Annex IV - Practical guidance and criteria concerning services provided by Healthcare Professionals or by Healthcare Organisations
Introduction
The interaction between pharmaceutical industry and Healthcare Professionals and Organisations is indispensable. On the one hand, it ensures that Healthcare Professionals refresh and improve their knowledge, while on the other facilitates that biomedical research progress is not interrupted. The exchange of knowledge and clinical experience between Healthcare Professionals and the industry is crucial for research (almost half of R&D investment by the industry in Spain is assigned to collaboration agreements with public and private institutions outside the companies themselves) and for the appropriate use of medicinal products.
These relationships therefore not only serve to keep Spain at the cutting edge of scientific and clinical knowledge, but are also essential so as to maintain the highest level of quality in the healthcare provision received by patients.
In line with the provisions in the EFPIA Code, the FARMAINDUSTRIA Code of Practice of the Pharmaceutical Industry has since 2010 covered the possibility of hiring Healthcare Professionals and Organisations to provide services. In addition, the Code establishes the obligation to communicate such services 10 working days before provision of the service begins.
The unit for the communication of these services will be the Project. For the purposes of this communication, every project will include all services that the company is planning to contract with Healthcare Professionals or Healthcare Organisations within the timeframe of one year and throughout Spain, that share the same approach, objectives and methods.
Communication is mandatory in the case of the services mainly sponsored or financed in by the pharmaceutical company and that involve paid participation of 10 or more Healthcare Professionals.
It should also be recalled that transfers of value made by pharmaceutical companies to Healthcare Professionals and Organisations as a result of the provision of services are subject to the transparency obligations set out in article 18 of the Code.
Purpose
The purpose of this guide is to provide practical guidelines and criteria to assist pharmaceutical companies in complying with the requirements set out in article 16 of the Code.
General action criteria
Once the execution of these projects has ended, and taking into account their rigorousness, professionalism, quality, etc. and the value that they contribute to the main stakeholders with whom the pharmaceutical industry interacts, the general criterion is to be able to provide public information as to their origin, nature, scope, characteristics and results. In other words, it is desirable and necessary in the origin and underlying purpose of each project that the pharmaceutical company ask itself whether it will be prepared to announce public information as to its details once it has come to an end.
Practical criteria and guidelines depending on the type of service
By way of example, a list is given of the different formats under which the Code of Practice Surveillance Unit (or 'USD') has over the past nearly 10 years classified those projects that have been communicated by pharmaceutical companies.
Without prejudice to the different typology and classifications of services that may exist, details are given below of a series of practical guidelines and criteria that must be taken into account by pharmaceutical companies, for each of the categories identified by the USD.
(i) CLINICAL CASES:
1. Clinical case competition: an initiative promoting the participation of Healthcare Professionals under specific terms and conditions, with one or more winners being established by means of predefined selection mechanisms. In this type of project, the pharmaceutical company will need to comply with the following requirements:
- Approve sufficiently in advance the publicly available terms and conditions announcing, among other aspects, the organising or sponsoring entities, the conditions for participation, dates, nature, content/topic, minimum number of cases for the competition not to be declared void, value and number of prizes, judging panel appointed to select the winners, etc.
- Prevent these projects from constituting an inducement mechanism. For these purposes, measures will be established as necessary so as to ensure that only the winners of the competition will receive the established economic consideration, in the form of a prize.
2. Clinical case library: In general, this is an initiative aiming to gather together a considerable number of cases so as to make them available to the medical sector with an eminently educational purpose. The sponsoring pharmaceutical company will need to fulfil the following requirements:
- Where necessary, the pharmaceutical company may offer remuneration to a limited number of Healthcare Professionals responsible for reviewing, accepting and selecting the cases that are ultimately published.
- Healthcare Professionals contributing as "case authors" will not receive any type of economic consideration.
- It must be ensured that no confusion is generated with regard to the genuine purpose and nature of the initiative.
- Clear information must be provided in advance as to the minimum requirements imposed for a case to be accepted.
- Information must be given as to the mechanisms or procedures that will be used to disseminate and convey the contents to Healthcare Professionals. This decision will need to be based on criteria of efficiency and optimisation of the available resources.
3. Compilation of clinical cases at the request of a third party: initiative promoted by a third party outside the pharmaceutical company (such as a scientific society), the aim or purpose of which is to publish clinical cases connected with a particular subject or content matter. Irrespective of the format used for execution and dissemination, the pharmaceutical company will need to fulfil the following requirements:
- Limit its collaboration solely to covering the cost of purely logistical aspects, such as editorial and printing expenses, creation and maintenance of the IT platform.
- Explicitly call on the promoter to seek out other additional sponsors (multiple sponsorship), so as to guarantee and underpin the independence of the Project.
(ii) EXPERT MEETINGS / ADVISORY BOARDS
These are advice or consultancy services provided on a distinctly personal basis and which because of their nature require a qualified professional with a high level of knowledge and technical expertise on their professional field. They are typically services involving a small number of professionals acting as experts, with higher levels of remuneration and with planning and contracts established further in advance.
In this regard, the pharmaceutical company must:
- Establish rigorous selection criteria demonstrating, among other aspects, the level of knowledge, experience, qualifications, prestige, etc. of the hired professionals.
- Refrain from basing their selection purely on general selection criteria which would be insufficient to demonstrate the degree of knowledge or qualifications of the professional to be hired (such as geographical location, years of practice, active practice, etc.).
(iii) EDUCACIONAL PROJECTS
These are projects organised or mainly sponsored by a pharmaceutical company, the aim or purpose of which is to disseminate scientific/professional content of use to Healthcare Professionals.
Usually they involve: (a) the preparation of a "slide-kit" presentation approved by the scientific service/medical department of the pharmaceutical company; (b) training for a number of Healthcare Professionals with regard to the content of said presentation; (c) remunerated speaker contracts for those Healthcare Professionals who have previously received such training, so that they disseminate such content to other Healthcare Professionals; and (d) meetings that share methodology, structure and content.
Meetings held within the context of this type of project tend to be given a range of names (workshops, sessions, seminars, courses, etc.), although they all pursue the same shared goal: "train the trainers".
Without prejudice to the fulfilment of any requirements that might be imposed, the pharmaceutical company must adopt the following measures:
- Remunerate only those Healthcare Professionals who actively collaborate in the educational activity (speakers, authors of the educational materials).
- Each meeting must fulfil the speaker/attendee ratio established internally by the pharmaceutical company.
- Have a record or similar detailing, among other aspects, the total number of educational activities undertaken within the context of the Project, number of attendees per activity, evaluation of the educational activity by the attendees (for example, through a quality survey). For educational activities conducted at the request of a Healthcare Organisation, have an evaluation issued by the Healthcare Organisation itself.
- Comply with the hospitality and meetings rules detailed in article 11 of the Code.
(iv) PUBLICATIONS
This refers to remuneration contracts for Healthcare Professionals in order to promote the creation and preparation of scientific materials for subsequent publication. The inclusion and content of such materials must be subject to the independent review processes used by each publication (commonly known as peer review).
The material must, among other aspects, state potential conflicts of interest, and the contribution by the pharmaceutical company, specifying its nature and scope (logistical, medical authorship and/or payments to the authors).
Unless it is the sponsor of a study covered by the publication, the pharmaceutical company is not involved in and does not supervise authorship. If the pharmaceutical company supports or contributes to medical authorship, this will be via an independent specialist.
This type of publication includes a limited number of authors, who have made a significant contribution in the preparation of its contents.
In this type of Project, the pharmaceutical company will need to adopt the following measures:
- Delegate management to an academic or scientific entity which will be responsible for, among other aspects, setting and objectively justifying the number of contributors, and directing the work and outcome.
- Delegate the selection and designation of the contributing Healthcare Professionals to an independent body. Verify that said selection is conducted on the basis of objective criteria.
- Manage and coordinate execution via the medical department.
- Allow the involvement of other sponsors.
- Support this type of project only in the case of independent publications of established reputation.
- Evaluate the outcome of the project, the level of dissemination and acknowledgement achieved.
Other practical questions
In line with the document approved by IFPMA1 “Note for Guidance on Fees for Services”, and in order to ensure that the contracted services are consistent with the terms of article 16 of the Code and its supplementary rules,
The pharmaceutical company must be able to answer “yes” to the following questions:
1. Are all those involved in providing the services (company employees, third parties and consultants) clear on the legitimate need and intended purpose?
2. Has the company evaluated the consultant selection criteria to ensure their suitability and qualifications?
3. Is the intended remuneration for the consultants consistent with objective criteria defined and approved by the pharmaceutical company as the “fair market value”?
4. If there is a connection with an unlicensed/unapproved medicine/indication, is the pharmaceutical company confident that the service (including its design, content, provision, etc.) does not directly or indirectly constitute a promotional activity of that unlicensed/unapproved medicine/indication?
5. Has it been verified whether, if a service is considered to be part of the consultant usual duties, this consultant should not receive any type of remuneration? (For example, a departmental head training their own team.)
6. Are all organisational and logistical aspects connected with provision of the service consistent with the Code (hospitality: site or venue for provision of the service, travel, accommodation, meals and living expenses; agreed general expenses)?
7. Have measures been adopted to avoid any potential conflict of interest, and to ensure the transparency of the interrelationship/collaboration covered by the service provision agreement?
a) Does the agreement require the consultant to obtain the authorisation from their regular employer, or other forms of consent as applicable (such as authorisation from the employer to provide the service during working hours)?
b) Does the agreement specify the obligation for the consultant to declare their relationship with the pharmaceutical company every time that they write or issue a statement in public about any matter covered by the agreement?
c) Have measures been adopted to ensure that the presentation (in the case of speakers) or the publication (in the case of consultants), provides clear, visible and transparent information as to the company/companies with which the healthcare professional has entered a contractual agreement for the provision of these services?
8. On an annual basis, are the number of occasions on which a single person has been hired and the total remuneration paid to them reasonable?
a) Has the pharmaceutical company adopted measures to ensure that both the frequency with which it hires Healthcare Professionals and the total payments made to them are reasonable? Do these measures prevent the risk of such contracts being perceived as "undue influence"?
For example, those measures may be: (i) internal procedures establishing limits or CAPS; (ii) inclusion in the agreement a declaration of responsibility under the terms of which the Healthcare Professional hired explicitly states that the total amount received from the pharmaceutical company during the year does not exceed a certain percentage of his/her annual income.
b) Have measures been adopted to avoid the recurrent and excessive hiring of the same Healthcare Professionals, when there are others with the same level of expertise, qualifications and availability?
In the case of "Expert Meetings/Advisory Boards" (a type of service defined above), and without prejudice to compliance with the terms of article 16 of the Code and its supplementary rules, and as detailed throughout this guide, the pharmaceutical company must be able to answer “yes” to the following questions:
9. Is there really an unanswered business matter that the pharmaceutical company needs to resolve and that would justify the contracting of this type of service?
10. Is this type of service ("Expert Meetings/Advisory Boards") the most appropriate way of obtaining the information?
11. Does the pharmaceutical company firmly believe that the only way to satisfy its "legitimate need" is by contracting this type of service?
12. Are the number of experts hired and the number of meetings scheduled strictly necessary and limited to achieve the intended purpose?
13. Do the experts hired have in place all the qualifications, experience and scientific/technical expertise required in order to make a significant contribution to the purpose and the expected outcome of the service?
14. Do the number of experts hired and the designed methodology for provision of the service promote and allow active participation by all of them?
15. Does the structure and design of each meeting prove efficient? Is there enough time for discussion? Is most of the time spent gathering experts feedback and opinions?
16. Before provision of the service begins, are the hired experts provided with clear information and instructions regarding the purpose of the service, the expected advisory role, and the workload to be undertaken?
17. Is the documentation (presentations, articles, etc.) that the pharmaceutical plans to provide to the experts relevant for the established object of their hiring: "consultancy/advise about a specific business question/matter"?
Additional questions to be taken into account by pharmaceutical companies
18. Does the pharmaceutical company really need to hire this type of "expert meeting/advisory board" service, or could the information be obtained any other way?
19. Are the consultants expected to do prior preparatory work?
20. What criteria were used to select the consultants?
21. If participation or attendance by representatives of the pharmaceutical company is planned at the expert meetings, who from, or on behalf of the company would participate? Can their attendance/participation be justified? Is the task to be performed at these meetings clearly defined? Is it proportionate, bearing in mind the number of experts per meeting?
22. How are the outcomes documented? What use will be made of the conclusions/recommendations report?
23. If the pharmaceutical company has contracted such services (expert meetings/advisory boards) during the previous 12 months for the same treatment area/medicinal product, are there clear reasons justifying a renewed contract?
1 International Federation of Pharmaceutical Manufacturers and Associations: IFPMA Note for Guidance on Fees for Services, January 24, 2020