GENEVA/COPENHAGEN – For the first time, EU countries have more people over 65 years of age than under 15 years of age. Echoing the trend seen in Europe, much of the rest of the world, including low-and middle-income countries, is moving in a similar direction. A new WHO report calls for pharmaceutical researchers to adjust their research and development efforts to account for this shifting demographic.
“Despite an over three-fold rise in spending on pharmaceutical research and development in Europe since 1990, there is an increasing mismatch between people’s real needs and pharmaceutical innovation.”
Nina Sautenkova, WHO/Europe
The report, Priority medicines for Europe and the world 2013 update, emphasizes that this shift in EU countries is ‘bell weather’ for the rest of the world as globally more people will be ageing and face similar health challenges in the future.
The report focuses on pharmaceutical ‘gaps’, where treatments for a disease or condition may soon become ineffective, are not appropriate for the target patient group, does not exist, or are not sufficiently effective.
“Despite an over three-fold rise in spending on pharmaceutical research and development in Europe since 1990, there is an increasing mismatch between people’s real needs and pharmaceutical innovation. We must ensure that industry develops safe, effective, affordable and appropriate medicines to meet future health needs,” says Nina Sautenkova, Health Technologies and Pharmaceuticals, WHO/Europe.
From a public health view, the trend of an increasing population over 65 leads to greater prevalence of diseases and conditions associated with ageing, such as heart disease, stroke, cancer, diabetes, osteoarthritis, low-back pain, hearing loss, and Alzheimer disease. In combination with health promotion and disease prevention initiatives, these conditions also require more investment in research and innovation to bridge the pharmaceutical gaps.
Since the original report was published in 2004, progress has been mixed
Patients, and particularly the elderly, often require medication for multiple chronic conditions. However, research and treatment guidelines tend to be more disease-driven than patient-centered. “Multiple small-scale trials of combination therapy have been undertaken but no large scale studies have been initiated. One such example is fixed dose polypills for ischemic heart disease (or myocardial ischaemia),” says Kees De Joncheere, Director of WHO’s Essential Medicines and Products department. “Although there are some promising results from small trials, we need the investment in large-scale trials to have the evidence to see if we can get the right formulations and make this work in practice to save more lives.”
In addition to conditions related to ageing, the report identifies a number of other important topics for future pharmaceutical research.
One area of concern is the need for more medicines that do not require storage in cool temperatures, such as heat-stable insulin for diabetes and oxytocin for childbirth. This would provide an important benefit to improve health services in countries without consistent access to refrigeration.
As identified in the 2004 report, the increasing resistance of common microbes to the medicines used to treat them, otherwise known as antimicrobial resistance (AMR), threatens to make many current health care interventions impossible. There is an urgent need not only to preserve current medicines, but also to develop new options.
Other highlights of the report include additional critical factors to pharmaceutical innovation, such as optimizing regulatory systems for market authorization; adopting effective pricing and reimbursement policies to create incentives; and leverage of existing electronic health records to obtain valuable data to improve medicine safety and effectiveness. Within Europe there are moves towards adaptive licensing and value-based pricing that will potentially change access to and incentives for new medicines. The need for meaningful patient and citizen involvement in pharmaceutical innovation and access was highlighted.
This report is an update to the 2004 version and is a collaborative product of the experts from WHO, EU Member States, industry, academia and other interested stakeholders including patients.
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