For the first time, European Union nations have more people aged over 65 than under 15, and a new report from the World Health Organisation says pharmaceutical R&D efforts must be adjusted to account for this shifting demographic.
Around the rest of the world many countries, including low- and middle-income nations, are moving in a similar direction, says the report. It focuses on pharmaceutical “gaps,” where treatments for a disease or condition may soon become ineffective, are inappropriate for the target patient group, do not exist or are insufficiently effective.
“Despite an over-threefold rise in spending on pharmaceutical R&D in Europe since 1990, there is an increasing mismatch between people’s real needs and pharmaceutical innovation,” says Nina Sautenkova of WHO Europe’s health technologies and pharmaceuticals division.
“We must ensure that industry develops safe, effective, affordable and appropriate medicines to meet future health needs,” she emphasises.
Patients – particularly the elderly – often require medication for multiple chronic conditions, but research and treatment guidelines tend to be more disease-driven than patient-centred, says the report.
“Multiple small-scale studies 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,” comments Kees De Joncheere, director of the essential medicines and products department at WHO.
“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,” he says.
As well as ageing, the report identifies a number of other important topics for future pharmaceutical research, such as the need for more medicines that do not require storage in cool temperatures.
Also, with antimicrobial resistance threatening to make many current healthcare interventions impossible, there is an urgent need not only to preserve current medicines but also to develop new options.
Other critical factors to pharmaceutical innovation include: optimising regulatory systems for market authorisation; adopting effective pricing and reimbursement policies to create incentives; and leveraging existing electronic health records to obtain valuable data to improve medicine safety and effectiveness, it says.
Moves within Europe towards adaptive licensing and value-based pricing will potentially change access to and incentives for new medicines, says the report, which also highlights the need for “meaningful” patient and citizen involvement in pharmaceutical innovation.
