Ensuring Ethical and Regulatory Adherence in Pharmaceutical, Biotech, and Healthcare Meetings

Unsurprisingly, pharmaceutical, biotech, and healthcare companies must adhere to strict compliance regulations when conducting meetings. It’s crucial that these organizations ensure transparency, ethical conduct, and adherence to legal requirements – especially when healthcare professionals are concerned.

If you’re in one of these highly regulated industries and looking to maintain compliance throughout your next meeting, we’ve put together a handy checklist to help you get it right.

1. Know and follow applicable regulations: It sounds obvious, but the number one most important step in planning meetings for pharmaceutical, biotech, and healthcare professionals is familiarizing yourself with the relevant local, national, and international regulations. Examples include the Food, Drug, and Cosmetic Act in the US, or the EFPIA Disclosure Code in Europe – make sure you understand them inside out to avoid running into trouble.
2. Ensure transparent reporting: Keep accurate records of all expenses related to the meeting. That includes travel, accommodation, meals, and honoraria for all healthcare professionals. This is a must in case you’re audited, as it allows you to prove your spend and compliance with disclosure requirements.
3. Create a clear invitation and selection process: Establish clear and transparent criteria for selecting healthcare professionals to attend the meeting. Also ensure that this selection process is not influenced by prescribing habits or potential for business benefits – keep it fair and unbiased so that the biggest spenders (or potential spenders) aren’t disproportionately invited.
4. Set your meeting agenda: As with any meeting, be sure to clearly define the meeting’s agenda, objectives, and educational content. Your meeting content should align with medical and scientific needs rather than promotional goals – remember, industry regulations are geared towards getting the best patient outcomes, not money-making opportunities.
5. Select the right venue: Choose meeting venues that are appropriate, comfortable, and conducive to the exchange of scientific information. Usually, this will be a dedicated event venue, such as a hotel conference center, rather than a flashy bar or expensive restaurant. Avoid extravagant or inappropriate locations, and be mindful of HCP meal caps to ensure suitable catering options – and don’t forget to negotiate with hotels or meeting venues to secure the best price.
6. Set up a reasonable communications plan: Send all invitations well in advance of your meeting, providing all necessary details to ensure everyone has all the information they need to attend. It’s also vital that you clearly state the purpose of the meeting and disclose the sponsor’s identity. This is essential to avoid accidental bias.
7. Disclose any conflicts of interest: Require all participants, including speakers and attendees, to disclose any potential conflicts of interest. If any conflicts of interest arise in this discovery process, make sure they are appropriately managed to maintain the ethical standards of your event.
8. Speaker selection: Select your speakers based on their expertise and ability to provide balanced, evidence-based information – and remember, this may not be the speakers you have worked with in the past. Ensure your speakers don’t have significant financial ties to the pharmaceutical, biotech, or healthcare companies sponsoring your event – again, to avoid the risk or appearance of bias.
9. Review and approve all meeting content: Don’t just assume all meeting content will be appropriate – set time aside to review and approve all materials, including presentations, handouts, and slides. Make sure that content is compliant with regulations, scientifically accurate, and not too heavily focused on any sponsoring organizations.
10. Maintain detailed records: Keep detailed records of your meeting, including attendance lists, expenses, and any changes to the agenda. Store these records securely for compliance reporting. Ideally, create a folder so you can easily access all meeting information in one place, and consider password protecting it if it contains sensitive data.
11. Provide compliance training: All staff involved in organizing and conducting the meeting should undergo thorough compliance training. This ensures that they can understand and adhere to compliance regulations. The more people who understand the rules and regulations, the fewer opportunities there will be to slip up.
12. Report any adverse events: Ideally everything will go off without any problems, but don’t assume that that will be the case. Establish procedures for reporting any adverse events or product complaints that may arise during the meeting, and ensure that appropriate follow-up actions are taken if necessary, with a clear process and owner for these actions.
13. Conduct post-meeting evaluations: Send out post-meeting evaluations to assess the meeting’s educational value and compliance with objectives. Alongside your attendees, you may also want to ask for feedback from your speakers. Use any feedback collected to improve future meetings.
14. Monitor compliance closely: Implement a system for ongoing compliance monitoring and auditing, and address any compliance violations promptly and appropriately. Proactively staying on top of any issues is much better than finding out about them later.
15. Prepare useful reports: Once all expense reports have been submitted, prepare and submit reports detailing these and transfers of value to healthcare professionals. Then, publish this information in accordance with disclosure requirements to help you stay ahead of the game.
16. Provide continuous training and education: Keep up to date with evolving compliance regulations and industry best practices – for instance, by following your industry’s regulatory bodies on social media or by signing up for newsletters. This will allow you to provide ongoing training to staff and stakeholders, ensuring all future events are managed in an ethical, compliant manner.

Complying with industry laws

It’s essential to consult legal and compliance experts in your jurisdiction to ensure that your pharmaceutical, biotech, or healthcare company is fully compliant with all relevant laws and regulations when conducting meetings with healthcare professionals. This checklist serves as a general guide, and should be adapted to meet the specific requirements and regulations in your region.

What do I need to know about HIPAA?

One of the most important regulations to understand for pharmaceutical, biotech and healthcare meeting organizers is HIPAA.

HIPAA (Health Insurance Portability and Accountability Act) compliance is a critical consideration for hospitals and healthcare organizations when it comes to patient data privacy and security. While HIPAA primarily relates to the protection of electronic health records (EHRs) and patient information, its principles extend to various aspects of healthcare, including medical meetings involving patients.

Here’s an overview of HIPAA compliance in medical meetings for hospitals and healthcare organizations – you will note that several of these points relate to our checklist above:

1. Securing patient data: Healthcare organizations must implement robust measures to secure patient data during medical meetings. This may involve password protection for electronic devices used during meetings, encrypting electronic communications, and maintaining physical security over printed patient records or documents.
2. Limited use and disclosure: HIPAA restricts the use and disclosure of patient information to the minimum necessary for the intended purpose. Healthcare organizations should ensure that only relevant patient information is shared during medical meetings.
3. Employee training: Staff members involved in medical meetings must receive HIPAA training to understand the importance of patient privacy and confidentiality. Training should cover the proper handling of patient information in various scenarios.
4. Data breach response: In the event of a data breach or unauthorized disclosure of patient information during a medical meeting, healthcare organizations must have a breach response plan in place. This includes notifying affected patients, regulatory authorities, and taking corrective actions.

Planning a pharmaceutical, biotech or healthcare event is no small feat – there are various moving pieces that need to be considered and prioritized. One of these is food and beverage meal caps for healthcare providers (HCPs).

As a meeting planner, you know that change is the only constant in your line of work. One of the most significant changes you’ll encounter is navigating food and beverage meal caps for healthcare providers (HCPs).

Understanding the ins and outs of HCP meal caps is crucial to ensure you comply with the strict regulations and policies set by healthcare organizations while still providing an outstanding dining experience for your attendees. In this article, we’ll highlight some key points about HCP meal caps and show you how to navigate them to get the most value for your budget while satisfying the nutritional needs of your HCP attendees.

What are food and beverage meal caps? 

Healthcare professional (HCP) meal caps refer to the limits or restrictions placed on the value or quantity of food and beverages that pharmaceutical or medical device companies can offer to HCPs as gifts or promotional items.

Food and beverage caps are put in place to ensure that the cost of food at pharmaceutical, biotech, and healthcare events are reasonable and in line with local pricing. These caps can vary between countries, with higher caps in countries like the United States compared to countries like France.

What’s the purpose of meal caps?

Many of the decisions HCPs make are literally life-changing for patients, so everyone needs to be sure that every decision they make is made without bias and isn’t a result of bribery. HCP meal caps prevent conflicts of interest and protect the integrity of medical decision-making. Pharmaceutical and medical device companies may offer HCPs meals, gifts, or other incentives to promote and market their products. However, these gifts could potentially influence HCPs to prescribe or recommend a particular product, even if it’s not the best option for the patient.

Aside from the ethical and legal considerations, HCP meal caps also help to promote transparency and accountability in the healthcare industry. By setting clear standards for gifts and incentives, HCPs can better understand and evaluate the marketing practices of pharmaceutical and medical device companies. In turn, this can help to build trust and improve the overall quality of healthcare.

What is the Sunshine Act?

In 2010, the Sunshine/Open Payments Act came into effect, promising more transparency and visibility of the financial relationships between HCPs and pharmaceutical manufacturers, with spending on food and beverage at life sciences events an important piece of the puzzle. Caps on food and beverage offerings at these events help ensure that HCPs get the most out of the event without running the risk of swaying opinions or decisions with extra fancy gourmet dining options or free-flowing champagne.

Are there meal caps for patients?

Meal caps also apply to patients, who often attend HCP events as patient advocates or to offer feedback. This meal cap will be the same as for HCPs – that way, the heavily regulated life sciences industry can ensure that there is no patient bribery taking place at these events.

Patients may attend the entire event or for a specific section – for instance as part of a patient committee, on a panel, or to offer valuable feedback on everything from drug side effects to the marketing of a new treatment. In terms of the food and beverage budget, patients must be treated the same as HCPs, making it easier for event organizers to standardize the menu across all attendees.

How to manage HCP meal caps for international groups?

If all of your attendees come from a single country, such as the US, it’s relatively simple to understand the per-head cost of your catering provision. The meeting organizer can simply refer to the meal cap for the US and apply this across the board.

However, what if your attendees comprise US and non-US attendees? When this is the case, 52% of meeting organizers choose to apply the most restrictive meal cap to all attendees, ensuring everyone is treated the same and making it easier to provide the same food and beverage to all participants.

An alternative option could be to apply the meal cap of each attendee’s home country to individuals. As an example, US attendees would receive a higher meal cap than French attendees, who may only have a €15 meal cap for breakfast and lunch. However, while HCPs will be very familiar with the concept of meal caps, most organizers prefer to avoid providing two tiers of catering for different attendees – after all, nobody wants to make a portion of their audience feel left out of the best hospitality.

How can I save on costs?

All HCPs will be very aware of the meal cap, so nobody will be expecting a five-course banquet. Consider buffet dining instead of a plated meal as a more economical option. Buffets equalize meal cap discrepancies among attendees, allowing meeting organizers to standardize and even elevate their fare across the board, while keeping costs down.

A set menu can also help the venue (and event organizer) keep costs down, rather than a full à la carte offering. Moreover, many hotel groups will be used to hosting events for HCPs, so they can work with you to create a menu that fits within your meal cap budget.

How can I avoid fines?

Pharmaceutical companies found to be exceeding the meal caps set for their attendees can be subject to fines, which can inflict reputational damage on highly regulated life science companies.

Each pharmaceutical company has its own meal caps, which may be even stricter than those imposed at the country level, so anyone organizing an event for HCPs must check and re-check the documentation given to them by the attending companies. They must ensure that they comply with all the relevant meal caps. Sometimes, it may work out in your favor – for instance, Belgium increased its meal caps on January 1, 2023, giving event organizers more budget to play with.

What’s new in HCP meal caps?

In the aftermath of the pandemic, numerous countries have been experiencing a rise in the cost of living, particularly in the realm of food and drink. The exponential increase in energy and gas expenses has caused prices to surge in areas like farming and food transportation. This hike in food prices has put a strain on event planners, particularly those operating under tight budgets, as they try to organize events for healthcare professionals. This creates additional stress on already constrained food and beverage budgets, with both event organizers and venues feeling the pressure.

Based on our observations, it appears that a number of pharmaceutical companies have raised their HCP meal limits in response to rising food costs in the United States. This adjustment may provide some relief to event planners, as it allows for more flexibility in the selection of food and beverages for HCP events. While it may not be feasible to switch from a buffet to a full banquet, these changes do provide more value for your budget compared to pre-pandemic times.

To make sure you’re up to date with the latest meal caps, please check the attendees every time a new batch of invitations is sent and cross-reference them against your documentation. If there are any changes to the meal caps halfway through the planning phase and you have enough time to adjust to the new cap, you will be expected to do so. So whether you’re a seasoned event planner or new to the industry, mastering the art of navigating these meal caps can be a real game-changer in delivering a successful healthcare meeting that leaves a lasting impression.

Healthcare congresses offer several important constituents the opportunity to educate, network, and explore the latest efficacy and safety on your drug. It also provides the opportunity to show the latest innovations and ground-breaking treatment options to thousands of healthcare providers (HCPs), medical professionals, and industry experts within just a few critical days. If you get it right, the ROI can position you as a market leader.

With many organizations vying for quality interaction from the same attendees, the mere presence of a well-positioned booth doesn’t always meet your objectives. Take advantage of the most innovative enhancements to maximize audience engagement and ensure attendees leave knowing your latest data and the next phases of your drug journey.

With that in mind, let’s explore five of the best engagement ideas for your next congress.

 1. Key messaging kiosks

Not every HCP who walks past will be ready to engage immediately in a conversation. Strategically placed key-messaging kiosks enable attendees to receive your message with little or no interaction. Give them the space to educate themselves.

These kiosks can be placed around your booth to draw in attendees with visual and sometimes interactive solutions. Experiential technology can include screens displaying looping product videos or a “sizzle reel” with your key messages. For instance, you might include your most important data points, patient testimonials, and short demo clips. On a busy congress floor, these will likely need to be easily understood without audio, so work with your media producer to create a video that utilizes subtitles or closed captions to ensure it makes sense to people passing your booth.

2. Tablets for Deeper-Dive Exploration

Tablets, such as iPads, are a popular choice at congresses, and with good reason. Setting up a bench of iPads at your booth allows people to get a deeper insight into your products. These tablets might include information on clinical trials, research, patient feedback, and/or how the product works.

Creating an event app is the best way to make the most of your congress iPads, as you can design it to match your branding and customize the content to include everything you want to communicate. This is especially useful if you’re promoting multiple messages, as you can provide easy access to data, videos, and papers without taking up too much desk space. Attendees can also airdrop permitted compliant information directly to their own devices.

Finally, ensure you have a visually appealing, branded screensaver and wallpaper on the iPads, which will entice them and encourages them to explore.

3. Airdropping Your Abstracts

Most pharmaceutical organizations have text-heavy poster studies at congresses offering a comprehensive overview of each product and its most recent data. While you could consider printing your abstracts for your next congress, busy HCPs are unlikely to take and read them, and it’s not the most sustainable approach.

Enter Airdropping your abstracts. Sending through an airdrop can quickly get your abstract into the hands of your HCPs. You can deliver your research in a matter of seconds, and the HCP can take it with them.

4. Virtual reality

Some therapeutic solutions must be viewed to be fully understood and can be challenging to bring to a busy congress floor. Virtual reality (VR) headsets are great for offering an immersive product experience.

Consider a “patient perspective” and their interaction with a doctor in an actual medical environment. Another option may be to show some approved VR footage of the research or packaging facility providing a “behind-the-scenes” look at your product development and manufacturing.

As an added benefit, these VR experiences can be reused across your in-person, hybrid, and virtual events, making them a powerful addition to your brand.

5. Bluetooth Headsets for Demos

If you’re hosting demos at your booth, consider providing Bluetooth headsets to deliver your message.  Historically, Congress venues are very loud, making it difficult to showcase the presenter during an on-floor demo.

Your presenter can use a microphone connected to Bluetooth headsets worn by the audience directly to hear what the presenter is saying. If this sounds complicated or intimidating, don’t panic! Working with a healthcare event agency means you have access to a team of AV specialists who can do all the setup for you.

For Q&A, you can have a Booth Ambassador (AV Assistant) on hand throughout the congress with a microphone for the audience. If there are any audience questions during the demo, everyone can hear them through their headsets, so everyone is involved in the conversation.