PLC: Pharmaceutical IP and Competition Law in Ireland: Overview

15-07-2014


PLC: Pharmaceutical IP and Competition Law in Ireland: Overview – Ireland Chapter

Regulatory overview

What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

Legislation

The regulatory framework for the authorisation of pharmaceuticals in the UK derives from EU legislation, specifically:

  • Directive 2001/83/EC on the Community code relating to medicinal products for human use, as amended (Code for Human Medicines Directive).
  • Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency (EMA Regulation), as amended.

The EU legislation has been implemented in the UK, through the Human Medicines Regulations 2012, which also contain provisions of UK law established independently of EU law and on matters of national competence (for example, the supply of unlicensed medicines).

The regulatory framework regarding pricing and reimbursement of pharmaceuticals in the UK derives from the National Health Service Act 2006, the Health and Social Care Act 2012 and subordinate legislation.

Regulatory authorities

The Medicines and Healthcare products Regulatory Agency (MHRA) (currently www.mhra.gov.uk, although the MHRA website is being transitioned to www.gov.uk) is the government agency responsible for the regulation of medicines and the investigation of harmful incidents. The MHRA is an executive agency of the Department of Health. Overall responsibility for pricing and reimbursement matters lies with the Department of Health. Assessments of various aspects of patient care are conducted by the National Institute for Health and Care Excellence (NICE), which issues recommendations to the National Health Service (NHS) in England, including appraisals of health technologies based on clinical effectiveness and cost effectiveness. Similar assessments are conducted by equivalent bodies in the devolved administrations.

To read more visit: Practical Law Multi-Jurisdictional Guide 2014/15 Life Sciences: Medicinal Product Regulation and Product Liability in Ireland

This PLC Pharmaceutical Q&A Chapter on Ireland* written by Colin Kavanagh, Isabel Foley, Pat O’Brien, Orla Clayton, Olivia Mullooly, Maebh O’Gorman of Arthur Cox gives a high level overview of key issues including patents, trade marks, competition and abuse of dominant position.

Have you checked ‘BioBrief‘, the Arthur Cox Life Sciences online resource? BioBrief brings you the latest news, updates and commentary on a range of issues relevant to the Life Sciences and pharmaceutcal sector in Ireland and around the World.

If you have any queries on any of the articles, information or links in BioBrief or on any other matter, please do not hesitate to contact any member of our team. For more information on our capabilities and experience please take a look at the Life Sciences page of our website.

*This article first appeared in the Practical Law Multi-Jurisdictional Guide 2014/15 Life Sciences: Medicinal Product Regulation and Product Liability in Ireland and is reproduced with the kind permission of the publisher Practical Law Company.

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