Regulatory approvals for psychedelic medicines are becoming a reality, and the focus in policy and advocacy work is shifting from “if” to “when” and – most importantly – “how”.
What keeps me increasingly up at night is what we should start doing now to use wisely the time we have before the widespread adoption. I’m thinking about issues like standardization, accessibility, affordability, sustainability and safety, which cuts across every other aspect.
Equitable access to psychedelic treatments will be key, and the access landscape in the European Union is far from perfect. Once the European Medicines Agency approves a new treatment, decisions related to pricing, marketing, and availability are in the hands of drug developers and the EU Member States (MS).
This creates huge access inequities across the bloc. The time to patient access for new medicines can vary from four months to 2.5 years, depending on the country and region. Some countries don’t see novel treatments at all. For instance, patients in Italy can access seven out of ten medicines approved by the EMA, while in Romania, it is less than two out of ten.
What we need to do now is to start building the necessary expertise and infrastructure for the highest quality, safe, affordable and equitable access to psychedelic medicines when they are likely to become approved in Europe in the coming years.
We had a chance to discuss these challenges during the recent PAREA meeting with the European Commission’s Health Directorate (DG SANTE).
It is important to understand here that there is no one EU health system – it is EU countries’ prerogative to organize and deliver their health services. As such, EU institutions have very limited competencies in this area – they can merely complement national policies and facilitate cooperation between countries.
However, there is still a lot that the EU could do in the area of psychedelic medicines. It could provide a platform and resources to help countries coordinate and prepare together for the roll-out of psychedelic treatments by exchanging best practices and establishing European guidelines that countries could choose to follow as they put in place frameworks and structures to accommodate the use of psychedelics.
PAREA is working towards building an understanding among EU policymakers that this type of collaboration could be an important opportunity to address the deteriorating mental health of Europeans, and could represent an effective use of limited resources.
During the meeting, we asked DG SANTE to consider the added value that EU coordination could offer to advance this agenda, and discussed which EU instruments could be appropriate. However, ultimately, it is not up to the European Commission to decide on health priorities – the suggestion must come from the EU MS themselves.
And here lies the fundamental challenge: what are the chances that the MS will start to proactively prepare for the roll-out of psychedelic medicines. The trouble, of course, is that political attention is usually fixated on managing the present – politicians focus on the urgent at the expense of what is more important over the long term. The DG SANTE representative even suggested a name for it: “progress by catastrophe”.
We are not good at drawing lessons from things like pandemics, climate change or severe mental health deterioration, and acting rather than reacting.
Driving our actions is what the philosopher Roman Krznaric called “the tyranny of the now”.
In the book “The 7 Habits of Highly Effective People,” Stephen Covey says that everything in life is created twice. The first creation is a deliberate design or planning, a blueprint, an intellectual creation of the mind and spirit, and it begins with an end in mind.
He also quotes Goethe, who said: “Things that matter most must never be at the mercy of things that matter least.”
The challenge is that the bias towards the present, the constant bombardment of emails, petty priorities, crises or our mental resistance to do the real work, make us infinitely postpone the important, both in the private space and certainly in politics.
Can we thoughtfully prepare for the likely arrival of psychedelic treatments so that we turn this into a success story rather than a “lessons learned” case study for those who come after us?
Don’t we owe it to so many people who could benefit from those treatments and yet might be left without any real access once they are approved? Or will we be building the car as we are driving it?
