Compliance - European Medical Journal

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Compliance

EMJ/American Medical Journal (AMJ), while not subject to Codes of Practice, is committed to the observance of those regulations that govern the promotion of medicines and the support of scientific and educational material.

  • Approximately 70% of EMJ/AMJ’s published content is independently commissioned by an in-house Editorial department from key opinion leaders in their respective specialities. The remaining 30% comes from industry support.
  • EMJ/AMJ requests support – potential supporting companies do not approach EMJ/AMJ.
  • Company support is clearly and prominently disclosed; once on the journal’s masthead and again on each supported article. Transparency is of primary concern.
  • EMJ/AMJ will request support for a non-promotional medical education programme, for which EMJ/AMJ can provide a budget and schedule if requested.
  • EMJ/AMJ assures that published content will be educational and will be planned, designed and implemented in accordance with applicable Codes of Practice.
  • Prior to development of content, EMJ/AMJ discusses with the supporting company all on-/off-label issues, subject to the supporting company’s legal team’s requirements.
  • Authors are commissioned by EMJ/AMJ.
  • Any commercial bias in the content is clearly disclosed.
  • Content will be neither misleading nor disparaging. All content is subject to external, independent peer review, and quality control procedures ensure objectivity, balance and scientific rigour. EMJ/AMJ does not publish exaggerated or all-embracing claims.
  • All authors either disclose conflicts of interest or clearly state their absence.
  • Where writers have received writing assistance, such assistance is disclosed.
  • Authorship of all supported content is in accordance with those criteria recommended in the PhRMA ‘Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results’, effective as of 1st October 2009.
  • All content distributed at meetings or derived from meetings is subject to the same standards of peer review rigour as content appearing in the journals.
  • All content distributed at meetings or derived from meetings complies with all applicable Codes of Practice, and is in accordance with all local regulations.
  • When content is distributed at meetings in countries for which a related product does not have marketing authorisation, it will be accompanied by a suitable statement indicating countries in which the product has marketing authorisation.
  • EMJ/AMJ does not publish content that induces to prescribe or that seeks to promote any product prior to the granting of marketing authorisation. However, the legitimate exchange of medical and scientific information during the development of a medicine is not prohibited; provided such information or activity does not constitute promotion.
  • Third-party scientific and educational conferences or professional meetings can contribute to the improvement of patient care, and therefore financial support from companies is appropriate. Care is taken to ensure that reports of meetings may not be interpreted as promotion.
  • All reprints will carry a label (where appropriate) disassociating a company from the views of the author and explicitly stating that their print is unsolicited.
  • Financial support of EMJ/AMJ’s content is never perceived as an inducement to healthcare professionals to prescribe or recommend a particular medicine or course of treatment.

Sources:

  • The Association of the British Pharmaceutical Industry (ABPI) Code of Practice.
  • The International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA) Code of Pharmaceutical Marketing Practices.
  • The European Federation of Pharmaceutical Industries and Associations’ (EFPIA) Code of Practice on the Promotion of Medicines.
  • The PhRMA Code on Interactions with Healthcare Professionals (effective as of January 2009).
  • The PhRMA ‘Principles on Conduct of Clinical Trials and Communications of Clinical Trial Results’ (effective as of October 2009).
  • The US Food and Drug Administration’s Guidance in Industry – Supported Scientific and Educational Materials.
  • Various European regulatory authorities, e.g. Spanish Code of Practice for the Promotion of Medicines.
  • The FDA’s Guidance for Industry (January 2009) – Good Reprint Practices for the Distribution of Medical Journal Articles and Medical Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.