At the end of last month, a milestone was reached in the US in the drive to make payments from pharmaceutical and medical device companies to doctors and teaching hospitals more transparent. The Physician Payments Sunshine Act, called for all transfers of value to doctors to be made publicly available by the 30th of September and the data has since been presented on a central website hosted by the US Government Agency in charge of providing health coverage programmes, the Centers for Medicare and Medicaid Services (CMS). The data contains 4.4 million payments valued at nearly $3.5 billion attributable to 546,000 individual physicians and almost 1,360 teaching hospitals. In the future, manufacturers will submit the reports on an annual basis but for this first disclosure, payments made between August and December 2013 have been uploaded onto the site.
Doctors were given a 45-day period to check that the data held on them was correct; however inconsistencies and inaccuracies were found in the data leading to harsh criticism of the system. For example, some payments were assigned to the wrong individuals and the system was often difficult for doctors to check and gave misleading error messages.
So far, the US has led the way in the move to make payments to doctors from pharmaceutical companies available for public scrutiny. An independent, non-profit group of investigative journalists known as ‘ProPublica’ set up a unique website in 2010, which publicly disclosed data on these financial relationships. The data came from a handful of drug companies that had been made to reveal payments as a part of lawsuit settlements.
With the new arrival of the CMS ‘Open Payments’ programme, the US has set a precedent that is soon to be followed throughout Europe: the European pharmaceutical industry’s regulatory group, EFPIA, have set a target in their guidelines for payments and transfers of value to individual doctors made in 2015 to be revealed to the public by 2016 but leave it up to individual member states to determine how the data will be collated and presented to the public. In the UK, these European guidelines have been incorporated into the ABPI (Association of British Pharmaceutical Industry) self-regulatory code. The results of a consultation held a year ago with doctors, drug industry workers and their representative organisations showed that almost 80% of participants believed that payment information should be disclosed on a single, publicly searchable database .
However, there are many questions remaining over the format of the central record keeping system in the UK. There is no consensus to who should host the database: a professional body, trade body or an independent regulator? What type of data will the database hold? How will this data be uploaded into the system? How will this be verified by doctors? How easy will it be for the public to access and search the database? And, reflecting on what has happened in the US, what can be done to ensure that data is captured accurately and in a timely manner?
Going back to basics may be the solution. The data that comes from individual pharmaceutical companies must be accurate and complete before it is uploaded onto a central database. Ensuring that individual companies have robust systems in place that can collate and store all of their data about payments would be one way of avoiding any problems that may occur further down the line. Big pharma companies have overcome these issues by using the NAYA data collection system from BMI SYSTEM. The NAYA software has been specifically developed in order to collate the large amounts of data related to transfers of value, which can be verified on a regular basis to eliminate missing and inaccurate data.
The problems with the data collection encountered in the US mean that around 40 percent of the records published will not be fully identifiable until 2015 after corrected data is submitted, and doctors and teaching hospitals have a chance to review and dispute. In addition, data that were disputed and not resolved by the end of the 45-day review period have not been published and will be updated at a later date. As well as the public not seeing the whole payment picture, therefore, critics of this central payment database also fear that there is not enough information on the database to allow the payments to be placed in context: the public, they argue will struggle to understand the relationship behind the payments. As a lesson from this, alongside the release of the data, the UK would do well to include more information on its central website about how payments have been used.
It is argued that financial interactions between pharmaceutical companies and doctors drive innovation, discovery, and changes in medical practice that can lead to better patient outcomes, however research clearly show that payments to doctors can influence their prescribing habits. Transparency is therefore a necessity and the recording of accurate payment data, using effective software solutions, has the ultimate goal of inspiring more public confidence in the pharmaceutical industry.
Ruth Knowles is a freelance science writer who has written articles and press releases on a range of life science and health topics. She received her MSc in Science Communication from the University of the West of England, Bristol.