EU Insights

It is with great pleasure that I’m sharing with you the first edition of PAREA EU Insights. The goal is to bring you the latest relevant policy news from Europe such as the EU funding opportunities, updates on the clinical trials and reimbursement landscape, Health Technology Assessment developments as well as changes in drug policies. We will also keep you up to speed with PAREA’s work. For now, our recent Year in review can give you an idea of what we achieved in 2022 and what are our plans for 2023.

The EU Insights will be circulated every 4-6 weeks and the first three issues will be free of charge. If you would like to already support PAREA by making an annual subscription, you can find out more details here.

Tadeusz Hawrot - PAREA Founder and Executive Director

REVISION OF THE EU
PHARMA LEGISLATION AND
MENTAL HEALTH STRATEGY

2023 will be critically important for drug development companies, including the psychedelic sector. The EU is conducting a significant revision of its pharma strategy and the shakeup promises to be major. The guiding philosophy is that incentives need to be rethought to address market failures. To this end, changes to market incentives – such as the length of market exclusivity – are likely. You can learn more about the pharma strategy revision in the brief PAREA analysis here.

Another important file to look for in 2023 is an EU mental health strategy, promised by Commission President Ursula von der Leyen. It is scheduled for 7th June under the name “A comprehensive approach to mental health.”

PAREA MEETING WITH EMA CHIEF MEDICAL OFFICER STEFFEN THIRSTRUP

In December, PAREA had a second meeting with the EMA CMO. The Agency plans two significant activities in 2023:
i) an update of its depression guidelines which will include psychedelics and
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.       
After the meeting, PAREA facilitated an interview between S. Thirstrup and POLITICO which was published in late December: EU drugs regulator addresses challenges in psychedelic-assisted therapies. In it, EMA’s CMO is quoted saying: “I’m excited by what we’ve seen so far in scientific literature. This looks promising … EMA is meeting regularly with the Psychedelic Access and Research European Alliance to keep up to speed on these therapies’ developments and to help to prepare developers for the regulatory task ahead.”

FACILITATING DECENTRALISED
CLINICAL TRIALS AND
CT INFORMATION SYSTEM

On December 19th, the European Commission, the Heads of Medicines Agencies and the EMA published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs). This is an outcome of their joint initiative to Accelerate Clinical Trials in the EU (ACT EU).

The aim of DCTs is to make it easier for patients to participate in clinical trials by reducing the need to travel to central trial sites. This approach has the potential to make CT available to a wider demographic of participants and reduce drop-out rates.

As of January 31st, all clinical trial sponsors will use the Clinical Trials Information System and follow the same process to apply for the authorisation of a clinical trial, no matter where they are located and what national competent authority or ethics committee they are dealing with. This initiative will increase transparency and better support medical research and innovation in the EU/EEA. You can find out more from the dedicated infographic or visit the CTIS portal.

EU FUNDING OPPORTUNITIES

In December, several important announcements were made about the disbursement of various EU funds and which priority areas that will be covered.

The Innovative Health Initiative (IHI, with a budget of €2.4 billion) has launched its third call for proposals, including opportunities in the area of digital technologies in mental health: Digital health technologies for the prevention and personalised management of mental disorders and their long-term health consequences. The aim of projects under this topic is to investigate how digital health technologies could improve the lives of people with mental health disorders, including by better prediction of relapses and better disease management. You can access a brief PAREA description of the IHI here. In 2022, PAREA met with the IHI and industry leaders to advocate for creating better funding opportunities for psychedelic science. As a result, Commission’s research department proposed a relevant project and early this year, brainstorming with the pharma industry will take place.

The biggest EU R&D fund Horizon Europe saw a publication of its work programme 2023-24, with €13.5 billion to support researchers and innovators. Among various areas, the work programme covers actions to support and strengthen international initiatives in global health. Looking beyond 2024, a significant opportunity for psychedelic science will come in the shape of a European partnership on Brain Health (at this stage, no details are available publicly). Running between 2025-2027 and being anchored in Horizon Europe, it will be a major collaboration between EU Member States, aiming to collectively raise €200 million via global outreach and industry involvement.

Similarly, a 2023 work programme of the European Innovation Council has just been published by the Commission. It opens funding opportunities worth €1.6 billion in for scientists and innovators to scale up breakthrough technologies and create new markets.

COUNCIL CONCLUSIONS ON
HUMAN RIGHTS-BASED APPROACH
IN DRUG POLICIES

In December, the Council of the EU adopted the most progressive stance on the EU drug policies in EU history, inviting the EU Member States “to further support the development and implementation of evidence-based policies and interventions that put human rights at the centre of drug responses.

EU GLOBAL HEALTH STRATEGY

The EU and its Member States are collectively among the largest funders of global health and it is an essential pillar of EU external policy. As such, the EU has a unique potential to drive international cooperation and it has now published the EU Global Health Strategy Better Health for All in a Changing World (browse a brief factsheet).

The strategy will address areas such as supporting regional and Country efforts to strengthen pharmaceutical systems, expanding the EU-US partnership to cover a more comprehensive set of health issues - with an EU-US task-force on health cooperation, ensuring that the private sector and health industries are appropriately considered as well as recognizing digitalisation and research as key enablers.

MEASURING THE RETURN FROM PHARMACEUTICAL INNOVATION 2022

Deloitte has just published its annual report: “Measuring the return from pharmaceutical innovation 2022” zooming in on 20 leading pharmaceutical companies. The ROI on pharmaceutical R&D plunged in 2022 after a record 2021: the projected return on pharma R&D fell to a record low of 1.2%, from a high of 6.8% the year before. It was a bad year for the industry on other metrics as well: average forecast peak sales per drug totalled $389 million in 2022, down from $500 million in 2021. The cost of developing a new drug, meanwhile, rose by $298 million to $2.3 billion in 2022. The amount of time it takes medicines to go from clinical trial to approval rose to 7.1 years, up from 6.9 in 2021. The analysts highlighted a growing trend of pharmaceuticals developing their own drugs “in house” rather than through co-development. In-house assets are responsible for 51% of forecast revenue in 2022, versus 29% the year before. In terms of recommendations, improved clinical trial processes are key to achieving efficiency. Virtual trials, including at-home check ups, remote monitoring and assessments, and direct-to-patient drug distribution are just some of the ways in which R&D leaders can decentralise the clinical trial process to cut drug development timelines.

A NEW TOOL TO MEASURE/REDUCE
THE BURDEN OF MENTAL AND SUBSTANCE-USE DISORDERS

Finally, a compelling tool has recently been released by the McKinsey Health Institute: Prioritizing brain health: Scaling what works to add years to life and life to years. The publication discusses the burden of mental and substance-use disorders and addresses in an interactive way the potential impact of evidence-based prevention or interventions to reduce it. The conclusion is that society could reduce approximately half of the burden by taking an integrated approach with interventions.

And topping it all up, here is a piece of advice on: How to collect and (quickly) publish real-world evidence as a digital health provider company.

I hope you enjoyed this first issue of the PAREA EU Insights, and I’d be keen to hear from you about what kind of areas you would want us to cover in future issues.

With best wishes,       
Tadeusz