SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – Preparation Authorisation under the SoHO Proposal

The SoHO proposal introduces the procedure for obtaining an authorisation for SoHO preparations by the introduction of an EU-wide procedure. SoHO preparations are defined as a particular type of SoHO that:

(a) has been subjected to one or more SoHO activities, including processing, in accordance with defined quality and safety parameters;

(b) meets a pre-defined specification; and

(c) is intended for application to a recipient for a specific clinical indication or is intended for distribution for the manufacture of a product regulated by other Union legislation, or as the starting and raw material thereof.

Any entity wishing to conduct such SoHO preparations must file for a specific authorisation, defined in article 3 (25) as ‘the formal approval by a competent authority of a SoHO preparation, including the approval of the chain of activities carried out to obtain the SoHO preparation.’ Currently, the Tissue and Cell Directive only requires tissue establishments (and procurement organizations) to be authorised, including their activities. The Blood Directive also merely requires an authorisation for undertaking activities as a blood establishment. The new SoHO proposal introduces the requirement of an up-front risk assessment and imposes the collection of clinical outcome data.

The introduction of such authorization for SoHO preparations does not simplify the obligations imposed upon actors active in the SoHO sector, as this was not required sensu stricto under the BTC framework. This is, a fortiori, the case for manufacturers of ATMP’s whose process will now require an additional SoHO authorisation on top of the ATMP manufacturing and marketing authorisations.

Concerns in light of the exclusivity and confidentiality of the information contained in the SoHO preparation authorisations:

Recital 30 and article 22.3 of the proposal will create legal uncertainty and could cause substantial criticism, as the clinical evidence and potentially sensitive commercial information provided in the context of the first authorisation for a SoHO preparation authorisation by one applicant may not have to be reproduced by a subsequent and different applicant for the same preparations. Please read our article (Lexxion: First Assessment of the SoHO Proposal for a New Legislation on Blood, Tissues and Cells (The SoHO Regulation)) to see which information exactly is provided by the applicants of preparation authorisations, as it could be shared by the competent authorities. Besides all this crucial clinical data that is provided to the competent authorities, it is most likely that other – possibly commercial sensitive – data will also be made available to them.

Recital 30 of the proposal states: ‘In order to facilitate innovation and reduce administrative burden, SOHO competent authorities should share with each other information on the authorisation of new SoHO preparations and the evidence used for such authorisations, including for the validation of certified medical devices used for SoHO collection, processing, storage, or application to SoHO recipients. Such sharing could allow SoHO competent authorities to accept previous authorisations granted to other SoHO entities, including in other Member States and to thus significantly reduce the requirements to generate evidence.’  The cited recital creates certain concerns in the light for instance of confidential commercial information provided by an application of SoHO preparations. In top of that, there is no data exclusivity, nor specific protection given to the SoHO preparation authorisation dossiers. This may become a substantial issue in terms of protection of innovation and fair competition, as clinical evidence provided in the context of the first authorisation for a SoHO preparation authorisation, as set out above, will de facto possibly not have to be reproduced by the subsequent applicants.

Article 22.3 of the proposal implements the above-mentioned recital 30: ‘In cases where the SoHO preparation subject to the application for authorisation pursuant to Article 21 has been duly authorised in another SoHO entity in the same or in another Member State, SoHO competent authorities may authorise that SoHO preparation in the applicant SoHO entity, provided that the SoHO competent authorities have verified, with the consent of SoHO entities implied,  that the SoHO activities performed and the steps of the processing applied for the SoHO preparation are carried out by the applicant in a manner such that the quality, safety and effectiveness results of the SoHO preparation will be equivalent to those demonstrated in the SoHO entity where the SoHO preparation was first authorised.’ (Bold emphasis indicates Council’s mandate of the 7^th of November 2023)

Firstly, the current proposal does not define how this equivalence assessment will be performed and demonstrated. Such crucial, yet undefined provisions may become an important source of legal uncertainty. Secondly, the Council added to the European Commission’s proposal, that SoHO competent authorities must verify, ‘with consent from SoHO entities implied’, that the applicant SoHO entity performs activities and processing steps for the SoHO preparation in a manner ensuring equivalent quality, safety, and efficacy results. It is not further specified to which SOHO entities exactly is being referred to (the SoHO entity to whom the initial authorisation is granted, the new SoHO entity-applicant or both and all other concerned). We suppose the Council refers at least to the SoHO entity holding the initial SoHO preparation authorisation.

We suppose the Council’s amendment came following the reactions in the ATMPs sector as well as following our article (Lexxion: First Assessment of the SoHO Proposal for a New Legislation on Blood, Tissues and Cells (The SoHO Regulation)) in which we highlighted the risks generated by this provision for sensitive commercial data of the original SoHO preparation authorisation holder.

Even though there is still a certain margin of interpretation, we understand the revised Article 22.3 of the Proposal, as explicitly requiring that the initial SoHO entity must give prior consent to the authorities to share information contained in its initial dossier. This information is necessary for assessing the equivalence of the new SoHO preparation in terms of quality, safety, and efficacy. This requirement would, a fortiori, apply to data qualifying as commercial confidential information under EU and national transparency regulations. However, it remains a question what discretion would be left to the competent authority if the original holder of the SoHO preparation authorisation were to refuse sharing any information in this regard.

Also, even though article 20 (3) imposes an obligation upon competent authorities to submit information regarding the SoHO preparation authorisations to the EU SoHO Platform, article 22 (3) does not oblige national competent authorities to follow other Member States’ decision to grant a preparation authorisation. Consequently, Member States maintain full discretion in granting or refusing the SoHO preparation authorisation, irrespective of the results of the above-mentioned equivalence assessment, i.e., whether the applicant’s quality, safety, and effectiveness results of the SoHO preparation are equivalent to those demonstrated in the first authorised SoHO preparation.

This means that, on the one hand, Member States are obliged to submit all data necessary for the assessment of preparation authorization to the EU SoHO platform. While, on the other hand, Member States maintain the discretionary power to decide on whether or not to grant the preparation authorization, irrelevant to the status of the (same or equivalent) authorisation in another Member States.

Finally, it is important to stress that national legislation protecting confidential commercial information remains fully applicable. Article 75 of the SoHO Proposal on “confidentiality” endorses the latter as follows: “Unless otherwise provided for in this Regulation or in national legislation on confidentiality, and without prejudice to Regulation (EC) No 1049/2001 of the European Parliament and of the Council, each party involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the effective implementation of this Regulation, in particular for the purpose of authorisations, inspections, investigations or Commission verifications.” (Bold emphasis indicates Council’s mandate of the 7^th of November 2023).

Nevertheless, the provisions regarding SoHO preparation authorisations lack explicit reference to the impacts of national law in this regard. A thoughtful acknowledgment of the interplay between national laws safeguarding confidential commercial information and the preparation authorisation provisions in the SoHO proposal would greatly benefit all stakeholders involved.

If you are interested in learning more about this topic, you can find the link to our detailed article in the European Health & Pharmaceutical Law Review. Read the full article here.

To read our first article on this topic, click here: SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin (bio-talk.law)