2018/2775(RSP) | [ParlTrack]

Recital A

A. whereas the Cannabis plant is made of more than 480 compounds which include more than 100 cannabinoids constituted of both psychoactive and non- psychoactive compounds. Many of the compounds constituting the Cannabis plant are unique to Cannabis;

Amendment 10 #

Recital C a (new)

Ca. whereas “cannabis-based medicines” are medicinal products, based on THC, on CBD and/or on other cannabinoids, supported by clinical trials and approved by a regulator, either EMA or other national regulatory agencies;

Amendment 11 #

Recital E

E. whereas EU countries differ widely in their legislation with respect to cannabis for medicinal purposes, as well as allowed quantities of medicinal cannabis and maximum levels of THC and CBD concentrations; which can lead to difficulties for countries applying a more prudent approach;

Amendment 12 #

Recital E

E. whereas EU countries differ widely in their ~~legislation with respect to~~approach to cannabis legislation, including the legislation on cannabis for medicinal purposes, ~~as well as allowed quantities of medicinal cannabis and~~for example on the maximum levels of THC and CBD allowed concentrations;

Amendment 13 #

Recital E a (new)

Ea. whereas there is mounting public debate about cannabis policy, but no scientific evaluation of the impact of current legislation;

Amendment 14 #

Recital F

~~F. whereas no country in the EU authorises the smoking of cannabis for medical purposes and no country in the EU permits home growing cannabis for medical purposes;~~deleted

Amendment 15 #

Recital G

G. whereas the policy landscape for medical cannabis and general attitude to cannabis is evolving both in the EU and worldwide; whereas there is still misunderstanding around the different uses of cannabis even among national administrations, often confusing the legalisation of cannabis for recreational use with the necessity to provide safe and legal access to cannabis for medical purposes to all patients in need;

Amendment 16 #

Recital G

G. whereas the policy landscape for medical cannabis ~~and general attitude to cannabis~~ is evolving ~~both~~ in the EU and worldwide;

Amendment 17 #

Recital G

G. whereas the policy landscape for medical cannabis and ~~general attitude to~~public opinion regarding cannabis is evolving both in the EU and worldwide;

Amendment 18 #

Recital G a (new)

Ga. whereas the use of cannabis in general may have an addictive effect and is responsible for significant social and health problems; whereas, therefore, addiction prevention and monitoring and control of illegal practices remain necessary, especially where medical cannabis is to be used more widely;

Amendment 19 #

Recital J

J. whereas a review of existing scientific literature on the subject of medical cannabis provides conclusive or substantial evidence that cannabis and cannabinoids have therapeutic effects such as in the treatment of chronic pain in adults (e.g. in cancer diseases), as antiemetics in the treatment of chemotherapy-induced nausea and vomiting or for improving patient- reported multiple sclerosis spasticity symptoms and is effective in the treatment of patients with anxiety disorders, PTSD and depression;

Amendment 2 #

Recital B

B. whereas D9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are the most known cannabinoids identified in cannabis. THC constitutes the main psychoactive and addictive constituent of cannabis, whilst CBD does not have intoxicating or addictive properties;

Amendment 20 #

Recital J

J. whereas a review of existing scientific literature on the subject of ~~medical~~ cannabis used in a medical setting provides conclusive or substantial evidence that cannabis and cannabinoids have therapeutic effects such as in the treatment of chronic pain in adults (e.g. in cancer diseases), as antiemetics in the treatment of chemotherapy-induced nausea and vomiting or for improving patient-reported multiple sclerosis spasticity symptoms;

Amendment 21 #

Recital K

K. whereas there ~~is limited evidence~~are indications that cannabis or cannabinoids are effective for increasing appetite and decreasing weight loss associated with HIV/AIDS, improving ~~clinician-measured multiple sclerosis spasticity symptoms, improving symptoms of Tourette syndrome, improving symptoms of~~symptoms of mental disorders (e.g. psychosis, depression, posttraumatic stress disorder, Tourette syndrome);

Amendment 22 #

Recital K

K. whereas there is limited evidence that cannabis or cannabinoids are effective for increasing appetite and decreasing weight loss associated with HIV/AIDS, ~~improving clinician-measured multiple sclerosis spasticity symptoms,~~ improving symptoms of Tourette syndrome, improving symptoms of posttraumatic stress disorder;

Amendment 23 #

Estefanía TORRES MARTÍNEZ, Stelios KOULOGLOU

Recital K

Amendment 24 #

Recital K

K. whereas there is limited evidence that cannabis or cannabinoids are effective for increasing appetite and decreasing weight loss associated with HIV/AIDS, improving clinician-measured multiple sclerosis spasticity symptoms, improving symptoms of Tourette syndrome, improving symptoms of posttraumatic stress disorder; but also Alzheimer’s, Arthritis, Asthma, Cancer, Crohn’s disease, Epilepsy, and Glaucoma and it contributes to the reduction of the risk of obesity and diabetes, mitigates menstrual pain and helps in processes of anxiety and depression.

Amendment 25 #

Recital K

Amendment 26 #

Recital K

K. whereas there is ~~limited~~ evidence that cannabis or cannabinoids are effective for increasing appetite and decreasing weight loss associated with HIV/AIDS, improving clinician-measured multiple sclerosis spasticity symptoms, improving symptoms of Tourette syndrome, improving symptoms of posttraumatic stress disorder;

Amendment 27 #

Stelios KOULOGLOU, Estefanía TORRES MARTÍNEZ

Recital L

L. whereas the medical potentialities of cannabis, as well as the long-term risks, have not been sufficiently proven by scientific research yet; whereas official data about research and research funding on medical cannabis remain scant. Research on medical cannabis has received no direct support during the current research programme in the EU and there is little coordination about research projects on medical cannabis in Member States;

Amendment 28 #

Recital M a (new)

Ma. whereas the global market for medicinal cannabis in 2015 reached $11, 4 billion, and in 2025, it is expected to reach $52, 8 billion. The market for cannabidiol (CBD) products for medicines, food and supplements is expected to grow by 700% by 2020, reaching $2,1billion in total. In Greece, 10 millions € in the pharmaceutical cannabis sector are expected as a surplus from the decriminalisation of cannabis for medicinal use in the near future. While it is estimated that 7,000 new jobs will be created and 2000 in the countryside for plant cultivation.

Amendment 29 #

Recital N

N. whereas there is no uniform standardisation system for the labelling of the drugs that contain THC ~~and CBD~~, CBD and other cannabinoids found within the cannabis plant; ;

Amendment 3 #

Recital B a (new)

Ba. whereas the cannabis plant constitutes of a numerous other cannabinoids such as Cannabichromene, Cannabinol, Cannabidiolic Acid, Cannabigerol and Tetrahydrocannabivarin, which can have neuroprotective effects, can contribute to the decrease of certain symptoms affecting patients such as chronic pain, inflammation, bacterial infections and stimulate bone growth.

Amendment 30 #

Stelios KOULOGLOU, Estefanía TORRES MARTÍNEZ

Recital N

N. whereas there is no uniform standardisation system for the marking and labelling of the drugs that contain THC and CBD;

Amendment 31 #

Recital N a (new)

Na. whereas, the decriminalization of cannabis in many countries, has reduced both the black market and criminal activities. Bearing also in mind, that patients end up in prison for possession of a small amount of cannabis for medicinal use. As a consequence national judicial authorities are overburdened by such cases.

Amendment 32 #

Recital O

O. whereas there is little or no ~~educational training~~reliable information on the impact of medical products containing THC and CBD in EU countries for medical staff - medical students, medical doctors and pharmacists, as well as ~~social campaigns~~ information and alerts for young people and women who have motherhood in their perspective;

Amendment 33 #

Recital O

O. whereas there is little or no educational training on the impact of medical products containing THC and CBD in EU countries for medical staff - medical students, medical doctors and pharmacists, psychiatrists, as well as social campaigns for young people and women who have motherhood in their perspective;

Amendment 34 #

Recital O

O. whereas ~~there is little or no~~ educational training on the impact of medical products containing THC and CBD in EU countries for medical staff - medical students, medical doctors and pharmacists~~, as well as~~ - is highly inadequate, as are social campaigns for young people and women who have motherhood in their perspective;

Amendment 35 #

Recital O a (new)

Oa. whereas there is no intra-EU regulation concerning the placing of cannabis-based drugs on the market;

Amendment 36 #

Paragraph 1

1. ~~Stresses the need for~~Calls on the Commission and national authorities to ~~draw~~work together to provide for a cle~~ar distinction between~~gal definition of medical cannabis, and ~~other applications of cannabi~~to draw a clear distinction with the non-medical applications (e.g. recreational or industrial); further stresses the need to create public awareness on the differences among these uses;

Amendment 37 #

Paragraph 1

1. Stresses the need for the Commission and national authorities to draw a clear distinction between ~~medical cannabi~~cannabis- based medicines approved by the EMA or other regulatory agencies, medical cannabis not supported by clinical trials and other applications of cannabis;

Amendment 38 #

Paragraph 1

1. Stresses the need for the Commission and national authorities to draw a clear distinction between ~~medical~~ cannabis based medicines approved by the EMA (or other national regulatory agencies), medical cannabis (not supported by clinical trials) and other applications of cannabis;

Amendment 39 #

Paragraph 1

1. Stresses the need for the Commission and national authorities to draw a clear distinction between ~~medical~~ cannabis- based drugs which have therapeutic applications in medicine, and other applications of cannabis;

Amendment 4 #

Recital B a (new)

Ba. whereas, according to the World Health Organisation1 a, cannabis use in general has an adverse impact on cognitive development, including associative neurological processes, memory and psychomotor functions, and has chronic harmful effects on the psychological health of users and other aspects of their health; _________________ 1a http://www.who.int/substance_abuse/facts /cannabis/en/

Amendment 40 #

Paragraph 1

1. Stresses the need for the Commission and national authorities to draw a clear distinction between medical cannabis and other applications of cannabis, many of which are illegal and possibly harmful to health;

Amendment 41 #

Paragraph 1

1. Stresses the need for the Commission and national authorities to d~~raw a clear distinction~~istinguish between medical cannabis and ~~other applic~~recreation~~s of~~al cannabis;

Amendment 42 #

Paragraph 1 a (new)

1a. Calls on the Commission and the Member States to address the issue of all the hemp-derived products present on the EU market which are bought without prescription, but often considered as having medical properties and/or treated as substitutes for medicines; further calls on the Commission and the Member States to work together with EFSA in this respect to guarantee comsumers’ and patients’ safety, starting from ensuring an accurate and clear labelling of these products and their content;

Amendment 43 #

Paragraph 1 a (new)

1a. Emphasizes that all possible use of medical cannabis must be based on scientific research which proves the functioning of the product and which shows that the same positive effect cannot be achieved by using ordinary medicines that do not have addictive effects;

Amendment 44 #

Paragraph 2

2. Considers that research on ~~medical~~ cannabis1a has been underfunded and should be properly addressed under the next Framework Programme 9; and national research programmes; _________________ 1aAlso research on recreational cannabis can be supportive for medical cannabis

Amendment 45 #

Paragraph 2

2. Considers that research on ~~medical~~the potential benefits of medicines derived from cannabis has been underfunded and should be properly addressed under the next Framework Programme 9;

Amendment 46 #

Paragraph 2

2. Considers that research on medical cannabis has been underfunded and should be properly addressed under the next Framework Programme 9 to explore the possible uses of THC, CBD, and other cannabinoids for medical treatment, as well as their effects on the human body, including lessons drawn from the experience of off-label prescribing of cannabis;

Amendment 47 #

Paragraph 3

3. Calls on the Commission and Member States to ~~address the regulatory and financial barriers which weigh on scientific research i~~define the proper conditions to enable creditable, independent scientific research, based on a wide range of material, to be conducted on the use of cannabis for medicinal purposes;

Amendment 48 #

Paragraph 3

3. Calls on the Commission and Member States to address the regulatory ~~and~~, financial and cultural barriers which weigh on scientific research in the use of cannabis for medicinal purposes;

Amendment 49 #

Paragraph 3

3. Calls on the Commission and Member States to address the regulatory and financial barriers which weigh on scientific research in the use of cannabis ~~for medicinal purposes;~~2a; _________________ 2aResearch on Cannabis in general is needed; lessons can also be drawn for medical cannabis from research on recreational cannabis

Amendment 5 #

Recital C

C. whereas ~~Cannabis products that are used for medicinal purposes are broadly referred to as “medical cannabis”~~the term “medical cannabis” may refer either to the general use of cannabis for medicinal purposes or to the treatment of symptoms of illness and other conditions with the whole, unprocessed marijuana plant or its basic extracts; whereas the latter mainly refers to off-label pharmacotherapy, which is regulated in some Member States, and it does not normally implies consumption through smoking, rather through ingestion or inhalation from a vaporiser; whereas, nonetheless, this term is largely undefined from a legal point of view and it remains ambiguous and open to interpretations;

Amendment 50 #

Paragraph 4

4. Calls on the Commission to determine the priority areas for research on cannabis for medicinal and recreational3a purposes in agreement with competent authorities and drawing on pioneering research in other countries and focusing in those areas which may have the greatest added-value; _________________ 3aResearch in the field of recreational cannabis can also be useful for the use and applications of medical cannabis

Amendment 51 #

Paragraph 4

4. Calls on the Commission to determine the priority areas for research on cannabis ~~for medicinal purpose~~-based drugs in agreement with competent authorities and ~~drawing on pioneering research~~with regard to research carried out in other countries and focusing ion those areas which may have the greatest added-value;

Amendment 52 #

Paragraph 4 a (new)

4a. Stresses the need to preventively exclude minors and other vulnerable groups that are susceptible to addiction from any form of such research and other research;

Amendment 53 #

Paragraph 4 a (new)

4a. Calls on the Commission and Member States to embark on more research and stimulate innovation with regards to projects related to the use of cannabis for medicinal purposes.

Amendment 54 #

Paragraph 5

5. Calls on the Commission to develop a comprehensive strategy to ensure the highest standards for the research, development, authorisation, marketing, pharmacovigilance and avoidance of abuse for cannabis-based medicines; ~~emphasises the need for standardisation and unification of products containing Cannabis-based medicines;~~

Amendment 55 #

Estefanía TORRES MARTÍNEZ, Stelios KOULOGLOU

Paragraph 5

5. Calls on the Commission to develop a comprehensive strategy to ensure the highest standards for the independent research, development, authorisation, marketing, pharmacovigilance and avoidance of abuse for cannabis-based medicines; emphasises the need for standardisation and unification of products containing Cannabis-based medicines;

Amendment 56 #

Paragraph 5

5. Calls on the Commission to develop a comprehensive strategy to ensure the highest standards for the research, development, authorisation, marketing, pharmacovigilance and avoidance of abuse ~~for cannabis-based medicine~~of products derived from Cannabis; emphasises the need for standardisation and unification of products containing Cannabis-based medicines;

Amendment 57 #

Paragraph 5 a (new)

5a. Calls on the Commission to create a department on cannabis for therapeutic use to have a place to centralize regulatory proposals and be the point of observation, advice, information, exchange and study for everything related which would serve as a reference to all countries equally in the European Union.

Amendment 58 #

Stelios KOULOGLOU, Estefanía TORRES MARTÍNEZ

Paragraph 5 a (new)

5a. Calls on the Commission to launch an informative campaign to raise awareness on the importance of the use of cannabis for medicinal purposes. National authorities should be responsible to ensure the effective implementation of the campaign.

Amendment 59 #

Paragraph 5 a (new)

5a. Stresses the importance of close cooperation and coordination with the World Health Organisation (WHO) in connection with further EU steps in the field of medical cannabis;

Amendment 6 #

Recital C

C. whereas ~~Cannabis products that are us~~the term “medical cannabis” should be distinguished forom medicin~~al purposes are broadly referred to as “medical cannabis”;~~es derived from Cannabis which have undergone clinical trials and are regulatory approved,

Amendment 60 #

Paragraph 6

6. Calls on the Commission to establish a network which would bring together both EMA and the EMCDDA as well as responsible national authorities and patient organisations, civil society, social partners, consumer organisations, healthcare professionals and NGOs together with other relevant stakeholders to ensure an effective implementation of the strategy for cannabis-based medicines;

Amendment 61 #

Paragraph 7

7. Calls on Member States to encourage increased knowledge among medical professionals regarding the use of such cannabis-based medicine and consider allowing doctors to freely use their professional judgement to prescribe cannabis and cannabis-based medicines to patients with relevant conditions, and allow pharmacists to lawfully honour those prescriptionsprovide proper medical training regarding the use of such cannabis-based medicine; emphasizes that this training should be based on relevant scientific research; highlights the need for this training and access to literature for all medical staff - medical students, medical doctors and pharmacists;

Amendment 62 #

Paragraph 7

7. Calls on Member States to encourage increased knowledge among medical professionals gained from independent and wide-ranging research regarding the use of such cannabis-based medicines and ~~consider~~from secondary symptoms and allow~~ing~~ doctors to freely use their professional judgement to prescribe ~~cannabis and~~ cannabis-based medicines to patients with relevant conditions, and allow pharmacists to lawfully honour those prescriptions; highlights the need for training and access to literature for medical staff - medical students, medical doctors and pharmacists - on the results of independent scientific research;

Amendment 63 #

Paragraph 7

7. Calls on Member States to encourage increased knowledge among medical professionals, in the context of preliminary and on-going training, regarding the use of such cannabis-based medicine and consider allowing doctors to freely use their professional judgement to prescribe cannabis and cannabis-based medicines to patients with relevant conditions, and allow pharmacists to lawfully honour those prescriptions; highlights the need for training and access to literature for medical staff - medical students, medical doctors and pharmacists;

Amendment 64 #

Paragraph 7

7. Calls on Member States to encourage increased knowledge among medical professionals regarding the use of such cannabis-based medicine and ~~consider~~ allow~~ing~~ doctors to freely use their professional judgement to prescribe ~~cannabis an~~regulatory approved cannabis-based medicines to patients with relevant conditions, and allow pharmacists to lawfully honour those prescriptions; highlights the need for training and access to literature for medical staff - medical students, medical doctors and pharmacists;

Amendment 65 #

Paragraph 7

Amendment 66 #

Paragraph 8

8. Calls on the Commission to work with Member States to improve equal access to ~~medicinal cannabis and ensure that medical cannabis, where allowed, is~~cannabis-based medicines and ensure that, where allowed, medicines which are effective in treating specific conditions are covered by health insurance schemes, as is the case for other medicinal products. Asks Member States to provide safe and equal choice for patients between different types of cannabis-based medicine, while ensuring that patients are accompanied by specialised medical professionals during their treatment;

Amendment 67 #

Paragraph 8

8. Calls on the Commission to work with Member States to improve equal access to ~~medicinal cannabis and ensure that medical cannabis, where allowed, i~~cannabis-based medicines covered by health insurance schemes as is the case for other medicin~~al product~~es. Asks Member States to provide safe and equal choice for patients between different types of cannabis-based medicine, while ensuring that patients are accompanied by specialised medical professionals during their treatment;

Amendment 68 #

Paragraph 8 a (new)

8a. Emphasises that to ensure that patients have access to the right therapy, which is case specific and caters towards their individual needs as patients with single or multiple disorders, it is essential to ensure that patients are provided with comprehensive information about the full spectrum profiles of the plant strains used within the medication provided. Such information would empower patients and medical practitioners to prescribe medication which takes into consideration the holistic needs to the patient and corresponding therapy;

Amendment 69 #

Paragraph 8 a (new)

8a. Calls on the Member States to reconsider their relevant legislation on the use of cannabis-based medicines when scientific research proves that the same positive effect cannot be achieved by using ordinary medicines that do not have addictive effects;

Amendment 7 #

Recital C

C. whereas Ccannabis products that are used for medicinal purposes are broadly referred to as “‘medical cannabis”’, and whereas this would, however, require a change to the names of cannabis-based drugs;

Amendment 70 #

Paragraph 9

9. Calls on Member States to secure sufficient availability of safe and controlled cannabis for medicinal purposes to cater for the actual needs; be it by local production in Member States or by imports;deleted

Amendment 71 #

Paragraph 9

Amendment 72 #

Paragraph 9

Amendment 73 #

Paragraph 9

9. Calls on Member States to secure sufficient availability of ~~safe and controlled cannabi~~cannabis-based medicines for medicinal purposes to cater for the actual needs~~; be it by local production in~~, by means of production by medical facilities in the Member States or bypossibly of imports;

Amendment 74 #

Paragraph 9 a (new)

9a. Calls on the Commission to work with Member States to ensure safe and controlled cannabis used for medicinal purposes can only be from cannabis derived products that have been through clinical trials, regulatory assessment and approval,

Amendment 75 #

Paragraph 9 a (new)

9a. Urges the Commission to ensure that research into, and use of, medical cannabis in the Union does not in any way favour criminal drugs networks or cause them to expand;

Amendment 76 #

Paragraph 9 a (new)

9 a. Calls on the Member States to develop a mechanism prohibiting the re- export of cannabis-based medicines in order to prevent their use as narcotic, psychotropic substances;

Amendment 77 #

Paragraph 10

10. ~~Underlines how a~~Notes that no comprehensive regulation of medical cannabis would translate in additional resources for public authorities, would limit the black market for medical cannabis consumption, would help control points of sale, would limit the access of this substance to minors and would give a legal and safe access to patients for its medicinal use - with particular precautions for young people and pregnant womehas yet been introduced in the Union;

Amendment 78 #

Paragraph 10

10. Underlines how a comprehensive and evidence based regulation of medical cannabis would translate in additional resources for public authorities, would limit the black market for medical cannabis consumption, would help control points of sale, would limit the access of this substance to minors and would give a legal and safe access to patients for its medicinal use - with particular precautions for young people and pregnant women;

Amendment 79 #

Paragraph 10

10. Underlines how a comprehensive regulation of medic~~al c~~ines deriving from Cannabis would translate into additional resources for public authorities, would limit the black market for medical cannabis consumption, would help control points of sale, would limit the access of this substance to minors and would give a legal and safe access to patients for its medicinal use - with particular precautions for young people and pregnant women;, ensure quality and accurate labelling of medicines and ensure legal and safe patient access to regulatory approved medicines,

Amendment 8 #

Recital C

C. whereas ~~Cannabis product~~products derived from Cannabis that are used for medicinal purposes are broadly referred to as “medical cannabis”;

Amendment 80 #

Paragraph 10

10. Underlines how a comprehensive regulation of medical cannabis would translate in additional resources for public authorities, would limit the black market ~~for medical cannabis consumption, would~~, would ensure product quality and accurate labelling to help control points of sale, would limit the access of this substance to minors and would give a legal certainty and safe access to patients for its medicinal use - with particular precautions for young people and pregnant women;

Amendment 81 #

Paragraph 10

10. Underlines how a comprehensive regulation of medical cannabis would translate in additional resources for public authorities, would limit the black market for medical cannabis consumption, would ensure product quality and accurate labelling to help in control of points of sale, would limit the access of this substance to minors and would give a legal and safe access to patients for its medicinal use - with particular precautions for young people and pregnant women;

Amendment 82 #

Paragraph 10

10. Underlines how a comprehensive regulation of ~~medical cannabis would translate in additional resources for public authoriti~~cannabis-based medicines, would limit the black market for ~~medical cannabis consumption~~the consumption of cannabis-based medicines, would help control points of sale, would limit ~~the~~ access tof this substance tofor minors and would ~~give a legal and safe~~provide safe, legal access tofor patients ~~for its~~to their medicinal use -, with ~~particular precautions for young people and pregnant women~~the exclusion of their use by pregnant women and with restrictions on their use by young people;

Amendment 83 #

Paragraph 10 a (new)

10a. Stresses that strict prevention of addiction among minors and vulnerable groups must always form part of every regulatory framework;

Amendment 84 #