EFPIA Disclosure Code: Frequently Asked Questions

15 questions and answers about the EFPIA Disclosure Code

What is the EFPIA Disclosure Code?

The ‘EFPIA Code on Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations’ ( EFPIA Disclosure Code) is a set of self-regulatory industry transparency standards for pharmaceutical companies operating in 33 European countries.

It requires EFPIA member companies and members of EFPIA member associations to publicly disclose payments and other transfers of value made to healthcare professionals (HCPs) and healthcare organisations (HCOs) in certain categories. For example, this could include grants given to HCOs, or consultancy fees for HCP speaking engagements.

The first reporting period will be 1 January – 31 December 2015. The first public disclosure will be made by 30 June 2016, retrospectively for the year 2015.

Who is EFPIA?

The European Federation of Pharmaceutical Industries and Associations ( EFPIA) represents the interests of around 1,900 pharmaceutical companies operating in Europe.
National pharmaceutical industry associations in the following 33 European countries are members of EFPIA: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, the Netherlands, Norway, Poland, Portugal, Romania, the Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom.

In addition, 40 leading pharmaceutical companies are EFPIA members.

Why this Code now?

In light of increasing public and governmental scrutiny concerning financial relationships between the healthcare industry and healthcare professionals, EFPIA and its members have decided to implement the ‘EFPIA Code on Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations’ (EFPIA Disclosure Code) as a set of self-regulatory industry transparency standards.

Who is affected by this Code?

The Code affects healthcare professionals and healthcare organisations in 33 European countries in which EFPIA has national member associations. Healthcare professionals and healthcare organisations in other countries may also be affected, as there may be pharmaceutical industry associations and companies that are not EFPIA members but decide to voluntarily implement the Disclosure Code.

Where will the Code be implemented?

The Code will be implemented in 33 European countries where EFPIA has national member associations: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom.

There may also be pharmaceutical industry associations and companies that are not EFPIA members but decide to voluntarily implement the Disclosure Code. So even if your country is not listed above, be sure to keep yourself abreast of any financial disclosure-related developments in your country. Your professional organisation and/or the relevant pharmaceutical industry association in your country may be able to provide this information.

Disclosures will be based on the national pharmaceutical industry code of the country where the healthcare professional or healthcare organisation has their principal practice or physical address.

How will the Code be implemented?

EFPIA members were asked to transpose the EFPIA Disclosure Code into their respective national codes and to comply with the relevant national laws and regulations. This means that the Disclosure Code will not be implemented in the same way in each individual country. For example, there may be different threshold values for payments and other transfers of value that need to be disclosed, depending on the country.

EFPIA member associations may decide to inform national professional healthcare organisations about the implementation of the Disclosure Code beforehand, but in most cases it will be the member companies of such associations that will contact healthcare professionals and healthcare organisations directly to inform them of this Code and obtain their consent to disclosure.

Disclosures will be based on the national pharmaceutical industry code of the country where the healthcare professional or healthcare organisation has their principal practice or physical address.

EFPIA member companies and members of EFPIA member associations are required to comply with applicable data protection and other laws in their countries and are encouraged to obtain consent from healthcare professionals and healthcare organisations prior to disclosure. They may also wish to renegotiate existing contracts to include the ‘consent to disclosure’ component. National EFPIA member associations are expected to sanction member companies in breach of the applicable code or law.

What will be disclosed?

There are different types of disclosure:

Individual disclosure of transfers of value to healthcare organisations:

  1. Donations and grants
  2. Contributions to costs related to events (registration fees; sponsorship agreements for event management; travel and accommodation)
  3. Fees for service and consultancy

Individual disclosure of transfers of value to healthcare professionals:

  1. Contribution to costs related to events (registration fees; travel and accommodation)
  2. Fees for service and consultancy

Aggregate disclosure

  • Where information cannot be disclosed on an individual basis for legal reasons
  • For each of the above categories (1/2/3):
    • Number of recipients covered (absolute number and percentage of all recipients)
    • Aggregate amount attributable to transfers of value to such recipients
  • Research and Development transfers of value

Non duplication

  • Indirect transfers made to an individual healthcare professional via a healthcare organisation shall be required to be disclosed once.

By whom, where, how often and for how long will the data be disclosed?

Data will be disclosed annually by EFPIA member companies and by the members of EFPIA member associations within 6 months after the end of the relevant reporting period and for a minimum of 3 years. Disclosures will be made on company websites or on national government body or industry association online platforms.

When will data collection start and when will the data be disclosed?

Data collection starts on 1 January 2015, and the first reporting period will be 1 January - 31 December 2015.

The first public disclosures will be made by 30 June 2016, retrospectively for the year 2015.

What can I do to ensure data accuracy?

Healthcare professionals and healthcare organisations are not required to report data themselves, but are advised to keep track of any payments and other transfers of value received from the pharmaceutical industry in order to ensure the accuracy of the related information reported by the pharmaceutical companies.

Healthcare professionals and healthcare organisations are encouraged to review the data collected and submitted by industry before publication. Contact your national professional association to find out about related procedures in your country. Data verification usually means that you have to register with the relevant online platform and that you can challenge inaccurate data within a predetermined timeframe.

Can I dispute inaccurate data?

This depends on the situation in your country. In case of data inaccuracies or concerns, contact the company in question and/or your national professional organisation. Healthcare organisations may also consider consulting the relevant pharmaceutical industry association in their country.

What about already existing disclosure platforms?

Depending on the situation in your country, there may be more than one public disclosure platform. Be sure to keep track of any payments and other transfers of value received from the pharmaceutical industry and update your own disclosures on a regular basis. If there are several disclosure platforms, check them regularly to avoid inconsistencies.

Is there any standardised European procedure in sight for handling disclosures?

Given the great variety of national laws and regulations and the multitude of different disclosure policies, codes and platforms, there is currently no standardised disclosure procedure in sight.

What to tell patients?

Research suggests that patients want to be informed about the financial relationships their doctors have with the healthcare industry, but they may prefer receiving such information in writing or through external sources, rather than directly during their doctor consultation. In case a patient asks you about this topic, you should provide this information in an open and transparent fashion.

You may want to speak about your research projects and highlight the importance of industry relationships for driving research and for bringing novel treatment options to patients. You could also stress that those relationships allow you to have continuous access to quality CME and to the latest scientific information, thus enabling you to provide state-of-the-art medical care and make use of treatment options in the safest, least toxic and most cost-effective way possible.

Where to get further information?

Links to EFPIA resources, member associations and companies as well as a list of national professional oncology societies in Europe that may be able to provide you with additional information can be found here.