THE CORE PRINCIPLES OF BIOETHICS GUIDE GRIFOLS’ OPERATIONS, WITH THE OBJECTIVE OF PROMOTING THE SAFETY AND DIGNITY OF EVERYONE INVOLVED IN THE PRODUCTION OF MEDICINES
The fundamental principles of bioethics guide the research, development, production and marketing of Grifols products. The company makes every effort to guarantee the safety and dignity of everyone involved in its value chain, while approaching scientific advances in the healthcare sector from an ethical vantage point.
A diversity of regulations, declarations and codes govern these core principles, including the Universal Declaration of Human Rights (1948), the Helsinki Declaration (1965) and UNESCO’s Universal Declaration on Bioethics and Human Rights (2005).
THE UNIVERSAL DECLARATION OF HUMAN RIGHTS INCLUDES THE FUNDAMENTAL PRINCIPLES OF BIOETHICS
Respect for human dignity and human rights inherent to Grifols is an indispensable requirement for all its activities. In parallel, the company strives to promote and preserve the welfare in communities where it operates.
Grifols promotes responsibility and commitment to human rights in all of its operations using international frameworks as points of reference, among them, United Nations Global Impact, OECD Guidelines for Multinational Enterprises, UN Human Rights, and ILO Tripartite Declaration of Principles Concerning Multinational Companies.
Grifols Code of Conduct governs the activities of all employees and collaborators, upholding strict adherence to the legislation and regulations in force throughout its value chain. This commitment includes promoting and respecting human rights. The company also offers a communication channel – the Grifols Ethics Helpline – to allow employees and outside collaborators to report any concerns of possible human rights violations or cases of ethical misconduct.
The Víctor Grífols i Lucas Foundation was established in 1988 to spark crossdisciplinary debate and dialogue on the subject of bioethics. The Foundation aims to foster ethical attitudes among healthcare organizations, companies and professionals and serve as the catalyst for new ideas insights and perspectives on the ethics of life. In support of its mission, the Foundation sponsors a Bioethics Chair that promotes research and educational initiatives, awards, scholarships and publications to stimulate and spread knowledge of specific areas of bioethics.
For more information: http://www.fundaciogrifols.org/es/web/fundacio/mission-objectives
Further information is available in the “Pride” chapter
GRIFOLS OFFERS ONGOING SUPPORT TO PATIENT ORGANIZATIONS, EDUCATING PATIENTS AND THEIR FAMILIES AND SERVING AS A TRUSTED ADVOCATE OF THEIR HEALTH AND WELL-BEING
Grifols continues to nurture its relationships with patient organizations through a range of services in alignment with its longstanding commitment to stakeholders.
The research, development and production of life-saving plasma-derived medicines, diagnostic systems and hospital pharmacy solutions that facilitate the work of healthcare professionals illustrate its staunch commitment to patients. Grifols complements these activities with a diversity of educational, awareness and patient advocacy programs and services.
Grifols organizes a number of social engagement activities in the United States, including Patient Community Open Houses, which invite members of the patient community to learn more about the collection of plasma and production of plasma-derived medicines. These events also offer a meeting point for patients and plasma donors. In 2018, Grifols welcomed 325 visitors in 80 plasma donation centers.
In 2018, Grifols took part in the Alfas en Camino (Alphas on the Way), an awareness pilgrimage to Santiago de Compostela, Spain organized by the Spanish association of patients with alpha-1 antitrypsin deficiency (AADT). In total, 80 patients from several different countries trekked more than 115 kilometers together.
For more details, please see the “Pride” chapter
The company supports the core mission of patient advocacy groups (PAGs) by partnering with them on projects, leading product-donation programs and facilitating access to Grifols’ treatments. Its collaborations with PAGs always adhere to the principles of transparency and country-specific regulations, which determine the types of information that need to be publicly disclosed.
Grifols has standard operating procedures based on the notions of eligibility, compliance, ethics and transparency that internally regulate its collaboration accords, aid initiatives and donations to patient advocacy organizations.
Grifols monitors and complies with all existing laws and regulations which govern interactions between the pharmaceutical industry and patient organizations. These rules include The Sunshine Act, EFPIA Code of best practice between the pharmaceutical industry and European Patient Organizations, and various legal reporting obligations at the national level. Grifols strongly supports and voluntarily complies with global disclosure practices in all territories where Grifols operates.
THE RESEARCH, DEVELOPMENT AND PRODUCTION OF PLASMADERIVED MEDICINES, DIAGNOSTIC SYSTEMS AND INTEGRATED HOSPITALPHARMACY SOLUTIONS ARE THE CULMINATION OF GRIFOLS’ COMMINTMENT TO PATIENTS
The cost and access to treatment is a topmost consideration for patients. Keenly aware of this concern, Grifols employs a pricing approach grounded on two core principles: first, cost should never be a barrier to optimal patient care and treatment, and second, pricing should support the company’s long-term sustainability and ongoing commitment to research, development and innovation.
The company actively works to increase access to treatment. Grifols has supported the PatientCare program since 2006, aimed at facilitating treatment for patients with hemophilia or primary immunodeficiency in the United States. The program includes an array of initiatives to address concrete needs:
As part of its commitment to serving global patient communities, Grifols pledged to donate 200 million international units (IU) of clotting factors to the WFH Humanitarian Aid Program over a eight-year period. Donated plasma-medicines are intended for patients in developing countries where access to appropriate treatment is often difficult. According to the WFH, these donations will provide approximately 10,300 doses to treat 6,000 patients a year until 2021.
As part of it’s overall pledge, Grifols donated 25 million IU of product in 2018. The company has been a proud supporter of the WFH for more than a decade in its efforts to improve access to hemophilia treatments.
In 2018, Grifols launched AlfaCare, the first support program for patients with alpha-1 antitrypsin deficiency in Spain. AlfaCare was developed in collaboration with the Alfa-1 Spain patient association and backed by an interdisciplinary team of professionals, including psychologists and patient mentors.
AlfaCare is a patient-assistance program that complements the standard care and clinical treatment offered by healthcare services. It provides personalized emotional support and psychological care, as well as detailed and easy-tounderstand information and motivational activities to help patients better cope with the disease. Grifols has rolled out similar programs in other countries such as the U.S., Germany and Canada.
Plasma donors play a pivotal role in the plasma derivatives sector. Plasma can’t be artificially manufactured in a lab, which is why the generosity of donors is so critical. Without them, the production of life-saving plasma medicines would not be possible.
Grifols recognizes the generosity of U.S. plasma donors by compensating them for their time and commitment to make regular plasma donations, and only uses plasma from qualified donors to produce its plasma-derived medicines. Donor compensation along with complete health screenings help ensure a sufficient supply of plasma to treat patients in need of plasma treatments. Hundreds of donations are needed to produce enough plasma-derived medicine to treat one patient for one year.
Plasma donors also have the option of waiving part or all of their donor commitment fee to support one of the charity organizations that form part of Grifols’ non-profit Plasma Possibilities program. Initiated in 2017, this program offers donors the chance “to give back twice” with their donation and helping a local charity. Since 2017, Grifols donors raised more than USD 12,000 for 22 organizations in the United States.
See “Safety” for more details on donors and the donation process
COMPENSATING PEOPLE WHO REGULARLY DONATE PLASMA RECOGNIZES THEIR COMMITMENT AND CONTRIBUTION TO PATIENTS IN NEED OF PLASMA-DERIVED MEDICINES
Grifols’ commitment to plasma donors also extends to the communities where the plasma donation centers are located. These centers add value to communities by creating employment, contributing taxes and stimulating the local economy. Grifols organizes community engagement events and gives back through charitable donations and volunteer programs.
In 2018, Grifols doubled the number of programs, implementing more than 2,700 initiatives that have had a tangible impact on local communities:
In 2018, Grifols also contributed to communities afflicted by Hurricanes Michael and Florence. Grifols employees donated USD 33,000 to the affected communities.
GRIFOLS’ PLASMA DONORS HAVE THE OPTION OF WAIVING COMPENSATION IN FAVOR OF NON-PROFIT ORGANIZATIONS
Dr. Josep Antoni Grífols i Lucas was a celebrated scientist and pioneer of the plasmapheresis technique. In 2008, a foundation called José Antonio Grífols Lucas, was created in his name to enhance the communities where Grifols operates its plasma donation centers through health, well-being and education programs aimed at enhancing the welfare and social environments of plasma donors who donated plasma in the U.S. plasma donation centers.
The Foundation also backs studies on the plasmapheresis technique and the potential discovery of new applications.
Blood donations provide three main components: red blood cells for transfusions, leukocytes and platelets for oncological treatments, and plasma, the most abundant substance found in blood.
Plasma contains proteins of great therapeutic value that, once separated and purified, can be used to produce plasma-derived medicines. The United States is the only country that collects sufficient plasma to produce the plasma-derived medicines its population requires. No European country is self-sufficient.
As a result, the World Health Organization, the Council of Europe and other institutions promote measures to help European countries achieve self-sufficiency, specifically strategies to encourage blood and plasma donations and leverage surplus plasma. For this reason, donation centers freeze surplus plasma from donations to industrially process it and produce plasma-derived medicines.
As a complement to its core activity, Grifols offers its installations, technology, expertise and technical team at the disposal of public donation centers and health public organizations to process its surplus plasma, purify the proteins and return them in their entirety as plasma-derived medicines. Regulated by fractionation service agreements, these collaborations lead to considerable cost savings for public healthcare systems. The company offers this service in Spain, Slovakia and Canada.
AT GRIFOLS, WE SHARE OUR CLIENTS’ CONCERNS. LEARNING FROM THEM HELPS US DESIGN VALUEADDING SERVICES AND PRODUCTS THAT RESPOND TO THEIR NEEDS
Learning from our customers is part of Grifols’ commitment and the foundation of building trust. Listening and understanding their problems, needs and expectations allows us to design and deliver superior services, value-adding products and agile solutions that address concrete needs.
Since its origins, Grifols has worked closely with wholesalers, distributors, group purchasing organizations (GPOs), blood banks, hospitals, healthcare institutions and public health systems to cultivate a climate of trust and joint learning. These collaborations play a pivotal role in helping us advance our mission of enhancing the health and well-being of people.
These alliances have translated into a number of initiatives:
The company is deeply committed to responsible marketing and sales practices. For this reason, it ensures that all of its promotional and educational collateral comply with applicable laws and regulations; align with the industry policies and codes voluntarily adopted by the company; adequately address the target audience and end users; and contain information that is truthful, accurate, comprehensive, clear and balanced.
Grifols has a standard operating procedure – the Grifols Review Process or GRP – that defines the activities and responsibilities related to the approval, review and control of promotional and education materials used to communicate Grifols products and services to external audiences.
The approval process for marketing materials includes several review stages involving decision makers from diverse corporate areas, among them, the legal, medical affairs, regulatory and publishing departments. In 2018, 3,788 materials were reviewed and 3,686 materials were approved through the GRP system.
The material and content are expressly approved for specific uses and countries, and can only be used without alternations. All promotional and educational materials are reviewed on a regular basis to ensure they remain valid and that their content complies with current standards and adopted codes.
Grifols’ three divisions have claims systems that register and review all notifications received from healthcare centers, patients and users with consumer appraisals regarding possible defects in product quality.
In each division, a trained professional or technical director is appointed to evaluate all claims received, including carrying out the appropriate inquiries and implementing corrective and preventative measures, if necessary.
Each division has a Product Recall System to address confirmed critical defects in the quality or safety of products. The trained individual or technical director is responsible for managing the product withdrawal, including relevant communication with healthcare authorities.
The claims and product withdrawal systems, outlined in the Standard Operating Procedures, are internally audited to verify their effectiveness and adaptation to current legislation, as well as by the competent health authorities
GRIFOLS’ CLINICAL RESEARCH ADHERES TO THE STANDARDS ESTABLISHED BY THE INTERNATIONAL CONFERENCE ON HARMONISATIONGOOD CLINICAL PRACTICE, THE PROTECTION OF HUMAN RIGHTS UNDER THE HELSINKI DECLARATION AND APPLICABLE LOCAL LAWS AND REGULATIONS
Grifols’ interaction with medical and scientific communities plays a key role in its ongoing innovation and corporate success. As explained in the chapter titled “Innovation and improvement”, Grifols recognizes the critical value of scientific research to enhance the health and quality of people lives.
Grifols is committed to guaranteeing the safety of patients who participate in the clinical trials conducted and sponsored by the company. All clinical research led by Grifols or on its behalf adheres to the standards established by the International Conference on Harmonisation Good Clinical Practice (ICH GCP); the protection of human beings under the Helsinki Declaration; and applicable local laws and regulations. The company is committed to protecting the rights, safety and wellbeing of people in its clinical trials since it firmly believes that these principles are more important and should prevail over corporate, scientific or social interests.
Every clinical trial follows a detailed protocol to guarantee the safety of participants and the integrity of the collected data. Before the onset of any clinical trial, Grifols sends the protocol to regulatory authorities and an external ethics committee, comprised by healthcare professionals and specialists from other sectors, to ensure it respects the dignity, rights, safety and well-being of trial participants. The clinical trial does not begin until a favorable decision has been handed down. Once approved, it strictly adheres the guidelines established by the Ethics Committee, the institution, ICH GCP and applicable regulatory requirements.
Every participant must give their informed consent, which is written, signed and dated. The Principal Investigator (or assigned healthcare professional) provides appropriate information, answers questions and allows sufficient time for potential clinical-trial subjects to make an informed decision on their participation. The participation agreement is strictly voluntary and subjects can freely withdraw their consent at any time during the clinical trial.
In order to assure quality control, Grifols has standard operating procedures to guarantee that the execution of clinical trials and the collection, documentation and notification of data adhere to protocols, ICH GCP and applicable regulatory requirements. Grifols has also established a procedure to provide a course of action to its clinical personnel to review and document any observations of potential fraud or misconduct during clinical trials.
Grifols has several measures in place to promote the transparency of its clinical trial data, which always maintains the anonymity of its subjects. More information on the protocol, status of clinical trials and related results are published on publicly accessible registries such as www.clinicaltrials.gov. Moreover, the results of clinical trials carried out within the framework of the European Medicines Agency (EMA) are published on the EudraCT website.
Grifols discloses the results of many of its clinical trials in international conferences and scientific journals.
MORE THAN EUR 6 MILLION ALLOCATED TO RESEARCH AWARDS AND EDUCATION
For decades, biomedical research using animal testing has led to significant medical advances for both human and animal health by validating the effectiveness and safety of pharmaceutical products. Grifols is committed to the responsible use of laboratory animals in cases in which animal testing is indispensable to develop new life-improving therapies.
Whether animal testing is carried out in a university or in a contracted external laboratory, Grifols researchers work closely with regulatory agencies and the Institutional Animal Care and Use Committee (IACUC) to guarantee the safe and humane treatment of research animals.
All of the Grifols’ collaborating research institutions are approved by the competent authorities in the regions where research is conducted. In the United States, installations are certified by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) or equivalent organization, and possess the highest accreditation possible for laboratories that perform animal testing. In Europe, all laboratories comply with the Directive EU 2010/63 on the protection of animals used for scientific purposes and are evaluated by the competent authorities in each country.
The company also adheres to the “Alternatives and the 3Rs” protocol as guidelines in the treatment of animal testing: replace the use of animals whenever possible or avoid it altogether; reduce the number of animals used to a minimum; and refine the way research is carried out to ensure animals suffer as little as possible.
In line with Grifols’ commitment to research, the company has a scholarship and awards program to promote and advance research in areas associated with its plasma-derived therapies.
Grifols established “The Grifols Academy” or TGA in 2009 as part of its longstanding dedication to employees and other stakeholders. The academy comprises “The Grifols Professional Development Academy,” “The Grifols Academy of Plasmapheresis” and “The Grifols Academy of Immunohematology.”
Through the TGA, Grifols offers professional and educational development opportunities to its global talent pool, reinforces the company’s philosophy and corporate values, and delivers a range of resources and services to healthcare professionals to enhance patient care.
In addition to its educational focus, The Grifols Academy offers development programs and initiatives designed to build awareness and promote the exchange of knowledge and expertise in the plasma industry. This approach differentiates the TGA from traditional professional development centers.
The Grifols Academy of Plasmapheresis is certified by the U.S. Accrediting Council for Continuing Education and Training (ACCET) for a five-year period. This accreditation recognizes the academy’s range of highquality programs in the U.S. on the sciences of human plasma.
GRIFOLS’ ACADEMIC ALLIANCES ENCOURAGES ITS EMPLOYEES’ PROFESSIONAL DEVELOPMENT BY OFFERING HIGHIMPACT LEARNING OPPORTUNITIES
In 2018, Grifols continued to build on its executive education program, designed to address the specific needs of Grifols’ senior and middle managers. The program emerged from a collaboration with two prestigious institutions: ESADE (Escuela Superior de Administración y Dirección de Empresas) in Barcelona and Georgetown University’s McDonough School of Business in Washington D.C.
The Grifols Academy partnered with College for America Association in 2015 to offer Grifols employees the opportunity to earn university degrees through a scholarship program.
To date, 67 employees have graduated, while 74 more work toward their degree under this initiative. In 2018, there were 21 graduation and 36 scholarships awarded to new Grifols students. Grifols covered more than USD 193,000 worth of schooling to College for America during the year.
Grifols Tuition Reimbursement Program offers financial aid for full-time employees to enroll in undergraduate or graduate programs related to their current or future professional roles. The program benefitted 117 people in 2018.
Grifols partners with several local universities in Los Angeles to support the continuous education and development of its employees, as well as create job opportunities in the area. So far, more than 100 Grifols employees have earned degrees at California State University-Los Angeles and over 150 people have been hired as a result of this collaboration.
In North Carolina, Grifols is actively involved in the Biomanufacturing Training and Education Center and the Johnston County Workforce Development Center. The company works closely with Johnston Community College to help educate students interested in pursuing careers in the biopharmaceutical industry.
The Probitas Foundation was established in 2008 to leverage Grifols’ expertise in the healthcare sector and help improve medical care in areas with limited resources. Grifols shareholders approved an annual allocation of 0.7% of corporate profits before taxes to support this private foundation.
The foundation combines in-house programs – among them, the Global Laboratory Initiative and the Child Nutrition Support Programme – with external collaborations with NGOs renowned for their work in the humanitarian sector. These include Spanish Red Cross, Save the Children, UNRWA (United Nations Relief and Works Agency for Palestine Refugees in the Near East) and the World Food Programme.
To learn more about Probitas and its core programs, please visit http://www.fundacionprobitas.org
The Community Realtions Grant Program establishes guidelines to guarantee that all in-kind donations and services not directly linked to healthcare are coordinated and aligned with the corporate mission. Subsidies are typically channeled to civic, social or educational programs to address the needs of the local communities where Grifols operates and build ties among the participating entities.
Girls Today, Women Tomorrow: A mentorship and support program that fosters diversity and gender equality by offering leadership and development opportunities to girls living in inner cities. Grifols donated USD 5,000 to the program.
Grifols Summer Science Academy: Grifols employees organize a summer internship program in collaboration with California State University-Los Angeles that allows high school students to gain experience working in the company’s laboratories.
Internships in Grifols facilities: A joint collaboration with Woodrow Wilson High School in the El Sereno neighborhood of Los Angeles, California.
Discover the Plasma Program: A collaborative effort joining Grifols, Johnston Community College and the Johnston Country Public School System to develop a science module called “Discover the Plasma” for middle-school students. The module would adapt to the county’s science program curriculum.
Grifols has been working with Habitat for Humanity in the U.S. since 2014. This NGO organizes efforts to build simple yet dignified homes to improve the living conditions of those most in need and strengthen the fabric of local communities. The company donated USD 215,000 toward new homes and materials in several cities of California and in Wake County, North Carolina. More than 250 of Grifols’ U.S.-based employees volunteered 4,160 hours of their time during 30 days of construction.
Grifols has collaborated with Direct Relief, organization that helps victims of natural disasters, for more than two years. In 2018, Grifols employees in the U.S. made a collective donation for victims of natural disasters, specifically those affected by hurricanes in the U.S. The company committed two separate corporate donations of $10,000 to support relief efforts in each area along with generous contributions from employees across the globe. In total, more than USD $33,000 USD was donated. 100% of donations went towards helping people impacted by these disasters.
Grifols has collaborated with the prestigious Fullbright Scholarship Program since 2013. Thanks to Grifols’ contributions, Spanish scholarship recipients were able to pursue and finalize master’s degrees in molecular medicine at the University of Maryland-Baltimore and in pharmaceutical sciences (Translational Medicine and Drug Discovery) at Boston’s Northeastern University. Fulbright scholarships form part of an educational aid program sponsored by the U.S. State Department’s Bureau of Educational and Cultural Affairs, governments of other countries and the private sector.
A team of 200 Grifols’ employees participated in the 5th Magic Line Solidarity Walk, organized by the Obra Social of the Sant Joan de Deu Hospital in Barcelona. Volunteers organized several initiatives that raised EUR 14,000, which were matched by the company. These funds will benefit a number of projects, including laboratory materials for research on childhood diseases, home visits for people at risk of social exclusion, and therapies for people with mental-health conditions or dependency issues.
Meanwhile, another Grifols team participated in the “Santander Cursa de les Empreses,” a run held in December 2018 in Barcelona. Including a total of 52 Grifols employees, the experience was shared within the framework of the CORREAMBMI Project, an organization that promotes sports, integration and solidarity.
Aigües de Vilajuïga is a century-old firm with one of Spain’s two natural water springs. Grifols’ share in Aigües de Vilajuïga allowed the business to move forward and avoid its imminent closure, as well as contributing to the social fabric of the Vilajuïga community.
Preserving a unique heritage
It all started in the small village of Vilajuïga, where a (seemingly) modest well supplied a particularly unique type of water to the villagers. They knew there was something special about this water, and they ascribed it mineral and medicinal properties. On July 15, 1904 Aigües de Vilajuïga was declared a mineral water fit for medicinal purposes.
Thanks to its unique qualities, Aigua de Vilajuïga rapidly became popular. Sales and exports grew exponentially, even reaching as far as the Americas. In 1929, the success of Aigües de Vilajuïga was rewarded with a gold medal at the World’s Fair in Barcelona, and in subsequent years the water went on to become an object of exaltation and praise for internationally renowned Catalan artists such as Josep Pla, Salvador Dalí and Ferran Adrià.
When Víctor Grífols heard that Aigües de Vilajuïga was going to close its doors after 114 years of history, his family ties and emotional connection to the region compelled him to do everything possible to protect the water and continue production, so that the people of Vilajuïga – and everyone who loved this unique and remarkable water – could continue to enjoy it for another 114 years (at least).