products available has been extended through the introduction of the two new ranges. Jext was authorised in 2011 and placed on to the Irish market in 2013. Epipen and Epipen Junior product was originally authorised in Ireland until mid-2010, at which time the authorisation was withdrawn by the then marketing authorisation holder for commercial reasons. In 2012, the product was relaunched in Ireland via an application through the European procedure and it finally came to market in 2014.

Adrenaline auto-injectors are automatic injectors that have been designed and developed for use by lay people for immediate self-treatment of anaphylaxis in an emergency situation, prior to seeking further appropriate medical treatment.

The difference and advantage of the adrenaline auto-injector products versus other adrenaline products, such as other pre-filled syringe systems or standard injectable forms, is that the intervention of a health care professional is not required for administration of the product.

Given the nature of the auto-injector, the product information and patient information leaflets contain detailed instructions on how to use the product. These include both written and pictorial descriptions for an emergency situation covering how to prepare the product for use and how to administer the product. They also highlight the need to seek immediate medical assistance.

In the 11 years since Anapen has been authorised there have been a number of updates to the product to improve its design and functionality. These include the incorporation of a variety of safety features to ensure safe administration of the product including accuracy of dosing, avoidance of needle stick injuries and inadvertent firing of the device. Another important update that was made related to the required storage conditions, which means that the product can now be stored at room temperature rather than in a refrigerator as originally required. This allows patients with allergies to carry the product with them at all times. While there are some variations in design between the available auto-injectors, the Jext and EpiPen ranges have similar design characteristics.

AAIs are supplied in packs containing two auto-injectors. One reason for this is the risk of biphasic anaphylaxis which can affect approximately 20% of patients who suffer an allergic reaction. Biphasic anaphylaxis is defined as the recurrence of symptoms in a patient without continued exposure to the allergen. The approved product information states that, in the absence of clinical improvement or if deterioration occurs, a second injection may be administered within a defined timeframe - ranging from five to 15 minutes - after the first injection. Therefore, it is important for patients to carry two AAIs in case a second injection is needed.

Notwithstanding the above developments in these products, AAIs are complex systems due both to the characteristics of the adrenaline active substance and of the delivery device, which is designed to be as patient-friendly as possible. The manufacture of these products is also complex.

I will now comment briefly on the current prescription status. Under the EU Medicines Directive and Irish law, products for injection must be supplied on prescription only. Accordingly, the marketing authorisations for these products stipulate that they are prescription only.

In addition to this legal requirement, there are safety concerns in relation to the possible incorrect use of adrenaline. These include the misdiagnosis of anaphylaxis and the potential adverse implications of incorrect or inappropriate administration of adrenaline, such as administration to patients with a history of - or underlying - cardiac arrhythmias, cardiovascular disease including angina and hypertension, where incorrect administration could result in an exacerbation of these conditions or significantly worsen health care outcomes. The fact that these are prescription medicines - and will be because that is what is required - does not mean that they cannot be provided in the kind of settings as described by earlier contributors.

I will now mention ongoing regulatory procedures. With the Chairman's agreement, that particular commentary is not especially relevant to the discussion, nor is the latter part of my presentation concerning shelf-life. Suffice it to say that shelf-life is an important issue, which feeds into any decisions that might be made about future availability.

I do have a brief comment on shelf-life. Adrenaline is a relatively unstable substance which readily degrades. This degradation is due to the chemical nature of the substance and is accelerated by factors such as exposure to light and oxygen, and pH changes. The manufacturers of all the authorised products have taken a number of steps to minimise the degradation of adrenaline and prolong the shelf-life, including protection from light and oxygen, the inclusion of an antioxidant in the formulations, and control of the pH.

While there are some minor variations in the shelf-life of the authorised products, the shelf-life of AAIs ranges from 18 months to two years. It is important that these products are not used after the shelf-life has expired. After this time the efficacy of the product can be reduced which may result in the product not working as required in an emergency situation.

If the Chairman agrees, I can stop there.

Sure. That is fine.

Mr. Pat O'Mahony

The other comments concern quality issues which have not been raised and are not relevant.

Thank you, Mr. O'Mahony. I also wish to thank Ms Nolan for being here, as well as Mr. Lynch. For the information of the meeting, we requested the Pharmaceutical Society of Ireland to make a presentation. As members are aware, the PSI wrote in reply to say it would not be in a position to attend as it is currently undertaking a statutory investigative process. The PSI said it would welcome an opportunity to discuss this important topic, including the pharmacist's role in the safe provision of medicines in an emergency. The society has asked the joint committee to facilitate this at a later date following the completion of the current ongoing statutory process. That letter was sent to the committee by the PSI.

I apologise to members, witnesses and those in the Visitors Gallery because there may be votes during the course of this meeting on the Health Service Executive (Financial Matters) Bill in the Dáil. We will be adjourning during the votes because democracy has to play its part. It may not happen, however, and hopefully it will not.

I welcome all the witnesses here today to discuss this important issue. I particularly want to welcome Ms Caroline Sloan and offer my sympathy on the loss of her daughter. I commend her on her campaign and thank her for telling us about the campaign to date.

The campaign is calling for better information for people with allergies. The issues that have been raised a very down to earth and normal for most people. I agree that there should be an EpiPen in every first-aid box and with trained first responders. I also agree that they should be readily available in schools, crèches and restaurants. People can cater for diabetics and are also trained to use defibrillators, so why not EpiPens?

I wish to ask Ms Sloan about training and supports. What type of awareness campaigns should be run on EpiPens? I am asking questions today on my own behalf and that of Deputy Ó Caoláin who has had to attend the Dáil Chamber. I wish to raise a few additional questions. Is it the witnesses' understanding that the State can introduce legislation to provide EpiPens to the public without the prior blessing of the EU Commission? Would this be in line with how we apply defibrillators?

Why does Ireland have fewer allergists than in the US or other EU countries? I read with concern the witnesses' comments that access to allergy services is in breach of HSE guidelines. This is alarming. Is there anything the HSE can do immediately without new legislation being introduced?

I read with interest that the campaign group established a first responder anaphylaxis auto-injector programme in 2010, but this is now dormant. Can Ms Sloan explain where the problem lies? Does she believe that the pilot programme can be expanded despite the lack of legislation, or is legislation required?

Are there any circumstances where a lay person should be allowed to use an injector? Is this just because we in Ireland do not have laws to cover this practice? Does it happen in other EU countries?

What implication will the current EU review have on the provision of injectors in Ireland? If the review calls for a change in regulations governing the supply of injectors, how long will it take to legislate for it in Ireland?

I wish to thank all the witnesses and, in particular, Caroline Sloan for her courageous testimony. In preparing for today's meeting, I thought of my experience in voluntary organisations such as the girl guides. That is when I had the experience of using an EpiPen. At the beginning of the meeting, our examination of the relevant legislation was mentioned along with civil liability issues. Having had to use an EpiPen, I realise that one must know how to use it correctly.

I refer to that judgment call to use or not to use an EpiPen. Are there negative effects of misusing one?

There is a significant issue with young people and allergies. Over the 20 years I have been bringing groups of young girls away, the range of allergies has been increasing. One can try to ensure the environment is clear of nuts, jelly and so on, but when young people are away, they will have midnight feasts, occasions on which I have had to use a pen.

We have been focusing on schools, and Deputy McLellan mentioned crèches, but for me it is more about remote locations. How do we ensure preparedness and provide appropriate training so that people know the symptoms of allergies? It is so quick and so apparent when it happens but, unfortunately, it can be too late to know that they are the symptoms.

Some young people are great while others are not so good. I am trying to work out how we can best respond. My fear of the box on the wall is that the person with the key will not be around and that one will be looking at this box, knowing it should be used. As legislators, how can we work to find a practical solution so it can made available appropriately? That is what I am trying to work through but I have not heard about the negative effects or misuse. Does somebody just get an adrenaline boost or are there other potential effects? I would be interested in exploring those issues. I thank the witnesses.

I thank the witnesses for their presentations. I thank Ms Sloan for sharing her experience with us at what, I am sure, is a really difficult time for her, her family and her daughter's friends and her school friends. Something which struck me, as a mother, was that Ms Sloan said she did not know Emma's allergy was fatal. I would like to ask the two physicians present about the screening process in terms of nut allergies among children. We all know that when babies are born, they are screened with the heel prick test, and the blood test done to see if a particular condition is present. How can we inform ourselves, as parents, of the kind of risk? Are particular groups more at risk than others? A comment was made about hay fever and how it is rampant at the moment. Are people with asthma and hay fever sufferers more likely to be allergic to nuts or shellfish? Is there something we can do in terms of screening when children present to public health nurses for their routine checks?

If a child, a young person or an adult is diagnosed as having a nut allergy, how is it explained to his or her parents or to him or her? Does he or she actually know what it means? I have a young daughter who goes away with various groups. They all give out that they cannot have Nutella but one of the children has a nut allergy. They are aware of it but I am not sure everybody would be. How is it explained to the parents or to the young person? Are they aware of how sudden the onset can be and how to react to it? I refer to the bracelets people wear, or do not wear. How common is it for people who have a diagnosis not to wear the bracelet? That is significant also.

A comment was made about the legislation, the pilot project run in UCC and the distribution of the morning after pill by pharmacists, that this would be covered in the same way, that a prescription could be written and that the public could access it. Will the witnesses talk a little bit more about that?

I offer my condolences to and express unbelievable admiration for Ms Sloan on her terrible loss and on her courage. I once saw a 16 year old girl die from an anaphylactic reaction in the hospital setting and it was one of the most horrific things I ever saw and it has stayed with me forever. A huge effort to prevent even one death like this is worthwhile. We are talking about the prevention of rare tragedies. All the time, as a society, we agonise over and debate the prevention of other rare tragedies but we should just fix this one.

I would be delighted if Professor Hourihane could help me on this but I was doing a bit of arithmetic from figures from the United States and I am guessing that we probably have between one and three food allergy deaths per annum in Ireland if we can extrapolate that from data that have been presented in the US. I do not know if it is correct.

Professor Jonathan Hourihane

As far as I am aware, Emma's was the only death of a child in the past eight years but I am aware of an adult who was being treated by a kinesiologist and who died of a peanut allergy and of a woman who died in Mayo in approximately 2004 from a shellfish allergy. They are rare deaths but they are only the documented ones. It is certain there are more deaths.

I thank Professor Hourihane. That is pretty helpful. We have had years of no maternal deaths in Ireland, which was wonderful. It is not the way it is now but it was that way for a while. We put a huge effort into ensuring there were no maternal deaths. Rarity should not be an argument for not doing something. This is an event for which there should be zero tolerance. We should have no deaths whatsoever.

I compliment Dr. Byrne and Professor Hourihane on their presentations. I rarely say this but Professor Hourihane made me proud to be a doctor. He made a really good presentation. It was unsentimental, pointed, focused, committed and passionate and I am delighted he had the courage to highlight the deficiencies because it is a microcosm of a lot of problems which happen in our public health service. We have huge deficiencies. No member of this committee should have been surprised to hear him say we are off the bottom of the league table for numbers of allergists per head of population because I have repeatedly told members we are off the bottom of the league table in every specialty one cares to mention. Whether general practice specialties or hospital-based specialties, we are hanging off the bottom of the league table. We should also not be too surprised at his totally appropriate, unveiled and unadorned critique of the sloth with which the bureaucracy reacts to problems like this. Those of us who have tried to effect different degrees of reform will be aware of it.

This is really simple. We could have legislation drawn up very quickly which would address the key elements of what is required which is to put mandates in place whereby places which either profit from, or take responsibility for, the presence of people who are eating would make appropriate provision for their safety in terms of dealing with food allergies should they arise and that there would be an elimination of legal liabilities for people who, in good faith, would make the kind of emergency decision which would have saved Ms Sloan's daughter but who are prevented from doing so because of fear.

We need to address, in this context and in so many other contexts, the callous attitude our system has put in place in terms of under-providing, whether dermatologists in the south east, which has the highest incidence of melanoma in the country but where there are no dermatologists, whether children waiting for two years for hearing tests-----

There is a vote in the Dáil.

Saved by the bell. It is important we tackle this on a number of fronts. There are people here who would support the witnesses in any way in trying to address these problems.

Sitting suspended at 6.40 p.m. and resumed at 6.56 p.m.

We will resume in public session. I remind all those present to switch off their mobile telephones. In apologising to the witnesses for the interruption to proceedings, I am mindful that further divisions may be called in the House.

I thank Ms Sloan, members of her family and friends for attending. We were all shocked to learn of the passing of her daughter, Emma, at Christmas. The witnesses have given us an insight into the tragic circumstances that can cause people to pass away in a short time.

I was struck by the use of the phrases "common sense" and "good faith". Politicians are sometimes thought not to have any common sense. I have had the privilege of being a member of a committee that shows an abundance of common sense. If I was walking down a street and saw someone experiencing breathing difficulties, it would be common sense to run to the person and provide, in good faith, as much help as possible. Whatever took place on the day Emma died was done on the basis of common sense and in good faith. No one present can comprehend the events that occurred in Dublin city centre that day.

I give a commitment that the joint committee will do everything in its power to ensure the wishes expressed by Ms Sloan are fulfilled. We must meet the Minister to discuss the implications of this tragedy and ensure no other child or adult is left in the position in which Ms Sloan and her daughter were left on the day in question. I express my sincere thanks to Ms Sloan for speaking so openly and with such love and affection for her daughter. I ask the Chairman to make arrangements to meet the Minister for Health, Deputy James Reilly, with a view to having legislation introduced as soon as possible on this matter.

I extend my sympathy to Ms Sloan on the tragic passing of her daughter, Emma. I thank her and member of her family for showing such bravery in appearing before the committee to explain to members the current position in respect of the EpiPen and treatment. I also thank our other witnesses.

The clinicians who spoke painted a picture for us when they noted that the condition is treatable and the events that occurred were avoidable.

That is the tragedy of the situation we are currently facing. We must, as a matter of emergency, put in place structures, procedures and resources to ensure that what happened to Ms Sloan and her family does not happen to any other family. This is very a straightforward, black and white issue and there is no confusion as to what needs to be done. It is about putting the procedures in place to ensure these devices are included in every first aid box in every pharmacy, voluntary organisation, workplace, restaurant and so on in the country. Every member of this committee wants to see that happen sooner rather than later. I agree with Deputy Catherine Byrne that we should take this issue directly to the Minister to ensure the structures and procedures are put in place without further delay to prevent any further tragedies. We are told here and elsewhere on a regular basis about the lack of resources we are facing, but this issue must be a priority.

I conclude by extending my sympathies once again to Ms Sloan and assuring her that we will pressurise the Minister and the Department to put in place the procedures necessary to prevent the same tragedy befalling another family.

I am not a member of this committee but I have a vested interest in representing my constituents. I have known Ms Sloan since before Emma's tragic death and saw what she went through in waking and subsequently burying her daughter. It would be remiss of me not to attend this meeting given that I know the family intimately. They have received massive support not just from relatives and neighbours, but also from community organisations such as the Bosco youth centre in Drimnagh, of which Emma was a member and which played a very important role in her life. The board of management of the centre and the participants in the various courses that are run there have been an endless support to the family. I renewed contact with some of these people only last week when the Drimnagh festival was in full swing.

Although it is difficult to relive the horrors of the past, they allow us to understand the terrible tragedy that is the death of somebody in such shocking circumstances. I listened with particular interest to what Ms Moynihan had to say. It is clear that she has done a great deal of legal preparation; in fact, she has practically written the Bill. I am biased in favour of Cork because my daughter opted to go to university there. Regardless of what is happening in Trinity College, UCD, DIT, DCU or elsewhere, I congratulate to Ms Moynihan and her colleague on doing such a wonderful job in Cork.

Unlike Senator Crown, I am not convinced that dealing with this issue will be as easy as bringing in the legislation. We have heard about what is being done in various countries, including the United States and Canada. The medical professionals have emphasised that we need a policy in this area. Before today I did not realise the extent of the legislative changes that are required and I do not fully understand what happened in the context of the provision of the morning after pill. Nevertheless, we now know what is required and the ball is in the committee's court. I wish members well in the lobbying they will have to do with a view to bringing forward legislation which will guarantee that no family will ever again have to go through the trauma the Sloans went through in their bereavement.

Thank you, Deputy Byrne. I will now invite each of the witnesses in turn to make any additional comments they might have, beginning with Ms Sloan.

Ms Caroline Sloan

Deputy McLellan asked about training in using the pens, but they are actually very simple to use. In fact, any training that would be required would relate to the ability to recognise the signs of anaphylactic shock. A Sinn Féin representative to whom I have spoken told me that in the United States mobile telephone apps are available explaining what anaphylactic shock is and how to recognise it. Information packs are sent to schools containing a USB device from which information can be downloaded and made available to every class. There really is no requirement for intensive one-on-one training. From what we have seen, the materials provided are very simple and easy to use, focusing on educating people to recognise the signs. In addition, if ID bracelets and cards were in use, anybody would know from looking at them what is happening to the person concerned and that the epinephrine pen should be administered.

One of the members asked whether there are any side effects if a pen is administered to somebody who is not actually in anaphylactic shock. There are no such effects as far as I am aware, but Professor Hourihane might confirm that.

Professor Jonathan Hourihane

The UK resuscitation guidelines and all the emergency protocols state that if there is any possibility that anaphylaxis is present, adrenaline is the drug of choice. The side effects can be dealt with after the benefits have accrued. In young children, such as Emma or those even younger, there has never been a recorded case of somebody who has been unnecessarily administered adrenaline coming to harm.

That is good to know.

Does Ms Moynihan have any comments?

Ms Yvonne Moynihan

Deputy McLellan asked if a layperson would be able to administer an epinephrine pen to another person. I carry one around with me and know how to use it. As members will see, if Professor Hourihane gives us a demonstration later, it is very easy to use. Moreover, a bystander who used it on somebody on the street would be protected by the Good Samaritan provision contained in section 51D of the Civil Liability Act (Amendment) 1996, as inserted by section 4 of the Civil Law (Miscellaneous Provisions) Act 2011. Subsection 51D(1) states:

A good samaritan shall not be personally liable in negligence for any act done in an emergency when providing—

(a) assistance, advice or care to a person who is—

(i) in serious and imminent danger, or apparently in serious and imminent danger, of being injured or further injured,

(ii) injured or apparently injured, or (iii) suffering, or apparently suffering, from an illness,

Subsection 51D(2) states: "The protection from personal liability conferred on a Good Samaritan by subsection (1) applies even if the emergency is caused by an act of the Good Samaritan." The only exception to this protection is "any act done by the Good Samaritan in bad faith or with gross negligence". In the case of certain categories of persons, such as teachers, a higher standard of care applies under the legislation because teachers, to use that example, have a duty of care to protect pupils from risk of injury. The only way to minimise that is to provide mandatory guidelines and set out the scope of liability.

The Deputy also asked about permission from the European Council or Commission. We already have a regulation that allows us to regulate for exceptions, namely, regulation 8 of the pharmacy regulations.

I do not see why this cannot be extended if legislated for properly. As long as each policy is dealt with clearly and comprehensively and the exceptions are set out in legislation, I do not see why we would need permission.

I refer to the comments of Deputies Healy and Byrne. I agree with Deputy Healy that change should be sooner rather than later. Following a comment that Deputy Byrne made on having already drafted the legislation, I would be willing to draft any heads of a Bill. I volunteer to offer my services to any Deputy who wishes to really make a change to this law. Deputy Byrne said we needed a policy and this is what I was referring to later. Policies can only be dealt with by primary legislation and that is why amending the regulations would not be sufficient.

Dr. Michael Byrne

I wish to explain the circumstances surrounding the decision to postpone the roll-out of the programme and to clear up the apparent link between the morning-after pill and adrenaline, of which there is none. In establishing the programme in University College Cork, we developed a working group comprising Professor Hourihane, myself, an expert from the school of pharmacy and other stakeholders. We sought legal opinion from our office of corporate legal affairs and entered into correspondence with the Department of Health to give the two medical directors comfort around what would be a very new development, the provision of a prescription-only medicine by a layperson to a person for whom it had not been prescribed, albeit in what would be a Good Samaritan situation.

Until the point of going live with it we were getting what was at best neutral support and might even have been interpreted as less than neutral. The eve of going live coincided with the occasion when the morning-after pill was suddenly to become dispensable by pharmacists. If members recall the events around that incident, other vested interests expressed considerable concern that pharmacists could suddenly dispense the morning-after pill and objections were made nationally around that. That gave us both cause for concern that if a health care professional, for whom there was an obvious indication for a drug that they had under their control, was going to be prevented from dispensing something that was necessary, we were unlikely to get support if a first responder under our direction gave adrenaline to a person for whom it had not previously been prescribed. In view of this we voluntarily suspended and then entered a three-year period of correspondence with committees and the Department of Health. We have not managed to get a clear instruction as to what our personal liability would be or whether we could continue with the programme. That is why we suspended it and why it remains in abeyance. In essence we were looking for comfort that a prescription-only medicine could be administered under a controlled programme. This is on a pilot basis with a world expert and a community that has a proven track record of delivering in this type of situation that a prescription-only medicine could be administered by a layperson to someone in extremis. We have already heard it is a medication which in essence can do no harm in the vast majority of cases.

That is the context in which we suspended. These are particular university-setting high-risk vulnerable people who will not come forward and admit they have an allergy. We think we have the perfect environment to test run. We would be ready to go in the morning if we could get the comfort we need.

What do other third level institutions do?

Dr. Michael Byrne

As usual, we in UCC would like to see ourselves as being ahead of the game - I say that as a Dub. In essence we would be the first in Ireland and we would probably be the first in the world to deliver this. There is a precedent in the UK for non-health care professionals to give adrenaline in some primary care trusts on a patient-group-directive basis, which does not exist in Ireland. However, other universities are not in a position to make provision. We thought we would demonstrate proof of concept because we have the world expert and we have someone who is keen to ensure this happens.

How do we overcome the lack of engagement by students? Dr. Byrne is right that students have risk-taking in their DNA but there is also a need for us, as leaders, and the witnesses, as professionals, to challenge them. How do we do that?

Dr. Michael Byrne

There are two issues. There are those who are known to have an anaphylaxis or an allergy and those who are unknown, and we need to be able to cater for both. Anaphylaxis, as a word, is in common coinage among all our students, just as is a proper approach to alcohol. They will recognise that they are at risk and be willing to come forward. However, it is a multipronged approach because we have to acknowledge that even if we do the best and raise the profile of the risks around anaphylaxis they still will not do so. So we need to make provision for that and make provision for the presence of these adrenaline pens in restaurants, on campus and beside the running track, and we need the first responders to be in place.

A student with asthma, by virtue of having the inhaler, might come forward. Can we make it as easy as that?

Dr. Michael Byrne

Students with asthma or anyone with any chronic illness, including people with type 2 and type 1 diabetes do not necessarily declare.

I wish to make two other points in terms of clarification. Deputy McLellan or Senator van Turnhout asked how we would cope if we made provision for adrenaline in remote areas. It is a definite challenge. Let us make it available in the high-risk areas first and demonstrate proof of concept, and we can then address the need in remote areas. If we can make it available in a place where we know there is a high risk, we should do so. The university community has been very positive about this initiative. Volunteers have come from among staff members who have anaphylaxis or children with anaphylaxis and even staff members who are concerned for the welfare of not just students but visitors and staff on site.

I thank the Chairman for his efforts in ensuring the issue was brought to this committee. Very few life-threatening situations can be treated as easily as this. Cardiac arrest and anaphylaxis are perhaps the only two things that are so eminently treatable with simple, available technology. People would have had the same debates before AEDs were made available in the community. AEDs are now in every sports hall in the country. They were often in sports halls before they were in GPs surgeries because the community knew that was where the risk was. We need to embrace this and do something about it.

Professor Jonathan Hourihane

I thank the members of the Joint Committee on Health and Children. As a paediatrician, I recognise that children are a neglected strata in the country - they have only just had their constitutional rights recognised. It is my contention that if Emma Sloan had been an adult female, we would already have the legislation because this committee drove through the hearings on pregnancy, etc., last year after the death of Savita Halappanavar. Children's deaths in this country have not counted for many years, in Tuam and elsewhere. The fact that this was a child means that we are still here so long afterwards. That is my personal view as a paediatrician.

Many of the questions committee members have asked relate to my expertise and I will start there. I will not talk about the EU legislation or reviews, etc. Why are there fewer allergists than in other countries? I have no idea. I do not think the HSE had any idea that it had an allergist until I arrived into an academic post in University College Cork on the basis of my research expertise. It was terrified as to what it would mean for its hospital to have an allergist in it. It means that they do fewer tests, patients turn around faster and have less restrictive diets. So it is cost effective. It may take the money-following-the-patient programme, which is at least part of the discussion, for the HSE to realise that an allergy clinic is low cost, high volume, highly effective and the money flows in for that service. That is how allergy services in the United Kingdom have flourished from a similarly low base. I gave evidence to the British House of Lords in 2007 and on the basis of those hearings the mandate was given to the NHS that each region needed to have two adult allergists and two paediatric allergists with full support teams around them.

We would probably need four or eight for the whole country and that would be fine.

I was asked how we could put this in place without legislation. I understand the HSE sends out mandates to do this or that all the time and causes major panic about trolleys or breast cancer or whatever it may be. I am not trivialising any other area and I know we cannot compete with trolleys or breast cancer and I am not asking that we should, but it would be possible for the HSE to require each hospital that has an emergency department to have the capacity for some physician in that hospital to be responsible for the after-emergency care and the community integration of the care for the people in their region. If they have children and adults in their emergency departments they should have a paediatrician and an adult physician available to them. The most common cause of anaphylaxis is medical equipment, biological agents for cancer and anaesthetics. The anaesthetist looks after those in a crisis but then these people drop off the radar again. It should be mandatory for the HSE to deliver on this but it would probably not be cost neutral.

In response to the question on the circumstances for lay use, there is no situation in which one should not do it. We have discussed that. I was asked about the negative effects. There are no negative effects and as we say to families when they come and see us, the kits are so easy to use that a man could do it.

It is usually the mothers who come and we insist that the fathers come to us for the training so that they are not getting badgered to do what the mother was taught by us. There is an expert disparity between the parents and it is always the mother who is the expert. That is nature and nurture and we would like everybody to be able to use these in a way that is understandable.

How long is the training?

Professor Jonathan Hourihane

Fifteen minutes. Everybody can afford 15 minutes to save their child's life.

We train lay members of the community but just because they have been trained by me does not make them a health profession. We are relying on those people to deliver the training to teachers, scout groups and guide leaders and soccer coaches. That is a HSE responsibility which has not been taken up by it.

Professor Jonathan Hourihane

It must be. Simply because the HSE has not said that it is, does not mean that it is not.

A very interesting question is how we screen for nut allergy. I do not know how one screens for nut allergy. We know that 80% of children with nut allergy have eczema and we know that 95% of children with peanut allergy have other forms of allergic disease. One might be able to find just the allergic children and test them for it. The problem we have with that, Chairman and members, is that the positive tests are less useful than the negative test. A negative test for a peanut allergy is very likely to be true that one is not allergic to it, so 95% likely and we send people home with a negative testing. The problem is that if one has a positive test it is only 50% likely that one is allergic. It is less useful as a positive test. There is an issue of sensitivity and specificity of the medical test so it is not amenable to screening because it does not work as well with either result. It is conclusive if it is negative but it is inconclusive if it is positive in the absence of a history of reactivity. If somebody has had a reaction, the likelihood of it being a true result goes up. If I tested everybody in a male hurling changing room with pregnancy tests and found a positive, it is likely the test is wrong. If I did it in a camogie changing room, that poor girl is pregnant. The likelihood of it being there affects how the test works. We use these examples when we explain our test to parents so it takes only a few minutes. However, that is what we say to them.

I do not know how much they hear. Do they need to hear it again? Are there other resources that we could use? There is the Inernet, there are apps, even a talking pen that gives one instructions like the defibrillators do. We give them what we think they need but that might not be what individual families need and we might need to rehearse it and deliver it in other formats. Bracelets are a very good idea. It is not a new idea as they are already available for those with diabetes, sarcoidosis and long-term illnesses that cause the sufferer to seek emergency care. We advise families to have them. The take-up is very low. We want the teenagers to wear them but they do not want to wear a medical bracelet, they want to have a tattoo or earrings. I am not saying that we should allergy earrings or allergy tattoos. I have, however, seen people in the United States with allergy tattoos so that when they are unconscious it is available. As Senator Crown said these are rare tragedies. I have made the comparison with maternal deaths and the national response to those cases. I think it could be made mandatory for the providers of food who are making profit from food that they make their restaurant a safe place to eat. The mandate for training cannot come from restaurateurs, it has to come from health authorities. I would be very keen to see even a temporary elimination of liability so that we can perform our pilot before we go to the wider availability. If it does not work, we should not do it.

Mr. Pat O'Mahony

I welcome the focus on training. It is a very important part of the overall solution. There were two specific questions addressed to our side, the first referred to the current EU review for these categories of products. Let me clarify that the review relates to the design of the products and the information that is provided to patients. It does not cover the prescription status and that is determined at national level so it will have no bearing on that issue. The second question relates to the legal basis that can be provided to make any changes that might be foreseen. There were comments on a comprehensive Bill, which would clearly provide for that. We also believe there are precedents existing under the prescription control and supply regulations which currently allow first responders to use prescription medicines. We think this provision could be explored as an option. The question of whether we could do it without EU Commission approval and the answer is yes it can be done locally at national level.

I thank all the witnesses for attending this afternoon. As a committee we now have a great deal of information to reflect on. Arising from today's meeting the legislative process is not as simple as some might say but there is the political will to deal with it. This committee has demonstrated that we do have the political will to deal with this issue. We need to take up the issue with the Department of Health and as Mr. O'Mahony said, it is a policy issue for the Department of Health and that we would also talk to the Minister and the Secretary General at the Department of Health and have a follow-up meeting on this issue with them. We should discuss with the HSE the issue of the mandate. We should communicate with the Pharmaceutical Society of Ireland regarding its investigations on the outcome, the timeline and when it ought to be concluded.

The purpose of our meeting today is to effect change in the area and to bring in much-needed change, which we in this room accept has to happen. We will certainly raise the issue at our quarterly meeting with the Department of Health and the HSE. We will put this topic on the agenda for our next full meeting with the Department of Health and the HSE. We are committed to bringing about change on this issue.

On behalf of all members I express our thanks to Ms Caroline Sloan for coming to this meeting and extend our deepest sympathy to her on the tragic death of her beautiful young daughter. We were glad that Ms Sloan had the photograph of her daughter to put in front of us to keep her in our minds as we continue to work for change. We know that sympathy is not enough and that is the reason why, as part of our meeting today, we invited Ms Sloan to attend.

I thank Ms Yvonne Moynihan, Dr. Michael Byrne, Professor Hourihane and Mr. O'Mahony and the members of the Irish Medicines for being present today. I hope this meeting will continue to raise and promote awareness, not just in the committee room but beyond it. I hope that any young person who is watching and listening to us today reads the transcripts of the proceedings. It is important that we promulgate the matter and that people do not hide their situation in any shape or form.

I thank Professor Jonathan Hourihane and Dr. Michael Byrne whom I have met on many occasions and I hope we will see change. As Senator Crown said, it is a cumbersome slow and bureaucratic process but we will persevere and at the end of the day we will bring about change sooner rather than later.

Finally, before I draw the meeting to a close, I thank all the members in the Visitors Gallery for their presence.

The joint committee adjourned at 7.30 p.m. until 9.30 a.m. on Thursday, 26 June 2014.