Data protection following a change of classification

Data protection following a change of classification reserves for one year the benefit of the trials that justified the switch of a medicinal product from prescription-only status to non-prescription status. It is provided for by Article 74a of Directive 2001/83/EC. It encourages pharmaceutical companies to fund the studies needed to open a substance up to self-medication.

Classification of medicinal products

When granting the authorisation, the competent authority classifies the medicinal product as subject or not subject to medical prescription, according to criteria relating in particular to the danger it presents without medical supervision, the risk of incorrect use or the need for further investigation. In France, prescription-only status results from the inclusion of substances on the lists of poisonous substances, and the change of classification is commonly known as delisting (délistage). It is decided by the ANSM for national authorisations and by the European Commission for centralised authorisations.

The protection regime

Where a change of classification has been authorised on the basis of significant pre-clinical tests or clinical trials, the authority may not refer to the results of those tests or trials for one year when examining an application by another applicant or holder for a change of classification of the same substance. The protection covers only the data relating to the change of status. It prevents neither the marketing of prescription-only generics nor the grant of the same status to a competitor that produces its own data. Its scope therefore remains modest compared with the data exclusivity attached to the initial dossier.

Practical issues

The switch to non-prescription status profoundly changes the regime applicable to the product. Advertising of medicinal products to the general public is in principle permitted only for non-prescription, non-reimbursable medicinal products, which gives the product’s trade mark new value. Delisting is often accompanied by withdrawal from reimbursement and by a packaging and formulation strategy, sometimes protected by patents of its own. The year of protection delays competitors’ alignment on the same status and gives the first mover time to establish its trade mark in pharmacies.

Key points

The one-year protection linked to a change of classification applies only to the data that justified the delisting and does not stop a competitor that has its own studies. Before embarking on such studies, the real competitive advantage of a one-year head start should be assessed in light of the trade mark, pricing freedom and advertising to the general public. For a competitor, the date of the decision on the change of classification indicates when its own applications may rely on the same results.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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