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[PUBLICATION] The life Sciences department signs the France chapter of “Healthcare Enforcement & Litigation 2024”
New distinction for the Healthcare Industries Department, in the Who’s Who Legal ranking
New publication for the Health Industries department in Legal Business Magazine
Distinction of the LifeSciences Department in TIER 2 of the Legal 500 EMEA 2023
New European regulations on substances of human origin (SoHO)
If you only have 30 seconds
On 13 June 2024, the European Parliament and the Council adopted Regulation (EU) 2024/1938 (1) (hereinafter referred to as the “SoHO Regulation”), laying down new quality and safety standards for substances of human origin intended for human use. This regulation marks a crucial step in improving health and safety practices in the European Union and harmonizes European standards for substances of human origin (hereinafter “SoHO”).
This new, broader legislative framework introduces enhanced traceability and monitoring requirements. One of the major objectives is to encourage innovation and the development of new therapies while ensuring patient safety. It therefore includes specific provisions designed to encourage research and development in the field of substances of human origin, while maintaining high safety standards.
The competent authorities in the Member States will be responsible for ensuring that these new standards are implemented and complied with, with the support of the European Medicines Agency (EMA). Regular inspections and audits will be carried out to ensure that practices are compliant.
By adopting the SoHO regulation, the European Union is reaffirming its commitment to protecting public health by ensuring that substances of human origin meet the highest standards of quality and safety. It will come into force on 7 August 2027.
1- Why these new regulations?
- Two European directives have formed the basis of the regulations governing blood and blood components (2) and human tissues and cells (3) for the last twenty years.
- A need to harmonise Member States’ rules following the observation that there are too many discrepancies between the various national rules, likely to create obstacles to the sharing of such substances.
- The need to put in place a regulatory framework that is up to date with scientific advances and new technologies.
- The shortage of substances of human origin, amplified since the Covid-19 pandemic (4).
2- Extending the scope of the regulation
- The new European regulation will replace the directives on blood, tissues and cells that have been in force for some twenty years (5).
- The introduction of the term “substances of human origin”, defined as any substance taken from the human body, whether or not it contains cells and whether or not these cells are living, including preparations based on a substance of human origin resulting from the processing of such a substance, will make it possible to cover not only blood, tissues and cells, but also human breast milk, intestinal microbiota and any other substance of human origin likely to be applied to humans in the future. (6) Excluded are organs intended for transplantation (7) and breast milk used exclusively for feeding one’s own child, without processing by an SoHO entity.
- The SoHO Regulation will cover all activities relating to substances of human origin, from the registration of SoHO donors, sampling, distribution, release and processing to human application. This non-exhaustive list is given in Article 2 of the above-mentioned regulation. The persons concerned by this regulation are SoHO donors, recipients and “offspring resulting from medically assisted procreation” (8).
- Regulations and regulated products :
The Regulation applies when SoHO is intended for human application or when it is collected for the manufacture of medical devices (hereinafter MDs), advanced therapy medicinal products or investigational medicinal products (9), under the conditions detailed below:
|
Context |
Application of the regulations |
|
In the case of SoHO used to manufacture medical devices or medicines |
The provisions relating to donor registration, donor background checks and medical examination, testing of donors or persons from whom SoHO is collected for autologous use or intra-relational use and release shall apply. |
|
Insofar as SoHO-related activities are carried out on SoHO up to and including their distribution to a manufacturer regulated by other EU legislation |
The regulation also applies to storage, distribution, import and export activities. |
|
When SoHO is used to manufacture regulated products that are exclusively intended for therapeutic use on the person from whom the SoHO was taken |
The provisions of the regulation relating to the control of donors or persons from whom SoHO is collected for autologous use or intra-relational use and to collection apply. |
|
When non-viable SoHO or their derivatives are incorporated as an integral part of a DM, and when their action is essential to that of a DM |
The regulations apply to non-viable SoHOs or their derivatives and to the final combination. |
|
If the action of non-viable SoHO or their derivatives is ancillary to that of the DM |
The Regulation applies to all SoHO-related activities to which non-viable SoHO or their derivatives are subject up to and including their distribution for incorporation into the DM/ The final combination is subject to Regulation (EU) 2017/745. |
|
In an autologous context without any processing or storage, as in the case of closed-system DM used in an autologous context (e.g. haemodialysis, recovery of red blood cells during surgery). |
The regulations do not apply. |
|
In the case of transformation of SoHO at the patient’s bed or as part of the same surgical procedure using DM whose quality, safety and efficacy have not been demonstrated as part of the CE marking process for this specific purpose |
The regulations apply. |
|
In the event of a conflict over the regulatory status of a particular substance, activity or product, a consultative mechanism between competent authorities is organised to ensure the consistency of the procedures put in place to apply the regulation. |
In the event of disagreement, the Commission is invited, where appropriate, at the request of a Member State or on its own initiative, to decide on the regulatory status of a particular activity, substance or product under the Regulation. |
3- Some of the key measures in this regulation
- Reinforcement of surveillance operations by the competent authorities:
The European Regulation provides for the designation of one or more independent and impartial national competent authorities by each Member State, responsible for the supervision of SoHOs (10). These authorities must have the necessary resources and skills to carry out SoHO surveillance activities. In particular, they will be able to access the premises, samples and documents held by SoHO entities or order the suspension or cessation of SoHO activities presenting immediate risks.
- The establishment of a coordination committee, a compendium and an EU SoHO platform:
The national competent authority of each Member State will have to appoint several members to represent it on the SoHO Coordination Committee (11). The members of the committee will be responsible for assisting the national authorities, in particular by preparing opinions on the regulatory status of certain substances, publishing best practices for monitoring SoHOs and setting criteria for determining critical entities and SoHOs. All these tasks are listed in article 69 of the regulation.
The SoHO compendium will be a list of decisions taken by the Member States on SoHO, kept up to date by the coordination committee and made public on a platform accessible to all (12).
- Tissue and blood transfusion establishments will be reclassified as SoHO entities and establishments:
SoHO entities, defined as entities legally established in the Union which carry out one or more of the SoHO activities referred to in Article 2(1)(c), will have to register (13) on the EU SoHO platform and designate a responsible person (14) before carrying out any SoHO activity. If an entity believes that it meets the criteria for dealing with critical SoHO, it will have to carry out a self-assessment and communicate the result when registering. Responsible persons must be qualified in the medical, pharmaceutical or life sciences field and have a minimum of two years’ experience in the area concerned by the entity in question.
SoHO establishments, defined as SoHO entities carrying out any of the SoHO-related activities of processing, storing, releasing, importing and exporting, will be required to apply for and obtain authorisation in advance (15). In addition to the person in charge, each SoHO establishment will appoint a doctor responsible for a certain number of tasks, such as drawing up, supervising and implementing establishment procedures (16).
- Authorisation of SoHO-based preparations:
SoHO preparations are subject to authorisation prior to release, or even prior to preparation and application in an autologous context, except in the context of the implementation of an approved clinical outcome monitoring plan as part of an authorisation for a SoHO preparation. SoHO entities may seek advice from their competent authorities on the applicability of the pre-authorisation requirements. Competent Authorities may, upon request, grant a waiver of the authorisation requirement in situations of health emergency, or for a specific recipient where justified by clinical circumstances.
- Data collection:
SoHO entities are required to collect and communicate data relating to donor registration, collection, distribution, import, export and human application (17).
The competent authorities for the SoHO entities ensure that the latter transmit an annual report containing these activity data via the EU SoHO platform (18), before 30 June of the following year.
The purpose of collecting this data is to evaluate and, if necessary, authorise new SoHO-based preparations or new indications for these preparations.
- Vigilance and shortages:
A vigilance system is detailed and a rapid alert system must be put in place to deal with serious reactions and incidents affecting recipients or donors. Member States are also encouraged to create national contingency plans including measures to respond to critical shortages.
The European Commission is responsible for compiling the annual summaries sent by the SoHO national authorities and draws up an annual report which includes a structural analysis as well as recommendations (19).
Regulation 2024/1938 states that SoHO entities are responsible for alerting their competent authority when a significant shortage of critical SoHO supply is anticipated. This alert must specify the underlying reasons, the foreseeable effects on recipients and any possible mitigation measures. Article 64 of Regulation 2024/1938 gives details of shortages considered “significant”.
Many other measures will come into force with the application of the SoHO Regulation, from 7 August 2027 (20), the repeal date (21) of the directives on blood products and tissues and cells.
Transitional provisions provide that establishments authorised, approved or licensed in accordance with the above Directives are deemed to be registered as SoHO entities or establishments and are subject to the obligations of the SoHO Regulation (22). Finally, other transitional measures determine the fate of SoHO preparations (23) or stored SoHO (24) before the date of application of the Regulation.
—
(1) Link: https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=OJ%3AL_202401938
(2) Directive 2002/98/EC setting standards of qualitý and safetý for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02002L0098-20090807
(3) Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, link: https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=celex%3A32004L0023
(4) Articles 62 to 64 of Regulation 2024/1938
(5) Directives 2002/98/EC and 2004/23/EC
(6) Article 2 of Regulation 2024/1938
(7) Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation, link: https://eur-lex.europa.eu/eli/dir/2010/53/2010-08-06
(8) Article 2 1.b. of Regulation 2024/1938
(9) Article 2 6. of Regulation 2024/1938
(10) Article 5 of Regulation 2024/1938
(11) Article 68 of Regulation 2024/1938
(12) Article 3 41) of Regulation 2024/1938
(13) Article 35 of Regulation 2024/1938
(14) Article 36 of Regulation 2024/1938
(15) Article 45 of Regulation 2024/1938
(16) Article 50 of Regulation 2024/1938
(17) Article 41 of Regulation 2024/1938
(18) Article 31 of Regulation 2024/1938
(19) Article 33 of Regulation 2024/1938
(20) Article 87 of Regulation 2024/1938
(21) Article 85 of Regulation 2024/1938
(22) Article 81 of Regulation 2024/1938
(23)Article 82 of Regulation 2024/1938
(24)Article 84 of Regulation 2024/1938