Ireland: Life Sciences Law Review 2018

Last Updated: 29 May 2018
Article by Colin Kavanagh and Ciara Farrell
Most Read Contributor in Ireland, October 2018

I INTRODUCTION

i Regulatory framework

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) (the Community Code). 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 2007 (SI 540/2007) (as amended) (Marketing Regulations).

The regulatory framework for medical devices in Ireland is based on the following directives that have been transposed into Irish law: Directive 93/42/EEC concerning medical devices, Directive 90/385/EEC on active implantable medical devices (as amended) and Directive 98/79/EC on in vitro diagnostic medical devices (IVD Directive) (as amended). National legislation transposing those Directives (as amended) include the European Communities (Medical Devices) Regulations 1994 (SI 252/1994) (as amended in 2001, 2002 and 2009), the European Communities (Active Implantable Medical Devices) Regulations 1994 (SI 253/1994) (as amended in 2009), the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 (SI 304/2001) (as amended in 2012), the European Communities (Medical Devices) (Reclassification of Breast Implants) Regulations (SI 358/2003) 2003, the European Communities (Medical Devices) (Tissues of Animal Origin) Regulations 2003 (SI 554/2003) and the European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 2007 (SI 92/2007) (collectively, the Medical Devices Legislation). The existing Medical Devices Legislation is due to be overhauled when the new EU Regulation 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostic medical devices (which formally entered into force at the end of May 2017) come into effect – 2020 for medical devices and 2022 for in vitro diagnostic medical devices. These two Regulations represent a significant development and updating of the existing regulatory system for medical devices in Europe and will replace the original EU Directives, which have been in place for over 25 years.

ii Regulatory authorities

The Health Products Regulatory Authority (HPRA; formerly the IMB)2 is the competent authority responsible for regulating medicinal products, medical devices, cosmetics and other health products in Ireland. The National Standards Authority of Ireland (NSAI) is the notified body in Ireland designated by the HPRA to carry out conformity assessment procedures to ensure compliance with the Medical Devices Legislation. The HPRA's main areas of responsibility are:

  1. ensuring the quality, safety and efficacy of medicinal products (including veterinary medicinal products) available in Ireland, participating in systems designed to do so throughout the European Union, and monitoring the quality of medicinal products and their manufacturing and distribution processes;
  2. acting as the competent authority for the implementation of EU and national legislation relating to blood, blood components, tissues, cells and medical clinical research, and cosmetics;
  3. regulating medical devices on the Irish market;
  4. regulating the protection of animals used for scientific purposes; and
  5. regulatory functions in respect of organs intended for transplantation.

II THE REGULATORY REGIME

i Classification

The decision as to whether a product will be deemed a medicinal product, a medical device or other regulated product will largely depend on the particular intended use of the product, as assigned by the manufacturer, and on the demonstrated mode of action. In arriving at any decision with regard to classification, the applicant must provide the HPRA with sufficient information about the product and its intended usage, including all promotional material. This includes not only labels, leaflets and all advertising materials but also any websites linked to that literature. In the event that the HPRA determines that the product could potentially be a medicinal or other product, the product may be referred to the HPRA Classification Committee, which meets once a month and is responsible for assessing products for which classification is not obvious, including those that are borderline medical devices or medicinal products. Alternatively, classification requests for borderline products may be sent directly to the Classification Committee as opposed to being referred by the HPRA.

Decisions made by the Classification Committee can be appealed to the HPRA Management Committee, which may request the advice of the Advisory Committee on Human Medicines (ACHM) set up under the IMB Act. The decision of the Management Committee is final.

ii Non-clinical studies

Non-clinical studies (e.g., non-interventional studies) are not regulated by the applicable laws and guidance for clinical trials in Ireland. They do not require the positive opinion of an ethics committee. There is, however, general legislation that applies, such as data protection legislation, the common law on consent for medical treatment and research, animal welfare protection laws and good laboratory practice.

Directive 2010/63/EU was transposed into Irish law in December 2012 by the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (SI 543/2012) (as amended). This legislation aims to improve the welfare of animals used for scientific purposes and to promote the principles of the three Rs – replacement, reduction and refinement:

  1. Replacement refers to the use of alternative methods that substitute the use of animals for scientific purposes. Where replacement is not possible, animal use must only be permitted where justified and where the expected benefits outweigh the potential adverse effects.
  2. Reduction measures must be applied so as to minimise the number of animals used in each research project.
  3. Refinement measures must also be applied to enable procedures to be carried out in the most humane manner possible and to minimise pain, suffering, distress and lasting harm.

European Communities (Good Laboratory Practice) Regulations 1991 (SI 4/1991) (as amended) give effect to Commission Directive 2004/10/EC, which requires certain testing on chemicals to be carried out in accordance with the Principles of Good Laboratory Practice. The Irish National Accreditation Board has statutory responsibility for enforcement of these regulations.

iii Clinical trials

Medicinal products

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 Directive 2001/20/EC on the conduct of clinical trials (Clinical Trials Directive) and Directive 2005/28/EC on good clinical practice for medicinal products for human use (GCP Directive).

The Clinical Trial Regulations apply to clinical trials conducted with human subjects and involving investigational medicinal products (IMP). On 16 April 2014, the new Clinical Trials Regulation (Regulation No. 536/2014) was adopted. It will repeal the Clinical Trials Directive and its aim is to simplify and harmonise the authorisation of clinical trials across the European Union. The new Regulation is expected to enter into force six months after the full functionality of a new EU Database and single online EU Portal created under the new Regulation. Clinical trials will, however, continue to be conducted in accordance with the Clinical Trials Directive until the new regulation becomes applicable.

Authorisations

A clinical trial authorisation (CTA), issued by the HPRA, must be obtained by a sponsor or person authorised to act on his or her behalf prior to commencing a clinical trial. An investigational medicinal product dossier should be submitted to the HPRA providing clinical and non-clinical supporting data for the investigational medicinal product, with evidence of the favourable ethics committee opinion and the sponsor's EudraCT number (see 'Trial preconditions', below).

Informed consent

The sponsor must obtain each trial subject's informed consent and inform each trial subject of the trial procedure and his or her right to withdraw at any time. Other conditions apply with respect to the requirements of the applicable data protection legislation and the Clinical Trials Regulations. Documentation relating to these matters must be submitted to the ethics committee for opinion before the application for a CTA is made to the HPRA (see below).

Trial preconditions

The following items must be satisfied before a clinical trial can commence:

  1. the sponsor, or the person authorised to act on his or her behalf in relation to the trial, is established in the European Union;
  2. the sponsor has registered with the European Economic Area (EEA) system for monitoring drug safety, EudraVigilance;
  3. a favourable ethics committee opinion in relation to the trial protocol has been obtained;
  4. the HPRA has granted a CTA; and
  5. insurance and indemnity cover for the conduct of the trial has been obtained.

To facilitate the effective initiation of clinical trials and the removal of administrative barriers, a single HSE clinical trial indemnity form (CTIF) has been agreed between the State Claims Agency and the Irish Pharmaceutical Healthcare Association (IPHA) for the conduct of industry-led clinical trials in Ireland. The CTIF is applicable to the conduct of any industry-sponsored clinical trial in any state hospital in Ireland. Use of the HSE CTIF, which refers to the IPHA clinical trial compensation guidelines, provides the assurance that the company sponsoring a clinical trial will, without legal commitment, adhere to certain guidelines in the event of injury caused to a patient that is attributable to participation in the trial in question.

Medical devices

Devices carrying the CE mark may be freely marketed anywhere in the European Union.3 Clinical assessments are usually required before non-CE marked medical devices may enter the Irish market. For any clinical investigation to commence in Ireland, approval from the HPRA is required, with a positive opinion of an ethics committee. Note that certain clinical investigations, such as those using CE-marked devices within their intended purpose, may not require a review by the HPRA. This must be assessed on a case-by-case basis.

Typically, applications are submitted by a commercial sponsor, such as a medical device manufacturer. By this application, the manufacturer is proposing to conduct an investigation to gather the necessary clinical data to demonstrate the basic safety and performance of their device. The requirements governing the conduct of clinical investigations are laid down in Directive 93/42/EEC and in the IVD Directive, as well as various Commission guidance documents (MEDDEVs) and international standards. The HPRA reviews the regulatory, technical and clinical aspects of the application. The HPRA reviews applications to conduct clinical investigations in Ireland in parallel with the appropriate ethics committee review. An initial decision will be issued within 30 days of the application being made, and the final decision will be provided by the HPRA within 60 days of the application.

iv Named-patient and compassionate use procedures

Medicinal products

Named-patient programmes

Regulation 2 of Schedule 1 of the Marketing Regulations regulates named-patient programmes in Ireland. Under the Marketing Regulations, a named-patient programme permits the sale or supply of an unauthorised product in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his or her individual patients on his or her direct personal responsibility, to fulfil the special needs of those patients.

To make use of the programme, the following conditions must be satisfied:

  1. receipt of an unsolicited order from a registered healthcare professional (HCP);
  2. the product must be supplied to the order or prescription of the requesting HCP;
  3. the product is only provided to the HCP's individual patient; and
  4. the provision of the product is supervised under the direct personal responsibility of the HCP.

There is no formal authorisation for establishing a named-patient programme in Ireland. However, wholesalers and manufacturers that receive or import exempt medicinal products intended for distribution in Ireland under a named-patient programme must notify the HPRA of this fact within two working days of receipt of the consignment. There are a number of exceptions to this notification requirement, all of which depend on the specific supply chain in question. Packaging and labelling requirements will apply, as well as fees and record-keeping obligations in terms of pharmacovigilance and quality defects.

Compassionate use

Medicinal products for use in an authorised clinical trial are exempt from the requirement to be subject to a marketing authorisation (MA). The HPRA does recognise the option of an Expanded Access Programme (EAP) for patients who have been treated with a medicinal product during a clinical trial and wish to continue treatment after the trial is completed. If, however, the EAP fulfils the definition of a clinical trial, it is required to be authorised as such under the applicable Irish legislation. In the event that it does not fulfil the definition of a clinical trial, the medicinal product can only be supplied via a named-patient programme. This essentially means that EAPs for groups of patients at a time are only recognised in Ireland if they are authorised as clinical trials and meet all applicable legislation governing clinical trials.

Medical devices

The CE marking does not have to be present on medical devices intended for clinical investigations, custom-made devices and in vitro diagnostic medical devices for performance evaluation. The CE marking does not have to be present on medical devices intended for exhibitions, demonstrations, trade fairs, etc. However, these devices must bear a visible marking indicating that they are not intended to be marketed or put into use.

To read this article in full, please click here.

Footnotes

1. Colin Kavanagh is a partner and Ciara Farrell is an associate at Arthur Cox.

2. See www.hpra.ie.

3. Where the medical device is to be exported outside the European Economic Area, it will be necessary to apply to the HPRA for a Certificate of Free Sale.

Originally published by Law Business Research Ltd., April 2018.

This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions