Update on COVID-19
The Management Board heard an update from EMA on the ongoing assessment activities for COVID-19 vaccines and treatments. The Board was informed that EMA and the European medicines regulatory network are facing an unprecedented workload related to the pandemic response. In view of the number of vaccines and therapeutics in the pipeline, the upcoming assessments for the COVID-19 variants, the increasing number of post-authorisation manufacturing-related changes and the intense post-marketing safety monitoring that is required once the vaccines are rolled out for use in EU citizens, the necessary specialised expertise is needed. The Board emphasised that it is critically important that enough resources are made available at national level to ensure that EMA can continue to conduct its assessments using the best possible EU expertise and within the shortest possible timeframes.
The Board was also updated on the ongoing investigation into the COVID-19-related cyberattack detected in early December last year. Board members were reassured that EMA has as a result further strengthened its defensive capabilities to protect the Agency from future attacks and will invest in the enhancement of its IT security systems as a priority.
Monitoring of EMA’s independence policies
The Board welcomed the progress made in 2020 with the implementation of the various Agency policies that aim to ensure the independence of members and experts of EMA’s scientific committees, Management Board members and Agency staff in the evaluation of medicines. The annual report on independence highlights how EMA implemented recommendations and carried out controls and how it updated the policies and the form for declarations of interest for experts. In line with the Agency’s commitment to continually review its operations, the report also identifies recommendations for further improvement. The report will be published shortly.
11th annual report: MUMS/limited markets scheme for veterinary medicines
The Board endorsed the eleventh report on the minor uses / minor species (MUMS) and limited markets scheme for veterinary medicines. The report concludes that the scheme has been successful in terms of incentivising the submission of requests for classification of products as MUMS/ limited market, resulting in new veterinary medicines becoming available to treat minor animal species and uncommon diseases in major animal species. Building on the success of this policy, the new veterinary legislation will introduce specific provisions in the EU legislation to boost the development of new medicines for limited markets. The report will be published on the EMA website shortly.
EU IT systems required by the Clinical Trial Regulation
The Board noted the progress in the development of the Clinical Trial Information System (CTIS). The independent audit began as scheduled, the first phase has been completed and preparation for the second phase is very advanced.
The requirements for a minimum viable product at the time of go-live have been prioritised by the group of experts mandated by the CTIS governance. On the basis of this prioritisation, a development plan for go-live and subsequent post-go-live periods has been prepared. The plan adds some very limited additional functionality, whilst continuing to focus on the technical robustness and quality of the system and the user experience, both at the time of go-live and after.
On this basis, the Board considers that the benefits that the Clinical Trial Regulation is expected to bring should now be realised. Lessons from COVID-19 and the EU Beating Cancer Plan indicate that streamlined regulatory processes are needed to enable researchers to work across Member States. Clinical research is very important in Europe, accounting for high levels of investment every year, and it needs to be empowered to generate better patient outcomes. The Board agreed to revise the go-live date to 31 January 2022. This go-live date is the aspiration of the Board, being without prejudice to verification of the final audit outcome and full functionality of CTIS by the Management Board, and the subsequent decision process of the European Commission. The final go-live will take place exactly six months after the publication of the Commission decision in the Official Journal of the European Union.
CTIS is a cornerstone to apply the principles of the Clinical Trial Regulation. Its success will be a composite of people, processes and technology. It is now vitally important that organisations, clinical trial sponsors or authorities, prepare their people and processes to work with CTIS and to use the strengths that the system and the legislation bring to their activities. To achieve this, an extensive training programme is being rolled out to support users.
Big Data Steering Group: 2020 report
The Board welcomed a report from the Big Data Steering Group (BDSG), which provides a summary of the key activities and achievements of the BDSG in 2020. It documents significant progress in the transformation to more data-driven regulation in line with the Network Strategy to 2025. This progress has been delivered despite the significant challenges posed by the COVID-19 pandemic. The report will be published shortly.
Revision of EMA’s anti-fraud strategy
The Board adopted a revised version of EMA’s anti-fraud strategy and related action plan for the next three years. The strategy was originally adopted in 2014, further to the European Commission’s initiative to develop a common approach for all EU decentralised agencies in the fight against fraud. Its overall objective is to improve the prevention and detection of fraud and to pursue adequate deterrence and reparation, in close collaboration with the European Anti-Fraud Office (OLAF).
The revision takes into account lessons learnt during the implementation of the strategy since 2017, the latest fraud trends as reported by OLAF, the Commission’s new anti-fraud strategy approved in 2019 and the Agency’s annual fraud risk assessments, which include some new areas (e.g. cybersecurity). Over the next three years, the Agency will continue to raise awareness among staff members and contractors in respect to fraud matters, whilst continuing to pursue a zero-tolerance policy against fraud at the Agency. The revised strategy will be published on the EMA website shortly.