INTELLECTUAL PROPERTY: TRIPS AND HEALTH
How to accept the Protocol Amending the TRIPS Agreement
Background information for Members on procedures.
- Consult the guide to downloading files
On 6 December 2005, the WTO General Council adopted the Protocol Amending the TRIPS Agreement and opened it for acceptance by Members. This Protocol is the first multilateral treaty amendment agreed by WTO Members since the WTO Agreement came into force in 1995. It serves to permanently incorporate into the TRIPS Agreement additional flexibilities to grant special compulsory licences for the export of medicines, commonly referred to as the “Paragraph 6 System”. This System was first established by a decision taken by Members in 2003 in order to facilitate access to medicines under the TRIPS Agreement. On 23 January 2017, upon acceptance of the Protocol by two thirds of the Members, the System became a permanent part of the Agreement. In accordance with Article X:3 of the WTO Agreement, the amended TRIPS Agreement applies to those Members that had accepted it on or before that date, and takes effect for other Members that deposit an instrument of acceptance after 23 January 2017 on such Member's respective date of deposit.
According to the WTO Agreement, a Member formally accepts the Protocol by depositing what is referred to as an “instrument of acceptance” for the Protocol with the Director General of the WTO. Members that are yet to do so have until 31 December 2023 or such later date as may be decided by the Ministerial Conference.
This website responds to frequently asked questions about the acceptance procedure, and provides a model instrument of acceptance that Members may wish to follow in preparing their instruments of acceptance.
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Frequently asked questions
What is the WTO practice regarding the deposit of acceptances?
The WTO closely follows established United Nations depositary practice, which is based in international treaty law, including the formalities and requirements concerning valid acceptance set out below.
What must be stated in the instrument of acceptance?
There is no single, uniform approach for drawing up an instrument of acceptance for the Protocol; each individual Member may have its own practice for accepting international treaties and treaty amendments. However, in line with established depositary practice, the instrument of acceptance must give clear and unambiguous expression to the relevant Member’s intention and consent to be bound by the agreement in question (in this case, the Protocol).
In particular, the instrument of acceptance must:
- clearly identify the Protocol by its full title and by the place and date of its adoption, i.e. “the Protocol Amending the TRIPS Agreement, done at Geneva on 6 December 2005” or, alternatively, reproduce the Protocol as an attachment to the instrument of acceptance;
- state that the Member concerned formally accepts the Protocol and expresses its consent to be bound by it;
- state the date and the place of issuance of the instrument of acceptance;
- be signed; and
- state the name and title of the person signing the instrument.
Who may sign the instrument of acceptance?
Established practice is for the instrument of acceptance to be issued and signed by the head of state, the head of government, or the minister for foreign affairs (the “Big Three”).1 The instrument may be signed by another official provided that he or she produces official documentation (“full powers”) to the effect that one of the “Big Three” has authorized him or her to issue and sign the instrument.
Unsigned instruments in the form of notes verbales, even bearing the seal of the ministry or of the presidency, are not sufficient for accepting the Protocol.
What are the arrangements for depositing a valid instrument of acceptance?
In practical terms, the instrument of acceptance should be deposited with the Depositary Assistant in the WTO Legal Affairs Division. Only original instruments are valid, and the date of deposit corresponds to the date when the valid original instrument fulfilling the above requirements is received by the Depositary Assistant. Copies in electronic or paper form are not acceptable.
When must the instrument of acceptance be deposited?
For an instrument of acceptance of the Protocol to be valid, it must be deposited within the period of acceptance. The original acceptance period ran until 1 December 2007, as set out in paragraph 2 of the 6 December 2005 General Council decision and in paragraph 3 of the Protocol. These same provisions, however, allow for the possibility of extending the acceptance period.
The General Council has extended the acceptance period several times, most recently in 2021. The current deadline for depositing acceptances is 31 December 2023. Therefore, as of today, for an instrument of acceptance to be valid, it would need to be deposited by that date.
Can a Member accept the Protocol without implementing the Paragraph 6 System?
Yes. Many Members have already accepted the Protocol without taking any domestic legislative action.
By accepting the Protocol, a Member expresses its consent to be bound by the Protocol on the international plane. Effectively, this means expressing its consent that all WTO Members are entitled — that is permitted, but not required — to use the Paragraph 6 System if they so wish. It does not bind that Member itself to take any positive action. In particular, acceptance does not create any obligation on the part of that Member to use the System, nor to implement it in its domestic law.
Therefore these two processes — accepting the amendment, and implementing the System — are entirely distinct: Members can choose to deal with them either at the same time or separately. A Member can deposit an instrument of acceptance of the Protocol without having adopted domestic legislation implementing the Paragraph 6 System. This is because accepting the Protocol is simply a commitment that additional flexibilities should become an integral part of the TRIPS Agreement and thus should be legally available for all WTO Members to use, should they choose to do so.
Model instrument of acceptance back to top
for the Protocol Amending the TRIPS Agreement, done at Geneva on 6 December 2005
Whereas the Protocol Amending the TRIPS Agreement (“the Protocol”) was done at Geneva on 6 December 2005 (WT/L/641);
And whereas pursuant to paragraph 3 of the Protocol, on 22 November 2021 the WTO General Council extended the period for acceptance of the Protocol to 31 December 2023 (WT/L/1122);
Now therefore, I, [name of signatory], [where applicable: head of state, head of government or minister of foreign affairs] of [Member], do hereby formally declare that [Member] accepts the aforementioned Protocol and expresses its consent to be bound by it.
In witness whereof, I [name and title of signatory] have signed this Instrument of Acceptance, at [place] on this [day] of [month] in the year [year].
[Signature, title and seal]
Interested delegations are invited to contact the Depositary Assistant in the WTO Legal Affairs Division, with any further questions, in particular if further assistance is needed with drawing up a valid instrument of acceptance.
Alternatively, where applicable, a Member’s competent authority, typically the highest ranking official responsible for external trade matters, may issue and sign the instrument. This is particularly the case for WTO Members that might not have officials with titles directly corresponding to the “Big Three” in a way that is acceptable for the entire WTOback to text