Datum objave: 20.07.2018. 17:45

Poziv za dostavljanje aplikacija u okviru programa Horizon 2020 za uspostavljanje zdravstvenog ekosistema za razvoj, proizvodnju i distribuciju farmaceutskih proizvoda

TOPIC : Blockchain Enabled Healthcare

Topic identifier:IMI2-2018-15-02

Publication date:18 July 2018

Types of action: IMI2-RIA Research and Innovation action

DeadlineModel: two-stage

Opening date: 18 July 2018

Deadline: 24 October 2018 17:00:00

2nd stage Deadline: 15 May 2019 17:00:00

Time Zone : (Brussels time)

Topic Description

Specific Challenge:

The pharmaceutical value chain and the extended healthcare ecosystem have many areas that suffer from complexity, a lack of transparency, coordination and trust.

Examples include:

- counterfeit medicines market estimated at EUR 160 billion with a huge impact on patient health;

- lack of access to medicines, especially in developing countries, impacting patient health;

- data accessibility leading to lost opportunities for improved research and new innovative medicines;

- patient privacy considerations (patient consent) hindering clinical trial recruitment and execution;

- lack of visibility and shared ’source of truth’ leading to friction and costs in development and distribution;

- increasing risk of cyber threats, especially with central data storage and sharing.

By addressing these challenges through a public-private consortium, the evaluation, design, and accelerated adoption of blockchain-enabled healthcare solutions across the industry can be fostered. This will facilitate the delivery of true innovation benefiting both patients and the industry.

Scope:

The overall objective of the agile project generated by this topic is to establish a common blockchain ecosystem for pharmaceutical development, manufacturing, and distribution that provides an incentive and serves as the basis for all participants to engage, adopt, and benefit from.

The project will initially establish an effective governance organisation and approach to enable continuous improvement and open competition among service providers, while ensuring that critical factors such as data integrity, privacy, regulatory compliance and efficiency are built into a ‘Healthcare Foundation’ which serves as an integration layer between underlying blockchain technologies and the business application layer (see architecture diagram).

The project aims to drive the agile delivery of use cases prioritised by clearly defined business value, benefits (return on investment, ROI) and feasibility. Use cases fall into the domains of supply chain, focusing on supply chain integrity and efficiency; clinical development, focusing on clinical trials and submission; and health data, which among others should enable blockchain-based machine learning data marketplaces. A likely focus for prioritised delivery is enabling end-to-end product tracking with blockchain technology to address the issue of counterfeit medicines, taking into account existing initiatives such as the proposed European Medicines Verification System. The project will also evaluate the use of medical devices across multiple use cases in order to ensure the integrity of device, data and services to enable the benefits of the internet of things (IoT). The initial technology deliverable is an architectural framework enabling such factors as digital identity management, efficient consensus mechanism, off-chain storage, global scalability, security, and high performance. Other use cases can be added based on a value analysis during the project lifetime and proposals from the selected applicant consortium. The scope includes a reference implementation of the solution but does not include specific industry partner implementations.

Expected Impact:

The project generated by this topic will generally position the industry as a leader in innovation and serve to improve the overall trust and reputation of participants. Full realisation of the envisioned benefits will require a transformation of many core processes in organisations over several years beyond the life of the project. The project will establish a strong foundation to enable these benefits in accelerated manner. Envisioned long term benefits include:

- Patients will have earlier access to both the medicines they need and information on drug provenance; this will improve overall transparency, and with it trust in and the reputation of the industry. The supply chain will be more secure through anti-counterfeiting measures, building on the solutions designed to fulfil the Falsified Medicines Directive (FMD). The project will evaluate and define additional potential patient-centric services.

- Permissioned and secure healthcare data sharing will be enabled between patients, healthcare providers, researchers and other stakeholders. Patients will have full control of their health data and be able to join clinical, sensor and behavioural data into a self-sovereign 360 degree health record. Patients will be able to donate data or grant access to their data for a defined / limited time or purpose to research and real world registries in a trusted and anonymous manner. If seeking information on clinical trials, patients will have recommendations made to them based on their health profiles.

- Healthcare providers will use limited resources more efficiently by streamlining clinical trials and eliminating expenses for counterfeit and substandard medicines. Automation of processes and reliability of data will enable significant improvements to the current status quo.

- The pharmaceutical industry will benefit from widely accepted standards and demonstrated actions to ensure the integrity of drug development and distribution to the patient. Accelerated adoption of digital technology will additionally result in efficiencies across the industry with improved transparency, visibility and availability of drugs to the market. It can also better position the industry for new innovative therapies relying on the patient’s own cells (chain of identity).

- The applicant consortium will benefit from investments in research programmes and early adoption of innovative solutions.

- Applicants should indicate how their proposal will impact the competitiveness and industrial leadership of Europe by, for example engaging suitable SMEs.

Topic conditions and documents

Please read carefully all provisions stated below before the preparation of your application.

The IMI2 JU 15th Call for proposals topics text as well as the Call Conditions are available here.  

The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information : 

1.   Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.

2.   Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.

Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.

3.   Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.

4.   Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.

Signature of grant agreements: maximum 3 months from the date of informing successful applicants.

5.   Proposal templates, evaluation forms and model grant agreements (MGA):

IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):

Proposal templates are available after entering the submission tool

Standard evaluation form

IMI2 Model Grant Agreement

Clinical trial template – the Clinical Trial template is compulsory at stage 2 only !

6.   Open access must be granted to all scientific publications resulting from Horizon 2020 actions.

Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.

Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.

Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.

Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.

Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.

Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.

The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement. 

Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.

7. Additional documents:

Summary of the most relevant provisions for participating in IMI2 actions

3rd Amended IMI2 Annual Work Plan 2018

IMI2 Regulators Guidance tool for researchers

IMI JU derogation to H2020 Rules for Participation  

Horizon 2020 Rules for Participation 

Horizon 2020 Regulation of Establishment

Horizon 2020 Specific Programme

https://ec.europa.eu/research/participants/portal/desktop/en/opportunities/h2020/topics/imi2-2018-15-02.html