Group-wide regulations for pharmaceutical marketing

Merck's number-one goal for patients is for them to receive effective, high-quality treatment. Patient-centered health care requires that the pharmaceutical industry market its pharmaceuticals transparently and responsibly. Merck is committed to ensuring that its promotional practices are responsible and patient-centered, and that they comply with or even exceed strict ethical standards and statutory requirements. In October 2013, Merck adopted a revised version of its “Pharma Code for Conducting Pharmaceutical Business and Pharmaceutical Operations”. This Code is compliant with industry association codes (IFPMA , EFPIA ) and sets the standards within Merck for ethical marketing practices.

In addition, Merck also abides by codes established by national industry associations as well as guidelines from major international industry associations, such as the “Code of Practice” and “Code of Pharmaceutical Marketing Practices” published by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Merck adheres to all provisions included in these codes, which cover marketing practices as well as interactions with health care professionals, medical institutions and patient organizations.

Merck’s marketing and promotion is based on robust scientific evidence, is consistent with national prescribing information documentation and complies with all applicable laws and regulations established at national levels. Individuals responsible for medicines promotion, as well as employees working in sales, marketing, medical, and regulatory positions, are annually trained on Merck marketing codes. In addition, all of Merck’s employees also have access to its marketing codes and must receive annual training on compliance (which includes the marketing and promotion of pharmaceuticals).

Merck has in place internal processes and compliance officers to govern its sales and marketing activities at the global, regional and national level.

Should one of Merck’s marketing/promotional codes be violated, Merck has a system to take immediate corrective and, if need be, punitive action. Merck Serono is in full compliance with local regulations on advertising. This includes policy requirements such as disclosing the side effects, contra-indications and effectiveness of the advertised prescription drug, as well as presenting clear, accurate and balanced health information to patients and consumers. Merck only engages in direct-to-consumer advertising (DTC) in jurisdictions where this is currently allowed. DTC advertising can increase people’s awareness of disease and available treatments, enabling consumers and patients to make informed decisions about their treatment.

The industry associations with which Merck is associated have put in place reporting channels for health care professionals, patients and the general public to report on any wrongdoing with regard to marketing practices. For Merck employees, we have implemented the Speak-Up Line to support anonymous reporting of compliance concerns. We have also set up systems to take immediate corrective and, if need be, punitive actions.

The Group-wide guideline "Pharmaceutical Operations of Merck KGaA and Merck Serono S.A. in the United States" specifically applies to Merck's pharmaceutical activities in the U.S. market.

Merck is a member of the Association for the Voluntary Self-Control of the Pharmaceutical Industry (FSA), which has defined its own rules of conduct for collaboration between physicians and industry. When violations of the FSA Code are suspected, members and third parties can file complaints with an arbitration board.

In 2013 and 2014, Merck had to deal with three proceedings regarding alleged violations of the FSA Codex with regard to the disclosure of sponsorship money. All three proceedings were terminated.

All guidelines pertaining to marketing and advertising are part of the Group-wide compliance program. They are regularly adapted to reflect current developments and apply for all employees who work in the corresponding fields.

Within the scope of the compliance training plan, all relevant employees receive online training and participate in classroom seminars. Participation is monitored, and the results of the online training are evaluated. In 2013 and 2014, 12,416 employees participated in seminars on the Merck “Pharma Policies”, in addition to the regular Code of Conduct training.

Marketing chemicals

Responsible marketing is likewise important in our Chemicals business. In order to ensure careful handling, we supply our chemicals only to commercial customers who have the proven expertise. In addition, we provide customers with information on the safe handling and use of our products. To prevent the misuse of dual-use products, Merck has established an extensive safety and security net. Standardized export control guidelines are monitored by our central Export Control & Customs Regulations unit, as well as by trade and export control officers at the local Merck subsidiaries. If we suspect misuse, we refrain from doing business with that customer.