2005 TRIPS amendment on public health (Article 31bis)

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TRIPS Agreement amendment World Trade Organization rule change international intellectual property law instrument

The 2005 TRIPS amendment on public health (Article 31bis) is a World Trade Organization rule change that allows countries to export patented medicines made under compulsory licenses to nations lacking sufficient pharmaceutical manufacturing capacity, in order to improve access to essential drugs.

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All labels observed (1)

Label	Occurrences
2005 TRIPS amendment on public health (Article 31bis) canonical	1

Statements (47)

Predicate	Object
instanceOf	TRIPS Agreement amendment ⓘ World Trade Organization rule change ⓘ international intellectual property law instrument ⓘ
addresses	public health problems affecting developing and least-developed countries ⓘ
adoptedBy	World Trade Organization General Council NERFINISHED ⓘ
adoptionDate	2005-12-06 ⓘ
allows	export of patented medicines produced under compulsory licences ⓘ regional trade agreements of developing or least-developed countries to use the system jointly ⓘ
alsoKnownAs	Article 31bis of the TRIPS Agreement NERFINISHED ⓘ TRIPS public health amendment NERFINISHED ⓘ
appliesTo	WTO member states NERFINISHED ⓘ
beneficiariesInclude	least-developed country WTO members ⓘ other WTO members with insufficient or no pharmaceutical manufacturing capacity ⓘ
concerns	access to medicines in developing countries ⓘ compulsory licensing of pharmaceutical patents ⓘ
createsExceptionTo	requirement that production under compulsory licence be predominantly for the supply of the domestic market ⓘ
criticizedFor	complex procedural requirements ⓘ limited practical use by WTO members ⓘ
designedTo	balance patent protection with public health needs ⓘ
enteredIntoForce	2017-01-23 ⓘ
entryIntoForceCondition	acceptance by two-thirds of WTO members ⓘ
field	global public health policy ⓘ intellectual property law ⓘ international trade law ⓘ
implementedBy	Annex to the TRIPS Agreement on the implementation of Article 31bis NERFINISHED ⓘ
influenced	national legislation on compulsory licensing for export in several WTO members ⓘ
legalBasisFor	export of pharmaceutical products made under compulsory licence ⓘ
legalForm	amendment to Annex 1C of the WTO Agreement ⓘ
linkedTo	Doha Declaration on the TRIPS Agreement and Public Health NERFINISHED ⓘ
modifies	Article 31 of the TRIPS Agreement ⓘ
originatesFrom	2003 WTO General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health NERFINISHED ⓘ
partOf	Agreement on Trade-Related Aspects of Intellectual Property Rights NERFINISHED ⓘ World Trade Organization legal framework ⓘ
permits	importation of generics produced under compulsory licence from other WTO members ⓘ
purpose	to implement the 2001 Doha Declaration on the TRIPS Agreement and Public Health ⓘ to improve access to essential medicines in countries with insufficient or no pharmaceutical manufacturing capacity ⓘ
replaces	2003 WTO waiver on exports of medicines under compulsory licence ⓘ
requires	measures to prevent re-exportation of products supplied under the system ⓘ notification to the WTO by exporting members granting compulsory licences under the system ⓘ notification to the WTO by importing members using the system ⓘ publication of information about quantities and destinations of products supplied under the system ⓘ remuneration to patent holders by exporting members granting compulsory licences ⓘ special labelling or marking of products supplied under the system ⓘ
scope	pharmaceutical products needed to address public health problems ⓘ
subjectOf	WTO notifications by importing and exporting members ⓘ debates on access to medicines and intellectual property ⓘ interpretative discussions in the WTO TRIPS Council ⓘ

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.

Doha Declaration on the TRIPS Agreement and Public Health → influenced → 2005 TRIPS amendment on public health (Article 31bis) ⓘ