EMA gets a budget boost

The EU drug regulator, the European Medicines Agency (EMA), has a beefed-up budget for 2022 and plans to grow further in the years ahead. The watchdog’s Management Board approved a budget of €417 million for 2022, an 8.16% increase on the previous year.

The EMA says the additional funding is needed to allow it to meet new responsibilities in crisis preparedness, and in the management of medicine and medical device shortages across Europe.

The Amsterdam-based agency has been in the stoplight since the outbreak of the SARS-CoV-2 pandemic, attracting particular public focus since it approved the first COVID-19 vaccines in late 2020. Since then, it has given the green light to five vaccines and made key decisions on the use of boosters, mixing vaccines, and vaccination of adolescents and children. The agency also approved six COVID-19 medicines in 2021.

The new budget includes €36 million in extra funds that reflect the growing profile and responsibilities EU lawmakers have given the Agency. It is also responsible for launching a new Clinical Trials Information System at the end of January 2022, which will allow clinical trial sponsors to register trials online. This has involved significant IT spending as well as an extensive training programme for users. From 2023, it will be mandatory to use the new CTIS for submitting clinical data.

The Agency is also leading collaborations among international regulators on the use of health data in evaluating the safety and efficacy of medicines before – and after – they are authorised for use. In addition, the EMA is charged with managing veterinary medical products, for which a new EU Regulation comes into force on 28 January 2022.

EMA funding is drawn largely from fees and charges applied to companies and others seeking approval for medicines and vaccines. This accounts for almost 86% of income, with a further 14% drawn from the EU budget and approximately 1% from other sources.

While health policy is the responsibly for EU Member States, EU agencies such as the EMA and the European Centre for Disease Prevention & Control (ECDC) are likely to have more prominent roles in managing and preventing public health crisis in the years ahead.