Grifols, S.A.
Grifols
Grifols is a global healthcare company with a mission to improve the health and well-being of patients around the world.
ID: 400747536239-04
Lobbying Activity
Meeting with Nicolás González Casares (Member of the European Parliament)
16 Sept 2025 · Critical Medicines
Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion)
19 Jan 2024 · Pharmaceutical Package (Regulation)
Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion)
25 Oct 2023 · Pharmaceutical Package
Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)
6 Jul 2023 · SoHO
Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)
19 Apr 2023 · SoHO
Meeting with Deirdre Clune (Member of the European Parliament)
8 Feb 2023 · SoHO Regulation
Meeting with Tiemo Wölken (Member of the European Parliament)
8 Feb 2023 · Verordnung über Qualitäts- und Sicherheitsstandards für zur Verwendung beim Menschen bestimmte Substanzen menschlichen Ursprungs (staff level)
Meeting with Christine Schneider (Member of the European Parliament)
8 Feb 2023 · SoHo
Meeting with Susana Solís Pérez (Member of the European Parliament)
12 Oct 2022 · SoHo
Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament, Rapporteur) and Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose
12 Oct 2022 · SoHO regulation
Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)
11 Oct 2022 · Blood, Tissues and Cells Regulation
Response to Revision of the Union legislation on blood, tissues and cells
8 Sept 2022
Grifols welcomes the adoption of the proposal for a Regulation on standards of quality and safety for substances of human origin (SoHO). The proposal is an important step to modernise the SoHO regulatory framework and has the potential to increase the supply of essential medicines for patients reliant on plasma therapies for rare, chronic and life-threatening conditions. Grifols, headquartered in Barcelona, is the largest plasma collector in Europe and a global leader in the production of plasma derived medicinal products (PDMPs) to treat such conditions.
The proposal includes many improvements, including differentiating plasma from blood and identifying the role of compensation to recognise donors for their commitment. However, the Regulation should build on the acknowledgement of the EU’s dependency on third countries by mandating that Member States develop a national plasma strategy, focused on increasing supply. To promote strategic autonomy the final text should reflect the following:
1) Safety of plasma donation
In Recital 13, the Commission characterizes plasma donation as implying significant risk, without scientific evidence to support this assertion. Grifols objects to this description as it is not scientifically valid and it will impact the willingness of the public to donate. Plasma donation via plasmapheresis is safe, without appreciable risk to donor health. Plasmapheresis is markedly different from the process to donate other SoHOs that may imply more risk such as oocytes, bone marrow, and peripheral stem cells.
2) SoHO donor protection standards
Article 56 requires SoHO entities follow guidelines published by ECDC and EDQM, or guidelines that achieve an equivalent level of donor safety. The EDQM Blood Guide includes a maximum of 33 plasma donations/year, without scientific evidence to justify this arbitrary limit. Donation limits exceeding 33/year have been successfully implemented in many countries including Germany, Austria, Hungary and the U.S. without jeopardising donor health. Requiring compliance with EDQM guidelines could harm Member States efforts to boost plasma supply by reducing the maximum donation limit to an unjustified artificial level, without improving donor health. Donors are protected by a robust set of procedures, including a health assessment and regular testing of protein levels. An EU-wide limit of 33 donations/year will negatively impact plasma supply.
3) Optimise approach to compensation
The proposal improves the plasma donation framework by acknowledging the role of compensation to safely and ethically increase plasma supply in order to meet increasing patient need. To further advance these goals without compromising donor health, Grifols recommends:
• In Recital 18, the reference to voluntary and unpaid donation as a factor that can contribute to high safety standards should be removed. This statement contributes to a negative perception of SoHOs from compensated donors, without scientific justification. In fact, the EMA has found that PDMPs derived from compensated donors have the same safety profile as PDMPs from non-compensated donors (reference: EMEA/CPMP/BWP/1818/02/Final)
• In Article 3, compensation is defined as ‘making good of any losses associated with the donation’. The text should revert to the definition of compensation from the Tissues and Cells Directive of ‘expenses and inconveniences’ associated with donation. This definition is clearer and better reflects the concept of financial neutrality. Also, framing compensation to offset “losses” could create regulatory uncertainty and a negative connotation for an altruistic act.
• In Article 54, the requirement for Member States to set a maximum limit for fixed-rate allowance should be removed if there is existing legislation governing compensation. Donor health is sufficiently protected by requirements to uphold the principle of financial neutrality, without a maximum limit.
Read full responseMeeting with Cyrus Engerer (Member of the European Parliament)
8 Feb 2022 · Blood Donation
Response to Evaluation and revision of the general pharmaceutical legislation
27 Apr 2021
Grifols, an EU-headquartered leader in plasma collection and fractionation of plasma derived medicinal products (PDMPs), welcomes the opportunity to provide input on the pharmaceutical strategy. As the roadmap noted, the EU is not as competitive as it could be: the current framework lacks dynamism and is not well suited to promote innovation. With proper policy changes, the pharmaceutical industry can be a stronger source of growth and innovation for the EU. Of the elements included in the roadmap, Grifols supports:
1. Efforts to promote supply chain security
PDMPs are unique products, some of which have been designated by the World Health Organization as essential medicines and as such require special considerations when promulgating policies aimed at promoting patient access and supply chain security. PDMP production begins with collection of plasma from healthy donors. Because there is no alternative starting material the final supply of PDMPs is directly related to the amount of plasma collected. The most effective way to ensure a reliable supply of PDMPs is to invest in an adequate plasma collection infrastructure, which is lacking in the EU. Currently, the EU imports almost 40% of the plasma and PDMPs necessary to meet clinical need*.
While product supply reporting requirements to reduce the risk of shortage may be appropriate in some circumstances, any such requirements should not increase the regulatory burden on industry. Reporting should be streamlined so that information is not required through different channels. Additionally, centralized reporting should prevent disclosure of proprietary information including information that could reasonably implicate anti-trust concerns.
For PDMPs the best way to avoid shortages is to increase plasma collection in the EU. This will make the EU less dependent on the US and will support strategic autonomy. To promote efficiency, the Commission should align the pharmaceutical strategy with other related frameworks including the BTC legislation.
2. Environmentally sustainable production
As a part of the EU’s transition to a greener future, Grifols recognizes the role of companies in achieving this goal. Grifols has established specific environmental targets aimed at reducing the Company’s environmental impact, including a goal to consume 70% of electricity from renewable sources by 2030. In addition, Grifols has implemented programs to improve energy efficiency in facilities, reduce water consumption, and other initiatives to reduce the Company’s carbon footprint. The Commission should consider creating new incentives to support industry’s transition to even greener production as well as seek to harmonize environmental rules in procurement policies.
3. Reducing regulatory burden and future proofing the legislation
A key part to improving competitiveness in the EU is reducing regulatory burden by increasing international harmonization. Plasma is collected and manufactured globally, creating an opportunity for a collaborative approach to reduce regulatory burden and improve efficiency. The EMA may consider working with global counterparts, including the U.S. FDA, to harmonize quality standards, plasma collection rules, and inspections of facilities.
Finally, Grifols supports the goal to future-proof the legislation to better accommodate ongoing innovation in the sector. The Commission should consider building on existing incentives to support research and development but also expand the use of real world evidence (RWE) to assess new indications, routes of administration or administration protocols for existing products. Greater reliance on RWE can help address unmet medical needs.
*Kluszczynski, T. et al. “Key Economic and Value Considerations for Plasma-Derived Medicinal Products (PDMPS) in Europe. Available at: https://www.vintura.com/wp-content/uploads/2020/03/White-paper-key-economic-and-value-considerations-for-plasma-derived-medicinal-products-PDMPs-in-Europe_Vintura
Read full responseResponse to European Health Emergency Response Authority
24 Feb 2021
Grifols welcomes the opportunity to provide input on the inception impact assessment for the establishment of HERA. Grifols recent experience working with governments around the world, including BARDA in the U.S., to develop therapeutics for COVID-19 demonstrates the important role such an agency can have in partnering with industry to improve preparedness.
Grifols, a global healthcare company, headquartered in Barcelona works to enhance the health and well-being of people around the world. Grifols is proud to be a world leader in the collection of plasma—the liquid portion of blood—and production of plasma derived medicinal products (PDMPs) to treat chronic and severe conditions. Grifols also serves an essential role in ensuring global blood safety by manufacturing infectious diseases screening diagnostics.
Building on Grifols experience working with governments, we recommend that HERA:
1) Promote robust public-private partnerships
COVID-19 highlighted the importance of cooperation between governments and industry to mount an effective response. During recent public health crises, including COVID-19, Ebola, and Zika Virus, Grifols has partnered with governments to rapidly develop therapeutics and diagnostics to aid in the response to these health emergencies. In the case of COVID-19, Grifols worked with BARDA to leverage our world leading plasma collection infrastructure to collect convalescent plasma from donors who recovered from COVID-19 and further manufacture that plasma into a polyclonal antibody product that is currently being assessed in a phase three international clinical trial. A collaborative approach and early engagement with government contributed to the rapid development and assessment of this novel therapeutic. HERA should model this approach of flexible partnerships with industry to address ongoing threats.
Public-private partnerships are important not only to develop medical countermeasures to a specific threat, but also to address supply chain vulnerabilities for traditional products exacerbated by infectious disease outbreaks. At the outset of COVID-19, widespread supply challenges associated certain medical products jeopardized the ability to slow the spread of SARS-CoV-2. While for many products, supply chain disruptions have been solved, for other products including PDMPs the EU’s supply chain is more vulnerable than ever. COVID-19 aggravated the reliance on third party countries for plasma and PDMPs. The Commission should consider how HERA can help strengthen supply chains for essential products, including PDMPs, to promote strategic autonomy.
2) Facilitate centralized whole value chain support for countermeasure development
To be most effective, HERA should take a centralized whole value chain approach to medical countermeasure development. Building on existing early stage research programs, HERA should serve as a centralized clearinghouse for information exchange, coordination to support late stage development, manufacturing and scale up. HERA should engage early and often with industry to share information about potential risks and learn about companies’ capabilities to contribute to mitigating those risks. HERA should be structured to support:
a) Flexible funding arrangements: HERA should be flexible in its approach to contracting with companies to encourage rapid product development to meet unmet needs.
b) Clinical trial and regulatory support: HERA should provide as much clinical and regulatory support as a funded entity requires. HERA should serve as a coordinator to facilitate clinical trial set up and speed regulatory reviews.
c) Pathway for product procurement: HERA should include a mechanism for post-development product procurement. A centralized system for stockpiling medical products will address challenges associated with diffuse Member State stockpiling systems as well as uncertainties regarding the viability of a commercial market for some products.
Read full responseResponse to Proposal for a Regulation on serious cross-border threats to health
2 Feb 2021
Grifols welcomes the opportunity to provide input on the Regulation on serious cross-border health threats. During recent public health crises, including COVID-19 and Ebola, Grifols has contributed our expertise in the development of plasma-derived therapeutics and diagnostics to aid in the response to these health emergencies. We look forward to working with the Commission to improve resilience.
Grifols, a global healthcare company, headquartered in Barcelona works to enhance the health and well-being of people around the world. Grifols is proud to be a world leader in the collection of plasma—the liquid portion of blood—and production of plasma derived medicinal products (PDMPs) to treat chronic and severe conditions. Grifols also serves an essential role in ensuring global blood safety by manufacturing diagnostics to screen for emerging and established infectious diseases.
To improve preparedness, Grifols recommends the Commission:
1) Build on capabilities developed during previous outbreaks
Grifols commends the proposal of a Union Health Crisis and Pandemic Plan as it is an important prerequisite for a coordinated approach to infectious disease response. As the Commission develops this plan, it should engage with all stakeholders, including the private sector, to ensure development of a comprehensive plan that catalogues all available resources to assist in pandemic response. We encourage the Commission to build on capabilities developed during previous outbreaks, including COVID-19, by supporting industry efforts to collect convalescent plasma and produce high titer polyclonal antibody products as well as highly sensitive nucleic acid-based diagnostics. Engaging early with industry will speed availability of therapeutics and diagnostics. Finally, Grifols acknowledges the potential for using existing substances of human origin collection infrastructure as a means for monitoring sero-epidemiological data in times of pandemics.
2) Promote additional plasma collection capacity in the EU
While plasma has been an important therapeutic option for COVID-19, the pandemic has also exposed latent weaknesses in the global plasma supply chain which could impact patient access to traditional PDMPs, some of which have been identified by the World Health Organization as essential medicines. The EU imports approximately 40% of the plasma and PDMPs necessary to meet the needs of patients. Pandemics exacerbate the vulnerabilities of the European plasma collection framework and enhance reliance on non-EU countries, primarily the United States. The causes and consequences of this over-reliance on the U.S. for plasma are nuanced and complex, necessitating the development of an EU “Plasma Strategy”, focused on increasing the supply of plasma in Europe. A new Plasma Strategy should recognize the important role of private sector collection in EU self-sufficiency and can work in concert with other Commission policies to ensure patients retain access to these essential medicines in emergency situations. To address supply challenges in emergency situations, the ECDC should clarify recent guidance by recommending a Union-wide exemption for plasma collection center employees, donors, and PDMP manufacturing employees from local stay at home orders implemented to control outbreaks. Additionally, these facilities should be prioritized for supply of critical equipment, including PPE.
3) Coordinate joint procurement and countermeasure stockpiling among Member States
Finally, Grifols supports the Commission’s objective to improve EU coordination of joint procurement and medical countermeasure stockpiling in the event of an outbreak. An EU-wide approach to procurement and coordination of rules aimed at ensuring sufficient supply of products will improve efficiency by standardizing divergent regulations at the Member State level. The EU should encourage Member States to recognize the unique plasma supply chain when setting stockpiling rules.
Read full responseResponse to Revision of the Union legislation on blood, tissues and cells
13 Dec 2020
Grifols welcomes the opportunity to provide input to the Inception Impact Assessment for the revision of the BTC legislation. This legislation has helped standardize quality and safety requirements for blood, tissues and cells but it has not adapted to an evolving reality for blood establishments and patients who rely on blood products. The shortcomings of the legislation are most apparent for plasma intended for further manufacture into plasma derived medicinal products (PDMPs).
Grifols is a global healthcare company, headquartered in Barcelona whose mission is to enhance the health and well-being of people around the world. Grifols is proud to be a global leader in the production of essential PDMPs to treat chronic and severe conditions.
The plasma supply landscape has changed dramatically over the last 20 years: demand for PDMPs has grown significantly, but the plasma collected in Europe has not increased at a similar rate. Additionally, COVID-19 has exposed latent weaknesses in the global plasma supply chain: resulting in a significant decrease in donations earlier this year. While donations are recovering, the EU must adopt policies that will encourage increased collections and be flexible to adapt to changing needs, including Europe-wide initiatives to promote plasma donation. A sustainable plasma supply will help support patient access to PDMPs. The Commission should start by explicitly differentiating plasma for further manufacturer from blood intended for transfusion. Unlike the blood supply, Europe is heavily reliant on the United States for plasma; addressing the causes and consequences of this over-reliance on the U.S. requires a bespoke plasma policy.
The production of PDMPs begins with collection of plasma from healthy donors. Grifols takes numerous steps to protect donor health including a comprehensive health assessment prior to donation. Additionally Grifols adheres to stringent final product safety and quality specifications—including screening for infectious diseases, and traceability from final product to donation. To ensure patient safety every step of the production process is regulated by international authorities and Grifols also complies with even more strict industry standards.
A reliable supply of PDMPs depends on an adequate plasma collection infrastructure. Plasma collection in Europe is not evenly distributed, with only four countries collecting over half of all plasma in Europe. These four countries permit the coexistence of public and private collection centers, highlighting the critical role of the private sector in helping ensure sufficient supply. The most efficient way to collect plasma is via plasmapheresis, a process that can take up to 90 minutes to complete. Due to this time commitment and the need for repeat donors, one of the most effective mechanisms to increase collections is compensating donors for their time. While the Commission makes clear that implementation of the voluntary unpaid donation (VUD) principle will remain the responsibility of Member States, the Commission should clarify that compensating donors for their time is fully consistent with VUD principle. This clarification will ensure the BTC legislation accurately reflects the reality that donors are compensated in a variety of ways, including paid time off, free transportation, and other items of value.
Grifols supports a more coordinated approach to safety and quality requirements for PDMPs. However these requirements must be evidence-based: any new binding requirements must be supported by data, tailored to current needs and informed by real world experience. When promulgating new requirements, EU expert bodies must be transparent in their processes and engage all stakeholders. Above all, the Commission must consider how regulatory changes may impact the supply of plasma and PDMPs for patients. Thank you for your consideration of our comments. Grifols looks forward to continued engagement with the Commission.
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