development of new pharmaceutical products that are or contain a biologic, as well as with a view to facilitating the timely availability of follow-on biosimilars, and to ensuring that the scope of application remains consistent with international developments regarding approval of additional categories of new pharmaceutical products that are or contain a In biologic.’ other words, there will be scope for a reconsideration of the protection of biologics at a future date. Article 18.50.3 of the provides a statement about access to Trans-Pacific Partnership essential medicines: paragraphs 1 and 2 and Article 18.52 (Biologics), a ‘Notwithstanding Party may take measures to protect public health in accordance with: (a) the Declaration on (b) any waiver of any provision of the granted TRIPS and Public Health; TRIPS Agreement by WTO Members in accordance with the WTO Agreement to implement the Declaration on and that is in force between the Parties; or (c) any amendment of TRIPS and Public Health the to implement the that enters TRIPS Agreement Declaration on TRIPS and Public Health into force with respect to the It is hard to know how these measures will operate in Parties.’ respect of access to essential medicines and the treatment of data protection, biologics, and trade secrets. There is also a side-letter between Vietnam and the United States on biologics. United States Republican Congressional Powerbroker Orrin Hatch was upset at the final text in respect of the protection of biologics in the He lamented: am Trans-Pacific Partnership. ‘I afraid this deal appears to fall He threatened to derail the agreement in the woefully short.’ United States Congress if his demands were not met. Likewise, the House of Representatives
development of new pharmaceutical products that are or contain a biologic, as well as with a view to facilitating the timely availability of follow-on biosimilars, and to ensuring that the scope of application remains consistent with international developments regarding approval of additional categories of new pharmaceutical products that are or contain a biologic.’ In other words, there will be scope for a reconsideration of the protection of biologics at a future date. Article 18.50.3 of the Trans-Pacific Partnership provides a statement about access to essential medicines: ‘Notwithstanding paragraphs 1 and 2 and Article 18.52 (Biologics), a Party may take measures to protect public health in accordance with: (a) the Declaration on TRIPS and Public Health; (b) any waiver of any provision of the TRIPS Agreement granted by WTO Members in accordance with the WTO Agreement to implement the Declaration on TRIPS and Public Health and that is in force between the Parties; or (c) any amendment of the TRIPS Agreement to implement the Declaration on TRIPS and Public Health that enters into force with respect to the Parties.’ It is hard to know how these measures will operate in respect of access to essential medicines and the treatment of data protection, biologics, and trade secrets. There is also a side-letter between Vietnam and the United States on biologics. United States Republican Congressional Powerbroker Orrin Hatch was upset at the final text in respect of the protection of biologics in the Trans-Pacific Partnership. He lamented: ‘I am afraid this deal appears to fall woefully short.’ He threatened to derail the agreement in the United States Congress if his demands were not met. Likewise, the House of Representatives
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