2014 Volume 2014 Issue 34 Pages 270-292
Economic crisis which began in 2008 has increased the pressure both on EU research budgets and on the health budgets of its member states, Studies have been made into the effective allocation of financial resources in response to the crisis, and the objectives of this paper are (i) to recommend strategies to protect patients with orphan diseases in the EU and ensure their access to medications; (ii) to improve the research and development capabilities of pharmaceutical companies in the context of Europe’s new growth strategy “Europe 2020”; while at the same time (iii) clarifying the direction that needs to be taken and the issues that need to be addressed to achieve a balance in these areas and identify any adjustments required, in order to increase the sustainability of healthcare resources.
With no resolution to the economic crisis in sight, there is increasing pressure to reduce health care costs as society continues to age. Meanwhile, the enforcement of the European Charter on Fundamental Rights has implemented a policy of social inclusion and developed “Strategies for Orphan Drugs” at EU level. Drugs for rare diseases (or orphan drugs) refer to drugs with an extremely small market, where companies cannot even expect to recover the investment costs they incur in the development of treatments, and preventive or diagnostic products.
In order to reduce the financial burden on patients, some EU states have chosen to meet the full costs from public expenditure but others lack the financial resources or political will to do this. It is problematic if drug costs are reimbursed from the public budget, in the sense that the greater the potential to diagnose a patient with a rare disease, the greater the impact on healthcare resources will be. The EU is trying to achieve a balance between all stakeholders such as pharmaceutical companies, patients with rare diseases and their families, individual member governments and public health authorities, and it needs to establish a system to evaluate the socio-economic worth of drugs used in the treatment of rare diseases. The greatest challenge will be to ensure that patients in all member states have equal access to orphan drugs without placing unbearable financial pressure on national or central budgets
