Trade-Related Aspects of Intellectual Property Rights - Importing Member’s Specific Notification of the Details Required under the Special Compulsory Licensing System

Importing Member’s Specific Notification of the Details Required under the Special Compulsory Licensing System - View details of the document

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IP/N/9/RWA/1

Distribution date

1. Notifying Member

Notifying Member

Rwanda

On behalf of group

On behalf of other Members

The following notification from Rwanda's Government Centre for the Treatment & Research on AIDS (TRAC) has been received from the Delegation of Rwanda on 17 July 2007 for circulation to the Council for TRIPS. _______________ Based on Rwanda's present evaluation of its public health needs, we expect to import during the next two years 260,000 packs of TriAvir, a fixed-dose combination product of Zidovudine, Lamivudine and Nevirapine (hereinafter referred to as the "Product") manufactured in Canada by Apotex, Inc. However, because it is not possible to predict with certainty the extent of the country's public health needs, we reserve the right to modify the foregoing estimate as necessary or appropriate. Pursuant to Paragraph 7 of the Doha Declaration and implementation thereof by the TRIPS Council (Decision of the Council for TRIPS of 27 June 2002), we have decided that we will not enforce rights provided under Part II Section 5 of the TRIPS Agreement that may have been granted within Rwanda's territory with respect to the Product.

List of Product(s) Needed

Name of the product	Quantity for product
There are currently no items in the database
TriAvir, a fixed-dose combination product of Zidovudine, Lamivudine	260,000 packs

Notification Details

1. Describe how it was established there are no or insufficient manufacturing capacities in the pharmaceutical sector

Member has no manufacturing capacities in the pharmaceutical sector.

Member has found that its manufacturing capacity in the pharmaceutical sector is insufficient to meet its needs for the needed pharmaceutical product(s).

*LDCs are not required to choose an option above regarding manufacturing capacity.

2. Information on how the lack of (sufficient) manufacturing capacity in the pharmaceutical sector was established

*LCDs are not required to provide information.

3. Is/are the product(s) needed protected by patent in the territory?

Yes

4. If patent(s) in force

The Member has authorized (or intends to authorize) use of the subject matter of the patent or patents in force for the pharmaceutical product(s) without the consent of the patent owner in accordance with the provisions of Articles 31 and 31bis of the TRIPS Agreement.The Member has authorized (or intends to authorize) use of the subject matter of the patent or patents in force for the pharmaceutical product(s) without the consent of the patent owner in accordance with the provisions of Article 31 of the TRIPS Agreement and the provisions of the WTO General Council Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health of 30 August 2003.

Having regard to the transitional period for LDC Members in Article 66.1 of the TRIPS Agreement, as extended for pharmaceutical products in line with Paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health and the related Decision on the Extension of the Transition Period under Article 66.1 of the TRIPS Agreement on 6 November 2015 (IP/C/73), this Member will not grant patents / enforce any patents in force for this (or these) pharmaceutical product(s).