Annex V – QUERIES (Questions and Answers) on the interpretation of the Code of Practice
ARTICLE 18. TRANSPARENCY OF THE PHARMACEUTICAL INDUSTRY’S RELATIONSHIPS
90. Are observational studies included in the category of Transfers of Value related to Research and Development under article 18?
Observational studies are regulated by article 14.2 of the Code. Likewise, the definition of "Research and Development" includes: activities associated with the design or execution of (i) preclinical studies (as defined by the OECD in "Principles of Good Laboratory Practice"), (ii) clinical trials (as defined in Regulation (EU) No. 536/2014, Royal Decree 1090/2015, and covered by article 14.1 of the Code), and (iii) observational studies with medicinal products (covered by article 14.2 of the Code).
As an exception to the terms set out in the above paragraph, Transfers of Value made to Healthcare Organisations and to Healthcare Professionals connected with observational studies with medicinal products of a retrospective nature, which are nonetheless considered Research and Development, must be published individually by pharmaceutical companies under the category "provision of services".
91. Is it understood that medical insurance is included within the subcategory "travel and accommodation" of contribution to educational and scientific meetings for the purposes of article 18?
Yes. Medical insurance is included within the total cost related to travel and accommodation.
92. Regarding Healthcare Organisations, what information should be included in the Disclosure Template (Annex II) in the column "registration fees" of the category "contribution to educational and scientific meetings"?
Those Transfers of Value made by the pharmaceutical company upon request of a Healthcare Organisation for "registration fees" to defray registration of those Healthcare Professionals selected by the Healthcare Organisation ("grant holders").
In these cases, the pharmaceutical company neither selects nor has the possibility of knowing which Healthcare Professionals are finally benefitting from its collaboration.
For the purpose of disclosing those Transfers of Value, the pharmaceutical company should bear in mind what is stated in article 18 of the Code (“general principle establishing that information must be disclosed on an individual basis, identifying the Healthcare Professional”), and in question nº 126.
93. When it is the parent pharmaceutical company the one that sponsors participation of a Healthcare Professional practicing in Spain to a congress in a different country, who should disclose the Transfers of Value related to such collaboration?
Each pharmaceutical company shall decide how to organise disclosure of the information, at a central level or at a local level. However, information will have to be publicly available in the country where the Recipient mainly carries out his professional activity.
If the pharmaceutical company does not operate or have an affiliate in the country where the Recipient mainly carries out his practice, the company shall disclose the information of such Transfers of Value in compliance with provisions of the local Code of the country where the Recipient mainly carries out his practice.
If the pharmaceutical company has several separate legal entities in the same country, it shall choose the most appropriate legal entity to disclose the information. All Transfers of Value made to the same Recipient shall be published in "one place" – disclosure in the country where the Recipient mainly carries out his professional activity shall enclose all Transfers of Value made to the same HCP/HCO, disregarding where they have taken place (both in and out of the country where the Recipient mainly carries out his professional activity).
Regardless of the decision made regarding publication (in the website of the parent company or the affiliate), disclosure shall be carried out in compliance with the local Code of the country where the Recipient mainly carries out his practice and in compliance with local regulations applicable in that country.
In those cases where different entities of a pharmaceutical company make payments in the same country to the same HCP, these payments shall be disclosed in one website; and not separately, arguing that there are different entities of the pharmaceutical company involved.
94. Should Transfers of Value made within the framework of a market research study, where the pharmaceutical company does not have access to the identity of the participating Healthcare Professionals, be disclosed?
The Code does not require disclosure of those Transfers of Value where identity of the Healthcare Professionals is unknown.
One of the basic characteristics included in the definition of market research studies and in the Codes of Practice regulating them worldwide is the right of participants not to make their identities known.
In those market research studies where it exceptionally has access to the identities of participating Healthcare Professionals, the pharmaceutical company shall disclose the Transfers of Value under the category "fees for service" on an individual basis complying with article 18 of the Code.
95. ¿What happens to those Transfers of Value related to corporate social responsibility projects? For example: sending doctors to carry out humanitarian work, which involves the existence of related costs of travel and accommodation.
This kind of collaborations shall be carried out and formalised through an organisation in all cases, never individually.
The Code is applicable because this is a form of relationship between the pharmaceutical company and Healthcare Professionals.
The pharmaceutical company shall provide information regarding treatment of this kind of Transfers of Value in the methodological note described in article 18.6 of the Code.
96. Are costs associated to the transfer airport-hotel-airport, by taxi or public transport, considered travel costs? Should they be disclosed?
Yes. They shall be disclosed under the relevant category; depending on whether they are related to "contribution to educational and scientific meetings" (travel and accommodation) or to "fees for service" (related expenses agreed in the fee for service or consultancy contract, including travel and accommodation); on an individual basis complying with article 18 of the Code.
97. Should general costs of organising a meeting, such as room, hostesses, etc., be divided upon the number of participants and be disclosed?
No. These are general expenditures made by the company for the organisation of the meeting.
98. What information should be disclosed in a meeting organised by a third party when the pharmaceutical company covers 100% of costs such as room rental, hostesses, AV, etc., and where all Healthcare Professional participants are from such location, there being no Transfers of Value related to accommodation or travel?
The pharmaceutical company shall only disclose under the category "contribution to educational and scientific meetings" the Transfers of Value made to the Healthcare Organisation in charge of organising the meeting (in the column "sponsorship agreements with HCOs/third parties appointed by HCOs to manage a meeting").
In a situation such as the one described in the question, no Transfers of Value would be disclosed regarding attendees on an individual basis.
99. What information should be disclosed regarding attendees in an educational meeting organised by a pharmaceutical company where there are no travel and accommodation expenses (for example: "webinar", "teleconference")?
No Transfer of Value need be disclosed regarding attendees, as there is no registration fee (it being a meeting organised by the pharmaceutical company) nor Transfers of Value related to accommodation or travel of attendees (it being held in such a way it avoids the necessity of such expenses).
The pharmaceutical company would not be forced to disclose the Transfers of Value related to logistical expenses stemming from organising a meeting of this type (room rental, AV, catering, hostesses, etc.).
100. Should Transfers of Value made through intermediaries be disclosed on an individual basis by pharmaceutical companies?
Transfers of Value shall be disclosed on an individual basis complying with article 18 of the Code.
In the agreements with third parties that are to act on behalf of a pharmaceutical company or on its representation it shall be guaranteed that these disclosure obligations are met. In this sense, it is recommended to pharmaceutical companies that in their agreements with these third entities the measures and provisions guaranteeing compliance with this obligation and with the obligations detailed in questions nº 116 and nº 117 herein. In this regard, pharmaceutical companies shall take into account article 19.1 of the Code, which states:
"In addition, companies member of FARMAINDUSTRIA or adhered to the Code on an individual basis will be liable for possible breaches of the Code committed by third parties acting on their behalf or representation, or under their control, or by virtue of a written agreement (for example, external sales networks, market research companies, travel agencies, advertising agencies, etc.) ".
101. How should a Transfer of Value be disclosed on an individual basis when the fees of a Healthcare Professional for provision of a service are paid to an entity or a legal person (for example: limited company, hospital foundation or scientific society), under Healthcare Organisation or under Healthcare Professional?
The Code of Practice for the Pharmaceutical Industry establishes, as a general principle, the obligation to disclose on an individual basis all the Transfers of Value made, either directly or indirectly through third parties, to Healthcare Professionals. Thus, in accordance with that principle, Section 18.1 of the Code establishes that to the maximum extent legally possible and provided that it can be made accurately and consistently, pharmaceutical companies shall disclose this information on an individual basis, identifying the Healthcare Professional (instead of the Healthcare Organisation).
The hiring of Healthcare Professionals for the provision of services is regulated by article 16 of the Code. Said article, in its section 16.1 requires, among others, the compliance of several conditions, "b) the existence of a written contract prior to providing these services".
An easy and useful criteria for a pharmaceutical company, in order to decide to whom the Transfer of Value should be allocated, and therefore in whose name should be disclosed, is to publish the name of the natural or legal person who signs the contract. In this regard:
(i) If the pharmaceutical company signs the contract for the provision of services with a natural person acting individually, in its own name and rights, the invoice should be issued in the name of the natural person (including a NIF number).
(ii) In case a legal person (*) provides the service, the invoice should be issued in the name of the legal person (including a CIF number).
In the methodological note stipulated in article 18.6 of the Code, the pharmaceutical company shall provide information with regard to the treatment of this Transfers of Value.
In any case, in order to comply with the general principle detailed in the first paragraph, it is the responsibility of each pharmaceutical company to previously verify, using the mechanisms it considers appropriate: (i) the characteristics, structure, bylaws, goals and corporate purposes, etc. of each Healthcare Organisation with whom plans to contract, and (ii) if, according to their scope and nature, it is deemed appropriate to contract those services with a legal person (instead of a natural person). In particular, if the service contracted (and the corresponding Transfer of Value) is directly attributable to a certain natural person (Healthcare Professional), the pharmaceutical company shall disclose and assign said Transfer of Value, on an individual basis, which is made to that Healthcare Professional.
(*) Legal person: organisation or natural person group to whom the law grants independent status differentiated from the one of each of its members or components. Legal persons are usually classified as corporations (societies or associations, depending on having profit or non-profit purposes) foundations, or legal persons subject to public or private law.
102. Sometimes Healthcare Professionals – without intermediation/participation of a Healthcare Organisation – directly request pharmaceutical companies’ sponsorship or collaboration with educational and scientific meetings organised by those Healthcare Professionals individually. Can pharmaceutical companies collaborate/sponsor such activities? If the answer is "yes", how would Transfers of Value related to such collaboration/sponsorship be disclosed?
Pharmaceutical companies shall not sponsor nor collaborate, directly or indirectly, with educational and scientific meetings organised individually by Healthcare Professionals.
103. Should the amounts disclosed in "Annex II Disclosure Template" be in gross or net?
In compliance with provisions of section 18.6 of the Code, each pharmaceutical company shall publish a document describing the methodology used, explaining with simple language the information provided and the way in which it has been obtained and classified.
Said document shall inform whether disclosed amounts are gross or net.
104. The Disclosure Template ("Annex II of the Code") includes ID/CIF, as fields of mandatory filling. It additionally shows a specific format to follow when filling that field, hiding the first three and last two digits. Should pharmaceutical companies apply the same format when filling this field? Does this procedure implies the use of algorithms for data encryption?
For each Transfer of Value, pharmaceutical companies shall be able to identify the Recipient. For this purpose, in Spain the use of ID/CIF number, as appropriate, was agreed as the unique identifier element.
Using the NIF number (for natural persons) or the CIF number (for legal persons) is more appropriate.
In order to avoid an inappropriate use of this information, pharmaceutical companies decided to publish this identification number partially. Hiding does not mean encrypting; therefore the use of algorithms is not needed.
Each pharmaceutical company shall decide the digits to hide, from a maximum of 5 to a minimum 3.
105. Under the usual confidentiality clauses included in contracts, would it be possible to avoid complying with the new transparency provisions established in the Code, avoiding in particular application of the provision that demands disclosure of the Transfers of Value?
In view of the query posed, it is deemed necessary to point out that the Code is binding and of compulsory compliance both for the pharmaceutical companies member of FARMAINDUSTRIA and the pharmaceutical companies that have adhered to the Code.
Consequently, the existence of confidentiality clauses in a contract does in no case exempt from compliance with the informational and transparency provisions imposed by the Code.
Furthermore, it would be advisable that, for those contracts of pharmaceutical companies subject to the Code signed after the entry into force of these new transparency obligations, all cautions and measures necessary to ensure and ease compliance with those obligations are adopted. In other words, inclusion of clauses or pacts contrary to compliance with provisions of the Code in such contracts shall be avoided. In this sense, inclusion of confidentiality clauses in contracts signed by pharmaceutical companies subject to the Code after the entry into force of the new transparency provisions – among them, disclosure of the Transfers of Value – and that are contrary to compliance with such provisions, may even be eventually regarded as a breach of the Code, as they would constitute a medium to shelter or encourage a potential breach.
106. If a pharmaceutical company sponsors attendance of 100 Healthcare Professionals to a congress of a Healthcare Organisation, how should such Transfers of Value be disclosed, as payments to the Healthcare Organisation or as payments to each Healthcare Professional? How should these payments made through third parties be managed (technical secretariats, Healthcare Organisations despite the beneficiary being the Healthcare Professional, etc.)?
If the identity of the Healthcare Professionals is known, the pharmaceutical company shall disclose the Transfers of Value derived from its collaboration for their attendance to the congress on an individual basis complying with article 18 of the Code.
If the identity of the Healthcare Professionals is unknown and the conditions detailed in question nº 126 are met, the pharmaceutical company shall disclose the Transfers of Value derived from its collaboration under the category "sponsorship agreements with HCOs/third parties appointed by HCOs to manage a meeting".
107. Article 18.6 of the Code establishes that each company shall publish a document describing the methodology used and explaining the information provided and the way in which this information has been obtained and classified. Where will this document be published?
This information shall be contained within the company’s own proceedings and the description of the methodology will be published in the same place where the Disclosure Template is made public.
108. If a Spanish Healthcare Professional is living temporarily in a non-European country and receives a fee or another Transfer of Value from the US parent company, is it necessary to collect and disclose it in the report of the Spanish affiliate?
It would not be necessary, given that such Healthcare Professional does not mainly exercise his professional practice in Spain.
Without prejudice to the location where the Transfer of Value takes place, disclosure of such information shall be made in the country where the Recipient mainly carries out his practice or has his registered office and complying with the local Code applicable in such country.
The Code demands Transfers of Value are disclosed where he mainly carries out his profession or has his registered office because this is the way of guaranteeing that interested third parties (patients, stakeholders) may easily find the information. The professional address of the Healthcare Professional or the registered office of the Healthcare Organisation has to be used as a reference when determining the country in which to disclose the information.
Example:
- A Spanish pharmaceutical company collaborating with the participation of a US expert in an advisory board meeting taking place in Argentina would not be forced to disclose the information related to such Transfer of Value. However, disclosure of such information may be compulsory in compliance with other jurisdictions.
109. Would Non-Governmental Organisations, "NGOs", to which sometimes medicines are donated for humanitarian projects, fall within the concept of Healthcare Organisations? What value should be applied to donated medicines? Company’s selling price, company’s selling price + VAT, cost for the company?
Pharmaceutical companies themselves shall determine, on a case by case basis, whether a specific NGO would fall within the concept of Healthcare Organisation provided in the Code, taking into account aspects such as its characteristics, members, statutes, goals and corporate purpose, etc.
As for the nature of the donation, accounting principles applicable in general to this type of collaborations or aids shall be taken into account.
At any rate, the pharmaceutical company shall provide detailed information regarding treatment of this kind of Transfers of Value in the methodological note described in article 18.6 of the Code.
110. Is it possible to provide or register Healthcare Professionals to educational courses on scientific subjects? If so, in what section would these educational costs be disclosed according to article 18?
It is possible. This would be disclosed under the category "contribution to educational and scientific meetings", in the "registration fees" section.
111. There are sponsorship agreements with Healthcare Organisations that are not directly related to the category of the Disclosure Template (Annex II): contribution to educational and scientific meetings, such as sponsorship of the Healthcare Organisations’ website, where, in exchange for a price, the institutional logotype of the sponsoring pharmaceutical company is included. In which section of the Template should Transfers of Value related to such sponsorships be disclosed?
This type of collaborations/sponsorships is not regarded as contributions to educational and scientific meetings.
Notwithstanding the above, due to the inherent educational nature of Healthcare Organisations’ websites, we understand that Transfers of Value related to this type of collaborations/sponsorships should be disclosed by pharmaceutical companies under the category contribution to educational and scientific meetings in section: "sponsorship agreements with HCOs/third parties appointed by HCOs to manage a meeting".
At any rate, the pharmaceutical company shall provide detailed information regarding treatment of this kind of Transfers of Value in the methodological note described in article 18.6 of the Code.
112. Are Transfers of Value derived from medicine assessment studies regarded as falling within the definition of Research and Development?
Pharmaceutical companies themselves shall determine, on a case by case basis, whether the Transfers of Value derived from medicine assessment studies would fall within the definition of Research and Development provided in the Code.
At any rate, the pharmaceutical company shall provide detailed information regarding treatment of this kind of Transfers of Value in the methodological note described in article 18.6 of the Code.
113. Are the Health Councils of the autonomous communities included in the definition of "Healthcare Organisations"?
Yes, due to the competences they have been assigned by applicable regulations.
114. Will Transfers of Value included in the aggregated category for R&D be detailed? (Fees, clinical research meetings, collaborations with studies driven by researchers or cooperative groups, CROs).
Just as specified in the Disclosure Template, the Transfers of Value related to Research and Development will be published on an aggregate basis.
However, the pharmaceutical company must be in possession of the itemisation of the Transfers of Value included in this category.
115. Should Transfers of Value made by pharmaceutical companies to third entities that – not falling within the definition of Healthcare Organisations – organise, manage, etc., on behalf of or representing a Healthcare Organisation, activities described in article 18.3.1 of the Code be disclosed? "For example: Transfers of Value made to a technical secretariat hired for the management of an educational activity".
Yes. These should be regarded as "indirect" Transfers of Value to Healthcare Organisations. In compliance with provisions of article 18.3 of the Code, pharmaceutical companies shall disclose them, in all cases, on an individual basis.
116. What information shall pharmaceutical companies provide to Healthcare Professionals, whose data are to be published, in order to comply with the Organic Law 3/2018, of 5th December, for Personal Data Protection and Guarantee of Digital Rights?
Before carrying out any activity or practice that implies a Transfer of Value to Healthcare Professionals, the pharmaceutical company should inform those HCPs, that their data will be published in accordance with the transparency obligations and following the rules, stated in article 18 of the Code, in an expressly, accurately, and unequivocally manner.
When informing those Healthcare Professionals whose data will be disclosed, pharmaceutical companies should expressly mention that its publication is based on the following principles:
- Appropriateness and relevance: the data to be published are the minimum and strictly needed for the purposes for which they have been collected.
- Purpose-oriented character: the use of that data is exclusively limited to comply with the Code transparency purposes and obligations.
- Accuracy: when collected, the information was accurate and responds to a truthful situation.
Standard provisions are available for pharmaceutical companies, in order to help them to comply with the obligation to inform Healthcare Professionals.
Moreover, the information provided should include the possibility of exercising the data protection rights as established in articles 15 and following of Regulation 2016/679, of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data.
117. How are data protection rights exercised by Healthcare Professionals?
Healthcare Professionals may freely exercise their data protection rights as detailed in articles 15 to 22 of the General Data Protection Regulation. Briefly, these rights include: Access (find the data you have the pharmaceutical company and which are to be published), Rectification (correct mistakes materials), Suppression (block data processing in accordance with the provisions of the Law), Limitation (to challenge the processing of data as it is considered excessive for the purposes pursued), Portability (to request an electronic copy of personal data), and Opposition (to object to the processing of personal data).
In reference to the Opposition right, it should be noted that, as stated in Spanish Data Protection Agency (AEPD) Report, of 22 April (Annex I of the Code), if a Healthcare Professional exercising this right justifies to the pharmaceutical company the existence of serious and legitimate grounds relating to a specific personal situation determining that, the reversal of the rule of balancing should apply, not prevailing the transparency legitimate interest that covers its publication, the company shall exclude that Healthcare Professional data and disclose it, exceptionally, on an aggregate basis.
118. Are travel agencies, technical secretaries, service providers, covered by Healthcare Organisation definition?
The Code defines Healthcare Organisation as: “any legal body or entity (i) that is a medical or scientific organisation, healthcare institution (of any legal status or organisation), such as hospitals, clinics, foundations, universities and other academic entities, scientific societies (excluding Patient Organisations covered by article 17 of this Code), or (ii) through which one or more Healthcare Professionals provide services”. Notwithstanding the above mentioned definition, it seems reasonable to consider Healthcare Organisations as those entities that mainly have, corporate purposes, aims and activities, among others, the provision of healthcare assistance, healthcare research, continuous medical education, etc. Where there is any doubt, pharmaceutical companies are recommended to review the bylaws of those entities which they interact with.
Sometimes Healthcare Organisations and pharmaceutical companies, hire third entities (service providers), for carrying out and manage their activities. The mere fact of providing those services does not automatically turns into or grants those entities the status of Healthcare Organisations. In these cases, pharmaceutical companies are recommended to request those entities, to identify the Healthcare Organisation to which they provide their services (for example through invoices, contracts, collaboration or sponsorship agreements, etc).
119. A group of physicians, with the collaboration of an entity specialised in meetings organisation and management, acting as "technical secretary", organised a scientific-professional meeting. Could pharmaceutical companies collaborate/sponsor that meeting? Will the answer be different, if that meeting counts with a continuing medical education credit recognition certificate?
Pharmaceutical companies could only collaborate or sponsor with that meeting, if a Healthcare Organisation in charge of its organisation or management exists. Transfers of Value made, directly or indirectly, for such collaboration or sponsorship will be disclosed, on an individual basis, to the Healthcare Organisation or to the Healthcare Professional in accordance with article 18 of the Code.
Pharmaceutical companies’ collaboration or sponsorship, with these kinds of activities depends, in any case, on the existence of a Healthcare Organisation.
Finally, pharmaceutical companies are recommended to review the Code´s definition of Healthcare Organisation, including also the previous question related with third entities/providers, and question nº 102 of Annex V of the Code.
120. How should pharmaceutical companies disclose those Transfers of Value made through subsidiaries, foundations, or group companies?
Previously, it is appropriate to clarify that, pharmaceutical companies including their subsidiaries, foundations, and any other legal entity that belongs to the Group of Companies, are expressly excluded from Healthcare Organisation definition.
Pharmaceutical companies could decide to which entity they assign the Transfers of Value made to those Healthcare Professionals or Healthcare Organisations, practicing or with a registered office in Spain. Each entity will individually publish that information using the Disclosure Template (Annex II of the Code).
In any case, and regardless its publication in the name of different legal entities, the pharmaceutical company must guarantee that, the information related to the Transfers of Value made to those Healthcare Professionals or Healthcare Organisations, practicing or with registered office in Spain, is accessible through one single website.
121. The pharmaceutical company´s OTC division, supports a Healthcare Professional attendance to a scientific meeting, paying for his/her registration fee, travel and accommodation. Shall the pharmaceutical company disclose that Transfers of Value?
Section 18.1 of the Code establishes that Transfers of Value related to products or medicines that are not prescription-only medicines, do not fall within the scope of the disclosure obligation described herein.
In any case, each pharmaceutical company should assess if a Transfer of Value, although is formally paid by a non-prescription medicines business unit/division, could in any manner be linked with prescription-only medicines and if it, hence considers, that disclosures applies.
Nevertheless it is important, not to use this mechanism or procedure; as a way to avoid transparency obligations, and also that a pharmaceutical company, when deciding if disclosure applies, takes into consideration the Healthcare Professional receiving the Transfer of Value.
At any rate, the pharmaceutical company shall provide detailed information regarding treatment of this kind of Transfers of Value in the methodological note described in article 18.6 of the Code.
122. Should in kind Transfers of Value, that do not "a priori" imply a direct cost for a pharmaceutical company, be disclosed? For example: collaborations based on pharmaceutical company assignation of resources or employees to provide a service, for a Healthcare Professional or Healthcare Organisation, benefit?
In principle these collaborations should be disclosed. In the methodological note, each pharmaceutical company shall explain those collaborations, and also the criteria used to determine their value.
123. Should Transfers of Value, derived from the collaboration agreements between pharmaceutical companies and governmental public institutions or healthcare providers, be disclosed?
Pharmaceutical companies must disclose the Transfers of Value derived from collaboration agreements with any kind of "healthcare entities or institutions", regardless if those have healthcare assistance nature or character.
In this regard, the criteria stated in question nº 113 Annex V of the Code, should be considered.
124. The information to be disclosed under the "scientific and professional meetings" category, according to the Disclosure Template (Annex II of the Code), exclusively applies to meetings organised by third parties?
No, it applies for both, meetings organised by third parties and also for meetings organised or mainly sponsored by one pharmaceutical company.
Under such a category, and broken down accordingly to each corresponding item (collaboration/sponsorship agreements, registration fees, travel & accommodation), pharmaceutical companies must disclose the Transfers of Value related with meetings.
The Code defines meeting as: "any promotional meeting, scientific-professional meeting, congress, conference, symposium, in-person or distance educational courses, or any other type of similar activity (including but not limited to expert meetings, visits to manufacturing and research facilities, as well as training meetings for investigators conducting clinical trials and observational studies with medicinal products) organised or sponsored by a pharmaceutical company or under its control".
125. For hiring a commercial stand, at a national scientific society congress (10.000€), the pharmaceutical company receives 10 individual registrations, free of charge. According to the published congress official dossier price list, the registration fee per person costs 300€.
Is there any practical guidance or criteria that pharmaceutical companies could follow, when disclosing these "special benefits or free of charge Transfers of Value", obtained from their collaboration or sponsorship with the Healthcare Organisation meeting?
As a general practical criterion, pharmaceutical companies should bear in mind that the "free for charge" concept does not exist. Hence it is recommended to calculate the value of the benefit received, in order to be able to subtract that amount, from the pharmaceutical company global collaboration in that activity.
Having said that, two scenarios could exist:
Scenario 1: the pharmaceutical company does not know the identity of those Healthcare Professionals benefiting from those free for charge registration and the conditions set forth in query nº 126 are met:
Assign to the name of the Healthcare Organisation it will disclose the following information: 7.000€ under "Sponsorship agreements with HCOs / third parties appointed by HCOs to manage a meeting" concept and 3.000€ under "Registration fees" concept.
Assign to the name of the Healthcare Professional, no information shall be disclosed.
Scenario 2: the pharmaceutical company knows the identity of those Healthcare Professionals benefitting from those free for charge registration:
Assign to the name of the Healthcare Organisation it will disclose the following information: 7.000€ under "Sponsorship agreements with HCOs / third parties appointed by HCOs to manage a meeting" concept. Assign to the name of each Healthcare Professional it will disclose, on an individual basis, 300€ under "Registration fees" concept.
In the methodological note, detailed in article 18.6 of the Code, the pharmaceutical company shall provide more information with regard to this kind of Transfers of Value registration.
126. Is there any circumstance in which collaboration provided by a pharmaceutical company to Healthcare Organisations for attendance by Healthcare Professionals at scientific-professional meetings does not need to be published individually, identifying the Healthcare Professional?
Prior to any possible collaboration, each pharmaceutical company will be responsible for verifying that the meeting and all elements connected with it are consistent with the Code of Good Practice for the Pharmaceutical Industry and comply with the requirements set out regarding "Scientific and professional meetings" (article 11, supplementary rules, queries, circulars, etc.).
The Code of Good Practice for the Pharmaceutical Industry establishes as a general principle the obligation to publish individually all Transfers of Value made directly or through third parties to Healthcare Professionals. As a result, and in accordance with this principle, article 18.1 of the Code establishes that to the extent legally possible, and so long as they can be provided accurately and consistently, pharmaceutical companies will need to publish Transfers of Value made to Healthcare Organisations on an individual basis, identifying the Healthcare Professional (rather than the Healthcare Organisation).
With regard to the circumstance raised in the consultation, the understanding is that it would not be possible to provide such information accurately and consistently if the identity of the Healthcare Professionals benefiting from the collaboration with the pharmaceutical company cannot be ascertained before, during or after the meeting is held.
In order for this circumstance genuinely to exist, in the collaboration provided by a pharmaceutical company to Healthcare Organisations for attendance by Healthcare Professionals at scientific-professional meetings, all the following conditions must be fulfilled:
(i) The meeting must have various sponsors (at least 2) not belonging to the same Corporate Group, and as a result no individual link may be established between the sponsoring pharmaceutical company and the Healthcare Professional. In any event, sponsorship by each pharmaceutical company (including companies belonging to their group) must not represent a majority.
(ii) Pharmaceutical companies wishing to collaborate with Healthcare Organisations offering the possibility of sponsoring Healthcare Professional educational support plans, on the terms defined in this consultation, will first need to ascertain that at least two months prior to the starting date thereof the following information is publicly available:
- Total approximate budget to be assigned to the training support plan, and the number of beneficiaries.
- Minimum number of sponsors required, at least two.
- Conditions for sponsorship. Maximum limit on participation by one single sponsor, which must be no greater than 50%.
- Public and objective procedure detailing:
a) Requirements and deadlines to request and obtain training/educational support.
b) Type, scope, concepts and amount of the support offered.
c) Assignment criteria, separate and independent from the sponsors.
d) Commitment and obligation to publish the beneficiaries within two months of the end of each activity, and to keep this information publicly available for a minimum period of 3 years.
e) Commitment and obligation to identify the sponsors of the support plan.
- Declaration of the party responsible for the training/educational support plan, with a commitment to comply with the terms of this consultation.
(iii) Pharmaceutical companies must include in the sponsorship agreement with the Healthcare Organisation all the safeguards needed to comply with the aforementioned conditions, and to guarantee that the collaboration provided is assigned to activities consistent with the Code of Good Practice.
If all the conditions detailed above are fulfilled, the collaboration provided by the pharmaceutical company in accordance with the terms of article 18.3.1(b) will be published in the name of the Healthcare Organisation.
Pharmaceutical companies will be responsible for verifying compliance with the terms of this consultation. In the event of a breach or non-compliance regarding any of the conditions detailed above by the Healthcare Organisation concerned, pharmaceutical companies must, without prejudice to the measures adopted to rectify said situation:
- explicitly call on the Healthcare Organisation to comply with the obligations assumed, and
- report this situation to the Code of Practice Surveillance Unit.
The Unit will report any incident derived from compliance and application of this consultation to the Governing Bodies of Farmaindustria, in order for them to adopt any measures they might deem appropriate, as applicable.
127. In relation to the publication of transfers of value, specifically with regard to Article 18.6 Methodology, of the Code of Practice for the Pharmaceutical Industry, is there a model or template that companies should use to summarise the methodology used, and explain the information provided and how it is obtained and classified?
To reinforce the transparency initiative approved by the pharmaceutical industry in 2014 and to make it more consistent, EFPIA has recently approved a methodological note model/template to be used by companies, at the latest, for the disclosure of transfers of value made in 2025.
The methodological note is usually made for a specific country; if this is the case, companies should specify the country concerned. In addition to the methodological note in the local language, it is recommended to have an English version.
The methodological note should have the following structure and content:
Definitions
- Recipients (Type of recipients included – If needed, include the definition of Healthcare Professional at national level – Treatment of retired and deceased HCPs)
- Kind of ToVs (donations and grants – contribution to costs of events – fees for services and consultancy – R&D – others)
Disclosure’s scope
- Products concerned (Type of products included in the disclosure report: Prescribed Only Medicines, Over the Counter Medicines, others)
- Company concerned (affiliate – merger – company rebrand)
- Excluded Transfers of Value
- Transfers of Value date
- Direct Transfers of Value
- Indirect Transfers of Value
- Non-monetary Transfers of Value
- Transfers of Value in case of partial attendances or cancellation and refund
- Cross-border activities
- R&D
- Voluntary disclosure (anything discloses beyond the national Code)
Specific considerations
- Country unique identifier (if needed, specify which identifier is used and for which purpose)
- Self-incorporated HCP (depending on the local legislation, qualified as individual or company)
- Multi-year agreements
- Country specificities
- Quality Checks (optional for pre-disclosure)
Data protection legal basis
- Consent collection (inc. consent withdrawal)
o Partial consent
- Legitimate interest (inc. balancing test, right to object)
Form of Disclosure
- Date of publication
- Disclosure platform
- Disclosure language
Disclosure financial data
- Currency (local or if not, specify the exchange rate)
- VAT included or exclude
- Calculation rules (e.g., in-kind ToVs)
Additional information