The BECA committee has delivered the first version of the compromise amendments after having worked through the over 1500 individual amendments on the draft proposal.
In the individual amendments, there were multiple inclusions of big data, modelling, and AI – as well as one mention of in silico specifically – highlighting the growing recognition of the need for standards and regulation on novel digital technologies.
In the compromise amendments (CAs), the majority of the in-silico community individual amendments have been condensed into two CAs:
- Considers the significant potential impact of the use of artificial intelligence, “Big data” algorithmic analysis and other modern technologies in diagnosis and decision-making for cancers in the coming years; underlines that the combination of real-world data, mathematical modelling, artificial intelligence and digital tools will significantly help to develop innovative treatments in a more cost-efficient way, and potentially reduce the required number of patients to be involved in clinical trials and the use of animals in research; encourages the Commission and the Member States to promote the knowledge of cancer biology through the implementation of genomics and informatics infrastructures; urges all implementation partners to be ever mindful of the principles of trust, transparency, patient centricity and patient involvement at all times;
- Considers that the sharing of expertise, data, training programmes and communication tools is needed to improve the knowledge of cancer among both health professionals, researchers and patients; calls for cross-sector and cross-country collaboration and knowledge sharing that will be crucial for further enhancing the quality of cancer care in the EU; notes that data sharing is key to applying artificial intelligence and machine learning tools to research, and to enabling the digital transformation of healthcare, to tackle disparities in cancer prevention, diagnosis, and treatment around Europe and to optimise the use of healthcare systems resources, increasing efficiency and thus allowing for wider availability of oncological care data, also in less urbanised and remote areas; stresses the sensitive nature of health data; calls for full compliance with Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) to avoid unnecessary restrictions for cross-border healthcare; stresses the need for harmonised interpretation and implementation of the GDPR, especially by Data Protection Authorities, including its Recitals 33 and 157, and its interaction with the Clinical Trials Regulation once applicable, including Recital 29 and Article 28 (2) of that Regulation, across the EU to facilitate scientific research; requests the European Data Protection Board to ensure that its guidelines concerning health research are updated with the aim of fostering research, and calls on the Commission to make concrete proposals by the end of 2021 for appropriate guidelines or other nonlegislative measures; should these fail to be effective, calls on the Commission to propose draft legislation for the revision of the GDPR;
Although negotiations on the text are still ongoing, compromise solutions have already been found and the progress is considered positively by key BECA members. As such, these formulated CAs have a significant chance of being included in the final report.
The multiple inclusions of digital technology, as well as the potential described for modelling, are promising inclusions in the compromise amendments. Indeed, the CAs better address in silico community’s goals than individual amendments did by combining interests – such as stating multiple benefits (cost, patient safety, and reduced animal testing) of digital technology instead of just one. As such, this is positive news for the in silico medicine community as it expands upon the previously observed focus on solely animal testing. The positive outlook from BECA members is a good sign for uptake of these amendments.
It is unclear what role – if any – BECA will fulfill upon the adoption of this own-initiative report. While officially the report would conclude BECA’s mandate, there are informal indications that the special committee may continue its activities in some format in 2022 onwards.