2021 Year in Review - EPF Policy Recap

2021 has been a very busy year for the Policy Team. We saw how the COVID-19 pandemic remained high in the EU health agenda, and thus had an influence on many of the health policies that were being discussed and implemented.

Certainly, the most important achievement of the year is the reintegration of Operating Grants for Health NGOs. On 25 October, EU Health Commissioner Stella Kyriakides officially confirmed that Operating Grants will be reintegrated within the framework of the EU4Health Programme at least at the level of the previous Health Programme. This achievement should be considered as an exceptional result of months of a strong campaign led by EPF in collaboration with EURORDIS, Alzheimer Europe, EPHA, and supported by more than 20 other health NGOs and 56 MEPs.

On Digital health, a key element of EPF’s recent work in the area was the submission of EPF’s views on the upcoming European Health Data Space. Following an info webinar jointly organised with the European Commission in 21 May and open internal consultation with members, EPF submitted its public consultation response and accompanying position statement on 26 July. Moreover, EPF has also submitted (last August) a  response to the European Commission feedback consultation on  Artificial Intelligence ethical and legal requirements. EPF has also engaged in extensive work on AI, both through policy inputs and capacity building. You can find more info on this topic on the new AI Knowledge Hub, launched earlier this year with the support of a dedicated fund.

On 25 November 2020, the European Commission adopted the Pharmaceutical Strategy for Europe. This Strategy identifies flagship initiatives and other actions to ensure the delivery of tangible results. Much of the work related to its implementation took place during 2021.

In April 2021, the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) published its draft report on the Strategy. We analysed the document and provided a series of amendments based on our priorities and previous position statements. The final report, including (although with different wording) some of the EPF amendments, was approved in Plenary during the 22-25 November session. EPF will continue engaging in this topic in 2022, for instance through the organisation of a roundtable on the important topic of patients’ unmet needs and embedding the concept of “patient value” in the new legislation (date and format to be confirmed).

Also, as an action envisaged within the Pharmaceutical Strategy for Europe, one key EU agency, the European Medicines Agency (EMA), has had its mandate extended. As part of the discussions leading to this, last January EPF responded to a public consultation on the implications of strengthening the agency’s role. On 28 October, EU institutions reached an agreement on the revised EMA role. The Agency will now be able to closely monitor and mitigate shortages during a public health crisis and more rapidly approve medicines that could treat or prevent it.

Finally, another topic of utmost importance has been the ongoing evaluation of the Cross-Border Healthcare Directive (2011/24/EU). EPF regularly liaised with EC representatives on this topic, organising an info webinar (last 23 March) and encouraged EPF Members to provide inputs to the Commission’s consultation processes on the matter. In addition, last September, EPF and DG Sante are co-organised a virtual workshop on the Commission’s draft Guiding Principles for the prior authorisation of cross-border healthcare, where we gave an intervention and comment on the draft principles.