Title I - PROVISIONS OF THE CODE
CHAPTER III - Relationships with Patients Organisations
17. RELATIONSHIPS WITH PATIENTS ORGANISATIONS
17.1. The pharmaceutical industry recognises that it has many interests in common with Patient Organisations that advocate for and/or support the needs of patients and/or caregivers.
In order to ensure that these relationships between the pharmaceutical industry and Patient Organisations are conducted in an ethical and transparent manner, a series of principles at European level were established. Those principles jointly agreed between EFPIA and the Pan-European Patient Organisations, on which the basic rules that should guide pharmaceutical companies are:
1. Independence: The independence of Patient Organisations, in terms of their political judgement, policies and activities, shall be assured.
2. Mutual respect: All partnerships between Patient Organisations and the pharmaceutical industry shall be based on mutual respect, with the views and decisions of each partner having equal value.
3. Non-promotion: The pharmaceutical industry shall not request, nor shall Patient Organisations undertake, the promotion of a particular prescription-only medicine.
4. Transparency: 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. Multiple sponsorship: The pharmaceutical industry welcomes broad funding of Patient Organisations from multiple sources.
Compliance with these principles ensures the respect and commitment of the pharmaceutical industry, both with the Patient Organisations – 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 Organisations, since 2008 Farmaindustria has adopted the EFPIA rules at all times, the contents of which are explained below.
17.2. Scope
It covers all forms of relationships between pharmaceutical companies and Patient Organisations. The objective is not to prohibit or limit the relationship between pharmaceutical companies and Patient Organisations, 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).
17.4. Agreements
Collaboration between pharmaceutical companies and Patient Organisations 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 Organisation 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. Materials or publications
When pharmaceutical companies sponsor a material or publication from a Patient Organisation, 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. Sponsorships and service contracting
Companies will refrain from requesting to be exclusive collaborator/sponsors of a Patient Organisation or any of their principal activities.
Agreements with Patient Organisations 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 Organisations 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 Organisations for the provision of these types of services does not constitute an inducement to recommend a specific medicine;
g) the engagement of a Patient Organisation by a pharmaceutical company must not in any way be linked or related to their participation in a promotional act for a medicine;
h) 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 formalised;
i) 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;
j) they are approved, prior to contracting, by the pharmaceutical company’s Compliance Officer;
k) in these contracts, it is recommended that the pharmaceutical companies include a clause in which the Patient Organisation commits to declare that he/she provides services or consultation to the pharmaceutical company every time he/she writes or makes public statements regarding any topic related to his/her agreement or to the company. In addition, the recommendation is that contracts should be drawn up in clear, comprehensible language;
l) each pharmaceutical company will make public the list of Patient Organisations with which they have agreements for the provision of services, in compliance with article 18.7. Furthermore, companies shall promote the transparency of their collaborations on the part of Patient Organisations;
m) the engagement of patients must be arranged through Patient Organisations;
17.8. Meetings and Hospitality
Meetings directly or indirectly sponsored or organised by a company must be held at a location that is appropriate in relation to the primary purpose of the meeting, 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 Organisations and their members will be reasonable and of a nature that is secondary to the purpose of the meeting, disregarding whether it is organised by the Patient Organisation or by the pharmaceutical company.
The hospitality provided for meetings will be limited to travel, accommodation and subsistence expenses and registration fees. Companies may only defray or finance these expenses through the Patient Organisation 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 organisation of recreational and/or entertainment activities (cultural, sports, etc.). Organising or collaborating in meetings that contain elements of entertainment or entertainment activities or are of a recreational nature is prohibited The welcome cocktail, working luncheons and gala dinners that normally occur within official programs at conferences and meetings are not included in this prohibition provided they are reasonable and moderate and do not include additional elements (cultural, leisure or entertainment, etc.). In all cases, a maximum cost of 70 Euro (including taxes) per guest applies for any form of hospitality associated with meals. Payment for a meal that costs more than the maximum threshold mentioned above will be considered a breach of the Code. For meetings that take place outside of Spain, the maximum threshold established by the National Association of the country where the meeting occurs will apply. Therefore, for hospitality offered outside of Spain involving meals, the general rule provided for in article 19.4 (“If there is a conflict between rules of the different applicable codes for a given activity, the most strict or restrictive rule will apply”) will not be applicable.
At meetings conducted in virtual or remote format, no type of hospitality should be offered (social events, accommodation, travel and/or personal/subsistence/pocket expenses). This general principle applies both to meetings organised or mainly sponsored by a pharmaceutical company, and to meetings organised by third parties.
In no case may money be offered to compensate merely for the time spent by patients in attending the meeting.
Companies may not organise or sponsor meetings 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 meeting 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 Organisations that perform their activities in Spain, whether they are invited to a foreign country or to other meetings that take place within Spain.
In general, the standards of hospitality established in article 11 of the Code must not be exceeded.
17.9 Prohibition of gifts
Gifts for personal benefit (such as sporting or entertainment tickets, social courtesy gifts) must not be given to patients or representatives of Patient Organisations.
Providing or offering, either directly or indirectly, gifts, monetary or in kind gifts, and/or personal services are also prohibited. For these purposes, personal services are any type of service that confer a personal benefit to the recipient.
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17.2. Scope. Activities conducted, organised 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 Organisations will be considered forms of relationships subject to the precepts of this Code.
17.4. Agreements. When support provided by the company to the Patient Organisation is economic, or of any other type (in kind, etc.), and is significant, a written agreement must be formalised 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 Organisation 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.
- Objectives.
- Role to be played by each of the par ties of the agreement.
- Duration of the agreement.
- Financial support 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.
- Signatories.
- Date.
17.6 Materials or publications. Irrespective of the format used (printed, digital, etc.), the contents of such materials or publications may be connected with patient health, specific diseases, hygiene-healthcare measures or healthy lifestyles. Such materials must serve to help patients better understand the course of their diseases and to enhance their quality of life.
To the extent that such materials or publications are intended for patients, their content, text, design and general characteristics must clearly and evidently demonstrate their main goal and purpose: a support tool for people affected by a particular disease. These must be educational and informative materials which will in all cases include visible warning messages standing:
- that their contents must not be interpreted as a potential substitute for a diagnosis performed by a Healthcare Professional, and that in the event of any query regarding their content, the recipient should contact their Healthcare Professional,
- and that the publication is intended to offer explanatory guidance, and that the reader must therefore not undergo treatments or follow advice without first contacting a Healthcare Professional.
The sponsorship of such materials or publications by a company must be explicitly reflected therein.
Pharmaceutical companies will be responsible for fulfilment of the obligations described above, irrespective of the medium, platform or channel of communication used to implement them. To this effect, companies should take into account article 8 of the Code.
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