It’s a Small World of Regulation After All

By Lauren Barnett

Compliance Content Specialist, PharmaCertify

The end of April was filled with exciting events for the United Kingdom. Apparently there was a wedding of some importance happening, but more importantly, April marked the end of the “grace period” for the implementation of the latest version of the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry. Like PhRMA here in the U.S., the ABPI is a trade association of the pharmaceutical industry in the U.K. With PhRMA updating its own Code of Interactions with Healthcare Professionals not too long -ago, it naturally begged the question, what are some of the differences and similarities between these two documents?

One notable difference between the two Codes is the breadth of topics covered by the ABPI Code. As made evident by the full titles of each document, the PhRMA Code deals specifically with interactions with healthcare professionals. The ABPI Code deals with commercial practices in general; from sampling, to relationships with patient organizations, to advertising.

Also notable is that the ABPI Code is mandatory for its members and affiliate members. The PhRMA Code is voluntary. Membership in the ABPI comes with the commitment that the company will “abide by the Code in both spirit and the letter.” Like PhRMA, the ABPI welcomes non-member companies to publically commit to abide by their code. This raises another difference; the ABPI requires documented training on its Code. Since the PhRMA Code is voluntary, certified training is not required, although expectations for that training are presented.

Let’s take a look at how the ABPI and the PhRMA Code line up in the areas specific to interactions with healthcare professionals. Both call for careful documentation when using healthcare professional as consultants and both suggest that consulting contracts should be for bona fide activities and not offered as an inducement. The ABPI, taking a page from the Sunshine Act, also includes the requirement for public disclosure of financial arrangements. And like the provision of the Sunshine Act, the disclosure provisions of the ABPI Code are effective in 2012 and 2013.

Like the most recent update of the PhRMA Code, the ABPI Code prohibits the provision of practice related items such as mugs, notepads, pens and the like. The ABPI Code does allow for the provision of notebooks and pens at bona fide meetings. These items cannot have product logos, (company logos are permitted), and may not exceed 6 pounds in value. The ABPI Code also prohibits the provision of entertainment by representatives and specifies that any meal provided during a call on a physician must be secondary to the discussion with the physician. Also, like the PhRMA Code, the ABPI Code limits the offering of these meals to the physician and appropriate office staff only. The ABPI also allows reps to provide items for patient education. The ABPI differs from the PhRMA Code in that it specifically addresses how DVDs, memory sticks and other items should be presented for patient education. For example, DVDs may be distributed for educational purposes, however they must be formatted to prevent re-use or alteration.

Unlike the PhRMA Code, the ABPI Code provides detail on sales representatives’ conduct beyond the provision of a meal or gift. The ABPI Code calls on representatives to ensure that the frequency and length of visits do not prove to be a disruption to the healthcare professional.  Interestingly, the ABPI also prohibits the use of subterfuge to secure a meeting with a healthcare professional, prompting curiosity about what could have gone on in the past to make that prohibition necessary.

Ultimately these two codes have the same objective; create a standard of conduct which helps ensure that the industry’s relationships with healthcare providers (and its promotional activities in the case of the ABPI) are about education and patient care. So the next time the regulated environment of commercial compliance feels overwhelming and uniquely frustrating, remember the ABPI shows us it’s a small world after all.

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