New Europe Regulations: 5 Steps for MedTech Planners to Prepare

Taya Paige
Taya Paige

Group of medical professionals at a meeting
Planning on heading to a medical conference in the coming season? You’re probably first working hard to get all of your ducks in a row regarding the new Ethical MedTech Europe regulations. (So are we!)

The new regulations go into effect this year and are already causing some confusion among professionals in the meetings industry: Who do they affect? What impact will they have on my company and our ability to participate in MedTech conferences with European delegate attendees? What will the biggest changes be?

I had many questions as well, so I went directly to the source: Aline Lautenberg, General Counsel – Director Legal and Compliance at Eucomed, EDMA and MedTech Europe. She was kind enough to talk with me and offer some explanations and tips.

“MedTech Europe started in October 2012 as an alliance formed by EDMA and Eucomed,” she said. “The goal is to eventually integrate these organizations into one.”

Why the guideline changes?

“The legal baseline for unique code and environment around the industry had changed and needed to be integrated,” she explained. 

She made it clear that a number of other countries are also developing new code or guidelines, and they will not be allowing the same amount of time for planning that MedTech Europe has strategically built in. The sooner we understand how to manage these ongoing regulatory changes, the better prepared we will all be in the future. Now we can make sure our executive and planning teams are positioned for success under any new guidelines.

What are the biggest changes to understand now?

Lautenberg agreed that the most-talked-about issue seems to be the phase-out of direct sponsorship. Healthcare companies used to choose the physicians they would host, which in turn translated to who would attend healthcare conferences. Now, member companies will not be able to directly sponsor a healthcare provider. Associations are responsible for the paperwork, not the company. The burden is now on the association to draw the provider.

How will this affect sponsorship? This is the issue that many of us are trying to figure out how to appropriately plan for.

Here are some first steps to get on the right path toward planning MedTech meetings moving forward.

1. Get Your Ducks in a Row

Do your research! The best advice Lautenberg gave was to reference the Ethical MedTech website and check in periodically for updates. 

You can also familiarize yourself with the Ethical MedTech website and read the code: MedTech Europe – Code of Ethical Business Practice-QA.

Create a folder to save key documents and information to share with your executive team.

Keep in mind there are a lot of details that need to be figured out and best practices to be shared as the meetings industry adjusts to the new guidelines. So it is necessary for companies to remain flexible in adhering to policy changes so you won’t inadvertently cause infractions that will impact your meetings and attendees. 

Also, research when the new guidelines start and if they apply to you. If you work for a smaller MedTech company, you may have an extended time period to comply. These details can make a big difference in your strategic plan, and your executives will appreciate that you took the time to research the information. Keep in mind that these regulations are written specifically for medical-technology companies that are members of MedTech Europe. Of course, your company’s legal counsel will need to review and confirm any findings. 

2. Take a Close Look at Your Meetings/Conferences for 2018–2020

It’s important to assess which of your upcoming meetings will be affected, and who your target audience will be.

Determine which of your meetings/conferences specifically will be affected. Which conferences are set within MedTech Europe geographical area (see page 55 of the Code for territory definition)? Which are in other countries, including the U.S., attended by delegates who are Healthcare Professionals registered and practicing in the MedTech Europe Geographic Area (see Annex I of the Code)?

The revised code prohibits direct support for Health Care Provider (HCP) attendance at third-party organized educational events, but permits direct support to a HCP to:

  • Speak at a satellite symposium where engaged to do so, pursuant to a consultancy contract. In this case, there will be an obligation to notify the purpose and scope of the agreement to the speaker’s employer.
  • Attend third-party organized procedure training.

Always check the Ethical MedTech website and consult with your legal counsel for the most updated regulations.

Understand the demographics of your target audience for each show. It’s more important than ever to clearly understand your target audience and include these demographics wherever a sponsorship forum will allow you to do so. You may not be able to sponsor a particular physician any longer; however, you may be able to give criteria on the type of physician who would be a good match for attending the conference. The conference organizer may appreciate this input, since they now are responsible for curating the delegate lists. The more targeted they can make their list, the better for all parties involved. Everyone wants to spend their time wisely, so properly matching the right medical credentials with the right audience will always be important. 

Anna-Sophie Bricca, Vice-Chair of MedTech Europe Ethics & Compliance, provided clarity for me on the criteria. She stated, “Examples of criteria for selecting Educational Grant Recipients are Healthcare Professionals’ specialty, years of practice, educational needs, country, city/region of practice and/or academic criteria such as number of publications, participation to clinical trials in a given pathology.” She further explained, “There is no per se prohibition in the Code on including a criterion specifying an individual hospital or hospital department. However, one of the guiding principles in the Code is that companies should not receive or be able to determine the names of the ultimate HCP beneficiaries. Therefore, PCOs should bear in mind that the smaller the hospital or department, the greater the risk of companies being able to make such a determination and therefore making the use of such a criterion not possible.”

Attendee acquisition is an issue that we, as a medical meeting planning community, should continue to discuss and improve, especially as we adapt to these new MedTech Europe regulations.  

3. Reach Out to Conference Contacts and Vendors

Once you’ve determined which shows will be affected, reach out to key conference contacts as well as vendors.

With conference organizers or executive directors: Become familiar with the conference organizers’ resources, what they are doing to comply with the new guidelines, and how they are selecting the delegates. This will be a very important relationship to establish. 

Ask questions about their decision-making process for attendees’ solicitation and how they will communicate to the global audience. Ask what information you will receive as a sponsor. Find out how the lists are determined. Ask the conference organizer what other questions you may not have asked that others have, and invite them to share any other helpful information or resources with you. Anticipate what your executive team would want to know, and become as informed as possible to prepare for a productive meeting with your executives.

With your vendors: Vet your vendors carefully. They will need to be compliant as well, so plan ahead and communicate now. Determine which vendors understand the new guidelines and what they are doing to comply. 

4. Brief Your Executive Team

Develop a plan to present to your executive team to keep them informed. As early in the year as you can, present the changes to MedTech Regulations and your strategic plan.

Even if you don’t have all the answers yet, it’s important to involve your company’s executives early so they understand the potential planning, marketing, operations and financial implications for 2018 and beyond.

While the subject may be sensitive, at some point you will need to discuss with your executives if the shows on your list are still the best shows to attend. There will no doubt be a greater focus on specific shows and seminars that will have optimal ability to attract your target audience. Use this as an opportunity to realign with your executives’ overall goals and objectives: What would they like to get out of their conference sponsorship investment? How can you help them achieve this? Which stakeholders should be included in communications on this topic? Ask them for their support as you navigate this transition.

Let them know you’re on top of these changes and working with other conference planners to collaborate on a strategy to keep attendance at MedTech conferences up.

5. Keep the Conversation Going

Share best practices and other resources on the MPI-MD website and discussion board. 

Help find solutions to continue to increase audience acquisition in this new, higher-regulated environment. As a medical meetings community, let’s share tips and experiences, and work together to make all of our meetings stronger.

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Taya Paige

Taya Paige

Taya Paige brings over 25 years of hospitality industry experience to ITA Group, including leadership positions in sales, marketing and operations in destination management, meetings and incentives and as an entrepreneur. She is known for her impact and roots within the pharmaceutical/healthcare meetings industry, and is a contributing author of the CMP-HC certification, which represents current and best practices in the industry. She has also been appointed to MPI’s new Medical Meeting Professionals Advisory Council. Her vision of success fuses with ITA Group’s vast experience in the healthcare and pharmaceutical industries, and offers incredible new insights from decades in the field.