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#EAPM - All change at Number 10, but no change of stance in Brussels

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Greetings, colleagues, and welcome to our latest update here on ‘Boris Day’, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Who would have thought a year ago that Boris Johnson would be about to move into Number 10 Downing Street, official home of the UK Prime Minister?

Then again, three years ago not too many believed that Britain would be heading for the Brexit door, or that Donald Trump would be working his way towards the White House.

It’s a funny old world, as they say.

Departing premier Theresa May will hold her last Prime Minister’s Question Time in the House of Commons today (24 July), and pop off to see Her Majesty The Queen, as will Boris in due course.

One can only image what will be going through the experienced monarch’s mind as she formally asks the former Lord Mayor of London, one-time Brexit ‘negotiator’ and ex-Foreign Minister to form a government.

After his victory in the Conservative Party leadership election was announced, Johnson was unsurprisingly upbeat, saying: “We are going to get Brexit done on 31 October. We are going to take advantage of all the opportunities. 

It will bring in a new spirit of can-do and we are once again going to believe in ourselves and what we can achieve, and like some slumbering giant, we are going to rise and ping off the guy ropes of self-doubt and negativity.

OK, ‘dude’…If you say so...

Over in Brussels…

…Boris can hardly expect a love-in, at least if comments by current European Commissioner for Health Vytenis Andriukaitisare anything to go by.

The Lithuanian compared the mop-headed oneto another Boris, namely Boris Yeltsin, in a blog yesterday.

“Without comparing the UK itself with the USSR because it is not comparable, I cant think of a better golden standard than the USSR in terms of fact distortion, reality falsification and blunt oblivions of reality,” wrote Andriukaitis.

He added that the heroes of the perestroika era” swore to “create a market economy in post-Soviet Russia within 500 days!” but this never became a reality. People paid for these empty and broken promises with impoverishment, inequality and much more. The programme also left one infamous quote: ‘Boris, ti ne prav’ (‘Boris, you are wrong)!”

The commissioner went on: “It is a different Boris, of course, but there was something in the way of doing politics that was similar: many unrealistic promises, ignoring economic rationales and rational decisions. These decisions led to a new autocratic constitution and finally paved the way to Vladimir Putin

Today in Russia we have oligarchs, a pseudo-market economy, a regulated, governed pseudo-democracy. And Putins authoritarianism. For Boris Yeltsin, the warning came true: Boris, you are wrong.Hopefully, it will not be the case for Boris Johnson…”

Andriukaitis said he “can only wish him luck in taking back control,’ spending more money on the NHS, swiftly concluding new trade agreements”.

So there we have it - Lithuanians do a great line in sarcasm. Who knew?

On the street where you live

Meanwhile, over to Number 10, where ‘BoJo’ will presumably try to make good on his claim that the £350 million per-week his battle bus said the UK pays to the EU budget could be used to fund the NHS.

Of course he won’t, as it was all nonsense.

In the meantime, the Boris “do or die” no-deal exit has been called “the worst-case-scenariofor pharmaceutical companies and pretty-much anyone involved in healthcare. Oh, and patients, who may well bear the brunt of potential medicine shortages.

Also on health-related matters, the new premier has declared against higher taxes for sugary drinks, despite the idea being backed by public health advocates to fight obesity, diabetes, et al.

With impeccable timing (well, Theresa May thought so - ‘legacy’ anyone?) a consultation paper on tougher public health rules was released by the Department of Health and Social Care late on Monday.

It talks about embedding genomics into routine health care and making England smoke-free by 2030 - although it doesn’t suggest forcing Big Tobacco into paying for smoke-quitting services. Instead, it advocates inserts in tobacco products giving quitting advice. 

Wow! That surely has to be lots better and much-more persuasive than packet-pictures of smokers on breathing equipment and men being told they won’t be able to get an erection if they keep clanging off the ciggies.

The pictures are now largely ignored (a Zippo lighter is the perfect size to cover one, by the way) and leaflets will probably simply be left in ashtrays after a cursory glance at the first one. Meanwhile, where’s a lung-cancer screening programme in all this?

For his part, current UK Health Secretary Matt Hancock has been accused of caving in “under pressure from Boris Johnson and the corporate lobbyists running his campaign”.

And so to Strasbourg…

…where Krista Kiuru, the (fairly) recently installed Finnish minister of family affairs and social services, spoke to the European Parliaments Environment, Public Health and Food Safety committee (ENVI) on Tuesday. 

Kiuru has the health-care brief and underlined Helsinki’s “Economy of Wellbeing” priorities under Finland’s six-month EU presidency, zooming in on poor mental health across the bloc.

“We need better EU action in this field,” she said.

That’s all very well, thinks the EPP, which has put a big focus on cancer -endorsed by Commission President-elect Ursula von der Leyen.

Kiuru was therefore askedto launch an initiative on cancer during the presidency, and amend the EU budget to finance the plan.

Later, the minister said: “We should have more equal access to treatments” between countries, adding that improved access to health data would boost European cooperation to find a better cure to cancer and other diseases”.

On HTA, meanwhile, an ongoing file that Finland has inherited, Kiuru said her country is “committed to maximizing progress”. “However,” she warned, “the challenges might be quite big compared to the expectations we are having. So we are pragmatic.

Staying on HTA, the ENVI committee is due to meet later today for the final time before the summer recess, and Politico reports that “file distribution could be on the table”.

There probably won’t be anew rapporteur named today, but the S&D Group is favourite to retain the file in the regrettable absence of former rapporteur and Spanish MEP Soledad Cabezón Ruiz, who didn’t put herself up for re-election.

EAPM’s friend Peter Liese (also EPP) pointed out that there are now former health ministers from Spain and Poland in ENVI, and quite a few more health experts than in the previous Parliament.Good news.

Less good news for that HTA file (now in Council), which has been dogging the last three EU presidencies, given that the Finns don’t expect to be able to wrap it up either.

Some say the whole thing may end up in the bin, given that Croatia is not expected to make much progress when it takes over on 1 January and the following presidency, Germany, is against any mandatory aspects of EU-wide joint HTA.

Come back Soledad Cabezón Ruiz. Europe’s patients need you!

Paediatric medicines

Departing Commission President Jean-Claude Juncker, in one of his few tangible moves on healthcare, had planned for cash to be made available under his ‘investment plan’ for paediatric drugs.

With that in mind, the European Investment Bank has signed a 20 million loan agreement with French pharmaceutical company Advicenne, which specializes in orphan drugs.

This money is designed to support the company as it looks to expand its orphan drug portfolio. 

And finally…

Back to Boris. Before he’s even had time to have the bed linen changed at Number 10, he’s already been told by the EU’s Brexit negotiator Michel Barnier that the Frenchman looks forward “to working constructively to facilitate the ratification of the Withdrawal Agreement and achieve an orderly Brexit".

Translation: 'No renegotiation, old bean.'

For her part, Ursula von der Leyenvery quickly said: “I think its very important to build up a strong and good working relationship because we have the duty to deliver something which is good for people in Europe and in the United Kingdom.

Translation #2: “No-deal .....”

Until next time, have a good weekend...

Consumer protection

How the EU aims to boost consumer protection

EU Reporter Correspondent

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Find out how the EU aims to boost consumer protection and adapt it to new challenges such as the green transition and the digital transformation. Society 

As the economy becomes more global and digital, the EU is looking at new ways to protect consumers. During the May plenary, MEPs will debate the digital future of Europe. The report focuses on removing barriers to the functioning of the digital single market and improving the use of articial intelligence for consumers.

Infographic illustration on consumer protection in the European Union
Reinforcing consumer protection  

New consumer agenda

Parliament is also working on the new consumer agenda strategy for 2020-2025, focusing on five areas: green transition, digital transformation, effective enforcement of consumer rights, specific needs of certain consumer groups and international cooperation.

Making it easier to consume sustainably

The 2050 climate neutrality goal is a priority for the EU and consumer issues have a role to play - through sustainable consumption and the circular economy.

Infographic illustration on Europeans support tackling climate change
Sustainable consumption  

In November 2020, MEPs adopted a report on a sustainable single market calling on the European Commission to establish a so-called right to repair to make repairs systematic, cost efficient and attractive. Members also called for labelling the lifespan of products as well as measures to promote a culture of reuse, including guarantees on pre-owned goods.

They also want measures against purposefully designing products in a way that makes them obsolete after a certain time and reiterated demands for a common charger.

The Commission is working on right to repair rules for electronics and legislation on the environmental footprint of products to enable consumers to compare.

The review of the Sale of Goods Directive, planned for 2022, will look into whether the current two-year legal guarantee could be extended for new and pre-owned goods.

In September 2020, the Commission launched the sustainable products initiative, under the new Circular Economy Action Plan. It aims to make products fit for a climate-neutral, resource-efficient and circular economy while reducing waste. It will also address the presence of harmful chemicals in products such as electronics and ICT equipment, textiles and furniture.

Making the digital transformation safe for consumers

The digital transformation is dramatically changing our lives, including how we shop. To help EU consumer rules catch up, in December 2020 the Commission proposed a new Digital Services Act, a set of rules to improve consumer safety across online platforms in the EU, including online marketplaces.

MEPs want consumers to be equally safe when shopping online or offline and want platforms such as eBay and Amazon to step up efforts to tackle traders selling fake or unsafe products and to stop fraudulent companies using their services.

MEPs also proposed rules to protect users from harmful and illegal content online while safeguarding freedom of speech and called for new rules on online advertising giving users more control.

Given the impact of artificial Intelligence, the EU is preparing rules to manage its opportunities and threats. Parliament has set up a special committee and emphasises the need for human centric legislation. The Parliament has proposed a civil liability regime for artificial intelligence that establishes who is responsible when AI systems cause harm or damage.

Strengthening the enforcement of consumer rights

EU countries are responsible for enforcing consumer rights, but the EU has a coordinating and supporting role. Among the rules it has put in place are the directive on a better enforcement and modernisation of consumer law and rules on collective redress.

Addressing specific consumer needs

Vulnerable consumers such as children, elderly people or people living with disabilities, as well as people in financial difficulties or consumers with limited access to the internet need specific safeguards. In the new consumer agenda, the Commission plans to focus on problems with internet accessibility, financially vulnerable consumers and products for children.

The Commission’s plans include more offline advice for consumers with no internet access as well as funding to improve the availability and quality of debt advice services for people in financial difficulties.

Because children are particularly vulnerable to harmful advertising, Parliament has approved stricter rules for audiovisual media services for audiovisual media services.

Guaranteeing the safety of products sold in the EU

Consumers often purchase goods manufactured outside the EU. According to the Commission, purchases from sellers outside the EU increased from 17% in 2014 to 27% in 2019 and the new consumer agenda highlights the need for international cooperation to ensure consumer protection. China was the largest supplier of goods to the EU in 2020, so the Commission will work on an action plan with them in 2021 to increase the safety of products sold online.

In November 2020, Parliament passed a resolution calling for greater efforts to ensure that all products sold in the EU are safe, whether manufactured within or outside the EU or are sold online or offline.

Next steps

Parliament’s internal market and consumer protection committee is working on the Commission proposal for the new consumer agenda. MEPs are expected to vote on it in September.

Find out more 

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Coronavirus: Health Security Committee updates the common list of COVID-19 rapid antigen tests

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The Health Security Committee (HSC) has agreed to update the common list of COVID-19 rapid antigen tests (RATs), including those whose results are mutually recognised by EU member states for public health measures. Following the update, 83 RATs are now included in the common list, of which the results of 35 tests are being mutually recognised. Commissioner for Health and Food Safety, Stella Kyriakides, said: “Rapid antigen tests play a crucial role to slow down the spread of COVID-19. Diagnostics are a central element for member states in their overall response to the pandemic. Having a wider list of recognised rapid antigen tests will also make it easier for citizens to benefit from Digital Green Certificates and to facilitate safe free movement inside the EU in the coming months.”

In addition, the Commission and the Joint Research Centre have agreed on a new procedure for updating the list of common and mutually recognised RATs in the future. From today onwards, RATs manufacturers will be able to submit data and information for certain tests that meet the criteria agreed by the Council on 21 January 2021. This includes only those rapid tests that are being carried out by a trained health professional or other trained operator and excludes rapid antigen self-tests.  Moreover, as part of the new procedure, the HSC is setting up a technical working group of national experts to review the data submitted by countries and manufacturers and to propose updates to the HSC.

They will also work with the JRC and the ECDC on a common procedure for carrying out independent validation studies to assess the clinical performance of RATs. The updated common list of COVID-19 RATs is available here. Manufacturers can submit data on rapid antigen tests available on the market here. The Council Recommendation on a common framework for the use and validation of RATs and the mutual recognition of COVID-19 test results in the EU can be found here.

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Mohsen Rezaee emerges as the West's man on the ground

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As nuclear talks in Vienna stall, negotiators are keeping a close eye on Iran’s upcoming presidential elections, the outcome of which could be key to breaking the current deadlock, writes Yanis Radulović.

With a fourth round of talks set to resume in Vienna this week, pressure is mounting on high-ranking European negotiators to reach an accord that bridges the geopolitical chasm between Washington and Tehran and brings Iran back into compliance with the 2015 Joint Comprehensive Plan of Action (JCPOA).

A historic non-proliferation agreement and widely regarded as one of the Obama administration’s premier foreign policy achievements, the JCPOA set out a framework to curtail Iran’s nuclear breakout time and established formal steps for capping the enrichment of fissile material, scheduling transparent atomic facility inspections, and dismantling excess centrifuge installations. In return for sustained compliance with this framework, the U.S. and other major world powers agreed to a gradual lifting of nuclear-related sanctions on Iran.

When the US withdrew from this landmark agreement in 2018, the European co-signatories of Germany, France, and the UK stepped up to keep the deal alive. However, European relations in the region quickly became strained by the revival of Washington’s “maximum pressure campaign” on Iran, a campaign which aimed to strangle the Iranian economy via unilateral sanctions and escalatory retaliatory actions.

Unsurprisingly, Washington’s pivot to maximum pressure has placed major European powers in a foreign policy double bind. While the recent uptick in U.S.-Iran tensions has trended downwards since the election of President Joe Biden, his predecessor’s approach in the region has had a lasting effect upon Iranian goodwill towards multilateral agreements like the JCPOA.

For the European co-signatories, the nuclear talks in Vienna are embedded within a broader strategy of strategic détente and diplomatic reintegration between Europe and Iran. Beyond the obvious advantages of nuclear non-proliferation, Europe is also eyeing a future where Iran can step up as a fully-fledged, sanction-free actor on the international stage. Despite having an estimated 9 percent share of the world’s oil reserves, the sanction-sapped Iranian economy is woefully underdeveloped. Throw in the simulative potential of Iran’s frozen assets — estimated to be worth between $100 and $120 billion — and it’s easy to see why Europe views Iran as such a promising partner for foreign direct investment.

On a condition of anonymity, a senior official from the US State Department spoke with Reuters and shed some light on the likelihood of a deal being inked during the fourth round of talks, saying: "Is it possible that we'll see a mutual return to compliance in the next few weeks, or an understanding of a mutual compliance? It's possible yes.”

Abbas Araqchi, Iran’s top negotiator, is slightly more pessimistic at the chances of a deal in the immediate future. Speaking on state TV, Araqchi emphasized that Iran would not rush into a new deal without a stable framework of safeguards.

"When it will happen is unpredictable and a timeframe cannot be set. Iran is trying (for) it to happen as soon as possible, but we will not do anything in a rush," Araqchi said.

As formal talks stall, European negotiators are looking at Mohsen Rezaee, one of three front-runners in the upcoming Iranian presidential elections, to cut through the diplomatic red tape and promote mutually beneficial collaboration with the US and EU.

Unlike his fellow presidential candidates, Rezaee is not a lifelong politician. Nevertheless, with a career spanning the Islamic Revolutionary Guard Corps (IRGC) to the Expediency Discernment Council, Rezaee is a seasoned diplomat and pragmatic negotiator. Perhaps Rezaee’s most impressive achievement is the fact that in all his years of civil, military, and political service, he has never once been subject to a corruption scandal or criminal probe.

While established politicians like Foreign Minister Mohammad Javad Zarif may be a more conventionally attractive partner with the West, there is growing conviction in Europe that Rezaee, a well-rounded, well-respected, and reliable candidate, is the man best suited to represent Iran and its position on international nuclear negotiations.

A proven leader who is unafraid to express his opinions, Rezaee has repeatedly shown that he is capable of adjusting his opinions and uniting coalitions. Despite his role as a representative of the “Revolution Generation”, Rezaee has made it clear that he is no radical. After years of civil service, Rezaee has broken ranks with many of the hardline views that are commonplace in the IRGC. In fact, in an interview with the Tehran Times, he went as far as to dismiss a nuclear arms race as unwise, remarking: “Political wisdom requires not to chase weapons that can destroy the entire humanity.”

With impediments to progress rearing at every turn in Vienna, it has become abundantly clear that the West needs a man on the ground in Iran. Mohsen Rezaee, and the emerging movement he represents, may be the key to breaking the deadlock in negotiations and bringing Iran back as a major player in the global economy.

The opinions expressed in the above article are thoseof the author alone, and do not reflect any opinion on the part of EU Reporter.

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