FDA to pharma: Follow the MCP, voluntary code of ethics

April 2, 2014 7:03 am 

MANILA, April 1 — The Food and Drug Administration (FDA) will issue sanctions to pharmaceutical companies who will not comply with the guidelines in following the Mexico City Principles (MCP) or voluntary code of ethics.

Dr. Cynthia Diza, medical specialist 3, officer-in-charge Ethical Market Communications Unit FDA, said that FDA has a guideline that mandates the pharmaceutical companies to practice and observe the “Mexico City Principles for Voluntary Code of Business Ethics for the Biopharmaceutical Sector or the Mexico City Principles (MCP).

Diza said that FDA will issue sanctions for those who will not comply with the MCP principles that include cancellation of license to operate or issuance of certificate of registration.

Diza was invited during the press briefing Tuesday held at the New World Hotel in Makati City, where the Pharmaceutical and Healthcare Association of the Philippines (PHAP) expressed support to the FDA adoption of the voluntary code of ethics for the pharmaceutical sector.

Through the FDA, the Philippines is expected to fully implement the MCP which was endorsed during the 19th Asia Pacific Economic Cooperation (APEC) Economic Leader Meeting in Hawaii.

“In delivering the best quality healthcare to patients, it is essential that professionalism and high ethical standard are maintained between the biopharmaceutical companies, the health professionals, and the regulatory body” said FDA in a circular that adopted the MCP.

Also, during the 17th APEC Small and Medium Enterprises Ministerial Meeting, the Ministers issued a Joint Ministerial Statement to promote SME cooperation for innovative growth in the APEC region.

The Ministers agree that corruption imposes a significant market access barrier and high costs for SMEs.

To address this challenge, they endorsed principles for voluntary codes of business ethics for specific sectors, including the biopharmaceutical sector.

Dr. Francisco Tranquillo, adviser of the PHAP and assistant to the Dean UP College of Medicine, discussed that MCP asserts that ethical interactions with healthcare professionals and other stakeholders, companies in the biopharmaceutical sector (companies should be guided by six principles namely: healthcare and patient focus, integrity, independence, legitimate intent, transparency and accountability.

Tranquillo said that any sponsorship provided to individual healthcare professionals must not be conditional upon an obligation to prescribe, recommend, or promote any medicine.

Likewise, any sponsorship provided to individual healthcare professionals must not be conditional upon an obligation to prescribe, recommend, or promote any medicine, he added.

Event should be held in an appropriate venue that is conducive to the scientific or educational objectives and the purpose of the event or meeting. Companies should avoid using extravagant venues or resorts such as in Boracay or hotels in Cebu, Tranquillo said.

Also agreed upon was that hospitality should be limited to refreshments and/or meals incidental to the main purpose of the event and should only be provided to the participants and not extended to individual’s spouse or other guests.

Adoption of the Mexico City Principles highlights the strong commitment of the government to promote a whole society approach to integrity that will ultimately benefit Filipino patients.

Ethical relationships are crucial to the country's mission of developing and making quality medicines available.

"The implementation of the MCP is a milestone for the Philippine healthcare sector and we call on everyone to respect these principles,” said Thomas Weigold, president of the PHAP.

PHAP, which represents the research medicines sector in the Philippines, composed of 37 member companies, has been following the MC principles since 2011. (PNA)



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