It is important that healthcare stakeholders, such as research institutes, healthcare professionals, and patient advocacy groups, have access to up-to-date information on diseases and treatments while safeguarding their independence at the same time. We help to facilitate this access. We also support cutting-edge research projects.
Our approach to interacting with health systems
The well-being of patients is our primary consideration when promoting pharmaceutical products. We support health systems by providing information to our healthcare stakeholders, such as professional medical associations, patient advocacy groups, university clinics and other healthcare providing institutions. We follow clearly defined internal approval requirements and procedures for each type of interaction, in line with applicable laws and codes. In countries with statutory or industry obligations on the disclosure of transfers of value to healthcare stakeholders, we comply with these obligations.
We adhere to all regulations concerning the promotion of pharmaceutical products. In most markets, pharmaceutical companies are permitted to advertise prescription medicines only to healthcare professionals, such as physicians and pharmacists. These promotional activities must always disclose the active ingredient, potential adverse effects and contraindications of the medicine. Our internal governance documents on the promotion of pharmaceutical products are part of our Group-wide program, which requires us to conduct business in compliance with the law, industry obligations and in line with the highest ethical standards. Our internal governance documents and various voluntary commitments exceed the applicable statutory regulations in many cases. We regularly review all our internal governance documents and revise them as required in response to any new developments.
We clearly differentiate between information-sharing activities (where we share scientific information but not with the intention of promoting or increasing sales of pharmaceutical products) and promotional activities (activities with the clear intention of promoting or increasing sales of pharmaceutical products performed only by the Commercial organization), in line with industry standards. This differentiation implies various internal policies and standard operating procedures, responsible functions and review and approval levels, depending on the intention of the activity.
Direct-to-consumer advertising only in certain countries
Direct-to-consumer (DTC) advertising for prescription medicines is permitted in some countries, such as the United States. In line with applicable local laws, we use DTC advertising in these countries to help increase people’s awareness of certain diseases and the available therapies. In doing so, we empower patients to make informed decisions about their own treatment.
Roles and responsibilities
For all engagements with healthcare stakeholders, we have established internal policies and review processes and tools, such as record-keeping systems, to ensure adherence to statutory requirements and transparency obligations.
Our Global Regulatory Affairs unit has established a dedicated standard and corresponding process document on the review and approval of our promotional materials. At the operational level, the relevant business and all employees involved in our sales and marketing activities must adhere to our internal policies, standards and procedures.
To ensure that all promotional materials meet our standards as well as local regulations end-to-end, we apply a harmonized Group-wide review and approval system. In our Healthcare business sector, we use a single global software tool. This has enabled us to unify, simplify and monitor the review and approval process for promotional materials and monitor that process in accordance with the dual-control principle. If the material has promotional intent and is product-related, a review is conducted by our Medical, Legal and Regulatory functions. This also helps us identify opportunities for improvement. All employees involved in creating, reviewing and approving promotional materials undergo training on the current process for reviewing, approving and decommissioning promotional materials based on our principles and standards.
Our commitment: Group-wide guidelines and industry standards
In addition to applicable laws and our own internal standards, we comply with the codes of conduct of various international industry organizations, such as the Code of Practice published by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
We are also members of various local industry associations, such as the German Association of Voluntary Self-Regulation for the Pharmaceutical Industry (FSA) and the U.S. Pharmaceutical Research and Manufacturers of America (PhRMA). Our activities adhere to the associations’ codes for collaboration between healthcare professionals and the pharmaceutical industry.
Our Group-wide Pharma Code for Conducting Pharmaceutical Business and Pharmaceutical Operations (Pharma Code) defines the general compliance for our activities in the Healthcare sector. It provides high-level and overarching principles that govern our interactions with physicians, medical institutions, and patient advocacy groups, along with our promotional practices.
Our Healthcare Ethical Guiding Principles, introduced in October 2020, supplement the Pharma Code and provide our Healthcare employees with six ethical guiding principles for decisions and activities specific to the particular challenges and responsibilities of this business sector. In 2021, we rolled out an e-learning course for Healthcare employees worldwide. The course introduced the principles and showed how they provide quick and efficient guidance in relevant situations.
Under the umbrella of our Pharma Code and Healthcare Ethical Guiding Principles, we have specific governance documents, procedures and tools for different types of interactions with healthcare stakeholders, covering topics such as service engagements, hospitality, payments (at fair market value) and sponsorships to participate in events.
Our Standard on Medical Activities provides the general principles and requirements that must be respected in all medical activities, including interactions with healthcare providers. The specific governance for the different types of activities and interactions is detailed in further policies and standards, standard operational procedures and other governance documents.
Collaborating with patient advocacy groups
Our Policy on Interactions with Patients, Patient Opinion Leaders and Patient Organizations provides a comprehensive framework for our interactions with these key stakeholders. Our guideline entitled Good Practice and Process Guidance: Engagement with Patients, Patient Opinion Leaders and Patient Organizations provides additional guidance for our interactions with these stakeholders. It reflects our commitment to prioritizing patient well-being. Through this policy, the supplementary guideline and specific local policies, we provide a robust guidance structure to support our employees in remaining compliant throughout their interactions with patients, patient opinion leaders and patient organizations.
We seek to improve patients’ quality of life, which is why we support the work of patient advocacy groups. These groups in turn provide patients, family members and caregivers with information on disease management.
Supporting medical education
In order to contribute to medical advances that benefit patients, we organize non-promotional global medical education programs worldwide through our Global Medical Education and Academic Organization Relations department. We offer an Integrated Medical Education Portfolio comprising company-led or independent and continuing medical education programs funded by third-party organizations (medical education providers, medical societies, academic organizations, etc). We take an ethical, transparent and responsible approach aimed at providing fair, balanced and objective content. This is designed to allow the expression of a diverse range of theories and recognized opinions.
All requests for medical education funding are channeled through an approval process that falls under our R&D and Compliance functions, in line with our Standard on Medical Education Funding and our Company-led Programs Policy. This process ensures that all funds available for medical education programs are granted according to established internal guidelines and criteria, while also complying with all applicable laws and industry codes.
We also partner with industry associations, such as Global Alliance for Medical Education (GAME), International Alliance for Continuing Medical Education, (iPACME), European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medical Affairs Professional Society (MAPS). Together with these associations, we discuss how to improve and harmonize quality standards for medical education.
In 2021, we continued to publish financial and non-financial contributions that we made to healthcare stakeholders in the healthcare industry, such as healthcare professionals and healthcare organizations, as appropriate and in accordance with local laws and codes. The published information includes the names of individual recipients and their addresses as well as the purpose and amount of the transfer, as required by the applicable laws and codes. 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 and development activities, as required.
Apart from disclosing transfers of value to healthcare professionals and healthcare organizations as required, we ensure transparency on our voluntary unsolicited donations to European patient organizations by publishing the contribution details on our website. The report is updated annually and includes all amounts, recipients and the purpose of each transfer of value, thus also meeting our obligation as an EFPIA member.
Regular employee training
In 2021, we continued with the international roll-out of our Code of Conduct-related training curriculum on dealing with dilemmas in healthcare-specific situations. This is a comprehensive and interactive training course that seeks to improve participants’ awareness and understanding of such dilemmas, for example when overhearing a conversation that may or may not constitute attempted bribery. We plan to further implement this training program in all countries where our Healthcare business sector operates. The success of this program has prompted us to introduce a similar program in our Life Science and Electronics business sectors.
Employees who are responsible for the promotion of our pharmaceutical products receive regular training on current guidelines. This applies to individuals in sales, marketing and functions who work directly with healthcare providers. We conduct these seminars either locally in a classroom setting or as e-learning courses.
New employees participate in onboarding training dealing with the review and approval of promotional materials. Additionally, employees in charge of marketing and promotion of pharmaceutical products can also access our respective guidelines via our corporate intranet.
Based on their roles and responsibilities and in order to remain up to date, employees participate in mandatory e-learning courses and classroom trainings on our policies and guidelines as well as important changes to the reporting requirements of transfers of value.