Trends in Europe: Coping with National Differences in Regulation of Marketing Practices and Relationships with Health Professionals. 6 June 2007, Brussels International Pharmaceutical Regulatory and Compliance Congress and Best Practice Forum. Linda R. Horton, Partner
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6 June 2007, Brussels
International Pharmaceutical Regulatory and Compliance Congress and Best Practice Forum
Linda R. Horton, Partner
Brussels and Washington, DC
+322 505 0931
+ 1 202 637 5795
Partnering with and engaging healthcare professionals
Article 86(2). “Advertising” excludes:
correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product
factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims
information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products
Dissemination of off-label information pursuant to section 401 of the FDA Modernization Act (FDAMA);
Non-promotional “scientific exchange” of information;
Dissemination of off-label information under the holding of the Washington Legal Foundation (WLF) case;
Responding to unsolicited requests from healthcare professionals;
Sponsorship of independent Continuing Medical Education (CME).Exceptions to ban on off-label use
“Representatives must not make claims … which are outside the terms of the marketing authorization for the medicine or are inconsistent with the summary of product characteristics. Indications for which the medicine does not have a marketing authorization must not be promoted.”
Italy: Farmindustria Code
“The information material prepared by the company on its products and used to provide information to physicians must be based on official documents issued by the Ministry of Health when the drug is registered or subsequently approved by the ministry on the basis of the relevant laws.”Examples of national code rules:
Sales reps should never volunteer information about off-label use.
Sales reps should never solicit questions about off-label use.
If sales reps receive unsolicited question (e.g. during visit, or during symposium), they should refer the questioner to medical affairs (“scientific service”).
The scientific service response must be in writing and cannot include any promotional material.Consequently, best practice in EU:
Sponsorships to Conferences,
The provisions of Article 94(1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality shall always be strictly limited to the main scientific objective of the event; it must not be extended to persons other than health-care professionals.
Violations of Member State laws and industry codes in the marketing practices area
Marketing Practice Compliance Plan, Policies, and Procedures
The 7 Elements of an Effective Compliance Health & Human Services Office of the Inspector General
Plan (U.S. Health and Human Services Insp Gen)
Many companies are using this list as guidance:
a part of strategy meetings.
according to those precepts.
Linda R. Horton
Hogan & Hartson, Brussels and Washington, DC
T: +32-2-505-0931 or
National Laws and Codes on Marketing Practices
and Relationships With Health Professionals
As part of a national strategic plan, the Pharmacy Committee of the Spanish National Health System will look at: