The European Commission has welcomed the 24 June political agreement between the European Parliament and Council on new EU rules related to the recovery and resolution of Central Counterparties (CCPs). CCPs play a systemic role in the financial system as they act as hubs for financial transactions, such as derivatives contracts.
They are already well-regulated and subject to stringent supervision, thanks to a raft of measures adopted in the wake of the financial crisis. The new rules will further strengthen financial stability in the EU, by setting out what will happen if a CCP were to run into financial difficulty. In particular, resolution authorities must come up with resolution plans on how to handle any form of financial distress, which would exceed a CCP's existing resources.
In the highly unlikely event of a CCP failure, national authorities can use resolution tools that include the write-down of shareholders' capital and a sizeable cash-call to clearing members. The aim of this is to minimize the extent to which the cost of a CCP's failure is borne by taxpayers.
Financial Stability, Financial Services and Capital Markets Union Executive Vice President Valdis Dombrovskis said: “I welcome the political agreement on CCP Recovery and Resolution and I would like to congratulate the Croatian Presidency for all their hard work on this file. It is another step towards making the EU's financial system more resilient. It also adds an additional layer of safety for our financial system. This agreement places the EU at the cutting edge of international developments in this area.”
Further technical work will follow this political agreement so that the European Parliament and the Council can formally adopt the final text soon. More details are available here.
EAPM: HTA delays, EMA…and beating cancer
Greetings, colleagues, and here’s the latest European Alliance for Personalised Medicine (EAPM) update as we approach what we hope will be a normal ‘summer’. It’s all just a bit different and better this year, of course, with the vaccine rates picking up. While a lot of countries are winding-back their lockdown processes slowly but surely, it remains to be seen how many of us will have the oppurtunity to take a holiday abroad - wherever that may be - amid continuing fears in respect of COVID-19 variants. Some daring souls have made their reservation, of course, but ‘staycations’ are in some cautious travellers likely to be the order of the day this time around again, with many deciding to holiday in their own countries. In the meantime, don’t forget that EAPM has a virtual conference coming up very soon - in less than two weeks, in fact, on Thursday, 1 July, writes EAPM Executive Director Dr. Denis Horgan.
Entitled Bridging Conference: Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems, the conference acts as a bridging event between the EU Presidencies of Portugal and Slovenia.
Alongside our many great speakers, attendees will be drawn from leading experts in the personalised medicine arena – including patients, payers, health-care professionals, plus industry, science, academia and the research field.
On Wednesday, (16 June) EU deputy ambassadors signed off on the Portuguese Council presidency’s latest health technology assessment (HTA) proposal so it can move to trilogues on 21 June. Countries are willing to shorten the date of application and compromise on the voting system, but are not eager to budge on Article 8 — a debate that could delay the deal. In the event there are divergent opinions, EU countries agreed that any country must explain the scientific basis for contrarian views.
EMA reform proposal – EU common position agreed
EU health ministers have met for the last time under Portugal’s presidency of the Council of the EU to agree on that body’s position for negotiations with the European Parliament on new rules to strengthen the role of the European Medicines Agency (EMA).
At a meeting in Luxembourg on Tuesday (15 June) chaired by Portuguese Health Minister Marta Temido, the 27 governments agreed on their position for the upcoming negotiations with the Parliament.
They had already agreed on some changes to the initial proposal presented by the European Commission in November on the revision of rules to strengthen the mandate of the EMA, as part of a broader package on the so-called European Health Union.
One of the main objectives of the new draft EMA rules is to better enable it to monitor and mitigate potential and actual shortages of medicines and medical devices that are considered critical to respond to public health emergencies such as the COVID-19 pandemic, which revealed shortcomings in this regard.
The proposal also aims to “ensure the timely development of high-quality, safe and efficacious medicines, with particular emphasis on responding to public health emergencies” and to “provide a framework for the operation of expert panels that assess high-risk medical devices and provide essential advice on crisis preparedness and management”.
Life after cancer with BECA
The Parliament’s special committee for beating cancer (BECA) held a hearing on national cancer control programmes on Wednesday to hear how different countries were tackling the challenge.
Despite advances in cancer diagnoses and effective therapies which have helped to increase survival rates, cancer survivors continue to experience significant challenges. According to Europe’s Beating Cancer Plan, cancer should be tackled across the entire disease pathway, from prevention to improving the quality of life of cancer patients and survivors. In fact, ensuring that survivors “live long, fulfilling lives, free from discrimination and unfair obstacles” is of utmost importance.
Life after cancer is multifaceted yet the focus of this online debate is on the implementation of policies addressing the specific challenge of returning to work for cancer survivors.
Northern Ireland cross-border health care directive reinstated
Health Minister Robin Swann is to reinstate the cross-border health care directive to the Republic of Ireland. The directive is a temporary measure for a 12-month period to help reduce Northern Ireland waiting lists and will be subject to strict criteria.
The minister said: “A key principle of our health service is that access to services is based on clinical need, not on an individual’s ability to pay. However we are in exceptional times and we must look at every option to tackle the waiting lists in Northern Ireland.
“Reinstating a limited version of the cross-border health-care directive to Ireland will not have a dramatic impact on the overall waiting lists, but it will provide an opportunity for some to have their treatment much earlier.
“We need an urgent and collective approach across government to tackle this issue and deliver a health service that is fit for the 21st century.”
The Republic of Ireland Reimbursement Scheme sets out a framework, based on the Cross-Border Health Care Directive that will allow patients to seek and pay for treatment in the private sector in Ireland and have the costs reimbursed by the Health and Social Care Board. Costs will be reimbursed up to the cost of the treatment in Health and Social Care in Northern Ireland.
Survey reveals attitudes of public toward rare diseases and medicines access
The UK BioIndustry Association (BIA) has published a report presenting the findings of a survey on the public attitudes toward equal access to medicines for those living with rare diseases, it was announced in a 17 June press release.
Results of the survey, which was conducted by YouGov, have shown that the public strongly believe that patients living with rare diseases should have equal access to medicines via the National Health Service (NHS) as those living with more common conditions.
Additionally, the majority of survey respondents agreed that patients with rare diseases should have access to medicines assured by the NHS on a basis of clinical need, irrespective of cost.
The survey findings follow recent assertions made by the National Institute for Health and Care Excellence (NICE), specifying that there isn’t an appetite among the general public for specific measures to tackle rare disease. BIA’s report, Public Attitudes to Rare Diseases:
The Case for Equal Access, recommends that NICE revises its position on rare conditions and medicines access, and that the body consider the value of a rarity modifier when performing health technology assessments.
This survey demonstrates that there is broad public support for measures to ensure access to medicines for rare diseases based on clinical need even if that would entail higher costs..
That is all from EAPM for this week – do enjoy your weekend, stay safe and well, and don’t forget to register for the EAPM Slovenian EU Presidency conference on 1 July here, and download your agenda here.
EU draws up list of which countries should have travel restrictions lifted - UK excluded
Following a review under the recommendation on the gradual lifting of the temporary restrictions on non-essential travel into the EU, the Council updated the list of countries, special administrative regions and other entities and territorial authorities for which travel restrictions should be lifted. As stipulated in the Council recommendation, this list will continue to be reviewed every two weeks and, as the case may be, updated.
Based on the criteria and conditions set out in the recommendation, as from 18 June 2021 member states should gradually lift the travel restrictions at the external borders for residents of the following third countries:
- New Zealand
- Republic of North Macedonia
- South Korea
- United States of America
- China, subject to confirmation of reciprocity
Travel restrictions should also be gradually lifted for the special administrative regions of China Hong Kong and Macao. The condition of reciprocity for these special administrative regions has been lifted.
Under the category of entities and territorial authorities that are not recognised as states by at least one member state, travel restrictions for Taiwan should also be gradually lifted.
Residents of Andorra, Monaco, San Marino and the Vatican should be considered as EU residents for the purpose of this recommendation.
The criteria to determine the third countries for which the current travel restriction should be lifted were updated on 20 May 2021. They cover the epidemiological situation and overall response to COVID-19, as well as the reliability of the available information and data sources. Reciprocity should also be taken into account on a case by case basis.
Schengen associated countries (Iceland, Lichtenstein, Norway, Switzerland) also take part in this recommendation.
On 30 June 2020 the Council adopted a recommendation on the gradual lifting of the temporary restrictions on non-essential travel into the EU. This recommendation included an initial list of countries for which member states should start lifting the travel restrictions at the external borders. The list is reviewed every two weeks and, as the case may be, updated.
On 20 May, the Council adopted an amending recommendation to respond to the ongoing vaccination campaigns by introducing certain waivers for vaccinated persons and easing the criteria to lift restrictions for third countries. At the same time, the amendments take into account the possible risks posed by new variants by setting out an emergency brake mechanism to quickly react to the emergence of a variant of interest or concern in a third country.
The Council recommendation is not a legally binding instrument. The authorities of the member states remain responsible for implementing the content of the recommendation. They may, in full transparency, lift only progressively travel restrictions towards countries listed.
A member state should not decide to lift the travel restrictions for non-listed third countries before this has been decided in a coordinated manner.
- Council Recommendation amending Council Recommendation (EU) 2020/912 on the temporary restriction on non-essential travel into the EU and the possible lifting of such restriction
- COVID-19: Council updates recommendation on restrictions to travel from third countries (press release, 20 May 2021)
- COVID-19: travel into the EU (background information)
- Visit the meeting page
NextGenerationEU: €93 million recovery and resilience plan in line for Luxembourg
The European Commission has today (18 June) adopted a positive assessment of Luxembourg's recovery and resilience plan. This is an important step towards the EU disbursing €93 million in grants under the Recovery and Resilience Facility (RRF). This financing will support the implementation of the investment and reform measures outlined in Luxembourg's recovery and resilience plan. It will support Luxembourg's efforts to emerge stronger from the COVID-19 pandemic.
The RRF – at the heart of NextGenerationEU – will provide up to €672.5 billion (in current prices) to support investments and reforms across the EU. The Luxembourgish plan forms part of an unprecedented coordinated EU response to the COVID-19 crisis, to address common European challenges by embracing the green and digital transitions, to strengthen economic and social resilience and the cohesion of the Single Market.
Commission President Ursula von der Leyen said: “Today, the European Commission has decided to give its green light to Luxembourg's recovery and resilience plan. The plan places a strong emphasis on measures that will help secure the green transition, demonstrating Luxembourg's commitment to creating a more sustainable future. I am proud that NextGenerationEU will play an important role in supporting these efforts.”
The Commission assessed Luxembourg's plan based on the criteria set out in the RRF Regulation. The Commission's assessment considered in particular whether the investments and reforms set out in Luxembourg's plan support the green and digital transitions; contribute to effectively addressing challenges identified in the European Semester; and strengthen its growth potential, job creation and economic and social resilience.
Securing Luxembourg's green and digital transition
The Commission's assessment finds that Luxembourg's plan allocates 61% of total expenditure to measures that support climate objectives. This includes measures to supply renewable energy to a housing district project in Neischmelz, a support scheme for the deployment of charging points for electric vehicles, and the “Naturpakt” scheme encouraging municipalities to protect the natural environment and biodiversity.
The Commission finds that Luxembourg's plan devotes 32% of total expenditure to measures that support the digital transition. This includes investments in the digitalisation of public services and procedures; digitalisation of projects for healthcare, such as an online solution for remote healthcare checks; and the establishment of a laboratory for testing ultra-secure communication connections based on quantum technology. In addition, investments in targeted training programmes will provide job seekers and workers on short-time work schemes with digital skills.
Reinforcing Luxembourg's economic and social resilience
The Commission considers that Luxembourg's plan is expected to contribute to effectively addressing all or a significant subset of challenges identified in the relevant country-specific recommendations (CSRs). Specifically, it contributes to addressing CSRs on labour market policies through addressing skills mismatches and enhancing the employability of older workers. It also contributes to increasing the resilience of the healthcare system, increasing available housing, the green and digital transitions, and the enforcement of the anti-money laundering framework.
The plan represents a comprehensive and adequately balanced response to Luxembourg's economic and social situation, thereby contributing appropriately to all six pillars of the RRF Regulation.
Supporting flagship investment and reform projects
Luxembourg's plan proposes projects in five European flagship areas. These are specific investment projects dealing with issues that are common to all Member States in areas that create jobs and growth and are needed for the green and digital transitions. For instance, Luxembourg has proposed measures aimed at increasing the effectiveness and efficiency of public administration service through enhanced digitalization.
An Economy that Works for People Executive Vice President Valdis Dombrovskis said: “Congratulations to Luxembourg for designing a recovery plan whose focus on the green and digital transitions goes way beyond the minimum requirements. This will make a significant contribution to Luxembourg's recovery from the crisis, promising a brighter future for its young people by investing in digital skills programmes, training for jobseekers and the unemployed, as well as increasing the supply of affordable and sustainable housing. These investments will make Luxembourg's economy fit for the next generation. It is also good to see Luxembourg's plans to invest in renewable energy and further digitalize its public services – both areas with potential for solid economic growth.”
The assessment also finds that none of the measures included in the plan significantly harm the environment, in line with the requirements laid out in the RRF Regulation.
The control systems put in place by Luxembourg are considered adequate to protect the financial interests of the Union. The plan provides sufficient details on how national authorities will prevent, detect and correct instances of conflict of interest, corruption and fraud relating to the use of funds.
Economy Commissioner Paolo Gentiloni said: “Although its financial contribution is relatively limited in size, Luxembourg's recovery and resilience plan is set to deliver real improvements in a number of areas. Particularly positive is the strong focus on supporting the Grand Duchy's climate transition, with important measures to encourage the take-up of electric vehicles and increase energy efficiency in buildings. Citizens will also benefit from the drive to boost digital public services and provide more affordable housing. Lastly, I welcome the fact that the plan includes significant steps to further reinforce the anti-money laundering framework and its enforcement."
The Commission has today adopted a proposal for a Council Implementing Decision to provide €93m in grants to Luxembourg under the RRF. The Council will now have, as a rule, four weeks to adopt the Commission's proposal.
The Council's approval of the plan would allow for the disbursement of €12m to Luxembourg in pre-financing. This represents 13% of the total allocated amount for Luxembourg.
The Commission will authorize further disbursements based on the satisfactory fulfilment of the milestones and targets outlined in the Council Implementing Decision, reflecting progress on the implementation of the investments and reforms.
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