EU Insights

Welcome to the second edition of the PAREA EU Insights, packed with news that are highly relevant to the psychedelic sector. If Europe is on your radar, some of these are a must-know while some others can give you a good sense of the EU health and research environment.

The EU Insights are circulated every 4-6 weeks and the first three issues are free of charge. If you find this service useful, consider subscribing here (Insights are free for PAREA Industry Partners).

I hope you will find this helpful.
Tadeusz Hawrot
PAREA Founder and Executive Director

EU PHARMACEUTICAL REFORM

Europe’s health systems remain fragmented and unequal. Patients in Romania or Bulgaria have to wait more than 800 days on average before new medicines become publicly available. In Germany, it is 133 days. Patients in Italy can access seven out of ten new medicines while in Romania it is less than two out of ten. Additionally, in the past 12 years, the EU has approved 158 drugs for cancers and drug makers have received generous incentives. In other areas, such mental, neurological, and substance use disorders, progress has been slower.

The EU’s revision of the pharmaceutical legislation is coming, and it will be a massive, once-in-a-generation reform. The aims are ambitious and include addressing the access inequities and fixing market failures by incentivizing drug development that society needs. The review will also provide an opportunity to address challenges such as those posed by new types of medicines and increasing blurring of boundaries between different types of products.

All this is highly relevant to companies developing psychedelic treatments.

Recently, a leak of the draft revision of the legislation became available. It’s 1608 pages long, and to save you time, we prepared a summary bringing together changes that are the most pertinent to the psychedelic sector.  

The planned revamp, officially scheduled for March 14, would see an across-the-board reduction in the amount of time that new drugs are protected from competition from unbranded rivals. Drugs that are launched throughout the bloc, meet unmet medical needs, or go through rigorous head-to-head clinical trials, would get some of that competition-free period back.

Significant changes will be made to how the EMA is operating with a key goal to “reduce the regulatory burden and provide a flexible regulatory framework,”. EMA will be obliged to increase its scientific advice to developers and smaller companies should get greater support.

Many changes in the new regulation impact the core market authorization procedures and life-cycle management of products.

The proposal’s March publication will mark the start of negotiations involving the European Parliament and the Council of the EU.

Read the detailed PAREA summary of the leaked draft here.

EU REGULATORS SPEAK IN SUPPORT OF PSYCHEDELICS AND DISCUSS THE CHALLENGES AHEAD

The European Medicines Agency, experts from the EU regulatory network, and representatives from the European College of Neuropsychopharmacology have jointly issued a commentary published in the Lancet entitled "The Therapeutic Potential of Psychedelics: The European Regulatory Perspective".

This marks the first time when the EU regulators officially speak in support of the psychedelic novel medicines.

Some of the paper’s key takeaways include i) an invitation for developers to get advice directly from the EMA; ii) acknowledging challenges related to blinding and expectancy; iii) a need for trials comparing different psychotherapeutic models; iv) importance of elucidating drug-drug interactions and other causes of potential adverse effects; v) a necessity of establishing by regulators conditions and restrictions of use at time of approval.

EU CONSULTATIONS ON MENTAL HEALTH AND RESEARCH PRIORITIES

In February, PAREA submitted feedback to two EU consultations:

1.      Consultations on a call for evidence supporting a comprehensive approach to mental health (EU initiative). See our submission here.

2.      Public consultation on the past, present and future of the European R&I Framework programmes 2014-2027. See our submission here and PAREA position paper concerning the Horizon Europe 2025 - 2027 Strategic Plan; Selected research priorities in the area of psychedelic science here.

UNDER-RESEARCHED CONDITIONS SUCH AS MENTAL DISORDERS WILL GET MORE EU ATTENTION

The European Commission's research department published an expert report: "Scoping study on evidence to tackle high-burden under-researched medical conditions". It was set to identify diseases with high degree of burden such as disability, mortality, prevalence, economic cost or intensity of care which are not funded adequately. The premises are straightforward: conditions with a high burden for patients and societies should receive a higher share of the total funding for medical research, than conditions with a low burden.

Unsurprisingly, among the 12 groups of conditions, leading the list are mental disorders. The Commission now plans to follow with rebalancing the funding landscape.

ONE-STOP SHOP FOR CLINICAL TRIAL APPLICATIONS – CLINICAL TRIALS INFORMATION SYSTEM

There’s no going back now. From January 31, all new applications to conduct clinical trials anywhere in the EU must be submitted through the new, centralized clinical trials information system, hosted by the EMA. With this, Europe wants to speed up the launch of clinical trials to make the region more attractive for research and improve access to innovation for patients. The new system switches to just one trial application for studies in Europe, regardless of the number of countries and centres involved, cutting hours of duplicated paperwork across the bloc.

SUPPORTING START-UPS SECTOR IN EUROPE WITH BIG MONEY

A report from industry group Life Sciences Acceleration Alliance raises some new concerns on the topic of competitiveness. It finds that biotechs in Europe raise three to four times less venture capital than their U.S. peers. Capital in China, meanwhile, now exceeds that raised in Europe.

Europe wants to change that. A group of EU countries and the European Investment Bank (EIB) launched on 13th February a new fund meant to help EU start-ups stay in Europe. The plan for the European Tech Champions Initiative is to finance start-ups that are scaling up. To do that, the ministers from Germany, France, Italy, Spain and Belgium signed a joint venture with the European Investment Fund, Europe’s biggest private equity financier and a subsidiary of the EIB, to launch the so-called “fund of funds” — which will inject fresh cash into private equity funds that in turn will be expected to fund promising start-ups on the verge of becoming big companies.

The countries will pledge to throw fresh money into a pot that will help funds invest in start-ups not at the beginning of their life, which the EU is already quite good at, but when they want to scale up and become unicorns. Anonymous source from one of the participating countries added that financing unicorns requires attracting much bigger amounts of investment in their third or fourth funding rounds which is when the Americans usually move in or when the companies have to leave Europe to move to the U.S. or Asia. According to that official, the hope is that the fund could help solve one of the EU’s big conundrums: While the Continent is top-class in terms of conducting fundamental research, it has performed much worse than the U.S. and China when it comes to harnessing its own inventions and innovations to create big tech companies.

WHO EUROPE’S NEW PLATFORM TO IMPROVE ACCESS TO NOVEL, HIGH COST MEDICINES + NEW DUTCH PRICING RULES

European countries are concerned over the escalating prices of new medicines, which have restricted patient access, increased inequities and, in some cases, resulted in financial hardship. To address these challenges, WHO Europe is working with countries across the European Region to develop a new multistakeholder platform to improve access to novel, high-cost medicines in the Region. The new Access to Novel Medicines Platform will focus on areas such as improving the transparency of the markets to build trust, promoting collaboration, horizon scanning, enhancing accountability, and supporting solidarity-based voluntary collaborations. PAREA has met with the WHO representative responsible for the Platform development.

New rules on drug pricing in the Netherlands

Staying on the topic of access to novel medicines, as of July, the Netherlands will launch new rules on drug pricing, designed to address the increase in spending on innovative medicines in recent years, the health ministry announced. The threshold that triggers drug pricing negotiations for innovative medicines will be lowered. Currently, new medicines that are forecast to cost the health system €40 million or less are placed immediately on the market, while the price for more expensive drugs must first be agreed with the ministry. From July, this limit would be reduced to €20 million. According to the health ministry, it is an important step in keeping innovative medicines available to the patients who benefit from this while preventing medicines from only becoming more expensive.

DIGITAL THERAPEUTICS IN THE EU

The EU landscape for digital health is changing rapidly. A common European approach to digital therapies could solve some major hurdle such as evidence generation and could allow startups to operate in all EU member states without re-validating their DTx.

A new report explores the state of digital therapeutics and barriers in selected 6 EU countries. It also indicates 11 strategic recommendations for the acceleration of DTx in the EU.

Another report on Digital therapeutics have been also recently released by the McKinsey & Company. It is highlighting the high impact high value contribution that Dtx is expected to have on the future of health care, and how Dtx companies can partner with big pharma and other major health care players to create better care and more value.

HORIZON EUROPE 2023 HEALTH RESEARCH CALLS NOW OPEN

€847 million in grants will be made available. The European Commission organized an infoday with Q&A on 2023 health topics and you can watch the recordings here.

HEALTH PRIORITIES OF THE SWEDISH EU PRESIDENCY

While the European Parliament, Commission and Council have fixed presidents, the Council of the EU - where national ministers discuss EU legislation - doesn't have a permanent, single-person president. Its work is led by the country holding the Council presidency, which rotates every 6 months. Each presiding country has an important role to play by leading the European Council's work in setting the EU's general political direction and priorities, including in the areas of health and research. As of January, Sweden is at the helm of the EU. Among its health priorities are:

i) overseeing the development of the European Health Data Space - a single market for digital health services and products that promises to dramatically reshape access to medical data and its use in research and policy

ii) advancing the revision of EMA fees regulation

iii) negotiating the pharmaceutical legislation package, and

iv) addressing mental health and in particular the issue of loneliness.