The 'sunset clause' for marketing authorisations
Under the 'sunset clause' of Article 24(4) to (6) of Directive 2001/83/EC, any marketing authorisation (MA) granted under the national, mutual recognition or decentralised procedure for a medicinal product, which has not been marketed for three years, will cease to be valid1. This also applies if the product was initially marketed, upon the MA being granted, but later ceased to be on the market. To be considered as being 'on the market', the product should be within the distribution chain, which means it should have left the control of the MA holder's company.
The sunset clause provisions came into force on 20 November 2005. The three year period for any product not on the market, which was granted an MA prior to this date, would begin to run on 20 November 2005. More generally, the period is effective from when the MA holder enters the last batch of product into the supply chain. If, on the other hand, the product did not enter the market at all, the date at which the MA was granted will be taken as the starting date of the three year period. In respect of generic products, the three year period starts on the later of:
- date of grant of the MA;
- the end of the period of market exclusivity; or
- the end of the period of patent protection.
Importantly, the MA will continue to be valid so long as there is at least one product presentation on the market in at least one Member State of the Community. This also extends to Iceland, Norway and Liechtenstein.
In exceptional circumstances, MA holders may request an exemption from invalidation of the MA. Such cases are evaluated in isolation on a case-by-case basis. Exemplary instances where cessation of the MA may be exempted have been suggested by the Medicines and Healthcare Products Regulatory Agency (MHRA) and European Medicines Agency (EMA). For instance, such requests may be considered if the product could not have been put on the market for intellectual property reasons, or was a medicinal product held as part of emergency medicinal preparedness arrangements (for further considered exemptions see The MHRA and The EMA). Depending on the grounds on which the three year cessation was exempted, the period of MA validity may be extended for up to a further 3 years.
Member States have responded to the sunset clause in various ways. In the UK for instance, in order to stress the significance of the obligations of MA holders, the MHRA has taken to notifying companies of any imminent MA expiry. In contrast, the response in Spain has been more indifferent, largely due to the lack of clarity in establishing when the sunset clause period begins and in the interpretation of the clause. Similar reservations are evident from the Icelandic Medicines Agency (IMA) which has adopted the view that enforcing such a clause would reduce the increasing variety of medicinal products available on the market. On these grounds, the IMA has therefore decided against enforcing such a clause.
Many questions arise when considering the implications of the 'sunset clause'. The MHRA has suggested that if the MA holder felt that the lack of alternative medicinal supplies would have an adverse effect on public health, exemption may be considered. Yet in such cases questions may surface as to why the product was not marketed for three years. The MHRA further suggests that, if exempted, an MA may be valid for up to six years in total. It is thus unclear what the interaction is between these six years and the procedural five years of validity of the MA before renewal is necessary. It seems that in such cases the 'sunset clause clock' would not be 'reset' and therefore, despite being renewed recently, the MA would only be valid for a further year.
For further details see the Question and Answer section in the following: MHRA Q&A
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