16
A crucial component of our business activities is the responsible marketing of our products in accordance with regulations.
In our Pharmaceuticals business, the requirements for marketing are very stringent, as they are for all interactions in the health care industry. Our number-one goal is for patients to receive effective treatment. For this to happen, all health care industry players must have continuous access to the relevant information, patients must have access to the medicines they need, and the medicines must be correctly prescribed and utilized. In order to achieve this, we adhere to strict ethical standards for the marketing of our products. These standards sometimes exceed the statutory requirements and are intended to prevent key players from being improperly influenced.
To ensure professional, transparent conduct in our pharmaceutical marketing operations, we comply not only with numerous statutory regulations, but have also defined our own code of conduct. Furthermore, we also adhere to the industry regulations of the International Federation of Pharmaceutical Manufacturers & Associations (an international umbrella organization) and the European Federation of Pharmaceutical Industries and Associations (a European umbrella organization), as well as the regulations of local industry associations.
Group-wide regulations for pharmaceutical marketing
Our Pharmaceutical Marketing Best Practices define internationally mandatory standards.
These best practices govern interactions with doctors, pharmacists and patient organizations, defining requirements for holding events and for advertising. This international standard is supplemented by country-specific regulations, whereupon the more stringent respective requirement takes precedence.
We have a Group-wide guideline that specifically applies to our pharmaceutical activities in the US market.
For employees of our German legal entities, there is also an internal guideline on interacting with physicians, hospitals, pharmacies, and other members of professional circles, as well as with patient organizations. Merck KGaA, Darmstadt, Germany is furthermore a member of the Association for the Voluntary Self-Control of the Pharmaceutical Industry (FSA), which has defined 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. At the beginning of 2013, Merck KGaA, Darmstadt, Germany received a warning letter from the FSA because Merck KGaA, Darmstadt, Germany had not abided by new rules in its communication regarding a sponsoring activity.
"Promotional Materials" is a Group-wide guideline that additionally applies to all businesses of the prescription medicines division. This guideline requires advertising materials to be examined by the Merck KGaA, Darmstadt, Germany functions Medical, Regulatory and/or Legal to ensure that they conform to global pharmaceutical regulations.
In general, Merck KGaA, Darmstadt, Germany does not use its prescription drug marketing activities to advertise directly to patients. When Merck KGaA, Darmstadt, Germany does conduct such direct-to-consumer campaigns, the provisions of our Pharmaceutical Marketing Best Practices apply, as do local requirements, which are often even more stringent.
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. For instance, in 2011 and 2012, 4,345 employees participated in seminars on our Pharmaceutical Marketing Best Practices, in addition to the regular Code of Conduct training.
Marketing chemicals
Responsible marketing is also 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 KGaA, Darmstadt, Germany has established an extensive safety 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 legal entities. If we suspect misuse, we refrain from doing business with that customer for safety reasons.
