Effectiveness of policy changes to reduce harm from unrecorded alcohol in Russia between 2005 and now

International Journal of Drug Policy 51 (2018) 1–9

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International Journal of Drug Policy journal homepage: www.elsevier.com/locate/drugpo

Research paper

Effectiveness of policy changes to reduce harm from unrecorded alcohol in Russia between 2005 and now Maria Neufelda,b,* , Jürgen Rehma,b,c,d,e,f a

Institute for Mental Health Policy Research, Centre for Addiction and Mental Health (CAMH), 33 Russell Street, Toronto, ON M5S 2S1, Canada Institute for Clinical Psychology and Psychotherapy, TU Dresden, Chemnitzer Str. 46, 01187 Dresden, Germany c Campbell Family Mental Health Research Institute, CAMH, 250 College Street, Toronto, ON M5T 1R8, Canada d Institute of Medical Science (IMS), University of Toronto, Medical Sciences Building, 1 King’s College Circle, Room 2374, Toronto, ON M5S 1A8, Canada e Department of Psychiatry, University of Toronto, 250 College Street, 8th Floor, Toronto, ON M5T 1R8, Canada f Dalla Lana School of Public Health, University of Toronto, 155 College Street, 6th Floor, Toronto, ON M5T 3M7, Canada b

A R T I C L E I N F O

A B S T R A C T

Article history: Received 8 February 2017 Received in revised form 1 August 2017 Accepted 11 September 2017 Available online xxx

Background: Consumption of unrecorded alcohol (alcohol that is not taxed and reflected in official statistics, but consumed as a beverage) has been identified as one of the main contributors to alcoholattributable premature mortality in Russia. The problem was highlighted by a recent a mass poisoning with surrogate alcohol occurred in the Siberian city of Irkutsk. Methods: Based on key publications and legislative documents, a narrative review was undertaken about alcohol-related harm reduction policies in Russia for the period between 2005 and 2017, as well as the impact of these policies on the recorded and unrecorded alcohol consumption and alcohol market. Results: Various policy measures mainly targeting availability and price of recorded and unrecorded alcohol have been introduced since 2005, which generally coincided with the decreases in alcoholrelated mortality observed at that time. However, regulations on medicinal and cosmetic products have remained inconsistent providing the foundations for the continued existence of a legal industry of surrogates with broad availability and misuse. Conclusion: The Russian experiences of introducing alcohol policies demonstrate that there are effective measures to reduce unrecorded alcohol consumption and attributable harm. The government’s multilevel strategy of alcohol consumption and harm reduction should be pursued stringently and all the possible loop-holes for producers, sellers and distributors of illegal and/or unrecorded alcohol should be eliminated or at least critically reduced. © 2017 Elsevier B.V. All rights reserved.

Keywords: Russia Unrecorded alcohol Alcohol policy Harm reduction Irkutsk poisoning

Background The most recent mass methanol poisoning due to counterfeit surrogate alcohol killed 78 people1 in the Siberian city of Irkutsk in

* Corresponding author at: Institute for Clinical Psychology and Psychotherapy, Technische Universität Dresden, Chemnitzer Str. 46, 01187 Dresden, Germany. E-mail addresses: [email protected] (M. Neufeld), [email protected] (J. Rehm). 1 Overall, 123 people were hospitalized with acute alcohol poisoning between the 17th and 19th of December 2016, the majority of whom were working class and lived in the same district of Irkutsk. The forensic medical investigation revealed that out of the 78 deceased, 74 died because of methanol poisoning and the rest died because of consumption of large amounts of ethanol. Apparently, the affected individuals have consumed different types of surrogates: the original ethanol-based product labelled as “Hawthorn bath lotion” and the methanol-based counterfeit. Although no new cases have occurred over the New Year festivities, as feared, several people have died in early January 2017 at the consequences of the poisoning. http://dx.doi.org/10.1016/j.drugpo.2017.09.006 0955-3959/© 2017 Elsevier B.V. All rights reserved.

2016 (Lenta.ru, 2017), drawing attention once more to the problem of unrecorded alcohol consumption in Russia. Unrecorded alcohol is not reflected in official statistics, but it is consumed as a beverage nonetheless (Lachenmeier, Gmel, & Rehm, 2013). Examples for Russia include homemade vodka or wine, surrogate alcohol (i.e., alcohol, not officially produced for human consumption such as medicinal alcohol), and illegally produced or smuggled products. As the alcohol content in these products is not taxed, they tend to be cheaper than their recorded counterparts, and thus, they are more popular with individuals belonging to lower socio-economic strata (Lachenmeier, Rehm, & Gmel, 2007; Rehm et al., 2014). For Russia, unrecorded alcohol consumption has been linked to hazardous drinking patterns, alcohol use problems and social exclusion of their consumers (Bobrova et al., 2009; Neufeld, Wittchen, & Rehm, 2017; Saburova, Keenan, Bobrova, Leon, & Elbourne, 2011). Most importantly, it has been identified as one of the main contributors to both alcohol-attributable mortality and

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M. Neufeld, J. Rehm / International Journal of Drug Policy 51 (2018) 1–9

premature mortality (Leon et al., 2007; Pridemore, Tomkins, Eckhardt, Kiryanov, & Saburova, 2010; Tomkins et al., 2007). According to the World Health Organization (World Health Organization, 2014), 24% (3.6 L of 15.1 L) of the total adult per capita alcohol consumption (pure ethanol) was unrecorded in Russia during the period of 2008–2010. Estimates from the previous years were considerably higher, ranging from 53% (7.8 L) in 1994 to 45% (6.7 L) in 2001 (Nemtsov, 2011), with suggestions of a steady decline since 2001 (Neufeld & Rehm, 2013). However, the most recent expert analysis suggests that about 33.4% (5.3 L) of Russian alcohol consumption is unrecorded (Probst, Merey, Rylett, & Rehm, 2017). This is consistent with other recent studies indicating that unrecorded alcohol consumption remains an integral part of Russian drinking culture and everyday life (Neufeld et al., 2017; Radaev & Kotelnikova, 2016). The usual policies to reduce alcoholinduced harm, such as pricing and taxation or marketing bans, do not work in the case of unrecorded alcohol consumption (Lachenmeier, 2009). They may even encourage the consumers to shift from the recorded market to the unrecorded market (Nemtsov, 2015). This contribution will summarize the policies implemented between 2005 and 2017, as well as current knowledge on the effect of these policies on alcohol consumption and it’s harms. In addition, this contribution will make specific suggestions on reducing the harms stemming from the consumption of unrecorded alcohol. Methods A narrative review was undertaken on alcohol-related policies in Russia, as well as their impact on the recorded and unrecorded alcohol markets. As such, the relevant Russian alcohol-related policies and key publications concerning their effects were reviewed (Khaltourina & Korotayev, 2008, 2015; Kolosnitsyna, Sitdikov, & Khorkina, 2014; Levintova, 2007; Nemtsov, 2015; Neufeld & Rehm, 2013; Radaev & Kotelnikova, 2016; Radaev, 2015; Skorobogatov, 2014; Shield, Rylett, & Rehm, 2016) (for sources of the various policies see Web-Appendix A). Results The most important measures introduced in 2006 Although the Russian government had adopted important alcohol-related policies in the 1990s, its first serious attempts to regulate the alcohol market started in 2005–2006 due to the negative outcomes resulting from the abolishment of the state’s monopoly on alcohol production in 1992. The legislative changes of this time period were triggered by President Putin’s speech to the Federal Assembly of the Russian Federation in April 2005, where he acknowledged that 40,000 people died each year from alcohol poisonings alone and that consumption of alcohol, especially cheap surrogates, was one of the biggest threats to the nation's health. The following sections focus on the legislations and their impact after 2005, while the most important alcohol-related policies for the period 2005–2017 and their specific implications are summarized in Table 1. Starting from 2005, various amendments to the Federal Law were introduced in a step-wise manner to reduce alcohol consumption and alcohol-related harms (for an overview see: Khaltourina & Korotayev, 2015; Nemtsov, 2015; Neufeld & Rehm, 2013). In 2006, a new licensing and registration procedure for alcohol producers came into effect and the minimal investment capital for producers and distributors of alcohol was raised. As a result of this new policy, many small companies were driven out of the market, whose products were most likely contributing to

unrecorded alcohol consumption (Khaltourina & Korotayev, 2015). At the same time, the centralized electronic tracking and monitoring system of alcohol (EGAIS) was implemented, along with the introduction of new excise stamps. The EGAIS system was designed to provide additional state control over the volume of production and sale of alcohol, as well as to make the production and sales processes more transparent to eliminate the illegal alcohol market. One of the most important measures in terms of reducing unrecorded consumption was the introduction of taxes on ethanolcontaining liquids in the form of the excise tax on spirits and the adoption of new, more effective (less toxic and more odorous) denaturizing additives for ethyl alcohol. Before 2006, diethyl phthalate (DEP) was one of the most commonly used denaturizers, despite that its chemical properties – colourlessness, neutral odour, toxicity and a much higher boiling point than ethanol, which made DEP very easy to separate from ethanol – characterized it unfit as a denaturizing agent. Additionally, products containing denatured alcohol (e.g. cleaning agents) had to be clearly labelled as “denatured” as per the new policy, and the usage of the term “ethyl alcohol” was no longer allowed for such products. A health warning on the danger of internal use had to be featured in a size not less than 10% of the product label. The only exception was made for cosmetic products. The high prevalence of DEP in samples of illegal vodka from that time (Onishchenko, 2007) suggests that this compound was routinely used to legally produce large volumes of denatured non-beverage alcohol, which was then used as a raw material for further manufacturing of illegal spirits (Ljustrickij, 2006). The new legislations intervened in this semi-legal profit scheme, forcing producers of non-beverage alcohol to either denaturize their products completely or to register them with EGAIS and pay excises. Medicinal alcohols remained the only exception to the law. Subsequently, a whole segment of pseudo-surrogates (alcoholic products officially not intended for human consumption, but in reality clearly intended and purposefully produced for consumption), such as cleaning agents, technical fluids and fire lightening products, disappeared in 2006 (Khaltourina & Korotayev, 2015). Other liquids often used as surrogates for alcoholic beverages, such as cheap colognes and cosmetic lotions, also became subject to taxation and were tracked with EGAIS, which also caused them to disappear from the market (RBK, 2007). Also, the 2006 amendments authorized the regional legislation to introduce time restrictions on retail sale of alcoholic beverages stronger than 15%. This legislation led to varying impacts in different regions, ranging from very limited hours of sale to no restrictions at all (Kolosnitsyna et al., 2014). Reorganization of the unrecorded alcohol market in 2006–2007 and its consequences The implementation of EGAIS, however, did not happen without complications. A general disorganization of the alcohol market occurred in 2006, since the new licensing procedure, as well as the issuing of new excise stamps, led to serious delays. This resulted in shortages of alcoholic beverages, most importantly spirits, because the new law prohibited the sale of products labelled with the old excise stamps (Nemtsov, 2015). Additional shortages were observed because The Federal Service for Surveillance on Consumer Rights Protection and Human Well-Being (Rospotrebnadzor) had issued a complete ban on imports of wine from Moldova (spring 2006) and Georgia (summer 2006), arguing that they do not meet the Russian consumer standards. These factors caused a steep decline in the consumption of both spirits and wine, overall recorded and unrecorded alcohol consumption and fatal

M. Neufeld, J. Rehm / International Journal of Drug Policy 51 (2018) 1–9 Table 1 Overview of the most important alcohol policies and their implications. 2005 President Putin addresses the problem of alcohol consumption and its harm in his Annual Address to the Federal Assembly of the Russian Federation, explicitly pointing to the dangers that arise from the consumption of surrogate alcohol. Adoption of the Federal Law N 11 “On restrictions on the retail sale and consumption (drinking) of beer and beverages, manufactured on the basis thereof”. This law forbids sale and consumption of alcohol in educational, medical and cultural facilities. Various amendments to the Federal Law N171, which is renamed in “On State Regulation of Production and Turnover of Ethyl alcohol, Alcohol and EthanolContaining Production and Restrictions of Consumption (Drinking) of Alcoholic Products”. 2006 In January the reformed version of the Federal Law N171 comes into force. Substantial increase in investment capital for producers and distributors of alcohol. Parallel introduction of the Unified State Automatic Information System (EGAIS) for alcohol producers. As a result, the licensing procedure becomes extremely difficult for producers and many small distilleries, who are suspected to be the main producers of unrecorded alcohol, are driven from the market. In July new excise stamps are introduced and the old ones are banned, but the production and distribution of new stamps experiences serious delays and much of the produced alcohol cannot enter the market. A shortage of alcoholic beverages, most importantly spirits, occurs. The Federal Service for Surveillance on Consumer Rights Protection and Human Well-Being (Rospotrebnadzor) issues a complete ban on imports of wines from Moldova and Georgia, which leads to additional shortages in retails sale. Regional authorities are granted the right to introduce night bans and/or time limits on the retails sale of alcoholic beverages with an ethyl concentration above 15%. In the following years, different regions adopt different regulations, ranging from extreme limitations to no consequences at all. A new list of four obligatory additives (gasoline, kerosene, denatonium benzoate and croton aldehyde) for denaturing ethyl alcohol is approved, making the use of surrogate alcohol for human consumption more difficult. The previously broadly used diethyl phthalate (DEP) is banned as a denaturizer. Certain segments of products commonly used as surrogate alcohol (cleaning agents or washer fluids) disappear from the market and surrogate consumers switch to other products in a “trial and error scenario”. A Russian-wide outbreak of cholestatic hepatitis occurs, where more than 12,500 patients are hospitalized after the consumption of antiseptics and fake vodka containing the toxic disinfectant polyhexamethyleneguanidine hydrochloride (PHMG). The Federal Service for Surveillance on Consumer Rights Protection and Human investigates and seizes thousands of samples of fake antiseptics containing PHMG and DEP, which points to the existence of large volumes of DEP containing alcohol, maybe stored as left-overs. Certain types of antiseptics containing PHMG are banned. 2007 The resolution N 401 “On approving the list of perfumery and cosmetic products, which turnover is not regulated by the Federal Law” is adopted. This resolution exempts certain types of cosmetics from taxation and the EGAIS monitoring. In the following years, cheap colognes and cosmetic lotions are widely and legally sold in kiosks, shops, supermarkets and vending machines. Regional bans on the sale of these products remain temporal and inefficient because of the federal resolution. Rospotrebnadzor issues an additional ban on methanol-based motor-service fluids in general. In the according resolution, he draws attention to the fact that these fluids are often consumed by socially disadvantaged and homeless individuals. Internet sale of alcoholic beverages is prohibited to reduce the share of counterfeit alcohol sold online. The Centre for Development of a National Alcohol Policy is formed as a public association. In the following years the association advocates for legislative measures to reduce the overall level of alcohol consumption in the population. 2008 Formation of the Federal Service for Alcohol Market Regulations. The main strategic tasks are alcohol policy development and market regulation, including regulation of excise duties and fixation of minimal prices on alcoholic beverages. 2009 In May the Public Chamber of Russia publishes a report on the current situation of alcohol use in Russia and on evidence-based measures to reduce alcohol-related harms. In December the Federal Service for Alcohol Market Regulations publishes a strategy paper with specific measures to reduce alcohol consumption and harms. These include suggestions of higher alcohol prices, reducing availability of alcohol, reducing the share of unrecorded alcohol and spirit consumption in favour of low alcoholic beverages, prevention of alcohol use disorders and promotion of a healthy life style on a population level. The Service also announces a stepwise price increase of alcohol over the next few years. 2010

Increase of minimal prices on vodka, spirits and pure ethyl alcohol designated for human consumption. The minimal prices are gradually increased for the next three years, along with increasing alcohol duties.

2011

Restrictions on alcohol sale locations are introduced. Alcohol sale is prohibited in and next to medical and educational facilities, sport and cultural facilities. Alcohol consumption is prohibited in stadiums, airports, public transport (including long-distance trains), markets and other places of mass gathering, as well as military establishments. The only exceptions are places where foodservices are provided (e.g. bars and cafes). Alcohol sale is also forbidden in kiosks.

2012

List of places where alcohol consumption is no longer allowed is expanded to every other public place, including house yards, stairwells and hallways of residential buildings, children’s playgrounds, recreational areas and parks — typical places traditionally preferred by heavy drinking individuals for gatherings. A federal ban of alcohol sale from 11 PM to 8 AM is introduced. Regions can keep or enforce longer night bans. Many 24-h stores close their businesses, since night sales of alcohol is their main source of income.

2013

Ban on beer sale in kiosks.

2014

Medicinal compounds containing ethyl alcohol have to be stored and monitored according to a special record keeping system, but are still outside of EGAIS. By the end of the year President Putin calls for a cap on rising vodka prices to prevent consumption of cheap surrogates.

2015

The minimal vodka price does not increase for the first time since the implementation of the long-term strategy, but on the contrary, decreases. A new draft law requires prescriptions for rubbing alcohol (pure ethanol) and limits the purchase of alcohol-based medicinal tinctures with an ethanol concentration of above 15% to only two packages per person. In November a poisoning with counterfeit whiskey occurs in the Siberian city of Krasnoyarsk, 11 people die. The whiskey was bought on-line and contained high volumes of methanol. Rospotrebnadzor blocks 14 online-shops selling counterfeit alcohol and claims for easier blocking procedures of according webpages.

2016

In January the EGAIS system is implemented for the wholesale trade. In April a second methanol poisoning with counterfeit whiskey occurs in Krasnoyarsk, killing two people. Rospotrebnadzor shuts down another 420 websites selling counterfeit alcohol. In July the EGAIS system is implemented for the retail sale. Alcohol outlets need to have a special cash register for alcoholic beverages, which transfer the information on the sold beverage directly to the system. First estimates suggest that the market share of legal spirits has increased because of this measure. Vessel size of various alcohol-based medicinal compounds are limited to 25 ml, 50 ml or 100 ml flacons, according to alcohol concentration and the estimated potential for misuse. In September the media announce that the Ministry of Industry and Trade works on a legislative proposal to decrease the minimal price of alcohol and take back restrictions on places of alcohol sale in order to make legal alcohol more available and attractive than unrecorded products.

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M. Neufeld, J. Rehm / International Journal of Drug Policy 51 (2018) 1–9 In November the State Duma increases excise duty rates on alcohol from 500 to 523 rubles per 1 L of pure ethyl alcohol and freezes the rate at this level for 2018– 2019. In December Ministry of Economic Development, Ministry of Industry and Trade and Ministry of Finance announce that they work on a new draft law to legalize the alcohol trade via the Internet to curb the sales of counterfeit and untaxed alcohol online. A mass poisoning with methanol-containing surrogate alcohol (a bath lotion) occurs in Irkutsk, local authorities declare a state of emergency. Rospotrebnadzor issues a 30-days long ban on the sales of alcohol-containing liquids not intended for human consumption and investigates the case. The investigation reveals that the poisoning was caused by counterfeit surrogates, which are only a small fraction of the different types of surrogates that were seized during the ongoing inspections. The Service also issues a special investigation of anti-freeze washer fluids. The Ministry of Industry and Trade denies any suggestions on decreasing the minimal vodka price and emphasize the importance of a balanced alcohol policy and the ban of non-beverage alcoholic liquids. 2017

In January Rospotrebnadzor prolongs the ban of alcohol-containing non-beverage liquids and reports first successes of harm prevention achieved by this measure. The ban is prolonged for another 60 days January and another three month in April and July, respectively. The ban affects cosmetic lotions only, while colognes, windshield wipers and medicinal tinctures remain available. In the following months Rospotrebnadzor seizes large amounts of antifreeze fluids containing methanol. Different Ministries suggest several measures to reduce the misuse of medicinal and cosmetic products, including taxation and complete abolishment. The Federal Service of Alcohol Market Regulation suggests mandatory denaturing of methanol to prevent further fatal poisonings. The Ministry of Finance argues against the legalization of alcohol trade via the Internet and suggests increasing the minimum prices for alcohol. In February a draft is presented to the State Duma, proposing a discounts ban on alcoholic beverages and a ban on websites that deliver alcohol as “a gift” for purchasing little things like lighters and decorative items. The draft is rejected in July. In May new minimum prices on alcohol are set- the minim vodka price is 205 roubles per 0.5 L. In July the Criminal Code of Russia is complemented by two new sections: “Illicit production and (or) turnover of ethyl alcohol, alcohol and alcohol-containing products” and “Illegal retail sale of alcohol and alcohol-containing food products”. The new legislation stipulates penalties for illegal production and sale as well as for the forging of excise stamps in the form of fines, limitation of freedom or imprisonment of up to several years, depending on the gravity of the offence. Also, the Federal Law on Production and Turnover of Ethyl Alcohol is amended, now prohibiting the sale of alcoholic products through vending machines and the distribution of information and advertisement for the retail sale of alcoholic beverages and alcoholic products on the Internet. The investigation of the Irkutsk poisoning reveals that the counterfeit bath lotion was made of illegally purchased methanol that was routinely used for the production of antifreeze fluids by local producers.

Sources: see ‘Method’ section.

alcohol poisonings in 2006 (Khaltourina & Korotayev, 2008, 2015; Neufeld & Rehm, 2013). At the same time there was a disorganization of the unrecorded market in part due to the ban of diethyl phthalate (DEP), which had served as an ineffective denaturing agent until 2006. since illegal producers could no longer mask alcohol containing DEP as denatured non-beverage alcohol that is exempted from excise duties. Between summer 2006 and spring 2007, a cholestatic hepatitis outbreak occurred in 44 different regions of Russia caused by the consumption of illegal vodka and surrogates. The tested samples of the consumed products contained polyhexamethyleneguanidine hydrochloride (PHMG), a toxic disinfectant routinely used in Russian hospitals, as well as DEP, which was officially prohibited at that time (Ostapenko et al., 2011). Most of the hospitalized individuals were heavy drinkers with a history of alcohol use problems, and thus, they constituted the typical surrogate consumers. They had poisoned themselves accidentally with certain antiseptic lotions and fake vodka made from antiseptics, as the surrogates they were consuming were no longer available in 2006. Since alcohol-containing medicinal compounds were exempted from the new regulations, they remained the only cheap alternative for the heavy drinking population, and thus, they were soon misused as surrogates. The consumers were simply not aware that these compounds contained PHMG, let alone the full form of the abbreviation. The presence of the banned DEP in the antiseptics might be explained by stored supplies of DEPcontaining alcohol, which were not sold before the law came into force (Solodun et al., 2011). Journalist investigations also implied that certain non-beverage alcohol producers reacted to the changed legislation by trying to use the only remaining loophole of medicinal products. They suggested that in an attempt to legally circumvent the law and avoid EGAIS registration, non-beverage alcohol producers had added PHMG to their unsold supplies of DEP-containing alcohol and subsequently sold them legally as antiseptics. Accordingly, the poisoning outbreak occurred because left-overs of DEP-containing non-beverage alcohol were used in the production of pseudosurrogates, and the producers did not know about the cumulative toxicity effects of ethanol, DEP and PHMG (Ljustrickij, 2006).

Rospotrebnadzor reacted quickly to the outbreak and banned the particular types of antiseptics, which were associated with the poisoning. Further investigations revealed that the broadly consumed surrogates were actually counterfeited antiseptics sold under the same name as the original medicinal products, but with different labels and no health warnings on them. In summer 2007, after enormous pressure from household chemicals companies (RBK, 2007), a special resolution was adopted. A list of perfumery and cosmetic products was introduced, which were excluded from the regulations of the Federal Law, and thus, subsequently released from EGAIS monitoring requirements. The list featured colognes and perfumes with a vessel size not larger than 150 ml, cosmetic lotions, skincare and aftershave products (250 ml), oral hygiene products (300 ml) and hair care products (500 ml). The resolution also featured separate product classifiers for each of the mentioned product, meaning that these were from now on exempted from excise duty. In 2007 a new resolution was adopted, banning internet sales of alcoholic beverages, since they have become frequent and common target of counterfeiting. In the same year the Centre for Development of a National Alcohol Policy was formed as a public association, being since an active cooperation partner for the Federal Service for Alcohol Market Regulation and further authorities in the fields of consulting and expert analysis. Russia’s long term strategy to reduce alcohol consumption and harm since 2008–2009 In 2008, the Federal Service for Alcohol Market Regulations was established with the goal to develop and implement alcohol policies targeting the alcohol market according to international standards. The Service began its work in the following year. In May 2009, the Public Chamber of Russia published an 80-page report on “Alcohol Abuse in Russia: Socio-economic Consequences and Countermeasures”, which summarized problems of alcoholattributable harm in Russia and featured an overview of evidence-based, internationally acknowledged harm reduction policies. In December of the same year, the “Strategy paper on national policies to reduce the level of alcohol abuse and on the

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prevention of alcoholism among the population of the Russian Federation until 2020” was published by the Federal Service for Alcohol Market Regulations with the support of the Centre for Development of a National Alcohol Policy. The long-term strategy aimed to reduce availability and consumption of alcohol, and thereby, reduce alcohol abuse and prevent alcohol dependence at the population level. The official goal was to reduce the volume of alcohol consumed by the Russian population by more than fifty percent by 2020. The main points of the legislation were to decrease alcohol availability and the share of unrecorded alcohol, to encourage a change in the drinking pattern through a shift from the consumption of strong spirits to low-alcoholic beverages, to encourage a healthy lifestyle in the general population and to provide people with alcohol use disorders with specialized addiction treatment services. The strategy materialized in a step-wise manner within the following years. In 2010, the Federal Service for Alcohol Market Regulations started to raise the minimal price on vodka, spirits and pure ethyl alcohol designated for human consumption, that has existed since 2000 at a minimal level. For the following three years, the minimal price gradually increased along with the increases in alcohol tax. For example, in the case of vodka, it more than doubled from 89 roubles to 220 roubles for a 0.5 L bottle between 2010 and 2014 (for an overview over the development of the minimum retail prices for vodka see Table 1 of the Web Appendix). In 2011, restrictions on alcohol sale locations were introduced. Alcohol sale in medical, educational, sport and cultural facilities, as well as their border territory, was prohibited, except for the case when foodservices were provided. Regional authorities could establish the allowed radius around the banned locations, ranging from 10 m to 1000 m. Also, alcohol consumption was forbidden in public places, such as airports, public transport (including longdistance trains), markets and other places of mass gathering, as well as military establishments. This restriction was expanded to every other public place in 2012, including house yards, stairwells and hallways of residential buildings, children’s playgrounds, recreational areas and parks. These were typical places, traditionally preferred by heavy drinking individuals for gatherings. Moreover, a federal ban on alcohol sale from 11 PM to 8 AM was introduced, with regions granted permissibility to enforce longer time restrictions. This measure effectively decreased retail availability of alcohol because many 24 h stores had to close their business, as night sales of alcohol (both, recorded and unrecorded) were their main source of income (Skorobogatov, 2014). Also, kiosk sales of any kind of alcoholic beverages were prohibited, which was an expansion of a much older measure from 1995 that targeted spirits only. In April 2014, the Ministry of Health included ethanol in a list of highly potent and toxic compounds, which required special record keeping and storage procedures. However, the documentation occurred locally, whereas EGAIS registration was and is still not required for medicinal alcohol producers, distributors and sellers. In 2015, the Ministry presented a new draft law, which required prescriptions for rubbing alcohol (pure ethanol) and limited the purchase of alcohol-based tinctures with an ethanol concentration of more than 15% to only two packages per person. The law is currently being negotiated with the Ministry of Internal Affairs regarding its enforcement aspects, but is partially put into practice. In the same year, another draft law was suggested that limited the vessel size of various alcohol-based medicinal compounds to 25 ml, 50 ml or 100 ml, according to alcohol concentration and the estimated potential for misuse. The draft underwent the Regulatory Impact Analysis of the Ministry of Economic Development and was pending for the following year due to the question of how to estimate misuse potential. In November 2016, a special interdepartmental commission for the regulation of package sizes of

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medicinal products and products for veterinary use was formed. In December 2016, the Ministry of Health quickly adopted the law for medicinal alcohols, while the regulation for veterinary products, which lies within the responsibility of the Ministry of Agriculture, is currently pending. In February 2015, the minimal vodka price did not increase for the first time since the long-term strategy had been implemented, but on the contrary, decreased from 220 roubles (2,85EUR) to 185 roubles (2,40EUR). The measure was introduced after the December 2014 speech of President Putin, who argued that “overpricing of alcoholic products leads only to an increase of surrogate consumption”(Kremlin.ru, 2014). In November 2015 a poisoning with methanol-containing whiskey has occurred in the Siberian city of Krasnoyarsk, of which 11 people have died subsequently (Interfax.ru, 2016). The consumed product was a cheap counterfeit of a popular international whiskey brand and was bought on-line. In the following weeks Rospotrebnadzor has shut down 14 illegal online shops selling cheap counterfeit alcohol and has claimed for a new legislation, which would allow to block internet shops of counterfeit alcohol without the required court order (Tass.ru, 2015). A second poisoning with the same product occurred in April 2016 in Krasnoyarsk, killing two more people (Interfax.ru, 2016). Rospotrebnadzor shut down 420 more websites. In January and July 2016, the final step of EGAIS implementation was accomplished: all wholesalers and retail outlets of beverage alcohol had to be connected to the system and register every bottle sold of alcoholic beverages through a specially equipped shop counter. This allowed for a complete monitoring throughout the whole production chain and the enforcement of night bans on alcohol sales. According to market-research reports, production of legal vodka increased by 16.1% between 2015 and 2016, with consumption remaining at the same level. This is seen as an effect of EGAIS in decreasing unrecorded consumption (Smirnova, 2017). In September 2016, Russian media reported that the Ministry of Industry and Trade suggested to substantially decrease alcohol excises and to establish a vodka price of 100 roubles per 0.5 L bottle to make recorded alcohol more affordable, and therefore, more attractive (Ivuskina, 2016). Increasing the number of alcohol outlets and simplifying licensing procedures for alcohol producers were named as further measures to decrease consumption of unrecorded alcohol in favour of recorded products (Bulanov, 2017). The proposal was, however rejected in November and the Ministry’s previous suggestion to withdraw the ban on alcohol sales in educational and medical facilities, markets, airports and other public places was heavily criticized by the Ministry of Health and Rospotrebnadzor. In early December 2016 it was also announced that different Ministries would work on the legalization of alcohol trade via the Internet, which was discussed as an important measure to curb online sales of counterfeit alcohol (Tass.ru, 2016).

After Irkutsk: the most recent policies and their impact on unrecorded consumption After some more ambiguous measures, which did not follow the global strategy of harm reduction, the situation changed after the Irkutsk mass poisoning of December 2016. New measures are now implemented for recorded and unrecorded consumption. Two days after the first individuals were hospitalized with an acute methanol poisoning, the Mayor of Irkutsk declared a state of emergency and the Prime Minister of Russia claimed to either ban the sale of alcohol-based cosmetic lotions or to seize full control of the market (BBC.com, 2016).

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Following that, Rospotrebnadzor issued a national ban on the sale of certain types of alcoholic liquids that were not intended for internal consumption for a period of 30 days, which was then prolonged for another 60 days in January and additional 90 days in April and July, respectively. The investigation found that the hospitalized people were poisoned not with the usually sold bath lotions containing 95% ethanol, but with methanol-based counterfeits of this product. A criminal case was opened with the prime suspect of the proceedings listed as “Unknown.” Within the first 30 days, Rospotrebnadzor seized over 500,000 bottles of different liquids during inspections, as well as reported that these measures helped to reduce non-fatal alcohol poisonings by 33% and fatal alcohol poisonings by 65% during the New Year festivities. Special investigations were initiated, focusing on the manufacturers of anti-freeze windshield washer fluids — a product known to be widely and illegally produced with methanol instead of the statutory required isopropanol and to be consumed by severely alcohol-dependent individuals (Neufeld, Lachenmeier, Hausler, & Rehm, 2016). According to Rospotrebnadzor, methanol containing windshield washer fluid were found in 44 different regions of Russia, a total of 291 different retail outlets were shut down, 3 production sites were identified and penalties of the amount of more than 1.5 billion roubles were imposed. In the following months Rospotrebnadzor seized several tons of methanol-based antifreeze fluids and the ongoing investigation of the Irkutsk poisoning revealed that the surrogate alcohol that has caused the outbreak was made of illegally purchased methanol that was routinely used for the production of antifreeze fluids by local producers. Also a new draft amendment to the Criminal Code was developed by a parliament member, suggesting a new article on ‘Illegal production and turnover of alcohol products, which led to death or other serious consequences’ in order to impose higher penalties (Molotov, 2017). In January 2017, three homeless people died from a methanol poisoning in Saint-Petersburg after consuming an anti-freeze windshield washer fluid and a criminal case was subsequently opened against the producers of the liquid (Nsn.fm, 2016). Although such cases of fatal methanol poisonings with anti-freeze liquids happen on a regular basis in Russia, they are barely investigated and legal cases are rarely filed. The investigation of Saint Petersburg was obviously pressed forward under the immediate actions of Rospotrebnadzor, as some media reported (Fontanka.ru, 2017). In February 2017 The Federal Service of Alcohol Market regulation suggested to make denaturing of methanol mandatory to prevent further fatal poisonings (Tvc.ru, 2017). The Service pointed out that this possibility has existed since the general amendments to the Federal Law of 2006, but was never used. In the same month, another draft law was presented to the State Duma, proposing a discounts ban on alcoholic beverages. Rospotrebnadzor supported the draft, stating that discounts and any kind of alcohol commercials should be prohibited (Rbc.ru, 2017). Finally, discussions on minimal alcohol prices, introducing taxation for cosmetic and medicinal products and making alcoholbased medicinal compounds a controlled class medication requiring prescription, started again. In December 2016, the Ministry of Industry and Trade denied any suggestions on decreasing the minimal vodka price and emphasized the importance of a balanced alcohol policy and the ban of non-beverage alcoholic liquids. Also in December 2016, it was announced that the State Duma will discuss a new legislation to undertake new clinical trials on the effectiveness of medicinal tinctures, which could lead to their

replacement with tablets or complete abolishment (Stepunina, 2016). In January 2017, the Ministry of Finances announced a new minimal vodka price of 219 roubles (for 0.5 L), which was the originally planned bench-mark price for 2015 (Guneev, 2016). In the same month the Ministry also argued against the legalization of alcohol trade via the Internet (Izvestia.ru, 2017). However, the actually introduced prices in May 2017 were slightly lower (for vodka 205 roubles instead of 219; see Table 1 of the Web Appendix). In July 2017 the Criminal Code and the Federal Law on Production and Turnover of Ethyl Alcohol were amended. Harsher penalties for illicit production, turnover and retail sale of alcohol and alcohol-containing products and the forging of excise stamps were introduced. Additional restrictions of retail sale included the prohibition of selling alcohol-containing products via a vending machines and the ban on advertising alcohol retailers online. Summary on the effects and suggestions for further measures Overall, the available evidence suggests that consumption of unrecorded and recorded alcohol, as well as alcohol-attributable harms have been declining since about 2005, generally coinciding with the introduction of important alcohol control measures (Khaltourina & Korotayev, 2008, 2015; Kolosnitsyna et al., 2014; Levintova, 2007; Nemtsov, 2015; Neufeld & Rehm, 2013; Pridemore, Chamlin, Kaylen, & Andreev, 2014; Radaev & Kotelnikova, 2016; Radaev, 2015; Shield et al., 2016; Skorobogatov, 2014). Despite the possibility that the considerable price increases and implemented restrictions of time and locations of alcohol sale could stimulate unrecorded consumption, in particular the substitution of vodka for homemade spirits (samogon), no such tendency was observed. On the contrary, available data from the Russian Longitudinal Monitoring Survey demonstrated the general decline of alcohol consumption, including samogon (Kolosnitsyna et al., 2014; Radaev & Kotelnikova, 2016; Radaev, 2015). One important exception is the study of (Skorobogatov, 2014), which suggests that the implemented night bans have affected different consumers groups in different ways. It was observed that unemployed individuals did partially substitute vodka for samogon following the night bans, whereas no such substitution effect was found in the segment of employed individuals, whose samogon consumption decreased. Unemployed people were also more likely to be regular drinkers and to consume spirits and other alcoholic beverages in higher quantities, which points to the importance of drinking patterns and possible alcohol use problems at play. Previous studies on unrecorded alcohol consumption in Russia (Bobrova et al., 2009; Saburova et al., 2011; Tomkins et al., 2007) as well as the results of our own research (Neufeld et al., 2016, 2017), demonstrate that heavy drinking individuals are mostly consuming alcohol surrogates rather than home-made beverages, although consumption of samogon still dominates in the largely understudied population of rural dwellers (Radaev & Kotelnikova, 2016; Zaigraev, 2004). The different mentioned policies, however, did not decrease the availability of alcohol-based cosmetics, which remained untaxed, and therefore, very cheap and popular as surrogates. On the contrary, the special resolution from 2007 on a separate list of perfumery and cosmetic products, which were not subject to the Federal Law, created the untaxed status of these products. By 2016 a huge variety of cheap colognes and cosmetic lotions could be bought legally and without any age limit in supermarkets, small shops and kiosks (Neufeld et al., 2016) and even through fully automated vending machines (Napeeva, 2016). Although some regions issued bans on the sale of these products (Bobrova et al.,

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Table 2 Suggested policies to reduce harm arising from unrecorded alcohol consumption. Measures suggested Stricter enforcement of the following existing measures: - ban on methanol-containing technical fluids, especially car products - ban on illegal or un-licensed online-shops of alcoholic beverages (counterfeited and/or untaxed beverages) - raise fines for violations of the Federal Law, especially in regard to location and time restrictions of sale, as well as illegal sales of non-beverage alcohol and home-made samogon - stricter border controls and narrowing tax differences to prevent large-scale alcohol smuggling, as well as private initiatives

Expansion of the following existing measures: - make the tracking system EGAIS mandatory for every producer of alcohol, including producers of non-beverage alcohol designated for medicinal and cosmetic products - limit the late sale hours of alcohol by expanding the federal ban from 9 PM–8 AM - enforce the suggested policies on medicinal products (prescriptions, vessel limitations and limitations of quantities per person) with the perspective of a phase-wise elimination of these products and the substitution for non-alcoholic alternatives, such as pills, etc.

Introduction of new measures: - ban the sale of alcoholic cosmetic lotions and perfumes in kiosks, supermarkets and grocery stores - introduce excise duties on alcohol-containing cosmetic and perfumery products and dismiss the 2007 resolution, which has created the exceptional status of this product segment - introduce a Spirits Monopoly Law according to the German model and create a special commission, which would buy the production of samogon manufacturers at a cost covering price to ensure product quality and safety, and hand it over to industrial distilleries, controlled by the Federal Law.

2009), they remained largely available until the mass poisoning of Irkutsk. Other important types of unrecorded alcohol commonly consumed in Russia are illegally sold non-beverage alcohol (in its pure or diluted form), alcohol counterfeits and smuggled alcohol, the latter being a problem in specific regions (Neufeld et al., 2017). Currently, there are no studies that could highlight the changes in the availability and consumption of non-beverage alcohol, except for expert’s opinions, which indicate that both have decreased since the introduction of the 2006 legislations (Khaltourina & Korotayev, 2015; Skorobogatov, 2014). Survey data on alcohol counterfeits suggest that the majority of Russians believe that counterfeiting has increased between 2012 and 2014, but the nature of the data cannot tell whether it is due to the consumer’s increasing awareness about fake alcohol (Kotelnikova, 2014). Besides small shops as the traditional outlets of counterfeits, internet shops have become the main trade channel of counterfeit alcohol over the past years (Kotelnikova, 2014; Neufeld et al., 2016). Research on illegal alcohol markets in Russia suggests that their dynamic is largely affected by the effectiveness of state enforcement practices (Radaev, 2017) and that illegal markets are sensitive to the anti-alcohol reforms implemented since 2006 (Kotelnikova, 2017), which is why their regulation should be considered crucial in reducing alcohol consumption on a population level. So far, the Russian outcomes of the implemented alcohol policies echo the international experience and demonstrate that effective measures have to target the market and the consumers to regulate the supply and demand for alcohol. Reducing the availability of recorded and unrecorded alcohol has been identified as one of the key elements to reducing consumption and associated harms and much more cost-effective than individually focused alcohol use disorder treatment (Babor et al., 2010; Lachenmeier, Taylor, & Rehm, 2011). Strategies and interventions based on harm reduction should systematically target unrecorded alcohol as well, especially given its clandestine nature and associated difficulties. On the basis of the identified alcohol policies and their impact on unrecorded consumption, further specific suggestions to reduce unrecorded consumption can be made to inform policy makers in their decisions. Suggested policies to reduce harm stemming from unrecorded alcohol are summarized in Table 2 as the main results of this narrative review.

Comparison to policies to for unrecorded in other countries The situation in Russia with respect to unrecorded consumption is unique, given the long tradition of industrially produced surrogate alcohol in large quantities (for a global overview see Rehm et al., 2014), on top of homemade and counterfeit alcohols. Unrecorded alcohol is a summary term for different categories, and policy measures against one category such as artisanal home production may not be effective for other categories such as counterfeit or surrogate alcohol (for an overview of policies: Lachenmeier et al., 2011). Thus, Russia in its current fight to reduce unrecorded alcohol and associated harm cannot rely on policy measures which had been shown to be effective in other countries, as these had been applied in different situations, mainly for reducing home production, cross-border shopping or counterfeit alcohol. Conclusion Various studies suggest that the consumption of both recorded and unrecorded alcohol has declined since 2006, and that this is at least partly attributable to the implemented alcohol policies (Khaltourina & Korotayev, 2015; Neufeld & Rehm, 2013; Radaev & Kotelnikova, 2016). In terms of specific measures, restricted sale hours seem to be more effective than price increases in terms of decreasing consumption and preventing hazardous drinking (Kolosnitsyna et al., 2014). Although consumption of home-made beverages has substantially decreased over the past years, introducing a Spirits Monopoly Act similar to the one in Germany (Lachenmeier & Rehm, 2010) is advisable to prevent backlashes and allow for more and better control over this sphere. According to this policy model, a special commission could be created to buy home-made alcohol at a cost covering price and hand it over to industrial manufacturers for further processing. This measure would ensure quality and safety of the alcohol, as well as a steady flow of revenues, because homemade beverages would no longer go untaxed and unrecorded (except for home-made beverages produced for own consumption only). However, the available evidence also indicates that despite all the new legislations there is still a large illegal and semi-legal

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unrecorded industry in Russia, mainly involving illegal and/or counterfeited spirits and surrogates (Rehm et al., 2014). The introduced policies of 2006 have left enough room of action for producers of unrecorded alcohol, most importantly, the manufacturers of non-beverage alcohol. The inconsistent application of taxation and denaturing and monitoring measures of alcohol not intended for human consumption (most importantly the special resolution on cosmetics) have created a loophole in the existing legislation, which was used for the production of a new segment of alcohol surrogates, masked as medicinal and cosmetic products. Market estimates suggest that this industry is growing since 2013 in terms of market volume and profit (Puzyrev & Kravcov, 2016). The recent events of Irkutsk, where a mass methanol poisoning with counterfeit cosmetic lotions occurred, are a dramatic example of the commonness of surrogates, as they also became the subject of counterfeiting. Vendors from Irkutsk reported that the demand for the cheap surrogates did not decrease despite the broad media coverage of the fatalities (Mishnov, 2016). This points to the existence of an enormous semi-legal or illegal alcohol market. The immediate actions of the Russian government after the tragic incident, especially pertaining to a strict enforcement of bans on different alcoholic liquids not intended for human consumption, and their outcomes demonstrate that specific measures to reduce unrecorded alcohol consumption and harms can be adopted quickly. Evidence-informed policy-making in the field of alcohol has been demonstrated to be effective internationally (Babor et al., 2010), and there is no evidence so far that the Russian case is an exception since the adopted policies in the past have clearly shown outcomes. Poisonings like the ones in Irkutsk are preventable, if the established multi-level strategy of alcohol consumption and harm reduction is pursued stringently and all the possible loop-holes for producers, sellers and distributors of illegal alcohol are eliminated or at least critically reduced. Conflict of interest None declared. Funding This research was supported by the Rosa Luxemburg Foundation, Germany (the PhD scholarship program of the Federal Ministry of Education and Research, Germany). The first author also received a research stipend from the Centre for Addiction and Mental Health. Acknowledgments We thank Lisa Belorusova and Tatiana Zabolotnaya for their help in the search for the original legislative papers. Michelle Tortolo is thanked for referencing. Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/j. drugpo.2017.09.006. References Babor, T., Caetano, R., Casswell, S., Edwards, G., Giesbrecht, N., Graham, K., et al. (2010). Alcohol: No ordinary commodity. Research and public policy, (2nd ed.) Oxford and London: Oxford University Press.

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