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PHARMABIOTIC RESEARCH INSTITUTE

PRI

The PRI is a non for profit organization supporting its academic and industry members in their effort to develop microbiome-based products.

Lobbying Activity

Response to Biotech Act

11 Jun 2025

The Pharmabiotic Research Institute (PRI) is a non-profit European organisation dedicated to advancing regulatory science for microbiome-based innovations. PRI welcomes the initiative to establish a European Biotech Act to support innovation, scale-up, and competitiveness in the EU biotech sector. 1. PRI calls for explicit inclusion of microbiome-based innovations, which represents a fast-growing and strategic area across biotech domains. Microbiome science is central to current innovation in biotechnology. It also plays a pivotal role in the One Health concept. A loss of microbiome diversity is associated with an increased risk of disease in humans, animals, plants as well as reduced soil fertility. Given this large potential, microbiome innovations include medicinal products, novel diagnostics, biostimulants, food and feed, cosmetics, and more. These technologies, often based on complex living systems, directly align with the goals of the Biotech Act, yet remain underrepresented in policy discussions. 2. One of the most pressing challenges for microbiome innovation in the EU is the lack of coherent regulatory pathways. Existing frameworks were not designed to accommodate the scientific features of microbiome-based innovations, leading to uncertainty, delays, and fragmentation across Member States. Consequently, most of the developments are currently done in the USA. The Biotech Act should prioritise the development of tailored, proportionate, and harmonised frameworks that account for the complexity and novelty of microbiome-based innovations. 3. To enable the full potential of biotech innovation, including microbiome innovation, coherence between horizontal and sectoral frameworks is essential. The future Biotech Act must be aligned with existing and evolving EU legislation, including the SoHO Regulation, pharmaceutical legislation, food and feed law, medical devices regulation and any other relevant regulation. This alignment is critical for microbiome innovations, which often sit at the intersection of multiple regulatory frameworks. Fragmented or conflicting interpretations across frameworks hinder innovation and market access. The Act should make sure the agencies or bodies enforcing regulatory frameworks are not overly restrictive and do not over interpret but instead engage constructively with innovative applications to support innovation in Europe. 4. The Biotech Act should promote and facilitate early engagement between innovators and regulators. Early interactions and structured dialogues should be systematically implemented in all regulatory frameworks. Furthermore, investment in regulatory science, including development and validation of methods and models relevant for microbiome innovation is key to ensure disruptive innovations. PRI, as a stakeholder bridging industry, academia, and regulators, can contribute actively to such efforts. 5. Support for secure, FAIR (Findable, Accessible, Interoperable, Reusable) microbiome data is essential. As microbiome technologies span health, food, environment, and agriculture, interdisciplinary and cross-sectoral collaboration must be actively encouraged. Open science should be a priority, and accessibility of the data should be encouraged for both academic and industrial research. The objective of the EU biotech act to accelerate the transition from lab to market is only possible if public and private sectors are working together. Conclusion Microbiome science is no longer exploratory it is entering the biotech pipeline, with applications in the three pillars of the One health concept (human, animal, and environmental health). As such, the microbiome must be recognised as a strategic pillar of EU Biotech Act. PRI stands ready to support the preparation and implementation of the Biotech Act. As a regulatory science centre, PRI ensures that regulations reflect both the scientific consensus and the real-world technical requirements necessary for microbiome R&D.
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Response to Evaluation and revision of the general pharmaceutical legislation

6 Nov 2023

The PRI welcomes the proposal for a pharma Regulation which will forge further EU harmonization in terms of the quality, safety, and efficacy assessment of "SoHO-derived medicinal products other than ATMPs (hereinafter abbreviated SoHO-DMP). Integration of provisions addressing Orphan and Pediatric medicinal products within the proposal for Regulation is also welcome as it serves for better centralization. Yet, it is regrettable that the exercise did not extend to those provisions on ATMPs which remain in the scope of a separate regulation while the reorganization of the EMA foreseen in the proposal will establish only one main evaluating committee (CHMP) covering all scientific areas (rare and paediatric diseases, advance therapy medicinal products, biological and biotechnological products). The use of both terminologies Committee for Medicinal Product for Human Use and Committee for Human Medicinal Products in various places in the Regulation and its annexes may lead to confusion. This might be improved by employing a single name and single abbreviation in the proposed regulation and its annexes. Clarification of definitions: The PRI welcomes the definition of significant benefit. Yet the definition of exceptional therapeutic advancement introduced in various provisions (such as phased review, Orphan status,) is lacking in Article 2 of the proposed pharma Regulation and could lead to divergent interpretations. Borderline products considerations and collaboration with other EU Agencies: The PRI appreciates the establishment of a procedure for scientific recommendation on the regulatory status of borderline products including a consultation phase with other relevant regulatory bodies established in related fields (especially in light of the recently published proposal for SoHO Regulation). The PRI also welcomes the introduction of an active cooperation among EMA and EU agencies established under other regulatory frameworks. However, due to the increasing diversity and complexity of products in development, such collaborations can be fully realized only if adequate human and financial resources are allocated within the competent authorities concerned so as not to create additional burden on product developers (procedures and delays). EMA reorganization: The assessment of innovative medicinal products such as SoHO-DMP, as well as any microbiome-based medicinal product, requires a diverse set of expertise and thus will greatly benefit from the simplification of committees within the Agency, as well as the establishment of scientific working parties and scientific advisory groups meeting the needs for specific multi-disciplinary expertise. The PRI would insist on the need for the Agency to extend its network of accredited experts to include microbiome science and microbiome regulatory science experts. Enhanced regulatory support: The PRI welcomes the possibility for entities which are not engaged in economic activities and/or not-for-profit organizations to have access to a complete regulatory support scheme. This is essential for early integration of regulatory considerations in R&D programs. Yet, the definition of entity not engaged in an economic activity as articulated in the proposed pharma Directive (Article 4) will require further clarification in order to avoid divergent interpretations.
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Response to Evaluation and revision of the general pharmaceutical legislation

6 Nov 2023

The PRI welcomes the proposal for a new Directive as it is a step towards recognizing microbiome-based medicinal products by defining SoHO-derived medicinal product other than ATMPs (hereinafter abbreviated SoHO-DMP) (which will include microbiome-based medicinal products produced from human microbiomes). However, specific requirements applicable to these products remain unknown. The PRI also regrets the absence of any provision on microbiome-based medicinal products originating from non-human sources (food, environment,) as they do not fall within the definition of SoHO-DMP ( attached). The PRI signals that all annexes in this proposal have not been updated after introduction of SoHO-DMP. Annex II (as for part IV - ATMPs) could clarify requirements for SoHO-DMP. Interplay: The PRI applauds the EC efforts to clarify the interplay between the proposed pharmaceutical legislation and SoHO Regulation with a definition for SoHO-DMP. However, the PRI regrets the lack of clarity in this definition (attached). The SoHO-DMP definition (containing, consisting of or deriving from a substance of human origin) does not explicitly include SoHO preparation, which may also be intended for distribution for manufacture of a product regulated by other Union legislation, such as SoHO-DMP. Furthermore, in the SoHO-DMP definition, the PRI highlights the need for clarity in the terms below, especially in the context of microbiome-based medicinal products: (1) standardized consistency, which is different from the commonly used concept batch-to-batch consistency based on predefined specifications. This introduces confusion as both EDQM Tissue and cell monographs and SoHO preparation meeting pre-defined specification (SoHO preparation definition) can be considered of standardized consistency. (2) industrial process (point a.), which is not defined in Article 4 of the Directive, whereas it is an important concept for the interplay between the SoHO Regulation and the Pharmaceutical legislation. Also, in this respect, the SoHO-DMP definition could be clarified by either introducing a comma :industrial process, which includes pooling: clarifying that pooling would be included in the larger concept of industrial process), or by using that (clarifying if only when a process includes pooling would it be an industrial process). (3) a process (point b. ): It is not specified if it is an "industrial process or any process. Because point (a) of the SoHO preparation definition mentions processing, and because processing includes separation (SoHO Regulation), the limit between a SoHO preparation and SoHO-DMP cannot be clearly established without clarifying the definition of process, and extraction in this context. Microbial strain isolation is different from extraction as strain(s) are not active ingredients until characterization and proof of concept have been established (attached). (4)a process that [] transforms the substance of human origin by changing its inherent properties. For example, the inherent properties of stool are always changed when performing any activities, such as the addition of preservatives, freezing for storage, or even freeze-drying. Such activities may fall under the scope of SoHO activities described in the SoHO Regulation and transform SoHO into SoHO preparation. The limit between a SoHO preparation and SoHO-DMP cannot be clearly established until inherent properties is defined (attached). Adapted framework: Annex VII includes phage-containing medicinal products, but SoHO-DMP and other microbiome-based medicinal products could also benefit from this adapted framework (regulatory challenges arising from the specific mode of action of these products, ). Support to not-for-profit entities: The distinction between not-for-profit entities (no definition provided) and entity not engaged in an economic activity (Article 4) is not clear.
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Response to Revision of the Union legislation on blood, tissues and cells

6 Sept 2022

The PRI welcomes the proposal for a Regulation on standards of quality and safety for Substances of Human Origin (SoHO) intended for human application which will increase EU harmonization on protection of the rights and safety of SoHO donors and recipients. Definition The PRI also appreciates the EC willingness to take into account the feedback from various stakeholders in the new definition of SoHO which provides regulatory clarity for presently unregulated SoHO such as human microbiomes. However, some definitions such as ‘SoHO preparation’ and ‘SoHO establishment’ merit further clarification. For example, in the particular case of microorganisms isolated from SoHO and stored in culture collections, it is not clear whether they are still under the definition of SoHO preparation (attached document). Borderline products considerations The PRI welcomes the clarification on those activities regulated under this new SoHO framework, versus the activities which apply to products regulated by other legislations. As such this will create common rules and regulatory status for SoHOs independently of their field of application. However, as the delineation is defined in other frameworks, and as the Pharmaceutical legislation is also currently under revision, particular attention must be paid to these delineation criteria and the exact definitions of terminology such as “placed on the market”, “industrially manufactured”, “substantial manipulation” etc… (attached document). Collaboration and high level of harmonization The PRI welcomes the creation of the SoHO Coordination Board (SCB) and EU SoHO platform which will allow for collaboration, coordination and harmonization among member states and between various authorities involved in the various frameworks of application, particularly in the context of SoHOs with wide applicability such as human microbiomes. The PRI appreciates the collaboration with expert bodies (EDQM, ECDC) for the establishment and revision of standards and guidelines. The PRI wishes to highlight the extensive work ahead in order to set up the various standards and guidelines for new SoHOs such as human microbiomes for which very little regulatory documentation is available today. Initiatives are currently taking place in Europe such as the Human Microbiome Action project (Horizon 2020, grant agreement No 964590) to harmonize and standardize microbiome research. The PRI hopes that sufficient resources will be allocated to the different bodies involved so that agility in the interactions between member states as well as the interactions among different competent authorities, agencies, working groups, and expert bodies (EDQM, ECDC, etc…) will be ensured for producing up-to-date standards and guidelines, harmonized regulatory status and preparation authorization. Overall, clarity on procedures, timing, associated fees, and respective responsibilities of the various bodies involved, as well as transparency on the process and experts involved in standards-making with systematic opportunities for public inquiry will be key in the successful implementation of the regulation so as to ensure innovation is not impaired by lengthy procedures or by the difficulty of various stakeholders to navigate the system (i.e. private vs public entities, SoHO entities vs SoHO establishments, authorities, expert bodies, etc…). Transitional provisions Art. 83 mentions the transitional procedure for SoHO released before application of the new regulation. However, nothing is mentioned regarding products manufactured from human microbiomes, and for which the collection, manipulation, and product manufacturing took place before the application of this new regulation and which may have already obtained authorization to reach market in the EU.
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Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

Border between substances of human origin' legal framework and substances of human origin-derived medicines' legal framework is not clear and this create confusion and inequality in the requirements expected from hospitals compared to other sponsors such as pharmaceutical industries. This is the major challenge to be addressed for the coming years. For example, definitions of "substantial manipulation" for SoHo and "industrially manufactured" for products should appear in the law.
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