Targeted stakeholder consultation from the European Commission on duplicate marketing authorisations for biological medicinal products

The European Commission (EC) is seeking consultation on proposed clarifications for handling duplicate marketing authorisations (MAs). Under certain circumstances the EC is allowed to issue duplicate MAs when issues with existing patents in certain Member States occur and for other public health reasons.

Since publication of the note on the handling of duplicate marketing authorisations in 2011, the EC have identified potential issues that relate to the granting of duplicate MAs for biological medicinal products on the ground that they would be a “first generic”. The EC states that “these issues relate to the possible impact of such duplicate marketing authorisations on the biosimilar market (including potential anticompetitive effects) and the undermining of treatment options available to patients.”

The aim of the targeted stakeholder consultation is to gather the views of interested parties on the specific issue of the impact of duplicate MAs of biological medicinal products on the availability of biosimilars to healthcare professionals and patients. The results of the consultation will enable to the EC to take an informed decision as to whether there is a need to clarify the current wording of Annex I, section 1 of the note on the handling of duplicate MAs applications on this matter.

The EC also plans to add a footnote that states the following: “On the basis of the experience gained since the publication of the notice, the first introduction of a generic product by the holder of a biological medicinal product may not improve availability. However, a case-by-case assessment of the impact on the availability of the product will be undertaken, on the basis of evidence provided by the applicant, with due consideration of the impact of the duplicate marketing authorisation on the availability of biosimilars to health care professionals and patients”

Stakeholders are invited to comment on the consultation by 10th September 2018.

To find out more on the targeted stakeholder consultation on duplicate MAs for biological medicinal products, please click here.