OR WAIT null SECS
The agency has been tasked with coordinating efforts to mitigate shortages of medicines within Europe during the COVID-19 pandemic.
According to the European Medicines Agency (EMA), Member States in the European Union are beginning to see shortages of certain medicines due to the COVID-19 pandemic, such as anesthetics, antibiotics, muscle relaxants, and medicines used off-label for COVID-19. According to EMA, an increase in shortages that has occurred in recent years is being aggravated by the COVID-19 pandemic because of factory lockdowns, border closures, export bans, increased demand, and hospital stockpiling. The stockpiling has led to some EU member states imposing restrictions on the number of prescriptions and purchases. Therefore, the EU authorities are putting together measures to mitigate the developing shortage problem, the EMA reported in an April 6, 2020 press release.
A system to deal with the potential shortages, i-SPOC (industry single point of contact), is being set up by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, which is coordinating actions within the EU. The i-SPOC system will fast-track interactions between industry and the EU Executive Steering Group.
With the system, an i-SPOC person within pharmaceutical companies will report anticipated COVID-19-related shortages to EMA as well as report shortages to the respective national competent authorities. “This new mechanism will allow better oversight of ongoing supply issues irrespective of the licensing route and a quicker flow of information with the pharmaceutical industry with the objective of mitigating and, if possible, preventing shortages in the context of COVID-19 medicines,” EMA stated in the press release.
Regulatory measures are also being considered by EMA and the EU network to support increased manufacturing through speeding up approvals of new manufacturing lines or sites. The agency is also talking with pharmaceutical companies about increasing production capacity for all COVID-19-releated medicines. The EU Executive Steering Group is also considering allowing flexibility in some regulatory rules during the pandemic.
“Although medicine shortages are dealt with at national level by national competent authorities, EMA has been asked to take on the role of a central coordinator to actively support Member States’ prevention and management actions during this extraordinary health crisis. This is a new type of activity that cannot make use of existing mechanisms and means the [a]gency is having to put in place new ad hoc processes and prioritize resources to this activity,” EMA stated in the press release.