Title I - PROVISIONS OF THE CODE
CHAPTER III - Relationships with Patients Organizations
17. RELATIONSHIPS WITH PATIENTS ORGANISATIONS
17.1. The pharmaceutical industry recognizes that it has many interests in common with Patient Organizations that advocate for and/or support the needs of patients and/or caregivers.
In order to ensure that the relationships between the pharmaceutical industry and Patient Organizations are conducted in an ethical and transparent manner, EFPIA adopted the EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organizations.
The principles, agreed jointly between EFPIA and the Pan-European Patient Organizations, on which this Code is based are:
1. The independence of Patient Organizations, in terms of their political judgement, policies and activities, shall be assured.
2. All partnerships between Patient Organizations and the pharmaceutical industry shall be based on mutual respect, with the views and decisions of each partner having equal value.
3. The pharmaceutical industry shall not request, nor shall Patient Organizations undertake, the promotion of a particular prescription-only medicine.
4. The objectives and scope of any partnership shall be transparent. Financial and nonfinancial support provided by the pharmaceutical industry shall always be clearly acknowledged.
5. The pharmaceutical industry welcomes broad funding of Patient Organizations from multiple sources.
Compliance with these principles ensures the respect and commitment of the pharmaceutical industry, both with the Patient Organizations – which are necessarily called on to become groups with greater social and institutional recognition – as well as with the rational use of medicines.
In light of the need to establish a collection of rules that govern the relationships between the pharmaceutical industry and Patient Organizations, since 2008 Farmaindustria has adopted the EFPIA rules at all times, the contents of which are explained below.
It covers all forms of relationships between pharmaceutical companies and Patient Organizations. The objective is not to prohibit or limit the relationship between pharmaceutical companies and Patient Organizations, but instead to establish rules of conduct that the entire pharmaceutical industry undertakes to comply with.
17.3. Promotion of Medicines
European and national laws are applicable as is this Code (article 7.1), which prohibits promotion of prescription-only medicines directed to the general public (except with the prior authorization of the competent health authority, where applicable, for example, during vaccination campaigns).
Collaboration between pharmaceutical companies and Patient Organizations must be documented in writing, describing at least: the activities to be carried out, the level and sources of funding, the purpose of said funding, relevant indirect support (e.g. services provided free of charge by public relations agencies) and any other type of non-financial collaboration that is relevant.
Pharmaceutical companies will establish a procedure for approving these types of collaborations prior to conducting them.
17.5. Registered Logos and Materials
The use of any logo, brand, identifying mark, registered material, etc., that is property of a Patient Organization will require prior consent. Any pharmaceutical company that requests said authorization must clearly indicate the specific purpose and manner in which said material will be used.
17.6. When pharmaceutical companies sponsor a material or publication from a Patient Organization, they will not intend to influence the content in favor of the company’s own commercial interests. This does not prevent the possibility of correcting eventual inaccuracies or material errors.
17.7. Companies will refrain from requesting to be exclusive sponsors of a Patient Organization or any of their principal activities.
Agreements with Patient Organizations for providing any type of service to a pharmaceutical company will only be permitted if said services are provided for the purpose of collaborating with healthcare and/ or research.
Contracting of Patient Organizations is permitted for providing advisory or consultation services such as communications at meetings as a speaker or moderator, expert meetings, etc. The agreements that cover the legitimate provision of services of this type must meet the following conditions:
a) the existence prior to providing these services of a written contract that specifies, at the least, the nature of the services to be provided and, in compliance with letter (g) below, the criteria that form the basis for calculating the remuneration for their provision;
b) clear identification, prior to requesting these types of services and signing any type of agreement, of the legitimate need for these services;
c) the criteria used to select the consultants are directly related to the identified need and the person responsible for their selection has the necessary expertise to evaluate whether the chosen consultants meet these requirements;
d) the number of consultants contracted does not exceed the number that would be reasonably necessary to achieve the planned objective;
e) the contracting company must maintain documentary support of the services provided by the consultants and employ these services for the planned use;
f) the contracting of Patient Organizations for the provision of these types of services does not constitute an inducement to recommend a specific medicine;
g) the remuneration for providing these services must follow market criteria and be in accordance with the time spent, the work performed and the responsibilities assumed. In addition, it must be appropriately formalized;
h) the remuneration must be monetary. In exceptional cases and with the prior authorization of the Code of Practice Surveillance Unit, the remuneration may be provided in kind;
i) they are approved, prior to contracting, by the pharmaceutical company’s Compliance Officer;
j) in these contracts, it is recommended that the pharmaceutical companies include a clause in which the Patient Organization commits to declare that he/she provides services or consultation to the company every time he/she writes or makes public statements regarding any topic related to his/her agreement or to the company;
k) each company will make public the list of Patient Organizations with which they have agreements for the provision of services, in compliance with article 18.7.
17.8. Events directly or indirectly sponsored or organized by a company must be held at a location that is appropriate in relation to the primary purpose of the event, avoiding sites that are known for their entertainment facilities or those that are extravagant or inappropriate.
Any form of hospitality provided by the pharmaceutical industry to Patient Organizations and their members will be reasonable and of a nature that is secondary to the purpose of the event, disregarding whether it is organized by the Patient Organization or by the company.
The hospitality provided for events will be limited to travel, accommodation and subsistence expenses and registration fees. Companies may only defray or finance these expenses through the Patient Organization and never directly to individual patients. Hospitality will only be extended to attendees. However, for health reasons (for example, disability), they may defray expenses for travel, accommodation, subsistence and registration of accompanying persons who attend in the role of caregivers.
Hospitality will not include the sponsorship or organization of recreational and/or entertainment activities (cultural, sports, etc.).
Companies may not organize or sponsor events that take place outside of Spain unless:
a) the majority of invited participants are from a foreign country; or
b) a resource or relevant expertise that is the primary object of the event is located in a foreign country.
This assumption (b) must receive the prior authorization of the Code of Practice Surveillance Unit.
Pharmaceutical companies incorporated in Spain that belong to business groups with headquarters or subsidiaries or, in general, associated companies located in foreign countries will be responsible for compliance with this Code by these affiliated companies for all activities related to promotion or interaction with Patient Organizations that perform their activities in Spain, whether they are invited to a foreign country or to other events that take place within Spain.
In general, the standards of hospitality established in article 11 of the Code must not be exceeded.
17.2. Activities conducted, organized or sponsored by a pharmaceutical company, or under its control – subsidiaries, foundations, associations, institutes, agencies, third-party providers, etc., from which direct or indirect collaboration, support and/or compensation to Patient Organizations will be considered forms of relationships subject to the precepts of this Code.
17.4. When support provided by the company to the Patient Organization is economic, or of any other type (in kind, etc.), and is significant, a written agreement must be formalized clearly establishing the nature and scope of the collaboration.
The following model can be used in its entirety or adapted in an appropriate manner, with the key points of a written agreement:
- Title of the activity.
- Names of the entities (pharmaceutical company, Patient Organization and, where applicable, collaborating third parties included by mutual agreement between the parties).
- Type of activity. Specify whether the agreement refers to grants or donations of a general nature for activities, specific meetings, sponsorships, brochures, campaign information, training programs, etc.
- Role to be played by each of the par ties of the agreement.
- Duration of the agreement.
- Financial suppor t provided (in Euro).
- Description of any other type of significant non-financial support (example: resources made available for free, free educational courses, etc.).
- The parties agree to conduct this collaboration publicly and transparently.