Privacy notice on Public Disclosure of Transfers of Value to Healthcare Professionals & Healthcare Organisations
Scope of this notice
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 (i.e. for speaking congresses, chairing meetings, participation at advisory board meetings, for attendance at educational meetings) also known as “Transfers of Value” (“ToVs”).
This Privacy Notice (the “Notice”) is intended to explain why and how Santen SA and each one of Santen’s Affiliates (hereinafter “Santen”, “we”, “our” or “us”) collects and discloses personal data to evidence transactions and to ensure transparency on ToVs under pharmaceutical and data protection laws and regulations.
Public disclosure of ToVs mandated by law or voluntary adherence to industry codes
In some European countries, public disclosure of ToVs made 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 currently include France, Denmark, Belgium, Greece, Portugal, Romania and Slovakia.
At the same time, the disclosure obligation is also part of a European-wide initiative of the pharmaceutical industry and the MedTech industry for self-regulation. At the European level, public disclosure of ToVs is regulated in the EFPIA European Federation of Pharmaceutical Industries and Associations (“EFPIA”) Code of Practice (the “EFPIA Code”), the MedTech Europe Code of Ethical Business Practice (the “MedTech Europe Code”) and other industry specific national codes of practice.
Santen’s practices in relation to public disclosure of ToVs
At Santen, we fully support the public disclosure of ToV payments made by us to HCPs or HCOs and opt to adhere to the EFPIA Code, the MedTech Europe Code and other applicable national disclosure codes in order to be transparent and open about all of our interactions and we sincerely hope the HCPs/HCOs we work with agree.
Where disclosure is mandated by law, as stated above, we hereby inform all HCPs/HCOs interacting with Santen, who may be receiving ToVs, of our intention to fully comply with applicable transparency laws, and on that basis we will proceed to comply with our public disclosure obligations are required by law; individual consent by HCPs will not be required.
On the contrary, where public disclosure of ToVs will be made by Santen in adherence to specific industry codes and applicable national disclosure codes, individual consent of HCPs shall be required. More specifically, Santen notifies 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 forms (Consent Form for Disclosure of Personal Data). HCP consent is provided on a voluntary basis. The HCP may refuse to grant his/her consent, in whole or in part, in relation to each one of the specific financial benefits granted or may at any time and in any manner withdraw such given consent, in whole or in part, in relation to each specific financial benefit granted, without prejudice to any of his/her rights. Depending on whether the HCP grants his/her consent to us, the method of public disclosure of ToVs will vary:
Scenario #1: HCP grants Consent for public disclosure
In that case, the total sum of ToVs and the sum by categories (i.e. registration fees, travel & accommodation, sponsorship, consultancy, consultancy expenses) provided to named individuals during one calendar year will be publicly disclosed.
Scenario #2: HCP does not grant consent for public disclosure
In that case, no disclosure of the total sum of ToVs or of any sum by categories, as set out above, provided to individual HCPs will take place.
However, please note that public disclosure of aggregate sums by categories of ToVs made to HCPs we work with (anonymised statistical data), and who have not granted consent, will still take place based on Santen’s legitimate business need to comply with our industry’s codes and at the same time be able to promote trust and transparency with the people we work with such as HCPs and HCOs. In such case scenario, no personal identifiers of specific HCPs will be disclosed.
Data processing activities for the purposes of public disclosure of ToVs
Any processing activities (including collection, storage, transfer etc.) being performed in order to document our relationship with HCPs/HCOs and to comply with our transparency related obligations regarding any ToVs made to HCPs and HCOs, as detailed above, will be made in accordance with applicable data protection laws and regulations, including but not limited to the General Data Protection Regulation 679/2016 as well as the applicable national data protection laws. Before carrying any data processing activity in relation to ToV disclosure, we inform as necessary the HCPs (through our contractual agreements with them and through this Notice) for the specific processing purposes as well as for our general privacy practices in relation to the handling of their personal data. Where required, we will also request HCP’s individual consent.
Santen publishes in a publicly accessible list, all the required personal data, including the specific financial value (money or monetary value in the currency of the country in which the publication is made) granted to HCPs/HCOs for the period of the preceding calendar year. In particular, the information subject to disclosure in this regard shall include the following:
- name, contact details and professional information;
- services and consulting fees;
- financial benefits for educational events, including:
- Accepting the costs of meeting and registration fees;
- Refunding travel and accommodation costs;
- Sponsorship of educational events;
- Other financial benefits (e.g. direct or indirect services);
- Information for calculation and assessment of the value of the benefits (e.g. payment documents).
The above information 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.
Any personal data collected and processed for transparency purposes will be stored by Santen and/or its designated third party service providers in a separate transparency database, and from said database it will be published on Santen’s EMEA website (www.santen.eu), or on a Santen country-specific equivalent transparency website for compliance with the applicable national regulation or disclosure code.
Exceptionally, disclosures concerning ToVs made to HCPs/HCOs established in the countries mentioned below will be published on the national central platform(s) dedicated for such transparency disclosure, as indicated in the table below:
|Country||Governmental body/ Association responsible for the disclosure rules
|Belgium||Agence fédérale des médicaments et des produits de santé (AFMPS)
|Czech Republic||Asociace inovativního farmaceutického průmyslu (AIFP)||http://www.aifp.cz/|
|Denmark||Lægemiddelstyrelsen - Danish Medicines Agency||http://laegemiddelstyrelsen.dk/|
|France||Ministére des Affaires Sociales et de la Santé||http://www.transparence.sante.gouv.fr|
|Greece||National Organization for Medicines (EOF); Hellenic Association of Pharmaceutical Companies (SFEE)|
|Ireland||The Irish Pharmaceutical Healthcare Association (IPHA)||http://www.transferofvalue.ie|
|Netherlands||Nepharma (Pharma) Gedragscode Medische Hulpmiddelen (GMH - Medical Device)||http://www.cgr.nl|
|Romania||Agentia Nationala a Medicamentului si a Dispozitivelor Medicale (ANMDM)||http://www.anm.ro/anmdm|
|Slovakia||Národné Centrum Zdravotníckych Informácií||http://www.nczisk.sk|
|UK||Association of the British Pharmaceutical Industry (ABPI)||http://www.abpi.org.uk/ethics/ethical-responsibility/disclosure-uk/
Under certain circumstances set out in applicable laws and regulations, individual HCPs may at any time request access to their personal data that Santen holds, rectification of any inaccurate personal data, deletion, restriction and objection to the processing. To the extent the processing is based on consent, kindly note that you have the right to withdraw your consent at any time, however, this will not affect the lawfulness of the processing carried out prior to and up to such withdrawal.
To exercise your privacy related rights or if you have any concerns about Santen’s commitment to privacy, you may contact our Privacy EMEA Office by email at: firstname.lastname@example.org.
If we do not handle a request in a timely manner, or if you are not satisfied with our response to the exercise of your rights, you can submit a complaint with the competent EU supervisory authority of your country of residence or place of work. Further information and contact details of the European competent supervisory authorities can be found here: https://edpb.europa.eu/about-edpb/board/members_en.
If you would like to learn more about the disclosure of data regarding ToVs made by Santen to HCPs and HCOs, in specific countries, during a given year, please consult the respective EFPIA, the MedTech Europe 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.
Updated version: January 23, 2020