News and Events
7th November, 2023
European Parliament event spotlights PAREA’s policy paper on rethinking unmet medical needs criteria
Yesterday, the European Parliament was the setting for a meeting of the MEP Action Group for the Medical Use of Psychedelics. This first meeting, held under the auspices of the recently established group, marked a significant step towards upscaling mental health treatment within the EU pharmaceutical legislation's framework.
PAREA welcomes its newest Community Partner: The Psychedelic Society (UK)
17 October 2023
The Psychedelic Society is a not-for-profit, UK-based organization, focusing on cultivating the psychedelic community and delivering education about the safe and responsible use of psychedelics.
Register for the upcoming event on psychedelics in the context of the EU pharma package revision
12 October 2023
On behalf of the MEP Action Group for the Medical Use of Psychedelics, we warmly invite you to an event at the European Parliament, focusing on the potential of psychedelic therapies within the evolving EU pharma legislation context. Find out more and register for an in-person/online participation here: https://tinyurl.com/EU-Par
PAREA meets with EMA
29 September 2023
PAREA facilitated a session on psychedelic therapies that took place during the 13th Congress of the European Pain Federation EFIC, held in Budapest, Hungary. Deirdre Ryan, Vice-Chair of PAREA was instrumental in creating this opportunity. James Close from the Imperial College London spoke at the session about his research on psychedelics in the realm of pain management.
PAREA facilitates discussions on psychedelics at EFIC 2023
24 September 2023
PAREA is excited to announce the release of its manifesto for the EU Parliament elections in 2024, focusing on transforming mental health care through psychedelic therapies. As Europe grapples with a rising mental health crisis, it offers a forward-thinking approach, advocating for the EU to prioritize mental health and explore innovative treatments. The manifesto also proposes the creation of an EU inter-institutional task force to establish guidelines for the safe and equitable use of psychedelic therapies.
PAREA EU Elections Manifesto 2024
21 September 2023
PAREA is an Association Partner for The Neuro Summit along with the Human Brain Project, the Brain Capital Alliance and more. The Summit, in Lisbon from the 11th to the 13th of October, brings global visionaries in brain health, neuro and mental health-centric digital health, medtech, deeptech, data, and artificial intelligence to chart the course for our collective brain well-being and prowess in the contemporary economy.
Find all the summit details here.
PAREA is a Association Partner for The Neuro Summit
20 September 2023
EU Parliament Health Subcommittee "own-initiative report" on mental health
19 September 2023
The European Parliament Health Subcommittee (SANT) is developing a mental health report, led by MEP Sara Cerdas, who is also involved in the MEP Action Group for the Medical Use of Psychedelics. During a recent SANT meeting, discussions were held on amendments to the report. PAREA, advocating for the inclusion of psychedelic medicines, is pleased to note a recent amendment recommending further exploration of innovative treatment options, specifically the use of psychedelic-assisted therapies for mental health conditions. The report is set to be adopted later this year.
EMA'S new Depression Guideline includes a section on psychedelics
18 September 2023
The European Medicines Agency has released a draft guideline on clinical investigation of medicinal products for depression, marking its third revision since 2002. Notably, the draft includes a dedicated chapter on psychedelics, recognizing their unique development needs for treating depression. The guideline also acknowledges the challenges of standardization, training, monitoring, and safety in psychedelic-assisted psychotherapy.
Read the full draft here.
The American Journal of Endocannabinoid Medicine interviewed PAREA Founder, Tadeusz Hawrot, during the MIND Foundation INSIGHT 2023 conference about the work of PAREA and the wider EU landscape.
Read the full interview here.
American Journal of Endocannabinoid Medicine interview
16 September 2023
PAREA EU Insights September
15 September 2023
Our September edition of PAREA EU Insights is out! Stay updated on the latest EU policy news. Highlights including: PAREA’s call to establish a Psychedelics Advisory board, the first time psychedelics are mentioned in official EU documents, and more. Read the full EU Insights here.
Psychedelic Health features PAREA manifesto
13 September 2023
Psychedelic Health featured PAREA’s call for a European advisory body on psychedelics in a recent policy briefing to the European Medicines Agency (EMA), aligning with the EMA's 2023 workshop on the topic. This development responds to a letter from cross-party MEPs, including Alex Agius Saliba, Robert Biedroń, and Sara Cerdas, urging swift EU action on psychedelics. Tadeusz Hawrot, Founder and Director of PAREA, emphasizes the need for a multidisciplinary advisory body to establish standards and facilitate regulatory approval for psychedelic therapies.
Read the full article here.
PAREA co-signs Joint Statement with EU 4 Health
8 September 2023
PAREA is proud to stand alongside other cosignatories in endorsing this crucial declaration with EU 4 Health, a unified coalition of civil society entities. The joint statement calls for the implementation of sustainable funding mechanisms and the establishment of more transparent actions by the European Union. These measures are essential in ensuring that civil society organizations have equitable access to funding, facilitating their continued contribution to the policy discourse.
Read the full statement here.
PAREA at MIND Foundations INSIGHT conference
31 August 2023
At the forefront of psychedelic research, this year's INSIGHT conference featured the founder of PAREA, Tadeusz, Hawrot, sharing policy, economic and ethical insights at a panel on Patients or Patents with philanthropists and other fiscal experts. Discussions and workshops at the event spanned psychedelic neuroscience, non-clinical uses, mindfulness in business, and integration of indigenous wisdom traditions.
See the full conference details here.
Position Statement: Leveraging The EU Pharma Package
24 July 2023
We're excited to announce the launch of our comprehensive position statement "Leveraging the EU Pharmaceutical
Package; A Life Cycle Approach to Address High Unmet Needs and Foster Mental Health Innovation by Incentivizing Psychedelic Novel Medicines." This document, while rooted in the EU Pharmaceutical Package, broadens the scope to encompass the full lifecycle of medicines, including critical aspects like access.
PAREA founder Interviewed on Drug Science podcast
19 July 2023
Exciting new podcast episode of Drug Science, hosted by Professor David Nutt, catches up with PAREA founder Tadeusz Hawrot and Frédéric Destrebecq, Executive Director of the European Brain Council (EBC) about the latest developments in research and clinical development with psychedelics in Europe
Psychedelic therapies are officially recognized in an EU document for the 1st time. The European Economic and Social Committee recommends further research and funding to investigate their potential in treating severe depression, PTSD, and alcohol use disorder. Read all the details in our news flash.
Psychedelics officially mentioned in EU document
13 July 2023
PAREA EU Insights July
13 July 2023
Our July edition of PAREA EU Insights is out! Stay updated on the latest EU policy news. Highlights including: New EU Mental Health Strategy with €1.23B for 20 flagship initiatives. Training 2K professionals for psychedelic therapy and a special Feature: EU HTA. Read the full EU Insights here.
Our Founder Tadeusz Hawrot speaks about the “Future of Psychedelic Medicine in the EU”, alongside Cyrus Engerer, MEP for Malta and Mikuláš Peksa, MEP for Czechia, with Steph Price moderating the PSYCH Symposium on 6th July in London, at the British Museum.
PAREA Founder speaking at the PSYCH Symposium
6 July 2023
Potential of psychedelics to transform mental health care
4 July 2023
Open Access Government publishes an article by Tadeusz Hawrot, Founder of PAREA, on the potential of psychedelic therapies in transforming EU's mental health care approach. A timely piece on the underserved area of psychedelic therapies. Read the full article here.
Australia becomes 1st country to classify psychedelics as medicines
1 July 2023
The BBC covers a historic moment in medicine. Starting today, Australia is the first country to classify psychedelics as medicines at a national level. Additionally, the Royal Australian and New Zealand College of Psychiatrists has just issued a relevant memorandum on the therapeutic use of these substances. PAREA founder, Tadeusz Hawrot, speaks with Polish television TVP World about concerns & progressions moving forward.
PAREA News Release
28 June 2023
Our latest news release is out, covering key relevant advancements in the field of psychedelics. For the 1st time the UN and EMCDDA included chapters on psychedelics in their reports. The FDA in the US issued its guidelines. Nature paper explores the potential of psychedelics in brain development.
In lead-up to the PSYCH Symposium, July 6th at the British Museum, Psychedelic Health interviews panel members Tadeusz Hawrot, founder of PAREA, and MEP for Czechia, Mikuláš Peksa about their thoughts on the future of Psychedelic Medicine in the European Union. Read about their thoughts, including parallels between psychedelics and stroke care in the interview here.
Psychedelic Health interview ahead of PSYCH Symposium
27 June 2023
PAREA presents at MAPS Psychedelic Science
22 June 2023
The largest gathering of its kind, MAPS Psychedelic Science took place in Denver, Colorado bringing 11,000 attendees together with experts and innnovators to converge and share. PAREA founder, Tadeusz Hawrot, spoke during the policy session "From research to regulatory changes: Australia, the EU, and beyond" on Thursday.
16 June 2023
Voices from the front lines, founder of PsyPAN, Psychedelic Participant Action Network, Ian Rollier is interviewed by EURACTIVE on the transformative process of the innovative mental health treatments, therapeutic value and the effects of psilocybin on depression.
Behind the scenes of psychedelic trials: Participant's perspective
First EU-wide Mental Health Initiative
7 June 2023
In solidarity, the EU Commission moves to support its citizens and their mental health and has released a comprehensive outline featuring 20 initiatives aimed at destigmatizing mental health issues and guaranteeing universal care access. €1.23 billion has been designated for this initiative. The new measures aim to improve prevention, treatment and care, plus social reintegration after recovery, truly making mental health a priority.
PAREA EU Insights May
30 May 2023
PAREA's latest EU Insights edition delves into the crucial intersection of EU policy and psychedelic science, particularly focusing on the recent transformation of EU pharma legislation. This update also introduces our new feature - a curated selection of the top psychedelic science developments. Support our mission to enjoy exclusive benefits and contribute to this ground-breaking field.
Video message marking the launch of the parliamentary group
25 May 2023
We are pleased to share a video message from the PAREA Founder marking the launch of the MEP Action Group for the Medical Use of Psychedelics in the European Parliament:
Launch of the parliamentary action group
24 May 2023
We are thrilled to announce the launch of the Members of the European Parliament Action Group for the Medical Use of Psychedelics (MEP AG), a platform to promote collective action for safe, responsible, and effective psychedelic treatments. The MEP AG, comprised of MEPs from seven EU nations, will be an important vehicle for change. PAREA, along with PsychedelicsEUROPE, provides secretariat support for the Group.
PAREA endorses the EU mental health statement
12 May 2023
As a cosignatory of the EU Mental Health in all Policies Thematic Network Joint Statement, led by the Mental Health Europe, PAREA supports the crucial importance of prioritizing mental health in all policies across Europe. Recognizing the societal and economic benefits, we urge policymakers to adopt a comprehensive, multi-sectoral approach that promotes mental health and reduces inequalities.
PAREA Founder speaking at the PSYCH Symposium
06 May 2023
Join our Founder at the PSYCH Symposium in London this July 6th, where he will be speaking about the future of psychedelic medicine in Europe.
Taking place at the historic British Museum, he will be discussing this emerging industry alongside around 350+ business leaders, key innovators & policymakers.
Use our personal discount code for 15% off your ticket. Secure your seat now.
26 April 2023
The European Commission has published a revision of pharmaceutical legislation, marking the most significant reform of the bloc's pharma rules in 20 years. This comprehensive overhaul is set to make a substantial impact in Europe and globally. PAREA has actively contributed input leading up to its publication and remains engaged in shaping the legislation during the institutional negotiations phase.
Revision of the EU pharmaceutical legislation
A need for a coordinated EU action on psychedelic therapies
24 April 2023
On 24th April, our Founder participated in the EC DG SANTE’s stakeholder event – “A comprehensive approach to mental health” and pitched for an EU-level coordination action to help member states prepare for the roll-out of psychedelic medicines. On this occasion, PAREA submitted concrete ideas on how to make this happen that you can access here.
We have just released the 3rd edition of EU Insights which can be browsed here. This newsletter will be freely available and you can subscribe at the bottom of our website. You can also help support our mission by becoming a funding supporter.
Third issue of PAREA EU Insights newsletter
20 April 2023
Submission to the EC consultations on health priorities
15 April 2023
PAREA makes a submission to the EC consultations Stakeholders' Targeted Consultation on EU4Health: future priorities, orientation and needs’. The consultation results will be used in the consultation report and will also feed into the EU4Health stakeholders’ conference on 9 June 2023.
Building for the future: Preparing for equitable access to psychedelic medicines in the EU
12 April 2023
PAREA’s Tadeusz Hawrot discusses the organisation’s recent meeting with the European Commission’s Health Directorate (DG SANTE), and the need to begin work on equitable access to psychedelic therapies in Europe in the Psychedelic Health article: Building for the future: Preparing for equitable access to psychedelic medicines in the EU.
Open Access Government editorial by Prof. David Nutt
11 April 2023
Meeting with the EC’s DG SANTE
4 April 2023
In early April, PAREA met with Stefan Schreck, Advisor for Stakeholder Relations at the European Commission DG SANTE (health directorate). Among discussed topics, PAREA emphasized a need for the EU Member States to proactively prepare for the roll-out of psychedelic medicines in order to build the necessary expertise and infrastructure for the highest quality, safe, affordable, and equitable access to psychedelic medicines.
One of the most influential psychedelic therapies media Lucid News profiled PAREA’s work in its recent article: The EU is Inching Closer to a Psychedelic Renaissance. The article covers topics like the beginnings of PAREA and the mental health political landscape in Europe. Read the full story here.
PAREA featured in Lucid News
31 March 2023
The involvement of the next generation of therapists will be crucial to expanding access to psychedelic medicine in the near future. Against this backdrop, PAREA Founder had an opportunity to sit on the panel "Psychedelic Interventions: When can psychedelic treatments be useful in a clinical context?” that took place during the 37th Congress of the European Federation of Psychology Students' Associations (March 27th – April 2nd 2023).
PAREA speaks at the psychologists’ students European congress
30 March 2023
PAREA saw a reply from the European Monitoring Centre for Drugs and Drug Addiction to the letter sent by a cross-party group of MEPs. The letter observed that some substances listed in the UN conventions have authorization for medical use. It is possible that the WHO-ECDD will consider re-evaluating these substances as the scientific evidence base changes in relation to their possible therapeutic value.
EMCDDA Director replies to MEPs
23 March 2023
PAREA Chair Prof. David Nutt provided a keynote lecture and PAREA Founder Tadeusz Hawrot brought the meeting to a close, presenting on the patient perspective at the European College of Neuropsychopharmacology meeting: New Frontiers Meeting on psychedelics which took place in Nice on 19-20 March
PAREA speakers at the ECNP New Frontiers meeting on psychedelics
19 March 2023
EMA to organize a multi-stakeholder workshop on psychedelic therapies
17 March 2023
In response to a letter from a group of cross-party MEPs calling for the EU to act fast on psychedelics, the EMA wrote that there are currently 16 clinical trials with psychedelic compounds in the EU and EMA will be holding a multi-stakeholder workshop on the topic towards the end of 2023.
Read the MEP’s letter to EMA here, the EMA reply here and the associated POLITICO article here.
EMCDDA - Technical meeting on the medical uses of psychedelics
1 March 2023
PAREA was invited to the EMCDDA’s technical meeting in early MArch 2023. This is one of the many recent signs that the European Union followed PAREA’s call to prioritise this area/to reflect on how we can prepare for the adoption of psychedelic therapies.
The more inter-agency collaboration that we can foster the better.
The past, present and future of the EU’s Horizon programmes
23 February 2023
In line with the European Commission’s effort towards Better Regulation, stakeholders were able to share their views on the performance of Horizon 2020 and Horizon Europe, as well as shaping the strategic orientations for the Horizon Europe Strategic Plan 2025-2027.
PAREA submitted a response to this consultation, read our response here->
MEPs urge European regulators to move faster on psychedelics
21 February 2023
The European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) need to play a more active role in psychedelics, say MEPs.
We are very pleased with this initiative from a cross-party group of MEPs who appreciate the important role that psychedelic-assisted therapies will likely play in addressing the pandemic levels of mental health and substance use disorders that we witness in Europe.
19 February 2023
PAREA would like to welcome:
The Polish Psychedelic Society
The Conservative Drug Policy Reform Group
The French Psychedelic Society
Sociedade Portuguesa de Aplicação Clínica de Enteógenos (SPACE)
As we continue to grow, PAREA is committed to working collaboratively with all of our supporters to expand access to psychedelic-assisted psychotherapy.
Four new supporters join PAREA
Europe needs to catch up with psychedelic research
17 February 2023
A recent PAREA editorial written by Professor David Nutt highlights that despite Europe once leading the psychedelic research field, we are now lagging behind the Americas and Australia in turning this science into clinical practice.
Read how the US, Canada and Australia are outpacing Europe.
PAREA submits feedback on EU mental health initiative
17 February 2023
PAREA applauds the new EU mental health initiative and, in particular, its objectives of support and improving access to treatment and care of mental health problems, focusing on evidence-based innovative, promising and personalised approaches and interventions, effective treatments and high-quality care.
Read more->
13 February 2023
Representatives from the European Medicines Agency, national experts from the European medicines regulatory network, and the European College of Neuropsychopharmacology co-authored a joint commentary in the Lancet: "The Therapeutic Potential of Psychedelics: The European Regulatory Perspective".
The Therapeutic Potential of Psychedelics: The European Regulatory Perspective
7 February 2023
Starting on July 1st, MDMA and psilocybin will be rescheduled and legalized in Australia for the treatment of PTSD and treatment resistant depression respectively, making Australia the first country in the world to officially recognize and regulate the medical use of these psychedelic drugs. The announcement was made on February 3rd by the Australian government’s Therapeutic Goods Administration
Australia becomes the first country to introduce psychedelic novel therapies to its medical healthcare
Rapid and durable response demonstrated in the first placebo-controlled study of DMT for depression
26 January 2023
Small Pharma announced the results of its Phase 2a clinical trial, treating moderate to severe Major Depressive Disorder (MDD) with DMT-assisted therapy.
The trial carries special significance, as it is the first-ever clinical trial attempting to treat a mental health disorder with DMT, the shorter-acting chemical cousin to psilocybin.
Second successful Phase 3 trial of MDMA-assisted therapy for PTSD
10 January 2023
The second Phase 3, philanthropy-funded, clinical trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD) was published confirming prior positive results from the first Phase 3 trial. No serious adverse events were observed among the participants. The full data, expected to be published in a peer-reviewed journal later this year, will support a new drug application to be filed with the U.S. Food and Drug Administration10 .
VJNeurology podcast with Tadeusz Hawrot
3 January 2023
In this episode, leading experts Tadeusz Hawrot; and Ellen James, Director of Research and Development, Small Pharma, discuss new research into psychedelic-assisted therapies and how the views surrounding psychedelics within the medical field are evolving.
PAREA - “We need an EU-led co-production approach”
7 January 2023
As the Biden administration establishes a federal task force to address the roll out of psychedelic medicines in the US over the next 5 years.
Europe needs to implement a similar initiative to ensure that it does not fall behind on an international level.
PAREA meeting with EMA CMO Steffen Thirstrup
14 December 2022
In December, PAREA had a second meeting with EMA Chief Medical Officer. The Agency plans two significant activities in 2023:
i) an update of its depression guidelines which will include psychedelics
ii) publishing a paper on academic and regulatory challenges in PAT, to support their development.
EMA acknowledges that regulating psychotherapy is a challenge and one of the critical issues to address will be the standardisation of therapy. The more heterogenous the PAT delivery will be across European countries, the more concerned the regulators might be.
PAREA European Parliament Event
6 December 2022
On 6th December, we organized our first policy meeting in the European Parliament, looking at the basic ingredients of psychedelic novel treatments captured in the event’s title: “Psychedelic-assisted therapies in the treatment of brain disorders”.
Over 400 people registered for online and in-person attendance, including many EU and government officials. This is a clear sign that Europeans start looking for evidence-based education on psychedelic medicines.
PAREA sends a communiqué
to EU policymakers
21 November 2022
Today, PAREA sent out a communiqué on several significant developments in the area of psychedelic science, policy and regulation that took place in the week of 14 November. You can access this by clicking on this post.
Sifted’s in-depth report on the European psychedelic landscape featuring PAREA
18 Nov 2022
“Despite numerous hurdles, it seems only a matter of time before psychedelics receive (some form of) regulatory green light in Europe.” This is how Sifted.eu - a Financial Times-backed media company covering startups and innovation in Europe – starts its in-dept report “Psychedelics for mental health. Ready for the renaissance”
This Europe-focused report assesses which psychedelic compounds are advancing through the clinical trial process. Analysing which might be best suited to a modern medical model, and considering the various risks of implementation.
This report also studies the regulatory landscape in Europe and asks which markets might open up to psychedelic healthcare soonest. Finally, it looks at the commercial models for psychedelic healthcare companies already functioning in Europe, as well as the emerging digital technologies to try and scale these treatments faster.
PAREA’s Executive Director Tadeusz Hawrot is one of the report’s contributors in Chapter two on European access
15 November 2022
This memorandum singles out the medicinal use of psychedelics (twice) and calls for the EU to become a global regulatory benchmark in this area.
This document suggests that patients ought to have access to novel interventions “including the medical use of psychedelics…especially those who remain resistant to the standard psychiatric care and treatments.”
Click the Resilient Mental Health poster to read the memorandum.
Czech EU Presidency launches a Memorandum on the Future EU Action on Mental Health includes psychedelic medicines
Whatever it is, the way you tell your story online can make all the difference.
Make it stand out
PAREA on the main stage at Wonderland Miami 2022
9 November 2022
PAREA was invited to speak at Wonderland Miami about the global regulatory approaches to psychedelics. The conference was heavily North American orientated so our European insights were a novel and welcome addition to the conference.
PAREA reacts to the largest randomised, controlled, double blind psilocybin therapy study
7 November 2022
PAREA was quoted in a POLITICO article describing the recent COMPASS clinical trial published in the New England Journal of Medicine. When asked to comment on the prevalence of adverse events in this clinical trial he responded:
”The presumed promise of psychedelic therapies could be a factor and unmet expectations could have fueled feelings of hopelessness and despair amongst non-responders to treatment.”
The MIND Foundation join PAREA
2 November 2022
We welcome the MIND Foundation to PAREA. MIND is a European non-profit science and education organization that promotes psychedelic research and therapy. Their work builds on the neurobiological and psychological potential of psychedelics to improve mental health and well-being in a clinical setting.
PAREA’s first in-person event will be hosted by the European Parliament
25 October 2022
Join us for our inaugural event in the European Parliament, co-organised by PAREA and the European Brain Council, where Europe’s leading researchers will discuss the application of psychedelic medicines in various brain disorders and will answer any questions you might have.
European Psychiatric Association joins PAREA
18 October 2022
We are thrilled to announce that the European Psychiatric Association (EPA) have joined PAREA as a Full Member!
Creating a safe and sustainable integration model will be one of the most critical issues this industry will face as we prepare for the rollout of psychedelic-based medical interventions across Europe.
The oversight and active involvement of the EPA will be indispensable in advancing these major tasks and in building significant medical oversight over psychedelic-assisted therapies in Europe.
Psychoplastogen Research Revival
13th October 2022
Pipeline Innovation Review 2022 released by the EFPIA - European Federation of Pharmaceutical Industries and Associations analyses 8 innovation areas, including psychoplastogens: psychedelics like psilocybin, dissociatives - predominantly ketamine, and empathogens - MDMA. The review anticipates that psychoplastogens are expected to reach the market in short to mid-term and present a potential paradigm shift in our approach to treating some psychiatric disorders. It adds that they are “emerging as feasible, efficacious, and toxicologically safe treatments … and offer a novel approach to MDD care, which may replace the chronic use of anti-depressants and healthcare system resources. … Psychoplastogens may have profound and enduring impact on patients' quality of life, as well as families and caregivers … and nurture enduring equity-oriented care, deepen cultural connections, and decrease socioeconomic costs”. Find out more in the full review or see selection relevant to psychoplastogens.
A deep dive by POLITICO: “Navigating the highs and lows of psychedelic therapies” in which PAREA's Founder underscores the benefits of regulatory oversight for retreats and how they could contribute with real-world evidence. We need to harness a greater understanding of how these medicines affect the body and the mind.
PAREA featured in the POLITICO Europe analysis
28th September 2022
PAREA in discussion with the EMCDDA about psychedelics for medical use
14th September 2022
PAREA met with Alexis Goosdeel, Director of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and his four colleagues. EMCDDA plays an important role in terms of providing evidence-based information to policymakers. To that end, PAREA was informed that the agency is currently working on a project to facilitate a greater understanding of the developments in the area of psychedelic substances for medical use.
A related publication is expected around April next year.
Tadeusz Hawrot meets with various policymakers in Brussels
7th September 2022
PAREA’s founder recently met with members of the European Parliament Alex Agius Saliba and Cyrus Engeler who will facilitate contacts with two EP groups: EU Medicinal Cannabis Alliance and Mental Health Coalition
Additionally, Mr Hawrot met with Tim Raemekers from DG Research, EC to discuss what opportunities for psychedelic research holds the EU Horizon Europe research programme and Magda Chlebus, from the European Federation of Pharmaceutical Industries and Associations to discuss what are the barriers for big pharma for engaging with psychedelic R&D and to discuss possible project ideas for the Innovative Health Initiative
European Medicines Agency supportive of PAREA
1st September 2022
At a recent meeting of EMA’s Chief Medical Officer Steffen Thirstrup, PAREA asked the agency to take a lead on bringing various EU institutions, agencies, scientists, and civil society together, similarly to what was done in the US earlier this year by the Federal National Institutes and National Academies. To that end, EMA could co-organize a European workshop with the US FDA and European stakeholders to discuss the future of psychedelic-assisted therapies in Europe.
PAREA met with Director for Health Systems, Medical Products and Innovation - Andrzej Ryś. The Commission is currently performing an extensive revision of the EU General Pharmaceutical Legislation and PAREA was requested to provide additional information on the psychedelic therapies, which could feed into the revision process. Additionally, following PAREA’s suggestion to organize an EU institution-led workshop exploring the future of psychedelics in Europe, the EC advised that PAREA engages with EMA in this regard. EMA would be best placed to organize such an event with the US NIH/FDA and in collaboration with other EU institutions.
Meeting with the European Commission’s DG SANTE
22nd August 2022
The DEA decide to withdraw their psychedelic censorship
5th August 2022
The US Drug Enforcement Agency (DEA) recently withdrew a proposal to ban five psychedelic substances thanks to an expert submission from PAREA chair - Professor David Nutt.
PAREA submits video evidence at the European Academy of Neurology 2022
2nd August 2022
Tadeusz Hawrot features in three videos at the 8th Congress of the European Academy of Neurology in Vienna for the Video Journal of Neurology - an independent, global, open-access video journal, dedicated to providing trusted and up-to-date information in order to improve the awareness and understanding of neurology
Tadeusz Hawrot met with Hugh Laverty, Head of Scientific Operations and Elisabetta Vaudano, Principal Scientific Manager & Responsible Strategic Area Neuroscience. In this meeting they discussed methods to translate health research and innovation into tangible benefits for patients and society, and ensure that Europe remains at the cutting edge of interdisciplinary, sustainable, patient-centric health research.
PAREA meets with the Innovative Health Initiative
27th July 2022
EU4Health - PAREA’s suggestions were accepted
8th July 2022
PAREA’s proposal to have an EU mental health strategy was acknowledged alongside ideas from other stakeholders. These suggestions were made into a poster format and shared with several hundreds of participants at a recent online EU4Health meeting. The Commission will also share all the posters with the relevant EU member states’ health authorities.
2023 Stakeholders Targeted Consultation on EU4Health
27th June 2022
EU4Health is seeking the opinions of stakeholders about current and future EU health priorities, strategic orientations and key health needs to be addressed through EU4Health annual Work Programmes.
PAREA recently submitted a contribution to this consultation arguing that psychedelic-assisted psychotherapy ought to be a key priority for EU healthcare over the next few years.
Parliament Magazine
23rd June 2022
New EU partnership PAREA sets to pave the way for psychedelic-assisted therapies to help patients in areas of huge unmet needs says Tadeusz Hawrot, founder and policy lead at PAREA.
PAREA members launched a Call to Action to European decision makers-bringing together our key priorities and policy asks.
Alliance launches to advance psychedelic healthcare in Europe
20th June 2022
“The Psychedelic Access and Research European Alliance (PAREA) is aiming to advance the dialogue around the implementation of psychedelic healthcare in Europe.” - Psychedelic Health
Joint Statement on an Inclusive Pharmaceutical Strategy
June 16th, 2022
For the first time, in known history, EU policy recommendations were made featuring psychedelic-assisted psychotherapy.
”New models of innovative/unusual treatments when they target unmet needs or vulnerable situations, for instance, psychedelic assisted therapies for brain disorders, which constitute a paradigm shift in the pharmacological space because these therapies will need to be registered as both a medicinal product and therapy.”
Shared European Brain Research Agenda
June 1st, 2022
PAREA provided recommendations on future areas for excellent, innovative and translational brain research in Europe. Shared European Brain Research Agenda covers all brain research fields and brain disorders, including both psychiatric and neurological disorders and will serve as a framework to guide future brain research investments in Europe.
A New European Innovation Agenda
May 23rd, 2022
PAREA calls on the EU to embark on more research activity and to stimulate innovation with regard to the use of psychedelics for medicinal purposes.
Psychedelic Medicines and non-communicable diseases
May 20th, 2022
The European Commission is working on a new ‘Healthier Together’ – EU Non-communicable diseases initiative to support EU countries in reducing the burden of NCDs, focusing on 5 key areas, including mental and neurological disorders. PAREA contributed to this initiative by making a detailed submission as part of the stakeholder consultations
PAREA invited to speak at Psychedelic Capital 2022
May 18th, 2022
A part of the bi-monthly investor series, this virtual Microdose Conference explores the new technologies driving the industry, the scope of psychedelic investments and the prospects. It offers a forum to connect businesses to the top capitalists and investors of the psychedelic spectrum. These online sessions offer tremendous networking scope where businesses build strong ties and associations.
