By Shirley Rhodes, our very own Event Director.
Advisory Boards are a chance for pharmaceutical companies to gain expert insight and guidance from key opinion leaders in the field in relation to an aspect of their medicine (clinical use, therapy area guidelines, market access, administration, development, supply etc.). The PMCPA Guidance states:
“Advisory Boards should only be held to enable companies to answer legitimate business questions to which they do not already know the answer.”
Advisory Boards represent a significant opportunity in the brand development process in a drug lifecycle, however, it should be purely scientific in the content and have no promotional element to it.
The planning of an Advisory Board needs to be meticulous and can be very resource intensive and is therefore sometimes outsourced. However, when you contract a third party to manage the logistics of an Advisory Board, you need to ensure they operate in a fully compliant manner to ensure your company is represented appropriately.
Below are 7 areas to consider to ensure ABPI compliance logistically:
The code states inn Clause 22 “meetings must be held in appropriate venues conducive to the main purpose of the event.” This basically means that the hotels cannot be sporting venues, they must be functional business hotels with a maximum of a 4-star rating. Some hotels are unclassified so can also be considered unless it’s clear they are a luxury spa hotel. Plus, the venue must be in a convenient location for all participants so as to not incur unnecessary cost. So, the thought of hosting the Advisory Board at a 5-star golf resort on a Greek Island, 2-hours drive from the airport when none of the attendees are coming from Greece is a big no no!
- Country approval
Once the Advisory Board date, venue, location and list of invitees has confirmed it is then imperative to seek approval from each country representative for the healthcare professional (HCP) attending. Each country in the EU has its own regulations regarding reimbursement, minimum amount of meeting time, meal costs etc and before the official invitations are sent out approval must be got from each required county.
Usually Advisory Boards invite HCPs from all over the world and travel costs can quickly escalate. In order to help budget and manage the costs, all HCPs should be offered Economy (coach) Class for any travel under 6 hours. For any travel over 6 hours then Business (similar) can be offered. However, this can differ depending on each individual company’s policy. HCPs may organise and pay at their own expense the genuine cost of an upgrade
Arranged meals must be deemed appropriate and the costs involved must not exceed that level which the recipients would normally adopt when paying for themselves. The Code of Practice states “the maximum of £75 plus VAT and gratuities is appropriate only in very exceptional circumstances, such as a dinner at a residential meeting for senior consultants or a dinner at a learned society conference with substantial educational content. The cost of a meal (including drinks) should normally be well below this figure.”
The above amount does not apply when a meeting is held outside the UK in a European country, in such circumstances the limits in the host country code would apply. Some countries require a dinner to be no more than €54 including drinks and gratuities.
HCPs can submit expenses after the meeting, however it must be reasonable e.g travel to/from the meeting. Receipts must be submitted for all expenses otherwise they cannot be claimed, so it’s a good idea to be clear about what can and cannot be reimbursed as part of the invitation process.
The payment of travel expenses and the like for persons accompanying the delegate is not permitted.
If an honorarium is offered it should be made clear that it is a payment for work and advice. Honoraria must be commensurate with the time and effort involved and the professional status of the recipients. Sometimes it is calculated on an hourly rate. When working out the rate to the pay the HCP, you must check the fair market value (FMV). Again, it’s a good idea to be clear about the expectation of effort in return for the honorarium payment as part of the invitation process. The payment of any advisory board members must be declared.
- Contract & Sign in
Depending on the content being discussed at the Advisory Board and who the HCPs are will determine if a non-disclosure agreement (NDA) will need to be signed. If it is, then this is imperative the contract is legally approved by the company’s legal team and that it is signed by both the HCP and the pharma company before the start of the meeting. All contracts should then be scanned and stored securely. Furthermore, to ensure compliance, it is imperative that every attendee sign-in to the meeting with the completed sign-in sheet also scanned and stored securely.
Think that’s it?? No time to relax just yet! Once all the planning has been done and the meeting has taken place then the final activity is the post reporting and ensuring every single expense for each HCP is clearly broken down and detailed with back-up. It can then be passed to the relevant authorities to ensure complete transparency.
Now not all meeting organisers (third parties and internal pharma company staff) run their Advisory Boards to ABPI standards which can put not only the individual HCPs at risk but also the pharma company. At the very least, the event may be a waste of the attendee’s time; at most, it could compromise the attendees’ professional standing, particularly where attendance constitutes bribery and/or the event is found in breach of the ABPI Code of Conduct.
So, as you can see it’s imperative for all parties involved to ensure your Advisory Board is fully compliant. The 7 areas listed above are only a few of the logistical elements to consider….there are so many other things to consider such as balance of HCPs to pharma company attendees, objectives are set and clear, time allows for presentation and group discussion, the right level of expert HCPs are invited and many more.
If you need advice on how to ensure your Advisory Board is compliant or need assistance with the logistics of planning an Advisory Board then please book in for a free event consultation with Shirley Rhodes, our Event Director and all round guru in Advisory Board event management. To find out more about our pharmaceutical event management capabilities click here.