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Parliamentary questions
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19 January 2018
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-007014/2017

According to the pharmaceutical legislation(1), the package leaflet containing information for the user of the medicines is approved by a competent authority, either by the Commission for the entire European Union or by a Member State for its own territory, as a part of the marketing authorisation.

The Commission notes that inclusion of sub-populations like transgender people can only be added to package leaflets if the Marketing Authorisation Holder (MAH) is applying for their product to be used in such a sub-population. In those cases, the MAH would have to conduct clinical studies for their product and to propose wording for such groups on the basis of the evidence generated.

The Commission acknowledges the importance of consideration of specific subgroups during the development, approval and use of medicines. To combat the discrimination of lesbian, gay, bisexual, transgendered and intersex (LGBTI) people, including transgender people, the Commission published the List of Actions to Advance LGBTI Equality(2).

One of them is the pilot project ‘Health4LGBTI’ (2016-2018)(3). Its objective is to increase the understanding of how best to reduce specific health inequalities experienced by LGBTI people.

The project includes the development of training modules aimed at increasing the knowledge, attitudes and skills of healthcare professionals when providing healthcare to LGBTI people. However, currently there are no specific initiatives ongoing or planned to address issues concerning the transgender population in the product information of medicines.

(1)Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, as amended.

Last updated: 8 June 2018Legal notice