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Test Data Protection and TRIPS-Plus Provisions: Ensuring Safety and Efficacy

This article discusses the requirements and provisions of test data protection under TRIPS, along with the implications for generic manufacturers. It also explores the case of colchicine and its data exclusivity period.

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Test Data Protection and TRIPS-Plus Provisions: Ensuring Safety and Efficacy

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  1. Test data protectionTRIPS requirements & TRIPS-plus provisions Carlos Correa

  2. Test data Safety – Efficacy Empirical information obtained through the application of standard protocols Preclinical and clinical trials

  3. Data exclusivity During the data exclusivity period, national drug authorities cannot use or rely on test data to register generic equivalents

  4. As long as data exclusivity lasts… Generic manufacturers must => Repeat the clinical trials => Wait until the expiry of the data exclusivity period

  5. TRIPS Article 39.3 Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

  6. PROTECTION OF UNDISCLOSED INFORMATION Article 39 1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect …data submitted to governments or governmental agencies in accordance with paragraph 3.

  7. USA v Argentina: WTO settlement • -Argentina kept its system based on fair competition law • - Argentina committed itself to change its law if WTO established that exclusivity was required under TRIPS

  8. Countries without data exclusivity for pharmaceuticals -Brasil- Filipinas- Ghana- India- Indonesia- Malaysia - Pakistan- Thailand- Uruguay

  9. Beyond patents Registration for new indication Registration; market entry Patent End patent term Data exclusivity Data exclusivity

  10. Colchicine : 3 years of data exclusivity -Widely available as a generic drug for gout pain in the USA sincethe 19th century: second-line treatmentforgout -Testswith 185 patients, oneweek: shorteneddosingregime : - Lawsuitsto remove any other versions of colchicine from the market -Price increase by a factor of more than 50, from $0.09 per pill to $4.85 per pill.

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