The opinion, if followed by the Court of Justice of the EU (CJEU), could make it more difficult for errors made by national regulators to be corrected – to the potential detriment of either manufacturers of originator products or those that make rival generic alternatives, depending on the circumstances.
According to advocate general Laila Medina, marketing authorisations for medicines granted by national regulators in the EU cannot be re-assessed by the European Medicines Agency (EMA), except on public health grounds. She also said EU law does not provide the European Commission with the power to verify a scientific assessment conducted by a national medicines regulator within an EU member state where it concerns a medicine to be placed on the national market, and said the principal of mutual recognition of decisions taken by medicines regulators in the EU applies to the EMA in respect of decisions by national regulators.
Medina’s opinion is relevant to a dispute that has come before the CJEU for a ruling. Her views are non-binding on the court, but the CJEU often follows the opinions of its advocates general when issuing its formal judgment.
The case before the CJEU concerns an appeal raised by Biogen Netherlands, the EMA and the Commission against a ruling of the EU’s General Court last year, which favoured generic medicines manufacturer Polpharma.
The dispute revolves around the extent of regulatory data protection that Biogen is entitled to in respect of its Tecfidera product, for which the Commission granted Biogen the right to market for use in the treatment of multiple sclerosis in 2014.
The Commission’s decision meant that rivals of Biogen could not refer to pre-clinical and clinical data in Tecfidera’s file for eight years or market a generic version of Tecfidera for 10 years. However, in 2017, Polpharma applied for marketing authorisation for a generic version of Tecfidera it had developed.
Polpharma has claimed that the period of regulatory data protection applicable to Tecfidera has expired. This, it has said, is because Tecfidera falls within a global marketing authorisation applicable to another of Biogen’s products, Fumaderm, which Germany’s medicines regulator first granted marketing authorisation for, for use in the treatment of psoriasis, in 1994.
Both Tecfidera and Fumaderm share a common component, dimethyl fumarate (DMF). Tecfidera contains DMF as its sole active substance, while Fumaderm is comprised of DMF and various monomethyl fumarate (MEF) salts.
EU medicines rules prevent a fresh period of regulatory data protection being triggered in respect of a new medicinal product if that product in question is a mere extension of another medicinal product for which marketing authorisation has been granted. In that scenario, the period of regulatory data protection is tied to the initial marketing authorisation. The rules are designed to strike a balance between incentivising investment in innovation in the market and ensuring fair competition by removing a disproportionate barrier to entry.
Polpharma was initially unsuccessful with its application for marketing authorisation for its generic alternative to Tecfidera, but the EU’s General Court last year annulled the EMA’s decision. The General Court ruling was that the Commission was not entitled to determine that Tecfidera was covered by a different global marketing authorisation from Fumaderm without having verified or requested that the Committee for Medicinal Products for Human Use (CHMP) of the EMA verify the role that MEF plays in Fumaderm.
Polpharma subsequently successfully re-applied to the EMA for an EU-wide marketing authorisation for its generic alternative to Tecfidera. This was granted on 13 May 2022. However, Biogen, the EMA and the Commission have all lodged an appeal against the General Court’s ruling before the CJEU.
In her opinion, Medina said that, in hearing the appeal, the CJEU has an opportunity to “clarify the requirements that apply, respectively, to the approval of the marketing of a medicinal product in the European Union and to the assessment of whether two medicinal products belong to the same global marketing authorisation”.
Catherine Drew, a specialist in life sciences regulation at Pinsent Masons, said: “The view that the principle of mutual recognition means that the EMA should not revisit decisions granting marketing authorisations previously adopted in another member state has to be correct. The case law has made plain that this is so in relation to decentralised approval procedures and so the same approach should be applied to centralised approval procedures.”
“Nevertheless, this is a difficult decision to rationalise in the particular case where the CHMP has undertaken a reassessment of the original German-approved product and found that the available data cannot establish that one component exerts a clinically relevant therapeutic contribution within the medicinal product – i.e. the medicinal product did not comprise two active substances, but rather only one. If the CJEU were to adopt the opinion, the assessment undertaken by the CHMP and, in particular, the output of that assessment based upon the scientific data is rendered irrelevant,” she said.