EU Insights May 2024

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PAREA NEWS

In April, EMA held a 2-day pivotal workshop to discuss the evolving regulatory landscape for psychedelic substances within the EU. It served as a platform for dialogue among various stakeholders, including patients, regulators, academics, clinicians, and industry representatives. PAREA's Chair Prof. David Nutt and representatives from several PAREA member organizations were attending and giving presentations.

 

PAREA's Tadeusz Hawrot presented on the global and EU legal status of psychedelics and called for a creation of a pan-European multidisciplinary advisory body or commission on novel therapies to combat the mental health crisis.

 

The event underscored a keen interest by the EMA to understand and potentially shape the future of psychedelic therapy and research. It tackled several key themes, focusing on the relationship between psychedelic substances and psychotherapeutic interventions, the challenges of standardizing therapeutic protocols, and the intricacies of conducting clinical trials in a regulatory environment that is still in its formative stages.

 

A notable aspect of the discussions was the emphasis on the need for a clearer guidance from regulatory bodies to help navigate the complex interplay of drug therapy and psychotherapy in clinical settings. The workshop also highlighted ongoing debates such as the role of 'set and setting' in psychedelic therapy, the importance of patient safety, and the need for standardizing the reporting of adverse events.

 

The workshop marked a significant step in fostering regulatory engagement and dialogue to support the safe and effective integration of psychedelic therapies into the European medical framework.

 

All presentation are available on the EMA website and the recording will be shared soon.

Following the EMA workshop on psychedelics, Dr. Steffen Thirstrup, Chief Medical Officer of the European Medicines Agency, participated in a Q&A session to delve deeper into the EU's regulatory stance on psychedelic therapy. This discussion served as a continuation of the multi-stakeholder dialogue, emphasizing the EU's readiness to adapt to new developments while upholding rigorous safety and efficacy standards.

 

During the session, Dr. Thirstrup underscored the importance of comprehensive clinical trials that meet both patient and regulatory needs, focusing on the sustainability of treatment effects and the necessity for re-treatment evaluation. He reiterated the EMA's commitment to fostering innovation through strategic advice and collaborative engagements with various stakeholders, including SMEs and academic institutions.

 

In response to a question from PAREA's Founder about using US clinical data for early access in the EU, Dr. Thirstrup clarified that while the EMA is willing to look at the FDA’s data, approvals must align with specific EU regulatory frameworks, ensuring independent evaluation within the European context.

 

You can watch the recording here and read the detailed meeting’s summary here. 

 

 

Following the EMA workshop on psychedelics, Dr. Steffen Thirstrup, Chief Medical Officer of the European Medicines Agency, participated in a Q&A session to delve deeper into the EU's regulatory stance on psychedelic therapy. This discussion served as a continuation of the multi-stakeholder dialogue, emphasizing the EU's readiness to adapt to new developments while upholding rigorous safety and efficacy standards.

 

During the session, Dr. Thirstrup underscored the importance of comprehensive clinical trials that meet both patient and regulatory needs, focusing on the sustainability of treatment effects and the necessity for re-treatment evaluation. He reiterated the EMA's commitment to fostering innovation through strategic advice and collaborative engagements with various stakeholders, including SMEs and academic institutions.

 

In response to a question from PAREA's Founder about using US clinical data for early access in the EU, Dr. Thirstrup clarified that while the EMA is willing to look at the FDA’s data, approvals must align with specific EU regulatory frameworks, ensuring independent evaluation within the European context.

 

You can watch the recording here and read the detailed meeting’s summary here. 

Emerging EU framework for unmet patient and societal health needs.

On 17 and 18 April, the Belgian presidency of the Council of the EU organised a high-level conference on health-related needs as drivers for healthcare policy and innovation with the aim to establish a research and innovation ecosystem that focuses on the most pressing health needs. PAREA was invited by the Presidency to attend, being represented by its Founder Tadeusz Hawrot and Vice-Chair (and Executive Director of the European Brain Council), Frédéric Destrebecq.

The conference is building on the work of the NEED project spearheaded by KCE, which is developing an EU scientific framework for assessing unmet patient and societal needs. It shifts the discussion from narrowly defined unmet medical needs to the health needs of both patients and society as a whole. Such an approach could steer current supply-driven innovation to a need-driven system, redirecting innovation and financial ecosystems towards those needs. This work can also expand traditional 'value for money' HTA evaluations and economic methods by including and measuring wider social, economic, and environmental outcomes and impacts.

 

While the FDA is poised to approve first psychedelic-assisted therapy for PTSD later this year in the US, the outlook for regulatory approvals and patient access in Europe is markedly more distant. To address this gap, PAREA is co-organizing the Pathways to Access Summit on June 5th, 2024, in Haarlem, Netherlands, alongside the OPEN Foundation and other European partners.

 

The Paths summit will bring together key stakeholders from government, industry, non-profits, patient organizations, and regulatory bodies, including the European Medicines Agency. Together, we will explore the specific opportunities and challenges that shape the development, approval, and integration of psychedelic medicines within the mainstream European healthcare system. Discussions will include critical areas such as EU requirements for clinical trial designs as well as pricing and reimbursement assessments.

 

As a special incentive, use our exclusive co-organiser discount code: PAREA100, to receive €100 off (33% discount) your ticket. Secure your place and discover more about the summit here.

 

A pre- Paths Summit Online Q&A is taking place on Thursday 16 May, 8PM CEST (7PM GMT, 2PM EST, 11AM PST). We will discuss the motivations and visions behind the Paths event. It will be your opportunity to connect directly with the co-organisers of Paths and gain insights into why access to psychedelic medicines in Europe is a critical issue at this moment. Register here. 

 

THE LATEST FROM EUROPE

The European Parliament recently gave the green light for a key pharma reform, marking a major overhaul of pharma rules makes in the past twenty years. The reform aims to enhance patient access and foster innovation, though it has sparked debate among MEPs regarding the optimal approach.

 

The Commission's initial plan was to cut the standard data protection period that blocks rivals from using clinical trial data for marketing approvals from eight to six years, adding two more years for market exclusivity before allowing the sale of generic or biosimilar versions.  The Commission’s proposal allowed for up to two additional years of data protection if the pharmaceutical was launched across all member states.

 

In response to the proposal, MEPs modified it significantly, shifting the responsibility to member states to ensure companies file their pricing and reimbursement applications promptly. On the matter of clinical trial data access, MEPs reached a consensus, agreeing on a protection period of seven and a half years, followed by two additional years where market exclusivity is maintained.

 

Extensions to this period would be granted under specific conditions: if a product addresses an unmet medical need, if comparative clinical studies are conducted, and if a considerable portion of the product's R&D is carried out within the EU, in collaboration with European research institutions. The total regulatory data protection could not exceed eight and a half years. Furthermore, MEPs proposed an additional year of market protection if a company secures approval for a new therapeutic use of the drug that significantly surpasses existing treatments in terms of clinical benefits.

 

Importantly, the Parliament expanded the definition of unmet medical need to include the aspects related to the quality of life of patients.

 

Now the proposal is in the hands of EU countries and the final EU agreement will likely take place only next year.  

In a joint statement, 18 industry associations and organizations, including EFPIA, EuropaBio and EUCOPE, called on the next Commission to ensure legislative and financial commitments for EU’s  initiative on boosting biotechnology and biomanufacturing in the EU.

European industry associations support the EU Commission's push to advance biotechnology and biomanufacturing. “The Initiative is a positive starting point for greater ambition and implementation for biotechnology and biomanufacturing as a recognised critical technology for economic security, whilst positioning the EU as a global innovation actor.”

 

The statement acknowledges the initiative's potential but emphasizes the need for immediate action. Streamlining regulations, securing resources for biomanufacturing, and fostering innovation are highlighted as key areas.

 

Industry urged the incoming Commission to prioritize this initiative with strong leadership and collaboration with member states and the Parliament. This united effort aims to solidify the EU's position as a global leader in biotechnology and biomanufacturing.

 

 

 

Good news for Horizon Europe grantees! The European Commission is finally publishing the full Annotated Grant Agreement (AGA) this month. This essential document explains the complicated Model Grant Agreement that researchers sign and provides guidance on reporting, audits, and other key aspects.

 

The AGA has been missing crucial sections, causing frustration for universities and researchers. However, a "corporate approach" to simplify grants across all EU programs caused delays.

 

While researchers welcome the full AGA, concerns remain. The promised simplification may not be significant, and frequent rule changes create additional burdens. Stability in personnel cost calculations is a top request. Find out more in this Science | Business article.

 

European pharmaceutical companies are racing to adapt to the EU's new drug assessment process launching in 2025, first for cancer drugs and then for cell and gene therapies. This assessment will determine a drug's value compared to existing treatments, impacting pricing negotiations.

 

Some companies, worried about a lack of clear guidelines, are rushing to submit applications before the deadline to avoid being the first assessed. Others are preparing well in advance. However, there are still many uncertainties about what kind of data is preferred by the new HTA coordination group that will assess the medicines, and how the review will be carried out. PRO subscribers can read our detailed write-up here.

 

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