Procedure for the incorporation of industry into the assessment reports of RedETS coordinated by the Evaluation Service of the Canary Islands Health Service (SESCS)
- Periodically, in the first quarter of each year, the RedETS Secretariat will publish its Annual Work Plan on its website; additionally, it will communicate this to the “umbrella” organizations of the healthcare industry (Spanish Federation of Healthcare Technology Companies (FENIN) and others) for them to disseminate among their associated companies.
- Subsequently, SESCS will identify those reports from the annual work plan where the intervention involves a commercial technology and, therefore, may incorporate the participation of companies related to the technology to be evaluated or its comparator (hereafter referred to as industry). For this purpose, based on the criteria of necessity, convenience, opportunity, and workload, SESCS will contact the companies of interest using a generic institutional email address (redets@sescs.es). Except for exceptions, all communications will be in writing and through this email account. All electronic text communications with the industry will be archived, following the detailed guideline below:
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- SESCS will request FENIN and other possible business organizations for the contacts of the associated companies related to the technologies to be evaluated in the selected Health Technology Assessment (HTA) reports.
- SESCS will also locate contact emails of companies related to the technology to be evaluated through their websites to send them the collaboration request. If it is a foreign company, the contact for the Spanish headquarters will be sought. Industry contact data will be stored for internal use by RedETS. Additionally, the Form 1: SESCS Confidentiality Statement will be sent.
- Company Database: As contact data from various companies is collected, it will be entered into a database available on the RedETS and SESCS intranet for consultation and use in subsequent reports of interest to these entities.
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- SESCS will disseminate the final draft of the work protocol, once reviewed by the working team, by sending it to FENIN and to the companies that have previously agreed to collaborate on the report and have completed the provided confidentiality document. The protocol will omit data related to the identity of the authors, collaborators, and external reviewers. Industry will be able to review the protocol to verify data regarding the technology and make possible contributions, without modifying the stated scope and objectives. Additionally, SESCS will request relevant regulatory, clinical, technical, environmental, and economic information for the evaluation report, specified in an attached form. A maximum period of 14 calendar days (non-extendable) will be established for responses, both to make objections to the protocol and to provide the requested information. For this phase, the protocol will be sent by email, with the Form 2: Verification of Facts and Contributions to Protocol and the Form 3: Documentation Request attached.
- SESCS will evaluate and consider the objections presented in the final version of the protocol and respond to those who made them. SESCS will also detail in its reports, in the Methods section, what specific information was requested and received from the industry. If the industry provides new studies that were not identified through the systematic search, these will be included in the PRISMA diagram.
- During the development of the report, if it is necessary to resolve doubts about the documentation provided by the industry, SESCS will try to resolve them by email. If necessary, the agency may propose a meeting with the company representatives, prioritizing the telematic format. For this purpose, at least 14 calendar days before the meeting, the company will receive the agenda and the questions to be addressed. At least 2 business days before the meeting, responses to these questions will be requested, as well as the names and positions of the representatives attending the meeting. The meeting will be recorded, with prior signed consent from all attendees, and archived. To carry out this activity, an invitation email for the meeting will be sent; in addition to the agenda to be addressed, the Form 4: Authorization for Image Rights Transfer and the Form 5: Preparation for Online Meeting will be attached.
- In the final phase of the evaluation process, when the preliminary version of the final report is available, and after external review, this document will be shared with the relevant industry for them to make objections regarding the information collected on the technology and the scientific evidence included. They will receive, in the same email, the necessary instructions and forms; having a maximum period of 14 calendar days (non-extendable) to respond. For this, the report will be sent by email, along with the Form 6: Factual Content. SESCS will evaluate and consider the objections in the final report and respond to those who made them. It will be stated in the report the right of the various involved parties to request from SESCS the objections received from the industry.
- Objections received from the industry will be posted, along with the responses provided by the evaluators, in a specific section of the RedETS website, once it is enabled. While it is not enabled, in the particular case of SESCS, they will appear tabulated, along with the treatment they have received, in an annex of the report; in the same way as contributions from patient and professional associations are handled.