Dame Prof Sally Davis Chief Medical Officer Department … to [email protected] 13 January 2015 Dear Dame Sally Thank you for the invitation to attend last week’s

AAGBI FOUNDATION | 21 PORTLAND PLACE | LONDON | W1B 1PY TEL +44 (0)20 7631 1650 | FAX +44 (0)20 7631 4352 | EMAIL [email protected] | WEB www.aagbi.org Patron: HRH The Duke of York, KG, KCVO. Registered as a Company limited by Guarantee. Registered No. 1963975 (England). Registered as a charity in England & Wales No. 293575 and in Scotland No. SC040697.

Dame Prof Sally Davis Chief Medical Officer Department of Health Richmond House 79 Whitehall LONDON, SW1A 2NS UK Sent via email to: [email protected] 13 January 2015 Dear Dame Sally Thank you for the invitation to attend last week’s WHO-EB External Partners meeting, which it was a pleasure to attend for the first time. I commented favourably at that meeting on the Expert Committee on Drug Dependence’s recommendation that ketamine not be placed under international regulation at this time. The committee acknowledged the important medical use of ketamine as an anaesthetic, especially in low- and middle-income countries and in crisis situations. I am aware that this matter will next be considered at the Commission on Narcotic Drugs, Fifty-eighth session in Vienna, 9-17 March 2015, and that the United Kingdom was not one of the countries that supplied comments on the proposal. You will be well aware of the extensive involvement of the AAGBI in promoting anaesthetic safety in the developing world, and I would ask that the United Kingdom respects the recommendation of the Expert Committee on Drug Dependence and does not support any attempt to subject ketamine to international regulation. The AAGBI would be happy to work with you further on this matter if this would be helpful. Yours sincerely

Dr Andrew Hartle President

http://www.aagbi.org/

mailto:[email protected]

United Nations E/CN.7/2015/7

Economic and Social Council Distr.: General 16 December 2014 Original: English

V.14-08359 (E) 301214 311214

*1408359*

Commission on Narcotic Drugs Fifty-eighth session Vienna, 9-17 March 2015 Item 6 (b) of the provisional agenda* Implementation of the international drug control treaties: changes in the scope of control of substances

Changes in the scope of control of substances

Note by the Secretariat

Summary The present document contains recommendations for action to be taken by the Commission on Narcotic Drugs pursuant to the international drug control treaties. In accordance with article 2 of the Convention on Psychotropic Substances of 1971, the Commission will have before it for consideration a proposal from the United Kingdom of Great Britain and Northern Ireland concerning a recommendation to place mephedrone (4-methylmethcathinone) in Schedule I of the 1971 Convention and a proposal from China concerning a recommendation to place ketamine in Schedule I of the 1971 Convention.

The present document also contains comments provided by Governments on economic, social, legal, administrative and other factors relevant to the proposed scheduling of mephedrone and ketamine under the 1971 Convention.

It further contains recommendations by the World Health Organization on the proposed scheduling of mephedrone and ketamine.

__________________ * E/CN.7/2015/1.

2 V.14-08359

E/CN.7/2015/7

I. Consideration of the notification from the United Kingdom of Great Britain and Northern Ireland concerning a proposed recommendation for international control of mephedrone under the Convention on Psychotropic Substances of 1971

1. Pursuant to article 2, paragraphs 1 and 3, of the Convention on Psychotropic Substances of 1971, the Government of the United Kingdom of Great Britain and Northern Ireland, in its correspondence of 23 January 2014, notified the Secretary-General of the United Nations that the United Kingdom recommended that mephedrone (4-methylmethcathinone) be provisionally scheduled in accordance with article 2, paragraph 3, in order to support Member States in taking voluntary measures while the scheduling request was under consideration, and that the substance be added to Schedule I of the 1971 Convention (see annex I).

2. In accordance with the provisions of article 2, paragraph 2, of the 1971 Convention, the Secretary-General transmitted to all Governments a note verbale dated 7 February 2014, containing in its annex the notification and the information submitted by the United Kingdom in support of the recommendation that mephedrone be placed in Schedule I of the 1971 Convention.

3. In accordance with the provisions of article 2, paragraph 2, of the 1971 Convention, the Secretary-General also transmitted to the World Health Organization (WHO) a note verbale dated 10 February 2014, containing in its annex the notification and the information submitted by the United Kingdom in support of the recommendation that mephedrone be placed in Schedule I of the 1971 Convention.

4. As of 15 December 2014, the following 22 Governments provided comments on economic, social, legal, administrative or other factors relevant to the possible scheduling of mephedrone in Schedule I of the 1971 Convention: Algeria, Argentina, Australia, Colombia, Czech Republic, El Salvador, Germany, Hungary, India, Ireland, Italy, Jordan, Latvia, Mexico, Oman, Philippines, Poland, Republic of Moldova, Russian Federation, Slovakia, Sweden and Uruguay.

5. The Government of Algeria reported that it was in favour of placing mephedrone under international control, as it was one of many synthetic drugs imitating euphoric effects of “ecstasy” and amphetamines, causing many casualties and disastrous secondary effects.

6. The Government of Argentina indicated that the substance has been incorporated into a new list of drugs which was under evaluation and was authorized by a presidential decree. Its competent authority reported that it had no objections to international control, as recommended by the United Kingdom.

7. The Government of Australia reported through its competent authority that it supported the inclusion of mephedrone into Schedule I or Schedule II of the 1971 Convention. It indicated that Australia placed the substance into Schedule 4 of its Customs (Prohibited Imports) Regulations 1956 in January 2011 and classified it as a prohibited substance in Schedule 9 of the Standard for the Uniform Scheduling of Medicines and Poisons in 2010. In the event that mephedrone was scheduled

V.14-08359 3

E/CN.7/2015/7

under the 1971 Convention, there would be a minor administrative amendment to the Customs (Prohibited Exports) Regulations 1958. The competent authority further indicated that although it supported the substance being placed under international control, there were challenges surrounding the identification and reliability of statistics on seizures and detections of mephedrone and all new psychoactive substances.

8. The Government of Colombia reported its support for the inclusion of mephedrone in Schedule I of the 1971 Convention. Once included in Schedule I or Schedule II of the Convention, mephedrone would be added to article 7 of Resolution No. 1478 of 2006 of the Ministry of Social Protection and would thus be subject to the other provisions of that resolution, such as the prohibition of sale through the Internet.

9. The Government of the Czech Republic indicated its support for international control of mephedrone. The substance had been surfacing as a recreational drug in the Czech Republic since 2010 and was therefore added to Schedule 4 of the Psychotropic Substances in Act 167/1998 Coll.

10. The Government of El Salvador indicated through its National Directorate of Medicines that the inclusion of mephedrone in the schedules of the 1971 Convention would have no economic, social, legal or administrative implications in El Salvador. The substance was not sold legally. There was no record of its legal or illegal use, and therefore its inclusion in the schedules would not have any commercial implications. In addition, mephedrone could be included in a list of substances subjected to special monitoring and control at any time of the year on the basis of an agreement of the Board of Representatives of the National Directorate of Medicines.

11. The Government of Germany reported that it had no information relevant to the subject matter.

12. The Government of Hungary indicated that it had no further comments in addition to the documents provided regarding scheduling of mephedrone. It reported that under national law, the substance was scheduled in list A, which was equivalent to Schedule I of the 1971 Convention.

13. The Government of India reported its support for international control of mephedrone pursuant to article 2, paragraphs 1 and 3, of the 1971 Convention. It further indicated that the substance was not approved for manufacture and sale in India for medical purposes.

14. The Government of Ireland indicated that mephedrone was controlled under the Misuse of Drugs Act 1977, as amended, and the regulations adopted pursuant to it. In addition, in 2010, the substance had been listed in schedule I of the Irish Misuse of Drugs Regulations 1988, as amended, which was the equivalent of Schedule I of the 1971 Convention. It was reported that given the lack of legitimate uses of mephedrone and the dangers associated with it, Ireland supported its inclusion in Schedule I of the 1971 Convention.

15. The Government of Italy reported that mephedrone was subject to narcotic drug control in Italy and should be added to Schedule I of the 1971 Convention.

4 V.14-08359

E/CN.7/2015/7

16. The Government of Jordan indicated that the substance was not registered in Jordan.

17. The Government of Latvia reported that mephedrone was currently scheduled under schedule I (“Prohibited especially dangerous narcotic substances, equivalent psychotropic substances thereof and plants, illegal handling and abuse of which endangers health”) of Cabinet Regulation No. 847 of 2005, and therefore all trade in mephedrone was prohibited.

18. The Government of Mexico reported that neither medical use nor industrial applications of mephedrone had been reported in Mexico, and therefore the proposal by the United Kingdom would not have any economic impact on its industry. It further indicated that the scheduling of mephedrone would have a positive social impact. As of 7 January 2014, mephedrone had been included in subsections I and II of article 245 of the General Health Act as a psychotropic substance, and therefore the inclusion of that substance in Schedule I of the 1971 Convention would not affect the domestic law of Mexico.

19. The Government of Oman reported through its competent authority that mephedrone had no industrial or medical use and was currently used solely for research purposes. It suggested that the substance be added to Schedule I of the 1971 Convention and indicated that to prevent its misuse, the Ministry of Health would discuss, at the local level, necessary controls in the upcoming meeting of the National Committee for Narcotics and Psychotropic Substances Affairs.

20. The Government of the Philippines reported that its Dangerous Drugs Board made no objection and supported the position of the United Kingdom to include mephedrone in Schedule I of the 1971 Convention, given the high risk of its abuse and the fact that the drug produced effects similar to methylenedioxymethamphetamine (MDMA), amphetamines and cocaine.

21. The Government of Poland indicated that mephedrone was subject to national control in accordance with the Act of 29 July 2005 on Counteracting Drug Addiction and was classified as a psychotropic substance listed in group I-P.

22. The Government of the Republic of Moldova indicated its support for adding mephedrone to Schedule I of the 1971 Convention.

23. The Government of the Russian Federation reported its support for the inclusion of mephedrone in Schedule I of the 1971 Convention. It indicated that the substance was included in the section “Narcotic drugs” of schedule I of the register of narcotic drugs, psychotropic substances and their precursors which were under national control, as approved by decision No. 681 of the Government of the Russian Federation of 30 June 1998.

24. The Government of Slovakia reported that scheduling of mephedrone would not have any significant impact as the substance had been subject to control under national legislation since 1 January 2011. It was included in Group I of narcotic and psychotropic substances, and as such could be grown, manufactured, imported, exported, produced, transited and distributed wholesale only for the purpose of research, study or expert activity.

25. The Government of Sweden indicated that mephedrone was subject to control measures at the national level since 2009 under the Narcotic Drugs Control Act

V.14-08359 5

E/CN.7/2015/7

(SFS 1992-860) and under the Narcotic Drugs Control Ordinance (SFS 1994:1554). It provided statistical information on seizures, fatal and non-fatal intoxications of mephedrone in Sweden from 2010 to March 2014.

26. The Government of Uruguay indicated that given the wide geographic distribution of mephedrone consumption and its emergence in neighbouring countries, the country was exposed to the risk of the emergence of the substance in its territory. It reported the need to strengthen its legislation in force through the inclusion of new emerging synthetic drugs in the lists of controlled substances and thus reported that the proposed inclusion of mephedrone in the schedules of the 1971 Convention was essential.

Action to be taken by the Commission on Narcotic Drugs

27. The notification from the United Kingdom is before the Commission for its consideration, in accordance with the provisions of article 2, paragraph 5, of the 1971 Convention, which reads as follows:

5. The Commission, taking into account the communication from the World Health Organization, whose assessments shall be determinative as to medical and scientific matters, and bearing in mind the economic, social, legal, administrative and other factors it may consider relevant, may add the substance to Schedule I, II, III or IV. The Commission may seek further information from the World Health Organization or from other appropriate sources.

28. The recommendation of the WHO Expert Committee on Drug Dependence is also before the Commission for its consideration (annex II).

29. With regard to the decision-making process, the attention of the Commission is drawn to article 17, paragraph 2, of the 1971 Convention, which stipulates that the “decisions of the Commission provided for in articles 2 and 3 shall be taken by a two-thirds majority of the members of the Commission”. From a practical point of view, that means that, for a decision to be adopted, an affirmative vote of at least 35 members of the Commission is required.

30. The Commission should therefore decide whether it wishes to place mephedrone in Schedule I of the 1971 Convention or, if not, what other action, if any, might be required.

II. Consideration of a notification from China concerning the proposed recommendation for international control of ketamine under the Convention on Psychotropic Substances of 1971

31. Pursuant to article 2, paragraph 1, of the Convention on Psychotropic Substances of 1971, the Government of China, in its correspondence dated 8 March 2014, notified the Secretary-General of the United Nations that China recommended that ketamine be placed in Schedule I of the 1971 Convention (see annex III).

6 V.14-08359

E/CN.7/2015/7

32. In accordance with the provisions of article 2, paragraph 2, of the 1971 Convention, the Secretary-General transmitted to all Governments and WHO notes verbales, dated 14 March 2014 and 24 June 2014, annexing the notification and the information submitted by China in support of the recommendation that ketamine be placed in Schedule I of the 1971 Convention.

33. As of 15 December 2014, the following 26 Governments provided comments on economic, social, legal, administrative or other factors relevant to the possible scheduling of ketamine under the 1971 Convention: Algeria, Argentina, Austria, Belgium, Colombia, Czech Republic, Ecuador, El Salvador, Germany, Hungary, Ireland, Italy, Kazakhstan, Latvia, Mexico, Morocco, Netherlands, Oman, Poland, Republic of Moldova, Russian Federation, Slovakia, Spain, Switzerland, Ukraine and United Arab Emirates.

34. The Government of Algeria reported its support for placing ketamine under international control, given its illicit use.

35. The Government of Argentina indicated that it had no objection to the proposal by China to place ketamine under international control as Argentina had already reported on the problems caused by the diversion of ketamine for illicit purposes and had taken the necessary legal and regulatory measures and established specific monitoring and control mechanisms to prevent such diversion.

36. The Government of Austria reported that there was no reason that would suggest the need to place the substance under international drug control and informed that it did not favour its scheduling. It further indicated that the use of the substance outside medical and veterinary settings in Austria was not common and thus scheduling the substance under national drug law was not planned. A risk assessment had been conducted by the Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction, which had not led to the placement of the substance under the drug control system at the level of the European Union. It suggested that regional control measures could be taken wherever relevant problems with the substance were observed.

37. The Government of Belgium reported that ketamine was virtually the only anaesthetic readily available in developing countries and that, in the absence of any alternatives, placing that human and veterinary medicine under international control could have a vast impact on the availability of that medicine in such countries. For that reason, it proposed maintaining the status quo in this matter.

38. The Government of Colombia reported that the substance was subjected to national control pursuant to article 7 of Resolution No. 1478 of 2006. In addition, it indicated that medicines containing ketamine (HCl 200 milligrams (mg)/ 20 millilitres (ml) and HCl 500 mg/10 ml injectable solutions) were added to a national list of medicines under control by the Special Administrative Unit of the National Narcotics Fund, and were mostly for veterinary use, although the concentration 500 mg/10 ml was used also for humans. It further informed that trafficking, production and possession of ketamine was penalized, pursuant to article 12 of Law No. 1453 of 2011. The proposal to include ketamine in Schedule I of the 1971 Convention would thus not have any commercial or legal impact in Colombia.

V.14-08359 7

E/CN.7/2015/7

39. The Government of the Czech Republic indicated its support for international control of ketamine. It informed that the substance had been surfacing as a recreational drug and was therefore subjected to national control in 2011. With regard to the use of ketamine for medical purposes, it recommended adding the substance to Schedule III of the 1971 Convention.

40. The Government of Ecuador reported that it did not consider international control of ketamine to be appropriate. Through the National Council for the Control of Narcotic and Psychotropic Substances, it recalled the critical review at the thirty-fourth meeting of the WHO Expert Committee, which concluded that there was insufficient evidence to justify international control of ketamine. It further reported that upon implementation of Resolution 072, imports of the substance had declined in the country and it had not registered any negative incidents regarding the use of ketamine.

41. The Government of El Salvador reported that placing ketamine under the international control of the 1971 Convention would have no effect in economic, social, judicial or administrative areas in the country. It informed that ketamine could be easily diverted to illicit use and informed that the substance was on the national list of controlled medications and substances.

42. The Government of Germany reported that it had no indication of a need for stronger international control of ketamine and suggested awaiting the WHO assessment report and the resulting WHO recommendation in the matter.

43. The Government of Hungary informed that ketamine, because of its criminal nature, had been considered a type of drug under national legislation since November 1997 and some illegal use of the substance continued to be present. It reported that ketamine was used in both human and veterinary medicine and that Hungary would support placing the substance under Schedule II of the 1971 Convention.

44. The Government of Ireland indicated that ketamine was subject to control under schedule 3 of the Misuse of Drugs Regulations 1988, as amended (containing substances with medicinal uses but with the potential to be misused). It was reported that the primary use of ketamine in Ireland was by the veterinary community, while seizures, outside legitimate trade, had been low. It further indicated that an appropriate balance was to be struck between the level of controls required to mitigate its misuse and the protection of its legitimate use.

45. The Government of Italy reported that ketamine was subject to narcotic drug control in Italy and should be added to Schedule I of the 1971 Convention.

46. The Ministry of Health of Kazakhstan informed that some of the most significant effects of ketamine were psychotic in nature and typically stopped immediately after patients’ emergence from anaesthesia. It informed that the drug was optimal for use in anaesthetic practice in adverse economic conditions. However, the discomfort experienced by patients on awakening and the possible consequences of such anaesthesia made use of the substance limited in practice. It further informed that cases of ketamine abuse by patients or use in the treatment of drug abuse or addiction had not been recorded.

47. The Government of Latvia reported that ketamine was not controlled under national legislation due to its use in veterinary care. It was indicated that scheduling

8 V.14-08359

E/CN.7/2015/7

of ketamine in Schedule II, III or IV of the 1971 Convention would strengthen the requirements for production, import, export and distribution, as well as for storage, inspection and monitoring of products containing that substance, which in turn would increase the administrative burden. However, it would not significantly increase financial costs. For that reason, Latvia could accept the placement of ketamine in Schedule II, III or IV of the 1971 Convention. With regard to scheduling in Schedule I of the 1971 Convention, Latvia indicated that it would have significant consequences in veterinary practice and therefore did not agree with adding the substance to Schedule I of the Convention.

48. The Government of Mexico indicated that at present, ketamine was listed in the General Health Act, under section 12, chapter VI (on psychotropic substances), article 245 (III), among substances that have therapeutic value but constitute a public health problem. Given that context, ketamine was controlled in Mexico and, in view of its properties, its inclusion in the 1971 Convention would be an appropriate measure. However, according to the Executive Directorate for the Regulation of Narcotic Drugs and Psychotropic and Chemical Substances of the Federal Commission for Protection against Health Risks (COFEPRIS), its addition to Schedule I would be excessive for its regulation, and it was proposed that the substance be included in Schedule III of the Convention. In addition, the Department for the Coordination of Expert Services of the Criminal Investigation Agency and the Directorate General for Legislative Analysis and Regulations of the Office of the Attorney General of Mexico indicated that in Mexico, the diversion of ketamine for illicit purposes was not common and there had been no reports that clandestine laboratories for ketamine synthesis had been found. Therefore, it was suggested instead that the authorities of each country should exercise greater control and establish stricter regulations in order to prevent the diversion of ketamine.

49. The Government of Morocco reported it had no objection to the potential listing of ketamine in the schedules of the 1971 Convention. It indicated that it had made proprietary ketamine-based medicines subject to the regulations for narcotic drugs. Ketamine-based medicines sold in Morocco were products intended to be used in hospitals, and the import of ketamine was subject to the prior acquisition of an import authorization required by the health authorities of the exporting country.

50. The Government of the Netherlands drew attention to Commission on Narcotic Drugs resolution 57/10, entitled “Preventing the diversion of ketamine from legal sources while ensuring its availability for medical use”, in which the Commission, among other things, noted that international control measures could adversely impact the availability and accessibility of ketamine for medical use. The Government of the Netherlands reported that the substance was used in the country both for human and veterinary medicine. It supported the development of health-care systems in least developed countries and countries with difficult circumstances, and that imposing stricter controls would be contradictory to that policy. It reported that national legislation (and its effective enforcement) seemed to be the appropriate response at the present stage, given that according to the notification, the diversion of ketamine seemed to occur at the domestic level.

51. The Government of Oman reported that no cases of abuse of ketamine as a psychotropic substance had been recorded in Oman and that the imported quantities of drugs containing ketamine were minimal compared with other substances on the local market. It could not recognize any economic, social, legal, administrative

V.14-08359 9

E/CN.7/2015/7

or other factor that it would consider relevant to the possible scheduling of ketamine, and it had no objection to the addition of the substance to Schedule I of the 1971 Convention.

52. The Government of Poland reported that ketamine was listed as a group II-P psychotropic substance in the Act of 29 July 2005 on Counteracting Drug Addiction. It indicated that the substance was used in medicinal products both in human and veterinary medicine, as an anaesthetic, and therefore there was no need to place it in Schedule I. It suggested that placing it in Schedule II would be sufficient.

53. The Government of the Republic of Moldova reported its support for adding ketamine to Schedule I of the 1971 Convention.

54. The Government of the Russian Federation reported that since 1988, ketamine had been classified as a psychotropic substance and included in schedule II of the register of narcotic drugs, psychotropic substances and their precursors which were under national control. Hence, the use of ketamine was permitted for scientific, educational and medical purposes, as well as in expert activities and veterinary sciences. It further reported that inclusion of ketamine in Schedule I of the 1971 Convention would not entail a reduction in volume sold on the internal market and thus the Russian Federation had no objection to the proposal by China. It indicated, however, that from the point of view of the Federal Drug Control Service, ketamine could be included in Schedule II of the 1971 Convention.

55. The Government of Slovakia reported that scheduling of ketamine would not have any significant impact as the substance had been subject to control under national legislation. It had been scheduled since 1 January 2010, in Group II of narcotic and psychotropic substances, and ketamine as a veterinary product was prescribed in justified cases.

56. The Government of Spain reported through its Agency of Medicines and Health Products that ketamine was subject to national control. However, its inclusion in Schedule I of the 1971 Convention would entail the prohibition of its use, manufacture, import, export, transport, trade, distribution and possession and its inclusion in any preparation containing the substance. The use of ketamine would be restricted to scientific research purposes. Therefore, the Agency supported international control, provided that it was not included in Schedule I of the 1971 Convention.

57. The Government of Switzerland reported that adding ketamine to Schedule I of the 1971 Convention would require strong control measures, which would not take into account the medical use of the substance and the need for its availability for medical use in Switzerland, both in humans and animals. It further informed that scheduling would have serious negative economic, social, legal and administrative impact in Switzerland and therefore it would not support the proposal.

58. The Government of Ukraine reported that ketamine was under national control by law and thus was of the opinion that the measures introduced and operational in Ukraine provided an adequate and effective mechanism of control over trafficking of the substance. It further informed that adding ketamine to Schedule I could cause significant harm to the domestic livestock industry. It had proved to be effective, and avoiding the use of the substance would necessitate the development and acquisition of new techniques, requiring significant efforts and financial resources.

10 V.14-08359

E/CN.7/2015/7

For that reason, the Government of Ukraine reported it believed that the classification of ketamine in Schedule II was the best option.

59. The Government of the United Arab Emirates reported that its competent national authorities saw no legal or other factors relevant to possible scheduling under the 1971 Convention. It informed that ketamine had been under national control since 2005, and its import was subject to authorization. The dispensing and consumption of ketamine was controlled by issuing controlled medicine prescriptions and was monitored by monthly/quarterly auditing.

Action to be taken by the Commission on Narcotic Drugs

60. The notification from China is before the Commission for its consideration, in accordance with the provisions of article 2, paragraph 5, of the 1971 Convention, which reads as follows:

5. The Commission, taking into account the communication from the World Health Organization, whose assessments shall be determinative as to medical and scientific matters, and bearing in mind the economic, social, legal, administrative and other factors it may consider relevant, may add the substance to Schedule I, II, III or IV. The Commission may seek further information from the World Health Organization or from other appropriate sources.

61. The recommendation of the WHO Expert Committee on Drug Dependence is also before the Commission for its consideration (annex IV).

62. With regard to the decision-making process, the attention of the Commission is drawn to article 17, paragraph 2, of the 1971 Convention, which stipulates that the “decisions of the Commission provided for in articles 2 and 3 shall be taken by a two-thirds majority of the members of the Commission”. From a practical point of view, that means that, for a decision to be adopted, an affirmative vote of at least 35 members of the Commission is required.

63. The Commission should therefore decide whether it wishes to place ketamine under Schedule I of the 1971 Convention or, if not, what other action, if any, might be required.

V.14-08359 11

E/CN.7/2015/7

Annex I

Notification from the United Kingdom of Great Britain and Northern Ireland concerning a proposed recommendation for international control of mephedrone under the Convention on Psychotropic Substances of 1971

The Permanent Mission of the United Kingdom of Great Britain and Northern Ireland to the United Nations presents its compliments to the Secretary-General of the United Nations and has the honour to inform him that the United Kingdom of Great Britain and Northern Ireland, being a party to the 1971 Convention on Psychotropic Substances, has information relating to the following substance which is not under international control, but which, in the Government’s opinion, may require its addition to one of the schedules of the 1971 Convention on Psychotropic Substances.

The substance is mephedrone (4-methylmethcathinone).

In the opinion of the United Kingdom of Great Britain and Northern Ireland, the above-mentioned substance should be provisionally scheduled under article 2, paragraph 3, in order to support Member States in taking voluntary measures while the scheduling request is under consideration, and be added to Schedule I of that Convention.

The United Kingdom of Great Britain and Northern Ireland transmits this notification to the Secretary-General of the United Nations, in accordance with paragraph 1 of article 2 of the 1971 Convention on Psychotropic Substances, in order to initiate the procedure provided for under that article.

Annexed to this note verbale for information is the United Kingdom Advisory Council on the Misuse of Drugs 2010 report on the cathinones, which includes evidence on mephedrone, as well as the United Nations Office on Drugs and Crime brief on mephedrone.

A copy of this note verbale has been transmitted to the Executive Director of the United Nations Office on Drugs and Crime.

12 V.14-08359

E/CN.7/2015/7

Annex II

Extract of the notification from the Director-General of the World Health Organization to the Secretary-General dated 25 November 2014 concerning the recommendation to place mephedrone in Schedule II of the 1971 Convention, including the relevant extract from the thirty-sixth report of the Expert Committee on Drug Dependence

With reference to article 2, paragraphs 1, 4 and 6, of the Convention on Psychotropic Substances of 1971 and article 3, paragraphs 1, 3 and 5 of the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, and following the 36th meeting of the Expert Committee on Drug Dependence in June 2014, I am pleased to submit the recommendation of the World Health Organization (WHO).

The recommendation is that mephedrone be placed in Schedule II of the Convention on Psychotropic Substances of 1971.

A notification has been made by the United Kingdom of Great Britain and Northern Ireland, pursuant to article 2, paragraphs 1 and 3 of the Convention on Psychotropic Substances of 1971, concerning a proposed recommendation for international control of mephedrone. The Expert Committee critically reviewed this substance and considered that the degree of risk to public health and society associated with the abuse liability of mephedrone is substantial and therefore considered that the evidence of its abuse warranted its placement under international control, in Schedule II of the Convention on Psychotropic Substances of 1971.

Extract from the report of the thirty-sixth meeting of the Expert Committee on Drug Dependence

Mephedrone (4-methylmethcathinone, 4-MMC) is chemically (R,S)-2-(methylamino)-1-(4-methylphenyl)propan-1-one.

Mephedrone had not been previously pre-reviewed or critically reviewed. A direct critical review was proposed based on information brought to the attention of WHO that mephedrone is clandestinely manufactured, of especially serious risk to public health and society and of no recognized therapeutic use by any party. Preliminary data collected from literature and different countries indicated that this substance may cause substantial harm. A critical review was further undertaken by the Committee given that the Government of the United Kingdom of Great Britain and Northern Ireland had made a notification concerning a proposed recommendation for international control of mephedrone (4-methylmethcathinone), under article 2, paragraphs 1 and 3, of the Convention on Psychotropic Substances of 1971.

The Committee considered that the degree of risk to public health and society associated with the abuse liability of mephedrone is substantial. Its therapeutic usefulness has been assessed to be none. The Committee considered that the evidence of its abuse warranted its placement under international control. As per the

V.14-08359 13

E/CN.7/2015/7

“Guidance on the WHO review of psychoactive substances for international control”, higher regard was made to the substantial public health risk as opposed to the lack of therapeutic usefulness [p. 18, para. 56, penultimate sentence].

The Committee recommended that mephedrone be placed in Schedule II of the Convention on Psychotropic Substances of 1971.

14 V.14-08359

E/CN.7/2015/7

Annex III

Notification from China concerning the proposed recommendation for international control of ketamine under the Convention on Psychotropic Substances of 1971

The Permanent Mission of the People’s Republic of China to the United Nations and other international organizations in Vienna presents its compliments to the Secretary-General of the United Nations and has the honour to inform him that the People’s Republic of China, being a party to the Convention on Psychotropic Substances of 1971, has information relating to ketamine, which is not under international control but may require its addition to one of the schedules of the Convention on Psychotropic Substances of 1971.

In the opinion of the People’s Republic of China, ketamine, as a derivative of phencyclidine (PCP, a controlled illegal drug listed in Schedule I of the 1971 Convention on Psychotropic Substances) and a widely abused psychotropic substance regionally and globally, should be added to Schedule I of that Convention.

The People’s Republic of China transmits this notification to the Secretary-General of the United Nations, in accordance with article 2, paragraph 1, of the 1971 Convention on Psychotropic Substances, in order to initiate the procedure provided for under that article.

Annexed to this notification is the Survey Report of Ketamine Abuse in China submitted by the China National Institute on Drug Dependence of Peking University, which includes evidence on ketamine, as well as other relevant research theses and reports in this regard.

V.14-08359 15

E/CN.7/2015/7

Annex IV

Extract of the notification from the Director-General of the World Health Organization to the Secretary-General dated 25 November 2014 concerning the recommendation not to place ketamine under international control

With reference to article 2, paragraphs 1, 4 and 6, of the Convention on Psychotropic Substances of 1971, and article 3, paragraphs 1, 3 and 5, of the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, and following the 36th meeting of the Expert Committee on Drug Dependence in June 2014, I am pleased to submit recommendations of the World Health Organization.

Following a notification under article 2, paragraph 1 of the Convention on Psychotropic Substances of 1971 by the Government of China concerning the proposed recommendation for international control of ketamine, the Expert Committee critically reviewed this substance, following its previous critical reviews of ketamine at its 35th and 34th meetings and the pre-review undertaken at its 33rd meeting. The information provided by China with its notification to the Secretary-General was brought to the Expert Committee’s attention. The Expert Committee’s assessment was that ketamine “is widely used as an anaesthetic in human and veterinary medicine, and is included in the WHO Model List of Essential Medicines and the WHO Model List of Essential Medicines for Children, as well as in many national lists of essential medicines”. The Expert Committee found that it was presented with “compelling evidence […] about the prominent place of ketamine as an anaesthetic in developing countries and crisis situations”. While the Expert Committee “acknowledged the concerns raised by some countries and United Nations organizations”, it stated that “ketamine abuse currently does not appear to pose a sufficient public health risk of global scale to warrant scheduling” and recommended “that ketamine not be placed under international control at this time”. “Countries with serious abuse problems may decide to introduce or maintain control measures, but should ensure ready access to ketamine for surgery and anaesthesia for human and veterinary care”.

EXECUTIVE BOARD EB136/48 136th session 19 December 2014 Provisional agenda item 15.1

Reports of advisory bodies

Expert committees and study groups1

Report by the Secretariat

EXPERT COMMITTEE ON DRUG DEPENDENCE

Thirty-sixth meeting of the Expert Committee on Drug Dependence2

Geneva, 16–20 June 2014

1. The Expert Committee on Drug Dependence was composed of 14 experts from the six WHO

regions. Meeting participants also included advisers to the Secretariat as well as observers from the

United Nations Office on Drugs and Crime (UNODC), and the International Narcotics Control Board. Twenty-six substances were assessed and recommendations for placing psychoactive substances under

international control have been conveyed to the Commission on Narcotic Drugs, which will make the

final decision on scheduling in March 2015.

Main recommendations

2. The Expert Committee recommended that the substances listed below be placed under

international control:

(a) in Schedule I of the 1961 Convention: AH-7921, chemical name 3,4-dichloro-N-{[1-

(dimethylamino)cyclohexyl]methyl}benzamide

(b) in Schedule I of the 1971 Convention:

• gamma-butyrolactone (GBL), chemical name oxolan-2-one

• 1,4-butanediol (butane-1,4-diol, 1,4-BDO or 1,4-BD)

1 The Regulations for Expert Advisory Panels and Committees provide that the Director-General shall submit to the

Executive Board a report on meetings of expert committees containing observations on the implications of the expert

committee reports and recommendations on the follow-up action to be taken.

2 WHO Technical Report Series, No. 990 (in press).

EB136/48

2

• 25B-NBOMe (2C-B-NBOMe), chemical name 2-(4-bromo-2,5-dimethoxyphenyl)-N-

[(2-methoxyphenyl)methyl]ethanamine

• 25C-NBOMe (2C-C-NBOMe), chemical name 2-(4-chloro-2,5-dimethoxyphenyl)-N-

[(2-methoxyphenyl)methyl]ethanamine

• 25I-NBOMe (2C-I-NBOMe), chemical name 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-

methoxyphenyl)methyl]ethanamine

(c) in Schedule II of the 1971 Convention:

• N-benzylpiperazine (BZP), chemical name 1-benzyl-1,4-diazacyclohexane

• JWH-018, chemical name naphthalen-1-yl-(1-pentyl-1H-indol-3-yl)methanone

• AM-2201, chemical name [1-(5-fluoropentyl)-1H-indol-3-yl](-naphthalen-1-

yl)methanone

• 3,4-methylenedioxypyrovalerone (MDPV), chemical name (R,S)-1-(1,3-benzodioxol-

5-yl)-2-(pyrrolidin-1-yl)pentan-1-one

• methylone (beta-keto-MDMA), chemical name (R,S)-1-(1,3-benzodioxol-5-yl)-2-

(methylamino)propan-1-one

• mephedrone, chemical name (R,S)-2-methylamino-1-(4-methylphenyl)propan-1-one.

3. With regard to mephedrone, a notification to the United Nations Secretary-General had been

made by the United Kingdom of Great Britain and Northern Ireland, pursuant to article 2, paragraphs 1

and 3 of the Convention on Psychotropic Substances, 1971, concerning a proposed recommendation

for international control of mephedrone. Preliminary data collected from the literature and from countries indicate that mephedrone may cause substantial harm.

4. The Expert Committee critically reviewed this substance and considered that the degree of risk

to public health and society associated with the abuse liability of mephedrone is substantial. There are

no data on therapeutic usefulness. The Committee therefore considered that the placement of mephedrone under international control was warranted, given the evidence of its abuse.

5. The Expert Committee recommended that the following substances are not placed under

international control:

• tapentadol hydrochloride (International Non-proprietary Name ), chemical name 3-

[(1R,2R)-3-dimethylamino-1-ethyl-2-methylpropyl]phenol hydrochloride

• JWH-073, chemical name (1-butyl-1H-indol-3-yl)(naphthalen-1-yl)methanone

• UR-144, chemical name (1-pentyl-1H-indol-3-yl)(2,2,3,3-

tetramethylcyclopropyl)methanone

EB136/48

3

• APINACA (AKB-48), chemical name N-(adamantan-1-yl)-1-pentyl-1H-indazole-3-

carboxamide

• RCS-4, chemical name 4-methoxyphenyl-(1-pentyl-1H-indol-3-yl)methanone

• JWH-250, chemical name 2-(2-methoxyphenyl)-1-(1-pentylindol-3-yl)ethanone

• 4-methylethcathinone (4-MEC), chemical name (R,S)-2-ethylamino-1-(4-

methylphenyl)propan-1-one

• 4-fluoromethcathinone (flephedrone; 4-FMC), chemical name (R,S)-1-(4-fluorophenyl)-2-

methylaminopropan-1-one

• alpha-methyltryptamine (AMT) chemical name 2-(1H-indol-3-yl)-1-

methylethylamine with (R) and (S) stereoisomers

• methoxetamine, chemical name 2-(3-methoxyphenyl)-2-ethylaminocyclohexanone

• methiopropamine (MPA), chemical name 1-(thiophen-2-yl)-2-(methylamino)propane

• ketamine (International Non-proprietary Name), chemical name (±)-2-(2-chlorophenyl)-2-

methylaminocyclohexanone.

6. With regard to ketamine, a notification to the United Nations Secretary-General had been made by China, under the Convention on Psychotropic Substances, 1971,

1 concerning a proposed

recommendation for international control of ketamine. The Expert Committee critically reviewed this

substance. It acknowledged the important medical use of ketamine as an anaesthetic, especially in low- and middle-income countries, in crisis situations and for veterinary use, because of its safety margin

and its ease of use. The Committee took note of concerns raised by some countries and organizations

within the United Nations system with respect to the potential for ketamine abuse. The Committee considered that the risk to public health posed currently by ketamine abuse on a global scale does not

warrant its scheduling. Consequently, the Committee recommended that ketamine not be placed under

international control at this time. The Committee recognized, however, that in countries where such

abuse is a problem, putting ketamine under national control may be considered.

7. For psychoactive substances for which pre-reviews2 were carried out, the thirty-sixth

Expert Committee recommended that critical reviews3 were not warranted for:

• lisdexamfetamine (International Nonproprietary Name), chemical name (2S)-2,6-diamino-N-[(2S)-1-phenylpropan-2-yl]hexanamide,(2S)-2,6-diamino-N-[(1S)-1-methyl-2-

phenylethyl]hexanamide dimethanesulfonate

1 Convention on Psychotropic Substances, 1971, Article 2, paragraph 1; see https://www.unodc.org/pdf/

convention_1971_en.pdf (accessed on 25 November 2014).

2 Pre-review: An initial review to determine whether a critical review is warranted (“the purpose of the pre-review is to determine whether current information justifies an Expert Committee critical review”).

3 Critical review: a review to make decisions on scheduling or a change in scheduling (“is to consider whether the Expert Committee should advise the Director-General to recommend the scheduling of, or amending of the scheduling status of, a substance”).

https://www.unodc.org/pdf/convention_1971_en.pdf

https://www.unodc.org/pdf/convention_1971_en.pdf

EB136/48

4

• tramadol (International Nonproprietary Name), chemical name (±)-trans-2-

(dimethylaminomethyl)-1-(3-methoxyphenyl)cyclohexanol.

Other matters

8. WHO and UNODC proposed that an international consultation take place in December 2014, the aim of which is to review criteria for the selection of new psychoactive substances to be assessed

by the thirty-seventh meeting of the Expert Committee. It is expected that this consultation would also

explore how to improve and align indicators, methodologies and tools for data collection on abuse, dependence potential and public health risks of new psychoactive substances, by the various

international and regional agencies. The outcomes of the consultation are expected to contribute to

broader goals, which include the generation of robust data, the minimization of duplicated effort, and

the facilitation of data collection in countries. The Secretariat will also use pharmacovigilance data on abuse and dependence potential for the review and assessment of substances using the Uppsala

Monitoring Centre VigiBase database.

Significance for public health policies

9. The substances that have been recommended for scheduling by the Expert Committee at its thirty-sixth meeting are considered to present risks in terms of abuse, dependence and public health.

Substances that present substantial public health risks have been placed in Schedule II of the

Convention on Psychotropic Substances, 1971. Those that present especially serious public health

risks have been placed in Schedule I of that Convention.

10. Substances with a medical use, such as tapentadol hydrochoryde (International Nonproprietary

Name Modified) and ketamine (International Nonproprietary Name), were critically reviewed. For

both substances, the Committee recommended not to place them under international control.

11. Tapentadol is primarily prescribed and dispensed on an outpatient basis for those with osteoarthritis, joint pain or chronic pain, and for whom other medications have not been effective.

Currently, the data available are not sufficient to carry out a sound assessment of the potential for

dependence or abuse, or with respect to the public health risks of this medication.

12. Ketamine is widely used as an anaesthetic in human and veterinary medicine, especially in low- and middle-income countries and crisis or emergency situations. The ease of parenteral administration

gives ketamine a major advantage when anaesthetic gases are impossible to use due to limited

equipment and lack of appropriately trained specialists. In many countries, there are no suitable alternatives that are affordable. Ketamine has, in addition, a wide margin of safety when compared

with other anaesthetic agents.

Implications for the Organization’s programmes

13. A Note Verbale to the United Nations Secretary-General has conveyed the recommendations of

the Expert Committee on scheduling of psychoactive substances for further decision by the Commission on Narcotic Drugs.

14. Owing to the high number of new psychoactive substances recently identified, work continues

on defining relevant criteria for the selection and prioritization of new psychoactive substances for

assessment by the Expert Committee. This will ensure that the Committee reviews priority substances for which sufficient robust data are available. WHO indicators, methodologies and tools for collection

EB136/48

5

of data on new psychoactive substances in countries, such as availability, use, abuse, dependence and

public health risks, will be improved and aligned with other international and regional organizations,

including UNODC and the European Monitoring Centre for Drugs and Drug Addiction.

15. Preparations are in place for the thirty-seventh meeting of the Expert Committee. Reviews will

be commissioned and peer reviews carried out. A global country survey to include 194 WHO Member

States and focusing on psychoactive substances will be conducted to assess substance availability, use, abuse, dependence and public health risk, among others. These data and those from other sources,

including from the Uppsala Monitoring Centre, UNODC and the European Monitoring Centre for

Drugs and Drug Addiction, will be analysed and will inform the reviews carried out by the

thirty-seventh meeting of the Expert Committee.

16. The Secretariat is also active in advocating for and supporting the implementation of balanced

country-level policies, that is, policies that aim for a balance between improving the availability of

controlled medicines, and preventing their misuse, diversion and trafficking, in line with the United

Nations international drug control conventions.1

17. In May 2014, the Sixty-seventh World Health Assembly adopted resolution WHA67.19 on the

strengthening of palliative care as a component of comprehensive care throughout the life course,

thereby providing strong support for the work of the Organization, at global and country levels, on

improving access to and use of medicines for palliative care. WHO is part of ATOME, a consortium that has a presence in 12 European countries and is funded by the European Commission, and that

works to improve access to opioid medications in Europe. In addition, a joint global programme is

being undertaken by WHO, the Union for International Cancer Control and UNODC on access to controlled drugs for medical purposes, the objective of which is to improve access to controlled

medicines, particularly pain medication.

EVALUATION OF CERTAIN VETERINARY DRUG RESIDUES IN FOOD

Seventy-eighth Joint FAO/WHO Expert Committee on Food Additives

Geneva, 5–14 November 20132


18. The Committee performed risk assessments and made recommendations on the safety of residues of eight veterinary drugs when used for food-producing animals and used in accordance with

good veterinary practices. Acceptable daily intake values for these drugs were established and

maximum residue limits that are compatible with human health were recommended for specified

animal species and tissues.

19. The report presents general considerations and guidance, in particular on improved risk

assessment methodologies, on the extrapolation of maximum residue limits to minor animal species

and commodities, and on the establishment of maximum residue limits for honey.

1 For more information on WHO guidance, see Ensuring balance in national policies on controlled substances, at: http://www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/index.html (accessed on 28 November 2014).

2 Evaluation of certain veterinary drug residues in food (Seventy-eighth report of the Joint FAO/WHO Expert Committee on Food Additives) WHO Technical Report Series, No. 988, 214 (in press).

http://www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/index.html

EB136/48

6

20. The Committee also discussed work undertaken by WHO in relation to antimicrobial resistance

as it relates to the work of the Joint Expert Committee, and decided to follow closely further

developments and to apply those aspects relevant to its work.

21. The assessments, recommendations and comments provided by the Committee will be discussed

by the Codex Committee on Residues of Veterinary Drugs in Food, and will result in the identification

of appropriate risk management and risk-mitigation measures to reduce human exposure where necessary, and in recommendations to national authorities for the safe use of these veterinary drugs in

food-producing animals.

22. WHO has published detailed monographs of toxicological and other related information upon

which the safety assessments of the compounds were made;1 FAO has published detailed residue

monographs.2

EVALUATION OF CERTAIN FOOD ADDITIVES AND CONTAMINANTS

Seventy-ninth Joint FAO/WHO Expert Committee on Food Additives

Geneva, 17–26 June 20143


23. The Committee evaluated the safety of nine food additives, revised the specifications for five

other food additives and evaluated 28 flavouring agents according to the Procedure for Safety

Evaluation of Flavouring Agents.

24. The report presents general considerations and guidance, in particular on improvements in the safety assessment methodology for the evaluation of flavouring agents, and for limiting contamination

in food additives for use in infant foods.

25. These assessments, recommendations and comments provided by the Committee will be

discussed by the Codex Committee on Food Additives, to provide recommendations to national authorities for the safe use of these food additives and to identify and recommend appropriate risk

management and risk-mitigation measures to reduce human exposure, where necessary.

26. WHO will publish detailed monographs of the toxicological and other related information upon

which the safety assessments of the compounds were based in the WHO Food Additives Series.4 FAO

publishes summaries of the identity and purity of food additives.

1 Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series No. 69, 2014. For further information on the WHO Food Additives Series, see: http://www.who.int/foodsafety/publications/monographs/en/ (accessed on 18 November 2014).

2 Food and Agriculture Organization of the United Nations. Residue evaluation of certain veterinary drugs. Joint

FAO/WHO Expert Committee on Food Additives, 78th meeting, 2014, JECFA Monographs 15, FAO, 2014.

3 WHO Technical Report Series, No. 990 (in press).

4 For further information on the WHO Food Additives Series, see: http://www.who.int/foodsafety/publications/ monographs/en/ (accessed on 18 November 2014).

http://www.who.int/iris/bitstream/10665/128550/1/9789241660693_eng.pdf?ua=1

http://www.who.int/foodsafety/publications/monographs/en/


http://www.fao.org/3/a-i3745e.pdf



EB136/48

7

Significance for public health policies1

27. The Committee’s work identifies and, if possible, quantifies the public health significance of

exposure to chemicals in food, in this case, residues of veterinary drugs, through scientific risk assessment based on international consensus. When a health concern is identified, clear

recommendations are issued for action by national governments or through the FAO/WHO Food

Standards Programme (i.e. the Codex Alimentarius Commission and its subsidiary bodies).

28. All Member States face the problem of assessing potential risks of chemicals in food, however, only a few scientific institutions systematically assess, on a national or regional basis, all relevant

toxicological, epidemiological and related data. It is therefore important that the present report

provides Member States with valid information on both the general aspects of risk assessment and the specific evaluations of those veterinary drugs, food additives and food contaminants mentioned. The

Committee’s work, in its complexity and in reaching an international consensus on the evaluation of

these compounds, is unique in its importance for and impact on global public health decisions related

to food safety.

29. The Committee’s recommendations are used by the Codex Alimentarius Commission in the

development of international food safety standards and other guidance and recommendations. Such

standards are science-based and are established only for substances that have been evaluated by the

Joint Expert Committee. This ensures that the international trade of food commodities meets strict safety standards, to protect the health of the consumer and ensure fair practices in food trade.

30. The advice provided by the Committee is also considered by Member States directly when

national or regional food safety standards are being established.

Implications for the Organization’s programmes1

31. The evaluation of chemicals in food by the Committee is an ongoing activity. Three meetings of the Joint FAO/WHO Expert Committee on Food Additives were planned and implemented in

2012–2013: two were held on food additives and contaminants, one in June 2012 and another in

June 2013; another on the evaluation of residues of veterinary drugs in food was held in November 2013. For 2014–2015, three meetings are scheduled: one was held in June 2014 and two

are planned for 2015.

32. WHO is a partner in the Joint FAO/WHO Food Standards Programme, whose principal organ is

the Codex Alimentarius Commission. In its capacity to assure the sound scientific basis for international standards and recommendations on food additives and contaminants in food, the Joint

FAO/WHO Expert Committee on Food Additives provides information that is crucial to the work of

the Codex Alimentarius Commission.

33. The Committee’s evaluations are also made use of by WHO Representatives and in regional offices when advice is provided to Member States on food safety issues.

1 This section is relevant to both meetings.

EB136/48

8

Report of the seventh meeting of the WHO Study Group on Tobacco Product Regulation1

Rio de Janeiro, 4–6 December 2013

34. The WHO Study Group on Tobacco Product Regulation has launched a series of reports to provide a scientific foundation for tobacco product regulation. In line with Articles 9 and 10 of the

WHO Framework Convention on Tobacco Control,2 these reports identify approaches to underpin the

regulation of tobacco products. Such products pose significant public health threats and raise questions on tobacco control policy.

35. The seventh meeting focused on issues critical to advancing the regulation of tobacco products,

particularly as outlined at the fifth session of the Conference of the Parties to the WHO Framework

Convention on Tobacco.3 The topics discussed included the evolution of novel tobacco products and

other related ones; smokeless tobacco; reduced ignition propensity cigarettes; nicotine reduction and

addictiveness; and a non-exhaustive priority list of toxicants.

Novel tobacco products


36. A tobacco product is considered novel if it contains tobacco and if at least one of the following applies: (a) it has been on the market for less than 12 years; (b) it has been on the market for a longer

time but with market share increases in countries or regions that traditionally did not use the product;

(c) it uses a new technology; and (d) it is marketed as being less hazardous to health than other tobacco products.

37. Novel tobacco products should be evaluated for toxicity, disease risk, consumer awareness and

perception, pattern of use, and product usage demographics. A standardized evaluation of such

products is needed and regulators should approve them only if pre-market testing shows a potential public health benefit. The concept of “harm reduction” used by the industry, and the impact and

effectiveness of strategies promoting the use of products that are allegedly less hazardous to health,

should be evaluated and communicated effectively to the general public in order to prevent misperceptions.


38. The major concerns relating to the use of novel tobacco products include unrecognized toxicity, increased or sustained prevalence of tobacco use, misconceptions about what makes a product less

hazardous, and “dual-use” consumption.4

1 WHO Technical Report Series No. 989 (in press).

2 For more information, see: http://www.who.int/fctc/text_download/en/ (accessed 28 November 2014).

3 For more information on the Conference of the Parties to the WHO Framework Convention on Tobacco, see

decision FCTC/COP5(6), paragraph 3(b) and decision FCTC/COP5(10), paragraphs 1–4, at: http://www.who.int/fctc/cop/en/ (accessed 28 November 2014).

4 The concomitant use of two forms of tobacco is an increasing public health concern. As yet, however, there is little consensus regarding a consistent definition of such “dual use”. For present purposes, the term refers to cigarette and smokeless tobacco consumption, or cigarette and a novel tobacco product consumption, with either product used daily or nondaily.

http://www.who.int/fctc/text_download/en/

http://www.who.int/fctc/cop/en/

EB136/48

9


39. It is essential that the approach to monitoring be more comprehensive and consistent, and that

the collection of research data on novel tobacco products be more systematic.

Smokeless tobacco


40. Clearer policy is required to address the challenges presented by smokeless tobacco products. In

comparison with their counterparts (i.e. smoked tobacco products), smokeless tobacco products are

more affordable, they carry weaker warning labels, and there are fewer resources spent on their surveillance, prevention and control. Evidence-based control policies must be strengthened, such as

ensuring disclosure of product content, establishing performance standards for toxicants and maximum

pH levels, banning flavourants, establishing effective and relevant health warning labels, increasing product taxes, restricting or banning marketing of such products, and increasing public awareness of

harm associated with their use.


41. Increased attention must be given to the overall impact of smokeless tobacco products, including their use by adolescents, dual use, poly use, and the growth in targeted marketing of them

for indoor use.


42. Additional data are needed on usage, surveillance and characteristics of smokeless tobacco

products, as well as on the health consequences relating to the use of different ones. Further, it is important to have an understanding of the market for such products and an insight into the measures in

place with respect to effective region-specific education, prevention and treatment interventions.

Resources and collaborative work are needed in order to obtain such data.

Reduced ignition propensity cigarettes


43. Technology used in cigarette manufacturing that reduces the fire-starting risk is referred to as

reduced ignition propensity (“RIP”). Laws relating to reduced ignition propensity have now been

enacted in Australia, Canada, South Africa, the United States of America, and the European Union, but this pattern has yet to be followed in many middle- and low-income countries. The ideal is the

universal application of this technology to cigarette manufacturing; to achieve this, testing must be

standardized in accredited laboratories and paid for by the tobacco industry. However, claims of a reduced risk to health should not be allowed. Monitoring is needed to establish whether such

technology has an impact, in particular whether it can be shown that there is a reduction in fires,

deaths and injuries related to cigarettes that use this technology. Health correlates should be monitored

for toxicity and for behavioural changes related to a heightened awareness of reduced ignition propensity in cigarette manufacturing.

EB136/48

10


44. Fires caused by smoking are a major public health risk and cause many deaths. A reduction of

approximately 30% in smoking-related fires has been shown in areas with reduced ignition propensity laws. Testing has not shown any difference in smoke emissions between cigarettes that have been

manufactured using reduced ignition propensity technology and those that have not. These findings

refute the claims of the tobacco industry.


45. More research is needed on toxicity, emissions, possible changes in smoking behaviours related

to reduced ignition propensity cigarettes, and evaluation of the potential reduction in fires and fire-

caused deaths.

Nicotine reduction

Main recommendation

46. Reduced nicotine cigarettes are feasible for reducing tobacco addiction, especially in combination

with nicotine-based treatment. Switching from conventional to reduced nicotine cigarettes, where the

reduced level of nicotine is approximately 0.1 mg nicotine per approximately 1 gram of tobacco, does not lead to a significant increase in craving or to withdrawal symptoms, and does not result in

compensatory smoking behaviour (such as a greater intensity of smoking or an increased number of

cigarettes smoked per day). A specific amount of nicotine has not yet been identified as an absolute

threshold for addiction, however, the level is likely to be less than approximately 0.1 mg nicotine per approximately 1 gram of tobacco. The benefits of such a strategy require: firstly, the replacement,

complete or partial, of existing products with reduced nicotine cigarettes; and secondly, the

implementation of steps to ensure such a replacement programme takes place.


47. A nicotine reduction strategy has the potential to: (a) reduce the acquisition of smoking and

progression to addiction among experimenters; (b) reduce the amount of cigarettes smoked among

some proportion of addicted smokers as a result of modified behaviour; and (c) support both an

increase in the number of addicted smokers who stop smoking and a reduction in the number of those who relapse.


48. The implementation of a nicotine reduction policy would need to be supported by a

comprehensive programme involving:

(a) a strategy on health communication and public education;

(b) treatment that is available, effective and affordable, which includes alternative forms of nicotine;

(c) the capacity to monitor the market and to test products;

(d) continued research to assess:

(i) likely use and effects of reduced nicotine cigarettes among non-smoking adolescents;

EB136/48

11

(ii) long-term use of reduced nicotine cigarettes;

(iii) long-term impact on smoking behaviours.

Non-exhaustive toxicant list of contents and emissions of tobacco products

Main recommendation

49. Among the chemicals found in cigarette smoke (as many as 7000), the WHO Study Group on

Tobacco Product Regulation identified a non-exhaustive priority list of 39 tobacco contents and

emissions of cigarette smoke. Criteria included toxicity potential for smokers and variability of concentrations between different cigarette brands. The Study Group concluded that measurement of tar

was uninformative.


50. Monitoring the non-exhaustive toxicant list will eventually guide the regulation of contents and

emissions, as stated in Articles 9 and 10 of the WHO Framework Convention on Tobacco Control. This priority list should be periodically re-evaluated as new knowledge becomes available.


51. Any monitoring and regulation of contents and emissions should be done in conjunction with

the existing validated methods of the WHO Tobacco Laboratory Network. Currently, laboratories in the Network have already validated tar, nicotine, carbon monoxide, tobacco-specific nitrosamines,

benzo[a]pyrene, and humectants. Validations for ammonia, volatile organic compounds and aldehydes

are ongoing. Among non-existing methods, priority should be given to laboratories in the Network for their development of standardized testing methods for the measurement of cadmium and lead in

tobacco contents, nicotine in the smoke of waterpipes, and nicotine, tob acco-specific nitrosamines and

benzo[a]pyrene in smokeless tobacco products.

ACTION BY THE EXECUTIVE BOARD

52. The Board is invited to note the report.

= = =

Documents

Dame Prof Sally Davis Chief Medical Officer Department … to [email protected] 13 January 2015 Dear Dame Sally Thank you for the invitation to attend last week’s