Key opinion leaders (KOLs) play a vital role in influencing the consumer market in the pharmaceutical field. Key opinion leaders are healthcare professionals (HCPs) that include, but aren’t limited to, physicians, nurses, researchers and care workers, who are paid by pharmaceutical companies to conduct research, attend conferences or speak on their behalf as a figure of medical authority and influence. Pharmaceutical companies pay KOLs an estimated £40 million each year1 in an effort to shape consumer decisions. So how can we be certain that scientific legitimacy isn’t compromised? Does paying KOLs for their medical expertise lead to (sub) conscious bias? Or are the pharmaceutical codes of practice stringent enough to prevent this?
Currently, two trade associations, the ABPI (Association of the British Pharmaceutical Industry) and the ABHI (Association of British Healthcare Industries), have codes of practice in order to regulate how pharmaceutical companies can market their products to HCPs, focusing on the principles of transparency, legitimacy, and equivalence. For example, the 20th clause of the ABPI code, ‘The use of consultants’, stresses a number of regulations to be considered when engaging with KOLs. These include; ensuring a contract is in place to document the details of the work to be done, giving a legitimate reason for the services, limiting the number of HCPs to what is required, having a selection criteria that is directly related to the identified need, and ensuring that any engagement with KOLs is not an inducement to market or sell any medicine.
However, despite these codes of practice, an investigation by The Telegraph newspaper2 identified that senior members of the NHS have been influencing which drugs are provided by GPs and hospitals, while working as consultants for pharmaceutical companies. In response to this, the ABPI have published financial agreements between KOLs and pharmaceutical companies, including payments for flights, hospitality and any other expenses. The ABPI have published this information with the aim to iron out any reservations consumers may have as to the motives of KOLs.
This system is similar to that imposed by the 2010 Physician Payments Sunshine Act in America, whereby pharmaceutical companies are required to track all financial records of KOLs before it is released to a public database. Failure to comply with the Sunshine Act can result in significant Civil Monetary Penalties, as well as bad publicity for the pharmaceutical company involved3.
The long term benefit of the Sunshine Act is yet to be ascertained; however, it gives the consumer the option to investigate whether or not a KOL has accepted payments from a pharmaceutical company.
So is there a conflict of interest within the KOL engagement system? It seems that the stringent documentation and strict codes of conduct reduce the chance for conflicts of interest significantly. In any case, KOLs are essential in the pharmaceutical industry, and it is important that we continuously refine the KOL payment system to promote consumer confidence in their medical expertise. In the words of the ABHI Code of Business, KOLs are ‘necessary to advance medical science [and] improve patient care’.