A Q&A guide to life sciences law in Ireland.
The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability.
To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool.
This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.
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).
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.
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.
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 evaluating the clinical and cost effectiveness of health technologies. The Corporate Pharmaceutical Unit within the HSE is responsible for evaluating the schemes operated by the HSE for the provision of drugs and medical devices to patients, in conjunction with the National Centre for Pharmacoeconomics (NCPE).
There is no specific legislation currently in force regulating the pricing of medicinal products. The Health (Pricing and Supply of Medical Goods) Bill 2012 has been proposed in the Irish parliament, although it is not yet clear when it will be passed into law (see Question 35).
A framework agreement between IPHA, the Department of Health and the HSE (Agreement) came into effect on 1 November 2012 and will operate for three years. It governs the pricing and supply of branded medicines that are reimbursed by the state through the reimbursement schemes, or that are supplied to state funded hospitals and agencies. It is envisaged that a separate agreement will be entered into between the Department of Health, HSE and the Association of Pharmaceutical Manufacturers in Ireland (APMI), the industry body representing manufacturers of generic medicinal products, in the near future.
The pricing provisions of the Agreement include a price freeze, whereby the price of medicines covered by the Agreement will not increase, save for exceptional circumstances, during the term of the Agreement. New medicines introduced in Ireland during the term of the Agreement will be priced at the currency-adjusted average price to the wholesaler of the medicine in certain nominated EU member states. If a Health Technology Assessment (HTA) has been deemed necessary and a lower price was submitted with the HTA application, the lower price will apply. Where the medicine is not available in any of the nominated EU member states, the price will be agreed between representatives of the manufacturer/importer of the medicinal product and the HSE.
The Agreement provides for a number of price reductions for patent expired medicines when the identical pharmaceutical form of the medicine approved by the IMB or the Commission becomes available for prescription within the reimbursement schemes or is supplied to state funded hospitals, the HSE or other state agencies.
The Agreement also includes a downwards-only price realignment for patented medicines, and for off-patent medicines for which there is no identical pharmaceutical form available for prescription within the reimbursement schemes, to the currency-adjusted average price to the wholesaler in the nominated EU member states in which the medicine is available.
Medicinal products dispensed in the community are funded by the state, through reimbursement of the pharmacist, where the patient in question is eligible under one of the reimbursement schemes, and where the medicinal product being dispensed is eligible for reimbursement.
The HSE Primary Care Reimbursement Service (PCRS) operates a General Medical Services (GMS) Scheme in addition to a number of other community reimbursement schemes (Community Drug Schemes) under which 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.
A medicinal product is eligible for reimbursement if it:
Has a current MA.
Is approved for reimbursement by the HSE.
Is prescribed by a doctor.
Is dispensed by a doctor or pharmacist.
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 healthcare 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) Regulations 2011 SI 300/2011.
Manufacturing is regulated by the Medicinal Products (Control of Manufacture) Regulations 2007 (as amended) (Manufacturing Regulations), which implement:
Title IV of the Code for Human Medicines Directive as amended by Directive 2011/62/EU on falsified medicinal products (Falsified Medicines Directive).
Article 13 of Directive 2001/20/EC on the conduct of clinical trials (Clinical Trials Directive).
Chapter 3 of Directive 2005/28/EC on good clinical practice for medicinal products for human use (GCP Directive).
A manufacturing authorisation is required for the manufacture, dividing up, packaging, labelling, presentation and importation of medicinal products from outside the European Economic Area (EEA). Applications are made to the IMB, and must include details of the:
Applicant.
Relevant medicinal products and pharmaceutical forms.
Proposed operations.
Premises, equipment and facilities.
Site master file.
"Qualified person", who ensures that each batch complies with law, the manufacturer's authorisation and the MA or equivalent. (Such person must be nominated by the applicant.)
Each applicant must give a written undertaking to comply with the conditions of the authorisation, if granted.
Applicants must have suitable and sufficient premises, equipment and facilities, and appropriate and sufficient staff, including the qualified person (see above, Application). The IMB can grant, refuse or conditionally grant an authorisation.
An authorisation only applies to the following, specified in the application and in relation to which it has been granted:
Medicinal products and pharmaceutical forms.
Manufacturing or importation operations.
Premises.
The manufacturer must not use the premises for any other purpose, and must comply with good manufacturing practice (GMP) and good distribution practice (GDP) (where applicable). The IMB must be informed of any change in qualified person or any particulars supplied in the application.
There is no restriction on foreign applicants. However, the IMB only issues manufacturing authorisations for Irish manufacturing or importation sites.
Applications must be granted or refused by the IMB within 90 days. A request for further information by the IMB extends this period, and the expiry of 90 days does not mean that an implicit authorisation is granted. Applications to vary an authorisation due to a change to the medicinal products, pharmaceutical forms, premises or equipment or the manufacture, control or storage facilities must be granted or refused by the IMB within 30 days, unless an inspection is required. In this case, a decision is made within 90 days. All other decisions relating to variation applications are made within 60 days.
The application fee as of 1 January 2013 is EUR1,853. Annual renewal fees vary from EUR3,703 to EUR16,669, depending on the number of employees at the site. The variation fee is EUR274 for an administrative variation, and EUR768 for a technical variation. Current fees are available on the IMB website (www.imb.ie).
Authorisations are valid indefinitely, unless otherwise specified by the IMB. Authorisations granted before 23 July 2007 continue in force until their expiry date. Renewal applications for such authorisations should be submitted three months before the expiry date. Renewals will not carry an expiry date.
The IMB is responsible for monitoring compliance with manufacturing authorisations, GMP and GDP requirements. The IMB can:
Enter and inspect sites.
Inspect and copy records.
Conduct tests or examinations at the site.
Take samples for testing.
The IMB can investigate whether a manufacturer or importer has:
Obtained an authorisation and is complying with it.
At his disposal the qualified person approved by the IMB who meets the requirements and is fulfilling his obligations.
The IMB can vary an authorisation at any time. The IMB can suspend or revoke the authorisation in total or in relation to certain medicinal products, on notice in writing to the authorisation holder, on certain grounds.
Breach of the Manufacturing Regulations is an offence under the IMB Act, resulting in:
On summary conviction, a fine up to EUR2,000 or imprisonment for up to one year, or both.
On conviction on indictment for a first offence, a fine up to EUR120,000 or imprisonment for up to ten years, or both, and for a subsequent offence, a fine up to EUR300,000 or imprisonment for up to ten years, or both.
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.
Clinical trials in Ireland are regulated by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 to 2009 (Clinical Trial Regulations), which implement the Clinical Trials Directive and the GCP Directive.
The Clinical Trial Regulations apply to clinical trials conducted in human subjects and involving investigational medicinal products (IMP).
In July 2012, the Commission adopted a proposal to repeal the Clinical Trials Directive in order to simplify and harmonise the authorisation of clinical trials across the EU. Final adoption of the legislation is not expected before 2014 and it is not expected to come into effect before 2016.
A clinical trial authorisation (CTA), issued by the IMB, must be obtained by a sponsor or person authorised to act on his behalf prior to commencing a clinical trial. An investigational medical product dossier should be submitted to the IMB providing clinical and non-clinical supporting data for the trial together with evidence of the favourable ethics committee approval and the sponsor's EudraCT number (see below, Trial pre-conditions). Within 25 days of receipt of a valid application, the IMB gives written notice to the sponsor of its decision to:
Refuse the authorisation, setting out grounds for the refusal.
Grant the authorisation.
Grant the authorisation, subject to conditions.
If no notice is given, a clinical trial can be treated as if it has been authorised. Where the IMB refuses an authorisation or grants it subject to conditions, the sponsor can send an amended request to the IMB within 14 days. The IMB must respond within 60 days of the original request with one of the following actions:
Setting out the grounds for refusing the amended application.
Granting the amended application.
Granting the amended application subject to conditions.
The procedure differs for clinical trials involving certain medicinal products, such as for gene therapy and somatic cell therapy including xenogenic cell therapy, or containing genetically modified organisms.
The sponsor must obtain each trial subject's informed consent, and inform each trial subject of the trial procedure and his right to withdraw at any time. Consent should include consents to data processing. Documentation relating to these matters must be submitted to the ethics committee for approval before the application for a CTA is made to the IMB (see below, Trial pre-conditions).
The following items must be satisfied before a clinical trial can commence:
The sponsor, or the person authorised to act on his behalf in relation to the trial, is established in the EU.
The sponsor has registered with the EEA system for monitoring drug safety, EudraVigilance.
A favourable ethics committee opinion in relation to the trial protocol has been obtained.
The IMB has granted a CTA.
Insurance and indemnity cover for the conduct of the trial has been obtained.
If a CTA application involves a trial site in a third country, the IMB may require an undertaking from the sponsor or the owner of the premises to allow the premises to be inspected by or on behalf of the IMB, to ensure that GCP is followed.
If the trial relates to a genetically modified organism, a separate application must be made to the Environmental Protection Agency.
The trial must be conducted in accordance with GCP, and comply with:
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals (ICH) Guidelines on GCP.
Commission Guideline ENTR/CT3 2006.
World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects 1964.
Annex 13 to the European Commission's GMP Guide on Manufacture of Investigational Medical Products.
The sponsor must:
Notify the IMB within seven days of any breach of GCP.
Ensure that all correct safety reporting is conducted, and that urgent safety measures are taken when there is an immediate hazard to health or safety.
Maintain a trial master file and retain all essential documents relating to the clinical trial for at least five years after its completion.
Notify the IMB of the end of the trial within prescribed time limits.
The placing of medicinal products on the market in Ireland is regulated by the Marketing Regulations, which implement certain provisions of the Code for Human Medicines Directive. Subject to certain exceptions (including the compassionate use exemption and clinical trial supplies), a medicinal product cannot be placed on the market in Ireland unless an MA has been granted for that product by the IMB or, where appropriate, the EMA.
An MA can be obtained through the following procedures:
National procedure. An application is submitted to the IMB and, if granted, the MA entitles the marketing authorisation holder (MAH) to place the medicinal product on the Irish market.
Mutual recognition procedure. If the medicinal product has received an MA in another EEA member state (Reference Member State), the MAH can apply to one or more other member states (Concerned Member State) to recognise that authorisation. If a product has received an MA in another member state, the MAH can apply to the IMB to mutually recognise that authorisation in Ireland.
Decentralised procedure. This can be used if the product has not yet received an MA in a member state, and the applicant wishes to apply for simultaneous authorisation in two or more member states. The applicant nominates one of the states as the Reference Member State, whose competent authority examines the application in full and prepares a report for the competent authorities of the Concerned Member State(s). The IMB is the competent authority for these applications in Ireland.
Centralised procedure. A Community MA, which is valid throughout the EEA, can be obtained by applying to the EMA, through the centralised procedure governed by Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency (as amended) (EMEA Regulation). The Centralised Procedure is compulsory for certain medicinal products.
The applicant must be established in an EEA state. Applications (whether to the IMB or EMA) must be accompanied by the appropriate fee and certain documents and particulars, including:
A summary of the product characteristics (SmPC).
A mock-up of the packaging and package leaflet.
The requisite safety, quality and efficacy data (including clinical trial results, and a description of the proposed pharmacovigilance system).
Applications under the mutual recognition or decentralised procedure must:
Include a list of all of the Concerned Member States.
Confirm that the dossier, the SmPC, package leaflet and labelling are identical in each of the member states involved.
To maintain authorisation following market entry, the MAH must comply with certain pharmacovigilance requirements (see below, Post-marketing commitments and pharmacovigilance obligations).
The key stages and timing are determined by the procedure used.
Under the national procedure, the Marketing Regulations do not specify any timescale within which the IMB must consider the application. If an application is refused, the IMB must provide the applicant with a notice in writing, detailing the reasons on which it has based its decision. The applicant then has 30 days in which it can give notice of its wish to appeal. The IMB, after considering the applicant's representations, will decide whether to alter its decision. If the applicant is unsatisfied with the appeal decision it can, in certain circumstances, seek judicial review of the IMB's decision-making procedure.
The applicable fees are available on the IMB website. As of 1 January 2013, the following fees apply for new applications (with complex dossiers and new active substances not previously licensed in Ireland):
National application: EUR15,211.
Mutual recognition incoming: EUR10,647.
Decentralised incoming: EUR15,211.
Decentralised outgoing: EUR40,000.
The fees for the centralised procedure are available on the EMA website (www.ema.europa.eu).
Unless a shorter time period is specified, an MA is valid for five years. If the product is not placed on the market within three years of authorisation or is not on the market for three consecutive years, the authorisation ceases to be valid. Renewal applications must be made at least six months before expiry of the current MA. If successfully renewed, the MA remains valid for an indefinite period (unless further renewals are required for pharmacovigilance reasons).
The Marketing Regulations require that a MAH must comply with certain pharmacovigilance requirements to maintain its MA. The pharmacovigilance framework is based on the EMA Regulation, as amended by Regulation 1235/2010 concerning pharmacovigilance of medicinal products for human use, and the Code for Human Medicines Directive, as amended by Directive 2010/84/EU. This EU legislation has been transposed in Ireland, in respect of human medicines, by the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations SI 272/2012.
In accordance with this updated legislation, the MAH must, among other things:
Have permanently and continuously available an appropriately qualified person (the nominated person) in the EEA who is responsible for the establishment and maintenance of a pharmacovigilance system.
Maintain, and make available on request, a pharmacovigilance system master file for medicinal products in respect of which a marketing authorisation has been granted on or after 21 July 2012 or, if granted before 21 July 2012, from the date on which the marketing authorisation is next renewed or 21 July 2015, whichever date is the earlier.
Operate, and keep updated, a risk management system for medicinal products in respect of which a marketing authorisation has been granted on or after 21 July 2012 or, if granted before 21 July 2012, where required by the IMB.
In the case of suspected adverse reactions, the MAH must, among other things:
Keep a detailed record of all suspected adverse reactions to the relevant medicinal product which are brought to the MAH's attention.
Report all serious suspected adverse reactions no later than 15 days following the day on which the MAH gained knowledge of the event.
In the case of a suspected adverse reaction to a biological medicinal product prescribed, dispensed or sold in the state, record the brand name and the batch number of the biological medicinal product concerned.
Following establishment of the Eudravigilance database, reports of serious suspected adverse reactions, and also those of non-serious suspected adverse reactions, along with updates on suspected adverse reactions, will have to be submitted to the Eudravigilance database.
The MAH must also submit Periodic Safety Update Reports (PSURs) to the IMB or EMA at specified intervals. PSURs must include certain information.
Other post-marketing commitments of the MAH required by the Marketing Regulations include:
Informing the IMB of certain information, including the date that the medicinal product is placed on, or removed from, the market, and any new information which may influence the evaluation of the benefits and risks of the medicinal product.
Complying with any obligations and conditions imposed on the MAH by the IMB or EMA in the grant of the relevant MA.
Ensuring that sufficient supplies of the product are provided to pharmacies on an ongoing basis.
Ensuring that the product information is kept up to date with current scientific knowledge.
An applicant is not required to provide the results of pre-clinical and clinical trials if it can demonstrate that the product is a generic medicinal product, or a similar biological product to a product which has been authorised in the EU for at least eight years (or six years, if the application for the reference product was submitted before 30 October 2005).
The application for authorisation of the generic or similar biological product can be made to the IMB eight years after authorisation of the reference product, when the period of data exclusivity for the reference product expires. If the application for the reference product was made before 30 October 2005, and the application was not in respect of a Community MA, this period is reduced to six years.
Once authorised, the generic or similar biological product cannot be placed on the market for ten years from authorisation of the reference product, known as the market exclusivity period. This is extended to 11 years if, during the first eight years after the grant of the initial MA for the reference product, the holder of that MA is granted an authorisation for a new therapeutic indication of significant clinical benefit in comparison to existing therapies.
An abridged procedure is also available for:
Applications relying on well-established (ten years) medicinal use of the active substance involved, where the applicant can replace the results of pre-clinical and clinical trials with the appropriate scientific literature.
Applications relating to new fixed combination products, where the results of new pre-clinical or clinical trials are provided, but scientific references relating to each of the individual substances are not required.
Applications where the product possesses the same qualitative and quantitative composition in terms of active substances as an authorised medicinal product, and the original MAH gives his consent to the use of his dossier for examining the application in question.
An MA issued by, or an application for an MA submitted to, the competent authority of another EEA state, can be recognised in Ireland under the mutual recognition or decentralised procedure (see Question 8). MAs issued by countries outside the EEA are not recognised in Ireland.
The IMB is responsible for monitoring compliance with MAs. The IMB has wide-ranging powers relating to:
Entry and inspection of sites.
Inspection and copying of records.
Conducting tests or examinations at the site.
Taking samples for subsequent testing.
The IMB also relies on manufacturers, healthcare professionals and the public to report adverse events and misleading information regarding medicinal products.
The IMB (or, in the case of centrally authorised medicinal products, the Commission) can impose an urgent safety restriction in respect of a product on the market and the relevant MAH is required to implement the safety restriction and to apply to vary the MA accordingly immediately, or at the latest within 15 days of imposition of the restriction. The IMB may also revoke, suspend, refuse to renew, or vary an MA, for a specified period or until further notice. Breach of the Marketing Regulations is an offence under the IMB Act. Such offences may be prosecuted by the IMB and liability is the same as for breach of the Manufacturing Regulations (see Question 6).
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 EMA 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 a manufacturer's authorisation. Parallel importers wholesaling the parallel product in Ireland are exempted from the requirement to hold a wholesaler's authorisation where they hold a manufacturer's authorisation, provided that the manufacturer's authorisation covers the parallel imported products. If the parallel importer wholesaling the parallel product in Ireland does not hold a manufacturer's authorisation, a wholesaler's authorisation is required, and the wholesaler's authorisation must name dual pack or parallel imported products as a category of medicinal product that may be wholesaled (see Question 5). 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 IMB.
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 IMB if all the following criteria are fulfilled:
The original product has a valid and current MA.
The parallel product is imported from another EEA country and it has a valid and current MA in that country.
The parallel product is identical to the original product, including the packaging, label, package leaflet, shelf life and SmPC.
The importer has given the original product MAH one month's notice of its intention to parallel import before submitting its application for a DPR.
Where the original product MAH responds to such notification indicating the non-existence of joint packs between the relevant markets, the product will not be eligible under the DPR scheme and the DPR application must not be submitted, or, where already submitted, must be withdrawn. A DPR is valid indefinitely, provided the parallel importer submits an annual declaration of compliance with the above criteria. The IMB expects the DPR holder to keep up-to-date with any changes to the original product, in order that each consignment of the parallel product is compliant with the above requirements. Prior to 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, which will commence with the letters "DPR". This label must not obscure any of the original text on the pack.
A PPA is required if the parallel product differs in any respect from the original product. A PPA is granted by the IMB if all the following criteria are met:
The original product has a valid and current MA or if not, the MA has been withdrawn for commercial reasons only.
The parallel product is imported from another EEA country and it has a valid and current MA in that country.
The parallel product has the same active substance(s) and pharmaceutical form, and is identical to, or has no significant therapeutic differences from, the original product.
A PPA can be granted indefinitely or may be limited to a maximum of 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 is replaced by a new version, provided that there are no risks to public health. In these circumstances, the IMB may request additional information from the parallel importer in order 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 IMB indicates that 15 working days would be considered reasonable notice.
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.
The promotion of medicinal products to healthcare establishments and professionals is governed by the Advertising Regulations and the IPHA Industry Code (see Question 15).
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. This prohibition does not apply to hospitality provided at sales promotion or other events for purely professional and scientific purposes, provided it is:
Reasonable in level.
Limited to the main purpose or scientific objective of the event.
Not provided to any persons other than those who are qualified to prescribe or supply medicinal products.
Free samples cannot be supplied to any person other than a person qualified to prescribe such product, and only where certain conditions are satisfied.
Companies are not prevented from providing educational, research or employment grants, donation or sponsorship of equipment, provided certain conditions are met. Any grants must be paid directly to an institution rather than to an individual healthcare professional and this support 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. The IPHA Industry Code encourages pharmaceutical companies to make publicly available information regarding these donations, grants and sponsorships.
Healthcare professionals may enter into consultancy agreements with pharmaceutical companies to provide speaking or advisory services. Such 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, and consultants must be chosen based on criteria directly related to this identified need and must be compensated at fair market value considering the services provided.
The Ethics in Public Office Acts 1995 (as amended) and the Civil Service Code of Standards are also relevant. Holders of certain public positions (including senior personnel within the HSE, the IMB, the Department of Health and in voluntary hospitals) must disclose certain interests to the Standards in Public Office Commission. These include gifts and/or the provision of travel facilities, living accommodation, meals or entertainment valued at more than EUR650 in aggregate in any given year. While responsibility for compliance rests with the recipient of the gift, the provider of the gift can be requested to assist the Standards in Public Office Commission in its investigations, and failure to do so can be a criminal offence.
The general rules relating to the advertising of medicinal products apply to the use of the internet and/or social media. Only non-prescription medicines can be advertised to the public, and this includes marketing that is conducted online or by post, telephone, e-mail 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. Additional restrictions on what may be stated in an advertisement to the public also apply (see Question 15). Prescription medicines 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. In certain circumstances, the use of a prominent disclaimer on the site to inform visitors that the site is suitable for healthcare professionals only and providing a hyperlink to a site appropriate to the general public may be possible. Caution should be exercised in relation to linking and reverse linking to sites, which may raise copyright issues or breach the Acceptable Use Policy of the relevant website. Companies should be careful not to target online advertisement to countries where the product in question may not have a MA.
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 IMB. 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 Manufacturing Regulations (see Question 6). The Consumer Protection Act 2007 and the European Communities (Misleading and Comparative Marketing Communications) Regulations 2007 also apply to general advertising and commercial practices.
Self-regulation plays an important role, and members of IPHA must comply with:
The Code of Marketing Practice for the Pharmaceutical Industry (Edition 7.5) (IPHA Industry Code): prescription and non-prescription medicines.
The Code of Standards of Advertising Practice for the Consumer Healthcare Industry (Edition 5.1) (IPHA Consumer Code): non-prescription medicines.
The IPHA Industry Code fully reflects the standards of the June 2011 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, Promotional and Direct Marketing in Ireland (6th Edition January 2007) (ASAI Code). The ASAI Code applies to the advertising of medicinal products, with the exception of specialised marketing communications addressed to the medical, veterinary and allied professions.
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 (see Question 17). All advertisements must:
Comply with the terms of the MA and the SmPC.
Encourage the rational use of the product and not exaggerate its properties.
Not be misleading.
The advertisement of a medicinal product to the general public is prohibited if it is either:
A prescription-only product.
A controlled drug under the Misuse of Drugs Act 1977 (as amended).
Where an advertisement of a 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 such 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:
The name of the medicinal product, and, where it contains only one active ingredient, the common name of the medicinal product.
The information necessary for the correct use of the medicinal product.
An advertisement to the public must not contain material which, among other things:
Gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail.
Suggests that the effects of taking the medicinal product are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product.
Suggests that the health of the subject can be enhanced by taking the medicinal product.
Suggests that the health of the subject could be affected by not taking the medicinal product.
Is directed exclusively or principally at children.
Refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity status, could encourage the consumption of medicinal products.
Suggests that the medicinal product is a foodstuff, cosmetic or other consumer product.
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.
Any 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 IPHA Industry Code imposes a number of restrictions on pharmaceutical companies in their dealings with patient associations in respect of the promotion of their products.
The packaging and labelling of medicinal products is regulated by the Marketing Regulations and Title V of the Code for Human Medicines Directive. A mock-up of the label text and art-work design of the outer and immediate packaging together with the package leaflet must be submitted to the IMB for approval. Any subsequent changes must also be submitted for approval. If there is a breach of labelling and packaging requirements, the IMB can suspend the MA until the breach is remedied. Criminal sanctions can also apply.
The packaging must contain certain information, including:
The invented name (which must also be expressed in Braille format), strength and pharmaceutical form (to be expressed in Braille where a risk of confusion occurs) of the product.
The active substances using their international non-proprietary names or common names.
The contents by weight, volume or by number of doses of the product.
The method and, if necessary, the route of administration.
The expiry date.
Any special storage or other instructions.
The name and address of the MAH and, where applicable, its representative.
The authorisation number and the manufacturer's batch number.
For non-prescription medicinal products, instructions for use.
A package leaflet must also be included if certain further information (including therapeutic indications, duration of treatment and action in case of emergency) is not included on the packaging. The information outlined above must appear in English, or in both Irish and English. Such information can also appear in other languages, provided that the same information is given in all of the languages used. In addition, a form of the package information leaflet that is suitable for people with visual impairment must be available to the patient promptly on request, and this form of the package information leaflet should not be abridged in any way.
There are separate specific labelling requirements for homeopathic products and traditional herbal medicinal products.
A herbal medicinal product is any medicinal product exclusively containing one or more herbal substances, one or more herbal preparations or one or more herbal substances (in combination with one or more herbal preparations) as active ingredients. With certain exceptions, herbal medicinal products are subject to the Manufacturing Regulations and Marketing Regulations.
A manufacturing authorisation is required for the manufacture of a herbal medicinal product, unless all of the following apply:
It is not industrially produced or manufactured by a method involving an industrial process.
It is supplied without any written recommendations as to its use and under a designation only specifying its composition.
No other name is applied to it.
Herbal medicinal products cannot be placed on the market without an MA or certificate of traditional-use registration. The marketing of herbal medicinal products can be authorised by:
A conventional MA (see Question 8) or on the basis of well-established use. Products must be able to demonstrate appropriate standards of quality, safety and efficacy, and be accompanied by the necessary information for safe use.
A traditional use certificate (TUC) issued by the IMB, if the product has been used for at least 30 years at the time of the application, of which 15 years of this period must have been in the EU. A TUC is a simplified alternative to obtaining a conventional MA. A person seeking a TUC must provide certain information.
A traditional herbal medicinal product is a product that fulfils all of the following criteria:
Intended and designed for use without the intervention of a medical practitioner for diagnosis, prescription or monitoring of treatment.
Taken orally, for external use or inhalation.
Administered exclusively at a specified strength and dose.
Is on the market for a period of traditional use.
Medicinal products and related substances, as well as 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:
Be new or novel.
Involve an inventive step.
Be capable of industrial application.
Not fall within any excluded categories (for example, a mathematical method or scientific theory).
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).
The following, among others, are not patentable inventions (Patents Act):
A method for treatment of the human or animal body by surgery or therapy.
A diagnostic method practised on the human or animal body.
However, a product, substance or composition used in any such method can be patented (such as medicines and surgical instruments).
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, among others (European Communities (Legal Protection of Biotechnological Inventions) Regulations, 2000 (S.I. No. 247 of 2000):
Biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature.
Plants or animals, if the technical feasibility of the invention is not confined to a particular plant or animal variety.
A microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.
Patents can be registered through filing an application with either:
The Irish Patents Office (IPO) for a patent that is effective in Ireland (www.patentsoffice.ie).
The European Patents Office (EPO) for a patent which is effective in Ireland if the applicant designates Ireland on the EPO application (www.epo.org).
Details of current fees and guidance on the application process are available at www.patentsoffice.ie for the IPO, and www.epo.org for the EPO.
Domestic patents. For an Irish patent, a filing date will be issued to the applicant by the IPO once the minimum requirements for requesting the grant of a patent have been supplied to the IPO (that is, an indication that a patent is sought, information identifying the applicant and a description of the invention) subject to any further requested information being provided within prescribed time limits. The invention is then assessed as at this date for patentability by the IPO Examiner. If satisfied that the invention is patentable, the IPO 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 Official Journal of the IPO.
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 twelve months of the filing date.
EPO Patents. An application for a European Patent will be 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.
When a European Patent designating Ireland is granted, the EPO transmits the particulars of the patent to the IPO. 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 domestic application, an application for the same invention is filed in the EPO or a country that is a party to the Paris Convention for the Protection of Industrial Property 1883 (Paris Convention) within 12 months of the initial filing date, then the initial filing date becomes the priority date of the new application.
Provided the annual renewal fees are paid and the patent is not revoked or deemed invalid:
A full-term patent lasts for 20 years from the date of filing.
A short-term patent lasts for ten years from the date of filing.
The term of full-term and short-term patents (see Question 18, Conditions and legislation) can be extended, for a maximum of five years, by the granting of a supplementary protection certificate (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. Once an SPC has been 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 a 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.
Section 42 of the Patents Act 1992, as amended, governs the acts which do not come within the scope of a patent (that is, the specific acts that a third party can carry out without infringing the patent rights of a patent holder). Section 42(g) was inserted by S.I. No. 50 of 2006 (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.
The Bolar exemption means that the necessary studies, tests and trials required to obtain a marketing authorisation in respect of a generic, pseudogeneric or biosimilar will not amount to patent infringement.
An application for revocation of a full-term patent can be made on any of the following grounds (section 58, Patents Act):
The invention subject matter of the patent is not patentable.
The specification does not disclose the invention in a manner allowing it to be carried out by someone skilled in the field.
The matter disclosed in the specification extends beyond that in the filed application.
The protection conferred by the patent has been extended by an amendment which should not have been allowed.
The proprietor of the patent is not entitled to the patent under the Patents Act.
An action for revocation can be taken either in the High Court or before the Controller. The Controller can revoke a patent on his own initiative if the invention formed part of the state of the art (section 60(1), Patents Act). If the Controller intends to revoke a patent, he must grant the proprietor a three-month period to make observations or amend the specification. Additionally, a short-term patent can be revoked if the claims of the specification are not supported by the description.
If a third party uses the patented invention without the owner's consent, the owner can take action to enforce his rights, including by preventing any other party from (section 40, Patents Act):
Making, offering, putting on the market or using a product which is the subject of a patent or importing or stocking the product for those purposes.
Using a process which is the subject of a patent.
Doing the above in relation to a product obtained directly by a process which is the subject of the patent, in each case without the consent of the patent holder.
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).
Proceedings for patent infringement can be brought before the Commercial Court, a division of the High Court, which deals with certain specified matters, including intellectual property infringement. An injunction is generally sought in the first instance to prevent continued infringement, pending the full hearing of the action. Available remedies at the full hearing include:
Damages or an account of profits.
Order for delivery up or destruction of any infringing product.
Declaration of validity of the patent and of infringement by the defendant.
The Commercial Court offers a faster litigation process through case management conferences, stringent filing and documentation requirements and compliance obligations in respect of pre-trial judicial directions. Applications for admission to the Commercial List can be made by either party to a dispute.
An applicant is not required to provide the results of pre-clinical and clinical trials if he can demonstrate that the product is a generic medicinal product, or a similar biological product to a product which has been authorised in another EU member state or the EU for at least eight years (or six years, if the application for the reference product was submitted before 30 October 2005).
However, in accordance with the transitional data protection principles, the generic or similar biological product, once authorised, cannot be placed on the market for ten or 11 years (depending on the exclusivity period available for the reference medicinal product) following authorisation of the reference product. If the application for the reference product was made before 30 October 2005, the period is reduced to six years (S.I. 240/2007 Medicinal Products (Control of Placing on the Market) Regulations 2007).
The owner of an orphan product is entitled to ten years' market exclusivity if certain conditions are met (Regulation (EC) 141/2000 on orphan medicinal products).
In order for a trade mark to qualify for registration, it must be (section 6(1), Trade Marks Act):
A sign.
Capable of being represented graphically.
Capable of distinguishing goods or services of one undertaking from those of other undertakings.
A medicinal brand can be registered as a trade mark, provided it complies with the legal conditions for registration (see above, Conditions and legislation) and is not prevented from registration by sections 8 to 10 of the Trade Mark Act.
Trade marks will not be registered if they fall within the prohibited categories set out in sections 8 to 10 of the Trade Marks Act, for example, a lack of distinctiveness or the use of descriptive or functional characteristics.
Trade marks can be registered by filing one of the following:
An application for a national registration to the Controller in the IPO.
An application for a Community trade mark (CTM) with the Office of Harmonisation in the Internal Market (OHIM) in Alicante, Spain.
An application under the Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks 1989 (Madrid Protocol), an international system of registration, administered by the International Bureau of the World Intellectual Property Organisation (WIPO). This allows a trade mark proprietor to apply to protect its trade mark in several countries through one application with a single office.
Details of applicable fees and guidance on the application process for a national trade mark are available at www.patentsoffice.ie, and for a CTM at http://oami.europa.eu/ows/rw/pages/index.en.do.
An application for the registration of an Irish trade mark is made to the IPO. The application will be granted a filing date on the submission of:
A completed prescribed application form (or otherwise submitting the requested information).
The name and address of the applicant.
A representation of the mark.
A statement or list of the goods and/or services for which registration of the mark is sought.
The application then goes through an examination process to ensure that the mark, or a similar mark, has not already been registered. If registration is to be refused, the applicant will be given an opportunity to make further submissions. Once the application is accepted for registration, details of the mark will be published in the IPO's Official Journal. Opposition to the registration can be lodged with the IPO within three months of this publication.
The length of time taken to obtain a registration depends on several factors, including whether the IPO raises any objection concerning the application, or the application is opposed by any third party.
The initial registration period is ten years (from the date of filing of the application). Subsequent registration periods are also ten years in duration, provided the renewal fees are paid. A trade mark registration can last indefinitely if it is renewed on or before the dates noted in the registration, by payment of the renewal fee.
Details of the renewal fees for:
A national registration, are set out at www.patentsoffice.ie.
A CTM, are set out at http://oami.europa.eu/ows/rw/pages/index.en.do.
An Irish registered trade mark can be revoked from the trade mark register if one of the following applies:
There has been no genuine use of the trade mark in Ireland for five years (by or with the consent of the registrant or proprietor) without proper reasons for non-use.
Use of the trade mark has been suspended for an uninterrupted period of five years, without proper reasons for the non-use.
The trade mark has become generic (a common name) in the trade for a product or service for which it is registered, due to acts or inactivity of the proprietor.
The manner of use of the trade mark by or with the consent of the proprietor has resulted in the trade mark being likely to mislead the public about the nature, quality or geographical origin of the goods or services for which it is registered.
Revocation proceedings can be made by any person before the High Court or the Controller, although they are usually undertaken by a competing third party or by way of counterclaim in infringement proceedings.
The proprietor of a registered trade mark has exclusive rights in that trade mark within the scope of its registration. These rights are infringed by any use of the trade mark without the proprietor's consent, including use of a sign in the course of trade, which is identical or similar to the trade mark, for goods or services that are identical or similar to those for which the trade mark is registered.
The trade mark proprietor can enforce his registration rights in the courts (including the Commercial Court) through injunctive relief or at a full hearing. Available remedies at the full hearing include:
Damages.
An account of profits.
An order to deliver up and/or destroy the infringing goods.
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 IPO. Failure to do so may result in the grant of the licence being ineffective against a third party acquiring a conflicting interest in, or under, the registered mark.
For a 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 the state or for the manufacture of medicinal products for developing countries, subject to certain conditions.
Ireland is party to international patent and trade mark conventions, including the:
Paris Convention.
WIPO Madrid Agreement for the Repression of False or Deceptive Indications of Source of Goods 1891.
WIPO Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks 1989.
WIPO Strasbourg Convention on the Unification of Certain Points of Substantive Law on Patents for Inventions 1963 (Strasbourg Patent Convention).
Strasbourg Agreement Concerning the International Patent Classification 1971.
EPC 1973 and 2000.
Patent Cooperation Treaty 1970.
International Convention for the Protection of New Varieties of Plants 1961.
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure 1977.
WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS).
WIPO Patent Law Treaty 2000.
WIPO Trademark Law Treaty 1994.
Liability can arise under the following:
Contract. Liability can arise under the Sale of Goods Act 1893, as amended by the Sale of Goods and Supply of Services Act 1980.
Tort. The general common law principle of duty of care applies in Ireland. Therefore, product manufacturers owe a duty of care to all those who may be foreseeably injured or damaged by their products.
Statutory liability. The Liability for Defective Products Act 1991 (LDPA) implements Directive 85/374/EEC on liability for defective products (Product Liability Directive) into Irish law.
Criminal. The European Communities (General Product Safety) Regulations 2004 (GPSR) implement Directive 2001/95/EC on general product safety (General Product Safety Directive).
Statutory test. A producer is liable for damages in tort for injury resulting wholly or partly by a defect in his 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 the:
Presentation of the product.
Use to which he could expect that the product would be put.
Time when the product was put into circulation.
In the context of pharmaceutical products, specific circumstances are taken into account when determining safety under section 5 of the LDPA.
Negligence. For an action against the manufacturer or producer of a product to be made in negligence, the following must be present:
A duty of care owed by the producer or manufacturer of the product to the consumer.
A breach of that duty of care.
A causal relationship between the breach of duty and the damage caused to the user of the product.
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:
Is there a relationship of proximity or neighbourhood between the parties and is there foreseeability of damage?
Is there a public policy reason as to why that duty should not be imposed?
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 he was not negligent.
A producer is liable for damages in tort for damage caused wholly or partly by a defect in his products (section 2(1), LDPA). Producer is defined broadly (section 2(2), LDPA). Further, section 2(3) of the LDPA covers situations where a producer cannot be identified. The GPSR give rise to potential criminal liability for producers who place an unsafe product on the market.
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).
However, 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.
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. Irish law provides for representative action, which can arise 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 not through the representative action procedure, but through test cases. 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 these recommendations have not been made law.
A producer is free from liability under the LDPA if he proves any of the following (section 6, LDPA):
He did not put the product into circulation.
It is probable that the defect causing the damage came into being after the product was put into circulation by him.
The product was not manufactured for profit making sale.
The product was not manufactured or distributed in the course of business.
The defect was due to compliance of the product with mandatory regulations issued by the public authorities.
The state of the scientific and technical knowledge at the time when the product was put into circulation was not such as to enable the defect to be discovered (development risks defence).
In the case of a manufacturer of a component of the final product, the defect was attributable to the design of the product or to the instructions given by the product manufacturer.
A defendant essentially seeks to establish that:
He was not negligent.
He did not owe a duty of care.
There was no causal link between the action/inaction and the injury.
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.
Compensatory damages can be sub-divided into:
General damages, which cannot easily be quantified in monetary terms and are presumed to flow from the wrong of a defendant.
Special damages, which are the specifically quantifiable expenses that the claimant has incurred as a result of the defendant's tortious act.
Aggravated damages are available, and are awarded where the claimant suffers further injury due to some or all of the following:
The manner in which the wrong was committed.
The conduct of the defendant after commission of the wrong.
The defendant's conduct in the defence of his action, including the trial.
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.
The Health (Pricing and Supply of Medical Goods) Bill 2012 proposes to introduce generic substitution and reference pricing for groups of interchangeable medicinal products in order to reduce healthcare expenditure in Ireland. Under this Bill, the HSE will set a common reimbursement price for groups of interchangeable medicinal products, known as the reference price. If a supplier wishes to charge above the reference price, the patient would be obliged to pay the difference, as the HSE would only reimburse at the reference price. The introduction of generic substitution will allow pharmacists to dispense a less costly medicine than that which has been prescribed, provided that the less costly medicine falls within the same group of interchangeable medicinal products. The IMB will be responsible for drawing up the list of groups of interchangeable medicinal products. It is not yet clear when this proposed legislation will be enacted.
In September 2012, the Commission adopted a proposal for a regulation on medical devices and on in vitro diagnostic medical devices which will, once adopted by the European Parliament and by the Council, replace the existing three medical devices directives.
Directive 2011/62/EU amending the Code for Human Medicines Directive, known as the Falsified Medicines Directive (FMD), introduces and strengthens measures preventing the entry into the pharmaceutical supply chain of falsified medicinal products. In particular, it introduces a mandatory authenticity feature which will be required on the outer packaging of designated medicines, and it strengthens controls on starting materials and on the regulation of producers of active substances and excipients. It also introduces a requirement that brokers of medicinal products, and manufacturers, importers and distributors of active substances, register with the relevant competent authority. The Department of Health has recently published draft regulations for the transposition of the FMD into Irish law, and it is expected that these will be enacted shortly following a brief consultation phase. Brokers of medicinal products, and manufacturers, importers and distributors of active substances, that commenced their activities before 2 January 2013 must have registered with the IMB by 2 March 2013, and those that commenced such activities after 2 January 2013 must have registered with the IMB prior to the date of commencement. Those that already hold authorisations to manufacture, import and/or distribute finished medicinal products are not exempt from this requirement to register in respect of active substances. From 2 January 2013, active substances imported into the EU must have been manufactured in accordance with standards of good manufacturing practices (GMP) that are at least equivalent to those of the EU. From 2 July 2013, the competent authority of the exporting country will be required to confirm in writing that such standards have been met, unless the active substances have been sourced from countries listed by the Commission as having GMP standards equivalent to those of the EU.
On 17 July 2012, the Commission adopted a proposal to repeal and replace the Clinical Trials Directive. The Clinical Trials Directive placed a high administrative burden on sponsors due to:
Separate applications being required in each member state for one clinical trial.
Differences in the implementation of the Directive by national authorities.
The proposed changes include:
A clinical trial will require a single assessment in one member state which will then be effective throughout the EU.
A risk based approach to clinical trials, distinguishing between low-intervention trials and other trials.
The rules will be adopted as a Regulation, in order to ensure that identical rules apply throughout the EU (see Question 7).
On 13 February 2013, the Commission adopted a Product Safety and Market Surveillance Package of measures, including a proposal for a Regulation on Consumer Products Safety (which would be directly binding on member states). This new Regulation would repeal the General Product Safety Directive. The proposed measures will be discussed by the European Parliament and the Council. The new legislation is expected to come into effect in 2015.
Agreement has been reached by 25 member states of the EU on the unitary patent system, that is, patents administered by the EPO having unitary effect in the participating member states. The Unified Patent Court Agreement was signed in February 2013. This step follows the adoption by the Council of the EU in December 2012 of the other two elements of the "patent package", that is, Regulation 1257/2012 implementing enhanced cooperation in the area of the creation of unitary patent protection, and Regulation 1260/2012 implementing enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation arrangements. The "patent package" is subject to ratification in some member states, and a number of other requirements must be met before the unitary patent system can come into effect. The earliest date for the new system coming into effect is 1 January 2014.
The IMB Enforcement Unit is becoming more active each year, with increased inspections and enforcement actions. One area of priority for the IMB is to encourage increased voluntary adverse event reporting by healthcare professionals.
Main areas of responsibility
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E colin.kavanagh@arthurcox.com
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Qualified. Admitted as a solicitor in Ireland, 1999
Areas of practice. Corporate; commercial; Head of life sciences.
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