Connect with us

Economy

MHRA confirms e-cigarettes are not medicinal products – but they still face ban

SHARE:

Published

on

We use your sign-up to provide content in ways you've consented to and to improve our understanding of you. You can unsubscribe at any time.

TotallyWickedE-cigarettes manufacturer Totally Wicked has obtained written confirmation from the Medicines and Healthcare Products Regulatory Agency (MHRA) that none of its current product range is a medicine or a medicinal device, and that it does not need to obtain medicines marketing authorisations for its products. 

Notwithstanding that, the MHRA has stated that if MEPs vote for the EU's draft Tobacco Products Directive (TPD) in its current form on the 10th of September, it will require Totally Wicked from 2016 to market the same products as medicines and obtain such authorisations.  In other words, it would have to seek medicines licences for products the MHRA has confirmed are not medicines.  This is the clearest statement yet that currently available e-cigarette products will be banned from 2016 if the TPD passes into law.

Asking for clarity on the intentions of the MHRA, as stated by them on the 12th of June 2013 to regulate ‘nicotine containing products’ in line with the proposed EU TPD, Totally Wicked’s lawyers this week received a reply to a litigation letter of claim.

Confident of the fact that its products are not medicinal, Totally Wicked has been proven right and the MHRA has confirmed that currently, under the Human Medicine Regulation 2012, and the Medicinal Products Directive 2001/83/EC, none of the products sold by Totally Wicked as of the 22nd of August 2013 are considered medicinal, nor are they considered medical devices under the Medical Devices Directive 1993 (Directive 93/42/EEC).

Advertisement

As a result of this confirmation, Totally Wicked is not required to seek marketing authorisations or any other form of license for its products.  However, in their reply, the MHRA stated that if the draft TPD passes into law in its current form, Totally Wicked, in order to legally sell its current product range, would be required to seek marketing authorisation from the MHRA under the Medicinal Products Directive.

Having established that none of Totally Wicked’s product range qualifies as a medicinal product, it would be impossible for Totally Wicked to obtain authorisations and as a result it would be prohibited in law from selling any of its existing products.

As Totally Wicked’s product range is broadly similar to that distributed by other electronic cigarette vendors in the UK, the logical conclusion to draw from the above is that if the draft TPD passes as proposed, there will be a shutdown of the general sale of currently available electronic cigarette products from 2016 throughout the UK.

Advertisement

The MHRA also confirmed in its reply, that it accepted that conventional tobacco cigarettes are “capable” of being regulated as medicinal products, but that it does not intend to include these nicotine containing products within the proposed new regime.  Accordingly, conventional tobacco cigarettes, which are responsible for the deaths of 700,000 people across the EU each year, will not be subject to the same de facto marketing ban faced by electronic cigarettes

Should the TPD be passed as proposed, Totally Wicked will mount a legal challenge, domestically and at EU level as a result of the perversity of being forced to make a medicinal claim for a confirmed non-medicinal product, while tobacco companies continue to sell their own nicotine containing products unimpeded by the medicinal regulatory regime.

Totally Wicked Chief Executive Officer Fraser Cropper said: “Since the commencement of the MHRA’s consultation in 2010 our company and our customers have made it very clear that our products were not and could not be legally or ethically classed as medicinal products.  Electronic cigarettes are transforming smokers’ habits by the thousands each week.  That our government and its regulators are knowingly attempting to destroy this product’s utility, whilst continuing to endorse the on-going endemic of tobacco availability, is one of the most incredible and concerning matters of our time.”

Share this article:

European Commission

Trade and security: Commission highlights work to defend EU interests and values

Published

on

The European Commission is presenting key findings related to defending EU interests when it comes to export controls and foreign investments in the EU. The Commission screened 400 foreign investments since the new Foreign Direct Investment (FDI) screening legislation entered into force. While only in place since a year, there has been an impressive take-up of this mechanism, meaning that EU interests will be better protected going forward. At the same time, over 30,000 requests for the export of goods with potential military use were reviewed by Member States under the EU Export Control regime, with 603 of these exports blocked. These are some of the highlights announced at the occasion of publication of the first reports on FDI screening and on export controls.

Executive Vice President and Trade Commissioner Valdis Dombrovskis said: “The EU remains open to trade and foreign investment – this is a pillar of our job creation and economic growth. But our openness is not unconditional and it needs to be balanced by appropriate tools to safeguard our security and public order. Foreign investment screening and control of exports of dual use goods help keep the EU safe, while protecting human rights. They are key elements of our open, sustainable, and assertive trade policy. These two reports highlight how these tools can help the Commission and competent Member State authorities to act decisively when the situation demands, defending our interests while promoting our values.”

FDI Screening

This report on FDI screening is the first to be published since the new EU FDI screening regulation came into force a year ago. Under this regulation, member states and the Commission work closely together to ensure that any foreign direct investment which can pose a security risk to EU member states or EU critical assets is effectively screened.

Advertisement

In terms of key findings, the report highlights:

  • The Commission screened 265 transactions notified by member states under the report until end of June 2021 (now the teller is above 400);
  • 80% of the transactions did not justify further investigation and were thus assessed by the Commission in just 15 days;
  • most notifications for screening from Member States concerned the manufacturing sector, ICT, wholesale and retail;
  • the top five countries of origin of investors among notified FDI cases were companies located in: the United States, the United Kingdom, China, Canada and the United Arab Emirates, and;
  • the Commission issued an opinion in less than 3% out of 265 screened cases.

The report confirms that the EU remains open for foreign investment, while ensuring the protection of EU security and public order. The FDI screening cooperation mechanism works effectively and does not create unnecessary delays for transactions. A growing number of member states have adopted their own screening mechanism – 18 now have a mechanism in place.  The European Commission expects all member states to adopt national screening mechanisms. This will further enhance the effectiveness of the screening system and ensure a comprehensive EU approach to tackle risks related to security or public order.

Export Controls

This is the last report on export controls before the entry into force of the upgraded Export Controls Regulation.

Advertisement

The report shows that dual-use exports represent about 2.3% of total EU exports. Out of a total number of 30.292 applications for and notifications of exports under licences, 603 transactions (exports) were denied (in 2019) representing about 0.02% of total exports. This would put the value of dual-use trade at €119 billion in 2019.

The new Regulation that entered into force on 9 September this year strengthens export controls further by:

  • Introducing a novel ‘human security' dimension in order to capture emerging dual-use technologies – especially cyber-surveillance tools;
  • simplifying procedures and making the export control system more agile and able to evolve and adjust to circumstances;
  • developing an EU capacity-building and training programme for member states' licensing and enforcement authorities;
  • co-ordinating and supporting robust enforcement of controls, and;
  • setting up dialogues with third countries so as to enhance global security and promoting a level playing field at global level.

Memorandum on Dual Use Controls 9 September 2021.

Background

FDI screening and export controls are part of the EU's renewed trade strategy, that seeks to enforce EU rights and defend its values more assertively. Other initiatives and actions under this strategy include:

  • A proposal on an International Procurement Instrument to help ensure a level playing field in the global procurement market. This is currently with the European Parliament and Council.
  • A legislative proposal for a new anti-coercion instrument due in December 2021 that will allow the EU to respond to attempts by other countries to force the EU or its countries to bring about policy changes.
  • A new tool currently prepared by the Commission, designed to tackle effectively foreign subsidies that cause distortions and harm the level playing field in the Single Market in any market situation.
  • A new ‘Access to Markets' portal launched in October 2020, providing easily accessible and multilingual information to help businesses of all sizes to make the most of EU trade agreements .
  • A Single Entry Point established in November 2020, making it quick and easy for any EU-based stakeholder to lodge complaints about non-compliance by third countries with their international trade commitments vis-à-vis the EU.
  • A more systematic use of the institutional structures established by EU trade agreements to ensure effective implementation of commitments by third countries and the resolution of market access barriers.
  • A more active use of dispute resolution mechanisms to enforce our rights.
  • Continued mobilisation of civil society representatives in the implementation of EU trade agreements and arrangements, notably on trade and sustainable development.

More Information

Report on the screening of foreign direct investments into the Union

Accompanying document to FDI report

Report on the control of exports, brokering, technical assistance, transit and transfer of dual-use items

Factsheet

Brochure

Share this article:

Continue Reading

Agriculture

EU agriculture statistics: Subsidies, jobs, production

Published

on

Discover facts and figures about farming in the EU, including funding by country, employment and production, Society.

Agriculture is an important industry for all EU countries and they all receive EU funds through the Common Agricultural Policy (CAP). These funds support farmers directly through the European Agricultural Guarantee Fund and rural areas, climate action and the management of natural resources through the European Agricultural Fund for Rural Development.

Find out how the Common Agricultural Policy supports farmers.

EU agricultural subsidies by country

In 2019, €38.2 billion was spent on direct payments to farmers and €13.8bn on rural development. A further €2.4bn supported the market for agricultural products.

Advertisement

The rules governing how Common Agricultural Policy funds are spent is determined by the EU’s long-term budget. The current rules run until December 2022, after which the most recent reform of the Common Agricultural Policy will come into effect and run until 2027.

Infographic with map showing the amount of Common Agricultural Policy subsidies per EU country in 2019. Key data can be found under the heading EU agricultural subsidies by country.
The division of the Common Agricultural Policy funds between EU countries  

EU agriculture employment statistics

The agriculture industry supported 9,476,600 jobs in 2019 and 3,769,850 jobs in food production (in 2018) and accounted for 1.3% of the EU's gross domestic product in 2020.

Romania had the most people employed in agriculture in 2019, while Denmark had the most people employed in food production in 2018.

Advertisement

For every euro spent, the farm sector creates an additional €0.76 for the EU economy. The gross value added from farming - the difference between the value of everything that the EU’s primary agricultural sector produced and the cost of the services and goods used in the production process - was €178.4 billion in 2020.

Infographic showing the employment in agriculture (in 2019) and food production (in 2018) per EU country. Key data can be found under the heading EU agriculture employment statistics.
The food and agriculture sectors in the EU  

Agricultural production in Europe

EU agriculture produces a rich variety of food products, from cereals to milk. The EU has legislated to ensure that the food produced and sold in the EU is safe to eat. The EU’s farm to fork strategy, announced in 2020, aims to ensure that food is also produced more sustainably. MEPs want to cut pesticide use to better protect pollinators and biodiversity, end the use of cages in animal farming and increase land use for organic farming by 2030.

Infographic showing how many tonnes of different foods were produced in the EU in 2019.
Food production in the EU  

Common Agricultural Policy 

Data sources 

Share this article:

Continue Reading

Agriculture

European Parliament set to vote on huge farm subsidies' deal

Published

on

By

Members of the European Parliament attend a debate on the Common Agricultural Policy (CAP) during a plenary session at the European Parliament in Strasbourg, France, November 23, 2021. REUTERS/Christian Hartmann/Pool
European Commissioner for Agriculture Janusz Wojciechowski speaks during a debate on the Common Agricultural Policy (CAP) during a plenary session at the European Parliament in Strasbourg, France, November 23, 2021. REUTERS/Christian Hartmann/Pool

Lawmakers who helped broker a deal with governments on reforms to the European Union's huge farming subsidy programme urged the European Parliament to give it the final green light on Tuesday (23 November), writes Ingrid Melander, Reuters.

The deal reached in June ended an almost three-year struggle over the future of the EU's Common Agricultural Policy, and accounts for about one third of the bloc's 2021-2027 budget -- spending about €387 billion ($436bn) on farmers and support for rural development.

The new CAP rules, which would apply from 2023, aim to shift money from intensive farming practices to protecting nature, and reduce the 10% of EU greenhouse gases emitted by agriculture.

The reforms have a good chance of being approved by the European Parliament later on Tuesday. But environmental groups and some lawmakers say they do not align farming with EU goals to fight climate change and that many of the measures planned to encourage farmers to shift to environmentally friendly methods are weak or voluntary.

Advertisement

"I'm urging you, please, in the interest of the European farmers, in the interest of the climate, to vote in favour," said Peter Jahr, a German member of the European Parliament.

Addressing criticism of the reforms, he said compromises were needed.

The executive European Commission's agriculture chief, Janusz Wojciechowski, said the reforms would "foster a sustainable and competitive agricultural sector that can support the livelihood of farmers and provide healthy and sustainable food for society while delivering significantly more in terms of environment and climate."

Advertisement

The reforms would require 20% of payments to farmers from 2023-2024 being spent on "eco-schemes", rising to 25% of payments in 2025-2027. At least 10% of CAP funds would go to smaller farms and all farmers' payments would be tied to complying with environmental rules.

The deal also creates a €450 million crisis fund in case agricultural markets are disrupted by an emergency such as a pandemic.

($1 = €0.8880)

Share this article:

Continue Reading
Advertisement
Advertisement

Trending