Specific strategies to implement guidelines for the study and evaluation of gender differences in the clinical evaluation of drugs have not been developed by the European Medicines Agency (EMEA). This agency accepts “that some of the factors that influence the effect of a medicine in the population may be important when considering potential differences in response between men and women” and “gender-specific influences can also play a significant role in drug effect”. But besides these statements, in a document about gender considerations in the conduct of clinical trials, the EMEA argues against the need for separate International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on women as a special population group, based on their internal review and experience, but without providing the sources.¹ The lack of sound fundaments of these convictions is worrisome. This paper analyses the document of EMEA,¹ and introduces some of the main reasons to reconsider the convenience to develop a policy on gender-related information for the clinical trials, an initiative already taken in the US.²

First of all, gender is not a demographic category of analysis as considered by the ICH guidelines. The parameters disaggregated by sex are not always the same as those by gender sensitivity (in some instances both are used as the same, but they are not equal). The information disaggregated by sex tells us whether differences by sex exist in some specific dimension of health, but the information by gender sensitivity is constructed to help to know the reasons (and consequences) of the sex differences. So, the term “gender” should be removed and replaced by “sex” in not all but many instances of the ICH guidelines.

As early as 1986, the NIH policy …