The question is whether it can look different to the one already in place. The special compulsory licensing system in the amended TRIPS Agreement, and the earlier 2003 waiver decision, (sometimes called the “Paragraph 6 System” because it refers to paragraph 6 of the Doha Declaration) only deals with compulsory licences to produce medicines expressly for export. The amendment to the TRIPS Agreement, which put this option on par with all other options, came into force on 23 January 2017. It's therefore a compulsory licence specially for production in one country, for export, to meet the public health needs of one or more other countries. The WTO has a new chief. The patent owner still has rights over the patent, including a right to be paid compensation for copies of the products made under the compulsory licence. A certain amount of confusion exists about the TRIPS Agreement�s provisions and compulsory licensing for medicines. Home | About WTO | News & events | Trade topics | WTO membership | Documents & resources | External relations, Contact us | Site map | A-Z | Search, TRIPS AND HEALTH: FREQUENTLY ASKED QUESTIONS. The amended rules create the legal pathway, but countries have to make use of it. Ms Okonjo-Iweala wants to set up a longer-term framework for responding to pandemics instead. L. 103–465 effective on date that is one year after date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], with provisions relating to earliest filed patent application, see section 534(a), (b)(3) of Pub. (Whereas under a compulsory licence buyers would have to pay some royalty, under the proposed waiver they would not.). Which products are covered by this mechanism? For “national emergencies”, “other circumstances of extreme urgency” or “public non-commercial use” (or “government use”) or anti-competitive practices, there is no need to try first for a voluntary licence. The WTO’s TRIPS Agreement is an attempt to narrow the gaps in the way these rights are protected and enforced around the world, and to bring them under common international rules. Another complaint has been that the WTO’s intellectual-property rules are too rigid, and protect pandemic profiteers over the poor. Ms Okonjo-Iweala is keen to beef up the WTO’s monitoring efforts, which should be easier. Compulsory licensing must meet certain additional requirements: the scope and duration of the licence must be limited to the purpose for which it was granted, it cannot be given exclusively to licensees (e.g. As for other products, Bryan Mercurio of the Chinese University of Hong Kong says that if governments have not issued compulsory licences, often the problem is not with the existing trade rules but with their own domestic lawmaking. Not necessarily. It’s the only instance when the TRIPS Agreement specifically links emergencies to compulsory licensing: the purpose is to say that the first step of negotiating a voluntary licence can be bypassed in order to save time. For compulsory licensing, it’s when the generic copy is produced mainly for the domestic market, not for export. Only if that fails can a compulsory licence be issued, and - even when a compulsory licence has been issued, the patent owner has to receive payment; the TRIPS Agreement says “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization”, but it does not define “adequate remuneration” or “economic value”. Not in general. Plainly, if a medicine is not patented in a least developed country, the government does not need to issue a compulsory licence to import.