Health Brief: Targeting loopholes in EU tobacco directives

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The EU is reviewing its regulatory instruments on tobacco, as planned in the EU beating cancer plan. Experts and stakeholders are hoping that the revisions will target the loopholes that exist in directives. 

Łukasz Balwicki, a professor at the Medical University of Gdansk, Poland, and a doctor at a smoking cessation clinic, has been involved in the tobacco control field for about 20 years.

“I wish there were bigger changes in Poland,” he said, reflecting on the evolution in tobacco control in his country during those years.

“After those 20 years, I see that we could probably do more in this field,” Balwicki told EURACTIV at the World Cancer Congress in Geneva, highlighting the lack of governmental investment and political will.

“In the Ministry of Health, there’s only one person who is devoted to tobacco control issues,” he said, adding that ”government tries not to touch the subject unless there is a need coming from, for example, the European Commission.”

Tobacco consumption is the single largest avoidable health risk, and the most significant cause of premature death in the EU. It is covered by a patchwork of EU directives: the EU Tobacco Products Directive, the Tobacco Taxation Directive, and several advertising directives targeting tobacco. 

With the EU’s beating cancer plan goal to create a tobacco-free generation by 2040 – no more than 5% of the population using tobacco – there is a need to step up. In 2020, the figure was around 18%, according to Eurostat.

To achieve a tobacco-free generation, the EU’s beating cancer plan highlights the need for a review of the Tobacco Products Directive, the Tobacco Taxation Directive, and the legal framework on cross-border purchases of tobacco by private individuals.

The Tobacco Products Directive is currently under a formal evaluation process with public consultation to be completed by the end of the year, a Commission official told EURACTIV.

In the meantime, the Commission’s proposal on the revision of the tobacco taxation directive is scheduled for 7 December 2022. The official added that in 2023, the Commission will put forward an update of the 2009 Council’s smoke-free environments recommendation, tentatively scheduled for the third quarter of 2023.

However, experts have highlighted that in order to make true progress, the EU must address loopholes in the regulations.

“You have the minimum standards that you have to implement coming from the institutions and then some countries go beyond and have very strong tobacco control legislation, while some implemented directive as it is,” said Irina Kubinschi, policy and senior legal and policy officer at Smoke-free partnership.

This seems to be the case in Poland. Balwicki said that existing loopholes “serve as an excuse” for some governments not to address tobacco control seriously enough. 

“We are so much concentrated on the economy […] that we sometimes leave behind that other maybe less important things like health,” he said.

“Regulations on the EU level help us to not forget about that and keep up with such issues.”

On 19 October 2020, the Commission highlighted several areas for tightening of regulations. 

One argument was that minimum tax rates on rules for tobacco have lost their effect, as a large number of member states tax most tobacco products above the minimum. Taxation plays a pivotal role in reducing tobacco consumption, in particular in deterring youth from smoking.

Additionally, the current directive does not fully cover several new types of tobacco products, leading the Commission to highlight the risk of cross-border purchases.

With the revision, the EU executive is considering a number of policy options based on minimum excise duty rates and harmonisation of the taxation of new products such as e-cigarettes, heated tobacco products, and modern oral products. 

Regarding the Commission’s upcoming proposal on the revision of the tobacco taxation directive, Kubinschi said that “we hope for an ambitious proposal that will look at all the new products that are on the market.”

“We want the new products to be defined as tax categories in the new directive because what happens otherwise is that you have some definitions, and then the industry is just creating new products that don’t fit those definitions,” she said.

Kubinschi expressed hopes new products with not much data will be included even at 0% taxation which will put them under the monitoring system of excisable goods and help to collect additional data and introduce changes if needed, while also stressing the importance of convergence of excise duties, and progressive increase of taxes.

By Giedrė Peseckytė

Subscribe to EURACTIV’s Health Brief, where you’ll find the latest roundup of news covering health from across Europe. The Health Brief is brought to you by EURACTIV’s Health Team Giedrė Peseckytė, Clara Bauer-Babef, Amalie Holmgaard Mersh, and Gerardo Fortuna.

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Purchase of vaccines. The purchase of COVID-19 vaccines during the pandemic has been a success story and “a small European miracle”, European Commission Vice President Margaritis Schinas told the European Parliament’s special committee on COVID during a hearing on Wednesday (26 October).

Fast virus. The virus is faster than we can ever be in adapting vaccines, Marco Cavaleri, head of health threats and vaccines strategy at the European Medicines Agency (EMA), said Wednesday (October 26).

Long COVID. ECDC’s systematic review and meta-analysis, published on 27 October, found that the risk of post-COVID-19 condition may be higher among individuals who experience more severe COVID-19 disease. Overall, the prevalence of any post-COVID-19 condition symptom was estimated at ~51% among cohorts recruited in the community setting; ~67% among cohorts recruited in the hospital setting; and ~74% among cohorts recruited in the ICU setting. 

Omicron variants. WHO’s Technical Advisory Group on SARS-CoV-2 Virus Evolution (TAG-VE) on 27 October announced that Omicron variants XBB and its sublineages (indicated as XBB*), as well as BQ.1 and its sublineages (indicated as BQ.1*) do not diverge sufficiently from each other, or from other Omicron lineages with additional immune escape mutations, in terms of the necessary public health response, to warrant the designation of new variants of concern and assignment of a new label. The two sublineages remain part of Omicron, which continues to be a variant of concern.

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Pfizer’s Respiratory Syncytial Virus (RSV) vaccine candidate. Pfizer announced on Tuesday (2 October) the 82% efficacy against severe medically attended lower respiratory tract illness due to Respiratory Syncytial Virus (RSV) in infants from birth through the first 90 days of life with high efficacy of 70% demonstrated through the first six months of life of its bivalent RSV vaccine candidate based on data from the phase 3 global maternal immunization trial. RSV is a contagious virus and a common cause of respiratory illness. The virus can affect the lungs and breathing passages of an infected individual and can be potentially life-threatening for young infants, persons with certain chronic medical conditions, and older adults.

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Flu Awareness. On 28 October Andrea Ammon, Director of ECDC, released a statement calling to increase the uptake of seasonal influenza vaccination for people with underlying risk factors by raising awareness of the importance of vaccination for people’s health and well-being, as part of the Flu Awareness Campaign marked across the WHO European Region every year in October. “With the arrival of autumn and winter, we are expecting to see more influenza cases and potentially COVID-19 and seasonal influenza circulating at the same time which will put vulnerable people at increased risk of severe illness and death,” she said, adding that “We need to avoid the burden of this co-circulation on our healthcare systems”. Ammon also stressed the importance of surveillance and preparedness in the European Region to protect people’s health. 

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EMA news

Withdraw the marketing authorisations for amfepramone obesity medicines. On 28 October EMA’s safety committee (PRAC) confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which the companies that market these medicines requested. The recommendation follows a review which found that measures to restrict the use of these medicines for safety reasons have not been sufficiently effective. 

Measures to minimise the risk of serious side effects associated with Janus kinase (JAK). EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects, such as cardiovascular conditions, blood clots, cancer and serious infections, associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. The Committee recommended that these medicines should be used in the following patients only if no suitable treatment alternatives are available: those aged 65 years or above, those at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past and those at increased risk of cancer.

Heavy menstrual bleeding was added as a side effect of mRNA vaccines. The PRAC has recommended that heavy menstrual bleeding should be added to the product information as a side effect of the unknown frequency of the mRNA COVID-19 vaccines Comirnaty and Spikevax. Cases of heavy menstrual bleeding have been reported after the first, second and booster doses of Comirnaty and Spikevax. Committee concluded that there is at least a reasonable possibility that the occurrence of heavy menstrual bleeding is causally associated with these vaccines and therefore recommended the update of the product information. There is no evidence to suggest the menstrual disorders experienced by some people have any impact on reproduction and fertility. 

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BERLIN

Germany sets out plans for cannabis legalisation amid EU law worries. German health minister Karl Lauterbach presented plans for legalising cannabis for recreational use – a key promise of the country’s “traffic light” government, although the project could still be halted by the EU Commission. By Julia Dahm | EURACTIV.com

HELSINKI

Finland updates its abortion laws. Parliament approved new legislation reforming the country’s abortion laws from the 1970s – strict compared to EU standards – by a clear margin of 125 in favour and 41 against. By Pekka Vanttinen | EURACTIV.com

DUBLIN 

Protesters call for reform of Ireland’s abortion laws. A reform of Irish abortion laws to make accessing services easier was called for by protesters in Dublin this weekend. By Molly Killeen | EURACTIV.com

3 November | WHO briefing: WHO at COP27 Climate Action for Health

6-18 November | WHO and health at COP27

7 November | Public health and disease prevention – What benefits for an adult immunisation policy in Europe?

7-8 November | Meetings in the European Parliament’s Committee on the Environment, Public Health and Food Safety

7-9 November | Global pharma and biotech summit

8-9 November | 8th World Cancer Series Europe

9-10 November | European Parliament’s plenary in Brussels

9 – 12 November | 15th European Public Health Conference 2022

10 November | Together 4 Rare Diseases

16 November | Perinatal Mental Health Conference

5 December | EPHA 2022 Universal Access and Affordable Medicines Forum

7 December |The European Care Strategy: challenges and the way forward

[Edited by Nathalie Weatherald]

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