Pesticide Registration Toolkit

Data protection and confidentiality

Many different types of data exist, for which there are different mechanisms and levels of protection. There is also wide variability in the way in which individual countries protect such data as a separate category of intellectual property rights (IPRs) in their domestic legislation. For Members of the World Trade Organization  WTO), the protection of undisclosed information is mandatory under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), contained in Annex 1C of the Agreement Establishing the World Trade Organization (WTO).

In an attempt to achieve a balance between competing interests, and to promote public interest in the development of such data by firms and reference to them by regulatory authorities, WTO Members are required to provide for two forms of protection of undisclosed test or other data pursuant to Article 39.3 of the TRIPS Agreement. The first is against unfair commercial use, where:

  • the data have to be submitted as a condition of marketing approval for pharmaceutical or agricultural chemical products;
  • those products utilize new chemical entities;
  • the origination of the data involves considerable efforts; and
  • the data is undisclosed.

The second form of protection of test data is against disclosure, except where necessary to protect the public, or unless steps are taken to ensure the data are protected against unfair commercial use.

The TRIPS Agreement remains silent about how protection against unfair commercial use should be implemented by WTO Members. Some form of protection of test data has generally been implemented into national legislation. For example, a number of WTO Members provide for a fixed period of exclusivity during which neither regulatory authorities nor third parties can rely on the data submitted by the originator company for regulatory approval purposes without the originator’s consent. Other WTO Members have implemented approaches to data protection that do not provide for a specific period of exclusivity.

Countries may take different approaches as to which government authorities should be responsible for data protection. However, for data on agricultural or public health pesticides, the pesticide registration authority is usually responsible for developing and administering pertinent national legislation, including its adherence to international obligations on intellectual property rights. Where appropriate, pesticide authorities should consult the national office with general responsibility for intellectual property rights, in order to ensure a consistent approach regarding the protection, handling and access to registration data, materials and documents.

For WTO Members, it can be expected that relevant national laws and regulations, and their administration, reflect the minimum standards established by the TRIPS Agreement as set out above. Countries that are not members of WTO may have legislation on intellectual property or rules in place that should be adhered to. Where no such legislation or rules exist, pesticide registration authorities are advised to use the TRIPS Agreement, and the specific choices taken by different WTO Members, as a point of reference. Details of the diverse national approaches of many countries to implementing TRIPS standards on data protection.