PLC Life Sciences Multi-Jurisdictional Guide 2012



  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), which was implemented 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).

    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). The European Commission (Commission) proposes to replace the existing medical devices directives with one single regulation or directive consolidating and harmonising the law surrounding medical devices across the EU (see Question 35).

    Regulatory authorities

    The Irish Medicines Board (IMB) (see box, The regulatory authority) is responsible for regulating medicinal products and medical devices. The IMB is a statutory body created by the IMB Act.

    Healthcare policy and expenditure is determined by the Department of Health and Children and administered through the Health Services Executive (HSE).

    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.

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


  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 HSE was established by the Health (Amendment) Act 2004. The HSE integrates the delivery of health and personal social services. They are delivered through three service delivery units, namely:

    Population Health, which promotes and protects public health. Primary, Community and Continuing Care, which delivers health and personal social services in the community and other settings and funds payments to healthcare professionals. National Hospitals Office, which provides acute hospital and ambulance services throughout the country. There are three categories of hospitals in Ireland:

    HSE hospitals. Voluntary public hospitals owned by private bodies but which receive state funding. Private hospitals which receive no state funding. The Health Information and Quality Authority (HIQA) regulates and accredits public hospitals.

  3. How are the prices of medicinal products regulated?

    There is currently no specific legislation regulating the pricing of medicinal products. However, in September 2011 the Government approved the general scheme of the Health (Pricing and Supply of Medicines) Bill which provides for the introduction of reference pricing by the HSE and generic substitution for drugs prescribed under the CD Schemes (see Question 4). It is expected that the text of the implementing legislation will be published in 2012.

  4. When is the cost of a medicinal product funded by the state or reimbursed to the patient? How is the pharmacist compensated for his dispensing services?

    The HSE Primary Care Reimbursement Service (PCRS) operates ten Community Drug Schemes (CD Schemes) and provides reimbursement services to primary care contractors for the cost of providing health services and medicines to the public, along with fixed dispensing fees and mark-ups in certain circumstances.

    A medicinal product is eligible for reimbursement if it:

    Is approved by the HSE. Is prescribed by a doctor. Is dispensed by a doctor or pharmacist. Holds a current Marketing Authorisation (MA). Payments to pharmacists are regulated by HSE Community Pharmacy Contractor Agreements and the Health Professionals (Reduction of Payments to Community Pharmacy Contractors) Regulations 2011. A reduction in the wholesale mark-up rate from 10% to 8% on most drugs was implemented in 2011, according to the Financial Emergency Measures in Public Interest Act 2009. Payments to doctors are regulated by the HSE GP Contracts.

    Reimbursement prices and procedures are agreed between the HSE and the Irish Pharmaceutical Healthcare Association (IPHA) and the Association of Pharmaceutical Manufacturers, respectively (Pricing Agreements). Price reductions were negotiated subsequently. New medicines, for which an MA has been granted, become reimbursable within 60 days of receipt of a reimbursement application by the HSE. High cost technologies may be referred by the HSE for pharmacoeconomic assessment before reimbursement, and the decision is notified within 90 days of receipt of the application.

    Pricing Agreements use national price referencing and provide that the price to the wholesaler must not exceed the average wholesale prices in Belgium, Denmark, France, Germany, The Netherlands, Spain, Finland, Austria and the UK. If a product is not available in any of these reference countries, the wholesale price is agreed between the representatives of the manufacturer/importer and the HSE. Each month, manufacturers must rebate to the HSE 4% of the value of all medicines dispensed under the General Medical Services Scheme, which is one of the CD Schemes.

    The current Pricing Agreements expire on 31 March 2012. However, their replacements have not yet been published. See Question 3.


  5. What is the authorisation process for manufacturing medicinal products?

    Manufacturing is regulated by the Medicinal Products (Control of Manufacture) Regulations 2007 (as amended) (Manufacturing Regulations), which implement:

    Title IV of Directive 2001/83/EC on the Community code relating to...

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