Grifols’ operations are grounded in an intrinsic respect for human dignity and human rights. Additionally, the company follows the fundamental principles of bioethics to guide the research, development, production and marketing of its 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 perspective. A range of international regulations, declarations and codes govern these core principles, including the Universal Declaration of Human Rights (1948), the Helsinki Declaration (1964) and UNESCO’s Universal Declaration on Bioethics and Human Rights (2005).
Furthermore, as part of Grifols’ commitment, it supports and preserves the well-being of the diverse communities where it operates. Using international frameworks as reference points (United Nations Global Impact, OECD Guidelines for Multinational Enterprises, UN Human Rights, and ILO Tripartite Declaration of Principles Concerning Multinational Companies), the company promotes responsibility and commitment to human rights in all of its operations, including the refusal of any child or forced labor in the entire value chain.
In this regard, the Grifols Code of Conduct governs the activities of all employees and collaborators, upholding strict compliance with legislation applicable to its operations and activities. The company also offers a communication channel that enables employees and outside collaborators to report any concerns of potential ethical breach or cases of ethical misconduct (Grifols Ethics Helpline).
Grifols’ Ethics Helpline is established to enable employees and third parties to anonymously raise any concerns of non-compliance or misconduct.
All allegations follow a standard operating procedure to guarantee that claims are adequately channeled, investigated and resolved. To ensure the proper functioning of this process, Grifols appointed an Ombudsperson, who is responsible for reviewing all allegations and ensuring the proper implementation of this process.
The Grifols’ Ethics Helpline received 226 allegations in 2019 (230 allegations in 2018). The company continues encouraging the use of the helpline in all of its countries of operation, although most of them (212) occurred in North America, 9 in Europe and 5 in other countries.
Grifols’ crime prevention policy’s objective is its unequivocal rejection of the commission of crimes, criminal acts or any other type of unethical behavior and its steadfast determination to prevent and combat these actions. The policy was developed through the Crime Risk Management System (CRMS) and is accessible on Grifols’ corporate website for all employees and third parties.
The objective of the CRMS is to assure public administrations, judicial and administrative entities and third parties that Grifols effectively complies with the requisite supervision, monitoring and control of board members, executives, employees, subsidiaries and other individuals by establishing measures to prevent crime or reduce the risk that one is committed.
An independent expert reviews the CRMS every year to ensure the existence of a crime-prevention system that complies with current legislation and includes adequate and efficient measures to prevent and detect crime, both in terms of its design and operational effectiveness.
Grifols enforces a “zero-tolerance” approach to acts of bribery and corruption. Grifols’ Anti-Corruption Policy extends to all employees of Grifols S.A., its subsidiaries and investee companies, as well as third parties that collaborate with the company. Grifols seeks compliance with this policy through various review processes.
The anti-corruption policy establishes appropriate standards of conduct for interactions between public officials and individuals operating in the private sector and is accessible on the corporate website for all Grifols personnel and third parties.
The company organizes regular training sessions for both new and current employees to guarantee compliance with its anti-corruption policies and procedures. In addition, additional training is provided to employees who interact more frequently with public officials or who carry out functions related to the marketing of Grifols’ products and services.
Compliance with the Anti-Corruption Policy is also reinforced through a series of review processes according to the type of interaction assumed from Global Compliance. In 2019, 4,600 interactions between employees and public officials or other professionals were subject to review. Particular attention was paid to transactions with higher risks.
In 2019, Grifols had no confirmed incidents of corruption in the markets where it operates.
As of December 31, 2019, close to 90% of employees whose roles and responsibilities place them at greater risk of witnessing acts of corruption had received special training on Grifols Anti-Corruption Policy and other internal controls that support it. More than 56% received this training in 2019. In addition to its continuous education efforts, Global Compliance is in permanent contact with Grifols employees to inform them of changes or novelties regarding policies and procedures, as well as relevant resolutions of public authorities such as the U.S. Department of Justice and the Spanish courts, among others. These initiatives contribute to continuously fostering ethical conduct within the organization.
To ensure compliance with anti-corruption policies and procedures, Grifols business associates undergo a complete verification process before any transactions are authorized or released. The third-party management system forms part of the Anti-Corruption Compliance Program and includes various control mechanisms for potential Grifols business partners.
Before entering any commercial relationship with Grifols, third parties are subject to a thorough two-part verification process: a first phase, which establishes the legitimacy of the potential commercial relationship, and a second phase of due diligence, which includes an in-depth analysis of the third party including its internal organization, key employees, its business approach and corporate reputation, among other aspects.
Furthermore, subsequent third-party contracts include current anti-corruption obligations, as well as an annex with a summary of Grifols’ Anti-Corruption Policy. They are also required to provide an annual certification of compliance with this policy.
In some cases, third parties such as international distributors are required to complete annual online training on anti-corruption regulations, such as the U.S. federal law with regard to the Foreign Corrupt Practices Act (FCPA).
Additionally, Grifols requires its distributors to provide an annual certification of compliance with the applicable anti-corruption regulation. These contracts also include a clause granting Grifols the right to audit on an as-needed basis. These clauses stipulate the termination of business relationships in the case of any breach of anti-corruption norms.
Grifols has mechanisms, procedures and policies in place to prevent money laundering and respond to any possible breaches detected in the course of the company’s operations.
As a forerunner in the healthcare sector, Grifols has broad experience and expertise in the areas of patient behavior and disease management. Its ongoing interactions with healthcare organizations and health professionals undoubtedly enrich this knowledge base by serving as a continual source of new ideas and insights. Leveraging this expertise is crucial to guide the industry and enhance the quality of patient care and treatment options. These interactions should be grounded in integrity and transparency.
Grifols Global Compliance Program establishes internal processes and procedures related to transfers of value stemming from interactions with healthcare professionals and organizations, including their approval on behalf of the pertinent committees.
In the U.S., the Sunshine Act (PPS Act), also known as Open Payments or Transparency Reports and Reporting of Physician Ownership or Investment Interest, requires manufacturers and group purchasing organizations of pharmaceuticals, biologicals, medical supplies and medical devices to itemize all information regarding payments and transfers of value provided to covered healthcare organizations and healthcare professionals, such as physicians and teaching hospitals. Additionally, under the PPS Act, manufacturers and group purchasing organizations must disclose if a physician has ownership interests in said companies. The Centers for Medicare and Medicaid Services (CMS) releases spend information extracted from these reports every June.
Grifols has a policy and procedure in place that describes how it implements its transparency program in order to comply with the reporting obligations required by U.S. state and federal governments.
Grifols both complies with and is a signatory to the Pharmaceutical Research and Manufacturers of America Code1 (PhRMA) on Interactions with Healthcare Professionals. Grifols may engage healthcare professionals as consultants or advisors to furnish important and needed information to Grifols, provided that it selects such consultants based on their relevant qualifications, experience, and expertise and compensates at fair market value for their legitimate services, pursuant to written contracts.
Grifols also complies with all legislation at the local level. Per requirements under California’s Health and Safety Code, Sections 119400-119402, Grifols has established a USD 1,500 aggregate annual limit on promotional materials, gifts, and other items or activities that it may provide to an individual healthcare professional practicing in the state of California.
In 2019, Grifols rolled out a comprehensive transparency-training program in the U.S. for new and current employees whose roles require them to interact with healthcare institutions and professionals. In addition, the company established a quarterly sub-certification process in 2019 to promote data integrity, demonstrate commitment to accurate reporting and establish corporate accountability throughout the organization globally.
In Europe2, Grifols voluntarily adopted the European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code in 2015. In 2019, for the fourth consecutive year, the company disclosed all payments and other transfers of value made to healthcare professionals and organizations in diverse European countries that fall within EFPIA’s scope.
In addition, as a member of MedTech Europe, Grifols applies the transparency guidelines stipulated by its Code of Ethical Business Practice, reporting its “Educational grants” initiatives in 2018.
The company also discloses all information regarding transfers of value by country, in accordance with local regulations.
In 2018, Grifols distributed EUR 12.3 million in transfers of value in accordance with criteria outlined in the EFPIA Disclosure Code, including EUR 8.8 million related to R+D activities in Europe. Of these, 66% have been made in Spain.
In the U.S., the company transferred USD 9.3 million under the Open Payment Program, compared to USD 13.6 million reported in 2017, denoting a 32% reduction as a result of lower activity related to R+D and contracting of services, which represent 90% of the total reported.
Advocacy is an important part of the democratic process that provides stakeholders an opportunity to share their perspectives and insights with policymakers. For Grifols, this means educating policymakers about the unique nature of plasma medicines and the importance of unrestricted access for patients to all products in all appropriate sites of service. The Grifols’ code of conduct and anti-corruption policies define the proper guidelines and standards of conduct for interactions between Grifols and public officials.
In the U.S., the company fully complies with all federal and state lobbying regulations and regularly files publicly available activity reports with the U.S. Congress as required by the Lobbying Disclosure Act. Grifols also voluntarily participates in the European Union’s Lobby Transparency Register and subscribes to the principles governing the rules of conduct for interactions with EU institutions articulated in its code of conduct.
Public information available at https://www.senate.gov/legislative/Public_Disclosure/LDA_reports.htm