Michael McGrath (Cork South Central, Fianna Fail)
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60. To ask the Minister for Jobs, Enterprise and Innovation if her Department has examined whether Ireland is approaching a patent cliff specifically in the pharmaceutical industry (details supplied); and if she will make a statement on the matter. [46674/19]

Heather Humphreys (Cavan-Monaghan, Fine Gael)
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The Budget 2020 Economic and Fiscal Outlook noted that Ireland’s production base is highly concentrated in a small number of high-tech sectors. However, the overall macro-economic risk assessment matrix in Budget 2020 regarded the likelihood of risks relating to our concentrated production base as low.

The pharmaceutical sector in Ireland operates within a broad national and European legislative framework. That legal regime means companies here benefit from a level of patent protection for medicinal products that is amongst the strongest in the world. Protection is afforded, for example, for original discoveries for a period of 20 years. In addition, Supplementary Protection Certificates (SPCs) grant protection for a maximum of five additional years following expiry of the initial patent. This is to account for the time period between patent filing and approval of medicinal products by medicines regulators.

The impact of the patent cliff on the pharmaceutical industry in Ireland was the subject of a working paper produced by the Department of Finance in 2013. That paper addressed the expiry of specific patents and associated issues. My Department also continues to monitor and analyse trends in the pharmaceutical and biopharma sectors on an on-going basis, given the importance of those areas to our economy.

More broadly, the pharmaceutical industry continues to perform well here. The global top ten biopharmaceutical companies all have a manufacturing presence in Ireland, as do many other firms. The sector employs approximately 30,000 people directly in IDA-supported companies. Along with high export figures and high-value employment, the sector also contributes strongly to the Irish economy in many other ways, such as investments in research and development and through sub-supply contracts for goods and services. We also have many highly innovative indigenous firms that are continuing to grow.

It is the case as well that Ireland continues to win new investments in the areas of small and large molecule manufacture and cell and gene therapies. This is a result of IDA Ireland’s strong client engagement across every aspect of the industry, with a view to generating new employment opportunities and consolidating Ireland’s position and reputation in the pharmaceutical industry.