Remuneration Guidelines for Non-voluntary Use of a Patent on Medical Technologies - Health Economic and Drugs Series No. 018
(2005; 110 pages)

The 2001 Doha Declaration on the TRIPS Agreement and Public Health declared that WTO Members should implement intellectual property laws in a manner that promotes access to medicines for all, using to the full TRIPS flexibilities. The TRIPS Agreement allows WTO Members to use a number of different limitations and exceptions to patent rights, including cases where governments can authorize persons to use patents, even when the patent owner does not give permission. Although it establishes certain procedures that countries must follow in issuing compulsory licences, the TRIPS Agreement provides countries with broad discretion to establish the conditions under which they may issue compulsory licences. The Doha Declaration reiterated that countries have "the freedom to determine the grounds upon which such licences are granted". In some cases, before a decision is made, WTO members must first require prior negotiation with patent holders on “reasonable commercial terms and conditions”. Normally this would involve an offer to license a patent for a “reasonable” royalty. The terms “reasonable commercial terms” and “adequate remuneration” are not defined in the TRIPS Agreement. WTO Members are free to determine the appropriate method of implementing the TRIPS Agreement, within their own legal system and practice, and this extends to the standards they apply for “reasonable” royalties, or “adequate” remuneration.
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