Interactions with health systems

Part of the non-financial report

We want all patients to receive the best possible medical treatment. To achieve this, it is essential that research institutes, physicians, patient advocacy groups, and other key actors in health systems have access to detailed and up-to-date information on diseases and treatments. We help facilitate this access by sponsoring independent initiatives and medical capacity advancement programs, as well as by donating money and supplies. In addition, we promote outstanding research projects. In all our endeavors, transparency is our number one priority.

Our approach to interacting with health systems

We support health systems by providing information, making monetary contributions, and donating supplies to professional medical associations, university clinics and other hospitals, as well as to patient advocacy groups. These contributions are expressly not intended to influence decisions regarding treatment, prescriptions or purchasing. Consequently, we have committed ourselves to providing complete transparency. We prepare detailed reports on our donations that align with industry-wide codes and with statutory requirements such as those governing data protection. Every year we disclose all transfers of value to healthcare professionals, healthcare organizations and patient organizations. We also report on transfers of value made by our R&D activities in every country where our company operates within the region covered by the European Federation of Pharmaceutical Industries and Association (EFPIA). Furthermore, we fulfill the relevant voluntary commitments of our industry.

How we’re ensuring transparency and compliance at an organizational level

In all interactions with health systems, Group establishes internal policies and related review processes to ensure adherence to statutory requirements and transparency obligations. Group Compliance also provides the necessary training and communication to all employees involved. Furthermore, the Global Transparency Operations team of Group Compliance serves as a center of excellence, providing support for transparency reporting and our end-to-end management process for interactions with healthcare professionals, healthcare organizations, patients, and patient advocacy groups.

Our Internal Audits unit monitors the implementation of these initiatives locally. Before entering into a partnership or collaboration with third parties, we also involve our Business Partner Risk Management unit in the respective selection process. The Compliance chapter of this report provides more details on how we implement legal requirements across the Group.

Our commitment: Group-wide guidelines and industry standards

Our “Interactions with Patients, Patient Opinion Leaders and Patient Organizations” policy provides a comprehensive framework for our prescription medicines business. For our over-the-counter product business we have a comparable policy that was revised in 2017 and is now in effect throughout the Group. Supplementing this, our guideline “Good Practice and Process Guidance: Engagement with Patients, Patient Opinion Leaders and Patient Organizations” provides additional guidance for our interactions with patients and patient advocacy groups. It furthermore ensures that patient wellbeing is always our top priority. Through this policy, the supplementary guideline and specific local policies, we provide a robust compliance guidance structure to support our employees in conducting compliant interactions with patients, patient opinion leaders and patient organizations.

In all transfers of value, we comply with the principles set forth by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in its “Code on disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organizations”. Furthermore, our efforts are aligned with the Code of Conduct of the German Association of Voluntary Self-Regulation for the Pharmaceutical Industry (FSA).

In addition to complying with these codes, we adhere to all statutory transparency requirements worldwide, such as the stipulations of the in the United States and the Loi Bertrand in France. Specific national laws and requirements are implemented by our local units. In doing so, we consistently adhere to the applicable data privacy legislation and make a best effort to ensure our partners also comply fully.

Through mandatory online training and classroom seminars, the relevant employees are kept up-to-date on our interactions guideline and policy, as well as on important changes to reporting requirements for transfers of value.

Transparent reporting

In 2017, we continued to publish all financial and non-financial contributions made to European medical professionals and organizations in the health industry. As required by the EFPIA Disclosure Code, this information includes the names of individual recipients and their addresses, as well as the purpose and amount of the transfer. Before publishing, we secured all necessary informed consent forms as required by applicable data privacy regulations. In 2017, as part of the EFPIA transparency initiative, new laws were adopted in several European countries including Greece, Spain, Belgium, and Turkey. These changes have already been incorporated into our 2017 reporting processes. Other than disclosing monetary transfer of value on an individual level, we also published our overall spending on our research & development activities as required by the EFPIA Disclosure Code.

Partnering with patient advocacy groups

Patient advocacy groups support patients, family members and caregivers, providing them with information on disease management. Just like these organizations, our company has also made it our goal to improve patient quality of life, which is why we endeavor to support their vitally important work. We provide the highest level of transparency on our donations by publishing the details of contributions to European patient organizations. Updated annually, the 2017 report includes all donation amounts, recipients and the purpose of each donation, thus fulfilling our obligation as a member of EFPIA.

Transparently promoting research and education

We sponsor research and continuing medical education around the world in order to contribute to medical advances that will benefit patients. Through our Grants for Innovation, for example, we support research projects in fertility, multiple sclerosis, oncology, and growth disorders. Through our Global Medical Education unit we also provide grants to continuing medical education providers, enabling them to develop and deliver advanced medical training to scientists, physicians, nurses, pharmacists, and other healthcare professionals. We take an entirely transparent approach to this collaboration as well. All direct and indirect financial aid aligns with the principles of EFPIA. According to our internal “Medical Education Funding Policy”, all requests for medical education funding are channeled through an evaluation process under the responsibility of our R&D and Compliance functions. This process ensures that all funds for medical education programs are granted according to established internal guidelines and criteria while also complying with all applicable laws and industry codes.

In 2017, we partnered with other experts belonging to a sub-group of the International Pharmaceutical Alliance for Continuing Medical Education (iPACME) to write a joint position paper setting out suggestions for improving and harmonizing quality standards for continuing medical education (CME) in Europe. We explicitly invited our to take part in this discussion. The position paper was published in July 2017 in the Journal of European CME and is supported by the European CME Forum and the Global Alliance for Medical Education.

Compliance
Adherence to laws and regulations as well as to voluntary codices that are internal to Merck KGaA, Darmstadt, Germany. Compliance is a component of diligent corporate governance.
Sunshine Act
The Sunshine Provisions of the U.S. Patient Protection and Affordable Care Act aim to create more transparent relationships between manufacturers of drugs, medical devices and medical aids on the one hand, and doctors and teaching hospitals on the other.
Stakeholder
People or organizations that have a legitimate interest in a company, entitling them to make justified demands. Stakeholders include people such as employees, business partners, neighbors in the vicinity of our sites, and shareholders.

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