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Uniform packaging regulations for tobacco were introduced in the UK in May after a legal challenge against the new law was dismissed by the UK High Court. Four large tobacco companies had challenged the regulations which the UK government was introducing in line with the European Union’s Tobacco Products Directive. The directive stipulates that graphic health warnings with photos, text and cessation information must cover 65% of the front and the back of cigarette and roll-your-own tobacco packs and is in furtherance of the policy laid down by the World Health Organization’s Framework Convention on Tobacco Control. The EU’s directive also allowed the UK to introduce its own regulations, requiring all tobacco products to be sold in uniformly olive green packaging with large images designed to act as health warnings, a move that had received a large parliamentary majority in its favour. According to Mr Justice Green’s ruling the tobacco companies had attacked the EU regulations, and the UK parliamentary process that had adopted them, “deploying the full gamut of challenges ranging from international law through EU law and human rights law right down to domestic common law.” Among their arguments, the companies claimed that the government had acted unlawfully because it attributed only “limited” weight to the evidence the companies had presented against plain packaging “upon the (erroneous) basis that it lacked independence and otherwise failed to meet ‘best practice’ standards for the preparation of evidence.” Mr Justice Green dismissed all their grounds of challenge, saying, "The essence of the case is about whether it is lawful for states to prevent the tobacco industry from continuing to make profits by using their trade marks and other rights to further what the World Health Organisation describes as a health crisis of epidemic proportions and which imposes an immense clean-up cost on the public purse," and that "In my judgment the regulations are valid and lawful in all respects."
The Food and Drug Administration (FDA) released its regulations on e-cigarettes and vaping products in May. The FDA first announced its intent to regulate e-cigarettes in 2011. In April 2014 the FDA first proposed bringing e-cigarettes and other non-traditional tobacco products, including cigars, hookah tobacco and pipe tobacco, under its authority but the timetable to finalise the proposal by June 2015 slipped due to resistance from the tobacco industry. The new rules bring e-cigarettes under federal oversight for the first time and will subject all manufacturers, importers and/or retailers of the newly-regulated tobacco products to any applicable provisions, and bring them into line with other tobacco products the FDA has regulated under the Family Smoking Prevention and Tobacco Control Act (TCA) since 2009. Under the new rules manufacturing companies must seek marketing authorization for any tobacco product introduced after 15 Feb 2007. E-cigarette brands will have to undergo a federal review to assess their impact on public health in order to stay in the market. Manufacturers have two years to submit product applications to the FDA for review, and the FDA has another year to finish the evaluation. Products already on the market are allowed to remain on sale during this period.The FDA review process will evaluate new products by assessing factors such as “ingredients, product design and health risks, as well as their appeal to youth and non-users.” Those e-cigarette manufacturers that do not submit the required information or do not meet federal standards would have their products removed from the market. The new rules will also limit e-cigarette sales to over-18s, although this ban will only affect Michigan and Pennsylvania as the other 48 states already ban sales of e-cigarettes to under-18s. E-cigarettes must carry warnings that they contain nicotine from May 2018. In Vox Mitch Zeller, director of the FDA's Center for Tobacco Products said: “as a regulatory agency, we have to make decisions at the population level. That's where it gets complicated. E-cigarettes have a positive and negative impact. In the US, that kids' use of e-cigarettes is way [up] is a negative. When it comes to adults, we have a disproportionate percentage of adults using e-cigarettes and cigarettes together.”
The latest European Drug Report from the European Monitoring Centre on Drugs and Drug Abuse (EMCDDA) provides an overview and summary of the European drug situation and responses to it. The statistical data in the report relate to 2014 (or the last year available) and is based on information provided to the EMCDDA by the EU Member States, the candidate country Turkey, and Norway. The report notes a resurgence in the use of ecstasy and that synthetic cannabinoids account for over 60% of the seizures of novel psychoactive substances. Twenty-five of the 98 new substances detected for the first time in 2015 and reported to the EU Early Warning System for new psychoactive substances were synthetic cannabinoids. The report also highlights new concerns about rises in deaths associated with heroin and other opioids particularly in countries in the north of Europe. In the preface to the report the Chair of the EMCDDA’s Management Board, Laura d’Arrigo, and the recently elected Director of the EMCDDA, Alexis Goosdeel, also draw attention to the demands on treatment services in Europe having to respond to the more complex health needs presented by an ageing cohort of heroin users.
The briefing paper, Cannabis Regulation and the UN Drug Treaties: Strategies for Reform, is produced by a range of drug policy and human rights organizations. Taking into account the discussions at the 2016 United Nations General Assembly Special Session (UNGASS) on drugs, the briefing examines options for the alignment of recent cannabis policy changes in countries like the US and Uruguay with obligations under the international drug control system.
In May the U.S. Food and Drug Administration (FDA) approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. The FDA said: “Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis.” The approval is part of the FDA’s opioid action plan to expand the use and availability of medication-assisted treatment.
Prompted by interest in the US in supervised injecting facilities (SIFs), the Harm Reduction Coalition convened a meeting in 2015 with international law enforcement and public health experts to explore the lessons learnt from the setting up of SIFs in Frankfurt, Germany; Sydney, Australia; and Vancouver, Canada. Among the major themes emerging from the meeting was that the key to the success of the SIFs “has been in cooperation, coordinated efforts, local participation, and a commitment to creating a safer and healthier community for everyone.”
BBC News reports that AXA, one of the world's biggest insurers, announced in May that it will stop investing in the tobacco industry and sell its investments in the industry worth more than €1.6bn (£1.3bn). The Economist noted that while AXA plans to sell its €184 million of equity holdings immediately, it planned to retain its €1.6bn of tobacco industry bonds until their maturity. In making the announcement AXA said that the role of healthcare providers is changing and that prevention is becoming more important. Thomas Buberl, Deputy CEO and incoming CEO of AXA said that the decision would generate savings by resulting in fewer claims for tobacco-related diseases and added: "It makes no sense for us to continue our investments within the tobacco industry. The human cost of tobacco is tragic - its economic cost is huge." Mr Buberl also said that the firm wanted to encourage other institutional investors to follow its lead.
The Globe and Mail reports that Health Canada has announced that it plans to allow doctors to apply for special access to prescribe diacetylmorphine to severe addicts under Health Canada's Special Access Programme (SAP). The SAP allows doctors access to non-marketed or otherwise unapproved drugs for patients with serious or life-threatening conditions. The move overturns a ban imposed by the previous Conservative government after clinical trials at Insite, the supervised injection site in Vancouver, Canada, found prescribed heroin safe and effective for patients who had failed to respond to standard medical treatment options such as methadone and buprenorphine. Patients in the trial continued to receive prescribed heroin despite the ban after challenging the Conservative government decision and winning an injunction.
Dr Leonie Brose at the Addictions Department, King’s College, London, UK, has been awarded the Fred Yates Prize for 2016. The prize is awarded annually, following open competition, by the Society for the Study of Addiction. The award is based on the outstanding research contribution of the mid-career researcher and recognises Dr Brose’s contribution to the field of smoking cessation, harm reduction and policy.
Wayne Hall writes: In April this year the Marron Institute at New York University hosted a 2 day Cannabis Science and Policy Summit. Mark Kleiman, who convened the summit, said that his intention was to “pry cannabis policy from the culture wars,” dispel the false policy polarisation between prohibition and legalisation to ensure that legalisation and prohibition were not seen as exhausting the cannabis policy space.
In the opening plenary, Jon Caulkins from Carnegie Melon University argued that cannabis should be regulated as a dependence producing, performance degrading, temptation good by using taxation and regulation to minimise the amount of heavy cannabis use (which accounted for most consumption) and the harms arising from it.
In the remainder of the meeting a series of parallel sessions covered topics as varied as the effects of cannabis on the brain; the impacts of medical marijuana and recreational cannabis legalisation on cannabis and other drug use (especially the opioids); emerging new medical and recreational cannabis products, such as edibles and extracts with a THC content up to 40%; and the implications of US cannabis policies for the international drug control treaties.
The old tension between supporters of cannabis legalisation and prohibition was replaced by another tension familiar to those in the alcohol policy field, namely, a split between public health advocates who advocated regulations and taxation policies to reduce heavy use and harms and representatives of the emerging legal cannabis industry who argued that restrictions on potency would limit consumer choice; that restrictive regulations, higher taxes and testing would limit their success in replacing the cannabis black market. The cannabis industry’s answers were always better consumer education and self-regulation.
The main take home messages for me were confirmation of an impression formed at a distance that it is much too early to judge how legal cannabis markets will be regulated, how soon they will increased availability and lower prices, and how these changes will affect rates of cannabis use and cannabis-related harm. There were some indications that liberal medical marijuana laws have reduced prices and increased the frequency of regular use among current users but it will take longer still to detect any increases in new users.
A major surprise was the increased use in legalisation states of high potency cannabis products, especially edibles and concentrates with up to 40% THC. Public health attendees raised concerns about increased risks of dependence, psychosis and other acute adverse effects. The industry was more concerned about pesticide contamination because pesticide levels (which are a minor issue for herbal cannabis products) increase along with the THC content in these concentrated products.
There are plans for similar summits in future to monitor the effects of cannabis legalisation. It will be interesting to see how many more will include representatives of cannabis industry and the public health community on the organising committee and among the speakers.
A report from the Royal College of Physicians (RCP), Nicotine without Smoke: Tobacco Harm Reduction, examines “the science, public policy, regulation and ethics surrounding e-cigarettes and other non-tobacco sources of nicotine.” The report concludes that e-cigarettes “represent an important means to reduce the harm to individuals and society from tobacco use” and that they should continue to receive government support and be promoted as a harm reduction strategy for tobacco.
The United Nations adopted a new framework that puts “people at the centre of global policies on drug control” at the UN General Assembly Special Session on the World Drug Problem (UNGASS) in April. “Putting people first means balanced approaches that are based on health and human rights, and promote the safety and security of all our societies. Putting people first means looking to the future, and recognizing that drug policies must most of all protect the potential of young people and foster their healthy styles of life and safe development,” said the Executive Director of the United Nations Office on Drugs and Crime, Yury Fedotov. The framework had been drafted in March by the Commission on Narcotic Drugs in Vienna and was adopted on the special session's opening day. The document, Our Joint Commitment to Effectively Addressing and Countering the World Drug Problem, reaffirmed a commitment to "promote a society free of drug abuse," and recognized the three UN drug control treaties as "the cornerstone of the international drug control system." Margaret Chan from the World Health Organization told the meeting that “In the view of WHO, drug policies that focus almost exclusively on use of the criminal justice system need to be broadened by embracing a public health approach. A public health approach starts with the science and the evidence.” Advocates of a change of international drug policy away from a prohibitionist approach were disappointed by the outcome of the meeting. In The Guardian, former president of Switzerland and critic of current drug policy Ruth Dreifuss said, “the world community is not ready, is not willing, to have the change of politic that is absolutely necessary.”
Reuters reports that India’s Supreme Court has ruled that the Indian tobacco industry must adhere to government rules requiring health warnings covering 85% of the cigarette pack surface. The court also rejected the tobacco’s industry’s petition to stay the introduction of the new tobacco control rules. The Supreme Court judges said that the tobacco industry "should not violate any rule prevailing as of today." The cases had been filed by bidi manufacturers and the Tobacco Institute of India (TII), which represents large tobacco firms.
The European Union’s Court of Justice has rejected a legal challenge by tobacco companies against the European Union’s 2014 Tobacco Products Directive (TPD). The court ruled in May that standardisation of packaging, the future EU-wide prohibition on menthol cigarettes and the special rules for electronic cigarettes are lawful. The TPD will take effect on 20 May and will ban menthol cigarettes by 2020, standardise packs and impose rules on e-cigarettes, such as limits on nicotine strength, tank size and advertising. Wholesalers and retailers will be given a year to sell stocks manufactured before that date. In its decision the court said that “The court finds that, in providing that each unit packet and the outside packaging must carry health warnings … the EU legislature did not go beyond the limits of what is appropriate and necessary.”
On 1 April Brazil launched the first of five planned regional centres that will collect and share information about tobacco industry strategies to undermine tobacco control. The observatory will house an online database that will be available to governments, civil society stakeholders, academic researchers and the public. The centre is a partnership of the Government of Brazil and the International Union against Tuberculosis and Lung Disease, a member of the Framework Convention Alliance (FCA). The observatory is part of a project to create industry monitoring centres in the five BRICS countries (Brazil, Russia, India, China and South Africa), and was initiated by the Secretariat of the WHO Framework Convention on Tobacco Control (FCTC).
ABC News reports that the Access to Medicinal Cannabis Bill was passed by parliament in Victoria in April. Victoria is the first state in Australia to legalise the use of medicinal cannabis. The Government is establishing the Office of Medicinal Cannabis to oversee manufacturing and all clinical aspects of the medicinal cannabis framework. Children with severe epilepsy will be the first to have access to the drug in 2017. "We're starting with these children with severe epilepsy, whose lives have been shown to improve so significantly, because we know these children often don't make it until [sic] adulthood," Victoria's Health Minister Jill Hennessy said. "I just think that in this day and age, it's unfair and unacceptable to ask a parent to make a decision between obeying the law and acting in the best interests of their child," she added. Access to medicinal cannabis will eventually be made available to people in palliative care and with HIV.
The Supreme Court of Canada has ruled that a federal law introduced by the former governing Conservative Party was unconstitutional. The law had made a one-year minimum sentence mandatory for a drug crime when the offender has a similar charge on his or her record. The court said the law constituted “cruel and unusual punishment,” a violation of section 12 of the Charter of Rights and Freedoms. Chief Justice Beverley McLachlin wrote on behalf of the court majority, “At one end of the range of conduct caught by the mandatory minimum sentence provision stands a professional drug dealer who engages in the business of dangerous drugs for profit, who is in possession of a large amount of drugs, and who has been convicted many times for similar offenses. At the other end of the range stands the addict who is charged for sharing a small amount of drugs with a friend or spouse, and finds herself sentenced to a year in prison because of a single conviction for sharing marijuana in a social occasion nine years before. Most Canadians would be shocked to find that such a person could be sent to prison for one year."
The Los Angeles Times reports that California governor Jerry Brown signed five anti-tobacco bills in May, including one that raises the legal age to purchase cigarettes from 18 to 21 and another that regulates e-cigarettes the same as tobacco products. Under the bills, California follows Hawaii to become the second state in the US to raise the smoking age. The five bills signed by the governor went into effect on June 9. Governor Brown vetoed one anti-tobacco bill that would have allowed counties and cities to ask voters to approve local tobacco taxes. In vetoing the bill Governor Brown wrote, “Although California has one of the lowest cigarette tax rates in the nation, I am reluctant to approve this measure in view of all the taxes being proposed for the 2016 ballot.” There are several tax initiatives proposed for California’s November ballot, including one to increase the tax on a pack of cigarettes from 87 cents to $2.
The Cigarettes and Other Tobacco Products (Packaging and Labelling) Amendment Rules, 2014 came into effect in India on April 1, following the Indian health ministry’s notification on September 24, 2015 of its plan to implement the rules. The new rules stipulate that tobacco products should have pictorial health warnings covering 85% of the packaging space. In March a parliamentary committee had recommended that the warnings should be just 50% on both sides of the principal display area “as it will be too harsh and result in the flooding of illicit cigarettes in the country.” Immediately following the introduction of the new rules the major Indian tobacco and bidi companies decided to shut all their factories and stop production, citing an “ambiguity” in the new policy. In response a senior health ministry official said: “We want to clarify that there is no ambiguity. This is a bogey raised by the tobacco industry. The case is crystal clear. We had issued the notification in September last year. If they had found an ambiguity, why did they send their letter in March, 2016?”
Data from the Coroners Court of Victoria (Australia) have shown that overdose deaths in the state have increased by nearly 23 per cent since 2010, with 420 overdose deaths recorded for 2015. In 2015 almost twice as many overdose deaths involved legal prescription medication, compared with illicit drugs. The data were released with coronial findings into the death of Frank Edward Frood, a 47-year-old man who died from bronchopneumonia "in a background of methadone and benzodiazepine use." The coroner wrote that the death "reinforces the immediate need for a real-time prescription monitoring system to assist doctors in their clinical decision-making around drug prescribing... to tackle the ever-increasing toll of pharmaceutical drug related deaths in the state." The Age reports that the Victorian Alcohol and Drug Association executive officer Sam Biondo said there had been calls for prescription monitoring going back 20 years: "If you add up this sort of death level and multiply it over 20 years, how many thousands of people have died deaths that were preventable and who is responsible for that?" A health ministry spokesperson said that the Victorian government has committed $300,000 to start work on a prescription monitoring system.
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