1.      Definitions

Capitalized terms used in this document are defined on the website of the European Federation of Pharmaceutical Industries and Associations (EFPIA), in EFPIA Code of Practice: https://www.efpia.eu/media/fg2n40ks/efpia-code.pdf

2.      Introduction and scope

Theravia must document and disclose any Transfer of Values (ToVs) made, either directly or indirectly, to any Healthcare Professional (HCP) or Healthcare Organization (HCO) or Patient Organization (PO) whose primary practice, principal professional address or place of incorporation is in Europe, hereafter “Recipient”.

Transfers of Value means:

• Direct and indirect ToV, whether in cash, in kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development and sale of Prescribed Only Medicines exclusively for human use.

• Direct ToVs are those made directly by Theravia for the benefit of a Recipient.

• Indirect ToVs are those made on behalf of Theravia for the benefit of a Recipient, or those made through a Third Party and where Theravia knows or can identify the Recipient that will benefit from the Transfer of Value.

EFPIA disclosure code provides that disclosure can be made on Theravia’s website.

In case the country of the Recipient has a National Code, disclosures of ToVs shall be made in accordance of the provisions of such National Code.

Depending on the country of the recipients, Theravia must also comply with the applicable national law.

3.      Data collection

Theravia has implemented internal processes to ensure interactions with HCP, HCO and PO are legitimate and they are documented correctly.

ToV can be provided:

• Directly by Theravia

• Indirectly by third parties

Contracts with third parties that can provide ToVs on behalf of Theravia must describe the necessity to collect the appropriate information for Transparency according to EFPIA code:  collection of ToVs to Recipients with the required accuracy.

According to EFPIA code, meals and drinks do not fall within the scope of the transparency obligations according to EFPIA code, but if applicable, Theravia will also have to comply with additional disclosure reporting requirements of National laws.

For direct ToVs done by Theravia, the date of payment will be considered to determine the year of publication.

For indirect ToVs, the event or the meeting date will be used to determine the date of collection of ToVs.

4.      Publication format

ToVs are reported as the following way:

• as net values, unless other provision from the legal requirements of a country.

• in the original currency in which they are made.

In case of event cancellation or in case of force majeure, no ToV takes place and therefore there is not any publication of ToVs.

5.      Standardised disclosure format

5.1.1.     Unique Country Local Identifiers

Numbers are provided if they are required in the countries, and where the applicable data privacy laws and regulations allow.

5.1.2.     Recipients

Recipient means any HCP of HCO or PO as applicable, in each case, whose primary practice, principal professional address or place of incorporation is in Europe.

HCO means any entity that provides healthcare which is not an individual HCP but may be a group of HCPs. For instance, Hospitals, clinics, medical schools or universities, group practices, laboratories.

Theravia has an internal database with all ToVs made to Recipients.

5.1.2.1.          Particularities

Indirect recipient: If Theravia is informed that an individual HCP will benefit from a ToVs to a HCO or PO we will disclose individually the name of the indirect Recipient provided that he/she gave his/her consent as required by data privacy laws.

Indirect Recipients can be identified in the following situations for example:

• in educational grant (for an educational event) allocated to a HCO by Theravia,

• in clinical research sponsored by Theravia, when the Clinical Research Organization pays HCP or HCO for research purposes.

5.1.3.     Country

Theravia use the EFPIA standardized disclosure format and implement one databoard per country:

• Country of exercise of the HCP, or

• Country where the Recipients have their business,

• Country of the PO’s registered office.

5.1.4.     Categories of ToVs

5.1.4.1.          To HCPs, HCO and PO’s

• Donations and grants (for HCO and PO's only),

• Contribution to costs of Events: sponsorship, registration, travel and accommodation,

• Fees for services and consultancy.

5.1.4.2.          Research and Development

Research and Development ToVs are disclosed using aggregation. Only events that are clearly related to research purpose are considered (Steering committee, Data and Safety monitoring…).

6.      Data privacy

Theravia must comply with data privacy laws, therefore we inform HCPs about the processing of their personal data and get their consent in order to disclose ToVs. Nevertheless, if local law requires publication, consent is not required.

Where consent is required, the healthcare professional is free to revoke it at any time.

THERAVIA will ensure that HCP can exercise his/her rights in terms of Personal Data, as provided by data protection laws. Recipient can contact the Data Protection Officer of Theravia either by post mail (16 rue Montrosier 92200 Neuilly-sur-Seine) or by e-mail data.protection@theravia.com.

7.      Date of disclosure

According to EFPIA Code, Theravia must disclose ToVs within 6 months after the end of the relevant reporting period and the information disclosed must remain in the public domain for a minimum of 3 years after the time such information is first disclosed unless, in each case, (i) a shorter period is required under applicable national laws or regulations, or (ii) the relevant data protection legal basis (e.g. the legitimate interest grounds, a legal duty or the Recipient’s consent relating to a specific disclosure) is no longer applicable. The common reporting period for publication of ToVs to Recipients is set during the time interval from 20th to 30th June each year at the latest.

8.      Application