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Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
(2002; 77 pages) [Spanish] View the PDF document
Table of Contents
View the documentTHE SOUTH CENTRE
View the documentFOREWORD
View the documentEXECUTIVE SUMMARY
View the documentINTRODUCTION
View the documentI. DATA REQUIRED FOR THE REGISTRATION OF PHARMACEUTICALS
Open this folder and view contentsII. THE RATIONALE FOR DATA PROTECTION
Open this folder and view contentsIII. CONDITIONS OF PROTECTION UNDER TRIPS
View the documentIV. NON-DISCLOSURE OBLIGATION
Open this folder and view contentsV. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
View the documentVI. MEANS OF PROTECTION AGAINST UNFAIR COMMERCIAL USE
View the documentVII. THE EXCLUSIVITY APPROACH
View the documentVIII. THE HISTORY OF THE TRIPS NEGOTIATIONS
View the documentIX. CONCLUSIONS
View the documentANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)
View the documentBIBLIOGRAPHY
View the documentBACK COVER
 

ANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)

1. Under the "exclusive use" provision, some data are temporarily protected from use by a data submitter's competitors. FIFRA § 3(c) (1) (D) (i). Registrants are granted a ten-year period of exclusive use for data on new active ingredients first registered after September 30, 1978. FIFRA § 3(c) (1) (D) (i). During that period, no other applicant may use the data to support an application for registration. To be eligible for exclusive use, data must pertain to a "new" complete data package. The second registrant, however, is not necessarily required to duplicate exactly the original submitter's data package.

2. Under the "data compensation" provision, most data can be used by any company willing to pay compensation to the data submitter. FIFRA § 3(c) (1) (D) (ii). Compensation is required whenever data submitted after December 31, 1969 is considered by EPA in support of another company's registration. § 3(c) (1) (D) (ii). The duty to pay compensation, however, ends fifteen years after the data are submitted, after which no further payment is required for use of the data. § 3(c) (1) (D) (iii). In the case of an active ingredient subject to exclusive use protection, the data are subject to compensation for five years after the ten-year period of exclusivity expires.

3. Under the "joint data development" provision, two or more registrants can agree to develop jointly, or to share the cost of, new data needed for re-registration or to respond to data call-ins. FIFRA § 3(c) (2) (B) (ii). Registrants may agree to develop jointly new data needed by EPA for re-registration. FIFRA § 3(e) (2) (B) (ii). Applicants for re-registration which are not developing re-registration data either alone or jointly must offer to share in the cost of the data being developed by other registrants. See FIFRA §§ 4(d) (3) (B) (ii), 4(e) (1) (H) (ii). FIFRA does not establish a formula or standard for determining the amount of compensation under § 3(c) (1) (D) or the manner in which costs should be shared under § 3(c) (1) (D). Instead, the statute leaves it to the parties themselves to work out compensation or cost sharing arrangements, or to agree upon a dispute resolution procedure. Any party, however, has the right to initiate binding arbitration proceedings in order to resolve a data compensation or cost sharing dispute. FIFRA § 3(d) (1) (D) (ii), 3(c) (2) (B) (iii).

4. Under FIFRA's binding arbitration provisions, data compensation or cost sharing disputes can be resolved by a neutral arbitrator. FIFRA § 3(c) (1) (D) (ii), 3(c) (2) (B) (iii). In the Thomas v. Union Carbide Agricultural Products Co., 473 U.S. 568 (1985). case, several pesticide manufacturers challenged the FIFRA arbitration system on the grounds that it delegated too much power to an arbitrator to determine compensation, without review of the soundness of arbitration awards by the federal courts. The Supreme Court concluded that this delegation of adjudicatory power to arbitrators, rather than the courts, does not violate the "separation of powers" required by the Constitution. 473 U.S. at 592-93. A federal district court subsequently held that the lack of a standard in FIFRA for measuring compensation is not unconstitutional. PPG Industries v. Stauffer Chemical Co., 637 F. Supp. 85 (D.D.C.1986), appeal dismissed, No. 86-5502 (D.C. Cir.Nov.4, 1987).

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