Pharmaceutical marketing is regulated by legislation worldwide. In marketing our pharmaceuticals, the wellbeing of patients is always our primary consideration. A variety of internal guidelines shape our business conduct. Since November 2018, we mainly commercialize prescription medicines. In order to strategically focus on innovation-driven businesses, we divested our over-the-counter Consumer Health business.
Our approach to responsible marketing
We adhere strictly to all regulations concerning pharmaceutical marketing. In Germany, for instance, manufacturers are only permitted to advertise prescription drugs to medical professionals such as physicians and pharmacists. These adverts must always disclose the active ingredients, adverse effects and contraindications of the drug. Our internal guidelines governing marketing and advertising are part of our Group-wide compliance program, which requires us to always conduct business in compliance with the law and in line with the highest ethical standards. This is complemented by our internal guidelines and various voluntary commitments that, in many cases, exceed the applicable statutory regulations. We regularly review all our internal guidelines and revise them as required, in response to any new developments.
How we conduct ethical marketing
Our Group Compliance unit is responsible for setting up internal overarching compliance policies to ensure our business activities adhere to the statutory regulations that are applicable to our sales and marketing activities. This unit is further supported by other functions that provide topic-specific expertise to offer further detailed guidance and processes for review. For instance, our Global Regulatory Affairs unit has established a dedicated policy and corresponding process document on the review and approval of our promotional materials. The necessary training and communications are carried out by the units responsible for each of the respective policies. 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. Our Group Internal Auditing unit regularly conducts risk-based reviews of our sales and marketing activities. You can find more details on how we ensure compliance with statutory regulations worldwide under Compliance.
Our commitment: Code of Conduct and industry-wide regulations
Our Group-wide “Pharma Code for Conducting Pharmaceutical Business and Pharmaceutical Operations” defines the relevant standards for our ethical marketing practices. It also governs our interactions with physicians, medical institutions and patient advocacy groups.
In 2018, we revised ten Biopharma compliance policies to ensure we provide the required up-to-date compliance guidance to the business. We also extended the scope of this policy to our Healthcare business in the United States, operating under the name of EMD Serono, to Allergopharma and to the Foundation sponsored by Merck KGaA, Darmstadt, Germany. This will enable them to effectively adhere to our compliance principles and guidance around the world while maintaining the necessary flexibility to implement specific local policies or procedures that additionally comply with local regulations.
Through our “Principles of Review and Approval of Promotional Materials and Other External Communications”, we ensure that all promotional materials conform to our rigorous standards. All our employees involved in creating promotional materials have received training on updates made to the principles and the associated standard processes.
In addition to local laws and our own 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). This code was revised in May 2018 and became effective on January 1, 2019. We simultaneously revised our internal policy “Items Provided to Healthcare Professionals” to harmonize our internal guidance with IFPMA Code of Practice requirements. We are also a member of the German Association of Voluntary Self-Regulation for the Pharmaceutical Industry (FSA), which has defined its own code of conduct regarding collaboration between physicians and the industry.
Reviewing marketing material Group-wide
Our aim is to review all promotional material end-to-end to ensure that it meets our standards, which is why we apply a harmonized Group-wide review and approval system. Approximately 2,200 Healthcare employees use a centralized platform that allows us to streamline the review and approval process more efficiently, while also providing a better overview of global marketing data. This also helps us identify opportunities for improvement.
Addressing violations of standards and regulations
We have a number of channels for reporting wrongful marketing practices to the industry associations where we are members. For instance, when members of the FSA or third parties suspect a violation of the FSA Code, they can file complaints directly with the respective Arbitration Board. In 2018, no significant complaints of this kind were sustained against our company worldwide.
We have also established an internal SpeakUp Line that allows our employees to anonymously report potential compliance violations. If our marketing or advertising rules of conduct are broken, we have a committee in place to take immediate countermeasures. Any violations are dealt with using appropriate corrective action. In 2018, we experienced no significant cases of non-compliance regarding regulations and voluntary codes.
Regular employee training
Employees who are responsible for our pharmaceutical advertising receive regular training on current guidelines. This particularly applies to individuals working in sales, marketing and drug registration. These seminars are conducted locally in a classroom setting but are also offered online and as e-learning courses.
During 2018, we asked newcomers to our company to participate in an onboarding training on the topic of “Review and Approval of Promotional Materials and Other External Communications”. More than 1,100 employees already took part in a similar training course in 2017. Additionally, employees in charge of marketing and the promotion of pharmaceuticals can also access our respective compliance guidelines via our Intranet.
Direct marketing only in certain countries
Direct-to-consumer (DTC) advertising for prescription drugs is allowed in some countries, such as the United States, and we only pursue DTC campaigns in these areas. We use direct advertising to try and increase people’s awareness of certain diseases and the therapies that are available, thus empowering patients to make informed decisions about their own treatment.
We also approach the marketing of our chemical products with the deepest sense of responsibility. For instance, we only supply our chemicals to commercial customers with proven expertise and we provide them with detailed information on the safe handling and use of our products. We have an extensive safety and security network in place to prevent the misuse of dual-use products. This network features standardized export control guidelines for these products, which are monitored by our central Export Control and Customs Regulations unit, as well as by trade and export control officers at our local subsidiaries. If we suspect or are informed of misuse, we terminate our business relationship with the customer. When necessary, we work with the responsible authorities to prevent illegal use. In 2018, there were eight attempts to obtain our products for illegal purposes. The business relationship with these customers was terminated.