We commercialize both prescription medicines and over-the-counter products. Pharmaceutical marketing is regulated by legislation worldwide. In Germany, for instance, manufacturers are only permitted to advertise prescription drugs to medical professionals such as physicians and pharmacists. In doing so, they must always disclose the active ingredients, adverse effects and contraindications of the advertised drug. In marketing our pharmaceuticals, the wellbeing of patients is always our primary consideration - because they deserve effective, high-quality treatment.
Our approach to responsible marketing
We adhere strictly to all regulations on pharmaceutical marketing. All guidelines pertaining to 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. Our compliance program 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, adapting them to new developments.
How we conduct ethical marketing
Our Group Compliance unit is responsible for setting up internal compliance policies and procedures to ensure that our business activities adhere to the statutory regulations applicable to our sales and marketing activities. Our Global Regulatory Affairs unit has also established a dedicated policy and complementary process document on the review and approval of our promotional materials. The necessary training and communication are carried out by each policy owner. On the operational level, the businesses and every employee involved in our sales and marketing activities must carry out these activities in adherence with our internal policies and procedures. Our Internal Audits 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. Due to specific regulations in the United States, our pharmaceutical activities there are subject to a specific guideline entitled “Pharmaceutical Operations of Merck KGaA, Darmstadt, Germany and the biopharmaceutical business sector in the United States“.
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. In 2017, we updated these principles along with the associated standard process, focusing particularly on our requirements for scientific communication with health workers. All employees involved in creating promotional materials worldwide have received training on these updates.
Beyond national laws and our own standards, we furthermore comply with the codes of conduct of various industry organizations, such as the Code of Practice and Code of Pharmaceutical Marketing Practices published by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Moreover, 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 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 Group-wide review and approval system. In 2016, we updated this system and harmonized a variety of locally used tools. Since the beginning of 2017, approximately 2,200 Healthcare employees have been using 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 helps us identify opportunities for improvement.
Addressing violations of standards and regulations
A variety of channels has been established so that wrongful marketing practices can be reported to the industry associations to which we belong. 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 2017, no such complaints were lodged against our company.
In addition to external reporting options, we have also established a SpeakUp Line that allows our employees to anonymously report potential compliance violations. If our marketing or advertising rules of conduct are violated, we have a committee in place to take immediate countermeasures. Appropriate corrective action is taken to deal with violations as required.
We have not identified any significant cases of non-compliance regarding regulations and voluntary codes.
Regular employee training
Employees 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. In 2017 for instance, more than 1,100 employees took part in the training course on the “Review and Approval of Promotional Materials and Other External Communications”. Additionally, the employees in charge can also access our compliance guidelines on the marketing and promotion of pharmaceuticals 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. We only pursue DTC campaigns in these jurisdictions. Through direct advertising, we hope to increase people’s awareness of certain diseases as well as available therapies, empowering consumers and patients to make informed decisions about their own treatment.
We 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 furthermore 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 & Customs Regulations unit, as well as by trade and export control officers at our local subsidiaries. If we suspect misuse, we terminate our business relationship with the respective customer. In 2017, too, there were attempts to obtain our products for illegal purposes. In questionable cases, we additionally engage the responsible authorities to prevent illegal use.