On Ratification of the Protocol on Amendments to the Agreement on Trade-Related Aspects of Intellectual Property Rights

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The Law of the Republic of Kazakhstan dated May 20, 2024 No. 85-VIII SAM

To ratify the Protocol on Amendments to the Agreement on Trade-Related Aspects of Intellectual Property Rights, signed in Geneva on December 6, 2005.

President of the Republic of Kazakhstan

K. TOKAEV

UNOFFICIAL TRANSLATION

Protocol on Amendments to the Agreement on Trade-Related Aspects of Intellectual Property Rights (Geneva, December 6, 2005)

Members of the World Trade Organization;

Having regard to the Decision of the General Council WT/L/641, adopted in accordance with paragraph 1 of article X of the Marrakesh Agreement establishing the World Trade Organization ("WTO Agreement");

We have hereby agreed on the following:

1. The Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement"), after the entry into force of the Protocol in accordance with paragraph 4, shall be amended, as indicated in the Annex to this Protocol, by supplementing article 31bis after Article 31 and by supplementing the Annex to the TRIPS Agreement after Article 73.

2. Reservations to any of the provisions of this Protocol shall not be permitted without the consent of the other members.

3. This Protocol is open for adoption by Members until December 1, 2007 or until a later date by decision of the Ministerial Conference.

4. This Protocol shall enter into force in accordance with paragraph 3 of Article X of the WTO Agreement.

5. This Protocol shall be deposited with the Director General of the World Trade Organization, who shall promptly provide each member with a certified copy of this Protocol and a notification of each acceptance in accordance with paragraph 3.

6. This Protocol is subject to registration in accordance with the provisions of Article 102 of the Charter of the United Nations.

Done at Geneva on December 6, 2005, in a single copy in the English, French and Spanish languages, all texts being equally authentic.

Annex to the Protocol on Amendments to the Agreement on trade-related aspects of intellectual property rights

Article 31bis

1. The obligations of the exporting member under article 31 (f) shall not apply to the granting of a compulsory license to the extent necessary for the production of a pharmaceutical product(s) and its export to the territory of the importing Member meeting the requirements in accordance with the conditions set out in paragraph 2 of the Annex to this Agreement.

2. If a compulsory license is issued by an exporting member under the system described in this article and in the Annex to this Agreement, the said member shall be paid an appropriate remuneration in accordance with article 31 (h), taking into account the economic value allowed by the exporting member for the use of the importing member. If a qualifying importing member issues a compulsory license for the same product, the obligations of that member under article 31 (h) shall not apply to those funds for which the exporting member has paid remuneration in accordance with the first sentence of this paragraph.

3. In order to use economies of scale to increase purchasing power and promote local production of medicines: if a WTO member from among developing or least developed countries is a party to a regional trade agreement within the meaning of Article XXIV of GATT 1994 and the Decision of November 28, 1979 "On differentiated and more favorable treatment, Reciprocity and fuller participation of developing countries" (L/4903), with at least half of its current membership consisting of countries included in the United Nations list of least developed countries, The obligation of this member under article 31 (f) does not apply to the extent necessary for a medicinal product manufactured or imported under a compulsory license into the territory of this member to be exported to the markets of such other developing or least developed countries participating in a regional trade agreement that also have a corresponding the problem of healthcare. It is understood that this does not prejudice the territorial nature of the relevant patent rights.

4. The Members undertake not to challenge any measures taken in accordance with the provisions of this Article and the Annex to this Agreement under subparagraphs 1 (b) and 1 (c) of Article XXIII of GATT 1994.

5. This Article and the Annex to this Agreement and their interpretation shall not prejudice the rights, obligations and flexibility that members have under the provisions of this Agreement, other than paragraphs (f) and (h) of Article 31, including those confirmed by the Declaration on the Agreement on TRIPS and Public Health (WT/MIN(01)/DEC/2),. They also do not affect the extent to which medicines produced under a compulsory license may be exported in accordance with the provisions of article 31 (f).

Annex to the Agreement on Trade-Related Aspects of Intellectual Property Rights

1. For the purposes of article 31bis and this Annex:

(a) "Medicinal product" means any patented product or product manufactured using a patented pharmaceutical sector process necessary to solve public health problems, as specified in paragraph 1 of the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2). It is understood that it also includes the active ingredients necessary for its production, as well as the diagnostic tools necessary for its application1;

(b) "eligible importing member" means any least developed country member and any other member that has notified the TRIPS Council of its intention to use the system set out in Article 31bis and this Annex (the "system") as an importer, on the understanding that a member may at any time notify that he will use this system in its entirety or within certain limits, for example, only in case of a national emergency or other circumstances of extreme necessity, or for public, non-commercial use. It is noted that some members will not use this system as importing members3, and that some other members have stated that if they use this system, it will only be in cases of national emergency or other circumstances of extreme necessity.;

(c) "exporting member" means a member using this system to manufacture medicines and export them to a qualifying importing member.

2. The conditions specified in paragraph 1 of article 31bis are as follows:

(a) the eligible importing member4 sends a notification2 to the TRIPS Council, where

(i) indicates the name and expected quantity of the required medicinal product(s)5;

(ii) which confirms that the eligible importing member, with the exception of a least developed member country, has determined that it does not have or has limited capacity in the pharmaceutical sector to manufacture the specified medicines using one of the methods set out in the Appendix to this Annex; and

(iii) which confirms that, in cases where a medicinal product is patented in its territory, it has issued or intends to issue a compulsory license in accordance with articles 31 and 31bis of this Agreement and the provisions of this annex.6;

(b) a compulsory license issued by an exporting member under this system contains the following conditions:

(i) only the quantity required to meet the requirements of the eligible importing member(s) may be produced under license, and all products produced must be exported to the member(s) who has notified the TRIPS Council of their needs.;

(ii) licensed medicinal products must be clearly identified as manufactured under this system by special designations or labeling. Suppliers should distinguish such medicines by special packaging and/or special coloring (shape) of the medicines themselves, provided that such differences are acceptable and do not significantly affect the price; and

(iii) prior to the start of shipment, the licensee shall post the following information on the website7:

- the quantity of products delivered to each of the destinations, as indicated in subparagraph (i) above;

- distinguishing features of the products specified in subparagraph (ii) above;

(c) The exporting member notifies8 the TRIPS Council of the fact that the license has been granted, including the conditions under which it is granted.9 The information provided contains the name and address of the licensee, the medicinal product(s) for which the license was issued, the quantity for which it was issued, the country(s) where the medicinal product(s) are supplied, and the validity period of the license. The notification also includes the website address specified in subparagraph (b) (iii) above.

3. In order to ensure that medicines imported under this system are used for the public health purposes underlying their import, eligible importing members shall take reasonable measures within their means, proportionate to their administrative capabilities and the degree of risk of trade distortion, in order to prevent the re-export of medicines, which were actually imported into their territory within the framework of this system. In the event that a qualifying importing member, which is a developing country member or a least developed country member, experiences difficulties in implementing this provision, developed country members shall provide, upon request and on mutually agreed terms, technical and financial assistance to facilitate its implementation.

4. The Members undertake to ensure the availability of effective legal means to prevent the import and sale in their territories of medicines produced under this system and entering their markets in violation of its provisions, using the means to be established in accordance with this Agreement. If any member considers that such measures are insufficient for this purpose, the matter may be considered by the TRIPS Council at the request of such member.

5. In order to use economies of scale to increase purchasing power and facilitate local production of medicines, it is recognized that the creation of systems providing for the issuance of regional patents applicable in the member countries described in paragraph 3 of Article 31bis should be promoted. To this end, the developed member countries undertake to provide technical assistance in accordance with article 67 of this Agreement, including jointly with other relevant international organizations.

6. Members recognize the usefulness of facilitating technology transfer and capacity-building in the pharmaceutical sector in order to overcome the challenge faced by members with insufficient or missing production capacity in the pharmaceutical sector. To this end, eligible importing and exporting members are encouraged to use the system in a way that will help achieve this objective. The Members undertake to jointly pay special attention to technology transfer and capacity-building in the pharmaceutical sector in the work to be carried out in accordance with Article 66.2 of this Agreement, paragraph 7 of the Declaration on the TRIPS Agreement and Public Health, as well as any other work of the TRIPS Council in this area.

7. The TRIPS Council annually reviews the functioning of the system in order to ensure its effective operation and annually reports to the General Council on its application.

________________________

1 This subparagraph does not limit the provisions of subparagraph 1 (b).

2 It is understood that this notification does not require the approval of the WTO body for the use of this system.

3 Australia, Canada, the European Communities and, for the purposes of Article 31bis and this Annex, the member countries Iceland, Japan, New Zealand, Norway, Switzerland and the United States.

4 Joint notifications containing the information required in accordance with this subparagraph may be sent by the regional organizations referred to in paragraph 3 of Article 31bis on behalf of their member and eligible importing members using this system, with the Consent of such members.

5 The notifications will be posted by the WTO Secretariat for general access on a special page on the WTO website dedicated to this system.

6 This subparagraph does not affect the provisions of Article 66.1 of this Agreement.

7 The Licensee may use his own website for these purposes or, with the assistance of the WTO Secretariat, the WTO website page dedicated to this system.

8 It is understood that this notification does not require the approval of the WTO body for the use of this system.

9 Notifications will be posted by the WTO Secretariat for general access on a special page of the WTO website dedicated to this system.

Addendum to the Annex to the Agreement on Trade-Related Aspects of Intellectual Property Rights

Assessment of production capacities in the pharmaceutical sector

The least developed member countries are considered to have limited or no production capacity in the pharmaceutical sector.

For other eligible importing members, the presence of limited or no production capacity in the pharmaceutical sector can be determined in one of the following ways:

(i) the member concerned has stated that it has no production facilities in the pharmaceutical sector at all;

(ii) if a member has some production facilities in the pharmaceutical sector, it has assessed these facilities and concluded that, with the exception of facilities owned or controlled by the patent holder, the existing facilities are insufficient to meet its needs. When it is determined that such capacities are sufficient to meet the needs of the member, this system should no longer be used.

I confirm that the above document is an original and complete copy of the Protocol on the Amendment of the Agreement on Trade-Related Aspects of Intellectual Property Rights (Geneva, December 6, 2005) in English.

Minister of Health

Republic of Kazakhstan

A. Giniyat

President

Republic of Kazakhstan

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