Regulators, HTAs and payers
IMI projects cover the whole medical research and drug development process ranging from understanding the causes of diseases, through drug discovery, all the way to patient access to innovative medicines. Scientific knowledge derived from many of our projects is of direct relevance to regulatory authorities, health technology assessment (HTA) bodies and payers. For example:
- PROTECT focused on the assessment of the benefits and risks of medicines and has had an impact on regulatory practice in a number of ways.
- WEB-RADR has developed apps to aid in the collection of reports of adverse reactions.
- GetReal has generated tools and guidance on the integration of real world evidence in drug development.
- ADAPT-SMART is creating a multi-stakeholder platform for discussions on ‘medicines adaptive pathways to patients’ (MAPPs).
Many more projects are developing tools and methods with a potential regulatory impact, such as tests and measures to evaluate medicines safety or efficacy, or alternative clinical trial designs. The involvement of organisations like regulators, HTA bodies and payers is essential to ensure these project outputs meet the required standards and are good enough to be taken up and used in drug development. For this reason, we encourage all projects to seek regulatory/HTA/payer engagement as early as possible. Detailed guidance on opportunities for interaction with regulators can be found in the 'Documents for projects' section of this page.
The benefits of collaboration
- Influence relevance of project outputs. As outlined above, most IMI projects have direct or indirect impacts on regulatory, HTA and payer processes. With their experience in medicines development and patient access, these organisations can contribute from the beginning to ensure that project outputs would be directly applicable to regulatory, HTA and payer practices.
- Receive funding. Most national regulatory, HTA and payer organisations are eligible to receive funding from IMI. Among other things, IMI funding can be used to cover staff costs, allowing recipients to allocate and even hire staff to carry out the work.
- Access to the latest science. Our projects are at the cutting edge of their fields. By joining one of our projects, you will have access to emerging technologies and science. This will help you to be aware of the latest developments and prepare for innovation, and give you the chance to share this information with your wider network.
- Avoid conflicts of interest. Our projects work in the non-competitive space and focus primarily on the development of tools, resources and processes that will improve and accelerate drug development in general.
How to get involved
There are a number of ways for regulatory authorities, health technology assessment (HTA) bodies and payers to get involved in our projects and activities. These include:
- As full project partners. To become a full project partner in a project, you will need to form or join an applicant consortium in response to an IMI Call for proposals. IMI launches a number of Calls throughout the year, and publishes draft topic texts on the Future Topics page of the website. To stay up to date on our latest Calls news, sign up to our newsletter, follow us on Twitter, or join our LinkedIn group.
- As members of project advisory boards. Many projects include representatives from regulatory authorities, health technology assessment (HTA) bodies and payers on advisory and ethics boards, for example. Members of these advisory boards do not receive funding directly from IMI. However, the project may cover some costs. For opportunities in this area, you should contact directly the project you are interested in.
- By proposing ideas for topics. You can suggest ideas for our projects by filling in a simple form. If you choose this option, you should be aware that if your idea is adopted and ultimately used in one of our Call for proposals, you will have to apply for funding like any other organisation. Your proposal would therefore be evaluated by independent experts alongside all other proposals received for the topic in question.
Regulatory science summits
Every few years, IMI teams up with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) to organise a regulatory science summit to review the regulatory relevance of the results of ongoing IMI projects; gain regulators’ input on future IMI Call topics; and discuss which research questions could be addressed by a public-private partnership like IMI. The meetings are an opportunity to discuss the value of collaboration, the evolution of science and its impact on regulatory science.
- Read the summary report of the IMI-EMA-FDA Regulatory Science Summit 2017.
Getting to grips with intellectual property
Intellectual property (IP) represents a challenging area for collaboration involving so many diverse stakeholders. IMI’s IP policy has proven effective at protecting project partners’ interest while encouraging the sharing and exploitation of knowledge. The IP policy’s strength lies in its flexibility; this allows it to be readily adapted to the needs of each project. Thanks to the IP policy, project partners are sharing compounds, data and knowledge with one another in an unprecedented way.
- For questions about our Calls for proposals, application procedures, and funding rules contact the IMI Infodesk
- Read our tips for finding project partners