PAREA EU Insights July

Welcome to the July edition of EU Insights. We're bringing you an overview of the latest EU policy news, as well as developments shaping the psychedelic landscape.

At long last, the European Commission is bolstering its support for mental health. The Commission has rolled out a €1.23 billion mental health strategy, comprising 20 initiatives that focus on areas such as prevention, early intervention, workplace well-being, and stigma reduction. Additionally, it aims to improve health service accessibility and capacity. A €9 million call for tenders on mental health training and exchange programmes for health professionals has already been announced by the Commission. Its goal is to support health professionals in the EU through multidisciplinary mental health training, aiming to train 2,000 professionals across the EU by 2026. The project also intends to develop a study to identify the needs, gaps, and obstacles in the current knowledge, competencies, and training needs of health professionals. This provides a unique opportunity to highlight the need for developing standards and training healthcare professionals who wish to become psychedelic therapists.

Find out more about this and other recent developments below. Also, don't forget to check out our new feature: a curated selection of the latest top updates in psychedelic science and policy.

PRO subscribers can also access PAREA's review of the most recent advancements in the area of EU Health Technology Assessment. This field plays a critical role in defining access, as it serves as the cornerstone of reimbursement and pricing decisions.

With best wishes,
Tadeusz Hawrot
PAREA Founder & Executive Director

In an editorial piece for the July publication of Open Access Government, PAREA’s Tadeusz Hawrot states the case for a new focus in the EU’s mental health care approach given the prevalence of mental illness and the lack of funding and innovation in this field.

The article argues that psychedelic therapies hold potential to greatly improve the EU's mental health care, but to realize this potential, these therapies need a supportive regulatory environment that encourages the development and safe implementation of psychedelic medicines. Drawing inspiration from successful approaches to orphan drugs, paediatric medicines, and antimicrobial resistance, the EU can and should incentivize the advancement of psychedelic therapies.

The editorial also highlights the EU's role in facilitating this shift through initiatives on mental health and the ongoing revision of the pharmaceutical package. It is also drawing parallels with the successful development and implementation of stroke rehabilitation in Europe.

PAREA AT DENVER’S PSYCHEDELIC SCIENCE 2023

PAREA founder, Tadeusz Hawrot, spoke at Psychedelic Science 2023 that took Denver by storm, transforming the city into a psychedelic Mecca for three exhilarating days. With over 12,000 attendees at the Colorado Convention Center, the event attracted luminaries from the psychedelic world, esteemed scientists, medical researchers, community leaders, and policymakers.

The conference featured an impressive line-up of sessions and lectures, offering participants a glimpse into the forefront of the psychedelic movement. PAREA’s Founder took part in two panels: i) The regulatory considerations and opportunities and ii) From research to regulatory changes: Australia, the EU, and beyond.

PAREA at PSYCH SYMPOSIUM

Held at the British Museum, PSYCH Symposium returned after a sold-out event in 2022. PAREA Founder was there to share insights into the future of EU psychedelic developments alongside two MEPs: Cyrus Engerer and Mikuláš Peksa.

Leading investors, regulators, scientists, and industry leaders gathered to explore the transformative potential of psychedelic medicine. The Symposium provided a platform for experts to discuss research, development, and commercialization of psychedelics for medical conditions. Keynote speeches, panel discussions, and workshops covered topics like clinical trials, regulatory updates, and investment opportunities.

PAREA NEWS RELEASES

Have you seen the latest from PAREA News Releases highlighting significant advancements in policy and science related to psychedelic therapies? Notably, both the UN and the European Monitoring Centre for Drugs and Drug Addiction have incorporated sections dedicated to psychedelics in their latest reports, marking a milestone. Furthermore, the U.S. Food and Drug Administration has issued its inaugural guidelines specifically addressing psychedelics. Moreover, an article published in Nature explores the potential of psychedelics to reopen important stages of brain development, which holds profound implications for future research and applications.

The Latest From Europe

BEYOND HEALTH POLICY: EU COMMISSION MENTAL HEALTH STRATEGY

The European Commission unveiled a mental health strategy, aiming to integrate mental health into various policies through 20 flagship initiatives backed by €1.23 billion in funding. The strategy focuses on prevention, early intervention, vulnerable groups, well-being at work, breaking stigma, and a global approach. Improved accessibility and capacities of health services are highlighted. Specific measures include supporting depression and suicide prevention policies, providing evidence-based recommendations, and developing a child and youth mental health network. The strategy acknowledges the importance of addressing work-related stress and burnout.

The Commission sees this strategy as the beginning of a longer journey towards comprehensive mental health care in Europe.

PAREA warmly welcomes this critical development. A rising tide lifts all boats, and we are convinced that the strategy will contribute to further raising the profile of psychedelic medicines in the EU.

NEEDS-DRIVEN APPROACH TO
PHARMA INNOVATION

Five EU nations have collaboratively composed a letter entitled “Applying a Needs-Driven Approach to Pharmaceutical Innovation”, published under the auspices of the Council of the EU. This letter robustly asserts that R&D activities should be steered by the needs of patients and society at large, as opposed to being predominantly motivated by private investments that primarily aim for the highest expected return on investment. The authors thus propose a shift towards prioritizing interventions that deliver the greatest health benefits to society. They propose achieving this by i) strategically utilizing public research funding; ii) directing market incentives towards the most needed products; and iii) transparently communicating what payors are willing to remunerate for specific types of medicines. To facilitate these changes, they propose a lifecycle approach that encompasses: (1) the identification of the most pressing unmet needs; (2) the creation of intelligent and predictable incentives to guide R&D activities towards these needs; and (3) the implementation of approval and reimbursement processes that consider these unmet needs, while ensuring predictable financial compensation for innovation in selected therapeutic areas.

CANNABIS LANDSCAPE: EMCDDA REPORT

Wondering what to make of the hodgepodge of cannabis laws in Europe? The European Monitoring Centre for Drugs and Drug Addiction has put together a report looking at the various policies across the Continent, finding that the policy challenge is growing in “importance and complexity.” They write that in some countries in Europe “public and political support for reconsidering the approach to cannabis control has grown significantly, and this has led to proposals for policy changes in this area.” Five EU countries and Switzerland “are NOW introducing, or are giving serious consideration to introducing, new approaches to regulate recreational cannabis supply.”

DIGITAL THERAPEUTICS: THE NEXT FRONTIER OF HEALTH CARE

Digital therapeutics may be the future of health care, but a new report from EFPIA shows that just a couple of EU countries actually have clear ways to bring these services to patients. Only Belgium and France offer value assessments, reimbursement and funding pathways, while France has “more intermittent offerings.” If there were a structured approach to the authorization, launch and use of digital therapeutics, which include things such as the self-management of diabetes or CBT for depression, EFPIA believes this could improve health care, empower patients and be financially beneficial for health systems.

EFPIA argues that several changes need to be made, including harmonized regulatory requirements; countries and the Commission working together to support sharing data on these tools; and payers having “flexible approaches” to give provisional access to these tools while the data is being generated.

PLATFORM TRIALS

Clinical trials are changing. That’s due to cost pressures, challenges in recruitment, the types of diseases being treated, and challenges thrown up by the pandemic. The Innovative Health Initiative, the EU-backed public-private funder of research, is exploring how to solve some of these issues.

Platform trials that use one control group to test against multiple treatments hold great promise for recruitment in certain disease areas, and can allow several companies to test their products at once. But they can be hard to set up and get a regulatory approval for. However, regulators are interested in trying to improve this.

REAL-WORLD EVIDENCE SUPPORT

The real world evidence (RWE) from studies led by medicines regulators can be complementary to other sources of evidence, such as clinical trials. It can help with pre- and post-authorisation assessments, the EMA found in a new report on the use of RWE over the past 18 months.

The EMA says that “more effort is needed to better anticipate the need for such studies and to speed up their initiation to ensure that regulators have access to RWE in a timely manner.”

RWE is used by pharma companies, but it’s not that common for regulators themselves to lead these studies. In recent years, during the pandemic, regulators did this much more — gathering RWE on the COVID-19 vaccines and treatments.

The EMA says there needs to be an acceleration of the generation of RWE, as well as more work to identify research topics in areas where it’s less common to use RWE.

START-UPS HIT HARD

A new report: the Global Startup Ecosystem Index lists a combination of rising inflation, increasing interest rates and unstable geopolitics as major culprits for the deteriorating conditions in start-up funding.

Not much remains from a huge spike in 2021, a golden time for start-ups. Funding in the first quarter of this year was around $76 billion, 56% lower than the same period in 2022, when $162 billion was pumped into start-ups. The biggest impact is on established start-ups that are trying to grow – a group that a lot of developers of psychedelic treatments are in - rather than brand new ventures, with angel seed investment having increased slightly in the past year. Late stage investments fell by 43% year-on-year.

While Europe is home to many thriving start-up hubs, the index shows it trails North America and Asia Pacific in creating high impact ecosystems.

Europe has 410 cities in the index’s ranking of the top 1,000 best start-up ecosystems, far more than any other geographic region. But fewer than 30 of them are in the top 100, suggesting a lack of quality. North America is home to just 29.1% of the top 1,000 cities, but attracts nearly 50% of global start-up funding. Europe, on the other hand, attracts just 19.7%.

Predictions don’t look optimistic: “the general expectation is that as long as interest rates stay high, more and more startups will run out of money, and we will enter into a winter period in start-up funding,”.

INTERIM PARALLEL SCIENTIFIC ADVICE

Starting from September 2023, manufacturers of health technologies can seek parallel scientific advice from the national Health Technology Assessment (HTA) bodies and the EMA to plan pivotal studies for new medicinal products and medical devices. This process, known as "Parallel EMA/HTA body (HTAb) Scientific Advice," is part of the preparation for the implementation of the EU HTA Regulation in 2025. The German Federal Joint Committee (G-BA) will serve as the central coordination contact for these consultations, offering its expertise and facilitating the procedure with national HTA bodies.

UK MENTAL HEALTH BOOST

Psychedelic drug developers in the UK are set to benefit from the 'Life Sci for Growth' package, which aims to address mental health needs. The package introduces commitments and funding initiatives specifically targeting clinical trials and mental health research. Key components include £121 million for commercial clinical trials and £42.7 million for mental health research. The government aims to expedite new medicine delivery by rebuilding capacity, reducing approval timelines, and establishing an international recognition framework. Efforts will also focus on utilizing health data to involve patients in trials and streamlining patient recruitment processes. The package reflects the government's commitment to making the UK an attractive hub for testing new products in the mental health sector.

GRIM NEWS FOR UK PHARMA

The U.K. is at risk of losing its status as a “first launch market” for new drugs, warns the country’s biotech lobby group as it publishes a new report on the Voluntary Pricing and Access Scheme that has become a hated initiative among industry.

The BioIndustry Association’s interviews with members show just how detrimental the scheme has been to the U.K. A Sanofi representative said that between 2020 and 2022 there was a 22 percent reduction in the number of clinical trials they conducted in the country. “This is reflective of the growing perception that the UK is a challenging environment to conduct trials and launch new medicines,” they said.

The head of market access at Autolus Therapeutics said the lack of transparent and joined up processes, from regulatory approval to the HTA process and adoption by the national health service, “is creating a scenario where the company is considering commercializing in the U.S. and Europe ahead of the U.K., even though it is U.K. HQ company, with manufacturing capabilities in the U.K.”

The BIA argues that financial controls need to be more predictable, equitable and competitive; the scheme needs to be mutually beneficial and health technology assessment methods need to be properly reviewed.