FDA Adopts Business Ethics for Biopharmaceutical Sector

The Mexico City "voluntary codes of business ethics" was recently made compulsory by Food and Drugs Administration within the Philippine settings. FDA Circular no. 2013-024 entitled "Adoption and Implementation of "The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector" was issued last September 5, 2013, which administrative issuance was made to take effect immediately on said date.

Violation of the circular is a ground 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 measure was an offshoot of the 17th APEC Small and Medium Enterprise (SME) Ministerial Meeting, where the principles for voluntary codes of business ethics for medical device, biopharmaceutical  and construction/engineering sectors, were endorsed by the APEC Ministers.

For medical devices, the Kuala Lumpur (KL) Principles for Medical Devices Sector Codes of Ethics served as first example of adherence to the APEC Principles for Voluntary Codes of Business Ethics. After the tireless efforts of the Expert Working Group, APEC Ministers further officially endorsed "The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector, referred briefly as "The Mexico City Principles".

The Mexico City 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.

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.