Jan 13, 2012

Asia - Advancing biopharmaceutical ethics in the region



Important regional issues such as economic integration, food security, expansion of trade, open governance, environmental protection and public health were among those addressed by the Asia-Pacific Economic Cooperation (APEC) Summit in Honolulu, Hawaii attended by no less than President Benigno S. C. Aquino III and 20 other heads of state.

During the Summit, APEC Ministers held a High Level Policy Dialogue on Open Governance and Economic Growth where they recognized that transparency and open governance are a “critical element” of sustainable economic competitiveness, leading to economic growth and prosperity.

A vital part of the transparency and open governance initiative is the conduct of ethical business practices.

In line with this, APEC Ministers endorsed three sets of principles to promote an ethical commercial environment in the areas of medical devices, construction and engineering, and biopharmaceutical.

Prior the Ministers Summit, an APEC Expert Working Group (EWG) was convened to discuss and formulate a common set of APEC Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector in Mexico City in September 2011.

Invited to participate in the EWG were members of the academe, government and the pharmaceutical industry.

Both the global International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the Pharmaceutical and health care Association of the Philippines (PHAP) were consulted during the said expert discussion.

In fact, several provisions of the Code of Pharmaceutical Marketing Practices developed by PHAP were considered during the preparation of the draft.

Now known as the “Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector,” these set of principles aim to advance standards for the ethical promotion of medicines.

Also referred to as the “Mexico City Principles,” the ethical standards help ensure that medical decisions are made in the best interests of patients.

It consists of six principles, namely: health care and patient focus, integrity, independence, legitimate intent, transparency and accountability.

The said principles apply to the biopharmaceutical sector, health care professionals and other stakeholders.

It is grounded on the fact that ethical relationships are critical to the mission of the biopharmaceutical companies to help patients by developing and making medicines available.

The APEC-endorsed document recognizes that ethical interactions between the biopharmaceutical sector and health-care professionals help bolster patient care and advance the practice of medicine.

For one, it allows the manufacturers or distributors of medicines to provide health-care professionals the information about the risks and benefits of pharmaceutical products.

Such exchanges are likewise beneficial as they provide an avenue for scientific and educational information and education.

During these interactions, the Mexico City Principles emphasize that biopharmaceutical companies have an obligation and responsibility to provide objective, accurate, and balanced information about their medicines so that there will be a clear understanding of the appropriate use of medicines.

They also stress that medicines should be promoted, sold and distributed in a manner that is ethical, objective, balanced and accountable, and in accordance with all relevant laws and regulations.

In relation to these principles, pharmaceutical companies in all their interactions must not improperly influence health-care professionals whether they may be physicians, nurses, pharmacists or their staff.

So as to avoid undue influence, all scientific or educational events must be held in modest venues and not in extravagant locations or even resorts.

Moderate hospitality must also be limited to participants and not to their guests.

The principles clearly state that companies should not pay any costs associated with individuals accompanying health-care professionals.

Furthermore, nothing should be offered or provided by a company in a manner that will affect the prescribing behavior of a health care professional. For one, the Mexico Principles states that payments in cash or cash equivalents or gifts for the personal benefit of health-care professionals must not be provided or offered.

It also asserts that to ensure that all interactions are professional in nature, any form of entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips are highly being discouraged.

Education and promotional materials, on the other hand, should encourage the use of appropriate medicines by presenting them objectively and without exaggerating their properties among others.

They should be based on an up-to-date evaluation of all relevant scientific evidence and should not in any way mislead by distortion, exaggeration, undue emphasis or omission.

The said set of principles also provides for the ethical and professional public sector relationships during government procurement, donations for charitable institutions and clinical trials among others.

APEC economies, biopharmaceutical companies and health-care professionals are encouraged by the Mexico City Principles to develop and implement codes of ethics consistent with the newly-endorsed set of guidelines.

The economies also recommend that industry associations consider publicizing those members who have agreed to abide by the codes to motivate the adoption of an industry code.

They also urge industry regulators and anti-corruption enforcement authorities to endorse the Mexico City Principles.

Implementing the regional set of standards for the biopharmaceutical sector requires collaboration of industry associations, individual companies, health-care professionals, patient and anti-corruption groups, and the government, among other important stakeholders.

Advancing ethics in business will not only yield benefits to patients but will also result in trust and confidence in the biopharmaceutical sector and those who belong to it.

Reiner W. Gloor
Business World
Weekender



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