Important Moments of the Medical Cannabis Legalisation in the Czech Republic

• April 8^th 2010: an expert workshop in the Parliament of the Czech Republic under a patronage of prof. MUDr. Tomáš Zima, DrSc., MBA, the dean of the 1^st faculty of medicine of the Charles’ University, and an MP MUDr. Mgr. Ivan Langer; the workshop was named: ”The Perspectives of Treatment with Hemp: Medicine, Legislature, and Politics.”  The workshop program, presentation, and recorded speeches and discussion, plus a short concept arisen from the debate can be downloaded from www.adiktologie.cz/seminar. In the conclusion of the workshop all the participants – the experts, and the representatives of the government – agreed that cannabis should be made available for medical purposes, and the whole process should be launched at the Ministry of Health as the corresponding authority.
• May 11^th 2011: after the dean of the 1^st faculty of medicine Tomáš Zima sent a written inquiry in March asking about dealing with the 2010 workshop conclusion, the Minister of Health Leoš Heger answered that “we noted almost no particular interest in cannabis treatment from the experts who would be actively interested in research or potential use of cannabis in medicine” (sic!), and the Ministry of Health due to “time pressure” cannot include the legalization of cannabis treatment to the amendment of the law on opiate and psychotropic drugs even though his ministry was obliged to deliver this amendment by the end of 2011. A few days later the same answer is given to an independent written inquiry by another MP, MUDr. Pavel Bém. Thus the Minister of health Heger explains in a rather Dadaistic style to two prominent doctors interested in research of medical cannabis and its practical use in medicine that their interest is not a real interest, and the parliamentary workshop attended by a wide expert audience never took place.
• May – June 2011: the organizers of the parliamentary workshop from April 2010 are addressed by several patient organizations whose members treat themselves (illegally and in a DIY fashion) by cannabis about possibilities of further movement, and with an appeal for help.
• August 16^th 2011: a petition committee of ten doctors, researchers, representatives of patients and public issues the petition http://www.lecebnekonopi.cz/ which raises interest of the media and politicians. The first person to support the demands of the petition is the Chairwoman of the Czech Parliament Miroslava Němcová, the next day after the publication.
• August 19^th 2011: the spokesman of the Health Ministry Vlastimil Sršeň claims in a media release that the problem of treatment with cannabis has not been discussed in the Czech Republic, and such a discussion must be initiated. The Health Ministry yet refuses to include the legalization of the medical cannabis in the amendment of the laws despite having been tasked to do so by the Government Legislative Plan for 2011.
• August 2011: The Czech Prime Minister Nečas establishes the Work Group for Availability of Cannabis for Treatment and Research (PSK) presided by prof. MUDr. Tomáš Zima, with the National Drug Coordinator, and the Vice-President of the Government Board for Drug Policy Coordination Mgr. J. Vobořil as his deputy; for details see http://bit.ly/u5WRWo
• September 13^th 2011: The Second Parliamentary Workshop on cannabis treatment in the Czech Republic takes place under patronage of the MP MUDr. Jiří Štětina; the deputy for legislature of the Health Minister Mgr. Martin Plíšek announces that the ministry is ready to actively take part in the process.
• September 15^th 2011: the first meeting of the PSK with its 26 members. The commission led by prof. Zima for four months works out the consensual proposal of the legislature for making the medical cannabis available (with the participation of directors of two departments of the Health Ministry, the director of the State Institute for Drug Control (SÚKL), the representatives of expert association ČLS JEP including its chairman prof. Blahoš, the representatives of the law enforcement, and other state authorities, researchers, and patients – the list of the participants is HERE).
• December 8^th 2011: The first PSK handed in the bill to the Prime Minister, and the chairwoman of the Czech Parliament.
• December 11^th 2011: the last PSK meeting.
• February 1^st 2012: The bill is distributed among the MPs. The bill was presented and by Miroslava Němcová (ODS), Pavel Bém (ODS), Milada Emmerová (ČSSD), Zuzka Bebarová-Rujbrová (KSČM), Jiří Skalický (TOP 09), Radek John (Věci veřejné), Jiří Štětina (Věci veřejné), Jiří Koskuba (ČSSD), and Michal Janek (TOP 09).
• February 3^rd 2012: The bill was sent to the Czech government to take its stand.
• February 13^th 2012: Despite the participation of relevant departments of the Ministry of Health, and the director of SÚKL during the preparations of the parliamentary bill the Health Minister Leoš Heger (TOP 09) recommends the government to take a negative stand; the government refuses his recommendation, takes a neutral stand, and proposes the presenters a revision of the bill taking in account some suggestions of the Health Minister (see Press conference after the governmental meeting).
• February 29^th 2012: The governmental stand was sent to the MPs as the press 590/1 (suggestions).
• March – April 2012: The chairwoman of the Czech Parliament Miroslava Němcová established the Second Work Group for Medical Cannabis (2. PSK) again led by prof. T. Zíma, with the MP Pavel Bém as his deputy. The Health Ministry deputy for legislature Mgr. Martin Plíšek participates in the group.
• April 16^th 2012: 2. PSK handed in the proposal of the amendment to the bill-presenting MPs.
• May 2^nd 2012: the Health Minister recalled RNDr. Martin Beneš from his office of the SÚKL director replacing him with MUDr. Pavel Březovský.
• June 8^th 2012: The first reading of the bill during the Parliament session. The bill was passed over to the parliamentary committees for discussion.
• June 26^th 2012: The Agricultural Committee of the Czech Parliament discussed the bill, and issued the recommendation as press 590/2 (the discussion was adjourned).
• June 28^th 2012: in an interview for the Medical Tribune the SÚKL director Pavel Březovský confesses his (contradictory with the law) faith that “SÚKL should be an acting hand of the Health Ministry.”
• July 17th 2012: The Health Care Committee of the parliament discussed the bill and issued the recommendation as press 590/3 (the discussion adjourned).
• September 11^th 2012: The Agricultural Committee of the Czech Parliament discussed the bill and issued the recommendation as press 590/4 (amendments).
• October 11^th 2012: The Health Care Committee of the Czech Parliament discussed the bill and issued the recommendation consistent with the government recommendation based on the proposal of the 2. PSK as press 590/5 (complex amendment).
• October 26^th 2012: The second reading of the bill and general discussion. The amendments issued as press 590/6.
• December 7^th 2012: The third reading of the bill. The bill was passed by 126 votes of 154 present MPs; 7 MPs were against, 21 MPs abstained (resolution No. 1400).
• January 30^th 2013: The bill was discussed during the fourth parliamentary session. The Senate passed the bill by 56 votes of 62 present; no one voted against, 6 senators abstained.
• February 15^th 2013: The bill was signed by the Czech President Václav Klaus.
• February 15^th 2013: The Health Minister Heger answered the interpellation of the MP Václav Votava (ČSSD) concerning the possibility of covering the cost of medical cannabis and medicaments from the obligatory health insurance: “(…) despite all the popular articles and various proclamations it is a fact that the effectiveness of cannabis as a medicine is not considered seriously, and such medicaments are seen as a medicinal complements which are basically not covered at all.”
• March 4^th 2013: The law is published in the Collection of Laws, issue 22, under the number 50/2013 Coll.
• March 4^th 2013: The State Institute for Drug Control (SÚKL) published a proposal of General Regulation No. sukls 17954/2013 where under the paragraph 5c) there is intention to enforce an administrative ban of covering the cost of medical cannabis for the indicated patients from the health insurance in the Czech Republic. In the justification they claim: “it is a group of medicaments of herbal origin (...) lacking the proof of their effectiveness (...) there is no available study proving its therapeutical value.”
• March 19^th 2013: In the statutory time limit the SÚKL received comments against the content of the above mentioned General Regulation from more than ten subjects, e. g. the chairman of Czech Medical Academy prof. MUDr. Rudolf Rokyta, DrSc., from the Ministry of the Interior’s Department of Home Security, from the National Drug Centre of the Czech Police, from several affected patients, and from a petition committee of the Petition for Availability of Medical Cannabis for Treatment and Research.
• April 1^st 2013: The law on legalization of the use of medical cannabis in treatment and research becomes effective; however due to the absence of the regulations by the time of the last revision of this text (April 23^rd 2013) the Czech pharmaceutical market have not received a single milligram of medical cannabis or individually manufactured medicinal compound with the content of medical cannabis. The only mass produced medicament made from cannabis de iure available on the Czech market was after its approval in 2010 imported in the amount of 3 packages (roughly a three week dose for an average multiple sclerosis patient.
• April 15^th 2013: The Ministry of Health sends a proposal of regulation to the inter-resort debate which must be analysed and commented by the governmental resorts (the pertinent ministries and inter-resort bodies) in an unusually short limit of five days. In its proposal the Czech Ministry of Health attempts to:
  • Limit the amount of prescribed cannabis to 30 g a month regardless of the patient’s diagnosis,
  • Forbid the physicians to treat persons under the age of 19 with cannabis and cannabis containing medicaments, regardless of their diagnosis.

None of these restrictions are supported by any study or worthy medical or legal reasons in the explanatory report attached to the regulation. Neither the Ministry of Health nor the SÚKL is legally empowered to issue the latter restriction thus breaching the rule a silentio legis meaning that state bodies are not empowered in matters which are not regulated by law.

• April 29^th 2013: the SÚKL published the General Regulation 04-13 together with resolved comments as they were presented by March 19^th 2013. The objections against the ban of covering the costs of individually manufactured medicaments by health insurance were raised by:(1) Mgr. Jindřich Vobořil, MSc. (the Czech National Drug Coordinator); (2) Mr. Zdeněk Majzlík (a father of a multiple sclerosis patient); (3) the law firm PPK Partners on behalf of their client Martina Kafková (a multiple sclerosis patient); (4) Mr. Michal Wagner (a sponsor of the program agenda “Drugs,” Pirátská strana – Pirate Party); (5) MUDr. Tomáš Zábranský, Ph.D. (petition committee of the Petition for Medical Cannabis Legalisation); (6) Mgr. Martin Smetana, a botanist; (7) ing. Jiří Kadrnka; (8) Mgr. Dušan Dvořák, MMCA (the chairman of the board of Diag Human Cannabis); (9) Col. Mgr. Jiří Frydrych (the commander of the National Drug Centre of the Czech Police); (10) Mgr. Martin Linhart (the director of the Department of Security Policy, the Ministry of the Interior); (11) Prof. MUDr. Richard Rokyta, DrSc. (the director of the Czech Medical Academy). The proposal of the regulation was endorsed by MUDr. Jarmila Bohumínská (the representative of the Health Insurance Union) and ing. Miloslava Šlajsová (The General Health Insurance). The SÚKL endorsed none of the objections; the General Regulation 04-13 banning the health insurance companies to cover the cost of medical cannabis should according to the SÚKL plan be effective on May 14^th 2013.
• April 30^th 2013: Though the Law No. 50/2013 has been effective exactly one month, the Czech Ministry of Health nor the SÚKL failed to establish the “Register of restricted medicaments according to the § 81a” which should have been fully functional from April 1^st 2013 as stated by the law. Due to the fact it is not possible to legally prescribe and distribute medical cannabis to indicated patients thus the law has not been fulfilled because of the in/activity of the Czech Ministry of Health.