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Pharmaceutical Sector

Dáil Éireann Debate, Tuesday - 13 November 2018

Tuesday, 13 November 2018

Questions (301)

John Brassil


301. Deputy John Brassil asked the Minister for Business, Enterprise and Innovation her views on proposed changes to Regulation (EC) No. 469/2009 to allow for a SPC manufacturing waiver; her views on this initiative; and if she will make a statement on the matter. [47188/18]

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Written answers (Question to Business)

Supplementary Protection Certificates (SPCs) are an intellectual property right that serve as an extension to a patent right. They apply to specific pharmaceutical and plant protection products that have been authorised for use in the market by regulatory authorities.

Medicinal products require market authorisation before they can be sold commercially and this process can take a number of years. SPCs compensate the patentee for this loss of time, by extending the protection conferred by the patent beyond its 20-year term for a period of up to five years.

In its 2015 Single Market Strategy (SMS), the Commission indicated it would explore a recalibration of certain aspects of patent and SPC protection to remove any unintended consequences which make the EU pharmaceutical sector less competitive compared to non-EU pharmaceutical manufacturers.

The proposal will allow EU based manufacturers of generics and bio-similars to produce medicines for export purposes only to non-EU countries where SPC protection never existed or has expired.

Studies carried out by the Commission indicate that an SPC manufacturing waiver could allow the European generic and biosimilar medicines industries to create thousands of high-tech jobs in the EU.

Officials of my Department are actively engaged in ongoing discussions on this matter at working party level in Brussels.