The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In line with the Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The Minister for Health has no role in these decisions.
Under the 2013 Act, the HSE also has statutory responsibility for the administration of the General Medical Services (GMS) scheme and the community drug schemes, including the Long Term Illness (LTI) scheme.
The LTI scheme was established under Section 59(3) of the Health Act 1970 (as amended). Regulations were made in 1971, 1973 and 1975, prescribing 16 illnesses covered by the scheme. These are: acute leukaemia; mental handicap; cerebral palsy; mental illness (in a person under 16); cystic fibrosis; multiple sclerosis; diabetes insipidus; muscular dystrophies; diabetes mellitus; parkinsonism; epilepsy; phenylketonuria; haemophilia; spina bifida; hydrocephalus; and conditions arising from the use of Thalidomide.
Under the LTI scheme, patients receive drugs, medicines, and medical and surgical appliances directly related to the treatment of their illness, free of charge. While there are currently no plans to extend the list of illnesses covered by the scheme, the LTI scheme will be included in a review of the current eligibility framework, including the basis for existing hospital and medication charges, to be carried out under commitments given in the Sláintecare Implementation Strategy.
In the meantime, for people who are not eligible for the LTI scheme, there are other arrangements which protect them from excessive medicine costs.
Under the Drugs Payment Scheme (DPS), no individual or family pays more than €80 a month towards the cost of approved prescribed medicines. The DPS significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines. The HSE's reimbursement list is the same for the DPS as it is for the GMS scheme.
People who cannot, without undue hardship, arrange for the provision of medical services for themselves and their dependants may be eligible for a medical card under the GMS scheme. In accordance with the provisions of the Health Act 1970 (as amended), eligibility for a medical card is determined by the HSE.
In certain circumstances the HSE may exercise discretion and grant a medical card, even though an applicant exceeds the income guidelines, where he or she faces difficult financial circumstances, such as extra costs arising from illness. In circumstances where an applicant is still over the income limit for a medical card, they are then assessed for a GP visit card, which entitles the applicant to GP visits without charge.
Individuals may also be entitled to claim tax relief on the cost of their medical expenses. This includes medicines prescribed by a doctor, dentist, or consultant. Relief is at the standard tax rate of 20%.