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EAPM: First-class round table frames discussion for COVID testing, EU countries set to begin vaccination campaigns

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Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update heading into Christmas week and 2021. There is much ahead to look forward to, and perhaps some chance for hope as an incredibly difficult and challenging year comes to an end, writes EAPM Executive Director Denis Horgan.

Resounding success for EAPM round table

Yesterday (17 December) EAPM conducted a very successful virtual round table, ‘Forward together with innovation: Understanding the need and framing the discussion for Serology testing for SARS-CoV-2’. Comprising notable stakeholders and keynote speakers from across the health spectrum, the objective of the round table was to assess the factors, understand the need and frame the discussion for Serology testing for SARS-CoV-2 at a country level by engaging with experts. 

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Speaker included Bettina Borisch, Executive Director World Federation of Public Health Associations (WFPHA) (10 Minutes); Vicki Indenbaum, Laboratory expert working on sero-epidemiological Studies, World Health Organisation (10 minutes); Charles Price, Health security and vaccination Unit, European Commission; Stefania Boccia, Professor, Department of Health Sciences and  Public Health, Università Cattolica del Sacro Cuore & Jean-Charles ClouetSiemens-healthineers

The round table concluded that a key target audience is decision-making (public health professionals, public health institutes, medical authorities as WHO Europe, and EMA) so as to understand the barriers and enablers so that serology testing in vaccination surveillance systems can be adopted.

EU4Health: MEPs reach deal with Council 

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The new EU health programme, EU4Health, worth €5.1 billion, will help to fix shortcomings exposed by COVID-19 and boost quality and resilience of EU health systems. Parliament negotiators agreed on a deal with member states to significantly step up the EU’s action in the health sector through a dedicated EU4Health Programm” as part of the EU’s recently agreed long-term budget. 

The new programme will support actions in areas where the EU’s contribution will clearly be valuable, invest in health promotion and disease prevention measures and prepare European health systems to face future health threats. The COVID-19 crisis has highlighted many weaknesses in national health systems including their dependence on non-EU countries to supply medicines, medical devices as well as personal protective equipment. 

The programme will therefore support actions, which foster the production, procurement and management of such crisis-relevant products in the EU in order to make them more available and affordable. Actions to develop medicinal products and medical devices that are less harmful for the environment are also eligible.

Health top of the bill for incoming Portuguese EU Presidency 

Portugal is declaring as its aims helping to shift Europe out of the coronavirus and an ambitious broader programme on health, according to senior diplomat João Lança. Improving access to medicines; reinforcing the EU’s ability to respond to crises; and championing digital health will be the country’s three main approaches, as well as making forward progress on the European Health Union. 

Vaccination campaigns begin across EU

Italy, Spain, Germany, Malta, Portugal and a number of other EU countries are set to begin their vaccination campaigns before the new year, on 27 December, after the regional drug regulator accelerated its approval process following the launch of immunization campaigns in the United States and Britain. The European Medicines Agency (EMA) said an expert panel would convene on Monday 21 December to evaluate the vaccine made by US company Pfizer and German partner BioNTech. 

While EMA’s mandate is to issue recommendations on new medical treatments, the European Commission has the final say on approval and typically follows EMA’s advice. EMA said its expert meeting was brought forward after the companies had provided more data, as requested, and the EU Commission would fast-track its procedures to rule on approval “within days”. 

Germany should start giving coronavirus shots 24 to 72 hours after the BioNTech/Pfizer vaccine gets EU approval and could begin as soon as Christmas, Health Minister Jens Spahn said. “On 27, 28 and 29 December vaccination will start across the EU,” Commission President Ursula von der Leyen tweeted. However, the Dutch government is facing criticism because it still hasn’t drawn up its vaccination plan. Health Minister Hugo de Jonge said the country’s vaccinations will begin on 8 January. 

Merkel convinced of need for a European Health Union

The European Council welcomed the positive announcements on the development of effective vaccines against COVID-19 and the conclusion of advance purchase agreements by the Commission. German Chancellor Angela Merkel said that co-operation has improved since the start of the pandemic and that she was convinced of the need for a future European Health Union.Health has always been an area that has been jealously guarded by EU member states. While there has always been some degree of cooperation between states in this field, the pandemic demonstrated how the EU could help strengthen national responses. 

The EU will now take forward proposals for a Health Union.The President of the European Commission, Ursula von der Leyen, said that the EU was working full speed on vaccine approval. However, she added that vaccinations and not vaccines saved lives and she called on all countries to finalize their preparations for the timely deployment and distribution of vaccines, including the development of national vaccination strategies, to ensure that vaccines are made available to people in the EU in good time and in a co-ordinated manner.

Gene therapy

And for those who want some excellent additional reading over the festive season, EAPM has released a paper on gene therapy, based on its recent policy discussion, Propelling Health Care with Advanced Therapy Medicinal Products’. The paper is available hereand it covers specific recommendations for all stakeholders, ranging from early dialogue on potential products, linking of clinical data, and patient registries or standardization of control frameworks, to a comprehensive approach to evidence generation, assessment, pricing, and payment for Advanced Therapy Medicinal Products (ATMPs).

Italy prepares for Christmas lockdown

Italy is getting ready to impose another set of restrictive measures to apply over the Christmas break, Italian media reports. While the exact rules are still being debated, the idea would be to apply a uniform “red zone” over the entire country and restrict travel between regions. Some ministers are pushing for an even tougher line. 

Regional Affairs Minister Francesco Boccia says everyone should have to spend Christmas “in their house” according to La Repubblica. Ministers were due to meet later today (18 December) and the official text of the rules is expected to be published tonight. 

UK and EU agree deal on reciprocal health treatment in event of Brexit talks failure

Existing EU reciprocal health-care arrangements are tied to freedom of movement, and provide citizens of EU and EEA nations, as well as Switzerland, with the ability to access health and social care services while in another of those nations. Care accessed through these schemes is provided on the same terms as it would be for a resident of the nation providing the treatment, with its cost met by the recipient’s home country. Brexit could lead to significant changes in the UK’s existing reciprocal healthcare arrangements with the EU. 

This will not just affect access to care for UK, EU and EEA citizens, but it could also significantly increase pressure on health and social care services and their funding. However, under a deal announced Thursday (17 December), Britain and the EU agreed a temporary, time-limited deal targeted at patients who need regular treatment for chronic conditions. It is intended to prevent disruption to treatments such as oxygen therapy or chemotherapy. The agreement, covering the European Economic Area and Switzerland, will last for a year, covering travel between 1 January and 31 December 2021. 

And that is everything from EAPM for this week – do check our gene therapy paper, available here, have an excellent, safe weekend, and see you next week for the last EAPM updates of 2020.

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Brexit impact ‘will get worse’ with supermarket shop to cost more and some EU products vanishing from shelves

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The full impact of Brexit on both businesses and consumers will not be felt until next year with shortages set to worsen in sectors ranging from food to building materials, a leading customs expert has claimed, writes David Parsley.

Simon Sutcliffe, a partner at tax and advisory firm Blick Rothenberg, believes Government delays in implementing post-Brexit customs laws have “softened the impact” of the UK’s exit from the European Union, and that “things will get worse” when they are finally brought in from January 2022.

Despite leaving the EU on 1 January 2020, the Government has delayed many of the customs laws that were due to come into force last year.

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The requirement for pre-notification of arrival in the UK of agri-food imports will be introduced on 1 January 2022 as opposed to the already delayed date of 1 October this year.

The new requirements for Export Health Certificates will now be introduced even later, on 1 July next year.

Controls to protect animals and plants from diseases, pests, or contaminants will also be delayed until 1 July 2022, as will the requirement for Safety and Security declarations on imports.

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When these laws, which also include the customs declaration system, are brought in Mr Sutcliffe believes the food and raw material shortages already experienced to some extent – especially in Northern Ireland – will worsen on the mainland with some products disappearing from supermarket shelves for the foreseeable future.

Sutcliffe, who was among the first to predict the truck driver shortage and border issues in Northern Ireland, said: “Once these extra extensions come to an end we’re going to be in a whole world of pain until importers get to grips with it just like the exporters from the UK to the EU have had to already.

“The cost of the bureaucracy involved will mean many retailers will simply not stock some products from the EU any longer.

If you know your fruit delivery is stuck in a UK port for 10 days waiting to be checked, then you’re not going to bother importing it as it’ll go off before it even reaches the store.

“We’re looking at all kinds of products disappearing from supermarkets, from salami to cheeses, because they will just be too expensive to ship in. While a few boutique delicatessens may stock these products, they will become a more expensive and be harder to find.”

He added that the supermarket shop will also face steep price rises as the cost of importing even basic products such as fresh meat, milk, eggs and vegetables will cost retailers more.

“The retailers will not have much choice but to pass on at least some of the increased costs to the consumer,” said Sutcliffe. “In other words, consumers will have less choice and will have to pay more for their weekly shop.”

A spokesman for No 10 said: “We want businesses to focus on their recovery from the pandemic rather than have to deal with new requirements at the border, which is why we’ve set out a pragmatic new timetable for introducing full border controls.

“Businesses will now have more time to prepare for these controls which will be phased in throughout 2022.”

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Europe ministers say trust in the UK at a low ebb

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Commission Vice President Maroš Šefčovič, updating ministers on the latest developments, said that trust needed to be rebuilt and that he hopes to find solutions with the UK before the end of the year. 

European ministers meeting for the General Affairs Council (21 September) were updated on the state of play in EU-UK relations, in particular with regards to the implementation of the protocol on Ireland/Northern Ireland.

Šefčovič updated ministers on the latest developments, including his recent visit to Ireland and Northern Ireland, and ministers reiterated their support for the European Commission's approach: “The EU will continue to engage with the UK to find solutions within the framework of the protocol. We will do our utmost to bring back predictability and stability for the citizens and businesses in Northern Ireland and to ensure they can make the most of the opportunities provided by the protocol, including access to the single market.”

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The vice president said that many ministers had spoken in the debate at the Council meeting with concern over whether the UK was a trustworthy partner. French Europe Minister Clement Beaune said on his way into the meeting that Brexit and the recent dispute with France over the AUKUS submarine deal should not be mixed up. However, he said that there was an issue of trust, saying that the UK was a close ally but that the Brexit agreement was not being fully respected and that trust was needed in order to move on. 

Šefčovič aims to resolve all outstanding issues with the UK by the end of the year. On the UK’s threat to make use of Article 16 in the Protocol which allows the UK to take specific safeguarding actions if the protocol results in serious economic, social or environmental difficulties that are liable to persist or to a diversion of trade, Šefčovič said that the EU would have to react and that ministers had asked the Commission to prepare for any eventuality. Nevertheless, Šefčovič hopes this can be avoided.

Northern Ireland is already experiencing trade diversion, both in its imports and exports. This is due in large part to the very thin trade deal that the UK has chosen to pursue with the EU, despite being offered less damaging options. Any safeguarding measures must be restricted in terms of scope and duration. There is also a complicated procedure for discussing safeguarding measures laid out in annex seven of the protocol, which involves notifying the Joint Committee, waiting a month to apply any safeguards, unless there are extraordinary circumstances (which the UK will no doubt claim there are). The measures will then be reviewed every three months, in the unlikely event that they are found to be well grounded.

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Britain delays implementation of post-Brexit trade controls

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Britain said on Tuesday (14 Sseptember) it was delaying the implementation of some post-Brexit import controls, the second time they have been pushed back, citing pressures on businesses from the pandemic and global supply chain strain.

Britain left the European Union's single market at the end of last year but unlike Brussels which introduced border controls immediately, it staggered the introduction of import checks on goods such as food to give businesses time to adapt.

Having already delayed the introduction of checks by six months from April 1, the government has now pushed the need for full customs declarations and controls back to Jan. 1, 2022. Safety and security declarations will be required from July 1 next year.

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"We want businesses to focus on their recovery from the pandemic rather than have to deal with new requirements at the border, which is why we've set out a pragmatic new timetable for introducing full border controls," Brexit minister David Frost said.

"Businesses will now have more time to prepare for these controls which will be phased in throughout 2022."

Industry sources in the logistics and customs sector have also said the government's infrastructure was not ready to impose full checks.

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