Case T-52/09

Nycomed Danmark ApS

v

European Medicines Agency (EMA)

(Medicinal products for human use – Authorisation to place a medicinal product on the market – Regulation (EC) No 1901/2006 – Application for a waiver from the obligation to submit a paediatric investigation plan − Rejection by the EMA − Misuse of powers)

Summary of the Judgment

1.      Approximation of laws – Medicinal products for human use – Authorisation to market –Medicinal products for paediatric use – Diagnostic products – Decision of the European Medicines Agency refusing a waiver of the obligation to submit a paediatric investigation plan

(European Parliament and Council Regulation No 1901/2006)

2.      Approximation of laws – Medicinal products for human use – Authorisation to market – Medicinal products for paediatric use – Diagnostic products – Decision of the European Medicines Agency refusing a waiver of the obligation to submit a paediatric investigation plan

(European Parliament and Council Regulation No 1901/2006)

3.      Approximation of laws – Medicinal products for human use – Authorisation to market – Medicinal products for paediatric use – Diagnostic products – Decision of the European Medicines Agency refusing a waiver of the obligation to submit a paediatric investigation plan

(European Parliament and Council Regulation No 1901/2006)

4.      Approximation of laws – Medicinal products for human use – Authorisation to market – Medicinal products for paediatric use – Diagnostic products – Decision of the European Medicines Agency refusing a waiver of the obligation to submit a paediatric investigation plan

(European Parliament and Council Regulation No 1901/2006)

1.      In so far as it is based on an alleged misinterpretation of Article 11(1)(b) of Regulation No 1901/2006 on medicinal products for paediatric use, an action for annulment brought against a decision of the European Medicines Agency (EMA) rejecting a company’s application for a waiver with respect to the obligation to submit a paediatric investigation plan in the context of the marketing authorisation procedure for a diagnostic product in accordance with that regulation must be rejected, since, pursuant to the interpretation of the provision adopted in that decision, the purpose of a medicinal product must be assessed objectively, after taking into consideration merely the properties of that medicinal product.

That provision refers to the disease or condition for the treatment (or, in the case of a diagnostic, diagnosis) of which the specific medicinal product is ‘intended’, without mentioning the word ‘indication’, although the word ‘indication’ is used, in other contexts, by Regulation No 1901/2006, such as in Article 11(2) thereof.

Taking a teleological approach, the opposed interpretation, according to which a medicinal product cannot be regarded as being intended for the diagnosis of diseases or conditions other than those corresponding to the indication chosen by its promoter, if it were adopted, would give pharmaceutical companies the opportunity to circumvent with ease their obligations under Regulation No 1901/2006, since, in order to obtain a waiver of those obligations, it would be enough for them to restrict sufficiently the scope of the indication of the medicinal products they develop. In particular, a company which had designed a medicinal product for detecting a sign that is characteristic of diseases affecting both the adult and the paediatric populations would need only to propose an indication excluding the paediatric population from its scope in order to be sure of obtaining a waiver. However, in such a case, the absence of suitably adapted medicinal products for the paediatric population, at least for diagnosis, would not be overcome, although that is one of the objectives of Regulation No 1901/2006.

Moreover, as provided in the second sentence of Article 6(2) of that regulation, the Paediatric Committee is to take into account any information available to it, which argues against such an interpretation. On the other hand, the interpretation made in the contested decision complies with the role and competencies granted by Regulation No 1901/2006 to that committee. It allows it to establish, by a reasoned opinion based on scientifically-reasoned, objective evidence, that the diagnostic product at issue permits detection of a sign that may be associated not only with the diseases or conditions covered by the indication proposed by its promoter, but also with one or more other diseases or conditions which exist in the paediatric population, in particular. In such a case, the EMA is obliged to reject the waiver application unless the applicant, under the administrative procedure introduced by Regulation No 1901/2006, manages to rebut that contention, by demonstrating to the Paediatric Committee, on the basis of objective evidence, that the medicinal product concerned permits detection only of signs attributable to diseases or conditions that exist only in the adult population.

(see paras 52-53, 62-64, 67)

2.      In so far as it is based on an alleged infringement of the principles of the freedom to conduct a business and of proportionality arising from an alleged misinterpretation of Article 11(1)(b) of Regulation No 1901/2006 on medicinal products for paediatric use, an action for annulment brought against a decision of the European Medicines Agency (EMA) rejecting a company’s application for a waiver with respect to the obligation to submit a paediatric investigation plan in the context of the marketing authorisation procedure for a diagnostic product in accordance with that regulation must be rejected, since pursuant to the interpretation of the provision adopted in that decision, the purpose of a medicinal product must be assessed objectively, after taking into consideration merely the properties of that medicinal product.

That interpretation limits the opportunity of obtaining a waiver of the obligation to submit a paediatric investigation plan and, in doing so, ultimately constitutes a restriction of the right of pharmaceutical companies to conduct their business freely. However, it must be held that the restriction of that right, which seeks to achieve a general-interest objective pursued by Regulation No 1901/2006, namely, to improve medical care for the paediatric population, does not affect the actual substance of that right, since the opportunities of obtaining a marketing authorisation are not, in fact, either totally removed or even excessively reduced.

That is all the more so since Articles 20(1), 22 and 36(1) of Regulation No 1901/2006 temper the disadvantages of the interpretation of Article 11(1)(b) of Regulation No 1901/2006 adopted in that decision.

(see paras 91-96)

3.      In so far as it is based on an infringement of the principles of legal certainty and the rule of law arising from an alleged misinterpretation of Article 11(1)(b) of Regulation No 1901/2006 on medicinal products for paediatric use, an action for annulment brought against a decision of the European Medicines Agency (EMA) rejecting a company’s application for a waiver with respect to the obligation to submit a paediatric investigation plan in the context of the marketing authorisation procedure for a diagnostic product in accordance with that regulation must be rejected, since pursuant to the interpretation of the provision adopted in that decision, the purpose of a medicinal product must be assessed objectively, after taking into consideration merely the properties of that medicinal product.

The EMA adopts decisions under that provision in the exercise of circumscribed powers and not as a matter of discretion. After taking into account the opinion of the Paediatric Committee, which merely establishes the facts on the basis of scientifically-reasoned, objective evidence, the EMA is obliged to grant the waiver sought if the relevant conditions are met. If not, it is obliged to refuse to grant it.

Therefore, if the interpretation contained in the contested decision is accepted, the principles of legal certainty and the rule of law will not be affected in any way. In those circumstances, rejection of an application for waiver of the obligation to submit a paediatric investigation plan will be based on objective, scientific evidence known to the person concerned. That person will also be able to challenge that evidence effectively before the final decision is adopted, under the administrative procedure laid down in Articles 13 and 25 of Regulation No 1901/2006.

(see paras 98-100)

4.      In so far as it is based on the existence of a misuse of powers, an action for annulment brought against a decision of the European Medicines Agency (EMA) rejecting a company’s application for a waiver with respect to the obligation to submit a paediatric investigation plan in the context of the marketing authorisation procedure for a diagnostic product in accordance with Regulation No 1901/2006 on medicinal products for paediatric use must be rejected.

The concept of misuse of powers refers to cases where an administrative authority has used its powers for a purpose other than that for which they were conferred on it. A decision may amount to a misuse of powers only if it appears, on the basis of objective, relevant and consistent evidence, to have been taken for purposes other than those stated. Therefore a misuse of powers can arise only when the authority concerned enjoys wide discretion. However, misuse of powers is not possible in connection with the exercise of circumscribed powers.

In so far as both the actions of the Paediatric Committee, which are confined to drawing up opinions after establishing the facts on the basis of scientifically-reasoned, objective evidence, and the decisions taken by the EMA in response to applications for waiver of the obligation to submit a paediatric investigation plan laid down in Article 11(1)(b) of Regulation No 1901/2006 are indeed taken in the exercise of circumscribed powers, there can be no question of misuse of powers in such cases.

(see paras 103-105)