In December 2020, the European Commission granted a conditional marketing authorisation for Comirnaty®, which required the marketing authorisation holder (BioNTech) to provide additional data on the characterisation of the active substance and the finished product.

In 2021, a citizen requested access to this information from the European Medicines Agency (EMA). The EMA granted partial access, but withheld certain technical data to protect BioNTech’s commercial interests.

The applicant challenged this decision before the General Court of the European Union (GCEU), which was called upon to determine whether there was an overriding public interest justifying disclosure of the redacted information.

Nature of the redacted information

Before examining whether an overriding public interest existed, the GCEU first analysed the nature of the redacted information. It consisted of trial results relating to the characterisation of the active ingredient and the finished product, as well as the technical parameters used to conduct those trials. This was therefore highly technical information, derived from BioNTech’s specific scientific know-how.

The EMA argued that, given the innovative nature of the technology, its disclosure would enable competitors operating in the same therapeutic field to save scientific effort and human and economic resources.

The GCEU accepts this reasoning and concludes that the redacted data constitutes commercially sensitive information, the disclosure of which could harm BioNTech’s commercial interests. Furthermore, the Court recalls that Regulation (EC) No 1049/2001 on public access to documents does not require the harm to be quantified, nor does it require a detailed market analysis to assess it. It is sufficient that the risk of harm be reasonably foreseeable and not merely hypothetical, unless an overriding public interest justifies disclosure.

What about the public interest?

Having confirmed the commercially sensitive nature of the information, the GCEU turned to the question of whether an overriding public interest nevertheless justified disclosure.

The Court is clear on this point: where access to documents is refused by the public authority, it is for the applicant to demonstrate the existence of such an overriding public interest. A general invocation is insufficient. The applicant must demonstrate, in concrete terms, that disclosure specifically contributes to protecting the public interest. Accordingly, public authorities are not required to assess ex officio whether such an overriding public interest exists.

In the present case, the Court agrees with the EMA that the redacted information was limited in scope, and strictly technical, and likely to benefit BioNTech’s competitors if disclosed. Granting access would therefore upset the balance struck by the European legislation between companies’ obligation to provide sensitive information to the EMA and the strong protection given to that information under professional and commercial secrecy.

What happens if the information has already been leaked?

Directive (EU) 2016/943 and Spanish Law 1/2019 on Trade Secrets define a trade secret as information that is secret, that has commercial value precisely because it is secret, and that has been subject to reasonable measures by its owner to keep it secret.

This classification allows access to be refused where disclosure would cause economic harm to its owner.

In this context, the question arises as to what happens if such secret information is leaked.

In this case, part of the redacted information had been disseminated online following a cyberattack on the EMA. The Court examines whether such a leak altered the legal assessment.

The Court’s response is unequivocal: unauthorised disclosure does not automatically render that information publicly accessible for the purposes of the rules on freedom of information and access to public documents.

Conclusions

Three main conclusions can be drawn from this Judgment:

First, no quantification of harm is required. It is sufficient that the risk to commercial interests be reasonably foreseeable. This issue remains controversial at national level, for example in relation to access to pricing and reimbursement decisions.
Second, public authorities are not required to assess ex officio whether an overriding public interest exists. The burden of proof lies with the applicant who has been denied access to specific information.

Third, a leak or unauthorised disclosure of part of the requested information does not prevent the remaining information from continuing to merit protection.

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The precise and unambiguous definitions of “active substance” and “similar active substance” is essential in the field of medicinal products for rare diseases: the so-called “orphan medicinal products”.

Regulation (EC) 847/2000, where the definitions of “active substance” and “similar active substance” are contemplated, was recently amended by Regulation (EU) 2018/781, effective as of  19 June. Changes introduced by this new Regulation (mainly referring to the definition of “similar active substance” as opposed to “same active substance”) are theoretically limited to the field of rare diseases. However, it is to be noted that the content of such changes may be useful in other fields in which a calm reflection on the terms and scope of the terms “active substance” and “similar active substance” is also necessary. This is the case, for example, of the new reference price system for medicines of the National Health System announced by the MoH earlier this year.

Regulation (EU) 2018/781

Two are the main amendments introduced by the new European Regulation which deserve special attention. The first of them is the deletion of the “active substance” definition contained in Regulation (EC) 847/2000 which differed from the same term defined in Directive 2001/83/EC. Such deletion is due to the fact that the Commission was not empowered to modify, through implementing regulations (such as Regulation (EC) 847/2000), the legal term of “active substance” already defined in the above-mentioned Directive. The second relevant amendment is the development and clarification of the term “similar active substance”. In this regard, the new Regulation accurately determines what “principal molecular structural features” should mean, which has been the only criterion used so far for the similarity assessment between two active substances.

Additionally, the new Regulation incorporates an additional criterion to assess similarity between certain kinds of medicines such as advanced therapy medicinal products. This criterion refers to the evaluation of the active substances to be compared on the basis of their biological and functional characteristics.

New rules regarding the reference price system

Several considerations arise from the new Regulation, which may be useful in connection with the announced amendment of the reference price system in Spain. First, we consider that changes must be addressed carefully to prevent them from altering the current definition of “active substance” which, as this new Regulation reminds us, is a well-established definition of in the Community legislation. Second, the precise definition provided by Regulation (EU) 2018/781 of “similar active substance”, as opposed to “identical active substance”, is something that, in our opinion, should be considered by Spanish authorities when defining the term of “same active substance” in the context of the Spanish reference price system.

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The former Royal Decree 2208/1994, which was repeated, introduced a transitory provision, according to which companies marketing homeopathic medicinal products in Spain could continue marketing such products as long as they had submitted an application to obtain a marketing authorization within 6 months following the entry into force of such Royal Decree. Later on, such provision was regulated by the sixth transitory provision of Royal Decree 1345/2007, which provided that companies marketing these medicinal products must submit a communication to the AEMPS indicating their intention to follow the registration procedure foreseen for these products in said Royal Decree 1345/2007. The period for sending such communication was 3 months from the entry into force of the order of the MOH, establishing the minimum requirements and the procedure to be followed in order to make such communication.

The order SSI/425/2018 has come to implement these provisions, providing that those companies which are marketing these medicinal products and which are interested in continuing doing so, must send a communication through the website enabled by the AEMPS within the  corresponding period, providing the information required and, in particular, informing whether or not the product in question will claim certain therapeutic indications. If such period elapses without sending any such communication, the company will not be able to continue marketing these medicinal products, which must be withdrawn from the market.

Once the period for the submission of communications has ended, the AEMPS will have a maximum period of 3 months to set a timetable so that companies that communicated their intention to register their products may submit the corresponding marketing authorization applications.

According to the provisions of Royal Decree 1345/2007, the ordinary registration procedure must be followed, attending to the specific characteristics of this type of medicinal products. However, there is a simplified procedure available for products having an oral or external administration route, provided that no specific therapeutic indications are claimed and that the degree of dilution of such product ensures its safety. If the application is not submitted in accordance with the established timetable, companies must proceed to withdraw the product from the market.

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This case refers to the position taken by the European Medicines Agency (“EMA”) in relation to an application filed by Shire to obtain orphan designation for Idursulfase-IT. The EMA rejected to validate such application on the grounds that Idursulfase-IT contained the same active substance (“API”) as that of Elaprase®, another medicinal product for which Shire had previously obtained orphan designation and a marketing authorization.

The EMA did not give value to the fact that Idursulfase-IT had been developed so that it would be possible to deliver its API directly into the cerebrospinal fluid through intrathecal administration. This new route of administration, according to Shire, met an unsatisfied clinical need for treatment of some patients with Hunter Syndrome: the ones suffering from a severe form of that disease with cognitive disorders. Shire considered that the medical condition that Idursulfase-IT could treat was different from the common Hunter Syndrome.

Court’s position and local consideration

In its judgement, the Court departs from the idea that the sole fact that both Idursulfase IT and Elaprase® contain the same API does not necessarily mean that they are the same medicinal product. The API, the Court says, is the main constituent of a medicinal product but it must not be confused with the medicinal product itself.

In order to assess the differences between two medicinal products, the Court understands it is necessary and reasonable to take into account their methods of administration and the therapeutic effects that may be achieved using one or the other. In this case, the Court argues that the intrathecal administration of Idursulfase-IT allows the API to be delivered directly into the cerebrospinal fluid, and this results in the possibility of treating the cognitive disorders exhibited by some of the patients suffering from Hunter Syndrome. Considering this, the Court concludes that the EMA should not have refused to validate the application for the orphan designation because at least in respect of the route of administration it does not seem that Idursulfase-IT should be considered the same medicinal product as Elaprase ®.

As a local consideration, in our opinion these ideas of the Court should inspire new rules on reference prices in Spain. At present, products containing the same API are included in the same reference price group and their price is determined only taking into account the unitary price of the API of the product having the lowest price in the group. This is known as the reference price system.

The products for which a new route of administration has been developed that may result in a significant clinical benefit for the patient deserve special treatment, and their price should not be determined only taking into account the unitary price of the API of the product having the lowest price in the group.

Otherwise, companies may be bound not to market some of the products, and research on improvements which may be beneficial to patients may be unfairly harmed.

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