In 2015, many European Union–based pharmaceutical companies took steps to voluntarily comply with the then–newly introduced European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code. The aim of the code was to provide patients with insight into dealings between pharmaceutical companies and physicians, including details on when companies would foot the bill for doctors to attend medical conferences.
Although many pharmaceutical companies already had internal codes of ethics for such matters, the Disclosure Code standardized the level of accountability expected of EFPIA members. At the time, meeting planners prepared for the worst, fearing that physicians would shy away from attending meetings altogether. But the Disclosure Code ultimately had no significant impact on participation at medical meetings.
Europe’s pursuit of transparency in health care continues, now moving on to the medical-device industry. Effective Jan. 1, 2018, the MedTech Europe Code of Ethical Business Practice will forever change MedTech Europe members’ relationship with health-care providers — and possibly, with organizers of medical meetings.
What is changing?
Once upon a time, member companies of MedTech Europe — which started as a partnership between the medical-technology trade organization Eucomed and the European Diagnostic Manufacturers Association (EDMA) in 2012 — could directly sponsor specific health-care providers (HCPs) to support their trip to a third-party organized event such as a medical meeting. But the Code of Ethical Business Practice will do away with that. “We expect MedTech to have a big change in the industry,” said Patricia Andrade, vice president of marketing, communications, and community relations at ABTS Convention Services, an international partner and group-housing arm to medical associations such as the American Diabetes Association and the American Academy of Ophthalmology.
Instead of spending upwards of $4,000 sponsoring an individual HCP, member companies now must provide indirect sponsorships to health-care organizations (HCOs) — such as medical associations, schools, and practices — via educational grants. “The way that the process is going to work,” Andrade said, “is that the health-care organizations are going to have to present a grant request to the [medical-device] companies — the sponsor — saying that they are going to request a certain amount of funds in order to bring a certain amount of doctors that are going to meet a specific criteria.”
The catch? Guidelines require that sponsors keep the decision-making process “at arm’s length,” according to Andrade — meaning they can’t know the identity of the individual grant recipients. And unlike the EFPIA Disclosure Code before it, this new code doesn’t simply ask for better transparency on a voluntary basis — it demands it.
“As you can imagine, this presents a challenge,” said Davide Veglia, ABTS’s president and CEO. “How can we ask a company to make a certain kind of investment without even knowing who is invited or who is the recipient of the grant? It’s very different from the existing condition where we are now.”
Although the strict new code presents unique challenges for HCPs, HCOs, and sponsors alike, Veglia said medical-device companies are all but guaranteed to comply; the code will be monitored by an independent MedTech Europe council. “You know, it’s not that a medical-device company can pull out of MedTech,” Veglia said. “The medical-device companies are MedTech. These are changes they have requested of themselves. There are many, many benefits for medical-device companies to be part of MedTech Europe. They’re going to follow the guidelines. They’re not going to stand aside and continue to do what they are doing if the rest of the organization is moving to a different direction.”
How will it affect medical meetings?
The new code — which applies to events worldwide at which attendees are sponsored by MedTech Europe member companies — was crafted with the intention of showcasing the ways in which the industry supports education. It was also created to level the playing field for HCPs, some of whom might never have been sponsored to attend a medical conference. If physicians meet the criteria, they will be eligible for funds, even if they’ve never been invited to a particular meeting in the past. “It shouldn’t only be offered to the one favorite doctor of the salesperson who wants to keep inviting the same person,” Andrade said.
While the new code will benefit a number of HCPs, it puts a heavy workload in the HCOs’ laps. MedTech’s Conference Vetting System (CVS) first will need to review an event to assess its appropriateness for MedTech members. “It would have to fit certain parameters as far as education, as far as entertainment, as far as the programming,” Veglia said.
MedTech’s CVS existed before the new code, so this is nothing new for event organizers. The primary difference is what comes after an event is approved. Once cleared by MedTech, member companies are allowed to invest in educational grants. “If you pass that, you already have a good starting point,” Veglia said, “but then you have to start preparing the grant requests for sponsors and make sure that the process is adhering to the MedTech guidelines — which means that everybody has the opportunity of being sponsored.”
The responsibility of submitting grants, sorting through sponsorship opportunities, selecting delegates, and arranging travel and lodging for chosen HCPs now falls squarely on HCOs’ shoulders, representing a significant increase in required resources. For example, if a meeting has 1,000 international attendees and they’re coming from 100 different medical sponsors, they’re going to have 100 different grant applications to manage for each group. MedTech guidelines do not include national and European regulations, so HCOs will additionally be responsible for making sure that grants abide by those laws as well.
ABTS fears these additional tasks could overwhelm the medical-device industry and hinder attendance. They estimate that five to 40 percent of ABTS’s international capture at certain events will be affected, and many HCOs aren’t even aware of what the new code means for them. “We are concerned that there is going to be a decrease [in attendance] if there is no action taken,” Andrade said.
This past July 4, MedTech launched its Ethical Charter initiative in an effort to create “trusted partners,” meaning PCOs who will be trained on the details of the code and will be able to organize educational events based on the new standards without compromising attendance.
How will this affect the rest of the world?
The new code initially will affect international meetings that host delegates sponsored by MedTech Europe member companies, and those parameters are likely to expand in the future. MedTech is interested in enacting similar guidelines around the world, according to ABTS. “They have already talked and are in contact with medical-technology associations in Latin America, in Asia, and in the Middle East to roll this out region by region,” Andrade said. “This might soon be something that is a requirement everywhere in the world, because in the end these medical associations — they’re worldwide organizations.”