Earlier this month, the European Commission and representatives of the EU Member States discussed potential revisions to the European Commission's Note on handling of duplicate marketing authorisation applications (the 2011 Note). According to the information published by the Commission, the discussion took place on 7 November 2019 during the latest Pharmaceutical Committee meeting. The discussion was intended to be focussed on duplicate marketing authorisations for biological medicinal products and the outcome of the related public consultation that took place in 2018.
As we set out in our previous blog, the 2011 Note provides guidance on how the European Commission handles requests for duplicate marketing authorisations submitted through the centralised marketing authorisation procedure in accordance with Article 82.1 of Regulation (EC) No 726/2004 which was motivated by concerns that several MA's granted for the same product could lead to partitioning of the market. As a general principle, the Regulation contemplates the existence of duplicate marketing authorisations only in two situations; first, where co-marketing with an independent company is envisaged and secondly "where there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients". In this latter case the Commission has required the applicant to demonstrate that the grant of a duplicate marketing authorisation will result in improved availability of the medicinal product in the EU. The 2011 Note states that, in principle, the grant on "public health" grounds of a duplicate marketing authorisation for a "first generic" granted to an originator (known as an "authorised generic" in the USA) is possible because of its potentially positive impact on the availability of the medicinal product.
The 2011 Note does not, however, specifically discuss applications for duplicate marketing authorisation for biological medicinal products. Therefore, between May and September last year, the Commission carried out a public consultation on proposed changes to the 2011 Note. The objective of the consultation was to seek views on the impact of duplicate authorisations of biological medicinal products on the availability of biosimilars to healthcare professionals and patients. Companies marketing biosimilars had voiced their concerns that where the first "copy" of the originator's biological product was marketed by the originator, this did not improve availability of the product, but rather made the marketing of biosimilars less attractive.
There have been very differing views expressed by stakeholders about the proposed amendments, which has led to some delay since the end of the consultation in the Commission making proposals for amendment.
According to the document now published by the Commission, the competent authorities of nine EU Member States (Belgium, Denmark, Spain, Finland, France, Hungary, the Netherlands, Portugal, Sweden) responded to the public consultation, as well as ten representatives of individual pharmaceutical companies, trade associations, healthcare professionals' organisations and patient organisations.
Discussion at the Pharmaceutical Committee meeting
The objective of the discussion at the recent meeting of the Pharmaceutical Committee was to seek updates on the experience of the EU Member States with biological medicinal products placed on their markets on the basis of duplicate marketing authorisations. More importantly, however, the representatives of the EU Member States were invited to comment on proposed revisions to the 2011 Note, which had been prepared by the Commission to table at the meeting. The proposal was to include the following language in the guidance:
"A duplicate marketing authorisation is an exceptional process. For duplicates (chemical or biologics) requested on the basis of public health reasons the applicant should provide specific evidence with regards to the product in question to allow the Commission to verify a positive effect on availability. Taking into account the experience gained with market realities, the first entry of a generic on the market is not automatically considered to increase availability.
The applicant should justify why a duplicate is needed and demonstrate how a second marketing authorisation would increase availability and patient access, based on objective and verifiable reasons, as required in Article 82 (1) of Regulation 726/2004. In this regard, one possibility is to ask the applicant, as part of their justification for increased availability and patient access, to list the Member States where the "first" medicinal product is actually marketed and indicate where the duplicate will be made available. If the market intention does not cover the entire EU, justification should be provided and the Member States in which the product is not to be placed on the market should be listed." [no additional emphasis added]
It is clear from this proposal that while the public consultation was focused on duplicate marketing authorisations for biological medicinal products, the proposed revisions address duplicates for both chemical and biological medicinal products.
The proposed revisions further highlight the Commission's interpretation of the law that duplicate marketing authorisations should only be granted on an exceptional basis and that the applicant seeking a duplicate marketing authorisation for public health reasons must provide "scientific evidence" demonstrating the positive effect on availability. The first entry of a generic on the market will no longer be automatically considered to increase the availability of the medicinal product.
The proposed amendments are, arguably, not a dramatic change from the previous wording of the 2011 Note, but rather an amplification and clarification of the existing language. However, we believe the changes may have a significant impact on when a duplicate will be approved. In particular, one material change is the departure from the presumption that the first entry of a generic on the market from the originator "usually increases accessibility". To date, requests for duplicates on the basis that they will be the "first generic" of the reference product have generally been accepted without detailed analysis of the reasons why this will increase availability to patients. Although the Commission provides some guidance in the above suggested amendments on the type of information that would need to be provided, it is difficult to see how "scientific evidence" can be generated about a product that is not yet on the market. Significantly, if the proposed revisions are adopted in their current form, the applicant for a duplicate marketing authorisation for a generic or a biosimilar would, for instance, also be required to:
- describe their marketing plans in the individual EU Member States;
- justify a decision not to place the medicinal product in one or more EU Member States.
The summary record of the discussions at the meeting is not yet published. It is, therefore, unclear whether the representatives of the EU Member States agreed to the Commission's proposed revisions, or whether the text was amended during the meeting. If the revisions were agreed, we anticipate the Commission will update and publish a revision of the 2011 Note in the near future. However, some of the responses to the Consultation argued that there is a need for other aspects of the Guidance to be clarified, a position that we believe is well founded.
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