Modelling regulatory sandbox mechanisms and enabling their deployment to support breakthrough innovation
European Comission
ExpectedOutcome :
The action under this topic must contribute to all of the following outcomes:
- A horizon scanning for potential sandbox candidates including how sandboxes provide an additional tool to existing frameworks and identified examples to model the process;
- Analysis of how regulatory sandboxes can drive science and health technology innovation in an evolving environment;
- Recommendations for end-to-end operations of regulatory sandboxes to inform healthcare innovation developers, regulators, and other decision makers. Scope :
While there is no concrete definition, regulatory sandboxes generally refer to regulatory frameworks that provide a structure for healthcare innovation developers to test and experiment with new and innovative products, services, or approaches under the oversight of a regulator for a limited period of time. These adaptive tools are meant to address challenges arising from the acceleration of technological/scientific advances and the mechanisms intended to regulate them. It offers customisation in terms of how a regulatory framework can be applied, combined with appropriate safeguards.
Regulatory sandboxes, first tested in the fintech sector (2015), are starting to transform the traditional methods used by regulatory agencies in the health sector to accompany the development of safe, efficacious, and high-quality health technologies1, which, due to their level of novelty, challenge the current regulatory framework. The mechanism enables breakthrough developments and the testing of alternative regulatory approaches for disruptive innovations for medicinal products, related platforms and their combinations, including where appropriate medical and digital technologies. Regulatory sandboxes are mentioned as important future-proofing elements in the legislative proposal2 of the European Commission on the general pharmaceutical legislation. The European Commission’s communication to boost biotechnology and biomanufacturing in the EU further promotes the establishment of regulatory sandboxes that allow the testing of novel solutions in a controlled environment for a limited amount of time under the supervision of regulators as a way of quickly bringing more of them to the market3. Regulatory sandboxes are not featured in the medical devices and in vitro diagnostics regulations (MDR and IVDR)4, but the artificial intelligence (AI) Act5 creates an opportunity for regulatory sandboxes focused on case studies for AI-enabled medical devices. Regulatory sandboxes entail a shared learning objective for innovators (finding a pathway and getting regulatory predictability) and regulators (understanding the technology and defining how best to regulate it). The mechanism helps to inform future regulation through experimentation and evidence generation and minimises the risks of regulating ex-ante innovative and novel approaches prematurely or inappropriately. For the same reasons regulatory sandboxes also potentially facilitate the more efficient or rapid subsequent adaptation of the legislation either through translation into an adapted regulatory framework and/or through recommendations when the time comes for revising existing or developing new legislation.
Regulatory sandboxes should be able to experiment and draw on several relevant healthcare innovation related frameworks other than pharmaceutical products (i.e. medical devices, in-vitro diagnostics, AI, digital health technologies, and substances of human origin among others). Due to their anticipatory and adaptive nature, regulatory sandboxes are well placed to address gaps and complexity within and across regulatory frameworks. Indeed, as the number of drug and device combinations increases, and technology integration becomes the norm rather than an exception in healthcare innovation R&D, manufacturing and healthcare delivery, the current siloed technology-specific frameworks may not provide a clear path forward. To that end, when considering an innovation, it is important to consider all relevant legislative frameworks including MDR and IVDR, the Clinical Trials Regulation6, the General Product Safety Regulation7 and AI ACT among others.
Although still new to the healthcare and pharmaceutical sector, there are a few examples of regulatory sandboxes such as the Sante Canada sandbox for advanced therapeutic products or the Singapore sandbox to test telemedicine. More recently, the UK launched the MHRA AI-airlock to assist in the development and deployment of software and AI medical devices, safely providing patients with earlier access to cutting edge innovations that improve care.
The overall aim of this IHI topic is to contribute to the progression and successful implementation of regulatory sandboxes for healthcare innovations by developing a comprehensive and shared understanding of their value and process of implementation. The topic should also enable the development of a cross-sectoral community of stakeholders including pharma and medical device companies, regulators, and health technology assessment bodies (HTAs), among other stakeholders.
To fulfil this aim, the proposal should:
- Scan the horizon for potential sandbox candidates including how sandboxes provide an additional tool to existing frameworks, and use the examples identified to model the process.
To this end, a key objective is to identify a number of healthcare innovation case studies to better understand how a regulatory sandbox could be used to solve further-defined challenges at an existing regulation level and inform recommendations for end-to-end operations. These cases could draw from the past, present and from horizon scanning activities (the EMA’s work in this area already provides a hint8) to anticipate future innovations, looking across their development value chain.
- Analyse how regulatory sandboxes can drive science and health technology innovation in an evolving environment.
The proposal should do this by:
- anticipating consequences for health technology development under a regulatory sandbox mechanism, acknowledging its time-limited scope and the consequences (considering the technical particularities of healthcare innovation) for other downstream activities e.g., standardisation, health technology assessment;
- proactively identifying any guardrails and mitigation measures.
- Develop recommendations for end-to-end operations of regulatory sandboxes to inform healthcare innovation developers, regulators and downstream decision makers.
The proposal should do this by:
- mapping out conceptual elements and operationalisation features of future sandbox mechanisms based on existing experiences in other fields such as governance, conditions fostering dialogue and collaboration, access to the right type of expertise, support, regulatory customisation, sharing/communicating lessons learned and their translation via the appropriate frameworks into new standards, among other elements to be further defined;
- modelling how to operationalise the sandbox(es) (including governance, operations, principles) and how they could be used in healthcare innovation development and evaluation in conjunction with existing regulatory mechanisms to advance innovation at European and national levels.
Part of the topic entails modelling a regulatory sandbox. The proposal should therefore consider good practices for designing and evaluating the necessary operating models to ensure the robustness and future applicability of the output of the project.
The project outcomes could also offer directions for the translation of the resulting recommendations into digital tools and systems deemed necessary for the functioning of regulatory sandboxes (e.g. ensuring collaboration between different health authorities’ triage mechanisms, horizon scanning, fitness check evaluations), as relevant.
When developing a comprehensive and shared understanding of the value of regulatory sandboxes, applicants will have to explore key aspects across the life-cycle of healthcare innovations with the objective of accompanying their ultimate adoption, which could include as appropriate R&D, regulatory authorities, HTA bodies, payers, governments, clinicians and patients. Ethical considerations would also have to be considered as some innovations could trigger questions in this field.A shared objective should include to develop a regulatory strategy and interaction plan for generating appropriate evidence, enabling engagement across all the different decision makers in a timely manner (e.g. national competent authorities, EMA and the respective Innovation Task Force, qualification advice) and identifying aspects that can be leveraged by existing regulatory tools, as well as the limiting aspects and the flexibilities that would be required under a regulatory sandbox to achieve the timely development and access of healthcare innovations.
1 ‘health technology’ means a medicinal product, a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare.
2 Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 Chapter IX Regulatory Sandbox (Articles 113-115)
4 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.
5 Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act).
6 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use.
7 Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety.
8 Health horizons: Future trends and technologies from the European Medicines Agency’s horizon scanning collaborations: https://doi.org/10.3389/fmed.2022.1064003.
Expected Impact :
The action under this topic is expected to achieve the following impacts:
- Meaningful contributions to the successful implementation of regulatory sandboxes through developing a comprehensive and shared understanding of their use and value among key stakeholders in the healthcare ecosystem;
- Support the future-proofing of the EU regulatory framework by design, enabling the efficient implementation of regulatory sandboxes where and when appropriate, and thus helping to make Europe more attractive as place of innovation;
- Enhancing and enabling the cooperation of key healthcare stakeholders, including patients, clinicians, small and medium-sized enterprises (SMEs) and academics, with regulators in developing a competitive and innovation-friendly landscape;
- Fostering interaction with regulators to develop healthcare solutions when it is not possible to develop them within the current framework.
The action will also contribute to a number of European policies/initiatives, which include:
- the European Commission’s Pharmaceutical Strategy for Europe, specifically the pillar on competitiveness, innovation and sustainability;
- related measures under the ongoing revision of the Pharmaceutical legislation;
- the European Commission innovation agenda (published in 2022) flagship initiative “Enabling innovation through experimentation spaces and public procurement” facilitating innovation through improved framework conditions including experimental approaches to regulation (e.g. regulatory sandboxes);
- the EU biotech strategy;
- the green and sustainability agenda.
General conditions
- Admissibility conditions: described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes
Proposal page limits and layout: described in Part B of the Application Form available in the Submission System
- at stage 1 of a two-stage Call, the limit for RIA short proposals is 20 pages;
- at stage 2 of a two-stage Call, the limit for RIA full proposals is 50 pages.
- Eligible countries: described in Annex B of the Work Programme General Annexes
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide .
Other eligibility conditions: described in Annex B of the Work Programme General Annexes and in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP)
Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes
Evaluation and award:
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes
and in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP)
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes
- Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes
Specific conditions
- Specific conditions: described in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP)
- specific conditions on Availability, Accessibility and Affordability (3A) do not apply to this topic
- JU's right to object to transfer/exclusive licensing
Documents
Where relevant, templates of the reference documents and associated guidance can be found on the IHI JU website.
Regarding the application forms for submitting proposals, the relevant templates and annexes are available to download in the submission system.
The IHI JU 8 th Call for proposals full topics text is available here .
Evaluation form (single and two-stage Calls)
- IHI JU Evaluation form for Research and Innovation Actions (single and two-stage Calls)
Proposal Templates Part A and Part B (Research and Innovation Actions – single-stage and second stage of two-stage procedure)
Proposal template - Part A of the proposal is generated by the IT system in the submission environment (for more information see the HE Part A template here ). In Part A of the proposal applicants insert general information on their proposal (e.g. proposal acronym), details on the participants and the overall proposal budget. Please note that only Part A of this template is applicable for this call. For Part B, see point below.
(applicable to the first-stage of two-stage Calls)
- IHI JU Proposal template (RIA/FP) - Part B (applicable to the second stage of two-stage Calls)
Proposal Annexes
- Annex: Type of Participants
The “type of participants” is an IHI specific annex.
The excel template for:
short proposals (first stage of two-stage calls) can be found here and
full proposals (single-stage calls, and second stage of two-stage calls) can be found here
The instructions on how to fill in this template can be found here.
This is a compulsory annex, and it must be uploaded as a separate document in the submission system.
This annex is applicable to single-stage and in both stages of two-stage Calls.
- Annex: Declaration of in-kind contribution commitment
The “Declaration of in-kind contribution commitment” is an IHI specific annex and it is applicable to the single stage and second stage of two-stage Calls.
The word document template can be found here.
This is a is a compulsory annex and it must be uploaded as a separate document in the submission system.
- Annex: In-kind contributions to additional activities (IKAA)
The ‘’In-kind contributions to additional activities (IKAA)’’ is an IHI specific annex. The excel template can be found here and the instructions on how to fill in this template can be found here.
This is an optional annex and it is applicable to the single stage and second stage of two-stage Calls.
- Annex: Essential information for clinical studies
The information on clinical studies is a Horizon Europe annex.
This is a is a compulsory annex and it must be uploaded as a separate document in the submission system.
If your proposal does not include clinical studies, please upload a statement declaring your proposal does not include clinical studies.
The information on clinical studies annex can be found here:
The annex is applicable to the single stage and second stage of two-stage Calls .
- Annex: Ethics
This is a HE annex. Ethics self-assessment should be included in proposal part A. However, in Calls where several serious ethics issues are expected, the characters limit in this section of proposal part A may not be sufficient for participants to give all necessary information. In those cases, participants may include additional information in an annex to proposal part B.
This is an optional annex and it is applicable to the single stage and second stage of two-stage Calls.
- Annex to the budget for the Full Proposal
This is a compulsory Annex, which complements the budget figures already included in the proposal budget in PART A. Its purpose is to correctly guide the consortium in providing IHI-specific budget items (e.g. IKOP, IKAA, FC PAID, FC RECEIVED, etc.) and to comply with IHI additional eligibility criteria (e.g. 45% industry contribution).
The annex is applicable to the single stage and second stage of two-stage Calls
Model Grant Agreement (MGA)
Additional documents:
Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014 (in short Single Basic Act ‘SBA’ or Council Regulation (EU) 2021/2085).
Horizon Europe Reference Documents
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 2. Marie Skłodowska-Curie Actions
HE Main Work Programme 2023–2024 – 3. Research Infrastructures
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 5. Culture, creativity and inclusive society
HE Main Work Programme 2023–2024 – 6. Civil Security for Society
HE Main Work Programme 2023–2024 – 7. Digital, Industry and Space
HE Main Work Programme 2023–2024 – 8. Climate, Energy and Mobility
HE Main Work Programme 2023–2024 – 10. European Innovation Ecosystems (EIE)
HE Main Work Programme 2023–2024 – 12. Missions
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual