62018TJ0211_RES
Case T‑211/18
Vanda Pharmaceuticals Ltd
v
European Commission
Judgment of the General Court (Sixth Chamber), 19 December 2019
(Medicinal products for human use — Application for marketing authorisation for the medicinal product Fanaptum — iloperidone — Commission refusal decision — Regulation (EC) No 726/2004 — Scientific evaluation of the risks and benefits of a medicinal product — Obligation to state reasons — Manifest error of assessment — Proportionality — Equal treatment)
Action for annulment — Actionable measures — Meaning — Measures producing binding legal effects — Preparatory measures — Excluded — Assessment report and scientific opinions of the Committee for Human Medicinal Products — Preparatory measures — Inadmissibility
(Art. 263 TFUE)
(see paragraphs 29-34)
Approximation of laws — Medicinal products for human use — Marketing authorisation — Varying the authorisation — Withdrawal and prohibition of placing on the market — Conditions — Interpretation in accordance with the principle that precedence must be given to the protection of public health and the precautionary principle — Evidentiary requirements
(European Parliament and Council Regulation No 726/2004, Art. 12(1))
(see paragraphs 44, 46, 105, 194, 195)
Approximation of laws — Medicinal products for human use — Marketing authorisation — Varying the authorisation — Withdrawal and prohibition of placing on the market — Scientific evaluation of the risks and benefits of a medicinal product — Assessment criteria — Pre- and post-marketing data concerning third countries — Discretion of the medicinal products committee — Scope
(see paragraphs 45, 87, 88)
Approximation of laws — Medicinal products for human use — Marketing authorisation — Varying the authorisation — Withdrawal and prohibition of placing on the market — Opinion of the Committee for Human Medicinal Products — Discretion of the Committee — Judicial review — Limits — No breach of principle of proportionality
(European Parliament and Council Regulation No 726/2004)
(see paragraphs 50-54, 89, 104, 106, 107, 152-157, 174-176)
Acts of the institutions — Statement of reasons — Obligation — Scope — Decision granting, refusing, varying, suspending or withdrawing a marketing authorisation — Minimum requirements
(Art. 296, second para., TFEU; European Parliament and Council Regulation No 726/2004, Art. 81(1))
(see paragraphs 60-62, 66, 150)
EU law — Principles — Equal treatment — Meaning — Difference in treatment for situations which are factually different and, accordingly, not comparable — No infringement
(see paragraphs 159, 160, 164)
Résumé
In the judgment in Vanda Pharmaceuticals v Commission (T‑211/18), delivered on 19 December 2019, the General Court dismissed in its entirety the action seeking the annulment of a European Commission implementing decision refusing marketing authorisation (MA) for the medicinal product for human use Fanaptum — iloperidone as that product’s risk-benefit balance was considered to be negative.
Vanda Pharmaceuticals Ltd (‘the applicant’) is the holder in the United States of a marketing authorisation for the medicinal product Fanaptum, which contains the active substance iloperidone. That medicinal product has been marketed in that country since 2010 and is indicated for the treatment of the symptoms of schizophrenia in adults.
In the first place, the Court reviewed the objectives and main features of the centralised procedure for MAs for medicinal products as governed by Regulation (EC) No 726/2004. (
1
) In that context, it stated that in the process of evaluating an MA request, exclusive responsibility for preparing opinions of the European Medicines Agency (EMA) on all questions concerning medicinal products for human use is vested in the Committee for Human Medicinal Products (CHMP). Consequently, the Court pointed out that a distinction had to be drawn between any documents drawn up by the co-rapporteurs, namely the independent teams which carry out a first scientific evaluation of a request for an MA, and the final assessment report of the CHMP on which the contested decision is based.
In the second place, the Court found that the Commission had not departed from the CHMP opinion, the content of which, like the content of the final assessment report on which it is based, is an integral part of the reasoning behind the contested decision, in particular as regards the scientific evaluation of the medicinal product at issue. Consequently, the Court held that the judicial review to be undertaken by it, in particular its review of whether there has been a manifest error of assessment, had to be carried out on the basis of all the considerations set out in those opinions and the assessment report of the CHMP. In that context, the Court considered that the contested decision was not vitiated by any manifest error of assessment with regard to the assessment of risks linked to the arrhythmogenic potential of iloperidone, which can result in an abnormal heart rate which can, in certain circumstances, be life-threatening. In particular, the Court considered that the CHMP could, without exceeding the limits of its discretion when evaluating scientific data submitted to it, take the view that the number of cardiac deaths recorded in the United States constituted evidence of iloperidone’s pro-arrhythmic potential and thus of the safety risk presented by that substance. In support of that position, the Court held that the fact the risk identified is ‘potential’ explains why the CHMP found it necessary to come to a negative opinion and that the CHMP cannot be required to establish the existence of a ‘significant actual risk’, such as a significant increase in cardiac mortality.
In the third place, as regards the CHMP assessment report not being consistent with current EMA practice, on the basis that the CHMP did not take into account the positive post-marketing experience of iloperidone, the Court found that the CHMP had in fact taken into account that experience, in particular on the American market, but that it found that experience to be inconclusive. Indeed, the Court stated that, in finding the post-marketing data provided by the applicant to be unconvincing, the CHMP did not refuse as a matter of principle to take such data into consideration when evaluating iloperidone’s safety, but rather was concerned with determining scientific reliability. Therefore, the Court concluded that the applicant failed to establish that the Commission had departed from the previous practice on the taking into account of post-marketing data provided in support of MA applications for certain medicinal products, in particular lurasidone and cisapride.
In the fourth and final place, the Court held that the Commission’s conclusion that the risk minimisation measures (
2
) proposed by the applicant with a view to the grant of an MA for iloperidone were insufficient is not vitiated by a failure to state reasons or manifest errors of assessment. In that regard, the Court pointed out, as regards the applicant’s proposal that iloperidone be used as a ‘second line’ treatment, namely in situations where the patient’s treatment with another medicinal product had not been satisfactory, the CHMP assessment report had established that there was a comprehensible link between the scientific findings brought to the EMA’s attention and the CHMP’s negative recommendation in the present case.
(
1
)	Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1).
(
2
)	Those measures seek, generally, to optimise the safe and effective use of a pharmaceutical product throughout its life cycle.