2. Determine if there is an 'unmet need'

Determine if there is an 'unmet need'

An 'unmet' need refers to a disease where either:

  • there is no suitable medicine available or
  • there is a medicine but some patients might have unacceptable side effects and are not able to take it.
The research and development process is resource-intensive and is expensive. Companies may only start a new programme for an unmet need if there is a commercial case to do so. This is because companies need to profit from the new medicine in order to pay their development costs and invest in projects for new medicines. There are many unmet needs where new medicines are not currently being developed. The European legislators are aware of this and they offer incentives and rewards to support the development of medicines in more difficult cases e.g. for patients with rare diseases, or children.

The basic steps in medicines development are explained in the following. One important step is the regulatory submission and approval process (marked in green in figure 1), which has to be passed before a medicine can be marketed (launched). However, this is not in the hands of the company.

Each stage of the medicine development process requires a budget (financial resources) and investment in personal resources or people to do the work. Each stage will provide results and these results will need to be reviewed and agreement obtained for the budget (investment) and the people to do the work – called an ‘investment decision’ (ID) before the next activity can start.

This pattern of “investment decision – activity – results – investment decision” continues for the entire development process. This means that if the results are not satisfactory, the project will be stopped and the financial and human resources can then be directed to other projects.