The decentralised authorisation procedure for the placing on the market of a medicinal product forms part of the EU Community code relating to medicinal products for human use. Current case law defines the powers of the courts of the EU Member States concerned in which the application for marketing authorisation was lodged. This is particularly relevant for the authorisation of generic medicinal products.
The legal framework
A medicinal product for human use is placed on the market in accordance with European Directive 2001/83/EC, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012. According to this Directive, Articles 28 and 29 determine the mutual recognition procedure in the EU and the decentralised authorisation procedure.
The decentralised authorisation procedure
- If the medicinal product already has a marketing authorisation at the time of application, the Member States concerned shall recognise the marketing authorisation granted by the reference Member State.
- If, at the time of application, the medicinal product has not yet been authorised for marketing, the applicant shall request the reference Member State to prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet.
- If, on grounds of a potential serious risk to public health, a Member State cannot approve the assessment report, the summary of product characteristics, the labelling and the package leaflet within the period referred to in Article 28(4), it shall provide the reference Member State, the other Member States concerned and the applicant with detailed reasons.
The decentralised authorisation procedure consists of several stages in which the Member States in which the application for a marketing authorisation has been lodged participate in the procedure. This procedure ends with the agreement of all the Member States, which consequently have no possibility of calling into question the outcome of the procedure in which they themselves participated.
Phases of the decentralised procedure
- the applicant requests the reference Member State to prepare an assessment report.
- The reference Member State shall then prepare the draft dossiers within 120 days of receipt of a valid application and forward them to the Member States concerned and to the applicant.
- Within 90 days of receipt of these documents, the Member States concerned shall approve the assessment report, the summary of product characteristics, the labelling and the package leaflet and inform the reference Member State accordingly.
- The reference Member State shall establish the agreement of all parties, close the procedure and inform the applicant.
Placing generics on the market
The marketing of generics is also regulated in the EU Directive 2001/83. Art. 10 of this Directive stipulates that a generic medicinal product may only be placed on the market after ten years have elapsed (extendable to a maximum of eleven years) from the granting of the initial authorisation for the reference medicinal product. The applicant is not obliged to provide the results of pre-clinical tests and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which has been authorised in the EU for at least eight years.
Data protection period for the reference medicinal product
But is the data protection period for the reference medicinal product also subject to this decentralised procedure?
The current case law of the ECJ defines the powers of the Member States in which the application for marketing authorisation was made. The expiry of the data protection period for the reference medicinal product is a condition for the granting of a marketing authorisation for a generic medicinal product, according to the judgment of 14 March 2018 Astellas Pharma (C:2018:181 ). Under the decentralised procedure for marketing authorisation, compliance with this condition must be verified by all participating Member States.
Therefore, if this condition is not met, a Member State may, from the submission of the application and in any event before the agreement of all is established, object to that application. Accordingly, a Member State may also reject the assessment report on the generic medicinal product in the event of disagreement as to compliance with the requirement of the expiry of the data protection period of the reference medicinal product.
However, once the decentralised authorisation procedure has ended with the agreement of all the Member States being established, a Member State may not itself determine the date on which the data protection period for the reference medicinal product begins. Nor may a Member State determine whether the initial authorisation granted in another Member State to place the reference medicinal product on the market was compatible with this Directive. (Astellas Pharma (C:2018:181 )).
However, the court of a Member State concerned hearing an appeal brought by the marketing authorisation holder of the reference medicinal product against the decision of the competent authority of that Member State authorising the marketing of a generic medicinal product in that Member State shall have the power to review the determination of the date from which the period for the protection of the data relating to the reference medicinal product begins.
Rights of the marketing authorisation holder of a medicinal product
The marketing authorisation holder for a medicinal product must tolerate that, in order to obtain an authorisation to place that other medicinal product on the market, the manufacturer of another medicinal product may refer to the results of pre-clinical tests and clinical trials contained in the application dossier for marketing authorisation for the first medicinal product instead of carrying out such trials himself (judgment of 23 October 2014, Olainfarm (C 104/13)).
However, the holder of a marketing authorisation for a medicinal product is entitled by Art. 10 of the EU Directive to require that this medicinal product not be used as a reference medicinal product or not be placed on the market before the expiry of the period of ten years from the granting of this marketing authorisation. This is renewable for a maximum of 1 year: if the application is for a new indication of an already well-established active substance, a non-cumulative exclusivity period of one year is granted for the data, provided that significant pre-clinical or clinical studies have been carried out in relation to the new indication.
It follows that the holder of the marketing authorisation for the reference medicinal product has the right to appeal against the decision of the competent authority granting the marketing authorisation for the generic medicinal product in order to ensure that the data protection of the reference medicinal product is maintained. He may appeal against the determination of the date on which the period for the protection of documents begins in the context of that appeal.
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