Trims Agreement Gives Protection To Patent Products

Trims Agreement Gives Protection To Patent Products

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The duration of protection is at least 50 years for performers and producers of phonograms and 20 years for broadcasters (Article 14.5). However, the argument put forward today is that data exclusivity is a precondition for the TRIPS agreement. The data exclusivity approach gives the initiator exclusive rights to its test data and prevents regulators from relying on test data for the registration of generic substitutes. Prior to the introduction of the TRIPS AGREEMENT, most countries authorized the authorisation of generic drugs on the initiator`s test data. Once the test data was submitted by the initiator, the regulators were able to rely on the data to approve subsequent applications for similar products or to support the demonstration of prior approval of a similar product in another country. Generic drug manufacturers must only demonstrate that their product is chemically identical to the brand, product of origin and, in some countries, bioequivalent. This approach has allowed for the rapid introduction of generic drugs without registration-related costs. Under the data exclusivity approach, no competing producer, once a company has provided original test data, can rely on this data for a specified period of time. Data exclusivity could therefore be an obstacle to the effective use of mandatory licenses, since the importation of the generic drug would be delayed for the duration of the exclusivity period or for the time required for a new collection of trial data. The public interest in restricting data protection is to promote competition and ensure that data protection does not become a means of blocking timely access to generic drugs of importance at affordable prices for public health. However, TRIPS also contain provisions that allow countries to demonstrate flexibility and flexibility to adapt to their own patent and intellectual property systems and development needs.

This means that countries have some freedom in changing their rules and that there are different ways for them to formulate their national legislation to ensure a fair balance between the objective of encouraging the future invention of new medicines and the objective of affordable access to existing medicines.