On October 1, 2001, the World Trade Organization (WTO) issued a “Report of the Working Party on the Accession of China.” The 180 page document (WT/ACC/CHN/49) included a discussion of the views of “some members” of the WTO regarding the “protection against unfair commercial use and disclosure of undisclosed test and other data submitted to authorities in China to obtain marketing approval for pharmaceuticals and agricultural chemicals.” (paragraph 282), other topics of interest to WTO members, and the commitments that China was required to make to receive approval of its application to join the WTO.
The accession commitments were set out in paragraph 284 of the report, which, through paragraphs 342 and in paragraph 1.2 of the Protocol on the Accession (Page 73), became “an integral part of the WTO Agreement.”
The China accession agreement obligated China to provide the following rights in regulatory test data:
no person, other than the person who submitted such data, could, without the permission of the person who submitted the data, rely on such data in support of an application for product approval for a period of at least six years from the date on which China granted marketing approval to the person submitting the data.
The six years of exclusive rights in test data in China were one year longer than the period of protection in the United States for an FDA New Drug Application (NDA), and represented an obligation beyond that in the TRIPS Agreement, which does not require its members to provide regulatory monopolies on test data. In this sense, the obligation is “TRIPS Plus.”
This raises an important issue: is the six years of protection on test data part of the TRIPS, or some other obligation related to the accession agreement, but technically not part of the TRIPS Agreement itself? And if not part of TRIPS, will the requirement be waived if the WTO agrees to a TRIPS waiver that includes Article 39.
Exclusive rights in test data are a controversial intellectual property right. Exclusive rights to rely on evidence that products are safe and effective, including most importantly clinical trial data, are economically wasteful, contrary to ethical prohibitions on conducting experiments on humans when results are already known, and often implemented without exceptions, even in emergencies.
The European Commission has indicated several times that it considers its test data monopolies to be in effect in the European Union, even during emergencies. For example, see this February 20, 2006 letter to Greg Perry, then representing the European Generic Medicines Association (EGA), under the subject “Tamiflu application and data exclusivity in an emergency compulsory licensing situation, with a subheading “No exception from data and marketing exclusivity.” (link) The notion that test data rights could last for years and not be subject to any exceptions is problematic in general and incredibly bad policy for emergencies.
China is not the only country that has made TRIPS plus commitments to join the WTO. The wording of the waiver, if the WTO adopts one, may be important in making it clear that all accession agreements that are related to the TRIPS will be considered waived.
1 October 2001 (01-4679)
Working Party on the Accession of China
REPORT OF THE WORKING PARTY ON THE ACCESSION OF CHINA
8. Requirements on undisclosed information, including trade secrets and test data
282. Some members of the Working Party expressed concern about China’s protection against unfair commercial use and disclosure of undisclosed test and other data submitted to authorities in China to obtain marketing approval for pharmaceuticals and agricultural chemicals. They noted that China’s laws appeared to prohibit the release of information by government officials but did not include provisions regarding the prevention of unfair commercial use, as required under Article 39.3 of the TRIPS Agreement. Some members requested that China specifically provide in its law and regulations that it would protect against unfair commercial use of undisclosed test or other data submitted in support of applications for marketing approval of pharmaceutical or of agricultural chemical products which utilize new chemical entities, by providing that no person other than the person that submitted such data may, without the permission of the person initially submitting the data, rely on such data in support of an application for product approval for a period of at least six years from the date on which marketing approval to the person that submitted the data had been granted.
284. The representative of China further confirmed that China would, in compliance with Article 39.3 of the TRIPS Agreement, provide effective protection against unfair commercial use of undisclosed test or other data submitted to authorities in China as required in support of applications WT/ACC/CHN/49 Page 60 for marketing approval of pharmaceutical or of agricultural chemical products which utilized new chemical entities, except where the disclosure of such data was necessary to protect the public, or where steps were taken to ensure that the data are protected against unfair commercial use. This protection would include introduction and enactment of laws and regulations to make sure that no person, other than the person who submitted such data, could, without the permission of the person who submitted the data, rely on such data in support of an application for product approval for a period of at least six years from the date on which China granted marketing approval to the person submitting the data. During this period, any second applicant for market authorization would only be granted market authorization if he submits his own data. This protection of data would be available to all pharmaceutical and agricultural products which utilize new chemical entities, irrespective of whether they were patent-protected or not. The Working Party took note of these commitments.
342. The Working Party took note of the explanations and statements of China concerning its foreign trade regime, as reflected in this Report. The Working Party took note of the commitments given by China in relation to certain specific matters which are reproduced in paragraphs 18-19, 22-23, 35-36, 40, 42, 46-47, 49, 60, 62, 64, 68, 70, 73, 75, 78-79, 83-84, 86, 91-93, 96, 100-103, 107, 111, 115-117, 119-120, 122-123, 126-132, 136, 138, 140, 143, 145, 146, 148, 152, 154, 157, 162, 165, 167-168, 170-174, 177-178, 180, 182, 184-185, 187, 190-197, 199-200, 203-207, 210, 212-213, 215, 217, 222-223, 225, 227-228, 231-235, 238, 240-242, 252, 256, 259, 263, 265, 270, 275, 284, 286, 288, 291, 292, 296, 299, 302, 304-305, 307-310, 312-318, 320, 322, 331-334, 336, 339 and 341 of this Report and noted that these commitments are incorporated in paragraph 1.2 of the Draft Protocol.
Part I – General Provisions
1. Upon accession, China accedes to the WTO Agreement pursuant to Article XII of that Agreement and thereby becomes a Member of the WTO.
2. The WTO Agreement to which China accedes shall be the WTO Agreement as rectified, amended or otherwise modified by such legal instruments as may have entered into force before the date of accession. This Protocol, which shall include the commitments referred to in paragraph 342 of the Working Party Report, shall be an integral part of the WTO Agreement.