It is essential that research institutes, physicians, patient advocacy groups and other key players 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. We also promote outstanding research projects, for example through our Global Grants for Innovation. 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, patient advocacy groups, university clinics and other hospitals. These contributions are absolutely not intended to influence decisions regarding treatment, prescriptions or purchasing. We have therefore 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, and we comply with all applicable laws and industry codes on transparency. In countries that have statutory or industry obligations regarding the transfers of values to health systems, we comply with these and are transparent in our reporting.
How we ensure transparency and compliance at an organizational level
In all interactions with health systems, Group Compliance 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 applicable employees. 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 local implementation of these initiatives. Before entering into a partnership or collaboration with a third party, we also apply a selection process based on a policy and standard operating procedure. This is part of our Business Partner Risk Management compliance program, which is conducted by Group Compliance. 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. This policy was updated in April 2018 to include more guidance for interactions with patients and patient organizations and is directly applicable to our Biopharma business, Allergopharma and the Foundation sponsored by Merck KGaA, Darmstadt, Germany. 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 reinforces our belief that patient wellbeing is always a top priority. Through this policy, the supplementary guideline and specific local policies, we provide a robust guidance structure to support our employees in being compliant during their interactions with patients, patient opinion leaders and patient organizations. We are also active in the enhancement of self-regulation within the industry, such as in the European Federation of Pharmaceutical Industries and Associations (EFPIA) sub-group discussions with patient organizations and industry representatives on delivering guidelines on patient compensation.
Transparent reporting
In 2018, we continued to publish all financial and non-financial contributions that we 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 the applicable data privacy regulations.
In addition to disclosing monetary transfers of value on an individual level, we continue to publish overall spending on our research & development activities, as required by the EFPIA Disclosure Code. In 2018, EFPIA issued further guidance on the disclosure of non-interventional studies (NIS) differentiating between retrospective NIS and prospective NIS for different reporting methods, either on an individual level or in aggregate amount. We have adopted the new requirement in our preparation of reporting from 2018 onward. When the EU General Data Protection Regulation (GDPR) became effective in May 2018, we revised our global agreement templates with healthcare professionals, healthcare organizations, patients and patient organizations, and the related disclosure consent templates, in relevant countries to ensure all clauses and processes related to transparency reporting are aligned with the requirements of the regulation.
We also adhere to all statutory transparency requirements worldwide, such as the Transparency Code of the German Association of Voluntary Self-Regulation for the Pharmaceutical Industry (FSA), the stipulations of the Sunshine Act in the United States and the Loi Bertrand in France. Specific national laws and requirements are implemented by our local units. We consistently adhere to the applicable data privacy legislation and endeavor to ensure the full compliance of our partners.
In 2018, we registered an increase in the number of countries adapting new transparency disclosure rules, including Canada and Saudi Arabia. The province of Ontario (Canada) has passed the Health Sector Payment Transparency Act, which came into effect on January 1, 2019. This makes it the first province in Canada to formally address the transparency of payments made by pharmaceutical and medical device companies. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) introduced new transparency reporting rules that were implemented on October 1, 2018.
Relevant employees participate in mandatory online training and classroom seminars, so that they stay informed about our interactions guideline and policy, and important changes to reporting requirements for transfers of value.
Partnering with patient advocacy groups
Patient advocacy groups support patients, family members and caregivers, providing them with information on disease management. We have also made it our goal to improve patient quality of life, which is why we support the vitally important work of these organizations. We ensure transparency on our donations by publishing the details of contributions to European patient organizations on our website. The report is updated annually and includes all donation amounts, recipients and the purpose of each donation, thus fulfilling our obligation as a member of EFPIA.
Transparently promoting medical research and education
We sponsor research and continuing medical education around the world so that we can 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. As of 2018, a total of 99 research proposals have been selected to receive research grants through the Global Grants for Innovation program since its inauguration in 2009.
Through our Global Medical Education and External Relations 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. As with our other collaborations, we take an entirely transparent approach to this. All direct and indirect financial support 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 2018, we continued our partnership with the International Pharmaceutical Alliance for Continuing Medical Education (iPACME). This group of 20 professionals from 17 different companies from around the world engages in continuous discussions for improving and harmonizing quality standards for continuing medical education.
We continue to promote research and education in and for developing countries through a series of programs, with a focus on malaria and schistosomiasis. These research programs, involving African post-doctoral fellows, include, for example, the sponsorship of three PhD fellowships in support to the governmental malaria control programs in Namibia, Botswana and Zambia.
Other examples of research programs enhancing local expertise include collaborations with the University of Cape Town and Medicine for Malaria Venture (MMV) to identify new potential anti-malarial drug candidates. We also work with the Kenya Medical Research Institute (KEMRI) to study the impact of schistosomiasis infection on the severity of malaria co-infection in children, and with the European and Developing Countries Clinical Trials Partnership (EDCTP) in a fellowship program on clinical practices and management.
Introduction of a new compliance tool
In May 2018, we introduced a new compliance tool called Quantum Connect, which replaced our previous tools for supporting the planning, review and confirmation of compliant interactions with healthcare professionals, healthcare organizations, patients, and patient organizations. Quantum Connect stands as a single global tool that is applied to all markets in which we operate. The new software encompasses elements to determine the appropriate compensation for service engagement and ensures agreements are compliant with applicable laws and codes, such as the EU General Data Protection Regulation (GDPR).