This year will feature prominently in history for many reasons; even perhaps as the year the “European Health Union” was born. It will be a difficult birth, albeit facilitated by the COVID-19 pandemic that shed a spotlight on inherent weaknesses in our health systems. COVID-19 reminds us that the greatest challenges we face - from stopping the virus itself and providing access to efficient and state-of-the-art medicines to antimicrobial resistance - are all interlinked.
The global health crisis is showing our interdependence, and how the only solution is cooperation, solidarity and reforms. The pandemic has had cruel direct and indirect consequences for many thousands of patients, disrupting vaccination and screening programmes, postponing long-awaited treatments and medicine shortages. European citizens are calling for change and want the EU to be at the front line. This requires more than the recent short- and medium-term actions, and pursuing a longer-term approach to public health.
“This requires more than the recent short and medium-term actions, and pursuing a longer-term approach to public health”
This is why, following President von der Leyen’s call for a “European Health Union” in her first State of the European Union address, the European Commission will table an ambitious set of proposals this autumn. It will include proposals for a stronger, more comprehensive EU framework for preparedness, surveillance, risk assessment as well as actions to improve early warning and crisis response. It will also propose revising the mandates of the ECDC and the EMA.
The EMA needs to be reinforced to monitor and report on medicine shortages and to play a key role in helping accelerate the approval of medicines. A European-style Biomedical Advanced Research and Development Authority (BARDA) is also likely to be proposed in the second semester of 2021. A pharmaceutical strategy for Europe, due to be unveiled in November, will reinforce the EU’s global position in developing and manufacturing medicines.
This means fighting the systemic causes of shortages, making medicines easier to access as well as more affordable and environmentally sustainable, while upholding existing quality and safety standards. Even although it takes into account the first lessons learnt, the strategy should not be seen as a crisis-driven initiative but rather one to tackle important problems that will resurface post-crisis.
The commitment to addressing these challenges was clear in Commissioner Kyriakides’ mission letter; since then the Commission has been listening to the Parliament and the Member States, to stakeholders, industry and patients’ associations. Presentation of the overall strategy will be just the start of the process, with specific proposals and initiatives following in the coming months and years.
The strategy contains four main pillars. First, we need to address patient access to, and availability of, pharmaceuticals, particularly in rare diseases, and ensure that further research is possible for health challenges such as AMR. We see wide discrepancies between Member States due, for example, to the fact that companies are not obliged to market a medicine in all countries. Equal access to medicines will be a key priority. Affordability of medicines and health systems’ budgetary sustainability is another theme.
This can be fostered either indirectly through market competition or directly by assisting Member States with public procurement or transparency in R&D costs. A third pillar is to enable innovation. Scientific and technological advances are crucial for improving patients’ health, as shown by the current search for a COVID-19 vaccine. Another example is the revolution we have seen in biotechnology, now central to developing cancer immunotherapy. Currently, more than 50 percent of newly approved medicines are biologicals. Last, supporting EU influence and competitiveness at global level will be crucial.
“The greatest challenges we face - from stopping the virus itself and access to efficient and state-of-the- art medicines to antimicrobial resistance - are all interlinked”
We must seek a level playing field for EU operators and launch a discussion with all stakeholders to identify and address weaknesses in Europe’s supply chains. Depending on third countries and precarious international supply chains may increase the risk of shortages of critical medicines. The Pharmaceutical Strategy is a marathon, not a sprint.
It does not start from scratch; the EU is already a world leader in pharmaceuticals and EU citizens have access to high quality medicines and safety standards. The strategy will cover the full lifecycle of a medicine, from the laboratories where early research takes place, to placing innovative medicines on the market, from HTAs to secure supplies of generics.
There will also be close links to other initiatives and strategies presented by the Commission, such as the EU’s digital agenda, the Industrial Strategy and the Green Deal as well as Europe’s Beating Cancer Plan, which will be unveiled just a few weeks later. Work will start almost immediately - from early 2021 - in a brand new political context, where the need to “do more” on health at EU level is universally acknowledged. We owe this to our citizens and our patients, who will be at the heart of our actions.