Ireland is one of the leading international locations for the life science industry. Its open economy, low corporate tax rate, research and development tax credit together with its highly skilled workforce makes it a popular choice for inward investment. It is home to 15 of the top 20 medical technology companies in the world and nine out of the top 10 global pharmaceutical companies, which produce seven out of the 10 most popular pharmaceutical products. Global players with substantial Irish operations include Abbott, Bayer, Becton Dickinson, Boston Scientific, Johnson & Johnson, Guidant, Medtronic and Stryker.
Ireland's indigenous and multinational company base is complemented by a world-class research base, an evolved technology transfer and clinical infrastructure and a well-respected regulatory environment. Enterprise Ireland, the government agency responsible for the development of Irish enterprise, and IDA Ireland, the government enterprise agency responsible for securing foreign direct investment for Ireland, help drive innovation and stimulate continued growth in this sector by offering various incentives and grants.1
In Ireland, the regulatory framework for medicinal products is based on the Code for the Human Medicines Directive 2001/83/EC (the Code for Human Medicines Directive) (as amended), which was implemented by the Irish Medicines Board Act 1995 (the IMB Act) (as amended) and various regulations. Health-care policy and expenditure is determined by the Department of Health and Children and administered through the Health Services Executive (HSE).
The role of the Irish Medicines Board (IMB) is to:
ensure the quality, safety and efficacy of medicines (including veterinary medicines) available in Ireland and monitor the quality, manufacturing and distribution processes of these products; act as the competent authority for the implementation of EU and national legislation relating to blood, blood components, tissues, cells and medical clinical research, and (since 1 October 2010) cosmetics; and regulate medical devices on the Irish market. The IMB therefore is the competent authority for the regulation of medical devices and cosmetic products and the authorisation of medicinal products. In addition, it is responsible for the implementation of EU and national legislation relating to blood and blood components and also for tissues and cells.
In addition to its regulatory activities the IMB also has an enforcement role.
All medicinal products for human use derived from biotechnology and other high-technology processes, must be approved by the European Medicines Agency (EMA).
Regulations on the contained use or deliberate release of genetically modified organisms (GMOs) in Ireland are implemented by the Environmental Protection Agency.
Combination products (medical devices incorporating a medicinal product) are regulated by the IMB under medical devices legislation. They are subject to high levels of compliance assessment and classified as Class III (highest risk) devices.
II THE REGULATORY REGIME
A medicinal product is defined in Article 1 of Directive 2001/83/EC as amended by Directive 2004/27/EC. The IMB helps stakeholders clarify which products should be categorised as medicinal products and medical devices and thereby fall under their remit.
A classification service is operated for products that are on the borderline of human medicines and other products such as food supplements, cosmetics and medical devices. This is very important since users need to be aware of the legal restrictions on the marketing of medicinal products and the fact that the more stringent legislation takes precedence.
Requests for classification on the relevant IMB form, whether external or internal, are presented to a monthly internal multidisciplinary classification committee. The decision will include a recommendation for any action that needs to be taken depending on the circumstances. The...