Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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331. To ask the Minister for Health the steps he is taking to address the shortfalls in patient diagnosis and treatment of Lyme disease within the health service; and if he will make a statement on the matter. [47698/18]

Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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333. To ask the Minister for Health the person or body that carried out the review of the final UK National Institute for Health and Care Excellence guidelines on Lyme disease; the input patient groups had into the review (details supplied); and if he will make a statement on the matter. [47700/18]

Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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335. To ask the Minister for Health the reason the health system is not following the NICE guidelines as it relates to the interpretation of results from the two tier testing (details supplied); and if he will make a statement on the matter. [47702/18]

Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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336. To ask the Minister for Health the reason many of the key recommendations from the NICE guidelines on Lyme disease are not being implemented in particular in relation to erythema rash which is definitive of a diagnosis of Lyme disease and should receive immediate treatment (details supplied); and if he will make a statement on the matter. [47703/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 331, 333, 335 and 336 together.

Lyme disease (also known as Lyme borelliosis) is an infection caused by a spiral-shaped bacterium called Borrelia burgdorferi.  It is transmitted to humans by bites from infected ticks and is the commonest cause of tick-borne infections in Europe.  Lyme neuroborreliosis was made statutorily notifiable in Ireland by the Infectious Diseases (Amendment) Regulations 2011 (S.I. no 452 of 2011).  Testing and treatment for Lyme borreliosis is widely available in Ireland in all major hospitals.  Lyme borreliosis is diagnosed by medical history and a physical examination which may be carried out by a General Practitioner.  Lyme disease may also be treated by infectious disease specialists (of which there are 12 nationally) or by general internal medicine available in all acute hospitals.  Medical training programmes at undergraduate or postgraduate level in Ireland provides specialist training in infectious diseases, including Lyme disease.

The Health Protection Surveillance Centre (HPSC) of the HSE is responsible for the surveillance of notifiable infectious diseases such as Lyme disease.  The Scientific Advisory Committee (SAC) of the HPSC established a Lyme Borreliosis Subcommittee, the aim of which is to develop strategies to undertake primary prevention with a view to minimising the harm caused by Lyme Borreliosis in Ireland.  The membership of the Subcommittee included a person nominated by Tick Talk Ireland to represent its views during the Subcommittee’s deliberations.

The Subcommittee will shortly submit its final report to the SAC.  During the report’s preparation, the HPSC learned that the National Institute for Health and Care Excellence (NICE) in the UK was undertaking a systematic review of Lyme disease which resulted in the NICE Lyme disease guidelines.  These guidelines are based on the most exhaustive systematic review yet undertaken of the evidence around Lyme disease and focused on producing recommendations based on best available evidence relating to diagnosis, management and public awareness of Lyme disease. 

Given the significance of the NICE guidelines to the subject-matter of its work, the Subcommittee determined that it would be appropriate to delay finalisation of its report with a view to ensuring that the findings of these guidelines could be taken into consideration and to ensure that no relevant evidence regarding Lyme disease would be omitted.  In considering the NICE report, the Subcommittee focused solely on the evidence and recommendations contained in the report that related to its remit (specifically in relation to awareness-raising - diagnostics and clinical management aspects fell outside the remit of the Subcommittee). 

The report is scheduled to be finalised by the Subcommittee shortly, at which point it will be sent for consideration to the SAC.  At this juncture, it would be inappropriate to consider making changes to the testing, treatment and/or management of the condition until this deliberative process has been completed.  However, I have been advised that the report of the subcommittee will be recommending the formation of a group of clinicians to review evidence regarding the diagnostics and clinical management of Lyme disease in Ireland as part of its report. 

Outside of the work of the Subcommittee, the HPSC website (hpsc.ie) provides extensive information on Lyme disease diagnosis, treatment and how to avoid tick bites for both the public and General Practitioners.  Lyme disease can be successfully treated using common antibiotics by General Practitioners.  These antibiotics are effective at clearing the characteristic rash (Erythema Migrans) that sometimes accompanies infection with Lyme disease and helping to prevent the development of complications.  Antibiotics are generally given for up to three weeks.  If complications develop, intravenous antibiotics may be considered.  Lyme disease can, however, be a difficult diagnosis to make in cases where there is no evidence of a rash.  It should also be noted that the symptoms associated with Lyme disease are also characteristic of other conditions such as Chronic Fatigue Syndrome, food poisoning, Rheumatoid Arthritis, Fibromyalgia, Depression and Multiple Sclerosis.

The infection can, however, be confirmed by blood tests which look for antibodies produced by an infected person's body in response to the infection.  These normally take several weeks to develop and may not be present in the early stages of the disease.  In undertaking Lyme testing, it is essential that the results are interpreted in the light of the clinical condition of the patient.  If the result of this initial screen is equivocal, the patient's samples are referred to the U.K.'s Rare and Imported Pathogens Laboratory.  This laboratory uses a two-tier system recommended by American and European authorities which involves a screening test followed by a confirmatory test.

Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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332. To ask the Minister for Health the action he plans to take to ensure Ireland implements the recent recommendations of the World Health Organisation regarding Lyme disease (details supplied); and if he will make a statement on the matter. [47699/18]

Marc MacSharry (Sligo-Leitrim, Fianna Fail)
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334. To ask the Minister for Health if his attention has been drawn to the fact that denial of treatment options that meet internationally accepted standards for chronic Lyme disease patients is a human rights violation (details supplied); and if he will make a statement on the matter. [47701/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 332 and 334 together.

On 18 June 2018, the World Health Organisation released its new International Classification of Diseases (ICD-11).  The ICD is the foundation for identifying health trends and statistics worldwide, and contains around 55,000 unique codes for injuries, diseases and causes of death.  It provides a common language that allows health professionals worldwide to share health information.  ICD-11 will be presented at the World Health Assembly in May 2019 for adoption by Member States, and will come into effect on 1 January 2022.  According to the WHO's website, the purpose of releasing the guidelines at this point in time is to provide an advance preview of them. Given the current status of the ICD-11 codes, it would be premature to comment upon their future implementation or any human rights implications with regard to their application at this stage of their development and roll-out. 

In the interim, Lyme neuroborreliosis was (for the first time) on 28 June 2018, included on the list of diseases under EU epidemiological surveillance, with a uniform EU case definition being formally released at the same time.  The Health Protection Surveillance Centre (HPSC) will shortly move to adopt this case definition for surveillance of Lyme neuroborreliosis in Ireland.  The choice of Lyme neuroborreliosis as the notifiable entity for Lyme surveillance in the EU was based on scientific advice provided by the European Centre for Disease Prevention and Control (ECDC) after following wide consultation with experts in all EU Member States.  As well as enabling Ireland to have a robust and reliable method to monitor Lyme disease, by adopting the EU case definition, Ireland's data will become directly comparable with data from other EU member states.

Testing and treatment for Lyme borreliosis is widely available in Ireland in all major hospitals.  Lyme borelliosis is diagnosed by medical history and a physical examination.  The infection is confirmed by blood tests which look for antibodies to Borrelia burgdorferi produced by an infected person's body in response to the infection.  These normally take several weeks to develop and may not be present in the early stages of the disease.  In undertaking Lyme testing, it is essential that the results are interpreted in the light of the clinical condition of the patient.  If the result of this initial screen is equivocal, the patient's samples are referred to the U.K.'s Rare and Imported Pathogens Laboratory (RIPL) Service of Public Health England Porton which uses a two-tier system recommended by American and European authorities.  This involves a screening serological test followed by a confirmatory serological test.  This two tier approach gives a great degree of certainty around the diagnosis of Lyme.  All testing in Ireland is confirmed by RIPL.