Concept

Pharmaceutical Test or Registration Data is the information generated in the preclinical and clinical testing of a drug and which is provided to national drug regulatory authorities, as evidence of its safeness, effectiveness and quality, in order to obtain marketing authorization.

To gain regulatory approval to sell generic versions of drugs, generic companies generally do not repeat these studies. Instead, they rely on the registration data submitted by the original applicant to establish the bio equivalence (meaning it will work the same way in the body as the brand-name drug) of their generic follow-on. There are economic, practical and ethical reasons why second/generic entrants into the pharmaceutical market should not replicate the test data. The tests may take several years to complete and delay the entry of cheaper generics into the market. Also, it has been argued that it is unethical to replicate some testing of drugs on human subjects.

Article 39.3 of the TRIPS Agreement requires WTO Members States to protect from unfair commercial use, the pharmaceutical (and agricultural) test data that is required to be submitted for marketing approval. Article 39.3 only requires protection of undisclosed test data originated from new chemical entities and that which requires considerable effort to generate.

WTO Members have considerable discretion to define unfair commercial use in the context of their own national interest and laws.

Controversy: marketing/data exclusivity

Under current regulations, the United States and the European Union implement their Article 39.3 obligations by granting a period of exclusive rights on pharmaceutical test data. The U.S./E.U. system, sometimes referred as "marketing exclusivity" or "data exclusivity" rather than "data protection", goes considerably beyond the minimum obligations under article 39.3 of the TRIPS Agreement. The problem with these regulations is that they prevent generic drug manufacturers and national regulatory authorities from relying upon the originator's test data to approve generic applications during a pre-determined period of time. If the generic entrant cannot obtain a "right of reference" (permission to use the test data) from the company that first marketed the product, they would have to re-conduct the tests, including the human use clinical trials, or wait until the data exclusivity period expires in order to obtain marketing approval.

The issue of data exclusivity has become especially relevant since the United States and the European Union, influenced by their brand-name pharmaceutical industries, are urging other countries to recognize this practice in a variety of trade negotiations: Special 301 List and Free Trade Agreements. Imposing another level of marketing exclusivity could have an important impact on access to affordable medicines in these countries, because one of the most successful tool to lower the prices of medicines is to rely on generic competition.

CPTech Position

When governments are pressured to implement TRIPS Plus Data Exclusivity regimes, the Consumer Project on Technology advocates for implementing article 39.3 obligations with a cost sharing mechanism. The proposal would allow, during the period of protection, generic companies to rely upon the originator's test data if they make reasonable contributions toward the cost of the investments. The proposal exceeds the minimum requirements of the TRIPS Agreement, but is a compromise between the very modest obligations of the TRIPS and the very high levels of protection advocated by the United States and Europe.

Details about the CPTech's Proposal found here.

Lastest developments

November 21, 2006. Judit Rius Sanjuan, James Love, Robert Weissman. Protection of Pharmaceutical Test Data: A Policy Proposal. Consumer Project on Technology.

November 20, 2006. CPTech Hosts Post-Election FTA Strategy Session. IP Disputes in Medicine.