Transfers of value (ToV)
Following the European Federation of Pharmaceutical Industries and Associations (EFPIA) AGM in June 2013, a new Disclosure Code of Transfers of Value (ToV) to healthcare professionals (HCPs) and healthcare organisations (HCOs) was adopted with a view to bringing greater transparency around industry’s financial transactions with them.
In one of the most far reaching developments in the relationship between the research based pharmaceutical industry and the medical community, these financial transactions, or ToVs, were first made public from June 2016.
As a result of this, IPHA as a member of EFPIA has changed its Code of Practice. From 30th June 2016 details of how member companies of IPHA engage with and support HCPs and HCOs have been publicly disclosed. ToVs for research and development, donations and grants (including medical education and unrestricted educational grants), consultancy fees, registration fees or travel costs to attend medical conferences will be disclosed.
The first data disclosed related to 2015 and was published in a central industry report on the IPHA website on 30th June. You can access the central report on www.transferofvalue.ie.
In order to adhere to data protection laws, HCPs must give consent for individual data to be disclosed. In the absence of this consent, the data will be published in aggregate form.
In the interest of greater transparency, IPHA has urged HCPs to grant such consent.
What is the Transfers of Value (ToV) initiative?
The ToV initiative is the main element of changes to the IPHA Code of Practice (specifically Annex V) which requires all member companies to disclose payments, collaborations and other ToV made to HCPs and HCOs. The type of collaborations include registering and attending medical conferences; taking part in clinical trials and research; patient education and awareness initiatives as well as details of specific interactions such as research and medical grants.
The first disclosure of ToV was made public on 30th June 2016 and was reflective of 2015 data.
Where did it come from?
It is important that these collaborations meet the high standards of integrity that patients, governments and other stakeholders expect.
EFPIA, as the representative body for the research-based pharmaceutical industry in Europe, has a number of codes and guidelines in place to support transparency in the pharmaceutical sector.
In 2013 it was decided that an additional level of transparency should be introduced around these relationship and hence the EFPIA Disclosure Code – in full, – was created in order to enhance the transparency surrounding relationships between the pharmaceutical industry and HCPs/HCOs.
IPHA, as a member of EFPIA, also changed its Code of Practice to reflect this additional transparency.
Why was it considered necessary to enhance transparency?
Interactions between the pharmaceutical industry and healthcare professionals have a profound and positive influence on the quality of patient treatment and the value of future research. This greater level of transparency is designed to assure the public that they can trust their doctor to recommend treatment or administer appropriate care based solely on clinical evidence.
Disclosing the financial aspect of industry support for HCPs is an appropriate step in providing this assurance.
Why does the pharmaceutical industry need to interact with HCPs/HCOs?
Healthcare professionals need to stay informed about current and new medicines to provide patients with the best possible care and treatment options. Industry support for medical education, expert-led forums and speakers meetings enables healthcare professionals to meet their ongoing information needs.
To help ensure that they are able to make the best treatment recommendations to their patients, the pharmaceutical industry provides doctors with the latest information about its medicines and vaccines.
The industry also helps set up discussions, meetings and conferences about diseases and treatments for healthcare professionals so they can share their knowledge and experience.
Healthcare professionals provide the pharmaceutical industry with information on how to improve its medicines: They do this through providing feedback about how medicines work in real-world patient settings. The pharmaceutical industry and healthcare professionals work together on clinical trials and share information about new medicines and patients’ responses to treatments, including side effects, in order to generate insights that all parties can use to improve patient outcomes. In the interests of patients and continuing pharmaceutical innovation, this close collaboration between the pharmaceutical industry and healthcare professionals are absolutely vital.
Are the changes being imposed on member associations by EFPIA?
No, although this is an EFPIA led initiative, IPHA and other national associations are fully supportive of it, as are IPHA member companies. IPHA is responsible for implementation in Ireland which have been shaped by considerations in this jurisdiction. In complying with the initiative, IPHA is ensuring that its Code is as robust and transparent as any in Europe.
Will there be individual disclosure of transfers of value to HCPs?
Consent must be given by HCPs for individual disclosure. In the absence of consent, only an aggregate figure for an unnamed HCP will be disclosed.
However, in the interest of greater transparency, IPHA is urging that such consent be given. Consent is not required concerning HCOs.
What is the reaction from HCPs/HCOs?
IPHA has been working closely with relevant representative and regulatory bodies in Ireland to promote awareness and buy in for this initiative and encouraging consent. The reaction has been very positive with many publicly supporting it and encouraging their members to do likewise.
What are the timelines and how will it be disclosed
ToV data was made publically available in a single industry report on the IPHA website on 30th June 2016. The first series of data related to ToVs made in 2015. Subsequent reports will be published within six months of year end and will be publicly available for three years from date of initial publication.
You can download further information on the ToV initiative below:
- the most recent version of the IPHA Code of Practice
- Template for disclosure of ToV
- Transfers of value booklet for HCPs/HCOs
- EFPIA FAQ HCP Code