Abstract
Today's trade agreements reflect in great measure the prevalence of special interests some of which, as in the case of originator pharmaceutical companies, seek to fence off their products from competition. This results in high prices that hinder the generic/biosimilar industry, which faces additional delays in the launch of its products, as well as consumers who are forced to pay higher prices for longer periods of time. The Trans Pacific Partnership (TPP) has become a key example of how powerful economic groups are striving to get countries to adopt regulations that would benefit them at the expense of everybody else. This is particularly clear in the case of biologic drugs, the most expensive drugs in today's market. Since their first patents have begun to expire, patent holders have been aggressively seeking to expand their rights and obtain additional protection through different means such as the adoption of long periods of exclusivity for data. If TPP negotiating parties end up yielding to the pressure, they would be endorsing a system that would simply not be sustainable.
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References
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35.“(7) EXCLUSIVITY FOR REFERENCE PRODUCT.— ”(A) EFFECTIVE DATE OF BIOSIMILAR APPLICATION APPROVAL.—Approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a). “(B) FILING PERIOD – An application under this subsection may not be submitted to the Secretary until the date that is 4 years after the date on which the reference product was first licensed under subsection (a). ”(C) FIRST LICENSURE.—Subparagraphs (A) and (B) shall not apply to a license for or approval of— “(i) a supplement for the biological product that is the reference product; or ”(ii) a subsequent application filed by the same sponsor or manufacturer of the biological product that is the reference product (or a licensor, predecessor in interest, or other related entity) for— “(I) a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or ”(II) a modification to the structure of the biological product that does not result in a change in safety, purity, or potency .
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