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European Patient Organisation for Dysimmune and Inflammatory Neuropathies

EPODIN

EPODIN’s contribution aims, by mobilizing and strengthening the patient’s voice, to give each European citizen living with a rare immune-mediated peripheral neuropathy the opportunity to reduce the burden and inequalities due to the disease.

Lobbying Activity

Meeting with Sérgio Humberto (Member of the European Parliament) and Repsol, S.A.

25 Mar 2025 · Presenting the organization to the office.

Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

EPODIN represents an important patient community in Europe suffering of life-threatening neurological conditions, and which rely on adequate access to lifesaving plasma-derived medicinal products (PDMPs). 1.EPODIN welcomes the proposed EU Pharma Regulation with its focus on tackling and preventing medicines shortages. The definition of shortage (article 2 p.14) facilitates a streamlined data reporting on medicines shortages across the EU. Clarifying and harmonizing EU-wide shortage monitoring provisions is thus welcomed. However, to efficiently address the root causes of shortages its key to not apply one-size-fits-all. But to consider the unique nature and specifics of PDMPs with its starting material plasma, as well as its complex, lengthy production process (7-12 months). This puts additional pressure on appropriate supply. Altogether, this should have an effect on keeping shortage notification timelines for PDMPs as long as necessary, but not over-extensive thus harming patients access. EPODIN considers that the timeframe of 6 months for shortage notification (article 116 §1 d) whilst intended to be in patients interests, is welcomed if it works in reality for patients as to shortage prevention. Otherwise a timeline reduction should be envisaged. Approaches such as the need to indicate alternative products to prevent shortages are not applicable to PDMPs, as these are not interchangeable. Each PDMP product has its own unique biochemical profile, due to differences in production and processing resulting in different clinical responses among patients. The Regulation should address a shortages prevention framework targeting critical medicines and a respective list of critical medicines to include PDMPs be drawn up. Any contingency plan requirements, including stockpiling (article 134) must consider PDMP specifics. Otherwise, they bear the risk of diverting PDMPs from patients which results in worsened patient access. 2. Patient participation: EPODIN welcomes the increased patient representation, such as in ERNs (eg Euro-NMD) and EMAs CHMP. More needs to be done. EPODIN thus welcomes that two patient representatives with voting rights will be included in EMAs Management Board (art 143 §1). The same applies to the participation in EMAs scientific committees, where patient involvement needs to be guaranteed, especially in the (indication-specific) working groups (Art. 146), where the patients expertise is of particular value. 3. Incentives: The current framework for incentives linked to regulatory data protection (RDP) and orphan market exclusivity needs to be efficientized. Regulation proposals to reduce incentives duration along with conditional modulations for incentives, like RDP or orphan market exclusivity, are supported by EPODIN on condition that patients access will get improved and innovation is not harmed. This should be carefully assessed. Should such conditionalities not work in reality and hamper innovation, they must be removed. The Regulation should also address how existing pathways can be gradually optimized to address the fundamental access barriers by working with stakeholders including patients. The Unmet Needs (UMN) concept should be broadened to address the social, economic, medical factors. Its crucial to develop a patient-centered inclusive definition of UMN. A narrow, legally binding UMN definition (Article 70) is not an effective solution for conditioning incentives. Such definition assumes that patient needs are met as soon as a treatment is authorized, which doesnt reflect reality, and risks to overlooking some patient populations over other. In EPODINs view, either a very broad UMN definition is addressed, or individual case decisions determining an UMN should be made by EMA with patients and other stakeholders involvement. EPODIN is ready to working with EU policymakers, so this Regulation ensures that EU patients needs for safe, innovative, adequately available medicines are
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Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

EPODIN represents an important patient community in Europe suffering of severely life-threatening neurological medical conditions. EPODIN welcomes the Commission proposal for a separate EU Pharma Directive and strongly supports the overall objective to harmonise the rules governing pharmaceuticals to ensure better access to medicines for EU patients. EPODIN takes stock of the comprehensive definition of SoHO-derived medicinal product (Article 4 point 31), which provides legal certainty by specifying that the pooling of (plasma) donations and that plasma preparations involving an industrial process, constitutes a human medicinal product. It is helpful that cooperation between member states and their competent authorities will further clarify on the regulatory status (Article 201). This contributes to clarify the interplay between the EU SoHO Regulation and EU Pharma Directive, given that both legal frameworks govern the complexities of the plasma sector, and this optimizes in the end PDMP output and patient access. EPODIN calls to define and adequately categorize plasma for fractionation (PFF) in the EU Pharma Directive, by specifying that it is collected by apheresis and intended solely for manufacturing of plasma-derived medicinal products (Art 3 point 69 EU Commission proposed EU SoHo Regulation). Also, PFF should be considered in the Pharma Directive as a biological starting material for the manufacturing of medicines and thus be subject to comparable regulatory provisions as for active pharmaceutical ingredients (APIs), see definitions in Art 4 Point 3-active substance-active ingredient and Point 4 starting materials. A definition of PFF in the EU Pharma Directive would be needed even more, since the PFF definition has been removed from the compromise text of EU SoHo Regulation recently adopted by the EU Council and it's unclear whether the final SoHo Regulation will address this. Such definition and categorization of plasma for fractionation in the proposed EU Pharma Directive leads to clarifying and optimizing the regulatory regime of PFF and the deriving medicines, to result in the end in an enhanced PDMP - and plasma collection output to the benefit of patient needs. EPODIN welcomes the Directives provisions aiming to simplify and streamline regulatory provisions, which in the end would benefit patients interests through an enhanced output of plasma-derived medicinal products, which is linked to an enhanced collection and release of plasma for manufacturing. To this extent any regulatory steps which are not contributing on scientific basis to product safety and quality, but are able to reduce the much wanted enhanced product output or plasma release, should be considered as redundant and thus eliminated. Given that the plasma sector is governed by two frameworks under revision (SoHO and Pharma legislation), the interlinkage and possible impacts resulting from the revision are unclear. EPODIN would thus welcome an explicit delineation of responsibility and authority for relevant EU agencies and bodies to avoid any redundant requirements. Given the unique nature of final PDMPs to be considered under the EU Pharma Directive, and that the collection of plasma is subject to SoHO Regulation, it is crucial to ensure an efficient exchange of information between EMA and SoHO Coordination Board while consulting all relevant stakeholders, patients included. EPODIN is ready to working with EU policymakers in the next phases of this Directive adoption process to ensure that the EU patients needs for safe, efficacious, innovative and adequately available PDMPs are met.
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Response to Revision of the Union legislation on blood, tissues and cells

8 Sept 2022

EPODIN POSITION AND PROPOSALS (see full version attached) EPODIN thanks the European Commission for all its work. In particular, EPODIN strongly supports the balanced approach of the European Commission. The complexity of the topic, and the multiplicity of stakeholders make the SOHO legislation something complex to work on. About donor protection The draft regulation addresses many of our concerns in the forefront of which is the enhancement of donors’ protection. EPODIN considers that the protection of patients includes the protection of donors. The reminder that donations of plasma should be considered to imply a significant risk is therefore not useless. Without a strong donor protection there is no trust, and without trust there is no way to build a sustainable plasma collection in Europe. About the voluntary unpaid donation and about compensation EPODIN supports the general principle of voluntary and unpaid donation (VUD). SoHO donation is also a factor which can contribute to high safety standards for SoHOs and therefore to the protection of human health. We also welcome the recognition of the fact that the VUD is compatible with the establishment by member states of a fixed-rate allowance to compensate plasma donors for the loss related to their donation. To ensure that donors are not financially disadvantaged by their donation, the principle of financial neutrality would benefit from clarification to make it clear that this includes both expenses and inconvenience related to the donation. About the absolute need to increase plasma collection in Europe Because of the repeated shortages of plasma-derived medicinal products, the promotion of plasma donation by states is crucial for both patients and the EU sovereignty. Member states should be encouraged to progressively increase their plasma collection to reach an EU self-sufficiency. To that end, EPODIN supports initiatives such as: • The inclusion in the text of the mandatory promotion of plasma collection for member states; • The definition of a volume of plasma to collect annually by member states (threshold) • The organization of a European day to sensibilize European citizens to plasma donation. About the cooperation between public and private sectors We completely agree with the necessity to encourage a strong public and non-profit sector involvement in the provision of SoHO services. However, it is essential to remember that European self-sufficiency can only be considered with a plurality of actors, including the private sector, which must be regulated to maintain an equilibrium in collection, particularly in all the countries of the Union. Only four countries in the European Union contribute to more than 40% of the total EU plasma collection. In the perspective of a sustainable organisation within the European Union, this must be rebalanced. Otherwise, the ambition to protect donors and respect ethical issues will be undermined. Regarding this point, before any validation of registration of any plasma collection centre, it should be necessary for the commission to evaluate, to what extent this new installation does not add pressure on the plasma donor population. A distribution of the collection over all EU countries should be sought. This implies a synergy between public and private collection centres. About development of standards See full version About equity in access to plasma-derived medicinal products within the European Union If some countries are high contributors, it does not mean that patients from those same countries have access to treatment. This situation creates an inequity between countries and patients. In the context of a better distribution of efforts between member states, it is up to the future regulation to ensure equal access to treatment regardless of the EU country. EPODIN and its national organisations will continue to contribute to the drafting of such an essential text for thousands of patients.
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