According to the Lancet’s latest Global Burden of Disease Study, around 11 million global deaths are attributed to tobacco and alcohol consumption, over 11.5 million if you include illicit drug (opioids, cocaine, amphetamines and cannabis) use.1 This is more than the number of deaths from all cancers in the world.2 Lancet’s study shows that tobacco use is declining, albeit from a very high rate, highlighting the success of stricter tobacco control regulations worldwide. Consumption of alcohol and illicit drugs are, however, on the rise. This Part 1 howtoregulate article analyses techniques for regulating alcohol, cannabis and tobacco so that the regulatory control measures can effectively control the public health and welfare costs of the harms caused by these addictive products. Part 2 will look at reference regulations showing how such regulatory techniques operate in the jurisdictions that have implemented them.
In 2018 we wrote two articles, one on regulating alcohol and the other on tobacco control regulations. This article provides an update on alcohol and tobacco regulations since that time and adds new regulatory techniques useful for regulating addictive substances generally noting emerging cannabis regulatory frameworks due to legalisation of cannabis. We recommend reading this article together with the 2018 articles to be familiar with the regulatory techniques outlined therein.
A. Preliminary issues for regulating addictive substances
1. Alcohol and tobacco are addictive substances that are also popular consumer products. Cannabis is also an addictive substance that is becoming socially acceptable as more jurisdictions decriminalise personal cannabis use and regulate cannabis as a consumer product. As consumer products, alcohol, cannabis and tobacco (ACT) are unique in that over consumption of which has negative health consequences, including premature death, ill-health and disability. These addictive substances also cause increased public health costs for acute care for ACT-related disorders, social security costs for lost productivity due to ill-health or disability and are often associated with physical and sexual violence, causing inter-generational repercussions. On the other hand, the production and sale of ACT generates employment and public revenue from taxes. Evidently, levels of ACT consumption, and their related harms, are a function of both the demand for the product and its supply or availability. Given these factors there is a clear need for strict controls, incentives and enforcement in regulating ACT to reduce the health consequences of over-consumption and in the very least, ensure balance between the costs and benefits of consumption (eg. public revenue generated from taxes of ACT, pleasure associated with ACT consumption).
I. Identifying the policy goals and developing measures
2. Given the societal costs (health, welfare, violence) associated with harmful use of ACT a number of worthy policy goals could include reducing death, reducing ill-health or extending healthy life years. The flow on effect from these goals would result in public health and welfare savings, which could be an intermediate goal. The Handbook: How to regulate? 2nd ed. outlines the value of identifying the ‘goals behind the goals’ as a means for determining appropriate regulatory measures:
“Some of the ‘goals behind the goals’ build chains. The goals which do not depend on other goals, at the end of the chains, shall be called primary goals…goals which are between the primary goals and the officially set goals shall be called intermediate goals.”3
By analysing what the primary and intermediate policy goals are, can widen the range of policy choices and measures. For example in the Handbook, an example policy goal to reduce the use of smoking tobacco is used to highlight a range of possible measures, which in this article about regulating addictive substances is also relevant:
increase the excise duty and/or sales tax on tobacco products, creating a financial incentive to smoke less;
offer lower health insurance rates for non-smokers, creating another financial incentive to smoke less;
oblige manufacturers of tobacco products to place warnings and deterring images on the packaging to deter smokers;
launch information campaigns managed by the media, health insurance and schools; and
Analysing the first measure of increasing excises/taxes will increase public revenue, which helps to offset the health and welfare costs of ACT harmful use. However, once the rate of excises/taxes reaches a threshold, any further increase will decrease overall public revenue either because the purchase cost is too prohibitive or the appeal to buy black-market products increases.5 Therefore, from a certain taxation threshold there could be a conflict between ‘creating a financial incentive to smoke less’ and ‘increasing public revenue to cover health and welfare costs of smoking’.
3. Focussing on addictive substances more generally, there are many policy goals to be pursued, but the primary ones include:
increasing healthy life years of consumers of ACT;
reducing harmful use of alcohol;
reducing harmful use of cannabis;
reducing tobacco consumption (smoking, chewing, snuff), including Electronic Nicotine Delivery Systems and Electronic Non-Nicotine Delivery Systems (ENDS/ENNDS);
reduce spending on public health and welfare; and
reduce deaths caused by ACT, including primary causes (eg. lung cancer, cirrhosis) or secondary causes (eg. death by dangerous driving while under the influence of alcohol or cannabis).
4. Examples of measures to achieve these goals can broadly be arranged according to the following objectives:
(a) Demand reduction:
permanent sales prohibition;
price and tax measures; and
non-price measures, including spaces protected from exposure to tobacco or cannabis smoking, regulation of product disclosures, packaging and labelling of ACT products, education, communication, advertising, promotion, sponsorship, training and public awareness, demand reduction measures concerning ACT dependence and cessation.
(b) Supply reduction:
- physical availability controls including restrictions on time and place, rationing and state monopolies;
- tacking illicit trade in ACT products;
- sales to and by minors;
- regulation of ACT sales licenses to reduce density; and
- provision of support for economically viable alternative activities.
(c) Harm reduction:
- regulation aimed at reducing the harmful contents of ACT products generally;
- regulation of the maximum alcohol content sold at specific venues and /or special events (summer festivals, sporting events, pop-up venues etc.);
- regulation requiring compulsory training for responsible sale of ACT products; and
- regulation of industry influence in public health policy.
II. Undue influence of industry
5. Alcohol and tobacco are profitable global consumer products. According to British American Tobacco “sales for the legal global tobacco market were worth approximately US$818 billion. The largest global tobacco category remains combustible cigarettes … 5,200 billion cigarettes consumed annually … over 19% of the world’s adult population still chooses to smoke and will likely continue to do so unless consumers are offered suitable alternatives”. The global market size of alcoholic beverages is worth US$1.47 trillion, beer represents the largest segment of the market. In the top 100 consumer products companies, 7 are tobacco companies and 12 sell alcohol, of which, 7 companies exclusively sell alcohol. Evidently, alcohol and tobacco companies would seek to influence regulations that aim to reduce consumption of their products.
6. The undue influence of the tobacco industry in public policies to regulate tobacco is the most notorious example. For this reason the international Framework Convention for Tobacco Control (FCTC) requires parties to protect public health policies from commercial and vested interests of the tobacco industry (Article 5), and if possible ban tobacco advertising, promotion and sponsorship (Article 13). No such international agreement exists for alcohol and very few jurisdictions prohibit alcohol advertising, although many jurisdictions have advertising regulations aimed at reducing exposure to children. Despite studies showing that the alcohol industry use similar patterns of policy-influencing strategies as the tobacco industry, there is not the same vigilance against alcohol industry involvement in public policy as there is with the tobacco industry.6 The fact that alcohol consumption is a global disease burden that is growing every year, regulation aimed at reducing alcohol industry influence in public policy is likely to be as effective as it has been in tobacco control regulation.
7. In comparison the cannabis market is significantly smaller. The legal global cannabis market is valued at US$20.5 billion (recreational and medicinal) and with more jurisdictions seeking to legalise cannabis, the global market is expected to reach US$90.4 billion. The cannabis industry is still emerging, and while it may not be as trans-national as the alcohol and tobacco industry, the tobacco industry is taking an interest and have supported pro-cannabis group lobbying for legalisation.7 Noting that senior tobacco industry staff have moved into the cannabis industry8 and similarities in forms of products (eg. smoking and e-liquids), cannabis legalisation and regulatory framework development should prohibit undue influence in policy-making.
8. Generally, the commercial interests of the ACT industry are served best by increasing product sales and consumption in the population, which is in direct conflict with the public interest in a healthy and productive population. The difficulty with ACT consumer products is that moderation of consumption is difficult to regulate given the addictive characteristics of the substance on different populations. For this reason, regulations should protect the public interest in a healthy and productive population and be strictly enforced. The howtoregulate articles on “Countering unfair lobbying” and “Restoring trust: using regulations to protect the impartiality of decisions and research in the public interest” contain regulatory techniques that seek to curb undue influence from industry.
III. Industry subsidies
9. Parties to the international tobacco control convention (FCTC) are obliged to “develop, implement, periodically update and review comprehensive multisectoral national tobacco control strategies, plans and programmes” and “protect these policies from commercial and other vested interests of the tobacco industry” (Article 5). FCTC Parties must also recognise the role that financial resources play in achieving the FCTC’s objectives, including using:
“bilateral, regional, subregional and other multilateral channels to provide funding for the development and strengthening of multisectoral comprehensive tobacco control programmes of developing country Parties and Parties with economies in transition. Accordingly, economically viable alternatives to tobacco production, including crop diversification should be addressed and supported in the context of nationally developed strategies of sustainable development.”9
In terms of tobacco industry subsidies, such government assistance must aim to encourage economically viable alternatives to tobacco. Outside of this narrow assistance, government funding to the tobacco industry is otherwise not done.
10. In the case of the alcohol industry, governments do provide support at various levels of the production chain, from agricultural subsidies to growers of ingredients used in alcohol through to trade delegations promoting national or regionally produced alcohol. Although such subsidies are generally a prerogative of government policy, subsidies have a legislative basis in order to direct public funds. It is incongruous to have a policy goal of reducing harmful alcohol consumption while also promoting and subsidising locally produced alcohol to other regions and nations, particularly noting the alcohol industry’s aversion to warning labels about harmful alcohol consumption on bottles. The same holds true for any subsidies that are introduced into emerging cannabis markets. In the very least, it is a reasonable expectation that there is coherence between trade policy in support of alcohol and cannabis production with the public health and welfare policies attempting to control harmful consumption. Eurocare, is a non-governmental organisation working on the prevention and reduction of alcohol-related harm, it cites an interesting example of policy incoherence between supporting European alcohol industry against its opposition to South Africa’s prohibition of alcohol sales as a public health COVID-19 control measure.
IV. Density of licensed retailers
11. Unsurprisingly, ACT consumption is sensitive to how easy it is to purchase such products. This was brought into sharp focus in 2020 as many jurisdictions prohibited, or restricted, alcohol and tobacco sales as part of COVID-19 control measures to limit public circulation to purchases of essential products (food and medicine). This saw sales of alcohol and tobacco drop, particularly as night-time venues that sold alcohol and tobacco were prohibited from opening. Given the effectiveness of sale control measures on reducing consumption, regulatory measures to control retail density via licensing frameworks should be seriously considered.
12. A regime to control overall retailer density of ACT products could, for example, permit retail licences for one retailer per square kilometre or per 10,000 inhabitants, with requirements that account for proximity to areas frequented by children eg. schools, playgrounds. Regulations aimed at controlling retailer density can be found in alcohol and cannabis regulation. However, they do not apply population-wide and are often linked to unwanted behaviour in specific areas or particular communities associated with excessive consumption of alcohol.10 Other measures to reduce retail density include a ‘sinking-lid’ policy approach to reducing retail density, which could be implemented in the following ways:
a licensing fee set according to retail sales volume: the fee would increase progressively over time, such that the more products sold the more expensive the licence so as to decrease the number of retailers choosing to sell alcohol or tobacco products;11
move from a licence application scheme to a licence auction scheme that progressively reduces available licenses to bid for over time, bidders for licences must satisfy conditions to participate and are disqualified if they have infringed any conditions on the licence in the past.
Measures to reduce retail density quickly would most likely require compensation in some form, include
prohibit sale of alcohol and tobacco at specific outlets eg. cafe’s, newspaper shops, vending machines, supermarkets and petrol stations, or increase the distance of retailers from places where children frequent eg. schools, childcare, playgrounds, such that like regulated cannabis, alcohol and tobacco are only sold at adult stores requiring all consumers to show their proof identity; and
licence buy-back or compensation schemes.
Another benefit of tackling retail density is that enforcement of licensed retailers facilitates enforcement as there are fewer retailers to monitor. When deciding on which regulatory measure to reduce retail density, regulators should monitor closely illicit market trade, which could increase as ACT products become less convenient to purchase. Enforcement action will be required to ensure that reducing retail density is effective.
V. Opportunities presented by emerging cannabis regulatory frameworks
13. The legalisation of cannabis beyond medical and scientific purposes is growing. In 2021, Mexico is on track to regulate the world’s largest cannabis market (Mexico’s population is 127 million), market sectors include medical, scientific, personal use and tourist industry. In the US, 15 states have licensed recreational cannabis sale, with Montana and New Jersey in the process of establishing licensing frameworks following legalisation in early 2021. Whilst we have no view on the appropriateness of the legalisation of cannabis as such, cannabis legalisation presents a unique opportunity for jurisdictions to develop a regulatory framework with proven effective regulatory techniques from both alcohol and tobacco regulation. Given that ACT products worldwide have age restrictions for sales, regulators could investigate licensing schemes that encourage co-location of cannabis retailers with alcohol and tobacco retailers, as a control measure for retail density and age restriction enforcement. For example, if ACT products are sold in age-restricted venues, it is easier to require all consumers to present proof of age on entry making enforcement much easier. In Uruguay, cannabis consumers must be registered in an anonymised card system and must present their registration card in order to purchase cannabis products, the card enforces identity and rationing of cannabis.13
B. International and supranational regulatory framework
I. United Nations (UN) and its agencies
1. Following a decision at the World Health Organisation (WHO) 146th Executive Board, a two-year process to “accelerate action to reduce the harmful use of alcohol” began in April 2020. The process includes a consultation towards an action plan 2022-2030 for the global strategy to reduce the harmful use of alcohol; development of a technical report on the harmful use of alcohol related to cross-border alcohol marketing; a call for more resources to be made available; and a review of the Global strategy in 2030. According to WHO’s most recent global status report on alcohol (October, 2018) “alcohol remains the only psychoactive and dependence-producing substance with significant global impact on population health that is not controlled at the international level by legally-binding regulatory frameworks”. See paragraphs 3 and 6 of this Part A below for the international regulatory frameworks that control cannabis and tobacco.
2. The WHO launched in late 2018 the SAFER alcohol control initiative to prevent and reduce alcohol-related death and disability. SAFER provides five actions that are prioritised for implementation to promote health and development:
- Strengthen restrictions on alcohol availability.
- Advance and enforce drink driving countermeasures.
- Facilitate access to screening, brief interventions, and treatment.
- Enforce bans or comprehensive restrictions on alcohol advertising, sponsorship, and promotion.
- Raise prices on alcohol through excise taxes and pricing policies.
The SAFER actions support the WHO global target of reducing harmful use of alcohol by 10% by 2025. The WHO monitors the health impact of alcohol use as it contributes to 3 million deaths globally every year, is a major risk factor for non-communicable diseases (cancers, cardiovascular diseases), communicable diseases (tuberculosis, HIV/AIDS), violence and injuries.14 WHO advocates that in addition to regulatory measures associated with alcohol excise taxes that most countries have in place, other effective regulatory measures could include:
price measures that prohibit below-cost selling or volume discounts;
broadening advertising bans from television and radio to include the internet and social media;
increasing the legal alcohol consumption age to 21 (US states that increased the legal alcohol consumption age saw a 16% median decline in motor vehicle crashes); and
reducing opening hours of bars (eg. in Brazil bars reduced hours from 24 hours a day to closure at 11pm resulting in 44% drop in homicides).
3. The UN’s international drug control conventions regulate the production and supply of controlled drugs, such as cannabis, listed in its schedules, as defined by the substance’s capacity to produce dependence and central nervous system stimulation or depression. The three main conventions are the:
- Single Convention on Narcotic Drugs of 1961;
- Convention on Psychotropic Substances of 1971; and
- Convention Against Illicit Traffic in Narcotics Drugs and Psychotropic Substances.
4. The 1961 Convention prohibits production and supply of specific drugs and of drugs with similar effects except under licence for specific purposes, such as medical treatment and research. Article 2 concerns the substances under control as listed in Schedules I, II, III & IV. Article 3 provides that the WHO must make a finding for substances to be listed. The four schedules are arranged as follows and each have separate regulatory controls:
Schedule I – The substance is liable to similar abuse and productive of similar ill effects as the drugs already in Schedule I or Schedule II, or is convertible into a drug. The regulatory controls of Schedule I substances include:
Limitation to medical and scientific purposes of all phases of narcotics trade (manufacture, domestic trade, both wholesale and retail, and international trade) in, and of the possession and use of, drugs;
Requirement of governmental authorisation (licensing or state ownership) of participation in any phase of the narcotics trade and of a specific authorisation (import and export authorisation) of each individual international transaction;
Obligation of all participants in the narcotics trade to keep detailed records of their transactions in drugs;
Requirement of a medical prescription for the supply or dispensation of drugs to individuals; and
Schedule II – The substance is liable to similar abuse and productive of similar ill effects as the drugs already in Schedule I or Schedule II, or is convertible into a drug. Drugs regulated in this category have slightly less stricter controls than those listed in Schedule I, including:
The drugs are not subject to the provisions of Article 30, paragraphs 2 and 5, as regards the retail trade;
Parties are thus not bound to prevent the accumulation of drugs in Schedule II in the possession of retail distributors, in excess of the quantities required for the normal conduct of business;
Medical prescriptions for the supply or dispensation of these drugs to individuals are not obligatory;
Such drugs are also exempted from the provision – which in fact is no more than a suggestion – concerning the use of official prescription forms in the shape of counterfoil books issued by the competent governmental authorities or by authorised professional associations; and
Schedule III – The preparation, because of the substances which it contains, is not liable to abuse and cannot produce ill effects; and the drug therein is not readily recoverable. This Schedule is the least strictest and requires Parties to enforce the following controls:
Government authorisations are not required for each import or export of preparations in Schedule III. The import certificate and export authorisation system laid down in Article 31, paragraphs 4 to 15, which governs the international transactions in drugs and their preparations, does not apply to the preparations in Schedule III; and
The only estimates and statistical returns that a Party need furnish to the INCB in reference to Schedule III preparations are estimates of the quantities of drugs to be used for the compounding of preparations in Schedule III, and information on the amounts of drugs actually so used.17
Schedule IV – The drug, which is already in Schedule I, is particularly liable to abuse and to produce ill effects, and such liability is not offset by substantial therapeutic advantages. Therefore such drugs are subject to the strictest controls, including limiting Schedule IV drugs to research purposes only. The Commentary to the 1961 Convention states that “[w]hether the prohibition of drugs in Schedule IV (cannabis and cannabis resin, desomorphine, heroin, ketobemidone) should be mandatory or only recommended was a controversial question … regarding the usefulness of prohibiting particularly dangerous drugs without therapeutic properties not obtainable from other less dangerous substances”18. The provision adopted represents “a compromise which leaves prohibition to the judgement, though theoretically not to the discretion, of each Party”19. The Parties are required to act in good faith in making this decision, or else they will be in violation of the treaty.
5. In December 2020 the Commission on Narcotic Drugs (CND), the UN’s central drug policy-making body, accepted the WHO recommendation to remove cannabis and cannabis resin from Schedule IV of the 1961 Convention. Cannabis was controlled under Schedule IV because it was previously judged as having little medical benefit, it (cannabis and cannabis resin, extracts and tinctures of cannabis) remains listed for control under Schedule I. The cannabis plant is defined as “any plant of the genus Cannabis” (Article 1) to cover the species Cannabis indica and Cannabis sativa and any variety discovered in the future. Article 28 of the 1961 Convention concerns the control of cannabis where a Party decides to permit the cultivation of cannabis that is not for industrial or horticultural purposes. The inclusion of the principal psychoactive constituent of cannabis, tetrahydrocannabinol (THC) in Schedule I and dronabinol (synthetic delta-9-THC) and its stereoisomers in Schedule II of the 1971 Convention on Psychotropic Substances remains unchanged. Cannabis THC and its synthetically produced substances obliges Parties to:
[Article 2. Scope of control of substances, paragraph 7. (a) Schedule I]
Require licences for manufacture, trade and distribution as provided in article 8 for substances in Schedule II;
Require medical prescriptions for supply or dispensing as provided in article 9 for substances in Schedule II;
Comply with the obligations relating to export and import provided in article 12, except in respect to another Party having given such notice for the substance in question;
Comply with the obligations provided in article 13 for substances in Schedule II in regard to prohibition of and restrictions on export and import;
Furnish statistical reports to the Board in accordance with paragraph 4 (a) of article 16; and
Adopt measures in accordance with article 22 for the repression of acts contrary to laws or regulations adopted pursuant to the foregoing obligations.
[Article 7. Special provisions regarding substances in Schedule I]
Prohibit all use except for scientific and very limited medical purposes by duly authorised persons, in medical or scientific establishments which are directly under the control of their Governments or specifically approved by them;
Require that manufacture, trade, distribution and possession be under a special licence or prior authorisation;
Provide for close supervision of the activities and acts mentioned in paragraphs (a) and (b);
Restrict the amount supplied to a duly authorised person to the quantity required for his authorised purpose;
Require that persons performing medical or scientific functions keep records concerning the acquisition of the substances and the details of their use, such records to be preserved for at least two years after the last use recorded therein; and
Prohibit export and import except when both the exporter and importer are the competent authorities or agencies of the exporting and importing country or region, respectively, or other persons or enterprises which are specifically authorised by the competent authorities of their country or region for the purpose. The requirements of paragraph 1 of article 12 for export and import authorisations for substances in Schedule II shall also apply to substances in Schedule I.
[Article 2. Scope of control of substances, paragraph 7. (b) Schedule II]
Require licences for manufacture, trade and distribution in accordance with article 8;
Require medical prescriptions for supply or dispensing in accordance with article 9;
Comply with the obligations relating to export and import provided in Article 12, except in respect to another Party having given such notice for the substance in question;
Comply with the obligations of article 13 in regard to prohibition of and restrictions on export and import;
Furnish statistical reports to the Board in accordance with paragraphs 4 (a), (c) and (d) of article 16; and
Adopt measures in accordance with article 22 for the repression of acts contrary to laws or regulations adopted pursuant to the foregoing obligations.
6. We covered in some detail the WHO treaty, the Framework Convention on Tobacco Control (FCTC), in our 2018 article. Since that time the FCTC Protocol to Eliminate Illicit Trade in Tobacco Products (Protocol) entered into force in September 2018 and some interesting national regulation has been developed in response. The Protocol defines “illicit trade” in tobacco products as any practice or conduct related to producing, shipping, receiving, being in possession of, distributing, selling or buying tobacco products that is prohibited by law. Parties to the Protocol are required to implement the following measures to make the supply chain for tobacco products secure:
establishment of a global tracking and tracing regime within five years of entry into force of the Protocol, comprising national and regional tracking and tracing systems and a global information sharing point located in the Secretariat of the WHO FCTC (Article 8);
ensure that interaction with the tobacco industry in developing any tracking and tracing regime is carried out with maximum transparency, and Parties must not delegate any of their obligations to the tobaccos industry;
licensing (Article 6);
record keeping requirements (Article 9);
regulation of Internet-sales (Article 11), duty-free sales and international transit (Articles 12 and 13); and
Where illicit trade has occurred, Parties are required to:
- establish a regime of offences (Part IV);
- addresses liability and seizure payments (Article 17); and
- the disposal of confiscated products (Article 18).
7. The UN also seeks to regulate tobacco industry interaction with agencies of the UN system through its Model Policy on preventing tobacco industry interference. The policy acknowledges that interference by the tobacco industry presents a great obstacle to implementation of the FCTC and takes many forms, including:
manoeuvring with lobbyists to influence law-making;
exaggerating the economic importance of the industry while ignoring the social, environmental and health costs caused by tobacco and tobacco products;
manipulating public opinion to gain the appearance of respectability, e.g. by investing funds in youth programmes or nature conservation groups or disaster relief (the corporate social responsibility of the tobacco industry is an inherent contradiction since the tobacco industry’s core functions are in conflict with the goals of public health);
fabricating support through front groups which are phoney “grassroots” groups that support tobacco industry interests;
attempting to discredit proven science; and
UN agencies are required to implement measures that limit interactions and avoid any real or perceived partnership with the tobacco industry by:
rejecting partnerships, joint programs, non-binding or non-enforceable agreements and any other voluntary arrangements with the tobacco industry;
not permitting the tobacco industry use of any UN agency name, emblem or logo; and
ensuring any interaction with the tobacco industry is strictly necessary to promote the goals of the UN agency, that any meetings are conducted at a neutral venue, that tobacco industry participants at the meeting are presented with the UN agency’s policy on engagement with the tobacco industry (based on the Model Policy) and be provided with a letter formally requesting that the outcome of the meeting not be mischaracterised to suggest any relationship, collaboration or partnership with the UN agency.
II. European Union (EU)
8. Not a lot has changed on the issue of control measures in alcohol regulation in support of reducing harmful consumption in the EU since our last article. The spirits regulation (Regulation (EU) 2019/787) was concluded in 2019 (will be in force from May 2021), which repeals Regulation (EC) No 110/2008 and introduces a new system for:
- defining, describing, presenting and labelling spirit drinks;
- the use of the names of spirit drinks in the presentation and labelling of other foodstuffs;
- the protection of geographical indications for spirit drinks; and
- the use of ethyl alcohol and distillates of agricultural origin in alcoholic beverages.
The spirits regulation contains no measures or requirements related to labelling about public health issues. Labelling of alcohol products follows a self-regulatory framework, based on the obligation to provide the list of ingredients and nutrition declaration (Article Y of Regulation (EU) No 1169/2011). The EU spirits industry have opted to publish ingredients and nutrition labelling online via a barcode or QR code on the bottle, former Commissioner for Health and Food Safety encouraged that such a system not be used to collect and track consumer data for targeted marketing purposes. The health related information of EU spirits provides information on how to drink moderately but not the dangers of over-consumption.22
9. There is no harmonised EU law controlling the use of cannabis. Although EU Member States are responsible for the control of cannabis for medical or scientific purposes only, regulatory frameworks that define cannabis plants according to their THC level, provide for lawful purposes eg. industrial hemp. The European Monitoring Centre for Drugs and Drug Addictions reports that although national responsibilities are to control cannabis for medical and scientific purposes there is an increase in the open sale of cannabis products in Europe. Sellers claim that their products are low in THC content, which exempts them from national drug control laws that specify unlawful THC content. The open sale of such cannabis products, particularly those that take forms similar to illicit cannabis products, such as smoking mixtures, raises questions about their legal and commercial status. EU law provides for crimes related to trafficking of cannabis (Article 2 of Council framework decision 2004/757/JHA) and expressly excludes conduct committed by persons exclusively for their own personal consumption as defined by national law. Under the orphan medicinal products regulation (Regulation (EC) No 141/2000) the European Medicines Agency authorises medicines for rare diseases where a medicine meets the following criteria:
must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;
prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development; and
no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorised, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.
To date, delta-9-THC and cannabidiol have been authorised as orphan medicines for a limited number of treatments (eg. Lennox-Gastaut syndrome, Dravet syndrome, Glioma etc.).
10. The European Parliament voted and approved a motion (2018/2775(RSP) of 13 February 2019) for a resolution on the use of cannabis for medical purposes. The motion calls on the European Commission and national authorities to work together to provide a legal definition of medicinal cannabis. The motion also urges to draw a clear distinction between (1) cannabis derived medicines approved by the European Medicines Agency or other regulatory agencies, (2) medical use of cannabis not supported by clinical trials, and (3) other applications of cannabis.
11. The EU’s Tobacco Products Directive regulates the supply and sale of tobacco products, details of which are covered in our earlier article. To date, the EU has the most advanced tracking and tracing system as part of its obligations as a Party to the FCTC and went live in May 2019. Information on the first operational year can be found here. The EU traceability system is regulated by the following acts:
- Commission Implementing Regulation (EU) 2018/574 on technical standards for the establishment and operation of a traceability system for tobacco products.
- Commission Delegated Regulation (EU) 2018/573 on key elements of data storage contracts to be concluded as part of a traceability system for tobacco products.
- Commission Implementing Decision (EU) 2018/576 on technical standards for security features applied to tobacco products.
The three acts regulate how to determine the identifier codes (economic operators, tobacco facility, product machine), registration of such codes, requirements of the primary and secondary data repository, procedures for contracting providers of repository systems, including requirements for ensuring the financial and legal independence from the tobacco industry, and the ongoing audit requirements. Tobacco manufacturers are required to use an external auditor to monitor the contracted repository system providers. The Guidelines on annual audit reports to be submitted in the context of the EU traceability system for tobacco products assists tobacco manufacturers select a suitable auditor and outlines how the auditor should carry out the audits and report their findings.
C. Non-government organisations
Eurocare – European Alcohol Policy Alliance
1. Eurocare is an alliance of non-governmental and public health organisations with member organisations across European countries advocating the prevention and reduction of alcohol related harm in Europe. The mission of Eurocare is to promote policies to prevent and reduce alcohol-related harm. The message, in regard to alcohol consumption, is “less is better”. Eurocare’s website has useful information on its website for regulators who are designing measures to reduce the harmful effects of alcohol, including: labelling,commercial communication (marketing and advertising), trade policies, price and taxation, youth and football, and alcohol health.
Institute of Alcohol Studies (IALS)
2. IALS is an independent charity registered in the UK that brings together evidence, policy and practice from inside and outside of the UK to promote an informed debate on alcohol’s impact on society. Its purpose is to advance the use of the best available evidence in public policy decisions on alcohol. IALS manages an online Alcohol Knowledge Centre presenting useful information for regulating alcohol.
3. Transform Drug Policy Foundation is an international think tank that promotes public health, human rights and social justice through drug policy reform. It works towards educating the public and policymakers on effective drug policy; developing and promoting viable alternatives to prohibition; providing a voice for those directly affected by drug policy failures; and supporting policymakers and practitioners in achieving positive change. Transform have developed a very useful guide on regulating cannabis.
STOP. A Global Tobacco Industry Watchdog
4. STOP is a partnership between:
- the Tobacco Control Research Group at the University of Bath (they also manage tobaccotactics.org, featuring over 750 profiles of individuals and entities linked to the industry, useful for state independence verification checks);
- the Global Center for Good Governance in Tobacco Control;
- the International Union Against Tuberculosis and Lung Disease; and
- Vital Strategies.
with US $20 million in funding to launch the partnership from Bloomberg Philanthropies. The STOP partnership monitors and publishes data about the tobacco industry’s efforts to avoid international and national tobacco control regulations and policies. Although it operates worldwide, it focusses on lower-to-middle income countries, where tobacco industry marketing is aggressive and the greatest concentration of at-risk populations for tobacco-related disease. It produced the Global Tobacco Industry Interference Index 2020, which outlines specific examples where tobacco industry has not complied with tobacco control laws of the nation and examples where national tobacco control regulations have been relaxed.
Framework Convention Alliance (FCA)
5. The FCA is a membership organisation of nearly 300 non-government organisations from over 100 countries working on the development, ratification and implementation of the WHO FCTC. The FCA has developed evidenced-based guidelines for implementing the FCTC, including:
- Article 5.3 (industry interference);
- Article 6 (price and tax measures – recommendations only);
- Article 8 (protection from second-hand smoke);
- Article 9 & 10 (regulation and disclosure of contents)23;
- Article 11 (packaging and labelling);
- Article 12 (education and awareness);
- Article 13 (advertising and promotion);
- Article 14 (demand reduction measures);
- the Illicit trade protocol Guidebook; and
- lessons re track and trace.
This article was written by Valerie Thomas, on behalf of the Regulatory Institute, Brussels and Lisbon.
1 The Lancet, Global Health Metrics, “Global burden of 87 risk factors in 204 countries and territories, 1990-2019: a systemic analysis for the Global Burden of Disease Study 2019”, published Oct. 17 2020, Volume 396, Issue 10258, pp. 1223-1249,https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30752-2/fulltext#%20.
2 Ritchie, H. & Roser, M., “Drug Use”, OurWorldInData.org, https://ourworldindata.org/drug-use.
3 Regulatory Institute, The Handbook: How to regulate?, 2nd ed. 2021, p. 69, https://www.howtoregulate.org/wp-content/uploads/2021/02/H2R_Handbook_FINAL.pdf.
6 Examples include extensive lobbying and attempts to shape public perceptions of alcohol and the scientific content of regulatory debates. Hawkins, B., “Why do we treat alcohol and alcohol industry so differently from Big Tobacco?” Institute of Alcohol Studies, 16 Mar 2018, https://www.ias.org.uk/2018/03/16/why-do-we-treat-alcohol-and-the-alcohol-industry-so-differently-from-big-tobacco/.
7 University of Bath, “Cannabis”, Tobacco Tactics, https://tobaccotactics.org/wiki/cannabis/.
9 Article 26 of the Framework Convention on Tobacco Control,https://apps.who.int/iris/bitstream/handle/10665/42811/9241591013.pdf?sequence=1.
10 In Australia some states use ‘dry area’ provisions which restrict both the availability of alcohol and the places it can be consumed (eg. Section 3 of the South Australian Liquor Licensing Act). In the Northern Territory’s Liquor Act 1978, the Licensing Commission, has broad powers and discretion to tailor licence conditions to local circumstances. It also has a duty to take into consideration the ‘needs and wishes’ of the community. This enables members of the public to lodge complaints about the operation of particular licensees and establishments, and obliges the Commission to set up hearings to investigate complaints. As a result of this hearing process, the Commission may decide to impose restrictions on the sale and supply of alcohol by some licensees. See also National Drug Research Institute, “Restrictions on the Sale and Supply of Alcohol: Evidence and Outcomeshttps://ndri.curtin.edu.au/ndri/media/documents/publications/R207.pdf .
11 Tobacco control experts in New Zealand https://www.nzma.org.nz/journal-articles/new-zealand-tobacco-control-experts-views-towards-policies-to-reduce-tobacco-availability.
13 Transform Drug Policy Foundation, How to regulate cannabis?, 2016, p. 148,https://www.unodc.org/documents/ungass2016//Contributions/Civil/Transform-Drug-Policy-Foundation/How-to-Regulate-Cannabis-Guide.pdf.
14 WHO SAFER Initiative https://www.who.int/substance_abuse/safer/launch/en/.
15 Commentary on the Single Convention on Narcotics Drugs, 1961 (Prepared by the Secretary General in accordance with paragraph 1 of Economic Social Counciil Resolution 914 D (XXXIV) of 3 August 1962) Paragraph 1, Commentary paragraph 1, pp. 51-52, https://www.unodc.org/documents/commissions/CND/Int_Drug_Control_Conventions/Commentaries-OfficialRecords/1961Convention/1961_COMMENTARY_en.pdf.
20 The Protocol to Eliminate Illicit Trade in Tobacco Products: an overview, https://www.who.int/fctc/Protocol_summary_3Jul18-en.pdf?ua=1&ua=1.
21 Model policy for agencies of the United Nations system on preventing tobacco industry interference, 2017 pp. 1-2,https://www.who.int/ncds/un-task-force/events/model-policy-agencies-united-nations1.pdf.
22 Eurocare, “Creating alcohol labelling chaos”, https://www.eurocare.org/cares.php?sp=labeling&ssp=creating-alcohol-labelling-chaos.
23 FCA Policy Briefing: Adoption of additional guidelines for implementation of Articles 9 & 10, 2012, https://www.fctc.org/resource-hub/fca-policy-briefing-adoption-of-additional-guidelines-for-implementation-of-articles-9-and-10/.