Japanese Pharma To Beef Up Transparency Policies In 2011 To Counter Public Concern - APEC Regulatory Conference

SEOUL - Japanese pharma agreed to rollout updated in-house transparency guidelines in 2011 to strengthen compliance and improve the industry's public reputation.

The Japan Pharmaceutical Manufacturing Association approved a transparency guideline in January that is expected to be implemented by all of its member companies this year, according to JPMA Promotion Code Working Committee Vice Chair Yota Kikuchi, speaking at the APEC Harmonization Center's Asia Regulatory Conference in Seoul, April 27.

The industry association said transparency guidelines would help with the public perception of the pharma industry's reliability.

JPMA has conducted a survey every year since 1999 to gauge the public's perception of whether the pharmaceutical industry is reliable. In its first year, JPMA reported a positive response of 66%, which has increased to 88.1% by 2010. But Kichuchi acknowledged that while the numbers are high, individual responses are not so positive. When asked why the pharmaceutical industry is reliable, survey responders often replied with answers such as "Because there is no other choice than to rely on the industry."

"We know this is not a firm reputation," Kichuchi said.

In general, Japan's government, industry and healthcare practitioners have done little to address concerns about transparency and public-private compensation. As of last year, only 21% of Japan's medical societies had conflict-of-interest guidelines, and the government has no specific conflict-of-interest laws in place to punish medical societies, physicians or pharma (Also see "Only One-fifth Of Japanese Medical Societies Have Conflict Of Interest Guidelines" - Scrip, 19 Jul, 2010.).

Global Trend Tipping Toward Transparency

There has been a global trend of transparency, particularly disclosure of payments to academic and medical societies, and within Japan the government has started discussions to establish conflict-of-interest policies for clinical research in Japan, according to Kichuchi.

JPMA felt it important to "take a proactive stance before being demanded," Kichuchi said, and JPMA approved transparency guidelines Jan. 19, and released the guidelines externally March 2.

The association called on its members to establish internal transparency policies in line with JPMA's guidelines. The focus is on disclosures for R&D expenses, academic research grants, honoraria and meeting and lecture expenses. JPMA expects all members to establish procedures to obtain consent for disclosure and a system to aggregate all payment information.

While the guidelines are voluntary and non-binding, JPMA expects all member companies will disclose new policies within the year. By 2013, Japanese pharma will disclose on their websites payments made the previous year.

The individual cost to pharma companies will differ, as some are expected to completely overhaul their current compliance systems, while other companies will make adjustments to existing policies.

In short, as industry-academia collaborations increases, JPMA feels it necessary to guide member to self-regulate transparency standards.

China 's Early Days Of Self-Regulation

While, JPMA hopes self-regulating can set the standard for ethical compliance in Japan, China's R&D-based Pharmaceutical Association Committee knows that China's pharma industry is in the early stages of self-regulation.

"Self-regulation is not in our cultural context," RDPAC Legal Affairs Director Jennifer Chen said at the conference.

Self-regulation is not as much of a concern among the 37 RDPAC member companies, but China has thousands of domestic pharmaceutical companies, making it difficult for industry groups to ensure its members are compliant. RDPAC petitioned for standardized training and certification for medical representatives in China, and gained the support of China's Ministry of Health (Also see "RDPAC's Lobbying Efforts To Regulate China's Medical Representatives Likely To Pay Off This Year" - Scrip, 26 Jan, 2011.).

RDPAC updated its ethical promotional code - which reflects the International Federation of Pharmaceutical Manufacturers & Associations' code - in 2010 to provide more specific rules on transparency and to address China-specific compliance.

The RDPAC Code calls on members to designate only medically qualified employees to communicate with healthcare providers regarding off-label uses of drugs. To avoid the possibility of conflict of interest, RDPAC encouraged companies to not use "theme venues associated with leisure activities" as well as adopt "no-go cities" for meeting venues.

- Daniel Poppy ([email protected])