Download Promotion of Pharmaceuticals

Merck’s Position Statement – The Promotion of Pharmaceuticals
Why it matters
There are often information asymmetries between health care providers and patients because of
the complexity and scientific nature of health care. Patient centered health care requires that the
pharmaceutical industry operate with high trust and transparency vis-à-vis the promotion of
pharmaceuticals. It is for this reason that pharmaceutical companies operate under tight scrutiny
regarding their marketing and promotional practices, particularly concerning advertisements on
prescription drugs and gifts to physicians. Health authorities are charged with regulating product
approval, labelling, information provision to the patient, product claims, and in some countries,
promotional materials and the provision of samples. In addition to government regulation, the
industry also self-regulates such as through the International Federation of Pharmaceutical
Manufacturers & Associations (IFPMA), the European Federation of Pharmaceutical Industries and
Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA)
codes.
Merck Position

Merck is committed to ensuring that its promotional practices are ethical, responsible, and
patient-centered and that they comply or even exceed the statutory requirements of strict
ethical standards. In October 2013, Merck adopted a strengthened Pharma Code for
Conducting Pharmaceutical Business and Pharmaceutical Operations. This Code is
compliant with industry association codes (IFPMA1, EFPIA2) and reinforces the standards
within Merck Serono for ethical marketing practices.

Merck abides by codes established by national industry associations as well as guidelines
from major international industry associations, such as the IFPMA “Code of Practice” and
“Code of Pharmaceutical Marketing Practices”.3 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 robust4 scientific evidence, is consistent with
national prescribing information documentation and complies with all applicable laws and
regulations established at national levels.

Merck does not promote medicines for off-label use. Off-label use of medicines should
always be limited to individual decisions of the treating physician.

Individuals responsible for medicines promotion, as well as employees working in sales,
marketing, medical and regulatory positions, are specifically and annually trained on Merck
marketing codes. In addition, all of Merck employees have access to the marketing code
and are annually trained in compliance (which includes marketing and promotion of
pharmaceuticals).

Any third party engaged in promotion activities on behalf of Merck is vetted by our
Compliance Department to ensure proper training and compliance with all applicable codes
and regulations.
1
IFPMA. (2014). IFPMA Code of Practice. Retrieved from http://www.ifpma.org/ethics/ifpma-code-of-practice/ifpma-code-ofpractice.html
2
EFPIA. (2014). The EFPIA Code. Retrieved from http://transparency.efpia.eu/the-efpia-code-2
3
http://ifpma.org/ethics/ifpma-code-of-practice/about-ifpma-code-of-practice.html
4
By robust we mean: Meets high standards for conduct, control, design, and statistical analysis.
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
Merck has in place internal processes and compliance officers to govern its sales and
marketing activities at global, regional and national levels.

Our employees are encouraged to use the various reporting channels that Merck has put in
place to report on any wrongdoing with regard to marketing practices.

Should the case arise that one or more of Merck marketing/promotional codes is violated,
Merck established a system to take immediate corrective, and where required, disciplinary
actions.

Merck is in full compliance with local regulations on advertising, including such policy
requirements as listing side effects, contra-indications and effectiveness of the advertised
prescription drug, as well as and presenting clear, legible, accurate, balanced, fair,
accessible and useful 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, making consumers and patients able to make informed decisions
about their treatment choice.
About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 40,000
employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat
cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and
LCD televisions. In 2014, Merck generated sales of € 11.3 billion in 66 countries. Founded in 1668, Merck is the world's oldest
pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group.
Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States
and Canada, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.
Merck’s biopharma business
With headquarters in Darmstadt, Germany, Merck’s biopharma business offers leading brands in 150 countries to help patients
with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. Merck
discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist
indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology,
immuno-oncology and immunology. For more information, please visit http://biopharma.merckgroup.com/en/index.html
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