As Europe lays the ground for the voluntary, ‘Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations’ pharmaceutical companies in the U.S. are working to comply with a statutory system that came into effect in August 2013.

The Physician Payments Sunshine Act, part of the Affordable Care Act, requires pharma companies and medical devices manufacturers that participate in government-funded healthcare programmes to record and report payments and transfers of value to healthcare professionals and teaching hospitals.

In the US a central reporting system is being set up by the Centers for Medicine and Medicaid (CMS), which will also make the information available on a public website.

In the US, as in Europe, it is recognised that interactions and collaborations between the pharmaceutical industry and healthcare professionals promotes innovation and improvements in patient care. Given this, the Sunshine Act is not intended to stop payments or transfers of value, but to ensure patients and the public have a clear view of who is paying who, and what for.

In the run up to establishing the system, companies began to collect payment records on 1 August 2013. They have until the end of March to file aggregate data for August – December 2013, and until May to submit detailed reports. The CMS is due to make the information public at the end of September 2014 on its Open Payments website.

Before it does so, healthcare professionals and teaching hospitals will be given 45 days to review their reports and to make corrections. In future, reporting will cover full calendar years.

Pharmaceutical companies will be required to report any direct payments of $10 or more and any payments of less than $10 each that in aggregate exceed $100 per year. There are some categories of transfers of value that are exempt, including educational materials and product samples intended to patient use.

The nature of the transfer of value, such as cash, in kind goods or services, or stocks, must be specified.

There is also a duty to report transfer of value through third parties, and give details of ownership interests such as stock or stock options (this excludes shares in publicly-quoted companies).

Any funding of research carried out by healthcare professionals or teaching hospital must also be reported. However, these records will be separate from payments to individuals, to make it clear, for example, that a payment to conduct a clinical trial does not end up in the pocket of an individual researcher.

Transparency reporting of financial relationships is already required in a number of US states and in addition several companies have disclosed information either voluntarily, or as a result of corporate integrity agreements.

The CMS View

CMS says the Sunshine Act will create a national resource for patients, providers and the public to understand relationships between healthcare professionals, teaching hospitals, and industry. Collaboration can contribute to the design and delivery of new drugs and devices, but payments from companies to healthcare professionals and teaching hospitals can also introduce conflicts of interests.

While financial ties alone do not signify an inappropriate relationship, transparency is necessary to:

  • Reveal the nature and extent of relationships
  • Prevent inappropriate influence on research, education, and clinical decision-making
  • Avoid conflicts of interest that can compromise clinical integrity and patient care

By publicising the financial relationships between industry and healthcare providers, Open Payments will promote the transparency that is needed to ensure the benefits continue to flow and avoid conflicts of interest.

The public website will be organised and designed to increase access to, and knowledge about, these relationships, and to provide information to enable patients, providers and the public to make informed decisions, CMS says.

Visit the Open Payments website for more details