The life sciences sector is a major industry in Ireland, employing over 40,000 people and accounting for 32% of the GDP in 2021. Major multinational and domestic pharmaceutical, diagnostic, and medical device companies, ranging from start-ups and university spin-outs to large multinationals and industry leaders have established operations in Ireland. Nine out of the top ten pharmaceutical companies, 14 out of the top 15 medical technologies companies and nine out of the top ten US technology companies operate in Ireland. Clients commonly seek legal advice in relation to establishing operations in Ireland and on all aspects and stages of the life cycle of a product, from clinical research and development through to manufacturing and marketing of finished products and post-marketing activities and compliance.

Securing investment for, and providing support to, life sciences entities in Ireland is provided by several governmental agencies along with the provision of various financial and tax incentives.

Various governmental agencies operate funding and support programmes for companies seeking to establish operations in this jurisdiction:

In addition to these funding programmes there are various tax and financial incentives that provide support to life sciences companies:

The Health Acts 1947 to 2023 (the Health Acts) set out the statutory basis for the structure of the national health care system. The public health care system is funded by the state through taxation and social security contributions. Private health care is funded by private insurance, social security schemes, and private funds.

The Department of Health determines health care policy and expenditure. This is implemented by the national health provider, the Health Service Executive (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:

There are three categories of hospitals in Ireland:

The Health Information and Quality Authority (HIQA) is a statutory body responsible for monitoring the safety and quality of HSE funded hospitals. HIQA is responsible for regulating designated centres which are health care residential settings.

The Corporate Pharmaceutical Unit (CPU) within the HSE is responsible for evaluating schemes operated by the HSE to provide drugs and medical devices to patients, in conjunction with the National Centre for Pharmacoeconomics (NCPE).

The Health (Pricing and Supply of Medical Goods) Act 2013 (Pricing and Supply Act) as amended, and the Irish Pharmaceutical Health Care Association Agreement 2021 (2021 IPHA Agreement) are the key documents regulating the prices of medicinal products in Ireland.

The Pricing and Supply Act introduced generic substitution and reference pricing for groups of interchangeable medicinal products, to reduce health care expenditure in Ireland. The introduction of generic substitution allows pharmacists to dispense a less costly medicine than that prescribed, provided that the less costly medicine falls within the same group of interchangeable medicinal products. The Health Products Regulatory Authority (HPRA) draws up the list of groups of interchangeable medicinal products.

Under the Pricing and Supply Act the HSE has set a common reimbursement price for groups of interchangeable medicinal products, known as the reference price, for the medicines in question. If a supplier wishes to charge above the reference price, the patient must pay the difference, as the HSE will only reimburse at the reference price.

In setting the reference price, the HSE must take into account:

Following the expiry of the 2016 IPHA Agreement, the 2021 IPHA Agreement governs the pricing and supply of medicinal products that are:

The 2021 IPHA Agreement includes an annual downward only price realignment, which commenced on 1 March 2022 and on the 1 March in each subsequent year. The price realignment is set as:

Under the 2021 IPHA agreement:

If a new medicinal product is not available in any of the nominated EU member states the manufacturer/importer must propose a price. This will be considered by the HSE, in accordance with the principles set out in Schedule 1 of the 2021 IPHA Agreement and the Pricing and Supply Act.

Medicinal products dispensed in the community are funded by the state, through reimbursement of the pharmacist, where the patient is eligible under one of the reimbursement schemes and the medicinal product is eligible for reimbursement.

Reimbursement schemes. The HSE Primary Care Reimbursement Service (PCRS) operates a General Medical Services (GMS) Scheme and a number of other community reimbursement schemes (Community Drug Schemes). Under these, it reimburses primary care contractors, including pharmacists, for the cost of providing health services and medicines to the public.

The GMS Scheme provides free general medical services, including access to doctors, surgeons, dentists, and medicines, to those who cannot afford such services. The Community Drug Schemes include the Drugs Payment Scheme, the Long Term Illness Scheme, the High Tech Drugs Scheme, and the European Economic Area Scheme, among others.

Reimbursement procedure. A medicinal product is eligible for reimbursement if it:

New medicines for which an MA has been granted may become reimbursable within 75 days of application to the HSE for reimbursement approval, subject to certain exceptions. New and existing technologies that are of high cost or that may have a significant impact on the Irish health care budget may be referred by the HSE for pharmacoeconomic assessment.

Payments to pharmacists are regulated by HSE Community Pharmacy Contractor Agreements and the Health Professionals (Reduction of Payments to Community Pharmacy Contractors) (Amendment) Regulations 2017, as amended.

Prescription medicinal products can only be dispensed by a person lawfully conducting a retail pharmacy business, and must be dispensed by or under the personal supervision of a registered pharmacist according to a prescription issued by a registered medical practitioner, a registered dentist or, in certain circumstances, a registered nurse.

Certain non-prescription drugs (as set out in the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended) can only be sold from a pharmacy under the supervision of a registered pharmacist.

General sale products can be placed on general sale, meaning that they can be sold in a pharmacy and any other outlet which is not a pharmacy, for example, a supermarket.

The supply of prescription-only medicines in Ireland by mail order is prohibited. Supply by mail order is defined as both:

For information about the Falsified Medicines Directive (2011/62/EU), see Country Q&A, Life Sciences Regulation in Ireland: Overview, Question 13: Serialisation.

The Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013 (Wholesale Regulations) regulate the wholesale distribution of medicines. Wholesale distribution includes all activities consisting of procuring, holding, supplying, or exporting medicinal products, other than activities involving the sale or supply of these products to the public.

Persons who, in the course of a business, are engaged in the wholesale distribution of medicinal products for human use, require a wholesale distribution authorisation (WDA). The purpose of a WDA is to ensure that the standards of medicinal product quality, safety, and traceability which exist within the manufacturing sector are also maintained within the distribution chain to the point where the hospital or retailer (pharmacy or general sale) takes possession of the product. In certain circumstances a WDA is not required, for example where a registered pharmacy sells or supplies a medicinal product in accordance with a registered doctor's prescription.

To apply for a WDA, the appropriate HPRA application form must be completed. The applicant must show compliance with the principles of good distribution practice (GDP). Compliance with these principles is determined by the HPRA through regular site inspections. Generally, there is a timeframe of between two to eight weeks (a maximum of 90 days) and a possible inspection. Wholesale distributors supplying controlled drugs must hold an additional controlled drug licence or registration, which allows the holder to store and supply these products.

The HPRA is designated as the competent authority in Ireland for the authorisation of wholesale distributors of medicinal products for human use under section 4(1) of the Irish Medicines Board Acts of 1995, as amended (IMB Act). Breach of the Wholesale Regulations is an offence under the IMB Act, resulting in:

If an offence is committed by a corporate body, and is proved to have been committed with the consent, connivance, or is attributable to the neglect of any person who is an officer or shareholder (if the shareholder manages the corporate body), this person may be personally liable for the offence.

To import medicinal products into Ireland from outside the EEA, the manufacturer must obtain a manufacturer's/importation authorisation (MIA). To obtain an MIA, an application must be made to the HPRA, and the applicant must provide information on manufacturing, importation, and testing operations. Further, the Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013 require authorisation holders to ensure that imported medicinal products have undergone:

Parallel imports of medicinal products from other EU member states and EEA countries into Ireland are allowed under the following two schemes: dual pack import registration (DPR) and parallel product authorisation (PPA). Products centrally authorised by the European Commission are not covered by these schemes and require separate notification to the EMA before parallel importation.

Parallel importers who engage in labelling and repackaging must hold an MIA.

Parallel importers wholesaling a parallel product in Ireland that:

Parallel importers must establish a clear audit trail from the supplier in the source country so that, in the event of a recall of a batch of the parallel-imported product in the source country, appropriate action can be taken by the importer and the HPRA.

DPR Registration. If the parallel imported product (parallel product) is identical in all respects to the product on the Irish market (original product), the importer can use the simplified DPR procedure. A DPR is granted by the HPRA if all the following criteria are fulfilled:

If the original product MAH responds to the notification, indicating the non-existence of joint packs between the relevant markets, the product is not eligible under the DPR scheme and the DPR application must not be submitted or withdrawn.

A DPR is valid indefinitely, provided the parallel importer submits an annual declaration of compliance with the above criteria.

The HPRA expects the DPR holder to keep up-to-date with any changes to the original product, so that each consignment of the parallel product complies with the above requirements.

Before placing the product on the market, the DPR holder must ensure that a label is placed on the packaging, with the phrase "parallel imported by" followed by the name of the DPR holder and its registration number commencing with the letters "DPR." This label must not obscure any of the original text on the pack.

PPA. A PPA is required if the parallel product differs in any respect from the original product. A PPA is granted by the HPRA if all the following criteria are met:

A PPA can be granted indefinitely or can be limited to five years for pharmacovigilance reasons. If renewed after this five-year period, it remains valid indefinitely.

A PPA can be granted or remain in force if the original product MA is withdrawn for commercial reasons or replaced by a new version, provided that there are no risks to public health. In these circumstances, the HPRA can request additional information from the parallel importer to monitor adverse reactions in Irish patients.

The PPA is invalidated if the parallel product ceases to have a valid MA in the country from which it is imported.

The parallel importer must provide the MAH in the Irish market with notice of its intent concerning parallel importation. Guidance from the HPRA indicates that 15 working days is considered reasonable notice.

Intellectual property rights (IPRs). There have been no reported cases on competition law issues arising from parallel imports of pharmaceuticals in Ireland to date. IP issues can arise if, for example, the patent holder has not already marketed the product in the EU, or if the imported product is repackaged in a way that may adversely affect the reputation of the trade mark and its owner.

In the EEA, if the IPR holder places or consents to the placement of the product on the market in an EEA state, it cannot generally rely on its rights to prevent that product being imported into or marketed in another EEA state.

IPRs can be used to oppose parallel imports from outside the EEA.

The advertising of medicinal products is regulated by the Medicinal Products (Control of Advertising) Regulations 2007 (Advertising Regulations). The Advertising Regulations are enforced by the HPRA or IPHA (for IPHA members only).

Non-compliant advertisements can be required to be withdrawn and the person responsible for the advertisement may be required to publish a corrective statement. Breach of the Advertising Regulations is a criminal offence under the IMB Act, and liability is the same as for a breach of the Medicinal Products (Control of Manufacture) Regulations 2007, as amended (Manufacturing Regulations).

The Consumer Protection Act 2007 (CPA), the European Communities (Misleading and Comparative Marketing Communications) Regulations 2007, and the Consumer Rights Act 2022 also apply to general advertising and commercial practices.

Self-regulation plays an important role, and members of IPHA must comply with:

The IPHA Industry Code fully reflects the standards of the 1 March 2021 edition of the EFPIA Code on the Promotion of Prescription-only Medicines to, and Interactions with, Healthcare Professionals, as published by the European Federation of Pharmaceutical Industries and Associations (EFPIA).

The Advertising Standards Authority for Ireland (ASAI) has published a Manual of Advertising Self-Regulation with the Code of Standards for Advertising and Marketing Communications in Ireland (7th Edition March 2016) (ASAI Code). The ASAI Code applies to the advertising of medicinal products, except for specialised marketing communications addressed to the medical, veterinary, and allied professions.

Under the Advertising Regulations, advertising includes any form of door-to-door information, canvassing activity, or inducement designed to promote the prescription, supply, sale, or consumption of medicinal products, including in particular:

Advertising is defined in the Advertising Regulations as any form of door-to-door information, canvassing activity, or inducement designed to promote the prescription, supply, sale, or consumption of medicinal products. This specifically includes:

An advertisement of a medicinal product made to persons qualified to prescribe or supply must contain certain prescribed information. A number of restrictions are also imposed on promotional materials, and medical sales representatives must comply with certain requirements in their meetings with persons qualified to prescribe or supply.

The Advertising Regulations require that a scientific service be established within the company to compile and collate all information relating to products. Medical sales representatives must be adequately trained and have sufficient scientific knowledge to enable them to provide information which is as precise and as complete as possible about the product they are promoting. Companies must keep available samples of all advertising coming from their undertaking together with information indicating the persons to whom it was addressed, the method of dissemination, and the date of first dissemination, and this information must be supplied to the HPRA on request.

The Pharmaceutical Code requires that the scientific service must include a doctor or, where appropriate, a pharmacist or other suitably qualified person who must approve all promotional material before release. This person must certify that the advertisement complies with the Pharmaceutical Code and all applicable laws, is consistent with the relevant SmPC, and is a fair and truthful presentation of the facts concerning the medicinal product being promoted. The Pharmaceutical Code requires that each company appoint at least one senior employee who is responsible for supervising compliance with the Code.

Advertising need not be pre-approved by a regulatory or industry authority. However, the HPRA reserves the right to pre-review advertisements.

From a general perspective, comparative advertising is permitted under the Trade Marks Act 1996, as amended (Trade Marks Act), provided it is in accordance with honest practices in industrial or commercial matters and does not take unfair advantage of, or is not detrimental to, the distinctive character or reputation of the trade mark.

Advertising must also comply with the Advertising Regulations, the CPA, and the European Communities (Misleading and Comparative Marketing Communications) Regulations 2007, which prohibit misleading comparative advertising. Brand names cannot be used in comparator advertisements without the prior consent of the relevant brand owner (Pharmaceutical Code). In addition, the products, services, and promotions of other companies cannot be disparaged in advertising either directly or implicitly. Due to the prohibition on the promotion of unauthorised medicinal products, unauthorised competitor products should not be referenced in promotional material.

There are limited exceptions to the general prohibition on promotion of unauthorised medicinal products. Indications regarding unlicensed medicines may be shared at independent international conferences held in Ireland, subject to the following requirements:

The general rules relating to the advertising of medicinal products apply to the use of the internet and social media. Only non-prescription medicinal products can be advertised to the public, and this includes marketing that is conducted online or by post, telephone, email, or other electronic communications. The advertisement must not give the impression that a medical consultation or surgical operation is unnecessary, particularly by offering a diagnosis or by suggesting treatment remotely. Prescription medicinal products can be advertised through the internet, but only to individuals qualified to prescribe or supply them, and only with the individual's prior consent. Restricted information should only be placed in a secure part of a website for registered users or subscribers only.

The Pharmaceutical Code includes Annex IV on Guidance on Digital Communication in the Pharmaceutical Sector. It states that providing responses to inquiries received from health care professionals through digital channels is acceptable if performed in accordance with the Pharmaceutical Code. The use of electronic data communications for promotion is prohibited except with the prior permission, or on request from, the recipient. The responsibility rests with the company to ensure that receipt of the response is restricted to the health care professional making the inquiry or their nominee. It may be acceptable to contact patients through social media channels in certain circumstances (for example, reminding them to regularly take their prescribed medication) if documented approval from both the health care professional and the patient is received and, in the example given, the message carries no purpose other than supporting patient compliance with the medication schedule instructed by the patient's health care professional.

Annex IV advises that it is a question of policy for a pharmaceutical company as to whether it is appropriate to correct erroneous entries on non-company mediated sites. It cautions that care needs to be exercised since, if a company corrects certain information but omits to correct other information that may be perceived as related, this behaviour may be interpreted as a breach of the Pharmaceutical Code.

The HPRA can require non-compliant advertisements to be withdrawn and the person responsible for the advertisement may be required to publish a corrective statement. A breach of the Advertising Regulations is a criminal offence and liability is the same as for a breach of the Manufacturing Regulations, that is:

The CPA and the European Communities (Misleading and Comparative Marketing Communications) Regulations 2007 also apply to general advertising and commercial practices.

Subject to certain exceptions for promotional materials at international congresses and symposia held in Ireland, a product cannot be advertised before the grant of an MA or certificate of traditional-use registration. All advertisements must:

The advertisement of a medicinal product to the general public is prohibited if it is either:

Where an advertisement of a non-prescription medicinal product to the public is permitted, the advertisement must clearly identify the product as a medicinal product, be easily intelligible to the consumer, and contain an express and legible invitation to carefully read the instructions for use. The IPHA Consumer Code requires that where cautionary warnings are contained in television advertisements, they must appear on the screen for a minimum of four seconds, regardless of the length of the commercial or television slide.

Advertisements of medicinal products must also state, at a minimum:

An advertisement to the public must not contain material which, among other things:

Exceptions and carve-outs are available for advertising registered homeopathic medicines, reminder advertising, and approved vaccination campaigns.

The IPHA Consumer Code also imposes certain requirements on advertisements to the public.

The general rules relating to the advertising of medicinal products apply to the use of the internet and social media. Only non-prescription medicines can be advertised to the public, and this includes marketing conducted online or by post, telephone, email, or other electronic communications. The IPHA Industry Code includes Annex IV on digital communication in the pharmaceutical sector.

Free samples of medicine (both prescription-only and over-the counter medicines) must not be supplied to members of the public or to any person who is not qualified to prescribe that product. This is prohibited under Irish legislation and the IPHA Industry Code.

Annex III of the Pharmaceutical Code contains guidelines for pharmaceutical companies on working with patient organisations. Pharmaceutical companies must ensure that the independence of patient organisations is respected and guaranteed. Medicinal products must not be directly or indirectly promoted through these groups.

It is permissible for a pharmaceutical company to donate to a patient organisation either for general purposes, for a particular project or piece of research, by sponsoring speakers for events or for undertaking projects of joint interest. Each company must make publicly available a list of patient organisations to which it provides financial support, or significant indirect/non-financial support, or both. This should include a description of the nature of the support, including the monetary value of financial support and of invoiced costs. For significant non-financial support that cannot be assigned a meaningful monetary value, the description must describe clearly the non-monetary benefit that the patient association receives. This information may be provided on a national or European level and should be updated at least annually.

When a pharmaceutical company provides financial support, significant indirect support, or significant non-financial support to patient organisations, they must have in place a written agreement. This must set out:

A pharmaceutical company may contract services from patient organisations, but only where they are provided for the purpose of supporting health care or research. A written contract is required. The compensation must be reasonable and not exceed the fair market value of services provided. A company must make publicly available a list of patient organisations that it has engaged to provide significant contracted services and the total amount paid per patient organisation over the reporting period. No one company should fund a patient organisation to the exclusion of other available and willing sponsors, except by the choice of the patient organisation, which is free to exercise its independence in determining who it wants to work with.

Any hospitality provided by a pharmaceutical company to patient organisations, and their members, should be reasonable, and secondary to the main purpose of the event for which it is provided, and must not involve sponsoring or organising entertainment. Hospitality can only be extended to persons who qualify as participants in their own right, but in exceptional cases, can be provided to a bona fide carer of a participant in the case of clear health needs.

Finally, pharmaceutical companies should not offer free samples to patient organisations.

Under the Advertising Regulations health care professionals include registered medical practitioners, dentists, pharmacists, and nurses. In addition, section 4 of the Health and Social Care Professionals Act 2005, as amended, designates clinical biochemists, dietitians, occupational therapists, physiotherapists, psychologists, radiographers, social workers, speech and language therapists, optometrists, orthoptists, and dispensing opticians and others as health care professionals.

A health care organisation is defined in the IPHA Code as any health care, medical or scientific association or organisation, for example, a hospital, clinic, foundation, university, or other teaching institution or learned society (except for a patient organisation) whose business address, place of incorporation, or primary place of operation is in Europe or an organisation through which one or more HCPs or other relevant decision makers provide services.

The Advertising Regulations require certain minimum information to be provided to health care professionals, including:

A clear and legible statement of the information in the SmPC regarding adverse reactions, precautions, and contraindications, dosage, and method of use relevant to the indications must be positioned within the advertisement to enable the reader to readily appreciate the relationship between this information and the claims and indications of the product. The name and address of the holder of the MA, certification of registration or certificate of traditional use registration, or the business name and address of the part of the business responsible for placing the medicinal product on the market, should also be provided along with the authorisation number. If applicable, the words "traditional herbal medicinal product for use in…," followed by one or more therapeutic approved indications, and followed by the words "exclusively based upon long-standing use," should be included.

Separate requirements exist for abbreviated reminder advertisements. The Pharmaceutical Code adds that this information should be clear, legible, and an integral part of the promotional material.

The promotion of medicinal products to health care establishments and professionals is governed by the Advertising Regulations and the IPHA Industry Code (see Question 9).

The supply, offer, or promise of any gift, pecuniary advantage, or benefit in kind to a person qualified to prescribe or supply medicinal products is prohibited, unless it is inexpensive and relevant to the practice of medicine or pharmacy. For example, pharmaceutical companies can provide pens or paper pads exclusively during company organised meetings, provided that they are non-product branded and inexpensive.

Items of medical utility aimed directly at the education of health care professionals and patient care are not considered gifts and can therefore be supplied, provided they are inexpensive and do not offset the cost of routine business practice of the recipient.

In addition, the transmission of company branded informational or educational materials is permitted, provided the materials are all of the following:

Hospitality can still be provided at sales promotions or other events for purely professional and scientific purposes, provided it is all of the following:

Where pharmaceutical companies provide or offer meals to health care professionals, the value of each meal (including food and beverages) cannot exceed the current monetary threshold set by the IPHA of EUR80 per recipient. This threshold includes VAT but excludes gratuities, and only applies to events held in Ireland. Hospitality occurring in another member state bound by the EFPIA Code must comply with the hospitality threshold in that member state.

Companies are not prevented from providing the following, provided certain conditions are met:

A donation or sponsorship of equipment must be relevant to the practice of medicine or pharmacy, and must be given to an institution and intended solely for use in the institution.

Any grants must be paid directly to an institution rather than to an individual health care professional, and must not be linked in any way to product promotion.

Financial support in the form of grants, donations, and sponsorship must be reasonable, modest, and in proportion to the scale and scope of the recipient institution.

Health care professionals can enter into consultancy agreements with pharmaceutical companies to provide speaking or advisory services. These agreements must satisfy a number of criteria, and importantly must not constitute an inducement to prescribe, purchase, sell, or supply a particular medicinal product. A legitimate need must be clearly identified before the request for services. Consultants must be chosen based on criteria directly related to this identified need, and must be compensated at fair market value given the services provided.

Under the IPHA Industry Code, direct and indirect transfers of value (subject to limited exceptions) from pharmaceutical companies to health care professionals and health care organisations must be documented and publicly disclosed by pharmaceutical companies.

It is prohibited to supply, offer, or promise gifts, pecuniary advantages, or benefits in kind to health care professionals, in the course of promoting medicinal products. Health care professionals are also prohibited from accepting these items.

On 1 July 2014, the limited exemptions that were previously in place were abolished and a blanket prohibition on gifts came into force. The prohibition does not apply to the transmission of information or educational materials or to items of medical utility which will be permitted in certain circumstances (see Question 21).

Companies may provide items including pens and paper pads exclusively during company organised meetings, if they are non-product branded and inexpensive. Items of medical utility aimed directly at the education of health care professionals and patient care may be provided if they are inexpensive and do not offset the cost of routine business practice of the recipient. These are not considered gifts. These items may be company branded only if the brand name is essential for the correct use of the medicine.

In addition, section 15 of the Ethics in Public Office Act 1995 imposes a disclosure obligation on the recipient for any gift given to a health care professional employed by the state or their spouse, civil partner, or child, which exceeds a monetary value of EUR650.

A pharmaceutical company may provide support in the form of HSSs, educational, research, or employment grants and the donation or sponsorship of medical equipment for the betterment of patients. The support must be in response to a written request from the health care organisation or health care professional for a specific type of support that must be genuinely needed. While health care professionals can request the support provided, support must be paid directly to the relevant health care organisation only and the support provided must be relevant to the practice of medicine or pharmacy and be intended for use solely in the organisation. The provision of any support must not be conditional on the prescription, supply, or use of the company's products or be linked in any way to promotion. The support must be modest, reasonable, and in proportion to the scale and scope of the recipient institution. The Pharmaceutical Code also obliges companies to make publicly available information in relation to these donations, grants, and sponsorship and from 1 January 2016, companies have been required to make public, on an annual basis, details of all transfers of value. There are no monetary limits for these forms of support. Companies should actively check that their support has been spent as intended and the written agreement must require that the support has been spent as agreed.

HSSs are defined as process enhancement initiatives or medical service supports (for example, patient compliance initiatives and sharps bin services) provided by a pharmaceutical company that ultimately improves patient care and welfare. An HSS must have the objectives of monitoring disease activity, achieving better health care outcomes, and enhancing patient care. They must be non-promotional, must not be designed as an inducement to prescribe, and must not be designed or operated in a promotional manner. The operation of the HSS must be monitored with reference to its objectives. An HSS may be provided directly or indirectly to patients. Contractual arrangements with service providers should clearly outline the service, the requirements for safety reporting, and adherence to data privacy requirements. Information collected in the provision of an HSS cannot be used for promotional purposes and cannot be used for clinical research purposes without the appropriate prior written consent of the health care provider and the patient.

The requirements for companies to make publicly available information about transfers of value is set out in the self-regulatory Pharmaceutical Code and are applicable only to members of the IPHA or EFPIA. Pharmaceutical companies must disclose transfers of value made by them, whether directly or indirectly. This obligation does not extend to transfers of value that are:

Disclosures must be made from 1 January 2016 on an annual basis and each reporting period covers a full calendar year.

The Pharmaceutical Code allows for disclosure through either the company's website, or a central platform. Disclosures must be made by pharmaceutical companies within six months after the end of the relevant reporting period (a calendar year), and the information disclosed must remain in the public domain for a minimum of three years after the information is first disclosed, unless there is a valid legal reason not to do so. Disclosures must be made under the national code of the country where the recipient has its physical address. Pharmaceutical companies must document all transfers of value required to be disclosed and maintain the relevant records of the disclosures for a minimum of five years after the end of the relevant reporting period.

Pharmaceutical companies must disclose, on an individual basis for each clearly identifiable recipient, the amounts attributable to the transfers of value to the recipient in each reporting period which can be reasonably allocated to one of the following categories:

Where a transfer of value, which would otherwise reasonably be allocated to one of the above categories, cannot be disclosed on an individual basis for valid legal reasons, a pharmaceutical company must disclose the amounts attributable to the transfers in each reporting period on an aggregate basis.

The Criminal Justice (Corruption Offences) Act 2018 (Corruption Offences Act) provides that it is an offence for any person to corruptly do any of the following:

If a company is found guilty of an offence under the Corruption Offences Act, and the offence was committed with the consent or connivance, or was attributable to any wilful neglect of a director, manager, secretary, or other officer of the company, that person can also be guilty of the offence.

The Ethics in Public Office Acts 1995 and Standards in Public Office Act 2001, as amended and the Civil Service Code of Standards and Behaviour are also relevant. Holders of certain public positions (including senior personnel in the HSE, HPRA, the Department of Health, and in voluntary hospitals) must disclose certain interests to the Standards in Public Office Commission. These include gifts and the provision of travel facilities, living accommodation, meals, or entertainment valued at more than EUR650 in total in any given year. While responsibility for compliance rests with the recipient of the gift, the provider of the gift can be asked to assist the Standards in Public Office Commission in its investigations, and failure to do so can be a criminal offence.

Medicinal products and related substances, and the processes for their production, can be patent protected, provided they meet certain criteria.

The relevant legislation is the Patents Act 1992, as amended (Patents Act). Patents granted under the Patents Act can be for 20 years (full-term patent) or ten years (short-term patent). To obtain protection on a long-term patent, an invention must:

The criteria for a short-term patent are similar. The key difference is that, for a short-term patent, there is a lower standard of inventiveness required and the applicant does not need to provide evidence of novelty in respect of the invention.

To fulfil the criteria of novelty and inventiveness for a full term patent, the invention must not form part of the state of the art (which includes anything made available to the public before the date of filing of the patent application) and must not be obvious to a person skilled in the art.

Patent protection can be applied to a wide range of inventions, for example, appliances and mechanical devices, biological and chemical inventions, and computer related inventions.

Full term patents. These provide protection for up to 20 years (supplementary protection certificates (SPCs) can be obtained in certain circumstances to extend the duration of a patent for medicinal and plant products by up to five years). The applicant must provide evidence of the invention's novelty, for example, by requesting a Search Report from the Irish Patents Office.

Short-term patents. Short-term patents are granted by the Patents Office for a ten-year period. The applicant does not need to provide evidence of the invention's novelty.

If applications are made for both a short-term patent and a full-term patent for the same invention, the short-term patent becomes void once the full-term patent is granted.

A patent will not be granted for:

(Section 10(1), Patents Act.)

Biotechnological inventions that are capable of protection must also fulfil the requirements for patentability set out in the Patents Act (see above, Conditions and Legislation). Biotechnological inventions are patentable if they concern any of the following:

(European Communities (Legal Protection of Biotechnological Inventions) Regulations 2000.)

Patents can be registered through filing an application with either:

Details of current fees and guidance on the application process are available at IPOI: Turning ideas into assets, and on the EPO website.

Ireland is a signatory to the International Agreement on a Unified Patent Court. The Unified Patent Court will hear disputes in respect of infringement and validity of European patents, including those with unitary effect. Unlike other European countries, Ireland must hold a referendum to ratify the unitary patent system, to allow the transfer of judicial powers from the current Irish court system to the Unified Patent Court.

A patent application must include a detailed description of the patent including what the invention is, what it does, and how it works. The description must be sufficiently clear and complete, allowing a person reasonably skilled in the art to be able to fully replicate the invention without needing further details.

Domestic patents. For an Irish patent, a filing date will be issued to the applicant by the IPOI once the minimum requirements for requesting the grant of a patent have been supplied (that is, an indication that a patent is sought, information identifying the applicant, and a description of the invention and the patent claims) subject to any further requested information being provided within prescribed time limits.

The invention is assessed as at this date for patentability by the IPOI Examiner. If satisfied that the invention is patentable, the IPOI Examiner will allow the grant of the patent. On payment of the appropriate fee, a certificate of grant is issued and a notice of grant published in the Patents Official Journal.

The application process for a full-term patent typically takes a minimum of two to five years. A short-term patent is typically granted within 12 months of the filing date. If applications are made for both a short-term patent and a full-term patent in respect of the same invention, the short-term patent will become void when the full-term patent is granted.

The filing fee for a short-term patent is 50% of that for a full-term patent and generally this is of particular interest to small enterprises and single inventors.

The date a patent application for an invention is first filed establishes a priority date. Applicants who file an application at a later date for the same invention are not entitled to a patent due to the earlier priority date. The main effect of the priority right is that the filing date of the first application counts as the date from which the state of the art is assessed against the application. If two or more persons make an invention independently, the right to a patent belongs to the person whose filing date or claimed priority date is the earliest.

EPO patents. An application for a European Patent is examined by a division of the EPO to determine whether the invention meets the requirements of the European Patent Convention (EPC). Applicants can apply for a patent which is effective in all member states. Alternatively, a patent can be sought for only a number of EPC countries, which have been designated on the application.

A published European Patent application provides provisional protection no less than that offered by a contracting state for a national application. The standard term of a European patent is 20 years from the date of filing (provided the annual renewal fees are duly paid).

When a European Patent designating Ireland is granted, the EPO transmits the particulars of the patent to the IPOI. Any European patents granted on or after 4 March 2012 do not require a translation to take effect in Ireland.

EPO patents following domestic application. If, following a domestic application, an application for the same invention is filed in the EPO or a country party to the Paris Convention for the Protection of Industrial Property 1883 (Paris Convention) within 12 months of the initial filing date, the initial filing date becomes the priority date of the new application.

If there has been more than one earlier filing for the same invention this can give rise to more than one priority date. Time limits run from the earliest of the priority dates.

In relation to domestic patents, provided the annual renewal fees are paid and the patent is not revoked or deemed invalid:

The term of full-term and short-term patents (see Question 24, Conditions and Legislation) can be extended, for a maximum of five years, by granting an SPC. These are granted for medicinal products or plant production products when the patent's commercial exploitation period is reduced by the process of obtaining an MA.

When an SPC is granted, it does not take effect until the end of the term of the basic patent, and extends protection only to the specific product which was the subject of the MA, rather than the patent as a whole.

A holder of an SPC can apply for a further extension of six months if the protected product has been tested for paediatric use and the relevant studies have complied with an agreed paediatric investigation plan. The granting of an SPC is governed by the European Communities (Supplementary Protection Certificate) Regulations 2008.

Section 42 of the Patents Act governs acts not within the scope of a patent (that is, specific acts that a third party can carry out without infringing the patent rights of a patent holder). Section 42(g) was inserted by the European Communities (Limitation of Effect of Patent) Regulations 2006 by transposing the Bolar exemption language of Article 10(6) of Directive 2004/27/EC amending the Code for Human Medicines Directive and Article 13(6) of Directive 2004/28/EC amending Directive 2001/82EC on veterinary medicinal products. This was further amended by the Intellectual Property Miscellaneous Provisions Act 2014 (IP (Miscellaneous Provisions) Act).

The Bolar exemption means that any necessary studies, experiments, tests, and trials (including clinical trials and field trials) required to obtain an MA in any jurisdiction will not amount to patent infringement.

A patent confers on its holder, for a limited period of time and in countries of protection, a right to exclude others from exploiting (making, using, selling, or importing) the patented invention without the consent of the patentee.

In Ireland, patents can be directly or indirectly infringed.

Direct infringement. If a third party uses the patented invention without the owner's consent, the owner can take action to enforce their rights, including by preventing any other party from:

(Section 40, Patents Act.)

Indirect infringement. A patent can also be indirectly infringed by a person who supplies or offers to supply any of the means, relating to an essential element of the invention, for putting the invention into effect (section 41, Patents Act).

The following are some relevant exemptions from infringement in the Patents Act:

Patent invalidity can be raised as a defence to infringement proceedings in the following circumstances:

Section 42 of the Patent Act provides limitations that also operate as statutory defences to patent infringement, including:

Research exemption. Acts done for experimental purposes relating to the subject matter of the relevant patented invention will not constitute infringement of a patent (section 42(b), Patent Act). A specific application of the research exemption is the Bolar exemption. Section 42 of the Patent Act provides for a similar research exemption, stating that the rights conferred by a patent will not extend to acts done in studies, tests, and trials that are conducted with a view to satisfying the application requirements for an MA in respect of a human or veterinary medicinal product.

IP exhaustion. As a member state of the EU, the European doctrine of exhaustion of rights applies to patent rights in Ireland. The doctrine of exhaustion means that where a patented product is put on the market in one member state of the EU by or with the consent of the patentee, the patentee cannot then use their patent rights to prevent or hinder the importation of that product into a second member state or prevent its sale there.

Other exemptions. The Patents Act sets out a number of additional defences that may be available to a defendant, including the following:

Additionally, where a defendant can prove that they were not aware and had no reasonable grounds to suppose that the patent being infringed existed at the date of infringement, the defendant can claim in their defence that neither damages nor an account of profit should be awarded.

Ireland is party to the WTO Agreement on Trade Related Aspects of International Property Rights (TRIPS).

Ireland is a signatory to or has ratified a number of international treaties relating to patents, including:

Ireland is a signatory to or has ratified a number of international treaties in relation to trade marks including:

Irish trade marks are governed by:

For a trade mark to qualify for registration, it must be:

(Section 6(1), Trade Marks Act.)

A registered trade mark grants its proprietor a potentially interminable monopoly right to prevent others from using an identical mark in relation to identical goods or services for which it is registered, or a confusingly similar mark with respect to identical or similar goods or services.

Trade marks can be registered by filing one of the following:

Details of applicable fees and guidance on the application process for a national trade mark are available at IPOI: Turning ideas into assets, and for an EUTM at EUIPO: Trade marks.

The HPRA does not review proposed trade marks to determine whether they should be registered by the IPOI.

An application for the registration of an Irish trade mark is made to the IPOI. The application will be granted a filing date on submission of:

The application then goes through an examination process to ensure that an identical or confusingly similar mark has not already been registered as an Irish trade mark or an EUTM. If registration is refused, the applicant will be given an opportunity to make further submissions in support of it.

Once the application is accepted for registration, details of the mark are published in the Patents Official Journal. Opposition to the registration can be lodged with the IPOI by a third party (usually a proprietor of a confusingly similar trade mark) within three months of publication.

An applicant can claim a right to priority for an identical trade mark application registration it has filed in a jurisdiction that is a party to the Paris Convention, within six months of the application date of the Irish trade mark. Where priority is claimed, a certified copy of the original application, as filed, must be submitted to the IPOI within three months of the application for the Irish trade mark.

The length of time taken to obtain a registration depends on several factors, including whether the IPOI raises any objection to the application, or the application is opposed by a third party.

Anti-competitive agreements. Arrangements between undertakings that prevent, restrict, or distort competition in trade in any goods or services in Ireland are prohibited and are rendered void (section 4(1), Competition Act 2002, as amended (Competition Act)). Horizontal agreements between competitors involving price fixing, market sharing, or output limitation will constitute a hard core cartel offence in breach of section 4(1). The Competition and Consumer Protection Commission (CCPC) tends to investigate and seek prosecution of hard core cartel offences on the criminal standard and can also impose civil fines of up to EUR10 million (or 10% of the company's worldwide turnover during the previous financial year) for an infringement of competition law.

Vertical agreements between operators at different levels of the supply chain, for example, between pharmaceutical suppliers and independent wholesalers or between wholesalers and retailers, can also breach section 4(1) where they have the object or effect of restricting competition, for example, where they provide for resale price maintenance. The CCPC tends to investigate and seek enforcement in respect of vertical agreements that it considers breach section 4(1) on the civil standard and can issue a public statement of objections setting out its preliminary views on why the agreement in question does not comply with Irish competition law.

In 2007, the Competition Authority, the predecessor to the CCPC, investigated allegations of an anti-competitive concerted practice among pharmacy contractors in Ireland. In 2008 the Competition Authority concluded the investigation and entered into an agreement with, and obtained undertakings from, the pharmacy contractors to confirm that the pharmacies would not in future engage in any concerted action contrary to section 4.

Apart from public enforcement, parties who claim to be aggrieved by a competition law infringement can take proceedings in the Irish courts and claim injunctive relief, declaratory relief, and damages. There are no reported private competition law actions in the pharmaceutical sector to date in relation to anti-competitive arrangements as prohibited by section 4(1).

Abuse of a dominant position. Abuse by one or more undertakings of a dominant position in trade for any goods or services in Ireland or any part of Ireland is prohibited (section 5(1), Competition Act). Therefore, dominant undertakings should exercise caution when engaging in certain practices that can constitute an abuse of dominance, for example, excessive pricing, predatory pricing, price discrimination, certain forms of rebates, exclusivity, tying or bundling products, or refusal to supply, unless there is an objective justification. Abuse of dominance cases are likely to be investigated and enforced on the civil standard.

Neither the CCPC nor the Competition Authority has reported abuse of dominance cases in the pharmaceutical sector. There has been one private action where a drug wholesaler was accused of abusing a dominant position in a region of Ireland by discontinuing supply to a pharmacist. The case was settled.

Merger control. Mergers or acquisitions that meet certain financial thresholds must be notified to and approved by the CCPC. The CCPC can block mergers or acquisitions that result in a substantial lessening of competition in markets for goods or services in Ireland.

The CCPC does not have any specific regulatory powers of which companies active in the pharmaceutical sector should be aware, other than the investigatory and merger control powers (see above, Competition Law and Main Provisions) (which apply equally in respect of the pharmaceutical sector).

Investigations and enforcement of competition law is not particularly common in the pharmaceutical sector compared with other sectors and, other than the two examples above (see Competition Law and Main Provisions), there are no instances of anti-competitive agreements or abuse of dominance in this sector.

In terms of merger control, the most notable transaction relating to the pharmaceutical sector is the recent Uniphar/Navicorp deal, which is the first transaction that the Irish competition authority has blocked since 2008. The transaction related to the proposed acquisition by Uniphar plc (which provides sales, marketing, and distribution services to pharmaceutical and medical devices manufacturers) of Navicorp Limited (a pharmacy solutions business). Following an in-depth review of the proposed transaction lasting almost a year, the CCPC ultimately determined in December 2022 that the result of the proposed transaction would be to substantially lessen competition in relation to the provision of pharmacy buying group services in Ireland and the provision of pharmacy common management and branding services in Ireland. On this basis, the CCPC determined that the proposed transaction could not be put into effect and Uniphar decided to abandon the deal.

There have been a few other notable transactions related to the pharmaceutical sector notified to the CCPC in last two years, for example:

There have been no reported cases in Ireland relating to the generic entry of pharmaceuticals and no reported abuse of dominance cases in the pharmaceutical sector.

There are also no reported cases on competition law issues arising from parallel imports of pharmaceuticals in Ireland to date. IP issues can arise if, for example, the patent holder has not already marketed the product in the EU, or if the imported product is repackaged in a way that may adversely affect the reputation of the trade mark and of its owner.

Within the EEA, if the IPR holder places or consents to the placement of the product on the market in one EEA state, it cannot generally rely on its rights to prevent that product being imported to or marketed in another EEA state.

IPRs can be used to oppose parallel imports from outside the EEA.

Irish competition law is based on EU competition law and is interpreted and applied by analogy. There is no equivalent under Irish competition law to Commission Regulation (EU) 316/2014 on the application of Article 101(3) of the Treaty on the Functioning of the European Union (TFEU) to categories of technology transfer agreements (Technology Transfer Block Exemption Regulation) but Irish competition law would be likely to be interpreted in a manner consistent with it. Specific issues have not arisen in any reported Irish competition law cases to date involving technology transfer licensing agreements or patent licensing.

A variety of potential competition issues can arise in commercial arrangements concerning manufacturers of pharmaceuticals, wholesalers, and retail distributors. Anti-competitive practices arise where pharmaceutical companies abuse their dominant position in the market or enter into agreements that are restrictive of competition. The most widespread competition concern in the pharmaceutical sector relates to companies abusing their dominant market position. Common abuses are excessive or unfair pricing for medicines and "pay-for-delay," that is, where the entry of generic medicines or biosimilars into the market is delayed or hindered by the incumbent originator. Restrictive agreements between competitors (for example bid rigging, price fixing, and market sharing) and restrictions on parallel trade can also artificially reduce or eliminate competition. Vertical restraints in commercial agreements which prohibit distributors from promoting and selling products of competing manufacturers or seek to co-ordinate the retail prices of medicines can also be restrictive of competition.

The CCPC's Declaration in respect of Vertical Agreements and Concerted Practices exempts certain categories of agreements and concerted practices from the prohibition set out in section 4 of the Competition Act. This Declaration is, in all material respects, equivalent to the Vertical Block Exemption Regulation and Vertical Guidelines issued by the European Commission.

Provided any patent licences comply with Irish and EU competition law, there are no restrictions on licensing or transferring patents to foreign parties. Changes in ownership or an interest in a patent or a patent application must be recorded on the register (section 85(1), Patents Act).

Compulsory licensing applies in certain situations, for example, to meet demand for a product in Ireland or for the manufacture of medicinal products for developing countries, subject to certain conditions (section 70, Patents Act).

The commercialisation or exploitation of inventions developed with the support of public grants or resources is governed by the terms of the agreements under which the grants or resources were made available. They are subject to any restrictions or conditions set out in such agreements on their transfer. Typically, the consent of the funding body is required.

There is no requirement for a patent or a trade mark licence to be approved by any government or regulatory body. However, an exclusive licence must be recorded in the IPOI. Failure to register an exclusive patent licence means that it will only be admitted in court as evidence of the title of a person to an interest in a patent if the court so directs. Failure to register an exclusive trade mark licence within six months of the grant of the licence will adversely affect the ability of the exclusive licensee to take enforcement proceedings and to recover its costs arising from any that action.

For a Community trade mark (CTM), an exclusive licence can be entered on the register at the request of one of the parties.

Compulsory licensing applies in certain situations, for example, to meet demand for a product in Ireland or for the manufacture of medicinal products for developing countries, subject to certain conditions (section 70, Patents Act).

For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, and labelling, see Country Q&A: Life Sciences Regulation in Ireland: Overview.

The HPRA is the competent authority responsible for regulating medicinal products. The Market Compliance Section of the HPRA is responsible for overseeing the recall of medicinal products in Ireland. All proposed recalls of a medicinal product from the market must be notified to the HPRA, so that the terms of the recall can be agreed and the implications for other products, the supply chain, and for patients/users can be evaluated.

In addition, the HPRA can order a recall under the Manufacturing Regulations. Failure to comply can lead to suspension or revocation of the product's MA.

The IMB Act 1995 provides general powers of inspection to the HPRA authorised officers and other authorised officers. These powers are to require any person at the premises or the owner or person in charge of the premises, and any person employed there, to give the officer assistance and information and produce to the officer books, records, or other documents in that person's power or procurement (and in the case of documents or records stored in non-legible form, to produce a legible reproduction of them).

Liability can arise under the following:

Contract. Where goods are sold by a seller under contract, there is an implied warranty that those goods are of merchantable quality where a seller sells them in the course of business (section 10, Sale of Goods and Supply of Services Act 1980).

Essentially, this means that the goods must be for the purpose or purposes for which goods of that kind are commonly bought and durable as it is reasonable to expect having regard to any description applied to them, the price (if relevant), and all other relevant circumstances.

Statutory test. A producer is liable for damages in tort for injury resulting wholly or partly from a defect in the producer's product (section 2, LDPA). This is a strict liability regime. The burden is on the injured person to prove the damage, defect, and causal relationship between the defect and damage (section 4, LDPA). A product is defective if it fails to provide the safety which a person is entitled to expect taking all circumstances into account (section 5, LDPA), including:

Therefore, in the context of pharmaceutical products, specific circumstances may be taken into account when determining safety.

The European Commission has launched a public consultation on the Product Liability Directive.

Negligence. For an action against the manufacturer or producer of a product to be made in negligence, the following must be present:

The burden of proof rests on the claimant and the standard of proof is on the balance of probabilities. A two-stage test has traditionally been applied to determining whether a duty of care exists:

An objective standard applies when assessing whether there has been a breach of duty. Factual and legal causation must be established during the assessment of the causal relationship. An act is held to be the cause of an event if the event would not have occurred without it.

If the circumstances of an accident speak for themselves, they give rise to a presumption of negligence (res ipsa loquitor). Consequently, the burden is on the defendant to prove that the defendant was not negligent.

A producer is liable for damages in tort for damage caused wholly or partly by a defect in the producer's products (section 2(1), LDPA). Producer is defined broadly in section 2(2) of the LDPA and can, in the context of medicinal products, include any of the following persons or entities in the supply chain:

The GPSR give rise to potential criminal liability for producers who place an unsafe product on the market.

Businesses cannot exclude or limit liability for death or personal injury. An injured person's recourse to legal remedies/right to compensation arises on the basis of the common law principle of negligence.

A producer is free from liability under the LDPA if it proves any of the following:

The LDPA provides for a long stop period, whereby the rights conferred on the injured party under the LDPA are extinguished on the expiry of ten years from the date on which the producer put into circulation the product which caused the damage (unless the injured party has brought proceedings against the producer in the interim) (section 6, LDPA).

In negligence, a defendant essentially seeks to establish that:

Damages are reduced if there is contributory negligence (Civil Liability Act 1961 (CLA)).

If two or more persons are liable under the CLA for the same damage, they are jointly and severally liable to the injured person as concurrent wrongdoers (LDPA).

The CLA also provides a defence of voluntary assumption of risk, although this is not often relied on.

There is a limitation period of three years from the date on which a claimant became aware (or should reasonably have become aware) of the damage, the defect, and the identity of the producer (section 7(1), LDPA). Rights conferred on an injured party are extinguished after ten years from the date on which the producer puts the actual product which caused the damage into circulation (section 7(2), LDPA).

The Civil Liability and Courts Act 2004 reduced the limitation period for personal injury cases from three years to two years, with effect from 31 March 2005. However, the Irish courts have considered this point (on a preliminary basis only) and held that the limitation provisions of the LDPA remain unaffected by the enactment of the Civil Liability and Courts Act 2004. It follows that in a personal injury action, this longer limitation period could apply to any element of the claim relating to statutory liability for defective products.

Contract claims can be made within six years from the date the breach of contract occurred.

There is no mechanism for class actions in Ireland. However, multiple product claims are frequently brought in Ireland following international class actions or other multi-party litigation.

Irish law provides for representative actions, when numerous persons have the same interest. However, the same interest requirement is very strictly construed. Remedies are limited to injunctive and declaratory relief, that is, no damages are available. In these circumstances one or more persons can sue on behalf of all interested persons. As a result, multi-party litigation in Ireland has historically been managed through test cases rather than representative actions. Findings in test cases are frequently applied by analogy to subsequent cases.

The Irish Law Reform Commission made recommendations in a report on multi-party litigation in 2005, but so far they have not been made law.

The Multi-Party Actions Bill 2017 is currently before the government. The Bill seeks to introduce certain procedural changes in civil actions, to provide for bringing multi-party actions and reduce the overall cost of litigation.

Compensatory damages can be sub-divided into:

Aggravated damages are available, and are awarded where the claimant suffers further injury due to some or all of the following:

A non-compliant producer is guilty of a criminal offence and liable to a fine up to EUR3,000 or up to three months' imprisonment, or both (GPSR).

Exemplary damages exist in Ireland and are punitive, not compensatory, in nature. However, they are only awarded in exceptional circumstances. This has been done by the civil courts, particularly where there has been an infringement of the claimant's constitutional rights, but even then at a relatively low level. There has only been one example of significant exemplary damages in Ireland (that is, exceeding EUR1 million). There have been no cases to date where exemplary damages have been awarded for a product liability claim.