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1. For the purpose of this Regulation, an unmet public health need shall be defined as a need currently not addressed by the health care systems for availability or accessibility reasons, for example where there is no satisfactory method of diagnosis, prevention or treatment for a given health condition or if people’s access to health care is limited because of cost, distance to health facilities or waiting times. People-centred care refers to an approach to care that consciously adopts individuals’, carers’, families’ and communities’ perspectives and considers them as participants as well as beneficiaries of health care systems that are organised around their needs and preferences rather than individual diseases.

2. Indirect actions funded by the Innovative Health Initiative Joint Undertaking may include clinical studies where the targeted area or the intended use represents an unmet public health need, significantly affecting or threatening the Union’s population.

3. Participants to indirect actions funded by the Innovative Health Initiative Joint Undertaking must ensure that the products and services that they develop based or partly based on the results of clinical studies undertaken as part of an indirect action are affordable, available and accessible to the public at fair and reasonable conditions. For that purpose, where relevant, the work programme shall specify additional exploitation obligations applicable to specific indirect actions.

4. Where provided for in the work programme and in addition to Article 5(2), point (a), legal entities identified by the Innovative Health Initiative Joint Undertaking may be required to participate in specific indirect actions. Those entities shall not be eligible for funding from the Innovative Health Initiative Joint Undertaking.

5. Any legal entities participating in specific indirect actions with the identified legal entities referred to in paragraph 4 shall not be eligible for funding where:

(a) they are for-profit legal entities with an annual turnover of EUR 500 million or more;

(b) they are under the direct or indirect control of a legal entity described in point (a), or under the same direct or indirect control as a legal entity described in point (a);

(c) they are directly or indirectly controlling a legal entity referred to in point (a).