Companies originating data for the registration of new products have requested from national health authorities and generally obtained protection of submitted data against disclosure. Confidentiality is essentially intended to protect secret information from misappropriation by third parties. However, problems with secrecy in drug regulation have historically raised public concern in several countries, including Great Britain, New Zealand, Germany, Sweden and the USA (Ollila and Hamminki, 1996, p. 168).
Historically, some health authorities relied on the first application data for the evaluation of second-entrant applications for similar products. Some companies brought legal action against the authorities arguing that reliance on the knowledge derived from one file to evaluate another one (e.g., a generic equivalent) caused them commercial injury.
In a number of court cases relating to Cimetidine decided in the United Kingdom, Australia and New Zealand, first entrants originating registration data invoked the ordinary law of confidential information to prevent regulatory authorities from relying on the originator's file when assessing an application for the approval of an equivalent drug by a generic competitor. Courts were, however, reluctant to apply such law (Cook, 2000, p. 5).
As a result of industry lobbying, some developed countries established sui generis protections for test data submitted for the approval of pharmaceuticals (and agrochemicals). Under different modalities, they adopted the concept of exclusive use of the test data by the originator company. The U.S. adopted a regulatory data protection regime for pesticides,4 and in 1984 regulatory exclusivity provisions for medicines. The U.S. health registration regulations provide for five years of exclusivity for new chemical entities, and three years for data filed in support of authorizations based on new clinical research relating to chemical entities which had already been approved for therapeutic use.5
4 This regime limits exclusivity by allowing third parties to use originator's test data if compensation is paid. In case of disagreement, the amount is determined through arbitration. See in Annex I a summary of the relevant legislation.
5 In October 1997, the U.S. Senate held hearings on "Health Registration Data Exclusivity, Biomedical Research, and Restrictions on the Introduction of Generic Drugs" (Subcommittee on Labor, Health and Human Services and Education and Related Agencies, Committee on Appropriations). These hearings considered a proposal for a voluntary five- year extension of the U.S. data exclusivity period, coupled with a 6 percent R&D commitment from the company electing to take the extension. The U.S. Congress did not adopt this proposal.
In the European Union (EU), the Member States have provided exclusivity protection for the data filed in support of marketing authorizations for pharmaceuticals since 1987. One of the original objectives of this regime was to compensate for the lack of patent protection for pharmaceuticals in some Members States (Portugal, Spain), but it was maintained after those countries introduced such protection (Watal, 2001, p. 201). During the exclusivity period, health authorities cannot rely on an originator's test to approve other applications without the originator's consent.6 The minimum period of such protection is six years, but 10 years is obligatory for "high technology products" (most biotechnology products), and also for new chemical entity authorizations granted by the European Medicines Evaluation Agency (EMEA). EMEA may also grant 10 years exclusive protection for test data related to medicines administered by means of "new delivery systems which... constitute a significant innovation", and "medicinal products containing a new substance or an entirely new indication which... is of significant therapeutic interest" (Cook, 2000, p. 18).
6 Article 8 of Directive 65/65, as amended by Directive 87/21/EEC, establishes that "without prejudice to the law relating to the protection of industrial and commercial property:
(a) The applicant shall not be required to provide the results of pharmaceutical and toxicological tests or the results of clinical trials if he can demonstrate:
i. either that the proprietary medicinal product is essentially similar to a product authorized in the country concerned by the application and that the person responsible for the marketing of the original proprietary medicinal product has consented to the pharmacological, toxicological or clinical references contained in the file on the original proprietary medicinal product being used for the purpose of examining the application in question;
ii. or by detailed references to published scientific literature presented in accordance with the second paragraph of Article 1 of Directive 75/318/EEC that the constituent or constituents of the proprietary medicinal product have a well established medicinal use, with recognized efficacy and an acceptable level of safety;
iii. or that the proprietary medicinal product is essentially similar to a product which has been authorized within the Community, in accordance with Community provisions in force, for not less than six years and is marketed in the Member State for which the application is made; this period shall be extended to 10 years in the case of high-technology medicinal products within the meaning of Part A in the Annex to Directive 87/22/EEC or of a medicinal product within the meaning of Part B in the Annex to that Directive for which the procedure laid down in Article 2 thereof has been followed; furthermore, a Member State may also extend this period to 10 years by a single Decision covering all the products marketed on its territory where it considers this necessary in the interest of public health. Member states are at liberty not to apply the above mentioned six-year period beyond the data of expiry of a patent protecting the original product. However, where the proprietary medicinal product is intended for a different therapeutic use from that of the other proprietary medicinal products marketed or is to be administered by different routes or in different doses, the results of appropriate pharmacological and toxicological tests and/or of appropriate clinical trials must be provided.
(b) In the case of new proprietary medicinal products containing known constituents not hitherto used in combination for therapeutic purposes, the results of pharmacological and toxicological tests and of clinical trials relating to that combination must be provided, but it shall not be necessary to provide references relating to each individual constituent".
Most Member States (Belgium, France, Germany, Italy, the United Kingdom, the Netherlands and Sweden) have applied the 10-year period to all medicinal products (Dodds Smith, 2000, p. 113). Moreover, the "data exclusivity that this affords can, if a marketing authorization is obtained only late in the life of a patent, extend beyond patent expiry. The only qualification to this is an option available to those few Member States which have not availed themselves of the 10-year period for all medicinal products, and which can also elect for such data exclusivity 'not to extend beyond patent expiry'" (Cook, 2000, p. 18).
Article 1711 of the North American Free Trade Agreement (NAFTA) of 1992 also establishes an exclusivity standard, requiring signatory countries to provide a minimum five years exclusivity period counted from the date of marketing approval. This model was followed in 1993 by the Andean Group countries under Decision 344 ("Common Regime on Industrial Property").
At the time of conclusion of the TRIPS Agreement, few countries had adopted the exclusivity approach developed in the United States and Europe. At the time, most countries in the world did not provide for exclusivity and most allowed the national health authorities to rely on test data submitted by the first applicant to approve subsequent applications on "similar" products.7 In some countries (e.g.. Argentina, Singapore, Taiwan, and the territory of Hong Kong) it was sufficient to prove that a similar product had been approved or commercialized in a foreign country.
7 Though the time of the adoption of the Agreement is to be taken into account, according to general principles of international law, for the interpretation of its obligations, it should be noted that even today, after the expiration of all except the transitional period for LDCs, only a minority of the WTO Members apparently confer data exclusivity (see, e.g. the February 2000 Pharma submission to the USTR on Section 301, at www.pharma.org). New Zealand introduced an exclusivity period in 1994, as part of implementing legislation of the TRIPS Agreement, and Australia did it in 1998 as a result of U.S. action under "Special 301" of U.S. Trade Act. The Andean Group countries, instead, revised Decision 344 in 2000 and eliminated the exclusivity period. A special exclusivity granted under the "Safety Monitoring Program" in Thailand was also abolished in January 2001.