In safeguarding the quality, safety and efficacy of medicinal products, the present EU regulatory system has become a time consuming and highly regulated process. This raises questions about the sustainability of the system. Today RIVM published the report entitled Minds Open: sustainability of the European regulatory system for medicinal products, which deals with the four key issues of safety and efficacy, cost, innovation, and availability.
The results of this study indicate that the present regulatory
system is not sustainable. The RIVM study also indicated that the
four themes are closely interrelated, with a change in one theme
always having an effect on the others. While more flexible
regulations to stimulate innovation enable pharmaceuticals to be
released to the market sooner, there is less knowledge about the
safety of a medicine when approval is granted. Additional safety
regulations lead to longer clinical trials and thus to higher costs
for the development of medicines and more limited availability.
The interests of the various parties (patients, pharmaceutical
industry, health insurers, health care professionals and society as
a whole) are difficult to balance to the satisfaction of all
parties. Seriously ill patients with diseases for which no
treatment is available appear to be willing to accept more risks in
terms of safety and efficacy so that a medicine can be made
available sooner. In addition, factors external to the regulatory
system can have an impact on the four themes, such as commercial
interests (forecasts of the financial return on a medicine to treat
a rare disease) and decision making on reimbursement for medicines
(a national matter).