Title I - PROVISIONS OF THE CODE
CHAPTER IV - Transparency of the Pharmaceutical Industry´s Relationships
18. TRANSPARENCY OF THE PHARMACEUTICAL INDUSTRY’S RELATIONSHIPS
Interaction with Healthcare Professionals and Organisations
Healthcare Professionals provide expert knowledge and an independent point of view derived from their clinical and professional experience and they share it with the pharmaceutical industry and other Healthcare Professionals in order to promote improvement in patient care. These services are fundamentally important to the industry and help to design and give form to the activities that the industry performs.
In order to increase confidence in the pharmaceutical industry, the industry has decided to publicly disclose the nature and level of said relationships.
18.1. Disclosure obligation on an individual basis
Companies subject to the Code as established in articles 19.1 and 19.3 must document and disclose payments and Transfers of Value detailed in this article (hereinafter "Transfers of Value") that they make, either directly or indirectly, to or for the benefit of the Recipients.
In the case of Healthcare Professionals, in accordance with Directive 95/46/EC article 7f), on the protection of individuals with regard to the processing of personal data and on the free movement of such data, there is a legitimate interest for the companies subject to the Code, recognized by the report issued by the SDPA, of 22 April 2016 (Code Annex I), so that the Healthcare Professionals´ consent is not necessary for the disclosure, on an individual basis, the Transfers of Value made to Healthcare Professionals. In any case, pharmaceutical companies will inform Healthcare Professionals, under Organic Law 3/2018, of 5 December, for Personal Data Protection and Guarantee of Digital Rights, that their data will be disclosed in accordance with the Code.
As far as Healthcare Organisations are concerned, the Transfers of Value made by pharmaceutical companies will be disclosed, in any case, on an individual basis.
Pharmaceutical companies must disclose this information on an individual basis, identifying the Healthcare Professional (instead of the Healthcare Organisation) whenever legally possible and whenever this can be provided with precision and consistency.
Transfers of Value (i) associated with activities not detailed in Annex II of the Code, such as, the provision of: materials regulated in article 10 Guarantees of Independence, samples regulated in Article 13 Medical Samples, hospitality associated with dinners or luncheons regulated in Article 11 Scientific and Professional Meetings; (ii) that form part of commercial transactions between pharmaceutical companies and distributors, pharmacy offices and Healthcare Organisations and (iii) those related to products or medicines that are not prescription-only medicines; do not fall within the scope of the disclosure obligation described herein.
18.2. Form of Disclosure
Pharmaceutical companies must have a specific internal procedure that guarantees compliance with the obligations of transparency indicated in article 18.
Within the established disclosure period — within 6 months after the end of the relevant reporting period — pharmaceutical companies will disclose the information on each reporting period on an annual basis. Within the first semester of each year, FARMAINDUSTRIA´ Board of Directors may establish specific dates for publication. Reporting period is defined as a full calendar year. The year 2015 is the first reporting period to be published.
The information disclosed shall be required to remain in the public domain for a minimum of 3 years after the time such information is first disclosed, unless, a shorter period is required under applicable national law or regulation.
The information will be disclosed openly on the company’s web page in accordance with the template provided in Annex II. Modification of this template must be approved the Farmaindustria Board of Directors.
Following the measures proposed in the report issued by the SDPA, of 22 April 2016 (Code Annex I), pharmaceutical companies must adapt their web sites, with the aim of avoiding further processing of this data in a manner which is not relevant or excessive for the purpose that justifies it. Specifically, companies must applied protocols preventing its indexation through search engines. Likewise, it would be relevant that the website clearly states the purpose of the publication, and that the publication does not grant a general permission for those accessing the website to undertake additional processing of the Healthcare Professionals´ data, such as crossing the data with information published in other companies’ websites.
In order to reinforce compliance with the transparency obligations, companies will provide the information to the Code of Practice Surveillance Unit on an annual basis.
Disclosure shall be made pursuant to the national code of the country where the Recipient carries out their professional activity or has its legal address. If a company is not resident or does not have a subsidiary or an affiliate in that country, the company shall disclose such Transfers of Value in a manner consistent with the national code to which it is subject.
Disclosure shall be made in Spanish. In addition, companies are encouraged to make disclosures in English.
Companies shall document all Transfers of Value required to be disclosed pursuant to this article and maintain the relevant records of the disclosures made under this Code for a minimum period of 5 years after the end of the relevant reporting period, unless a shorter period is required under applicable national laws or regulations.
18.3. Individual Disclosure
Transfers of Value shall be disclosed on an individual basis, except for those covered by section 18.5. The companies shall disclose, on an individual basis for each clearly identifiable Recipient, the amounts attributable to Transfers of Value to such Recipient in each reporting period which can be reasonably allocated to one of the categories set out below. Such Transfers of Value, disclosed on an individual basis, must be aggregated on a category-by-category basis, provided that itemised disclosure shall be made available upon request to (i) the relevant Recipient, and/or (ii) the relevant authorities.
18.3.1. Transfers of Value to Healthcare Organisations
Amounts related to any of the categories set forth below:
a) Donations. Donations and grants to Healthcare Organisations that support healthcare, including donations and grants (either in cash or benefits in kind) to institutions, organisations or associations that are comprised of Healthcare Professionals and/or that provide social or humanitarian healthcare services, research services, teaching or education (governed by article 15 of the Code).
b) Contribution to Costs Related to meetings. Contribution to costs related to meetings, through Healthcare Organisations or third parties, (including sponsorship to Healthcare Professionals to attend meetings), such as:
i) registration fees;
ii) sponsorship agreements with Healthcare Organisations or with third parties appointed by a Healthcare Organisation to manage the meeting; and
iii) travel and accommodation (governed by article 11 of the Code).
c) Fees for Service. Transfers of Value resulting from or related to contracts between pharmaceutical companies and institutions, organisations or associations of Healthcare Professionals under which such institutions, organisations or associations provide any type of services to a company or any other type of funding not covered in the previous categories. Fees, on the one hand, and on the other hand Transfers of Value relating to expenses agreed in the written agreement covering the activity will be disclosed as two separate amounts.
18.3.2. Transfers of Value to Healthcare Professionals
Amounts related to any of the categories set forth below:
a) Contribution to Costs Related to meetings. Contribution to costs related to meetings, such as:
(i) registration fees; and
(ii) travel and accommodation (governed by article 11 of the Code).
b) Fees for Service. Transfers of Value resulting from or related to contracts between pharmaceutical companies and Healthcare Professionals under which such Healthcare Professionals provide any type of services to a company or any other type of funding not covered in the previous categories. Fees, on the one hand, and on the other hand Transfers of Value relating to expenses agreed in the written agreement covering the activity will be disclosed as two separate amounts.
18.4. Non Duplication
Where a Transfer of Value required to be disclosed pursuant to section 18.3 is made to an individual Healthcare Professional indirectly via a Healthcare Organisation, such Transfer of Value shall only be disclosed once. Such disclosure shall be made complying with section 18.1 and 18.3 of this Code.
18.5. Research and Development Transfers of Value
Research and Development Transfers of Value in each reporting period shall be disclosed by each company on an aggregate basis. Costs related to meetings that are clearly related to activities covered in this section can be included in the aggregate amount under the "Research and Development Transfers of Value" category.
As an exception to the terms set out in the above paragraph, Transfers of Value made to Healthcare Organisations and to Healthcare Professionals related to observational studies with medicinal products that are retrospective nature, which are nonetheless considered as Research and Development, must be published on an individual basis by pharmaceutical companies under the category "provision of services".
18.6. Methodology
Each company shall publish a note summarising the methodologies used by it in preparing the disclosures and identifying Transfers of Value for each category. The note shall describe the recognition methodologies applied and should include the treatment of multi-year contracts, VAT and other tax aspects, currency aspects and other issues related to the timing and amount of Transfers of Value for purposes of this Code, as applicable.
Relationships with Patient Organisations
18.7. Collaborations.
Each company must make publicly available a list of those Patient Organisations to which it provides financial support and/or significant indirect/non-financial support. This should include a description of the nature of the support that is sufficiently complete to enable the average reader to form an understanding of the significance of the support. The description must include the monetary value of financial support and of invoiced costs. For significant nonfinancial support that cannot be assigned a meaningful monetary value the description must describe clearly the non-monetary benefit that the Patient Organisation receives. This information may be provided on a national or European level and should be updated at least once a year.
This information must be published during the first semester of each year including the activities that were carried out the previous year.
Companies must ensure that their sponsorship is always clearly acknowledged and apparent from the outset.
Services. Each company must make publicly available a list of Patient Organisations that it has engaged to provide contracted services. This should include a description of the nature of the services that is sufficiently complete to enable the average reader to form an understanding of the nature of the arrangement without the necessity to divulge confidential information. Companies must publish annually the total amount paid to each Patient Organisation for the provision of these services annually.
This information must be published during the first semester of each year including the activities that were carried out the previous year.
Listado inicial
lisini
18.1. Disclosure obligation on an individual basis. Pharmaceutical companies shall disclose Transfers of Value derived from Market Research Studies only when they know the identity of the Professional or Healthcare Organisation that participates in the study. These will be published as if they were fees for services.
18.2. Form of Disclosure - 18.7. Collaborations. Pharmaceutical companies will provide the Code of Practice Surveillance Unit with the link to their website where this information is published, as soon as it is available. FARMAINDUSTRIA will provide these links operating as a “gateway” to individual companies websites via the Self-Regulation System website (www.codigofarmaindustria.org).
Lisfin
ListadoFIn