By Marianne de Visser, EAN representative at EMA’s HCPWP
Looking back and ahead (annual report and new mandate)
The European Medicines Agency’s annual report for 2021 provides an overview of the Agency’s activities to protect and promote public (and animal) health in the European Union (EU) and highlights EMA’s most significant achievements. These include the Agency’s activities to tackle the COVID-19 pandemic but also its work related to the scientific assessment and supervision of medicines in the EU (see the digital report). Please find below some highlights.
In 2021, the number one priority for EMA and the European medicines regulatory network in 2021 was the efficient and timely response to the COVID-19 pandemic. EMA recommended four vaccines and five treatments for COVID-19 for marketing authorisation in the EU.
In addition, the annual report highlights key lessons learnt during the public health crisis.
In future, EMA will also closely monitor and mitigate shortages of medicines and medical devices during major events and public health emergencies and facilitate faster approval of medicines for the treatment or prevention of diseases causing a public health crisis.
The report also showcases how EMA continued to address public health needs beyond the pandemic. EMA recommended 92 human medicines for marketing authorisation in 2021. Of these, 54 had a new active substance which had never been authorised in the EU before. This is a 38% increase compared to 2020, by far the highest number in the last five years.
EMA also published the activities and objectives of the Agency for the period 2022-25 (https://www.ema.europa.eu/en/documents/report/final-programming-document-2022-2024_en.pdf). In 2022, EMA expects to continue to still face significant workload related to the ongoing COVID-19 pandemic. The Agency and its scientific committees will provide advice on new medicines under development, and will evaluate the quality, safety and efficacy of vaccines and therapeutics targeting the SARS-CoV-2 virus.
While EMA is committed to fostering scientific excellence in medicines evaluation and supervision, EMA also focuses on tackling current and future challenges in the areas of availability and accessibility of medicines, data analytics, innovation, supply chain and overall sustainability. Another area of focus for the Agency in the coming years is the implementation of new legislation. 2022 marks the entry into force of the new regulation on veterinary medicinal products, the longawaited Clinical Trial Regulation.
Collaboration between EAN and EMA
EAN is amongst the 22 eligible organisations participating in the Working Party of Health Care Professionals (HCPWP) of EMA since its inception in 2013. HCPWP and its counterpart the Patients and Consumers Working party (PCWP) provide recommendations to the EMA the Patients and Consumers Working party (PCWP) on all matters of interest in relation to medicines. Marianne de Visser represents EAN during the HCPWP meeting and Yves Dauvilliers is the substitute.
A number of EAN individual members (Carlo Colosimo, Marian Maria Molnar, Martin Rakusa) has volunteered to be added to EMA’s list of European experts who can be involved in the Agency’s work in the context of the authorisation, supervision and maintenance of medicinal products for human use.
On a regular basis EMA reaches out to EAN for relevant experts who may serve on ad-hoc working groups addressing a scientific advice and these will be sought amongst the Scientific Panel members.
Finally, EMA issue monthly newsletters with factual information about authorized drugs. If of specific interest it will be posted on the website, in EANPages, and preferably with a commentary of an expert of a Scientific Panel, e.g. ‘New gene therapy to treat rare genetic disorder metachromatic leukodystrophy’ (https://www.eanpages.org/2021/01/18/new-gene-therapy-to-treat-rare-genetic-disorder-metachromatic-leukodystrophy/).
If you come across any issues related to EMA, such as medicine shortage, please do not hesitate to contact me. On my part, I do hope that I can count on you if we need a commentary on a long-awaited drug that is clinically relevant for patients with a neurological disorder.
