There’s no doubt that the Sunshine Act provisions of the Affordable Care Act, which require pharmaceutical companies to track and publicly report what they spend on U.S. healthcare providers, will make life more difficult for life sciences meeting planners. But it gets even more complicated when you take your meetings outside the U.S. and have to deal both with the rules of the event’s host country and those of your healthcare provider attendees.
As Peter Burberry, senior director, global practices for a U.S.-based specialty pharmaceutical company, said during his keynote address at the 2012 West Coast Life Sciences Meeting Management Forum in San Diego in December, planning meetings for pharma and medical device companies “is a whole different ballgame when you go global.” The event was co-organized by magazine and The Center for Business Intelligence.
Regs Around the World
As government spending on healthcare continues to grow around the world, expectations are that more countries will develop healthcare provider aggregate spend and reporting requirements for pharmaceutical companies. In fact, in a recent survey at a pharmaceutical industry conference, attendees agreed that every country in the world will have some sort of reporting requirements within three to five years. Burberry detailed the status of regulations for a number of countries around the world:
Australia: The land down under has enacted an industry code of conduct, but it is only mandated if the company is a member of the Medicines Australia association, and it only covers spending related to prescription products. The code says that companies must publicly list on their Web sites the health consumer organizations to which they provide financial support and/or significant direct or indirect non-financial support.
Denmark: The Danish Pharmacy Act, which applies to pharmaceutical companies, covers products that are distributed or sold through pharmacies. Pharmaceutical companies have to disclose the name, address, civil registration number, and period of association of any doctors and dentists they work with. The Danish Medicines Agency may require further disclosure about the nature and extent of the relationship, and the total remuneration involved.
France: The Reinforcement of the Safety of Medicinal and Health Products law, often referred to as “Le Sunshine Act,” passed in 2011, but the final decree is still pending as government and industry continue discussing the details, such as threshold amounts for reporting. The law requires all pharma and medical device companies to disclose all of their financial relationships and agreements with physicians, experts, healthcare firms, patients’ associations, and specialized media. Another thing that’s still up in the air is the reporting timeframe. Burberry said that it initially required companies to report every 15 days: “Good luck with getting reps to do this,” he joked.
Slovakia: The Act on Medical Aid No. 362/2011 requires all pharmaceutical companies to report on advertising and marketing expenses and non-financial benefits (direct and indirect) to HCPs to the Ministry of Health by January 31 for the previous year. The Ministry of Health then publishes the data on its Web site.
India: Increasingly important in terms of the number of clinical trials conducted there and the rapid growth in its physician population, India has the voluntary Code of Marketing Practices for the Indian Pharmaceutical Industry. Only members of the association are required to comply. It requires companies to maintain a record of what they spend on promotional, scientific, and professional meetings, congresses, conferences, and symposia.
Japan: The Japanese Pharmaceutical Manufacturers Association has a code that is only mandatory for its members and only applies to pharma companies. The JPMA code, which was enacted in 2011 and requires companies to begin reporting in 2013, requires that its members have a transparency policy in place and that they publicly disclose clinical and non-clinical payments to HCPs and medical institutions. The Japanese Medical Device Association is expected to demand something similar of its members in 2013.
The Netherlands: In the Netherlands, pharmaceutical companies have to report all service agreements and related financial transactions related to nonclinical activities such as consulting, speaker fees, and advisory board activity, to a central agency. Currently this is a code that was defined by industry and associations, with some input from the government. Enacted in 2012, the first reports are due in 2013.
The United Kingdom: The Association of the British Pharmaceutical Industry code, enacted in 2012, involves self-reporting on a public Web site of pharma spend on nonclinical activities. For the first year, 2013, reporting can be done anonymously, and the code currently applies just to pharmaceutical companies. “Everyone was going to use the U.K. as an example if they enacted a law,” Burberry said, “but France beat them to it.”
Estonia: The Medicines Act, which applies only to pharmaceutical companies, requires them to report (on paper) any nonclinical HCP spend of more than 6.48 euros to the Ministry of Health.
Germany, Ireland, and Hungary all have laws requiring companies to make direct and indirect financial support to patient associations public, while Turkey, the Philippines, and Thailand are considering some sort of transparency legislation.
More Than Just Transparency Rules
It’s not just the transparency rules that planners need to know, Burberry pointed out. Here are some other issues:
Data privacy: Look at what data is being collected, where and how it will be used, and who will be using it, said Burberry. Ideally, HCPs would contractually agree to let you share their data. If they don’t, it may be illegal to share it, depending on the laws of that HCP’s country of residence. “This is mainly a European thing right now, but everyone is concerned” about data privacy, he said.
Origin: You need to find out as soon as possible whence your HCPs hail and their state/country of license, said Burberry. These may not always be the same thing. For example, he said, there are a lot of U.S.–licensed physicians who reside in Canada. If they have no influence in the U.S., do you still have to report their expenses?
Meals: “It’s easy to track honoraria and flights—if it goes through your travel agency, anyway. Unless your system is tied to expenses, though, it can be difficult to track meals,” said Burberry. He suggests knowing your attendees by name, and documenting all meal-related expenses to ensure you stay within the code limits on per-meal HCP spend.
“You need to know in advance what the limits are for each of your attendees, and how you are going to manage abiding by them,” he said. For example, Burberry said with tongue firmly in cheek, if you have a German attendee with a 60 euro limit and a U.S. doc with a $100 limit, do you ask the German to leave before dessert? And, he added, keep in mind that not all countries manage conferences the same way. For example, Asia-Pacific, Latin America, and Europe/Africa/Middle East countries may charge differently for conference space and other meeting-related costs. He suggested developing a glossary that defines the terms you’re using to ensure everyone’s on the same page.
Know the codes: Every country has its own code, and planners need to understand both those of their HCPs’ home countries and those of their meeting’s host country. For example, according to the Italian code, docs may only be allowed to fly coach, regardless of where in the world they travel. “Look at codes for both originating country and country where the meeting is held, and abide by the strictest,” he said. For third-party planners, this knowledge can make the difference between a long and happy relationship with pharma clients and being excluded from further business.
Know the other regulatory considerations. If you’re asking HCPs to work outside of their home country, you also have to think about contractual legality, visa requirements (did you know that anyone who “works” in Russia on a tourist visa risks the potential of jail?) and payment and tax requirements. Burberry said that a lot of companies are moving toward basingand payments in the HCP’s country of residence.
More Things to Consider When Going Global
Scaling domestic data collection to meet global requirements is a little more complicated that some may think, said Ashish Kalgaonkar, senior director, global transparency reporting, Eli Lilly and Company, at the 2012 West Coast Life Sciences Meeting Management Forum. “The perception is that we should be able to do this easily, like credit-card companies do, but it is much more complicated for pharma.” That’s because you can’t just take information from a centralized database, crunch it, and spit it out in a simple report— not when the players include travel and meeting services, research and development, IT, data governance, privacy, external communications, legal, finance, training and development, internal communications, the expense reporting system, the alliance management office, sales and marketing, and corporate affairs.
There also are operational considerations, such as what is currently available in terms of data collection and reporting systems, and what is required to keep up with the burgeoning world regulations. “There are a lot of vendors who can help us take data and hack it up, but you have to have accurate and complete data to give them to package,” said Kalgaonkar. You may need a European database, a U.S. database, and also a country-by-country database, which could get prohibitively expensive for those who operate in several countries. You also need to develop a dispute-resolution process, in case a healthcare provider disagrees with the amount you’re reporting. “We have had maybe seven disputes in total since we started our registry,” so it may not come up very often, but you should have a process in place to handle it.
Test Your Global Pharma Regs Knowledge
In a Jeopardy-style session that soon got participants popping out of their seats, attendees at the 2012 West Coast Life Sciences Meeting Management Forum had the opportunity to test their global regulatory knowledge.
Session leaders Agnes Canonica, CMP, CMM, general manager, North America and Latin America, MD Events; Michelle Bartolone, CMP, CEO of Meeting Sites Pro, Inc.; Angie Duncan, director, SMM operations, North America, Carlson Wagonlit Travel; and Kimmarie Everett,and event manager, Biolase, lobbed questions that started out fairly easy (e.g., the name of the U.S. law that will require tracking and reporting spend on physicians, which attendees quickly pegged as the Sunshine Act). But they didn’t always throw softballs. Test your international regs knowledge against some of their brain teasers:
1. The document issued by the Office of the Inspector General that outlines the obligations an entity agrees to as part of a civil settlement.
2. Makers of drugs, medical devices, biological, and medical supplies, and group purchasing organizations comprise this group.
3. The government agency that regulates life sciences companies’ marketing activities
1. Country with a 60 euro dinner cap (including beverages)
2. HCPs from this country must arrive no earlier than 12 hours prior to the start of the event and depart within 12 hours post event, and must fly coach no matter the destination.
3. The European Union’s equivalent of AdvaMed.
Click here for the answers.