It is important that healthcare stakeholders, such as research institutes, healthcare professionals, patient advocacy groups, and other key players have access to up-to-date information on diseases and treatments while safeguarding their independence. We help facilitate this access by sponsoring independent initiatives and medical capacity-building programs. We also support outstanding research projects through our Global Grants for Innovation, for example. Transparency is one of our top priorities in everything we do.
Our approach to interacting with health systems
The well-being of patients is always our primary consideration when promoting pharmaceutical products, which is why we support health systems by providing information to our healthcare stakeholders, such as professional medical associations, patient advocacy groups, university clinics, and other hospitals. We follow specific approval requirements and procedures for each type of interaction in accordance with applicable laws and codes. In countries that have 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, manufacturers and distributors are permitted to advertise prescription drugs only to healthcare professionals, such as physicians and pharmacists. These promotional activities must always disclose the active ingredients, potential adverse effects and contraindications of the drug. Our internal governing documents on drug promotion are part of our Group-wide program, which requires us to always 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 (activities in which 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.
How we ensure transparency and compliance
For all engagements with healthcare stakeholders, we have established internal policies, 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 policy 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 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, there is a review by medical, legal and regulatory functions. This also helps us identify opportunities for improvement.
Direct-to-consumer advertising only in certain countries
Direct-to-consumer (DTC) advertising for prescription drugs is permitted in some countries, such as the United States. In accordance 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.
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 industry organizations, such as the Code of Practice published by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) Code of Practice.
We are a member of the German Association of Voluntary Self-Regulation for the Pharmaceutical Industry (FSA), which has defined its own Code of Conduct for collaboration between physicians and the pharmaceutical industry.
Our Group-wide Pharma Code for Conducting Pharmaceutical Business and Pharmaceutical Operations defines the relevant general compliance for our activities in the Healthcare sector. It also governs our interactions with physicians, medical institutions and patient advocacy groups along with our promotional practices.
Our new 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.
We introduced new Healthcare Ethical Guiding Principles in October 2020 to provide our Healthcare employees with ethical guidance for decisions and activities specific to the particular challenges and responsibilities of this business sector. They complement our other policies by providing an accessible general guide for responsibility towards patients, the independence of safeguarding mechanisms, scientific integrity, responsible promotional activities, responsible interaction with healthcare stakeholders, and organizational responsibility and accountability. We have specific governance documents, procedures and tools for different types of interactions with healthcare stakeholders, covering topics, such as engagements, hospitality, payments (at fair market value) and sponsorships to participate in events.
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 research and education
Through our Global Grants for Innovation, we sponsor research and medical education worldwide in order to contribute to medical advances that benefit patients.
We organize non-promotional medical education programs through our Global Medical Education and Academic Organization Relations unit. We deliver these either directly as Merck Medical Education Programs or by providing grants to third-party medical education providers to fund independent and continuing medical education programs. We take an ethical, transparent and responsible approach aimed at providing fair, balanced and objective content, 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 Medical Education Funding and our Merck Programs Policies. 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.
Transparent reporting
In 2020, we continued to publish financial and non-financial contributions that we made to healthcare stakeholders in the health industry where required according to local laws and codes. As required by applicable laws and codes, 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 and development activities as required.
We ensure transparency on our voluntary unsolicited donations by publishing the details of contributions to European patient organizations on our website. The report is updated annually and includes all amounts, recipients and the purpose of each transfer of value, thus fulfilling our obligation as a member of EFPIA.
Regular employee training
In 2020, we rolled out our Code of Conduct-related training curriculum on dealing with dilemmas in healthcare-specific situations to several countries after piloting the project in China in 2019. This is a comprehensive 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 implement this training program in all countries where our Healthcare business sector operates.
In 2020, we also rolled out a Healthcare Ethical Guiding Principles training for our leadership teams, explaining the principles and discussing how they can be used in different scenarios. The goal is to enable our employees to make ethical decisions relating to scenarios that are not clearly defined in other governance documents, where necessary. For 2021, an e-learning course is planned for all Healthcare employees.
Employees who are responsible for the promotion of our pharmaceutical products receive regular training on current guidelines. This applies to individuals working in sales, marketing and drug registration in particular. We either conduct these seminars 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 intranet.
Relevant employees participate in mandatory e-learning courses and classroom seminars to stay up-to-date on our policies and guidelines and important changes to transfer of value reporting requirements.