The PharmaCertify™ Team

Christmas in July. It’s gone from a fun little saying to a marketing gimmick to help clear out the last of the summer merchandise with Christmas shopping-esque sales. Oh, and let’s not forget the cable networks breaking out all your favorite holiday movies and specials in an effort to gain summer viewers. (BTW…still waiting on someone to show the Star Wars Christmas special. Where’s the love??!!) So, who are we at the News Week in Review to buck this trend? Pull out your jingle bells and put on your Santa hat, it’s time for Christmas in July in this week’s News Week in Review.

Facilitation payments – naughty or nice? Well in certain countries they are definitely naughty, and while “nice” may not be the exact term one wants to use when talking about them, facilitation payments are certainly a reality of doing business in some countries. A columnist with Compliance Week points out that no compliance officer wants to see bribes labeled as facilitation payments, but if paid as intended – to speed up an action a government official would do anyway – then there shouldn’t be an issue. Governments are increasingly including bans on facilitation payments in their anti-corruption laws, but are such bans realistic considering the reality of the global business environment? The U.K. Bribery Act was the first to ban facilitation payments, but now there is a movement within the government to repeal that section of the law. Canada’s recent amendment to its anti-corruption law will phase out facilitation payments, but the no time table was indicated for the phase out.

The Chinese government has been busy handing out lumps of coal as it expands its probe into the pharma industry. Thirty-nine hospital workers will be punished for taking bribes, two more Chinese employees with Astra-Zeneca were questioned in connection with an investigation of that company, and an American from an unnamed company was detained by the government in connection with an industry investigation. A spokesperson for the U.S. Embassy said they were aware of the situation and were providing appropriate assistance.

The industry can expect some unwrapping of the details relative to drug patent settlements from the Federal Trade Commission going forward. Speaking to lawmakers, FTC Commissioner Edith Ramirez said the agency plans to continue on with current pay-for-delay cases it is litigating and will be investigating new settlements to determine if they are legal. She acknowledged that most patent settlements do not involve a pay-for-delay component but the FTC’s goal will continue to be to stop the anti-competitive settlements that do.

In Chile, where it actually feels like Christmas, the Chilean Medical Association (CMC) and the Council of Pharmaceutical Innovation (CIF) signed an agreement to address conflicts of interests between the industry and healthcare professionals. The agreement prohibits the provision of donations and gifts to influence healthcare professionals’ decisions and paying physicians to conduct clinical trials of new drugs. The Presidents of both organizations said they hoped the agreement would show the public they are serious about stopping conflicts of interest. The signing of the agreement comes in advance of a vote by the Chilean legislature on the Pharmacy Law which will bring transparency to the relationship between physicians and the industry.

The need for Rudolph’s shiny nose is starting to dwindle as the CMS starts clearing up some of the fog surrounding Sunshine requirements. Andrew Rosenberg of the CME Coalition met with CMS’ Sunshine implementation team to clarify some of the requirements related to reporting payments at CME events. He was able to confirm that events considered accredited under the final rule the following are exempt from reporting; speaker travel and lodging, attendee buffet style meals and most educational items. Rosenberg was pleased with the clarification, and said, “The goal here should be to continue to encourage doctors to pursue CME and not create a barrier for uncertainty about the rules.” The CME Coalition hopes to see CMS make changes regarding the accrediting bodies whose programs fall under the CME exemption in the final rule. Rosenberg points out there are number of other accrediting bodies that have adopted ACCME standards and follow the same rules as the organizations listed in the final rule. He also said that CME events supported by accrediting bodies with rules similar to CMS’ final Sunshine rules should be exempt from reporting. The Coalition plans to continue to push this point with CMS and Rosenberg believes eventually they will win on this issue.

Christmas may still be several months off, but the start of Sunshine Act data collection is just a few days away! It is essential that those who interact with physicians understand the requirements under Sunshine to avoid a “garbage in- garbage out” scenario with all necessary data. To ensure a clear understanding of Sunshine consider our customizable, off-the-shelf module. Click here to learn more about our effective eLearning program.

Unfortunately, we must wrap up our little holiday fantasy and return to the warm reality of summer. Have a great week everyone!