2022 is going to be a year with a lot of important health dossiers coming up. Something we have seen coming since the relevance of health policy on a European level increased drastically within the last few years. Besides the ongoing pandemic, European Commission president von der Leyen's ambitions can be seen already in Health Commissioner's Stella Kyriakides mission letter from 2019 or the pharma strategy. In 2021, a lot of pre-work has been done with stakeholder dialogues or consultations, so 2022 will see a lot of dossiers finally come to fruition.
The perhaps biggest dossier is going to be the Revision of the EU general pharmaceutical legislation in the fourth quarter. We can’t stress the importance of this bit enough. To give you an idea: Health enthusiasts often consider the Directive 2001/83/EC1 and Regulation 726/2004 as the “health bible”. Already in November 2020, the European Commission published a Communication on the Pharmaceutical Strategy outlining the reforms to the EU pharmaceutical legislation that it intends to promote during its tenure to 2024. The Commission’s objectives include for instance access to affordable medicines, the security of supply of medicines and prevention of drug shortages. The strategy roadmap anticipates that new legislation will be adopted by the end of 2022. This means nothing less, but that 20-year-old regulation on health is going to be revamped – and you can be sure that we are closely following this European facelift.
But that’s not the only dossier the health care crowd is waiting to come to light. The revision of the EU legislation on medicines for rare diseases (1901/2006) and for children (141/2000) is supposed to happen by the end of this year and will be published together with the general pharmaceutical legislation
Furthermore, in the third quarter, the Commission is supposed to publish a proposal to update the 2003 Council Recommendation on cancer screening to ensure the latest available scientific evidence is reflected. One of the aims will be to consider the extension of cancer screening beyond breast, colorectal and cervical cancer to include prostate, lung and gastric cancer, as well as other cancers if supported by scientific evidence. Europe’s Beating Cancer plan is the flagship that is leading these important goals.
Last but not least, the European Health Data Space will be more and more realized – leading to a better exchange and access to different types of health data (electronic health records, genomics data, data from patient registries etc.)., The data is not only important to support healthcare delivery (so-called primary use of data), but also for health research and health policy making purposes (so-called secondary use of data).
Apart from these major health dossiers, Europe’s man on the moon is waiting for you: the Green Deal. After several planned initiatives had to be postponed thanks to the ongoing pandemic, several dossiers relevant for the pharmaceutical industry related to environment will be published in 2022. These will include the circular economy with its regulation concerning for instance packaging and waste management or the REACH and CLP-legislation, addressing chemical substances and ingredients.
But there is even more – apart from health care and environment – on the dinner table: dossiers related to digitalization and industry policy are likely to shape EU health policy. We will see new initiatives such as the EU Due Diligence Law Proposal which has been postponed several times in 2021 but should be published in 2022. Moreover, the European Health Data Space to better promote exchange and access to different types of health data, is becoming more in shape.
Closing this brief outlook, we can say that 2022 is packed. The current legislative turn of the Commission president von der Leyen ends in 2024 and thus, the Commission wants to finalize as many dossiers as planned since the ongoing pandemic took already a lot of time. The pandemic delayed a lot of dossiers and the feeling to catch up and to switch the focus more to pre-COVID dossiers is in the air. These are going to be some tough 12 months. But you can be sure that we are going to be there, guiding all of you through the Brussels pharma jungle. Until then, we wish you again all the best for everything that is laying in front of us. Bring it on, 2022!
Contact: Teresa Vázquez López, (BPI office Brussels) bpi.brussels@bpi.de
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