Case C‑104/13

Olainfarm AS

v

Latvijas Republikas Veselības ministrija

and

Zāļu valsts aģentūra

(Request for a preliminary ruling from the Augstākās Tiesas Senāts)

‛Reference for a preliminary ruling — Approximation of laws — Industrial policy — Directive 2001/83/EC — Medicinal products for human use — Article 6 — Marketing authorisation — Article 8(3)(i) — Requirement to attach to the application for authorisation the results of pharmaceutical pre-clinical tests and clinical trials — Derogations relating to pre-clinical tests and clinical trials — Article 10 — Generic medicinal products — Concept of ‘reference medicinal product’ — Whether the holder of a marketing authorisation for a reference medicinal product has an individual right to oppose the marketing authorisation of a generic of the reference product — Article 10a — Medicinal products of which the active substances have been in well-established medicinal use within the European Union for at least 10 years — Whether it is possible to use a medicinal product for which authorisation has been granted on the basis of the derogation provided for in Article 10a as a reference medicinal product for the purpose of obtaining a marketing authorisation for a generic product’

Summary — Judgment of the Court (Fifth Chamber), 23 October 2014

1. Approximation of laws — Medicinal products for human use — Marketing authorisation — Abridged procedure — Generic of a reference medicinal product — Concept of reference medicinal product — Medicinal product based on active substances that have been in well established medicinal use — Included

   (European Parliament and Council Directive 2001/83, as amended by Regulation No 1394/2007, Arts 8(3)(i), 10(2)(a) and 10a and Annexe I)

2. Approximation of laws — Medicinal products for human use — Marketing authorisation — Abridged procedure — Generic of a reference medicinal product — Whether the holder of a marketing authorisation for a reference medicinal product has the right to challenge in legal proceedings the decision to register the generic product — Scope

   (Charter of Fundamental Rights of the European Union, Art. 47; European Parliament and Council Directive 2001/83, as amended by Regulation No 1394/2007, Art. 10)

1.  The concept of ‘reference medicinal product’ within the meaning of Article 10(2)(a) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Regulation No 1394/2007, must be interpreted as encompassing a medicinal product for which the marketing authorisation was granted on the basis of Article 10a of the directive.

   The procedure governed by Article 10a of Directive 2001/83 does not provide for any relaxation of the requirements of safety and efficacy which must be met by medicinal products, that procedure being simply designed to reduce the preparation period for a marketing authorisation application by relieving the applicant of the obligation to perform the preclinical tests and clinical trials referred to in Article 8(3)(i) of Directive 2001/83, provided that it is established by means of appropriate scientific literature, in accordance with the requirements laid down in Section 1 of Part II of Annex I to the directive, that those tests and trials have been carried out previously and have demonstrated that the constituent or constituents of the medicinal product concerned satisfy the criteria set out in Article 10a of the directive. Accordingly, such a medicinal product may be placed on the market only after the competent authority has verified its safety and efficacy.

   (see paras 29, 32, operative part 1)

2.  On a proper construction of Article 10 of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Regulation No 1394/2007, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, the holder of the marketing authorisation for a medicinal product used as a reference product in an application for a marketing authorisation under Article 10 of the directive for a generic product of another manufacturer has the right to a judicial remedy enabling him to challenge the decision of the competent authority which granted the marketing authorisation for the generic product, provided that that holder is seeking judicial protection of a right conferred on him by Article 10. Such a judicial remedy exists, inter alia, where the holder demands that his medicinal product is not to be used for the purpose of obtaining, under Article 10, a marketing authorisation for another medicinal product in relation to which his own product cannot be regarded as a reference product within the meaning of Article 10(2)(a) of the directive.

   Article 10 of Directive 2001/83 confers a concomitant right on the holder of the marketing authorisation for the reference medicinal product to demand observance of the rights attaching to him by virtue of the conditions under which the manufacturer of another medicinal product is entitled to refer to the results of pre-clinical tests and clinical trials contained in the dossier relating to the application for marketing authorisation for the former product. Accordingly, by virtue of Article 10 of Directive 2001/83, read in conjunction with Article 47 of the Charter, such a right holder is entitled to judicial protection in so far as concerns respect for his rights.

   (see paras 37, 39, operative part 2)

Case C‑104/13

Olainfarm AS

v

Latvijas Republikas Veselības ministrija

and

Zāļu valsts aģentūra

(Request for a preliminary ruling from the Augstākās Tiesas Senāts)

‛Reference for a preliminary ruling — Approximation of laws — Industrial policy — Directive 2001/83/EC — Medicinal products for human use — Article 6 — Marketing authorisation — Article 8(3)(i) — Requirement to attach to the application for authorisation the results of pharmaceutical pre-clinical tests and clinical trials — Derogations relating to pre-clinical tests and clinical trials — Article 10 — Generic medicinal products — Concept of ‘reference medicinal product’ — Whether the holder of a marketing authorisation for a reference medicinal product has an individual right to oppose the marketing authorisation of a generic of the reference product — Article 10a — Medicinal products of which the active substances have been in well-established medicinal use within the European Union for at least 10 years — Whether it is possible to use a medicinal product for which authorisation has been granted on the basis of the derogation provided for in Article 10a as a reference medicinal product for the purpose of obtaining a marketing authorisation for a generic product’

Summary — Judgment of the Court (Fifth Chamber), 23 October 2014

1. Approximation of laws — Medicinal products for human use — Marketing authorisation — Abridged procedure — Generic of a reference medicinal product — Concept of reference medicinal product — Medicinal product based on active substances that have been in well established medicinal use — Included

   (European Parliament and Council Directive 2001/83, as amended by Regulation No 1394/2007, Arts 8(3)(i), 10(2)(a) and 10a and Annexe I)

2. Approximation of laws — Medicinal products for human use — Marketing authorisation — Abridged procedure — Generic of a reference medicinal product — Whether the holder of a marketing authorisation for a reference medicinal product has the right to challenge in legal proceedings the decision to register the generic product — Scope

   (Charter of Fundamental Rights of the European Union, Art. 47; European Parliament and Council Directive 2001/83, as amended by Regulation No 1394/2007, Art. 10)

1.  The concept of ‘reference medicinal product’ within the meaning of Article 10(2)(a) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Regulation No 1394/2007, must be interpreted as encompassing a medicinal product for which the marketing authorisation was granted on the basis of Article 10a of the directive.

   The procedure governed by Article 10a of Directive 2001/83 does not provide for any relaxation of the requirements of safety and efficacy which must be met by medicinal products, that procedure being simply designed to reduce the preparation period for a marketing authorisation application by relieving the applicant of the obligation to perform the preclinical tests and clinical trials referred to in Article 8(3)(i) of Directive 2001/83, provided that it is established by means of appropriate scientific literature, in accordance with the requirements laid down in Section 1 of Part II of Annex I to the directive, that those tests and trials have been carried out previously and have demonstrated that the constituent or constituents of the medicinal product concerned satisfy the criteria set out in Article 10a of the directive. Accordingly, such a medicinal product may be placed on the market only after the competent authority has verified its safety and efficacy.

   (see paras 29, 32, operative part 1)

2.  On a proper construction of Article 10 of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Regulation No 1394/2007, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, the holder of the marketing authorisation for a medicinal product used as a reference product in an application for a marketing authorisation under Article 10 of the directive for a generic product of another manufacturer has the right to a judicial remedy enabling him to challenge the decision of the competent authority which granted the marketing authorisation for the generic product, provided that that holder is seeking judicial protection of a right conferred on him by Article 10. Such a judicial remedy exists, inter alia, where the holder demands that his medicinal product is not to be used for the purpose of obtaining, under Article 10, a marketing authorisation for another medicinal product in relation to which his own product cannot be regarded as a reference product within the meaning of Article 10(2)(a) of the directive.

   Article 10 of Directive 2001/83 confers a concomitant right on the holder of the marketing authorisation for the reference medicinal product to demand observance of the rights attaching to him by virtue of the conditions under which the manufacturer of another medicinal product is entitled to refer to the results of pre-clinical tests and clinical trials contained in the dossier relating to the application for marketing authorisation for the former product. Accordingly, by virtue of Article 10 of Directive 2001/83, read in conjunction with Article 47 of the Charter, such a right holder is entitled to judicial protection in so far as concerns respect for his rights.

   (see paras 37, 39, operative part 2)