The very best clinical practice does not take place in a vacuum. It requires input and expertise from many groups: clinicians; patient organisations; academics; healthcare organisations; and the manufacturers of new medicines and medical technology. Collaboration between my industry and these important customers results in three main benefits:
- making new medicines possible in the first place;
- providing vital health education needed to ensure that medicines are used appropriately; and
- capturing patient insights into current treatments and understanding unmet medical needs.
The adoption of the EFPIA Healthcare Professional (HCP)/Healthcare Organisation (HCO) Disclosure Code will deliver long awaited financial transparency around these collaborations. More importantly, it will be a positive force, serving to demonstrate that the over-riding objective is to keep the patient at the centre of our collective work.
But implementing the EFPIA Disclosure Code, which spans a region of 33 countries and 28 languages, presents more than its fair share of challenges from an operational perspective – it requires companies to adapt, or, in some cases, create business processes, systems, and data infrastructure.
For all pharmaceutical companies, I foresee three significant challenges to implementing the code.
HCP and HCO consent must be acquired. Because the EFPIA Code is not legislated, regional and national data protection laws require consent from HCPs (in virtually all countries) and HCOs (required in select countries such as Austria and Switzerland) for individual named disclosure. If consent is not provided, the transfer of value will be disclosed in the unnamed aggregate category. On the surface, this may seem like a simple task for companies – ask the question to the HCP or HCO, obtain an answer, and act accordingly. However, for many companies this myriad of decisions had to be operationalised, including:
- language to be utilised
- active or passive engagement with customers to get their preference
- when to seek customer preference
- who engages with customers
- how to obtain an answer (paper or electronic means)
- what happens if the customer doesn’t provide an answer/doesn’t sign or date, or does one and not the other
- how will customers be able to withdraw their consent/change their original answer
- the need for communication/training/support materials to customer facing personnel
- messaging to customers for awareness and understanding
Existing differences under the “standard” EFPIA Disclosure Code. A diversity of requirements has evolved from the “standard” EFPIA Code as it has been implemented at the national level. Some examples of varying disclosure requirements in some countries include:
- meeting room rental
- travel insurance
- joint working group agreements
- varying definitions of HCPs and HCOs
- treatment of company foundations
Taken alone these may not seem significant, but holistically such issues present significant design, resource, and financial challenges for companies that have attempted to take a standard automated approach. This situation has caused business and IT resources to continually partner to gather and understand requirements, design, test/validate, and communicate and train on changes.
Consolidating the data is complicated. The key to timely, accurate, and complete reporting is the ability to tie all transactions for a given customer together. One of the first complexities is to create a unique customer identifier that serves as the “golden thread” – internally or through purchased data – and steward the data via a central customer database. An inventory of all internal and external source systems that process disclosable transactions must then occur so all systems (financial, expense reporting, travel, meeting, research, etc.) have a means to utilise the same customer master data. The significant use of external partners within the industry, such as meeting planning companies, professional congress organisers, travel agents, clinical research organisations, contract sales organisations, etc. adds another layer of complexity. Companies have invested significant time and resources with their external partners to ensure appropriate actions are taken to enable timely, accurate, and complete data capture and reporting. Formal relationship owners have been established to serve as points of contact for the partners and significant time is being devoted to communication, training, data validation and analytics, monitoring, and continuous improvement.
Lilly has fully embraced the EFPIA Code and will continue with comprehensive readiness activities, while eagerly awaiting public disclosure in June, 2016. The preparation is challenging – even for an innovation driven company such as mine with a highly-sophisticated transparency reporting model, but the journey will be worthwhile, knowing the end result of keeping the patient at the centre of all that we do.
About the author
Mr. McGuire has 20 years of pharmaceutical industry experience and is a frequent speaker at international transparency conferences. He currently serves as Director, Global Transparency at Eli Lilly and Company. He has previously held leadership positions in Market Research, Finance, and Marketing Operations. He played a leadership role in several working groups associated with the development and implementation of the European Federation of Pharmaceuticals Industries and Associations (EFPIA) Health Care Professional (HCP)/Health Care Organization (HCO) Disclosure Code. Mr. McGuire earned a Bachelors of Business Administration in Finance at the University of Iowa and a Masters of Business Administration in Finance at DePaul University.
For more information on disclosure of payments to healthcare professionals, please visit www.efpia.eu/disclosure.23