Of a minimum of six years. In 2004, the EU extended this to ten years. This delay may be extended for yet another year `if, throughout the very first eight years of those ten years, the [originator] obtains an authorisation for 1 or additional new therapeutic indications which . . . bring a significant clinical advantage in comparison with existing therapies.’5 As in the US, the EU has introduced a separate regime of ten years of information exclusivity for orphan drugs.The TRIPS Agreement: the protection of undisclosed information against unfair industrial useIt is argued that TRIPS set the initial international standard with regards to information exclusivity. On the other hand, TRIPS doesn’t impose such an obligation Art. 39(three) merely needs the protection of undisclosed information against `unfair PubMed ID:http://www.ncbi.nlm.nih.gov/pubmed/21344983 industrial use’: Members, when requiring . . . the submission of undisclosed test or other data, the origination of which includes a considerable effort, shall defend such data against unfair commercial use. TRIPS will not define `unfair industrial use’. It’s tough to see how the `reliance’ of a regulatory authority on421 U.S.C. Sect. 355(c)(three)(E)(ii) (1984). Directive 200427EC, OJ L No. 13634-57: 39.2016 The Authors Developing Globe Bioethics Published by John Wiley Sons LtdLisa Diependaele, Julian Cockbain and Sigrid Sterckx2012, the EU concluded the EU-Peru-Colombia FTA, of which Art. 231(four)(a) requires 5 years of information exclusivity for pharmaceuticals and ten years for chemical agricultural products.16 Importantly, this FTA foresees the possibility to regulate `exceptions for factors of Chebulinic acid public interest, circumstances of national emergency or extreme emergency’, indicating the possibility of granting industry access for generic drugs to address overall health emergencies. The EU-South Korea FTA (2010; Art. ten(36)) also specifies a period of 5 years of data exclusivity, along with the EU-Canada agreement forbids the marketing approval of generics relying on originator’s information for eight years. (Chapter 22, Art. 10). Whilst the total quantity of countries at present bound to enact data exclusivity regulations may appear restricted, the impact of those TRIPS-Plus requirements must not be underestimated. The incorporation of information exclusivity provisions in FTAs has come to be the new normal. As an example, the recently concluded Trans Pacific Partnership (TPP) gives for an elaborate information exclusivity regime. As well as 5 years of data exclusivity for new chemical entities and three years for new clinical info, the TPP will be the initial treaty giving a precise data exclusivity regime for biologics, mandating eight years of information exclusivity, or 5 years combined with more measures.17 If the TPP is ratified, a total of 12 countries, representing 40 in the global GDP, is going to be expected to incorporate these measures.`a period of no less than five years from the date of approval for a pharmaceutical item and ten years from the date of approval for an agricultural chemical product’ (Art. 17 (10)). This wording has been normal ever given that. Several other US FTAs have raised the bar for data exclusivity additional by expanding the scope of your obligations. Whereas some early agreements limited information exclusivity to `new chemical entities’ and for clinical information that involved `considerable effort’, Art. 16(8) with the US-Singapore FTA (2004) demands information exclusivity for all regulatory approvals. Moreover, considering that 2005, many US bilateral agreements introduced a separate regime of data exclusivity for new clinical info, b.