Welcome to the May edition of EU Insights, where we delve into the monumental overhaul of the EU pharma legislation. A first in two decades, this sweeping reform promises to leave a deep imprint, not only within Europe but on a global scale through its ripple effect across free trade agreements.

In equally groundbreaking news, we're proud to have played a pivotal role in the launch of the MEP Action Group for the Medical Use of Psychedelics.

And as we wrap up, don't forget to check out our new feature, a curated selection of the month's top psychedelic science updates.

So, let's jump in and explore together!

Tadeusz Hawrot PAREA Founder & Executive Director

PS. This newsletter is now freely accessible, thanks to the backing from our two tiers of supporters - individuals and organizations. By becoming a supporter, you'll enjoy a range of exclusive benefits including in-depth reports, real-time alerts, and access to previous issues. If you share our passion for advancing psychedelic access and research in Europe and want to contribute to our mission, we warmly invite you to become a funding supporter. We're happy to extend the special rate by one more month. Your involvement can make a substantial difference.

During the European Mental Health Week, Members of the European Parliament (MEPs) launched the MEP Action Group for the Medical Use of Psychedelics, aiming to set the course for the advancement of psychedelic therapies in the EU.

Led by 10 MEPs from Czechia, Belgium, Malta, Portugal, Luxembourg, Finland, and Poland, the group is devoted to steering institutional discussions on the therapeutic use of psychedelics, fostering sound EU policies and regulations, and ensuring equitable access to these novel treatments.

The action group will serve as an educational platform for policymakers, promote pan-European scientific cooperation, and advocate for EU-funded research to increase clinical evidence for psychedelic medicines. Additionally, it aims to safeguard optimal patient care, guide treatment development with public health benefit in mind, and push for a harmonized EU policy and regulatory framework.

The establishment of the group is a significant EU achievement, and PAREA has played a critical role in its formation.

Empowering the Next Generation: PAREA's Engagement at the European Federation of Psychology Students' Associations Congress

A cornerstone of PAREA's mission is to inform Europe's scientific communities about the latest advancements in psychedelic therapies and to underscore the collective effort required for their successful implementation.

A particularly pivotal group of healthcare professionals in this arena is psychologists. We were therefore delighted to participate in the annual congress of the European Federation of Psychology Students' Associations.

Our engagement with such platforms emphasizes the importance of integrating young professionals into these discussions. These future leaders, currently determining their career paths, play a crucial role in shaping the direction of mental health care, including the adoption of innovative therapies like psychedelics. Their involvement ensures that our strategies resonate with the next generation, fostering a robust foundation for future psychedelic research and implementation.

Navigating the Path to Psychedelic Medicines: PAREA’s Insightful Dialogue with the European Commission

In an enlightening meeting with an Advisor for Stakeholder Relations at DG SANTE, European Commission, we at PAREA outlined the unique trajectory of psychedelic medicines and the need for strategic infrastructure and expertise development for their effective rollout.

The advisor highlighted the complexities surrounding healthcare systems and emphasized the importance of a bottom-up approach for coordination and implementation of these novel therapies, wherein Member States actively express interest and identify implementable priorities. However, Schreck also noted the prevalence of a "progress by catastrophe" trend, pointing towards reactive rather than proactive policy development in many cases.

We expressed concerns about the delays that a purely reactive stance could entail, particularly in regards to the significant impact these medicines could have on the mental health landscape. We were invited by the European Commission to continue educating EU policymakers and countries about the potential of psychedelic medicines.

A detailed report of the meeting is available to our paid subscribers.

EU Mental Health Strategy: Proposing a Roadmap for EU Integration of Novel Psychedelic Treatments

In 2022, European Commission (EC) President Ursula von der Leyen revealed the Commission's plan to introduce a new comprehensive approach to mental health in 2023, slated for publication in June. In the lead-up to this event, the EC sought stakeholder input through public consultations and meetings. PAREA actively participated in these discussions, providing valuable insights during the February consultations, and subsequently at a consultative meeting earlier this month. As a focal point of our contributions, we proposed a concrete action, “Develop the infrastructure and expertise for a meaningful EU rollout of psychedelic novel treatments” embodied in a detailed poster submission.

In the poster we submitted, PAREA advocated for the strategic development of infrastructure and expertise for a successful EU rollout of novel psychedelic treatments. We highlighted the emerging global acceptance of these treatments and emphasized the need for proactivity in creating comprehensive guidelines for their use, including safety standards, ethical norms, professional education, and data standards. This approach aims to address existing challenges in mental health care, foster innovative treatments, and ensure safe, ethical, and equitable access to these potentially life-changing therapies. With our broad collaboration network and strong institutional connections, PAREA is primed to help guide this transformative initiative.

The Latest From Europe

Reshaping the landscape: the bold revision of EU Pharma Legislation and its impact on medicine access and innovation

Currently, there is a massive access inequity across the EU. The number of novel medicines approved as of 2018 varies from more than 100 in the most wealthy countries to less than 20 in Latvia, Lithuania, and Croatia. In addition, the average waiting time in the block for new medicines differs from 4 to 29 months.

The recently published revision of the EU pharma legislation intends to balance pharma incentives and accessibility to ensure that all EU patients have timely and equitable access to safe and effective medicines, regardless of which member state they live in. It introduces measures to reduce red tape and incentivize drug development that society needs. It also provides an opportunity to address challenges such as those posed by new types of medicines and increasing blurring of boundaries between different types of products.

One of the most important changes is removing two years of data protection from all new medicines launched in the EU, bringing it down to 8 years from 10 years currently. Drugs that are launched throughout the bloc, meet unmet medical needs, or go through rigorous head-to-head clinical trials, can get that competition-free period back.

To incentivize pharmaceutical innovation in Europe, the legislation sets out measures simplifying the regulatory framework for the development of new medicines. At the moment, the EU approval times of new drugs span on average 400 days while it’s 244 days in the US. To address this, the EMA assessment time would go down from 400 days to 180 days for standard procedures and 150 days for accelerated procedures. T. The Commission says that the highest quality, safety, and efficacy standards for the authorisation of medicines will be maintained.

Publishing the proposal is only the beginning. It is now up to the European Parliament and Council of the EU to find a common ground ahead of trilogues (co-legislative process of those three key EU institutions). Given that the file is highly political, the negotiations will be long and heated and it is not clear whether they will be concluded before the next EU elections in 2024 (likely in May).

Paying subscribers can access our more detailed analysis of the strategy here.

Pharma's Response to Access Inequities:

Read on to better understand the future access challenges for psychedelic therapies in Europe.

As highlighted in the article above, access to new treatments in Europe is uneven at best. If you're living in Germany, you'll typically be able to use a new medicine about 128 days after its approval - the fastest period in Europe. However, if you reside in Bulgaria or Malta, it might take as much as 918 and 1351 days respectively. On average, across Europe, it takes about 517 days for new drugs to reach patients.

In addition, the availability of new medicines to patients can vary significantly from one country to another. Consider the 168 new medicines that were approved in Europe between 2018 and 2021. In Germany, people can access almost 90 percent of these. However, in Malta, which ranks last in this regard, only six percent of these drugs are available to patients. The average for Europe as a whole is about 45 percent.

The pharmaceutical industry attributes these delays in accessing new drugs to national health systems. The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued several reports about the availability of new medicines across Europe. These reports provide detailed information about the causes of these delays and hindrances in care, and suggest practical ways to make the distribution of new medicines in Europe more equitable. According to their findings, approximately 25% of the delays are caused by the companies' own product launch processes, while the remaining 75% of the wait time is due to countries' pricing and reimbursement setups for new drugs.

This response from the pharmaceutical industry comes in the wake of the recent publication of the EU's revised pharmaceutical strategy, which attributes a large part of the responsibility for uneven access to medicines in Europe to the pharmaceutical industry itself.

Parliament’s health committee prioritizes mental health

At a recent meeting, the Subcommittee on Public Health, also known by its acronym SANT, agreed to focus on several key health issues. These include mental health, non-communicable diseases (NCDs), and improving rules surrounding nutrition and health claims—specifically, what companies can and cannot claim about how their products affect health. The members plan to tackle these issues by producing reports, holding hearings on NCDs and mental health, and evaluating the effectiveness of current rules around nutrition and health claims. They also intend to review the regulations concerning medicines in the EU.

PAREA is committed to playing an active role in discussions with SANT members. We are devoted to ensuring that innovative approaches to mental health, such as psychedelic therapies, are considered in these critical mental health discussions. Earlier this month, we met with an office of the ENV Chair to ensure that our priorities are taken into account in the committee’s work.

Efforts underway to reduce multiple Health Technology Assessments (HTA) in the EU

Read on to understand better the future of HTA in Europe, a crucial factor for accessing psychedelic therapies in the future.

HTA is critical for access, as it is at the heart of reimbursement and pricing decisions. It extends beyond the clinical assessment of an intervention and takes into account financial and economic constraints that lead to decisions on what is included in the basket of covered services and at what price. The evidence of effectiveness pertains to the actual net benefits produced by interventions in regular settings and under usual practices, which may markedly differ from those of most clinical trials.

The HTA landscape in Europe has been complex and fragmented. Each EU member state has its own HTA body with distinctive evidence requirements. This situation creates significant additional work and uncertainty for developers and delays access to new therapies.

The question of whether multiple HTA procedures in the EU can be reduced lingered in the air at a recent meeting about the transition to an EU-wide HTA system, with no clear answer just yet. However, hope is on the horizon as efforts are being made to streamline the system and limit the need for drugmakers to submit multiple HTA files.

One of the first pilot projects is testing what data EU countries require to evaluate certain cancer treatments and advanced therapies. To avoid duplicated assessments, there's a push for close alignment on decisions such as which patient groups to include and which existing treatments to compare. Some common data needs have already been agreed upon.

The first meeting of the newly formed stakeholder network for the HTA regulation is set to take place in June.

European start-up funding challenges remain despite Commission optimism

Despite the European Commission's upbeat expectations, a sobering survey reveals that European start-ups are continuing to grapple with major obstacles in acquiring necessary funding. \

The data reveals that a significant 58% of start-ups face challenges in securing follow-on funding, while 42% report difficulties in obtaining their crucial initial funding.

While the European Innovation Council (EIC) Fund has made strides to support many start-ups through direct equity investment, the survey suggests that the fund's €3.5 billion budget is not enough to entirely bridge the existing funding gap. This points to a clear need for increased support and resources for these budding enterprises.

Against this backdrop, the European Commission has just reorganized its research department (DG RTD) to give it better oversight of the EIC. According to informal Commission sources, the change acknowledges the political importance of scaling up technology companies and ensuring Europe builds its capability in transferring technology from the lab to market. The EU intends to take a more proactive role in promoting company scale up through measures including improving access to finance for start-ups, simplifying rules for listing on public stock exchanges, updating conditions for regulatory sandboxes, providing deep tech training for one million people and introducing clearer innovation terminology and indicators.

EU-US Collaborative Health Task Force: An Inspiration for Psychedelic Research?

The new EU-US Health Task Force, recently presented, prioritizes combating cancer and global health threats With a strong focus on prevention, detection, and care, this initiative will blend expertise from both regions' individual cancer combat plans: Europe's Beating Cancer Plan and the US's Cancer Moonshot. In addition to tackling global health threats like the COVID-19 pandemic, the task force aims to enhance surveillance, technology development, and clinical trials.

The emphasis on transatlantic cooperation, particularly in clinical trials and technology development, could serve as a blueprint for future initiatives in novel mental health treatments. It symbolizes a cooperative move towards a more integrative approach to global health crises, which could benefit emerging sectors such as psychedelic research.

AI's transformative role in clinical trials: the advent of personalized clinical research

AI is changing the landscape of drug development and clinical trials, paving the way for more precise and personalized medicine. Gary Shorter, head of AI at IQVIA, recently explained to POLITICO how AI, with the aid of synthetic data, enhances our understanding of drug efficacy and safety in specific patient clusters.

Shorter describes the process as a 'real-time feedback' mechanism where trial data is continuously assessed and compared to predictions, allowing adaptations along the way. For instance, it enables personalization of drug dosage based on individual genomics and biomarkers.

With this progressive approach, regulatory authorities need to be actively involved throughout the trial process, monitoring drug development and understanding the planning and processing steps. With advances in technology, regulatory oversight can now be exercised remotely through an orchestration system platform.

The AI revolution, while complex and data-heavy, is inexorable and promises greater precision in medicine. The wealth of data available enables more informed prescription decisions, tailoring treatments to individual patients.

EMA enhances PRIME program: a boost for medicines targeting unmet needs

The European Medicines Agency's (EMA) Priority Medicines scheme (PRIME) is set to expand, as per a report reflecting on its first five years. PRIME, established in 2016, streamlines the regulatory process for companies working on treatments for unmet medical needs, ensuring they gather the right data for quicker application processing. To date, 22 medicines have been approved with PRIME's support.

Now, EMA plans to introduce a year-long pilot program providing additional scientific advice to PRIME-designated drug candidates who've already received initial assistance. A roadmap and a product development tracker will be introduced for promising medicines.

In addition, about a year before marketing authorisation application submission, developers will have the chance to meet with EMA experts in a "submission readiness meeting". This forum allows applicants to discuss prior advice received and the status of their data package, ensuring they're prepared for submission to EMA.

A call for automatic expanded indications for drugs

The Anticancer Fund advocates for the EMA and other regulators to proactively initiate the expansion of a drug's indications as soon as new supporting evidence emerges, according to an article in the Lancet.

Currently, regulators keep a close eye on safety data coming from the use of medicines. But it’s not the case when it comes to efficacy. It’s up to companies that own the patents to the drugs to go through the regulatory process to add new indications (drug repurposing). For old, off-patent medicines however, it might simply not be worth the cost to go through the regulatory hurdles to get the label extension, to the detriment of patients.

To remedy this, the Fund suggests the establishment of a 'Drug Evidence Watch' mechanism. The concept entails regulators taking the initiative to collect evidence for a label extension when a drug exhibits potential effectiveness in treating an additional disease.

Boost to UK Life Sciences Sector: Opportunities for Psychedelic Therapies Development

The UK Treasury recently introduced a suite of measures to bolster the life sciences sector. The improvements include significant regulatory changes, enhanced clinical trials procedures, and increased funding.

In response to industry reviews, the Chancellor pledged to streamline the approval process for clinical trials, accelerate clinical research, and improve access to real-time data through new Clinical Trial Acceleration Networks. Additionally, a significant funding allocation is directed towards medicines manufacturing, local R&D, and mental health initiatives.

However, it's worth noting these positive changes follow a period of decreased export value for the sector and the UK falling behind Europe, the U.S., and China in hosting clinical trials. There are also ongoing debates about improving the current drug pricing scheme.

Selected psychedelic medicines' global news

Building for the future: preparing for equitable access to psychedelic medicines in the EU PAREA Founder Tadeusz Hawrot writes for Psychedelic Health

EU lawmakers to steer discussions on therapeutic use of psychedelics EURACTIVE

Psychedelic MEPs POLITICO Morning Healthcare Bulletin

Psychedelics milestone for Europe: MEP Action Group launches Psychedelic Health

Global Conversation On Psychedelic Therapy: Perspectives From Europe And The UK Read about PAREA work in Europe in the Benzinga analysis

American Medical Association to Issue First New Code for Psychedelic Therapies Psychedelic Alpha

US could soon approve MDMA therapy — opening an era of psychedelic medicine Nature

Emerging Challenges for Psychedelic Therapy JAMA Psychiatry

The effect of lysergic acid diethylamide (LSD) on whole-brain functional and effective connectivity Nature

The Latest Promising Long COVID Treatment? Psychedelic Drugs Time

Prozac Lessons: 5 Questions for drug historian David Herzberg The Microdose

American Medical Association to Issue First New Code for Psychedelic Therapies Globe Newswire

Could Psychedelics Replace Antidepressants In Patients With Advanced Cancer? ScienceAlert

The Top 5 Psychedelic Clinical Trials of 2022 Psychedelic Alpha

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