Starting this year, most European Union pharmaceutical and life-science companies will begin tracking and reporting payments to physicians — voluntarily undertaking this task to comply with the new European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code. Under the new code, all EFPIA members — essentially all EU-based drug companies — must disclose direct and indirect “transfers of value” to health-care professionals (HCPs) and health-care organizations (HCOs). That means patients will be able to see exactly how much a drug company has paid individual physicians, and for what, such as consulting, travel, or meeting registration. A patient in Slovakia, for example, could look online and see that her Slovakian physician received thousands of dollars from a Danish drug company to travel to a medical conference in Orlando.
While the Disclosure Code is voluntary and not as extensive as the Sunshine provision of the U.S. Affordable Care Act, it’s similar in its call for increased transparency in industry-provider relations — and in that sense also resembles the revisions to the Pharmaceutical Research and Manufacturers of America (PhRMA) and Advanced Medical Technology Association (AdvaMed) codes of conduct that were implemented about five years ago. And EFPIA’s new code raises similar questions about how disclosure may affect medical meeting organizers, whose HCP attendees regularly interact with industry sponsors during CME programs and panel discussions and on show floors.
For example, some meeting professionals have expressed concern that EU physicians won’t want to be seen as being in the pocket of big pharma, and so may start turning down registration and travel sponsorship for conferences. Given that the majority of EU physicians attending North American meetings come on the dime of third-party sponsors, that could affect EU participation in live programs, said Davide Veglia, president of Miami-based ABTS Convention Services and author of the recent white paper “EFPIA and the U.S. Medical Meetings Industry.” “We do think there will be shifts in attendance,” Veglia said, “and we expect to see the foreign delegations from Europe shrinking.”
Given such predictions, Convene set out to learn how North American planners are preparing for the Disclosure Code. The response to our query, however, was mostly silence. In fact, a number of meeting professionals and CVBs we contacted said that they weren’t familiar with the code or weren’t prepared to discuss it. To help you get a handle on things, here are 10 questions about the code and how planners can prepare for it.
1. What is EFPIA?
EFPIA is a trade organization made up of industry associations from 33 European countries and 40 individual pharmaceutical manufacturers — all together representing 1,900 pharmaceutical manufacturers across Europe. EFPIA previously adopted Codes of Practice that set standards for advertising, interactions between industry and patient organizations, and relationships between industry and providers. It adopted the Disclosure Code in 2013 as a supplement to the existing EFPIA Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals (EFPIA HCP Code), and required that all members adopt the code themselves by Dec. 31, 2013.
2. What does the Disclosure Code say about meetings and events?
The code requires that pharmaceutical companies disclose all “contributions to costs related to events” — such as payments for HCPs’ registration fees, travel, and accommodations. Companies are required to identify HCPs by name, and detail the exact amount and purpose of payment. They also must disclose if they pay event registration, travel, and accommodation costs for a representative of an HCO, identifying both the HCO and the representative by name. Finally, companies must disclose sponsorship agreements with HCOs, including industry sponsorship of association meetings.
3. Where and when is the disclosure information going to be published?
According to the code, all disclosure information must be publicly accessible in the country where the receiving HCP or HCO practices. For example, if a physician practices in Spain, the disclosure must be available on a Spanish website, regardless of where the pharmaceutical company is headquartered or where the event took place.
Companies can choose to share information on their own websites or a common “platform” that contains disclosure information from multiple companies. The key, according to EFPIA, is that it’s “possible for the public to easily find and access the disclosed information in the country where the relevant HCP/HCO practices.”
The first disclosures will be made in 2016, reporting on payments and transfers made in 2015.
4. How is this going to be enforced? What are the penalties for non-compliance?
Because EFPIA is a member organization, compliance is voluntary, and enforcement falls to participating national industry associations. “The EFPIA Disclosure Code is a code, i.e., the responsibility and burden is on the company,” said Dermot Ryan, congress and events manager for the Zurich-based European Academy of Allergy and Clinical Immunology (EAACI). “If somebody breaks it, there may be a complaint within their association, but they are not breaking the law.”
5. If some EU countries already have their own transparency rules, why did EFPIA bother with a Disclosure Code?
A number of EU nations already have Sunshine-like laws regarding payment disclosure, but the Disclosure Code standardizes disclosure policies across EFPIA members. “The Disclosure Code is evolution, not revolution,” said Ryan, whose association annually hosts one of the largest international meetings dedicated to allergies and immunology, drawing clinicians from across the EU. “There are already legal provisions for disclosure in many EU countries, such as France, Germany, Denmark, the U.K., and Portugal. As EFPIA has a pan-European reach, the code provides some level of harmonization and will reach countries where no disclosure rules are in place.”
It also sends a message that the industry values transparency and is willing to take the lead on the issue, according to Simon Dufaur, global director of cardiology and haematology accounts at MCI, the Geneva-based association, meetings, and event-management and -consulting firm. “EFPIA has decided to adopt the position of being completely transparent, whiter than white,” Dufaur said. “They are saying that our own industry rules, guidelines, and policies are stricter than perhaps what government will legislate. Therefore, there is no need for government to dictate we have to do this. By doing this, we will win back trust of regulators and general public at large.”
In the code itself, EFPIA acknowledges that public scrutiny is the driver for more transparency, stating: “Interactions between the industry and healthcare professionals can create the potential for conflicts of interest. There is a growing expectation that interactions between corporations and society are not only conducted with integrity but are also transparent. EFPIA believes that it is critical to the future success of the pharmaceutical industry to respond to society’s heightened expectations.”
The code also emphasizes that the goal is to strengthen industry-provider relations, not sever them: “EFPIA hopes that, by taking this step, it can enable public scrutiny and understanding of these relationships and thus contribute to the confidence of stakeholders in the pharmaceutical industry. By creating greater transparency around industry’s collaborations and partnerships with HCPs/HCOs, the EFPIA Disclosure Code aims to strengthen the legitimate relationship between pharmaceutical companies and healthcare professionals by making these better understood by patients and other stakeholders.”
6. It sounds like most of the burden for tracking and reporting will fall on pharmaceutical companies. Is that right?
Yes, according to the people Convene interviewed. “It is the responsibility of the EFPIA members to track the payments for travel and registrations, maintain records, and report it to the appropriate country website,” Veglia said.
Lisa Astorga, CMP, director of meetings for the Carrboro, North Carolina–based International Society on Thrombosis and Haemostasis (ISTH), agrees. “As an international society,” she said, “[it] is not our responsibility to police this.” That said, the annual ISTH Congress draws 40 to 60 percent of attendees from the EU, depending on whether the meeting is held on U.S. or EU soil, and Astorga thinks that anything that might affect attendees should be on a planner’s radar. “We want to make sure those attending our meetings have full disclosure on what these codes are and how they will be impacted,” she said. “It is difficult, however, since much of this is a voluntary involvement on the side of pharma, and the rules and regulations are interpreted by their internal compliance departments very differently.”
We want to make sure those attending our meetings have full disclosure on what these codes are and how they will be impacted
There are also some association planners, as well as most third-party planning firms, that will be directly involved in tracking and disclosing payments. “The ultimate responsibility is with the pharmaceutical company; however, they may hire agencies or meeting planners in order to help them with their day-to-day work,” said Cerstin Steindorf, global account director for healthcare at MCI. “In this role of intermediary or service provider, you are responsible to track and record the transfers of value.”
7. What does any of this have to do with North America–based meeting planners?
About 90 percent of the EU physicians attending international medical meetings are sponsored by pharmaceutical, manufacturing, or biotech companies, according to Veglia — which means that any meeting that draws European physicians is likely to be affected by the code, because while industry may be willing to continue funding educational opportunities, doctors may be unwilling to accept it. “Physicians are concerned that patients might interpret regular, acceptable industry support as prejudicial,” Veglia said.
Ryan also thinks that is a possibility. “HCPs may be more selective about events they attend, and as a result the pharmaceutical companies may reduce the total numbers they are sending to meetings,” he said. “It may also be harder for companies to find speakers for industry symposia, as HCPs may restrict their participation.”
8. How can you keep EU physicians coming to your meetings?
With the public soon able to see which conference physicians accepted payment to attend, meeting organizers should ensure their events are marketed as highly educational and important to patient care. “We have to refocus on the content and on the legitimacy of why we need to bring these physicians together,” Veglia said. “There has to be a reason for these international attendees to come here, and a reason that justifies investment from a pharmaceutical company is that the science and educational opportunities at your conference is very valuable and important.”
That isn’t to imply that planners previously organized frivolous events. But it means that going forward, everything from the invite to the session names must be focused on the scientific merit of the meeting. In other words, ditch the palm-tree logos and emphasize knowledge sharing. “Whether it’s the registration website or email blasts, everything has to be focused on the science,” Veglia said. “The content should never mention extracurricular or leisure activity. Don’t say ‘cocktail reception.’ Even if it’s an opening reception, describe it in a different way. It could be an ‘opening keynote session.’ Don’t put on your program that it is a luncheon; put it as a ‘meet-the-professor activity.’ Try to keep all of your materials very lean and clean.”
MCI’s Dufaur agrees that the more scientifically legitimate the meeting appears on the surface, the more likely physicians will be willing to accept sponsorship to attend. “From the association side, it’s very much about making sure the visible components of the meeting stress the benefit of having combined knowledge power under one roof, and all the advancements that can come as a result of that,” he said. “The emphasis now should be on the mission of the meeting, whereas in the past, it may have been more about the venue or destination.”
Tom Sullivan, president of Rockpointe Corporation, a Columbia, Maryland–based medical-education and -communication company (MECC), suggests that planners submit their meeting to the e4ethics database, an online directory of events that have been assessed by EFPIA for adherence to EFPIA codes. A green rating indicates that sponsoring, participating in, or collaborating with the event would not raise concern with regard to EFPIA provisions, while an orange rating indicates that involvement with the event may raise concern. (A blue rating indicates the meeting hasn’t yet been assessed.) “If you host European meetings, it might be worth it to have your meeting rated,” Sullivan said. “It is one more way to add legitimacy to your meeting.”
9. Does the Disclosure Code create any new business opportunities?
Absolutely. “Rather than going to the giant, more costly annual meetings, HCPs may be more inclined to go to smaller, regional meetings,” Dufaur said. “What we’re seeing is opportunity for lower-cost or smaller CME meetings that are more localized in their scope.”
Veglia agreed that there are avenues to capture an EU audience in the post–Disclosure Code world. For example, planners could create online and hybrid events that generate new streams of revenue and allow international attendees to participate without traveling. “I think it should inspire you to do new things,” Veglia said. “Work on developing more online activities, develop content in different languages, or work on the live presentation of key lectures at your conference. Some of these activities require very little investment, and you may already have the staff to do this work for you.”
Pamela Wynne, HMCC, CMP, CMM, global program director with Carlson Wagonlit Travel, thinks MECCs in particular should seize the chance to distinguish themselves from the pack. “Planning companies have an opportunity to show their value to the companies hosting the [HCPs] by getting input and feedback,” she said, “and helping design programs that are beneficial to the attendee, regardless of reporting.”
10. Bottom line: Is this a big deal or not?
While some of the people we interviewed expect EU attendance at both European and North American meetings to drop as a result of the Disclosure Code, others say the impact will be minimal. That’s partly because physicians may not be as concerned about disclosure as some predict. “This seems to be a voluntary set of guidelines that pharma self-imposes, much like the Rx&D codes in Canada [enacted by the association Canada’s Research-Based Pharmaceutical Companies]. We are seeing that most HCPs are not even aware of these codes or how they impact them,” Astorga said. “Even those regulatory codes that are governmental, like the Sunshine Act’s, don’t seem to be on their radar screens.”
What’s more, Sullivan points out that several EU pharmaceutical companies have already pulled back on travel, so there is less sponsorship to disclose. Back in 2011, pharmaceutical giant AstraZeneca, headquartered in London, stopped paying for physicians to attend international meetings, focusing sponsorship on local educational opportunities instead; and in 2013, GlaxoSmithKline, also London-based, announced it would stop paying for physicians to attend medical meetings.
From an administrative standpoint, U.S. planners who have already dealt with the Sunshine Act should find the Disclosure Code fairly easy to deal with, according to MCI’s Steindorf. “Looking at the U.S. and what the planners went through with the Sunshine Act, I think they shouldn’t be afraid at all,” she said. “If they have managed through that change, then there is no reason to be afraid or worry about Europe and the Disclosure Code.”
Nevertheless, she said, every planner has a responsibility to get informed. “Start by reading the EFPIA Disclosure Code. It’s not difficult to read,” Steindorf said. “It’s complex, because each country has its own rules and regulations, but it’s not complicated.”
“Everyone engaged in the planning and execution of HCP-attended meetings should be prepared to have meaningful discussions with attendees about the impact of EFPIA,” Wynne said. “The most successful companies are going to be those who engage early and provide details to the [HCPs and HCOs] on how to make good decisions and understand the ramifications of the reporting process.”
In other words, rather than panicking, take the lead and communicate with your audiences about what the code is, why it matters, and how you’re going to manage it. “It’s actually a good thing,” Dufaur said, “and whether your client is an association, an internal board of directors, or doctors that attend your meeting, you have a role to inform them about the reason behind this change, and that it is something that should be embraced. The more transparency, the sooner the sector can boost its perception and re-establish a high level of trust with patients.”
Source: How Regulatory Changes in Europe Are Affecting Medical Meetings – PCMA Convene