Home Health Minister Kuipers answers questions about the therapeutic use of psychedelics

Minister Kuipers answers questions about the therapeutic use of psychedelics

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2022-03-16-Minister Kuipers answers questions about the therapeutic use of psychedelics

The Netherlands – Minister Kuipers (VWS) answers questions about the therapeutic use of psychedelics such as psilocybin, MDMA and ketamine. Members of Parliament Warmerdam, Paulusma and Sneller (D66) have asked the questions.

Answers to parliamentary questions from members Warmerdam, Paulusma and Sneller (all D66) about the therapeutic use of psychedelics such as psilocybin, MDMA and ketamine. (2022Z00701 submitted January 19, 2022).

Question 1.
Are you familiar with the report of January 16th. 'Keta may be a 'revolutionary' drug against depression, but there are also concerns' [1] and the manifesto 'Therapeutic use of psychedelics – a plea for central control'?[2]

Answer 1.

Question 2.
Do you recognize that there are 300.000 to 450.000 patients in the Netherlands with a treatment-resistant psychiatric disorder?

Answer 2.
In the Netherlands, more than 1,2 million people use curative mental health care every year. I have no insight or figures regarding possible treatment-resistant psychiatric disorders. There is, however, data available on the number of people who can be classified as patients with severe mental illness (EPA). The number of EPA patients undergoing treatment under the Health Insurance Act is approximately 215.000. These patients often have a psychiatric disorder for a longer period of time, as a result of which they experience long-term limitations and have multiple care needs. This group of patients may include a proportion that is difficult to treat with existing therapies.

Question 3.
Do you agree that research is needed into effective therapies to help this target group? If not, why not? If so, how do you plan to further this research?

Answer 3.
Yes, I agree. Scientific research into new interventions and their applicability for mental health care is of great importance. Only proven effective care can be part of the
basic package. The evidence is based on scientific literature that underlies the description of care in quality standards. In order to do good and structural research and to implement the acquired knowledge, I have
2026 million euros has been made available until 35 for the Mental Health Research Program that runs through ZonMw. The Mental Health Research Program is in line with the Mental Healthcare Administrative Agreement 2019-2022 and with a large part of the topics from
the research agendas put forward by mental health care parties. In the coming years, it will therefore focus on clinically applied research and issues from practice. In addition, larger, multidisciplinary studies are encouraged.

Question 4.
Do you agree that there are promising results in the therapeutic use of psychedelics such as psilocybin, MDMA and ketamine? If not, why not? If so, what steps do you intend to take or have you already taken to follow up on these results?

Answer 4.
I am aware that several studies on the therapeutic use of psychedelics show favorable results, such as research on MDMA in post-traumatic stress disorder (PTSD). Most of these resources
are still in the research phase. Judging the study results is not up to me.

Further steps to follow up on these research results are up to the parties in the field. This concerns, among other things, conducting the necessary research, going through the registration process to get the drug approved, and
drawing up guidelines and protocols for the application of the treatment. There will be a State Commission that will investigate the status of XTC (MDMA) in the context of public health and advise on the advantages and disadvantages of
medicinal use, including a multidisciplinary analysis of health risks, prevention and the European context and relevant conventions. In the second quarter of this year I will inform your House about
the progress of the establishment of the State Commission.

Question 5.
Can you indicate how the Netherlands can follow the example of the accelerated approval by the American FDA (breakthrough therapy status) of psychedelics for treatment-resistant depression, suicidality and post-traumatic
stress disorder (PTSD)? Which bottlenecks does the Netherlands encounter and what steps are needed to overcome these bottlenecks?

Answer 5.
Promising treatments may be granted breakthrough therapy status with the US Food and Drug Administration (FDA), with the FDA offering help and advice to develop such products (as happens with psilocybin in major depression and MDMA in PTSD). In the EU and in the Netherlands, parties can request scientific and regulatory advice at an early stage from the European Medicines Agency (EMA) or the Medicines Evaluation Board (MEB) about the steps required to obtain a marketing authorization for a product and about possible acceleration of the process from development to medicine.

Bottlenecks in the development process may lie in limited financial possibilities to conduct such clinical research and in the further development into a fully-fledged (registered) product for the patient. This also plays a role
these psychedelics themselves are often not patentable and in that sense do not fit within the standard development and revenue model. The potentially high cost of therapeutic treatment with these agents (due to the total number of hours
therapists make during the treatment sessions) can also be a bottleneck for inclusion in the basic package. With regard to making a treatment available to patients, the assessment of reimbursement by health insurers is also important. Parties can discuss this with, for example, the Zorginstituut or the health insurers.

The Future Affordable and Sustainable Therapies (www.FAST.nl) platform is being set up in the Netherlands as an expertise center that can provide assistance in the development of future treatments. In addition, FAST helps coordinate public investments in this area. With the establishment of FAST, an important impulse is given in the Netherlands
to identify bottlenecks and develop solutions. In the Netherlands, these psychedelics, with the exception of ketamine, are on the lists of the Opium Act. In the Netherlands, the fact that these substances fall under the
Contrary to many other countries, Opium Act is not an obstacle to researching it. An exemption must be requested for research.

Question 6.
Do you recognize the fact that without central control on implementation and research into therapeutic use of psychedelics, risks arise, such as independent experimentation by patients or commercial exploitation in which the
patient interest is not paramount? If not, why not? If so, what measures do you take to avoid these risks?

Answer 6.
Yes, I see those risks too. That is why it is good that parties in the field, both from the research field and, for example, mental health institutions, are now taking the initiative for collaboration. As they themselves state in the manifesto 'Therapeutic use of psychedelics', they can develop a framework for this new form of treatment, among other things by means of good guidelines, standards and protocols. In addition, the collaborating partners can make central agreements about the training of therapists. By carefully developing a framework with an eye for availability,
affordability and efficiency of the treatment, and while monitoring the quality, the interests of this vulnerable target group are safeguarded as much as possible.

In addition, it is important that the risk of independent experimentation by patients is counteracted by means of information. A lot of information can be found about the risks of using MDMA and psychedelics, for example
on the website or via the information line of drugsinfo.nl.

Question 7.
Can you indicate which steps you are planning to take or have already taken to ensure central guidance on implementation and research into therapeutic use of psychedelics?

Answer 7.
I consider it important that research into the therapeutic use of psychedelics and implementation is done in the most careful manner, with the aim being to develop new ideas for this vulnerable target group of EPA patients.
provide treatments that are effective, accessible and affordable. Central direction on research and implementation is up to the medical professions to shape. In addition, ZonMw is conducting a number of investigations (see answer to question 8). I am prepared to play a facilitating and advisory role in this regard. My ministry has already held exploratory talks with researchers and mental healthcare organizations for this.

Question 8.
Can you provide an overview of studies into therapeutic use of psychedelics such as psilocybin, MDMA and ketamine that are being conducted with (with the help of) government funding? Can you indicate how you progress and
implementation of these studies?

Answer 8.
I can report to you on the following studies that are ongoing at ZonMw (Dutch organization for health research and care innovation):

  • The Promising Care program is currently conducting research into esketamine: the (cost) effectiveness of oral esketamine in comparison with electroconvulsive therapy in patients with chronic depression (ZonMw website).
  • A study is underway in the Suicide Prevention Program to determine whether ketamine is effective as a treatment for suicidality (ZonMw website).
  • The Good Use Medicines program is currently conducting a study investigating oral ketamine versus placebo in patients who have not benefited enough from commonly available antidepressants.
    treatments (ZonMw website). Progress and implementation of these studies is monitored from
    SunMrs. In addition, the IGJ (and Farmatec) has insight into which parties are conducting research for which an exemption has been requested.

Question 9.
How do you reflect on the opportunity that the Netherlands can seize to be a frontrunner in research into and implementation of therapeutic use of psychedelics in mental health care? Can you indicate what plans you have for this
take a chance?

Answer 9.
For me, it is paramount that these and other potentially innovative treatments are safely accessible to the target group. The Netherlands is one of the countries leading the way in research into psychedelics in mental health
healthcare. The Netherlands can also play a pioneering role in developing the right frameworks, limiting risks and designing training for therapists. I am in favor of sharing the knowledge that the parties in the field gain in these fields with other countries. The Netherlands can stimulate cooperation in this area in a European and international context. The Netherlands can also draw attention to removing barriers to conducting research. In the framework of the United Nations Commission on Narcotic Drugs (CND), I continue to advocate for the removal of barriers to therapeutic use and research into substances listed in United Nations drug conventions.

Sources (NE)

[1] Nieuwsuur, January 16, 2022, 'Keta could be 'revolutionary' remedy against
depression, but there are also concerns'

[2] Therapeutic Uses of Psychedelics – OPEN Foundation

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