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Business Ethics in Biopharmaceutical Sector

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The Mexico City “voluntary codes of business ethics” was recently adopted by Food and Drugs Administration. Under FDA Circular no. 2013-024, dated September 5, 2013, ethical violations are grounds for filing appropriate administrative charges and/or imposition of administrative sanctions such as, but not limited to, imposition of fines, suspension, cancellation or revocation of any license, permit or registration issued by FDA.

The circular was issued as a result of the 17th APEC Small and Medium Enterprise (SME) Ministerial Meeting, where the “The Mexico City Principles” was  endorsed. The principles aim to:

  • Significantly reduce ethics compliance costs for SMEs by providing  greater clarity and collective understanding of what constitutes appropriate interactions with healthcare professionals to increase the benefits patient receive and enhance the ethical practice of medicine;
  • facilitate the safe and conduct of clinical research and assure that patients can benefit from objective and balanced research;
  • provide a more cost-effective way to access new APEC markets through lower risk of enforcement action and compliance cost;
  • position SMEs for greater contracting opportunities with large multi-national corporation in the global supply chain by raising awareness of the new ethics obligations required by large companies, and;
  • help ensure that medical decisions are made in the best interest of parties by advancing appropriate interactions between healthcare professionals and companies.

FDA Guidelines

Pursuant to the above principles, FDA Circular provides guidelines to implement the same, as follows:

  1. “The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector” shall be implemented (ANNEX to FDA Circular) pursuant to the provision of R.A No. 9711, also known as the “FDA Act of 2009″, in Section 4.o, which mandates FDA to prescribe standards, guidelines, regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities.
  2. The guidelines for application for approval of promotional advertisement, and/or  sponsorship materials for  pharmaceutical and biological products, among other health products, shall be formulated and issued by the Center for Drug Regulation and Research (CDDR).
  3. The CDRR shall implement compliance with the Mexico City Principles and, among others, monitor advertisement and other marketing instruments and promotion, sponsorship, and other marketing activities in the country.
  4. All monitoring, surveillance, and investigation on complaints and violations pertinent to the provisions of Section 4.o, of FDA Act of 2009, and other pertinent rules and regulations, shall be conducted with the assistance of the Regional Field Operations (RFO) Unit.
  5. All sanctions and penalties in violation of this Circular shall be imposed by  the CDRR in consultation with the Office of the FDA Director General.
  6. The CDRR shall issue guidelines, rules and regulations that are consistent with this Circular and the Mexico City Principles in consultation with the FDA Director General.

This FDA Order on business ethics was issued for compliance by drug establishments regulated by FDA, including the FDA as an organization and its officials, healthcare professionals and other stakeholders, such as media and advertisement firms.

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