In a judgment dated 21 November 2018, the EU Court of Justice ("ECJ") concludes that an EU Member State may reimburse the use of a medicine, such as Avastin, for a treatment not covered by its marketing authorisation ("off-label use"). All necessary authorisations for manufacture and sale of the medicine must however have been obtained in compliance with the Human Medicines Directive ("HMD") (C-29/17, Novartis Farma).
| what you need to know - key practical take-aways |
|---|
- A medicinal product may be used for therapeutic indications not covered by its marketing authorisation (off-label use), and may be repackaged with a view to such use, subject to compliance with EU pharmaceutical rules.
- A Member State may provide for the reimbursement of the off-label use of a medicinal product, provided that this product is manufactured (repackaged) and placed on the market in compliance with the HMD requirements.
|
Background
Novartis is marketing authorisation holder for Lucentis, a medicine approved in the EU for the treatment of eye diseases. Roche is marketing authorisation holder for Avastin, a medicine approved in the EU for cancer treatment. In practice, Avastin is often used "off-label" to treat eye diseases, as it is considerably cheaper than Lucentis. In that case, Avastin must be repackaged from its original vial into ready-to-use syringes suitable for intravitreal injection (i.e. shot of medicine into the eye).
In an attempt to cut healthcare spending, Italy allowed the reimbursement of Avastin's off-label use for eye diseases. Reimbursement was made conditional upon Avastin being repackaged at authorised hospital pharmacies and administered to patients at designated public hospitals, after having obtained the patient's informed consent for the off-label use of the medicine.
Novartis challenged the reimbursement of Avastin before the Italian courts claiming that Italy encouraged the off-label use of Avastin, despite the availability of Lucentis, a medicine specifically authorised to treat eye diseases. Novartis argued that Italy acted in breach of the HMD and in particular the requirement for any medicine to be used in conformity with the terms of its marketing authorisation. The Italian judge referred the matter to the ECJ for a ruling on the compatibility of the Italian decision with the EU legal framework for human medicines.
The Court judgment
In its judgment of 21 November 2018, the ECJ reaffirms that the organisation and management of health services and the allocation of the resources assigned to them are the responsibility of the Member States. This includes the price setting and reimbursement of medicinal products. In exercising that responsibility however Member States must comply with EU law.
The ECJ confirms that the sale and use of Avastin remains governed by the HMD, even after the medicine is repackaged for off-label use. Article 3 of the HMD exempts products prepared in pharmacies, i.e. officinal and magistral preparations, from the scope of the HMD. This exemption does not apply to Avastin, however, as it is produced industrially.
The ECJ then notes that EU pharmaceutical rules prohibit neither the off-label use of a medicine nor its repackaging for such use, but do require those processes to comply with the conditions laid down in those rules, including the requirement of holding the necessary marketing and manufacturing authorisations.
The ECJ concludes however that the process of repackaging of Avastin for off-label use does not require a new marketing authorisation, provided that this process (i) does not alter the composition, form or any other fundamental characteristic of the medicine, and (ii) is performed only by lawfully authorised pharmacies on the basis of an individual prescription.
The ECJ further finds that pharmacies repackaging Avastin do not require a new manufacturing authorisation under Article 40(2) HMD, provided that they are lawfully authorised under national law to repackage medicines on the basis of an individual prescription and the medicine is administered in hospitals.
The conclusion is therefore that Member States, such as Italy in the present case, are allowed under EU law to reimburse the off-label use of medicines, even where another medicine is specifically authorised for such use, provided that the repackaging and off-label use of the repackaged medicine comply with the HMD.
