(2002; 77 pages) [Spanish]
3. Undisclosed data
Article 39.3 does not require protection be given to public data submitted for marketing approval. To qualify for protection under Article 39.3, the pertinent information must be "undisclosed". This means that information that is already public does not fall within the scope of this article. Any requirement for the submission of published or otherwise disclosed information to national regulators shall not generate any private right limiting the use of such information by the government or third parties, since the information would be in the public domain.
While a substantial part of the information on tests relating to safety and efficacy of approved drugs becomes publicly available - because the information is published in scientific journals,9 or made public by the health authority,10 - many data remain confidential such as data relating to some of the product's physical and chemical attributes and manufacturing processes.
9 In the case of the EU regulations (Directive 65/65, as amended) the possibility of obtaining market approval on the basis of published literature has been interpreted very restrictively. It only applies where a product has a well established medicinal use and the documentation submitted by the applicant covers all aspects of the safety and efficacy assessment (Dodds-Smith, 2000, p. 111).
10 For instance, the European Medicines Evaluation Agency (EMEA) publishes summaries of clinical trials in the "European Public Assessment Report" (EPAR) However, no detailed information on toxicological/pharmaceutical tests or clinical trials is published which could be used for registration by another company. The manufacturing process is not published either.
Given that under Article 39.3 protection is only conferred on undisclosed information, it will be necessary to determine in cases of controversy which of the information accompanying an application for marketing approval is confidential and need to be protected, and which is not. The undisclosed or disclosed nature of information is an objective feature, and it is not dependent on the qualification given by the applicant to the information that it is submitted. Hence, any applicant's declaration that all or certain information is "confidential" or "undisclosed" should be subject to scrutiny.