Welcome all to the 3rd edition of EU Insights. I am delighted to let you know that this newsletter will continue to be freely published under our new stakeholder-focused business model.

We strive to consolidate our role as a key voice in Europe and provide value to global psychedelic and public health ecosystems. This is why we feel that open access to scientific, policy, regulatory, and business developments in the European space is essential.

In support of this, our newsletter will be freely available and funded by two supporter tiers - individual & organisation. These supporters will gain access to more in-depth reporting, timely alerts, past issues and other supporter-only benefits. If you are passionate about advancing psychedelic access and research in Europe and would like to help support our mission, please consider becoming a funding supporter.

Together we can work towards developing an infrastructure and expertise for the highest quality safe, affordable, and equitable access to psychedelic novel treatments. By doing so, we will pave the way for the safe, modern, and ethically responsible integration of psychedelic medicines into European mainstream health services so that they can benefit the greatest number of people.

Tadeusz Hawrot
PAREA Founder & Executive Director

One of our major achievements so far this year has been drafting two letters to the European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) calling on both agencies to become more active. We secured the support of cross-party Members of the European Parliament who co-signed the letters and mailed them as institutional letters from the Parliament.

Both EU agencies have already replied (these letters and responses are available for paying subscribers). The letters stated that both agencies are closely following developments in psychedelic medicines and will increase mutual collaboration in this area. They also inform that the WHO could consider re-evaluation of psychedelics in the UN scheduling as the scientific evidence base changes. Most importantly, EMA announced that it will organize a multistakeholder workshop focusing on promoting the development of psychedelics that address unmet medical needs.

This is what we asked of EMA twice last year and the ask was also included in the MEPs letter. The workshop can start a multistakeholder reflection process on what needs to be done to prepare Europe for the arrival of psychedelic treatments and what role the EU institutions could play in it.

We made sure that key Brussels media picked up the story with POLITICO writing about the letters here, here, and here.

Meeting with EMA Chief Medical Officer

PAREA recently met with the EMA Chief Medical Office, Steffen Thirstrup to discuss recent EU regulatory progress. Meaningful engagement of people with lived experience is at the centre of our work and Ian Roullier from PsyPAN (Psychedelic Participant Advocacy Network - PAREA member) took part in the meeting and emphasized the importance of recognizing the needs of trial participants and ensuring their safety.

We also discussed the role of therapeutic support in psychedelic treatments and a need to work towards its standardization, including developing guidelines and addressing post treatment support gaps and opportunities. Full meeting report is available for paid subscribers.

EMCDDA's technical meeting on the medical use of psychedelic substances

PAREA’s Founder attended the “Technical meeting on the medical use of psychedelic substances: opportunities and concerns” organised by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). Read Tadeusz's takeaway's from the meeting on LinkedIn

ENCP - New Frontiers Meeting 2023: Psychedelics"

PAREA Founding Member, the European College of Neuropsychopharmacy (ENCP) organized "New Frontiers Meeting 2023: Psychedelics" on 19-20 March in Nice, France, dedicated entirely to psychedelics. PAREA’s Chair Prof. David Nutt provided the keynote lecture and PAREA Founder Tadeusz Hawrot led the session on the patients’ perspective - read Tadeusz's reporting from the event on LinkedIn.

The major topics of discussion were molecular mechanisms and pharmacology, neuroimaging, psychological variables, clinical trials, regulatory requirements, and patient perspectives.

PAREA ANNUAL REPORT 2023

The Latest From Europe

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK announced plans to streamline the process for clinical trial approvals, in what is being called the biggest overhaul of trial regulation in two decades. The changes aim to simplify the application process and reduce the time it takes for clinical trials to receive approval, which should encourage more pharmaceutical companies to conduct trials in the UK.

A few days before the official announcement, the U.K. Chancellor Jeremy Hunt promised a new model for authorizing drugs. He said that from 2024, the MHRA will allow “rapid, often near-automatic sign off for medicines and technologies already approved by trusted regulators in other parts of the world, such as the US, Europe and Japan.” Some say this might be another sign that MHRA is no longer capable of fulfilling its mandate since Brexit. At the same time, the UK accounts for 35%of all life science start-ups created in Europe since 2012, according to McKinsey.

Applying for the EU funding can be an arduous task requiring “careful planning, precise budgeting, and a seamless collaboration with partners”. To better guide applicants, the European Research Executive Agency prepared a useful guide detailing Common mistakes to avoid when applying for Horizon Europe funding.

In addition, a first of a series of network events has recently explored what future non-European collaboration in Horizon Europe (with a budget of nearly €100 billion) could look like. The event gathered together international experts who have taken part in Horizon Europe or its predecessor, Horizon 2020. Read the report to see what they had to say. 

New rules on reimbursing drugs in the biggest EU economy

Germany has recently updated drug pricing regulations, detailing what are key metrics when deciding how to reimburse a drug. Germany’s Institute for Quality and Efficiency in Health Care has a helpful explainer of how Germany’s rules function.

What it comes down to is making sure that healthcare systems are getting value for their money. In areas like cancer therapies, experts are increasingly worried that spending for new medicines is constantly going up as more expensive drugs enter the market, with little or no evidence that it’s having any positive impact on patients compared to existing treatments. Connected to this are concerns that health authorities are accepting looser data standards — for example by looking at progression-free survival — rather than more solid metrics like overall survival.

Attitudes towards psychedelics are changing fast in Europe and at the highest levels.

In March, the Dutch Health Minister personally accepted a report “Therapeutic applications of psychedelics’ at the event in the University Medical Centre Groningen. The report includes recommendations regarding research and implementation of psychedelic treatments in health care such as setting up a national research program for coordinated knowledge development and creating accredited education institutes to oversee the delivery of therapy.

A few weeks later, the Dutch Government announced the establishment of a state commission to investigate the risks and benefits of MDMA, including its potential medical use. The commission will study the impact of MDMA on individuals, society, and public health. Additionally, the commission will examine the advantages and disadvantages of potential medical applications of MDMA.

European Health Data Space: towards an EU single market for digital health services and products

The European Health Data Space is on its way. It aims to create a single market for digital health services and products and promises to dramatically reshape access to medical data and its use in research and policy. Reusing health data for research is of particular importance to the pharma industry as it relies on this data to develop new technologies. Currently, the Parliament is revising the Commission’s proposal and the its draft report has now been published.

Relevant elements include the reference to the existing clinical trials regulation and the language around the need for “measures to preserve the confidentiality of IP rights” which is believed by some to be central to keeping and promoting R&D excellence within Europe.

Other discussed areas include making sure that the EHDS facilitates the uptake of real-world evidence to complement clinical trials. A suggestion is also made that the €220 million allocated to the EHDS is not sufficient. The report will be likely adopted in the EP in July.

High drug prices not justified by industry’s spending on R&D?

Do higher drug prices mean more cutting-edge research? Not so according to high-profile academics writing in the British Medical Journal. There “seems to be a disconnect between product R&D costs and prices,” write the authors and show how the growing pharmaceutical revenue in the U.S. is decoupling from research expenditure.

The central graph in the study shows company earnings booming in the last two decades while R&D expenses creep up very slowly, almost looking flat in comparison. This is happening while the median price of a new medicine in the U.S. has risen from $1400 a year in 2008 to more than $150,000 a year in 2021.

Worryingly, research suggests that the R&D expenditure offers little benefit: “Analyses of drug evaluation reports put out by health technology assessment bodies in France and Germany in the 2010s suggest that most new drugs offer little or no added clinical value, with only a fraction offering important or major improvement”.

The authors suggest rewarding only clinically beneficial innovation, raising standards for clinical data, using public funds to get what the health system actually needs, and making patents more stringent to avoid awarding “chemical novelty and inventiveness independent of added therapeutic value.”

30 Members of the EP have been nominated to sit in the new EU public health subcommittee (SANT), created under the umbrella of the Committee on the Environment, Public Health, and Food Safety (ENVI). The subcommittee, chaired by Polish MEP Bartosz Arłukowicz, will deal with programmes and specific actions in the field of public health such as pharmaceutical products.

The ENVI committee remains responsible for examining and voting on legislative proposals. The first official meeting of the subcommittee is being held in Strasbourg on April 20.

EMA supports medical device developers

In February, the European Medicines Agency launched its first pilot to provide scientific advice to medical device developers, marking the drugs regulator’s first foray into the development stage of devices under its expanded mandate.

The EMA is calling for developers of certain high-risk devices to come forward for advice, especially small companies. These could be devices in development for life-threatening or permanent medical conditions, or those that could have a major impact on a patient’s health, among others.

The first five applications will be selected in April.

At least every third prisoner in Europe suffers from mental health disorders according to a new report from the WHO’s Europe office looking at prison health in the WHO’s European Region. The analysis reveals that mental health disorders were the most common condition among people in prison.

While the number of psychiatrists available in prisons was comparable to that in the general community, the high levels of substance use and mental health disorders hint that more investment is needed to ensure equitable access to care, the authors write. Suicide was the most common cause of death in prison, followed by COVID-19 and then drug overdose. 

That’s it for now. In the next PAREA EU Insights, we will cover the upcoming publication of the EU Pharma Strategy (delayed and now scheduled for the end of April).

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