Regulatory Compliance is a challenging issue in the Life Sciences sector. In addition to the US (with the much-publicized, long awaited) Sunshine Act, many countries in the EU and Asia are also implementing transparency guidelines designed to make the public aware of the amount of money that is paid to healthcare providers (HCPs) and organizations (HCOs) by Life Science companies to demonstrate that there is no conflict between business interest and prescription influence. Disclosure codes are slowly appearing (e.g. the Netherlands, Australia, Japan & UK), are bringing to light a need for new internal systems that allow Life Science companies to work out how all of their siloed business units/therapeutic areas to report efficiently on HCP/HCO spend.
There are still many unanswered questions and problems to overcome on this route to global reporting standards. For example, some companies seem to be ‘alone’ in working towards global transparency. Some representatives spoke at a recent conference about the ‘challenge’ of being able to communicate their reporting needs to vendors, as many vendors do not understand the intricacies involved with HCP/HCO reporting. One such problematic detail is the requirement of tracking all HCPs and ensuring the accurate spend is allocated to the right person. This sounds simple in theory, however when it comes to common names, how do you know which individual you are identifying? For example, John Smith. Not only is there a possibility of having two HCPs by that name (problem 1), they might spell their names differently, and therefore register under a nickname: Johnny Smith, Jonathan Smith, J Smith—so how do you reconcile Johnny Smith on your list with the “Dr. John Smith” that the client was expecting (problem 2)? These problems are magnified by having attendees from many countries, and therefore the need for a unique, global identifying number has become apparent.
Another challenge to be resolved is the level of detail that is required in the reporting. Will we have to count every cup of coffee consumed by an HCP at an investigator meeting? Are we tracking them down to their last bite of bagel? Or do we just calculate an aggregate cost by meal consumed by HCPs? These questions profoundly impact how we run, and report on, the meetings that we plan.
Disclosure codes, which have appeared in country regulations, vary by country, in addition to how they are being interpreted and adopted by the Life Science companies. For example, they may only apply to some phases of clinical trials, as is the case in both the Netherlands and UK, who state that disclosure may only be required after Phase 3.
Even though some of these issues have yet to be resolved, the directives of many disclosure requirements state that data from 1 January 2012 onwards must be reported in 2013. And although some countries have already rolled out working transparency regulations (The Netherlands), others are still working on their guidelines: The French Sunshine Act is still a draft decree and is in its 3rd version, we are anticipating that the US Sunshine Act will be finalized by CMS at the beginning of 2013 (however this could change as it has done several times already), and we are looking ahead to the EFPIA launching their disclosure code in a couple of years, which will hopefully assist in standardizing European reporting.
At the current moment, each company is creating its own set of compliance regulations based on how these guidelines are being interpreted and adopted, which are aligned with what already exists in their respective markets. That is quite a lot to keep track of, but taking the “standard cost methodology” and creating reports aligned with those regulations helps MD Events to create a reporting model that can work for most companies, and can be easily adjusted to match the requirements of others. With many years of working with clients that are under Corporate Integrity Agreements (CIA), MD Events is very experienced in delivering compliant meetings and accurate HCP aggregate spend reporting.
The coming years promise to bring many more changes and international challenges. Our clients continue to choose MD Events as their meeting management partner due to our extensive knowledge of country- by-country guidelines, and by having two Compliance Officers on staff in order to stay on top of these evolving regulations and reporting requirements. We invest resources in attending industry conferences like the CBI Global Transparency Reporting Congress to get the most up to date information, which in turn allows us to have that insight to ensure the delivery of compliant meetings.
This article was written by Stacie Bradford, Compliance and Central Resource Officer and Robyn Todes, Marketing Manager.