ARPIM Disclosure Code in Interaction with HCP/HCO

ARPIM Disclosure Code in Interaction with HCP/HCO


ARPIM Disclosure Code in Interaction With HCP/HCO

  1. Q: Contracting 3rd parties organized events- “sponsorship”/ engagement of services, disclosure HCO+/- logistic partner logistic

-If the 3rd party is Ltd (SRL) then service contracts

-If the 3rd party is NGO and they provide invoice then service contracts

-If the 3rd party is NGO and they do not provide invoices then sponsorship contracts


In the example described below, all types of contracts would likely fall into the “Contribution to Costs related to Events” category and these transfers of value are subject to disclosure obligation.

Examples of activities that should as a minimum be covered under “Sponsorship Agreements” and/or service contracts:

-Rental of booths at an “Event”;

-Advertisement space (in paper, electronic or other format);

-Satellite symposia at a congress;

-Sponsoring of speakers/faculty;

-If part of a package, drinks or meals provided by the organizers;

-Courses provided by an HCO (where the Member Company does not select the individual HCPs participating).

Additionally, where ARPIM member companies make ToV through third parties appointed by an Healthcare Organizations (HCO) to manage an Event, they should use their best efforts to obtain the required consents from the HCOs who are the ultimate beneficiaries (either directly or through such third parties), so that the relevant disclosures can be made on an individual basis for each clearly identifiable event organizer (HCO). This may require making amendments to the existing contracts with intermediaries.

  1. Q:

Who is to be considered beneficiary of the ToV(intermediary beneficiary or final beneficiary)in case of a sponsorship contract concluded with an intermediate beneficiary (NGO), which will direct towards the final beneficiary (public healthcare institution) the funds or the goods received from the member company under the title of sponsorship?To be noted that the member company is aware of this transfer at the time the contract is concluded with the intermediate beneficiary.

A:Considering that the donation /sponsorship as a principle has as beneficiary the entity which becomes owner of donated / sponsored goods (the member company should request directly or via the intermediate beneficiary the confirmation of receipt of goods and inclusion in the inventory of the institution – if the case) the member company will disclose the name of the final beneficiary as recipient of the ToV.

  1. Q:Is the ARPIM member company required to disclose ToVs executed independently by a 3rd party (e.g.provider of rented salesforce, consulting company, market research company, PR agency...) to HCPs/HCOs, in the case that respective 3rd party was engaged by the ARPIM member company to perform activities as regulated by the ARPIM Code of Ethics?

A:considering that the ARPIM member is not involved in taking decisions with respect of such engagements and their value and does not execute payments to neither HCPs and/or HCOs the ARPIM member company is not required to disclose such transfers of value.

It is recommended by EFPIA and ARPIM that is such cases the ARPIM member company should include contractual provisions for the 3rd party to follow the provisions of the ARPIM Code and to disclose ToVs.

In addition the ARPIM will describe within the methodology of disclosure such particular cases and that obligations for disclosure were tranfered to the 3rd party as agreed within the concluded contracts.

4.Q:Is there a need to obtain consent for processing and disclosure of information based on article 799^1 of Law no. 95/2006 and by the Order no 194/2015 of the Ministry of Health?

A:Based on art. 5 para. 1 letter c) of Law no. 677/2001 for the protection of persons with respect to the processing of personal data and freedom of movement of this data, obtaining the data subject's consent is not necessary if the processing is necessary for the processor to comply with a legal obligation.

Therefore, obtaining the consent of the HCP for the processing under art. 799^1 and the Order no 194/2015 of the Ministry of Healthis not necessary.

5.Q:Is The consent to be obtained if the processing and disclosure exceeds the legal obligation provided by article 799^1 of Law no. 95/2006and by the Order no 194/2015 of the Ministry of Health

A: Yes. The consent still needs to be obtained in any situation when the processing and disclosure exceed the legal obligation, like for example:

- if the processing involves steps which are not required by law (e.g. transfer of information to group entities which do not have the legal obligation, but are only in charge with maintaining data bases, reporting etc);

- if the data is transferred outside Romania, the consent of the HCP will be required irrespective if the transparency obligations under EFPIA/ARPIM Code, Article 799^1 of Law no. 95/2006 and the Order no 194/2015 of the Ministry of Health;

-if the disclosure involves actions which are not required by law (e.g. publication of the ARPIM website, since the disclosure under Order no 194/2015 of the Ministry of Healthtakes place only on the website of the National Drug Agency and on the producer's website)