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Dear Readers,
There's no more fitting way to begin this newsletter than
by honouring the late Dr. Roland Griffiths, Ph.D., who
passed away earlier this week. A distinguished
psychopharmacologist at Johns Hopkins University, Dr.
Griffiths is widely credited with revitalizing medical
research on psilocybin. He notably led his first clinical
trial on the substance back in 1999. While he may not be
here to witness the full impact of his groundbreaking work,
the significance of his contributions will undoubtedly
continue to resonate long after his passing.
As we look forward to the European Parliament elections in
June 2024, EU political parties are busy crafting their
election manifestos. PAREA is joining this important
conversation with the release of our own manifesto. Our aim
is to shape priorities in health policy, with a specific
focus on mental health. Alongside this, we're developing an
implementation toolkit for engaging national MEP candidates.
If you are active in national policies or organizations that
focus on the therapeutic use of psychedelics within the EU,
we encourage you to get in touch. Together, we can ensure
that our future MEPs prioritize mental health and embrace
innovative treatment approaches.
In another significant development, the European Medicines
Agency (EMA) has published updated draft depression
guidelines, now including a section on psychedelic
therapies. This inclusion was mentioned as one of the
motivating factors for the EMA's decision to revisit the
guidelines, as we learned in a recent meeting with them.
Another key discussion during the meeting concerned the
upcoming EMA multi-stakeholder workshop on psychedelics,
slated for April 2024, in Amsterdam. Additional details on
our meeting with EMA can be found below. But first, consider
registering for the upcoming event on psychedelic therapies
taking place in the European Parliament.
With best wishes,
Tadeusz Hawrot
PAREA
Founder & Executive Director
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PAREA News
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European Union funds groundbreaking
research into psychedelic therapy
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A €6.5 million grant from the EU’s Horizon Europe program
has been awarded to a European consortium of 19 partners for
a groundbreaking study on psilocybin's potential in treating
psychological distress in palliative care patients with
progressive, incurable illnesses. Led by the University
Medical Centre Groningen, the PsyPal trial is the first
EU-funded multisite clinical study on psychedelic-assisted
therapy, with PAREA facilitating its realization. PsyPal
will investigate whether psilocybin therapy can alleviate
distress in patients with COPD, MS, ALS, or APD across four
clinical sites in Europe, starting in early 2024. This trial
marks a significant step in evaluating psilocybin's safety
and efficacy outside oncology contexts. With funding
entirely from Horizon Europe, PsyPal aims to address the
profound psychological and existential challenges faced by
patients with incurable diseases, offering a novel approach
to palliative care that integrates psychotherapy and
pharmacotherapy. Through interdisciplinary collaboration,
PsyPal seeks to enhance patients' well-being beyond
conventional treatments.
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MEP Action Group for the Medical Use
of Psychedelics submits Parliamentary questions to the
European Commission
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In December, the MEP Action Group for the Medical Use of
Psychedelics presented inquiries to the European Commission
regarding the prioritization of innovative mental health
treatments within the EU R&I sphere. Today, Health
Commissioner Ms Kyriakides provided a comprehensive
response, shedding light on various EU mental health
initiatives and unveiling plans for a substantial €500
million partnership on brain health. Her insights resonate
strongly with PAREA’s advocacy for collaborative efforts in
advancing psychedelic therapies. Additionally, the
Commissioner delved into the pressing issue of unmet medical
needs, a focal point addressed in our recent policy paper.
We anticipate further discussions on this matter at an
upcoming event, details of which will be shared soon. Read
the full reply here.
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Selected
psychedelic medicines' global news
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Redefining patient and societal
health-related needs
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To mark the 2024 Belgian EU Presidency, the Belgian health
presidency team and the European Observatory on Health
Systems and Policies collaborated to focus on key priorities
for the next Commission’s agenda regarding the European
Health Union. One of these priorities centred on unmet
needs, culminating in the paper: “Identifying
disease-specific patient and societal needs to
foster needs-driven healthcare and innovation
policies in the EU”, spearheaded by
researchers from the
NEED project.
The proposed
life-cycle approach in the paper involves (1) identifying
disease-specific health-related needs at both individual and
societal levels, (2) creating a needs evidence database, (3)
ranking diseases based on the relative importance of these
needs, (4) creating smart and predictable incentives for
health intervention developers and researchers to focus
R&D on the highest needs, and (5) approval and
reimbursement processes that consider the performance of new
health interventions against these needs.
The
paper includes the shift in language from (high) unmet
medical needs to patient and societal health-related needs,
and distinguishes between patient and societal
dimensions.
If this emerging framework is adopted, it could have
far-reaching implications. By fostering a needs-driven
ecosystem in healthcare and innovation, it can influence
public health domains such as redirecting pharmaceutical
research priorities by steering incentives towards
interventions that most effectively meet patient and
societal needs (though it needs to be recognized that pharma
R&D decisions are complex for various reasons), reshape
EU research funding prioritization and influence HTA/payor
decisions in areas like willingness to pay (the paper also
offers valuable recommendations regarding the EU HTA
Regulation).
In November 2023, PAREA released a
policy paper on unmet needs which overlaps in many areas
with the NEEDs work.
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Leaked Document Unveils EU's Bold
Biotech Leadership Ambitions
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The European Commission plans to significantly elevate the
EU’s biotechnology sector's standing on the global stage
with an ambitious initiative slated for early 2024.
According to internal documents, biotech will be designated
as “one of the critical technologies for the EU’s economic
security”. The strategy is set to enhance competitiveness
across the biotech landscape, encompassing medical,
industrial, and agricultural applications. Biopharma takes
central stage with plans to stimulate demand for
biotech-based products, possibly through legislative
measures, and to bolster the sector by enhancing
intellectual property rights protections. The draft strategy
stresses the need to regain “European leadership for health
biotech” focusing on "public health benefits, new
treatments, more tailored treatments” and “fostering an
enabling environment for clinical trials”. The Commission
plans to focus on R&D, supporting early-stage biotech
companies that often struggle to secure traditional
financing. The document mentions the need to support
“consolidation of investment funds, including venture
capital, stock exchanges and post-trading infrastructure”.
The initiative also includes proposals for increased funding
in medical research and the creation of a comprehensive
European biopharmaceutical strategy. This move comes as the
EU seeks to close the gap with the U.S., where public
investment and policy initiatives have propelled the biotech
sector
forward. By prioritizing biotechnology, the Commission aims
to assert the EU's leadership in this critical,
fast-evolving industry. PRO subscribers can read our
detailed description of the initiative here.
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Challenges ahead: EuropaBio warns of
EU pharma reforms disproportionate effect on biotech
SMEs
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A recent
report by EuropaBio, representing
Europe's biotech sector, cautions that the EU’s General
Pharmaceutical Legislation (GPL) proposal might
disproportionately affect SMEs. The report argues that the
GPL overlooks the diverse impacts on the innovation
ecosystem, particularly for companies at different stages of
maturity. It suggests that the legislation could increase
uncertainty for biotech firms, with potential reductions in
protections and uncertain benefits at later stages. This
change in the incentive structure could influence decisions
by both innovators and investors, affecting Europe’s
healthcare and innovation landscape, and ultimately patient
care. The report highlights that increased uncertainty may
hinder investors' ability to evaluate their investments,
impacting smaller and emerging companies more
severely.
While the GPL proposes some beneficial changes, like
streamlining regulatory processes, these are seen as
insufficient to counterbalance the negative aspects. The
report warns that reduced incentives could further
complicate market access, diminishing Europe’s appeal for
investment and novel medicine development. This could lead
to delays in European patients accessing new treatments,
impacting the biopharmaceutical sector compared to other
global regions.
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Accelerating innovation: how
priority review vouchers could fast-track psychedelic
therapies in Europe
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The concept of Priority Review Vouchers (PRV) is gaining
traction as a potential boon for developers of novel
therapies in Europe, with new research
published in the British Medical Journal
suggesting such vouchers could net over €100 million. This
innovative approach, distinct from the Commission's
exclusivity voucher for antibiotics, offers a "skip the
line" benefit for regulatory assessments by the European
Medicines Agency, potentially accelerating market entry and
revenue generation. Alternatively, the voucher could be
sold, permitting another pharmaceutical company to advance
in the queue for their drug's review.
Quicker assessments, if successful, lead to expedited
approvals, thus accelerating revenue generation. The BMJ
study concludes that a European voucher that could speed up
approval by 182 days would generate more than €100 million
in revenue for each product.
This proposal emerges as the EU institutions negotiate the
pharmaceutical package, which includes various incentive
proposals. Amid these discussions, several months ago PAREA
has issued a position paper advocating for similar
incentives to stimulate the development of novel mental
health treatments, including psychedelics.
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Medical Cannabis in Ukraine: A New
Era of Treatment Options Begins
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Ukraine has taken a historic step by legalizing medical
cannabis, with President Volodymyr Zelensky signing the bill
into law, targeting a 2024 rollout for treatments. This
legislation, aimed at conditions like pain, cancer, and
PTSD, could benefit millions, reflecting a significant shift
in healthcare policy. The law allows for both the
importation and future cultivation of medicinal cannabis,
with stringent prescription and distribution protocols akin
to models in Portugal and Germany. Only about 200 of
Ukraine's 18,000 pharmacies will be licensed to distribute
these medicines. This development not only marks a critical
advancement in medical treatment options but also sets a
potential framework for incorporating psychedelic therapies.
Full details on this legislation and its implications for
psychedelic therapies can be found here.
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EU Commission opens door to medical
cannabis initiative
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The European Commission has taken a
tentative step towards facilitating
cross-border medical cannabis access by approving a
European citizens’ initiative for easier
legal cannabis access. Spearheaded by the European Cannabis
Initiative, this proposal faces the challenge of gathering
one million signatures from at least seven EU countries
within a year. The initiative aims to enhance access to
medical cannabis for therapeutic uses across the EU and
boost research into its benefits. Despite this progress, the
Commission has not approved a proposal for a European
citizens’ assembly to review cannabis policies, citing
technical reasons. This development signals a potential
shift in the EU's approach to medical cannabis.
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EU Health Budget Faces Cuts to
Support Ukraine Aid, PAREA and Civil Society React
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In a worrisome development for public health, the European
Council has announced a €1 billion reduction in Europe's
health budget to contribute to the €50 billion aid package
for Ukraine. This cut represents a substantial 20% reduction
from the €5.3 billion allocated to the EU4Health program for
the 2021-27 period.
Funds are also being redirected from other crucial areas,
including the EU’s Horizon research program, and the
cohesion fund. This decision has sparked concern among
various stakeholders, including the EU4Health Civil Society
Alliance, a coalition of 31 civil society organizations.
Earlier this week, the alliance expressed its disappointment
in a letter to Belgian leaders, highlighting the critical
impact of reallocating funds from the health budget. PAREA
is member of the alliance and co-signed the letter.
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EU Joint HTA Implementation Faces
Delays: Impact on Clinical Assessments
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The European Commission has announced delays of 3-6 months
in publishing most implementing acts for the EU Joint Health
Technology Assessment, crucial for starting joint clinical
assessments by January 12, 2025. Key among these is the act
defining joint clinical assessments terms, now postponed to
Q1 of this year, with only six weeks left to meet this vital
deadline. Additional delays affect acts on managing
conflicts of interest and information exchange with the
European Medicines Agency. Training for national assessors
and HTA authorities, along with patient and clinical expert
training, has also seen extended timelines. These delays
raise concerns about readiness for the new HTA processes at
both EU and national levels. A full description is available
for Pro
subscribers, along with earlier PAREA
analysis on HTA.
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EIC's €675 million bet on European
tech sovereignty in 2024
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The European Innovation Council (EIC) is investing €675
million into promising startups in 2024, aiming to bolster
Europe's tech sovereignty. Despite a reduced budget from
previous years, the EIC's commitment to nurturing the next
generation of European tech leaders remains strong amidst
geopolitical tensions. The EIC Accelerator will distribute
funds through challenges and open calls, focusing on areas
like AI, health, and renewable energy. This initiative is
part of the EU's broader strategy to reduce dependency on
tech imports and enhance its global competitiveness. The
EIC's approach includes direct Commission investments in
startups, aiming to bridge the gap from lab to market. PRO
subscribers can read our detailed analysis here.
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