PLC Life Sciences Multi-Jurisdictional Guide 2013 (Ireland Chapter)

Author:Mr Colin Kavanagh, Isabel Foley, Orla M. Clayton, Diana Diamond, Olivia Mullooly and Maebh O'Gorman
Profession:Arthur Cox


  1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?


    Medicinal products. The regulatory framework for medicinal products in Ireland is based on Directive 2001/83/EC on the Community code relating to medicinal products for human use (as amended) (Code for Human Medicines Directive). This was implemented in Ireland by the Irish Medicines Board Act 1995 (as amended) (IMB Act) and domestic regulations, most notably the Medicinal Products (Control of Placing on the Market) Regulations SI 540/2007 (as amended) (Marketing Regulations).

    Pricing and reimbursement of medicinal products. A Framework Agreement between the Irish Pharmaceutical Healthcare Association (IPHA), an organisation representing the international research-based pharmaceutical industry in Ireland, the Department of Health and the Health Services Executive (HSE) came into effect on 1 November 2012 (see Questions 3 and 4).

    Medical devices. The regulatory framework for medical devices is contained in the following, as transposed into Irish law (Medical Devices Legislation):

    Directive 93/42/EEC concerning medical devices (as amended). Directive 90/385/EEC on active implantable medical devices (as amended). Directive 98/79/EC on in vitro diagnostic medical devices (IVD Directive) (as amended). Regulatory authorities

    The Irish Medicines Board (IMB) (see box, Regulator details) is the competent authority responsible for regulating medicinal products and medical devices. The IMB is a statutory body created by the IMB Act. The NSAI is the notified body in Ireland approved by the IMB to carry out conformity assessment procedures to ensure compliance with medical devices legislation.

    Biotechnology and combination products

    All medicinal products for human use derived from biotechnology and other high technology processes must be approved by the European Medicines Agency (EMA).

    Regulations on the contained use or deliberate release of genetically modified organisms (GMOs) in Ireland are implemented by the Environmental Protection Agency.

    Medical devices incorporating a medicinal product are regulated by the IMB under the medicinal products and medical devices legislation detailed above. They are classified as Class III (highest risk) devices and are therefore subject to high levels of compliance assessment.


  2. What is the structure of the national healthcare system, and how is it funded?

    The Health Act 1970 (as amended) sets out the statutory basis for the structure of the national healthcare system. The public healthcare system is funded by the state through taxation and social security contributions. Private healthcare is funded by private insurance, social security schemes and private funds.

    The Department of Health determines healthcare policy and expenditure. This is implemented by the HSE which was established by the Health (Amendment) Act 2004. The HSE integrates the delivery of health and personal social services through three service delivery units, namely:

    Population Health, which promotes and protects public health, and is responsible for immunisation programmes, infection control and environmental health. Primary, Community and Continuing Care, which delivers health and personal social services in the community (with the exception of acute hospitals). National Hospitals Office, which provides acute hospital, ambulance and other pre-hospital emergency response services throughout the country. There are three categories of hospitals in Ireland:

    HSE hospitals, which are owned and funded by the HSE. Voluntary public hospitals, which are owned by private bodies but which receive state funding. Private hospitals, which are owned by private bodies and receive no state funding. The Health Information and Quality Authority within the HSE (HIQA) is responsible for regulating and accrediting public hospitals, implementing quality assurance programmes, and...

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