12. Life-Cycle Management

Step 12. Life-Cycle Management

Finally, the development process continues to explore:

  • Other possible uses (indications) for the medicine. For example, if the initial use was for patients with asthma, a new indication might be for patients with a different type of lung disease, e.g. chronic obstructive pulmonary disease.
  • Improved ways of making and using the medicine (new formulations). For example, a special formulation for children.

All of these activities are known as ‘life-cycle management’.

Other changes in the life-cycle of a medicine

  • When a medicine is first marketed, it is protected by a ‘patent’. This means that other companies cannot market a similar medicine. At the end of the patent or data protection period, other companies are allowed to manufacture and market the same product. When this happens, the product is called a ‘generic’.

  • New medicines are usually licensed as Prescription-Only Medicines (POM). This means that healthcare professionals can supervise their use in the first few years. Where it is appropriate and safe to do so, the medicine can then be made available as an Over-The-Counter ( OTC) medicine. This involves a change in the regulatory status of the medicine and a new licence is required. Patients can buy the OTC medicine directly from a pharmacy without prescription.