Brexit and medicines - preparations by the European Medicines Agency
On 29 March 2017, the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), a process known as 'Brexit'. The European Medicines Agency (EMA) is making preparations to ensure that it can continue to deliver on its mission and protect public and animal health after the UK leaves the EU on 30 March 2019, the date currently set by the timeframe provided in Article 50 of the Treaty on European Union.
One of the consequences of Brexit is that EMA will relocate to Amsterdam, the Netherlands, where it has to take up its operations on 30 March 2019 at the latest.
The Agency continues its operations in accordance with the timelines set by its rules and regulations.
EMA is working on the scenario that the UK will become a third country as of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications for which the centralised procedure would finish after 30 March 2019. This is without prejudice to the outcome of the withdrawal negotiations.
No Member State has previously decided to leave the EU, so there is no precedent for this situation.
Continuity of EMA activities
EMA is essential to the functioning of the single market for medicines in the EU. The Agency's work is vital to providing EU citizens with effective, safe and high-quality medicines and to maintain a regulatory environment that fosters innovation and the development of new medicines.
The Agency is taking steps to ensure that it can continue to deliver on its mission and protect public and animal health while it prepares to relocate.
Regulatory preparedness
In April 2018, the EU27 Member States and EMA completed the redisribution of the UK's portfolio of over 370 centrally authorised products to rapporteurs and co-rapporteurs from the EU27 plus Iceland and Norway, in preparation for Brexit.
EMA informed the relevant marketing authorisation holders of the new (co)-rapporteurships at the end of April 2018.
EMA will facilitate knowledge transfer from the UK to the new rapporteurs and co-rapporteurs, who will only take full responsibility for these products as of 30 March 2019.
In September 2018, the new (co)-rapporteurs will receive a knowledge transfer package for each product, containing background knowledge on the regulatory and evaluation history of each product, including the most recent benefit-risk assessment.
This will also help each national competent authority to forecast upcoming workload, to better support the planning of resources, particularly for complex products in the portfolio.
The redistribution plan covers the post-authorisation stage in a medicine's lifecycle. It takes into account the diverse expertise in the European medicines regulatory network and allows Member States to participate in EMA activities according to their capacity.
The methodology draws on Member States' expertise with a specific class of medicines and knowledge gained through prior involvement in a medicine's evaluation. For more information see:
EMA's two working groups on committees' operational preparadness developed the methodology. For more information, see:
EMA first initiated discussions with the national competent authorities in April 2017 on how work related to the evaluation and monitoring of medicines will be shared between Member States in view of the UK's withdrawal from the EU.
Business continuity plan
EMA has developed a business continuity plan to ensure operational continuity while the Agency prepares for its relocation and the UK's withdrawal from the EU. It enables EMA to deliver its highest priority activities and to temporarily scale back or temporarily suspend lower priority activities if required:
The plan entered its second phase in January 2018.
EMA will launch a third phase of its business continuity plan on 1 October 2018 at the latest, following implementation of the first and second phases of the plan.
Activities to be scaled back or suspended in the third phase include:
- collaboration at international level, which will be temporarily scaled back to focus primarily on product-related requests, supply-chain integrity and procedures under Article 58. In global medicine regulation, EMA will only take a reactive role. EMA's engagement in other global public health issues such as antimicrobial resistance or vaccines will be maintained as long as possible, but reviewed on a case-by-case basis;
- development and revision of guidelines, which will be temporarily limited to those guidelines that address an urgent public or animal health need or are necessary to support and facilitate preparation for Brexit;
- holding of non-product related working parties, which will be temporarily reduced as a consequence of the scaling back of guideline development or revision;
- programmes and projects, where activities in relation to project governance will be reduced in line with the reduction and suspension of projects;
- organisation and attendance at stakeholder meetings, which will be limited to Brexit-related interactions;
- clinical data publication, for which the launch of new procedures will be temporarily suspended as of 1 August 2018. Data packages submitted for medicines until the end of July 2018 will be processed and finalised.
This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.
Overall, EMA expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention.
EMA is developing detailed plans for the implementation of these measures. EMA will communicate these to stakeholders and the public as soon as they are available.
EMA will continuously review and adapt its business continuity plan as necessary.
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Statement by Donald Tusk on Brexit negotiations
The European Union and its leaders fully respect the UK’s decision expressed in the referendum on leaving the EU. From the very beginning of the negotiations we have been focused on finding a deal that will minimise the damage resulting from Brexit.
Also important to us is to create the best possible relations between the EU and the UK in the future. We studied the Chequers proposals in all seriousness. The results of our analysis have been known to the British side in every detail for many weeks. After intensive consultations with Member States, we decided that for the good of the negotiations, and out of respect for the efforts of Prime Minister May, we will treat the Chequers plan as a step in the right direction.
In Salzburg, right before our meeting I said in a public statement: “I would like to stress that some of Prime Minister May's proposals from Chequers indicate a positive evolution in the UK's approach as well as a will to minimise the negative effects of Brexit. By this I mean, among other things, the readiness to cooperate closely in the area of security and foreign policy. On other issues, such as the Irish question, or the rules of economic cooperation, the UK's proposals will need to be reworked and further negotiated.”.
The UK stance presented just before and during the Salzburg meeting was surprisingly tough and in fact uncompromising. The response of the EU27 leaders was to reiterate our trust in chief negotiator Michel Barnier and to reiterate our position on the integrity of the Single Market and the Irish backstop. While understanding the logic of the negotiations, I remain convinced that a compromise, good for all, is still possible.
I say these words as a close friend of the UK and a true admirer of Prime Minister May
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Commission takes further action to ensure UK settles customs duties payable
Brussels, 24 September 2018
Based on a proposal by the Commissioner for Budget and Human Resources, Günther H. Oettinger, today the European Commission has decided to send a Reasoned Opinion to the United Kingdom because of its failure to make customs duties available to the EU budget, as required by EU law.
This is the second step the Commission is taking in the formal infringement procedure for this case in order to protect the financial interests of the EU. In March 2018, the Commission opened the infringement procedure following a 2017 report by the EU's anti-fraud body OLAF, which found that importers in the United Kingdom evaded a large amount of customs duties by using fictitious and false invoices and incorrect customs value declarations at importation. Further Commission inspections confirmed the very large scale of this undervaluation fraud scheme operating through British ports between 2011 and 2017. Despite having been informed of the risks of fraud relating to the imports of textiles and footwear originating from the People's Republic of China since 2007, and despite having been asked to take appropriate risk control measures, the United Kingdom failed to take effective action to prevent the fraud.
The Commission calculates that the infringement of EU legislation by the United Kingdom resulted in losses to the EU budget amounting to €2.7 billion (plus interest and minus collection costs) during the period between November 2011 and October 2017. In addition, the United Kingdom also infringed EU Value Added Tax legislation, leading to additional potential losses to the EU budget.
All Member States are liable for the financial consequences of their infringements of EU law.
The United Kingdom now has two months to act; otherwise the Commission may refer the case to the Court of Justice of the EU.
For More Information
On the March 2018 infringement cycle, see MEMO/18/1444
On the general infringements procedure, see MEMO/12/12
IP/18/58 Copyright European Union
Countries launch UN work to shut down global trade in torture tools
Brussels, 25 September 2018
UN work to shut down global trade in torture tools.
On Monday, 24 September, the Alliance for Torture-Free Trade agreed to step up the pace of its efforts and work towards a United Nations instrument - such as a binding convention - to stop the trade in instruments for torture and the death penalty. The Alliance for Torture-Free Trade is an initiative of the European Union, Argentina and Mongolia.
In a further boost to its work, the Alliance also saw a further five countries joining, bringing the total to more than 60. By joining the Alliance, countries commit themselves to restricting exports of these goods and to making it easier for customs authorities to track down shipments and identify new products.
Commissioner for Trade Cecilia Malmström, who co-hosted the Alliance's first Ministerial meeting, held in the margins of the United Nations General Assembly (UNGA) in New York said: "Systematic use of torture is a crime against humanity. Today, we demonstrate our commitment to human rights and taking concrete steps to eradicating torture and capital punishment. Torture is an instrument of fear and has no place in any society. We've come together with one voice to say that we will not stand for this trade – not in our countries, or anywhere else in the world."
The five additional countries joining the Alliance for Torture-Free Trade at the Ministerial were Australia, Cape Verde, New Zealand, Palau and Vanuatu.
The Alliance believes that UN instruments such as the Convention on International Trade in Endangered Species (CITES) and the Arms Trade treaty (ATT) provide working examples of international agreements to stop unwanted trade. Today's agreement to push for UN action marks a step forward in the process to create a global framework for shutting down the trade in goods used to torture people or to carry out executions.
The Alliance has in its sights goods such as batons with metal spikes, electric shock belts, grabbers that seize people while electrocuting them, chemicals used for executions, as well as gas chambers and electric chairs.
Opened by United Nations High Commissioner for Human Rights Michelle Bachelet, the Ministerial meeting saw contributions from a range of Ministers and a series of international experts, among them Secretary-General of Amnesty International Kumi Naidoo. They testified to the horrors that are still carried out daily with the panoply of goods manufactured and then bought and sold internationally in a lucrative trade.
In her opening speech, UN High Commissioner for Human Rights Michelle Bachelet said torture had directly affected her family. "Torture is a grave attack on human dignity," she said. "It inflicts severe damage on both victims and societies."
In recent years, export bans on torture and execution equipment - like the legislation in place in the EU - have made the trade in these goods more difficult. Such laws have not ended it, however; traffickers find ways to circumvent bans and controls through other countries. This is why the Alliance for Torture-Free Trade now aims to expand and take further steps.
Full list of countries in the Alliance for Torture-Free Trade
Albania, Argentina, Armenia, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cape Verde, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Madagascar, Malta, Mexico, Moldova, Mongolia, Montenegro, The Netherlands, New Zealand, Nicaragua, Norway, Palau, Panama, Paraguay, Poland, Portugal, Romania, Serbia, Seychelles, Slovenia, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, Uruguay, Vanuatu, European Union.
For more information
The website of the Alliance
The declaration agreed by the countries during the Ministerial
Photos and videos are available on EbS
Photos from the Ministerial meeting
Video from the ministerial meeting
/www.europeanlawmonitor.org/>//www.flickr.com/photos/154405462@N04/sets/72157684680715672">Press photos of instruments of torture
IP/18/5907 Copyright European Union
Industry unveils the Code of Practice on Online Disinformation
Brussels, 26 September 2018
Online platforms and the advertising industry have unveiled a self-regulatory Code of Practice that includes a wide range of commitments to fight online disinformation.
Commissioner for Digital Economy and Society Mariya Gabriel welcomed this as a step in the right direction, but urges the platforms to increase their efforts to fight the spread of disinformation online:
“The Code of Practice submitted today by the industry is the first tangible outcome of the Communication that the Commission adopted last April.
It is an important step in tackling a problem which has become increasingly pervasive and threatens Europeans' trust in democratic processes and institutions. This is the first time that the industry has agreed on a set of self-regulatory standards to fight disinformation worldwide, on a voluntary basis. The industry is committing to a wide range of actions, from transparency in political advertising to the closure of fake accounts and demonetisation of purveyors of disinformation, and we welcome this. These actions should contribute to a fast and measurable reduction of online disinformation. To this end, the Commission will pay particular attention to its effective implementation.
The Code of Practice should contribute to a transparent, fair and trustworthy online campaign ahead of the European elections in spring 2019, while fully respecting Europe's fundamental principles of freedom of expression, a free press and pluralism. This step complements the Commission's Recommendation presented by President Juncker in his 2018 State of the Union Address on election cooperation networks, online transparency, protection against cybersecurity incidents and fighting disinformation campaigns. Online platforms need to act as responsible social players especially in this crucial period ahead of elections. They must do their utmost to stop the spread of disinformation.
I urge online platforms and the advertising industry to immediately start implementing the actions agreed in the Code of Practice to achieve significant progress and measurable results in the coming months. I also expect more and more online platforms, advertising companies and advertisers to adhere to the Code of Practice, and I encourage everyone to make their utmost to put their commitments into practice to fight disinformation.
I will meet the signatories of the Code of Practice in the coming weeks to discuss the specific procedures and policies that they are adopting to make the Code a reality.
As foreseen in the Communication, the Commission will closely follow the progress made and analyse the first results of the Code of Practice by the end of 2018. Should the results prove unsatisfactory, the Commission may propose further actions, including actions of a regulatory nature.”
Background
In May, the Commission convened a multi-stakeholder forum on disinformation. It consisted of a working group of representatives from the major online platforms and the advertising industry; and a sounding board of fact-checkers, academia, media and civil society organisations. The working group was charged with drafting a self-regulatory Code of Practice on Disinformation for online platforms, the advertising sector, and advertisers. The sounding board was tasked to assess and adopt an opinion on the Code of Practice and monitor its implementation.
Signatories of this Code have committed to take action in 5 areas:
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Disrupting advertising revenues of certain accounts and websites that spread disinformation;
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Making political advertising and issue based advertising more transparent;
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Addressing the issue of fake accounts and online bots;
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Empowering consumers to report disinformation and access different news sources, while improving the visibility and findability of authoritative content;
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Empowering the research community to monitor online disinformation through privacy-compliant access to the platforms' data.
In the Communication published on 26 April 2018, the European Commission put forward an Action Plan and self-regulatory tools to tackle the spread and impact of online disinformation in Europe.
The actions foreseen in the Communication, including this Code of Practice, will contribute to protect free and fair election processes, as stressed by President Juncker in his 2018 State of the Union Address. They will complement the ongoing work of the EEAS East StratCom Task Force. Following the European Council conclusions of June 2018 and the State of the Union address, the Commission and the European External Action Service will present a joint action plan to fight disinformation, focusing on strategic communication policy, by the end of the year.
For More Information
Code of Practice on Disinformation
Factsheet: Tackling the spread of disinformation online
State of the Union 2018: European Commission proposes measures for securing free and fair European elections
European Commission's Communication “Tackling online disinformation: a European approach” and other links
STATEMENT/18/5914 Copyright European Union
