From January 2015 (and for individual public disclosure from June 2016) pharmaceutical companies across Europe have been capturing and recording details of payments and other benefits in kind made to Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs) with whom they collaborate, also known as Transfers of Value (ToVs).
ToV include, for example, the payments and other benefits in kind pharmaceutical companies make to HCPs and/or HCOs for speaking at and chairing meetings; registration fees; participation at advisory board meetings; and remuneration and/ or travel and accommodation costs for attendance at educational meetings.
In some countries public disclosure of ToVs to HCPs and HCOs is mandated by law, as the disclosure of such data is deemed to be required in the public interest. These countries now include: France, Denmark, Belgium, Greece, Portugal, Romania and Slovakia. Where public disclosure of ToVs is made by Santen SA (Switzerland) and each one of Santen’s Affiliates (hereinafter “Santen”) in compliance with its legal obligations, consent of HCPs shall not be required.
However, Santen will be notifying all HCPs, who may be receiving ToVs, of Santen’s legal obligation to publicly disclose their individual details, at the time of the specific ToV, using individual HCP contracts.
The disclosure obligation is part of a Europe-wide initiative of the pharmaceutical industry of self-regulation towards greater trust and transparency between pharmaceutical companies, the people they work with and the public. At the European level, public disclosure of ToVs is regulated in the EFPIA European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code.
Since disclosures shall be made pursuant to the national code of the country where the Recipient HCP or HCO has its physical address, Santen’s declaration is regulated by industry specific national codes of practice.
In the UK, for example, the requirement to disclose Transfers of Value (ToVs) on an individual basis is part of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry.
We, Santen, fully support the public disclosure of ToV payments made by pharmaceutical companies to HCPs or HCOs and opt to adhere to the EFPIA Code on Disclosure and applicable national disclosure codes. As an ethical company we feel it is important to be transparent and open about all of our interactions and we sincerely hope the HCPs we work with agree.
Where public disclosure of ToVs is made by Santen in adherence to the EFPIA Code on Disclosure and applicable national disclosure codes, consent of HCPs shall be required and obtained.
Santen will be notifying all HCPs, who may be receiving ToVs, of Santen’s intention to comply with specific industry codes and to publicly disclose their individual details, whether individually or in aggregate, and will seek to obtain consent at the time of the specific ToV, using individual HCP contracts with separate disclosure consent (Consent Form for Disclosure of Personal Data). Depending on whether the HCP grants his/her consent to us, the type of disclosure of ToVs will vary:
Scenario #1: HCP grants Consent for public disclosureIn that case, the total sum of ToVs provided to named individuals during one calendar year will be publicly disclosed.
Scenario #2: HCP does not grant consent for public disclosureIn that case, no disclosure of the total sum of ToVs provided to individual HCPs will take place.
However, please note that public disclosure of aggregate sums of Transfers of value to HCPs we work with (anonymized statistical data), and who have not granted consent, will still take place based on our legitimate business need to comply with the pharmaceutical industry’s codes and at the same time to promote trust and transparency with the people we work with such as HCPs and HCOs.
We, Santen SA (Switzerland) and each one of Santen’s Affiliates (hereinafter “Santen”) , will be processing personal data of HCPs for transparency in documenting our relationship with Healthcare Professionals (HCPs) and Healthcare Organisations, in relation to the EFPIA Code on Disclosure and applicable national disclosure codes.
For the processing of personal data for the purposes of public disclosure of ToVs made by us to HCPs, Santen is the Data Controller according to the relevant and applicable data protection laws.
Where disclosure is mandated by law, consent by the individual HCP will not be required.
Where disclosure is not mandated by law, consent by the individual HCP will be required and obtained for any public disclosure of personal data relevant to ToVs.
HCPs are not obliged to give consent. If HCPs do opt to grant consent they can withdraw it at any time without any reason.
Santen will collect name, practice or business address as well as permanent physician’s registration number (hereinafter “Personal Data”) of HCPs we work with. We have agreed under the conditions of the EFPIA Disclosure Code and other relevant applicable national disclosure codes to make a public disclosure of details of the specific financial value paid to an individual HCP as a Speaker, Consultant or other beneficiary. These include payments made to the HCP personally, a Company / Partnership of which the HCP is a Director or Partner, or a Healthcare Organisation or Charity. Since the year 2016, at the latest by June 30 of each year, the Personal Data and the specific financial value (money or monetary value) granted to HCPs/HCOs by Santen for the period of the preceding calendar year (the reporting period - starting with data from the year 2015) have been published in a publicly accessible list.
The subject information subject to disclosure in this regard shall include in particular:
Personal Data will be stored by Santen and/or its selected service provider in a separate database, and from said database those will be published on Santen’s website (www.santen.eu) or on the country-specific equivalent for compliance with the applicable national regulation or disclosure code. Exceptionally, disclosures concerning Transfers of Value made to HCPs/HCOs established in the UK will be published on the ABPI central platform for Disclosure (“Disclosure UK”) which can be visited at (http://www.abpi.org.uk/ethics/ethical-responsibility/disclosure-uk/).
For the purpose of enabling Santen to meet its obligations, transferring such information to other Affiliates and/or to any third party providing services to Santen, who may be established in jurisdictions outside the European Economic Area (EEA), may be necessary; such jurisdictions outside the EEA may not provide an adequate level of protection for such Personal Data; Santen shall ensure that appropriate safeguards are in place in the form of contractual arrangements to guarantee a level of protection in the processing of personal data in the recipient country equivalent to the one provided within the EU.
The publication will include Personal Data referred to above and will show the sum of the financial values granted to HCPs/HCOs by Santen in the currency of the country in which the publication is made.
Personal Data and the sum of the granted financial value will be published for a period of 3 years from the time of first publication, or until such time, consent relating to a specific disclosure, if required by applicable national law or regulation, has been revoked, whichever comes first. Thereafter, those data will be deleted.
Individual HCPs may at any time request a copy of their Personal Data Santen holds, and request changes and deletion of any inaccurate information.
Consent is voluntary. The HCP may refuse the consent in whole or partly in relation to each of specific granted financial benefits or may at any time and in any manner withdraw the given consent in whole or partly in relation to each of specific granted financial benefits, without prejudice to any of their rights.
For the access, rectification, deletion and restriction of processing and to exercise the right of withdrawal or any other right about the processing of Personal Data, or if HCPs feel that any of their rights relating to the collection or use of their Personal Data have been violated, they may contact our Privacy EMEA Office at:
Privacy EMEA OfficeSanten SA, La Voie-Creuse 14, 1202 Geneva, SwitzerlandE-Mail: firstname.lastname@example.org
HCPs also have the right to lodge a complaint with the appropriate data protection authority for which they can refer to the following website: http://ec.europa.eu/justice/data-protection/article-29/structure/data-protection-authorities/index_en.h
If you would like to learn more about the disclosure of data regarding Transfers of Value (ToV) to Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs) made by Santen, in specific countries, during a given year, please consult the respective EFPIA or Country Specific Disclosure Methodology used by Santen in each occasion. In each methodological note we have summarized the methodologies used by Santen in preparing our disclosures and identifying each category of ToV.