Model notifications for the use of the Paragraph 6 system

Notes to Model 2

This is the importing member’s specific notification of the details of the needed pharmaceutical products and other details required under the Paragraph 6 System.

Who needs to make the importing member’s specific notification?

A notification must be made by or on behalf of an importing member each time it uses the Paragraph 6 System to import pharmaceutical products. No notification is needed when pharmaceutical products are imported from another member party to a regional trade agreement under the regional mechanism (see paragraph 3 of Article 31bis of the amended TRIPS Agreement).

Making this notification does not commit a Member actually to procure medicines under the System — it simply flags a Member's needs which may ultimately be satisfied through other supply sources.

Point 1: the pharmaceutical product(s)

The importing member has to notify the names and expected quantities of the pharmaceutical product needed. The expected quantity can, for example, be a number of doses or packs [e.g. "5 million doses of medicine X"]. The importing member does not need to state the name of a supplier, nor the expected timeframe of supply and use.

Point 2: manufacturing capacity

Least-developed countries (LDCs) are assumed to lack manufacturing capacity and do not need to state anything about it. Other importing members need to confirm that they have established that they have insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question in one of the ways set out in the Appendix to the Annex of the amended TRIPS Agreement. The Chairman’s statement read out when the Protocol Amending the TRIPS Agreement was adopted mentioned that it was understood that notifications would include information on how the member had established this point (see WTO document WT/GC/M/100, paragraph 29).

Point 3: patent protection in the importing member

Where there is no patent for the pharmaceutical product(s) in the importing member, there is strictly no need to mention the absence of any patent, but it may be helpful to state this expressly, so that it is clear that it has not been overlooked. Where there is a patent for the product(s) in the importing member, the notification must address the issue of compulsory licensing. Alternatively, LDCs may refer to their transitional period, which was last extended until 1 January 2033, or until such a date on which they cease to be a least developed country Member, whichever date is earlier (Decision on the Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products, adopted by the TRIPS Council on 6 November 2015).

Joint notifications

A notification can cover more than one importing member. A regional organization that satisfies the conditions in paragraph 3 of Article 31bis of the amended TRIPS Agreement can also make a notification on behalf of its members, with their consent. Joint notifications should confirm that the members that they cover have consented.