by Robert Schaefer

Robert SchäferHealthcare professionals are in favour of transparency, but they have concerns about the practicalities. Not only will the onus to disclose fall to them, there is disquiet about the increasing number and variety of public disclosure platforms, the effect on doctor-patient relationships, and about the lack of public awareness and understanding of what payments are for, says Robert Schaefer

Increasing public scrutiny and suspicion of relationships between healthcare professionals and commercial organisations has sparked across the board transparency initiatives. As a result, physicians are confronted with a range of mandatory and self-regulatory disclosure requirements.

Healthcare professionals are well-used to making declarations of interest – such as who funded their research, who supported them to attend a medical conference, if they have acted as clinical investigator on a company-sponsored trial, if they have received financial compensation for a speaking engagement – and so on.

But while they are in favour of the greater transparency that will flow from disclosure of the number, duration and amount of payments they receive from pharmaceutical companies, there are concerns that, taken with increased mandatory disclosure requirements at a national level and other self-regulatory requirements to disclose, doctors may face a conflict between different codes, policies and regulations.

Furthermore, as Robert Schaefer of the European Society for Medical Oncology, told delegates at the meeting held in Brussels on 27 May to launch pharmadisclosure.eu, “There are no evidence-based standards for assessing the potential risks of undue influence or bias.”

The combination of a rising tide of mandatory and self-regulatory disclosure requirements, coupled with a huge variety of different approaches and perceptions of ‘risk’ is increasing the bureaucratic overhead and may very well have the opposite of the desired effect, resulting in a “cacophony of disclosure” that generates more heat than light.

No harmonisation in sight

Mr Schaefer noted that while there have been calls for harmonisation of disclosure requirements and procedures, “There is no single process or common framework in sight.”

For patients and their advocates the focus in medical research should be on progress in developing new treatments. When it comes to medical practice, however, they are concerned about financial ties between their doctors and the industry, and feel payments should be disclosed.

But they also recognise that disclosure has the potential to colour doctor-patient interactions and would prefer if disclosure is provided in writing or by an external source.

As one example of possible effects, Mr Schaefer pointed to the Centers for Medicare and Medicaid (CMS) in the US, which in April started to post payments made to 800,000 physicians under the federal health insurance schemes on a public register.

The information was immediately picked up by the media and made available in a searchable format on several news websites. As Mr Schaefer noted, this now enables patients to check on payments to their doctor on their smartphone, as they turn up for a consultation.

Learning the lessons

While healthcare professionals in the US support transparency and sharing information with patients and the public, they are concerned the CMS data were released without any context or explanation of the complexity of the payments system and the value of the services provided. In addition, there were apparently extensive inaccuracies in the data for many US doctors.

The US may be in the vanguard in setting up and implementing transparency rules and regulations, but Mr Schaefer said, “Sometimes it’s not bad to be behind and learn the lessons, before taking action. Doctors should not be put on the spot based on questionable data. Over-regulation is clearly the enemy of medical progress and innovation.”

The EFPIA disclosure code has the potential to affect healthcare professionals in a number of ways; influencing patient perceptions; undermining doctor’s independence; impacting on tax status and attracting unfavourable press coverage, to name but a few. In the face of this, some healthcare professionals may choose not to work with the industry or to attend sponsored medical conferences and may instead look for low-cost alternatives that may not always meet the highest educational standards.

Such negative impact can be avoided if the code is appropriately implemented. This calls for a concerted effort to manage patient perceptions, to educate professionals about the new requirements and to increase public awareness and understanding of the value the relationship between the industry and healthcare professionals holds for patients.  Transfers of value should always be put in the correct context, allowing for a proper assessment of their relevance, significance and proportionality.

In addition, healthcare professionals must have the opportunity to check the accuracy of data before publication, and there should be the means to check consistency of information across different registers of declarations of interest, Mr Schaefer concluded.

Robert Schaefer is an independent international healthcare communications and strategy consultant based in Berlin. Since September 2010, he has been working for the Swiss-based European Society for Medical Oncology (ESMO), managing projects in the fields of rare cancers, personalised medicine and professional affairs.