This "Resolution" allows WTO members to waive the time limit for fulfilling their obligations under this article. Moreover, according to this "Resolution", WTO member governments have unanimously agreed that this "waiver" will last until this article is revised.
The TRIPS Council believes that there are special circumstances that warrant the waiver of the obligations established in Article 31 (f) and (h) [Note] of the TRIPS Agreement on medicinal products, and its decision is as follows:
1. For the purpose of this resolution:
(a) "Pharmaceutical products" means products used in the pharmaceutical field to address public health problems recognized in paragraph 1 of the Declaration Any patented product, or product manufactured by a patented method, including active ingredients required for the manufacture of pharmaceuticals and diagnostic reagents required for the use of pharmaceuticals;
(b) "Eligible importing Member" means Any Least Developed Member State Party, as well as any Member Party that notifies the TRIPS Council of its intention to use this system as an importing party. According to the regulations, a member may notify the TRIPS Council at any time that it will use the system in full or with restrictions (for example, only in national emergencies, other special emergencies, or for public non-commercial use). It is worth noting that some members will not use the system established in this "Resolution" as importing members. The "Resolution" lists 23 developed countries that voluntarily give up the use of this system as importing members. They are respectively Are the United States, United Kingdom, France, Germany, Japan, Canada, Austria, Belgium, Denmark, Finland, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, Australia; and some Countries or members declare that this system will only be used in cases of national emergencies and other special emergencies. They are Hong Kong, China, Macau, Taiwan, Israel, South Korea, Kuwait, Mexico, Qatar, Singapore, Turkey and the United Arab Emirates. ;
(c) "Exporting Member" means a Member that uses the system determined in this Resolution to produce pharmaceutical products and export them to "eligible importing Members".
2. The "Obligations of an Exporting Member" stipulated in Article 31(f) of the TRIPS Agreement will be imposed by its authorization to produce pharmaceutical products and export them to "eligible importing Members" in accordance with the terms specified in this paragraph. The required compulsory license will not be implemented:
(a) The "eligible importing member" shall notify the TRIPS Council in advance, and the notification content shall include:
(i) Designation The name and desired quantity of the drug required;
(ii) Confirm that the disputed "eligible importing Member" (non-least developed country) has obtained 1. It is confirmed that its production capacity is insufficient or has no production capacity in the production field of the required medicine;
(iii) The member that confirms that the medicinal product has obtained patent rights in its territory shall, in accordance with Article 31 of the TRIPS Agreement and this Resolution, A compulsory license has been granted or intended to be granted in accordance with the provisions of ) The quantity of (drugs) produced under the compulsory licensing system can only be the quantity necessary to satisfy the "eligible importing party", and all products must be exported to members that have notified the TRIPS Council of such demand;
(ii) Drugs produced under the compulsory license system must be identified as being produced under the system established by this Agreement through special labels or markings, and suppliers must use special packaging, special colors or shapes to distinguish this products, and these methods of differentiation should be feasible and have no significant impact on price;
(iii) Before shipment, the licensee must publish the following information on the website:
— Quantities shipped to each destination specified in (i) above;
—The distinguishing characteristics of the product specified in (ii) above;
(c) The exporting Member shall notify the TRIPS The Council reports on the granting of licenses and the conditions attached to such licenses. The information provided should include the name and address of the licensee, the product (name) to which the license is granted, the license quantity and the license period. The notification must also identify the website address mentioned in subparagraph (b)(iii) above.
3. When an exporting member grants a compulsory license in accordance with the system established in this Resolution, the economic value brought by the license to the importing member shall be taken into consideration. According to Article 31(h) of the TRIPS Agreement ), provide the patentee with adequate remuneration. When an eligible importing Member exercises a compulsory license for the same product, that Member may not fulfill its obligations under Article 31(h) because the exporting Party has already paid remuneration for those products according to the first sentence of this paragraph.
4. In order to ensure that products imported under the system established in this Resolution are used for public health purposes, "eligible importing Members" shall take all reasonable measures within their capabilities Prevent products that have actually been imported into its territory under this system from being re-exported elsewhere. If an "eligible importing Member" is a developing or least developed country Member that has difficulty in implementing this Article, the developed country Member must provide technical and financial assistance upon request or in accordance with the terms and conditions agreed to in the Agreement, To facilitate the enforcement of these Terms.
5. Each Member shall ensure the availability of effective legal means required by the TRIPS Agreement with a view to preventing the importation and sale within its territory of products produced under this regime if any Member considers that, If the measures taken for this purpose are not sufficient, a request may be submitted, which will be considered by the TRIPS Council
6. In order to fully mobilize economies of a certain size and promote their purchasing power in the pharmaceutical sector and local Production capacity:
(i) If a member of the WTO that is a developing country or a least developed country is under Article 24 of the 1994 General Agreement on Tariffs and Trade (GATT) and November 28, 1979 Members of regional trade agreements within the meaning of Japan’s Resolution on Differential and More Preferential Treatment, Reciprocity and Fuller Participation of Developing Countries (L/4903) (at least half of its current members are included in the United Nations list of least developed countries), then that member can waive its obligation to perform Article 31(f) of the TRIPS Agreement, so that the pharmaceutical products produced or imported by the member under a compulsory license can be exported to members of the same regional trade agreement and developing or least developed country members facing the same health problems. This provision does not impair the territorial character of the relevant patent rights.
(ii) Regional patent licensing should be actively promoted to apply to the above-mentioned members. To this end, developed country Members undertake to provide technical cooperation in accordance with Article 67 of the TRIPS Agreement, including in collaboration with other relevant intergovernmental organizations.
7. Members recognize the need to promote the transfer of technology and production capabilities in the pharmaceutical sector in order to overcome the problems identified in paragraph 6 of the Declaration. Eligible "importing Members" and "exporting Members" are encouraged to apply the system established in this Resolution in a manner that promotes this objective. Members should pay special attention to the transfer of technology and production capabilities in the pharmaceutical field in their work carried out in accordance with Article 66.2 of the TRIPS Agreement, paragraph 7 of the Declaration and other TRIPS Council work.
8. The TRIPS Council will review the operation of the system established in this Resolution every year to ensure its effective operation and make an annual report to the General Council on its operation. This review will be deemed to complete the review requirements of Article IX:4 of the WTO Agreement.
9. This Resolution does not discriminate against the rights, obligations and flexibilities and their interpretation provided for in other provisions of the TRIPS Agreement (except Article 31 (f) and (h)), including those in the Declaration To reiterate, it also does not discriminate against the principle that pharmaceutical products produced under a compulsory license system can be exported under Article 31(f) of the current TRIPS Agreement.
10. A Member shall not impose any liability on any (other Member) for any violation of the provisions of this Resolution under Article 23, 1(b) and 1(c) of the General Agreement on Tariffs and Trade, 1994. Contains a waiver clause consistent with the objection to measures taken.
11. For all Members, this Resolution, including the "waiver rights" granted therein, will terminate on the date when amendments to the TRIPS Agreement replace the existing provisions in force for that Member . The TRIPS Council will start preparations for amending the TRIPS Agreement at the end of 2003 and hopes to adopt it within six months. The amendments will be based on this Resolution where appropriate and will not be included in the Doha Ministerial Declaration (WT/ part of the negotiations referred to in paragraph 45 of MIN(01)/DEC/1).
Attachment: Assessment of production capacity in the pharmaceutical field
Least developed country members are considered to have insufficient or no production capacity in the pharmaceutical field;
Others For a certain drug, an "eligible importing member" with insufficient or no production capacity can be confirmed through one of the following methods;
(i) The relevant member has confirmed that it is in the pharmaceutical field No production capacity; or
(ii) The member has some production capacity in this field, but upon review of this capacity, it is found that its capacity is insufficient if the capabilities owned and controlled by the patentee are excluded. Meet your own needs. Once it is confirmed that its capabilities are sufficient to meet its own needs, this system no longer applies. (Translated by Zhu Jin)
[Note]: Article 31 of the TRIPS Agreement: Other uses without the permission of the rights holder
(f) Any authorization for such use shall be Any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;
(h) Taking into account the relevant authorized use The right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization.