The European Medicines Agency plays an important role in protecting the health of all European Union (EU) citizens, including older people.
According to Eurostat, the number of people aged 65 years or over in the EU is expected to grow from around 84 million in 2008 to around 141 million by 2050. This represents an increase from 17% to 30% of the total EU population. This increase is partly due to developments in medicine over the past few decades.
As the older population grows, the Agency recognises that it will need to make sure that it takes the needs of the elderly into account during the development, approval and use of medicines.
The Agency engages with regulatory authorities, pharmaceutical companies and organisations representing the interests of elderly people in Europe and beyond, including with patient, consumer and healthcare professional organisations, such as AGE Platform Europe.
There are a number of differences between older people and younger people that have an impact on their treatment with medicines. These are particularly apparent in very old patients:
- Older people's bodies take up and eliminate medicines from the body differently than younger patients'.
- Older people are susceptible to a wide range of diseases, including Alzheimer's disease, heart disease, bone diseases and mental illnesses.
- Older people often have more than one disease at a time, making it difficult to treat the separate diseases.
- Older people may be weaker than younger patients, making them vulnerable to disease and the risks associated with medical treatment.
The role of the Agency
The Agency plays an important role in the development, approval and monitoring of medicines for older people.
The Agency is responsible for the evaluation of new medicines in the EU, including medicines for diseases affecting older people. These include all medicines for neurodegenerative conditions, which affect the way the brain and nervous system work, such as Alzheimer's disease and Parkinson's disease. The Agency is also responsible for evaluating medicines for cancer and diabetes.
- For more information, see central authorisation of medicines.
The Agency also monitors the safety of medicines once they are on the market. This safety monitoring or 'pharmacovigilance' is particularly important for medicines used in older people, because they may be at risk of different side effects to younger patients and because there may have been few older people in the clinical trials of the medicines.
Geriatric medicines strategy
In February 2011, the Agency published its geriatric medicines strategy:
The strategy states that the Agency will ensure that the needs of the ageing population in the EU are taken into account in the development and evaluation of new medicines by building on its existing activities. In particular, the Agency aims to:
- ensure that the medicines used by older people are of high quality and are studied appropriately in the older population, both before and after authorisation;
- improve the availability of information for older people on the use of medicines.
As part of the implementation of this strategy, the Agency started the development of a concept paper on the characterisation of the frailty status of patients enrolled in clinical trials in June 2013.
- Proposal for the development of a points to consider for baseline characterisation of frailty status
Update: Two reports on the impact of the first year of the strategy on product assessment and guidelines preparation have been prepared.
Preparation of scientific guidelines
The Agency produces scientific guidelines to help companies carry out the appropriate studies of medicines. These guidelines state that older people should be included in clinical trials to test the effects of medicines, and that safety measures should be built in to deal with the vulnerability of older participants in clinical trials.
In December 2006, the Committee for Medicinal Products for Human Use (CHMP) published a report on the request of the European Commission that reviewed the extent to which the Committee's guidelines and clinical trials used to support marketing authorisations addressed the needs of older people:
The report made a number of recommendations on how to improve the implementation of the existing guidelines and on how to update standard international guidelines on the design and conduct of clinical trials of medicines for use in older people. It also found adequate compliance with guidelines and requirements, including the standard international guideline:
- Studies in support of special populations: Geriatrics E7
- Final concept paper: E7(R1): Studies in support of special populations: Geriatrics
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) topic E7: Studies in support of special populations: Geriatrics - Questions and answers
Update: The Quality Working Party is also developing guidance on appropriate packaging and formulations:
Geriatric Expert Group
In May 2011, the Agency's CHMP established an expert group to provide scientific advice to the CHMP and the Agency secretariat on issues related to the elderly:
The Agency has organised a number of workshops on medicines for older people:
- European Medicines Agency workshop: Slowing the progression of neurodegenerative diseases (02/10/2006)
- Second European Medicines Agency workshop on neurodegenerative diseases: Focus on dementia (11/02/2008)
- Brain diseases in the elderly (16-17/05/2008)
- European Medicines Agency workshop on medicines for older people (22-23/03/2012)
- Geriatric Expert Group
- Eurostat: In the spolight - demographic change: challenge or opportunity?
- AGE Platform Europe
- Drug policy for an aging population — The European Medicines Agency's geriatric medicines strategy
- Geriatric medicines strategy (23/02/2011)