Sunset clause (clause de caducité)

The lapse rule, commonly referred to as the sunset clause, deprives of effect the marketing authorisation of a medicinal product that is not actually placed on the market. It is provided for by Directive 2001/83/EC for national authorisations and by Regulation (EC) No 726/2004 for centralised authorisations. It aims to prevent dormant authorisations from clogging the system and distorting information on the medicinal products actually available.

The two cases of lapse

The authorisation ceases to be valid if the medicinal product is not actually placed on the market within three years of its grant. It also ceases to be valid where an authorised medicinal product previously placed on the market is no longer actually present on the market for three consecutive years. For national authorisations, the condition is assessed in the State that granted the authorisation, and the legislation requires actual marketing. For centralised authorisations, marketing in a single Member State is in principle sufficient to prevent lapse.

Exemptions

The competent authority may, in exceptional circumstances and on public health grounds, grant an exemption from the sunset clause. The exemption must be duly justified, and it is interpreted restrictively. It may concern, for example, a medicinal product intended for health emergencies or a treatment whose availability must be ensured even in the absence of regular demand. A holder considering ceasing marketing must also inform the authority within the time limits laid down by the legislation, in particular for the prevention of shortages.

Lapse, generics and patents

The sunset clause weighs above all on manufacturers of generic medicinal products who obtain their authorisation long before the patents on the reference medicinal product expire. If marketing is prevented by a patent or a certificate for more than three years, the authorisation is liable to lapse before launch becomes possible. The generics manufacturer must then choose between filing its application later, an at-risk launch and a fresh application at a later date.

Key points

An authorisation not followed by actual marketing within three years, or whose product disappears from the market for three consecutive years, lapses, unless an exemption is justified on public health grounds. The rule primarily affects generics authorised early but blocked by patents. The filing date of the authorisation application should be aligned with the expiry timetable of the patents and certificates, and the dates of first marketing in each State concerned should be tracked precisely.

---

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.

Pharmaceutical patents and medicines regulation · Pharma case law · Tell us about your situation