CJEU confirms the broad scope of Article 6 of the Transparency Directive


On 16 April 2015, the CJEU handed down its decision in conjoined cases LFB Biomédicaments SA (“LFB”) (C-271/14) and Pierres Fabre Médicament SA (“PFM”) (C-273/14). The cases concerned the interpretation of Articles 6(3) and (5) of Directive 89/105/EEC (“the Transparency Directive”) and in particular the criteria used by Members States in deciding whether or not to include a particular product on the list of proprietary medicinal products covered by compulsory health insurance schemes and the provision of a statement of reasons in the event of a decision to exclude a product from such a list.

These cases concerned a decree by the French authorities dated 21 February 2012 (“the Decree”) which served to remove LFB’s and PFM’s proprietary medicines Alfalastin and Javlor from the list at issue. The French government argued that the removal did not mean that the medicines were no longer covered by the health insurance scheme as the coverage would henceforth be provided for by fixed payments in respect of periods of hospitalisation and inpatient care established in accordance with a classification of diagnosis-related groups. As a result, it was argued, Articles 6(3) and (5) of the Transparency Directive were not engaged. Conversely, LFB and PFM argued that the obligations under Article 6 cover all measures for covering medicines under the health insurance scheme and furthermore that the Decree had served to reduce the level of coverage as well as the demand for their products.

The CJEU confirmed the earlier jurisprudence on the logical interpretation of the scope of Article 6 and held that a failure to provide reasons for a decision which restricts the conditions of reimbursement or reduces the level of coverage of a medicinal product by excluding it from the list of medicinal products covered by fixed payments in respect of periods of hospitalisation and hospital care was contrary to the objective of transparency and as a result Article 6 was engaged.

Steven Willis