Bioplus Life Sciences Private Ltd & Ors v The Secretary of State for Health

For Francovich damages, a directive provision confers individual rights only where the claimed right is clear and its grant necessarily follows from the result or objective prescribed by the particular provision. A general interest in proper regulation, or the benefit gained from public supervision, is insufficient. Obligations requiring a state to prevent unauthorised medicinal products being marketed or distributed, or to operate inspections, do not necessarily confer on authorised-product suppliers a right to protection against losses caused by regulatory failure. Judicial-review standing does not establish an individual right to damages. The claim therefore failed at the threshold stage.

The claimants supplied an authorised glucosamine product. They alleged that the defendant had failed to comply with the Medicinal Products Directive 2001/83/EC by failing properly to classify materially identical products, prevent their unauthorised marketing and distribution, and carry out the required inspections. The claim was for Francovich damages.

The court considered whether Articles 6(1), 76(1) and 111(1) of the Directive were intended to confer individual rights capable of founding such a claim. The issue arose after earlier judicial-review proceedings in which the defendant’s classification decision had been quashed and the matter remitted for reconsideration.

1. Applicable test. The claimed right must have clear content, and its grant must necessarily follow if the result prescribed by the particular EU provision is to be achieved. The court must identify the purpose of that provision and adopt a purposive approach without giving “rights” an unduly restrictive meaning.
2. Supervisory obligations. A mere failure in supervision or surveillance does not itself confer the individual right needed for a Francovich claim. What is required is a right to protection against losses caused by the relevant failure. An interest in proper enforcement, including an interest sufficient to support judicial-review standing, is not enough.
3. Articles 6(1) and 76(1). Their prescribed result is to prevent unauthorised medicinal products being placed on, or distributed within, the UK market, while supporting public health and the internal market. They may entail a right to obtain a marketing authorisation for a qualifying product, but they do not necessarily confer a further right on an authorisation holder to protection against losses resulting from the failure to classify materially identical products as requiring authorisation.
4. Article 111(1). The provision imposes supervisory requirements concerning compliance with the legal requirements governing medicinal products, including inspections. It does not address the prior classification of products and does not require an enforceable individual right in favour of suppliers of authorised products.
5. Disposition. The claimants’ complaint ultimately asserted a right to a properly regulated market. That was no more than a general interest in implementation of the regulatory regime. The threshold for a Francovich claim was not established, no reference for a preliminary ruling was necessary, and the claim was dismissed.

The judgment records earlier judicial-review proceedings. Supperstone J initially dismissed the claim in [2014] EWHC 1679 (Admin). The Court of Appeal later upheld the challenge, quashed the classification decision and remitted the question of authorisation for reconsideration in [2016] EWCA Civ 554. This court dismissed the subsequent Francovich damages claim at the threshold stage.