Will Europe Discourage the Launch of New Alzheimer's Drugs?

The pharmaceutical industry is under pressure to deliver new therapies for Alzheimer’s disease, but the regulatory bureaucracy in Europe coupled with the demand for lower-priced medicines continues to hinder efforts in innovation.
Nov 02, 2012
Volume 36, Issue 11

Nathan Jessop
In September 2012, the first global World Alzheimer’s Month was held, representing an international campaign to raise awareness and challenge stigma concerning the disease.

Alzheimer’s disease has a heavy social and financial impact in Europe, particularly because of the rapidly ageing population. EU-funded research has shown that the current rate of ageing in the EU is economically unsustainable and that improving healthcare efficiency would have a greater impact than increasing per capita income (1). This research predicted that nearly 25% of the EU population will be over age 65 by 2030, which represents an increase from 17% calculated in 2005. Despite such officially backed studies, there are few data reflecting the current regional situation for Alzheimer’s disease. In 2011, the Alzheimer Europe’s European Collaboration on Dementia (EuroCoDe) project published its estimates for the economic impact of dementia in Europe in 2008 (2). EuroCoDe estimated the cost of illness of dementia to be €160 billion for 27 EU member states and €177 billion for Europe as a whole (2). The study authors concluded that the estimated cost of illness was higher than described in previous studies and that there was considerable variation in costs and the nature of such costs between different European regions. In northern Europe, direct costs contributed to a large extent to overall estimates, while in southern Europe, the cost of informal care was the major cost component.

These data are already outdated and campaigners believe that the impact of the disease is being underestimated and that European governments must allocate more resources to tackle the disease. There is also pressure on the pharmaceutical industry to deliver new therapies. Although there are several drugs in the industry pipeline, companies often complain that excessive regulatory bureaucracy hinders their efforts in innovation. European patient groups are also highly active in the Alzheimer’s disease field and are scrutinising approaches being taken by regulators.

EMA and Alzheimer’s

The World Alzheimer’s Day campaign was coordinated by Alzheimer’s Disease International, an umbrella organisation of Alzheimer associations worldwide, but also received the backing of many other organisations, including the EMA, which was keen to highlight its role in the authorisation of medicines to treat dementia. The EMA has attempted to counteract external criticism concerning bureaucracy and its perceived slow decision making by highlighting changes in its regulatory processes, such as the qualification of innovative development methods to encourage the development of new drugs for this disease area. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued five qualification opinions on biomarkers for Alzheimer’s disease that may enable the diagnosis of the disease before patients show signs of dementia (3). This qualification process is a new procedure whereby applicants can obtain scientific advice on new methodologies for regulatory clinical trials, offering companies greater confidence early in the research and development process that they are employing methods that will be considered robust by regulatory agencies when they reach the review stage. Pharmaceutical companies were able to comment on the EMA’s qualification procedure as it was developed; it will be interesting to see what happens when they submit a novel Alzheimer’s disease therapy for approval using the provisions.

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