Keywords

Summary



Keywords

1. Approximation of laws — Medicinal products for human use — Authorisation to market — Abridged procedure — Global marketing authorisation — Scope — Developments of a medicinal product forming the subject-matter of a separate marketing authorisation and name — Included — No new period of regulatory data protection granted

(European Parliament and Council Regulation No 726/2004; Council Regulation No 2309/93; Commission Regulations No 1085/2003 and No 1234/2008; European Parliament and Council Directive 2001/83, Arts 6(1), and 10(1))

2. Approximation of laws — Medicinal products for human use — Authorisation to market — Abridged procedure — Generic of a reference medicinal product — Exemption from the obligation to provide the results of pharmaceutical, pre-clinical and clinical trials — Objectives

(European Parliament and Council Directive 2001/83, Arts 6(1), 8(3)(i), and 10(1))

3. Approximation of laws — Medicinal products for human use — Authorisation to market –Protection different according to whether national or centralised authorisation procedure used — Not permissible

(European Parliament and Council Regulation No 726/2004; Council Regulation No 2309/93; European Parliament and Council Directive 2001/83; Council Directive 65/65)

Summary

1. The concept of a global marketing authorisation referred to in the second subparagraph of Article 6(1) of Directive 2001/83 on the Community code relating to medicinal products for human use is to be interpreted to the effect that new therapeutic indications, new doses, administration routes and new pharmaceutical forms of the original medicinal product do not enjoy an independent regulatory data protection period. Accordingly, if the marketing authorisation for any additional dosage, pharmaceutical form, route of administration, presentation or any variation or extension of the original medicinal product is included in the global marketing authorisation for that product, the grant of marketing authorisation for such developments does not give rise to an independent regulatory data protection period.

That interpretation is supported by the wording of the second subparagraph of Article 6(1) of Directive 2001/83, which does not make any distinction between a development of the original medicinal product authorised through an amendment of the terms of the initial marketing authorisation and a development of the original medicinal product authorised through the grant of a separate marketing authorisation and name; in both cases, the original medicinal product and any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions, irrespective of whether they were authorised by the grant of a separate marketing authorisation and name or by being included in the terms of the initial marketing authorisation, form part of the same global marketing authorisation for the purpose of applying the regulatory data protection period. The global marketing authorisation is thus given a substantive rather than a formal definition, which means that a global marketing authorisation thus construed may encompass, formally, a number of separate marketing authorisations.

Since the submission of an application for a separate marketing authorisation and a new name for the new medicinal product rather than the submission of an application for variation and extension of the marketing authorisation for the original medicinal product is a commercial decision on the part of the producer, the market strategy of an undertaking cannot affect the application of the regulatory period of data protection. To exclude the possibility of applying an abridged procedure for the issuing of marketing authorisations whenever a subsequently authorised variant of a reference product has been given a new designation would elevate form over substance, and would create an easy route for applicants to gain additional data protection in circumvention of the objectives in the general interest pursued by the establishment of that abridged procedure.

(see paras 45, 46, 52, 59)

2. Article 10(1) of Directive 2001/83 — which provides for the possibility of derogating from the requirement laid down in Article 8(3)(i) of that directive to provide the results of pharmaceutical pre-clinical tests and clinical trials for the purpose of obtaining marketing authorisation for a medicinal product, if the applicant can demonstrate that the medicinal product that is the subject of the application is a generic of a reference medicinal product which has been authorised within the European Union and the regulatory data protection period has expired — seeks to reconcile, on the one hand, the provision of adequate protection for the research and development work undertaken by innovative pharmaceutical companies and, on the other, the wish to avoid excessive testing on humans and animals.

Moreover, the concept of a global marketing authorisation referred to in the second subparagraph of Article 6(1) of Directive 2001/83 takes account of the objective of the ‘abridged’ procedure, which is to save the time and expense needed to gather the results of the pharmacological and toxicological tests and clinical trials, and to avoid the repetition of tests on humans or animals. That objective would clearly be jeopardised if the producer of the original medicinal product were able to extend indefinitely the regulatory period of data protection and thus prevent producers of generic medicinal products from using that product as a reference product when the regulatory data protection period expressly provided for by the legislature in order to reconcile the interests of innovative undertakings and the general interest expired.

(see paras 62, 63)

3. The rules established in Regulations No 2309/93, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products and No 726/2004, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and in Directive 2001/83, on the Community code relating to medicinal products for human use and, formerly, Directive 65/65, on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, cannot be read in isolation from one another and must be read together.

Whereas the rules laid down in the regulations contain a number of provisions that are essentially procedural, the rules laid down in the directive essentially contain substantive provisions regarding the standards to be observed to uphold product quality and protect human health. Therefore, irrespective of the procedure, medicinal products must satisfy the same substantive requirements and may claim the same protection.

An interpretation whereby, under the centralised procedure, unlike national procedures, the holder of a marketing authorisation has the option to apply for a new marketing authorisation for another product containing the same active substance for which access to the centralised procedure has been granted on the basis of innovation-specific access criteria is at odds with the principles established by Regulation No 726/2004. Thus, while, under the rules laid down by Regulation No 2309/93, there were no restrictions as to the number of marketing authorisation applications an applicant could make in respect of a single medicinal product, Article 82(1) of Regulation No 726/2004 now provides that, unless there are objective verifiable reasons relating, in particular, to public health, an applicant can make only one marketing authorisation application for a specific medicinal product under the centralised procedure, whereas Directive 2001/83 imposed no such restrictions for national authorisation procedures.

It cannot be maintained that the application of regulatory data protection rights to medicinal products differs according to whether the products are authorised in accordance with national procedures or with the centralised procedure under Regulation No 2309/93 and, now, under Regulation No 726/2004. The purpose of the eligibility criteria for the centralised procedure is not to enable innovative medicinal products to benefit from a new regulatory period of data protection, even where the product in question is a new variant of a medicinal product authorised previously, the purpose of those criteria being simply to govern access to the centralised procedure.

(see paras 70, 71, 73, 74, 77, 80)