EMA trumpets achievements ahead of Brexit
- During 2016, the European Medicines Agency, which approves drugs across all 28 states in the E.U., recommended marketing authorization for 81 drugs, including 27 drugs that are completely new to Europe, according to its 2016 annual report. Around half of the positive opinions were for drugs where the manufacturer had received scientific advice from the EMA, supporting development of clinical trials.
- Also in 2016, the EMA launched PRIME (PRIority MEdicines), offering support for the development of drugs for unmet needs. Over the year, over a third of the newly approved drugs were recommended for approval through one of the E.U.'s routes to early access.
- Currently based in London, but soon to have to move as a result of Brexit, the EMA has created a task force to manage the process once the decision on the new location is taken.
The European Medicines Agency, launched in 1995, recommended the approval of 975 therapeutics over its first two decades. Over the next few years, however, it faces what could be one of the biggest upheavals of its 22-year history – its potential relocation from London following the U.K.'s exit from the European Union.
"[2016 was] a year in which we were confronted with a decision that will potentially result in the Agency and its staff leaving London and the UK and moving to another country and city in Europe. At EMA, we are faced with the likely prospect of relocation and loss of expertise," said Guido Rasi, EMA executive director, in the report's introduction.
This isn't the only challenge that the EMA faces in the coming years. As outlined in its annual report, the authority sees "vaccine hesitancy" and surveillance of antimicrobial consumption as key medical issues. Europe is now one of the regions of the world that is most skeptical about vaccines, with 41% of people in France disagreeing with the idea that vaccines are safe. This is leading to reduced uptake of vaccines and increasing levels of preventable diseases.
Antimicrobial resistance is a growing problem, and one that the EMA is well-placed to tackle as it has responsibilities in both human and animal health. Its approach will need to include raising awareness of antimicrobial use in animals, sharing surveillance data on both animal and human medicine, and supporting the development of new products.
To deal with these challenges, and to continue to work safely and effectively through the transition to a new location, the EMA will have to continue to expand its scientific dialog, monitor cutting edge science, continue with training and education for all of its stakeholders, and expand its uptake of digital data technologies.
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