European Union

Slovenian PM Janez Janša, the current EU presidency-holder, Thursday tweeted a picture of 13 MEPs whom he accused of being "puppets" of Hungarian-born, American-Jewish philanthropist George Soros. Several of the MEPs no longer serve in parliament, while one recently died. Janša also exchanged barbed tweets with the Dutch prime minister and EP president over his Soros claims, while EU Council chief Charles Michel called for leaders to show "mutual respect".

A court in Naples sentenced the captain of the Asso28 tugboat to a year in prison for disembarking over 101 rescued migrants in Libya's capital city Tripoli, reports Avvenire.it. It is the first such sanction in Italy and in Europe, noted the media outlet. The tugboat was owned by an energy firm and used by oil platforms located near the Libyan coast.

Polish prime minister Mateusz Morawiecki will take part next Tuesday in the European Parliament's debate about the EU's concern on Polish adherence to EU rule of law. EU Commission president Ursula von der Leyen will also take part in the debate, while MEPs will vote a resolution Thursday. "how far will European nations retreat before this usurpation by some EU institutions," Morawiecki told MPs in Poland Thursday, setting the scene.

Poland's parliament on Thursday (14 October) passed a legal amendment allowing migrants to be pushed back at the border and for asylum claims made by those who entered illegally to be ignored.

MEPs in the industry committee on Thursday voted in favour of extending roaming rules for another 10 years. EU lawmakers want consumers to have the same quality and speed of internet mobile connection abroad as at home and be better informed of providers' policies. They also say prices for all intra EU-calls should be the same as those for national calls, while arguing that emergency-service calls should be free.

The World Justice Project (WJP) has released the 2021 edition of the annual Rule of Law Index, which evaluates 139 countries and jurisdiction areas. The latest index demonstrates multi-year negative trends in the rule of law, some of which have been aggravated by the pandemic.

Latvian President Egils Levits has contracted COVID-19 despite being fully vaccinated, his chief of staff said Thursday (14 October), as the Baltic country reported a new record for daily coronavirus cases.

There is an urgent need for a harmonised framework on corporate communications around product sustainability, and the U.S. Cotton Trust Protocol welcomes the EU’s efforts to drive greater sustainability in global supply chains, including in the textiles sector.

Bulgaria will try to negotiate 2040 as its target deadline to phase out coal for electricity production when it submits its coronavirus recovery plan to the European Commission, interim PM Stefan Yanev said Thursday (14 October).

US Deputy Secretary of State Wendy Sherman, in a meeting with Russian Deputy Prime Minister Aleksey Overchuk on Thursday (14 October), called on Russia to "do more to ensure European energy security," the US State Department said.

Germany's economic growth forecast for 2021 has been "significantly" reduced by a group of the country's leading economic research institutes in their bi-annual economic projection report, published on Thursday (14 October).

On 14 October 2021, the President of the Eurogroup, Paschal Donohoe, gave the keynote speech at the Single Resolution Board's annual conference on "Bank resolution: delivering for financial stability".

The European Parliament has backed the extension of free roaming services in the EU until 2032 and its position envisages lower cap prizes than initially proposed, provisions on intra-EU calls, stronger quality of service, and transparency obligations for telecom providers.

As public support for EU free trade deals is waning, civil society groups are hoping to help tighten the bloc's standards on trade sustainability as part of an ongoing consultation.

Written by Gianluca Quaglio with Marcos Fernández Álvarez.

Nanoparticles lie at the heart of a new method for delivering medicines inside the body – and they were crucial to the success of the Covid-19 mRNA vaccines. This new drug delivery method and others could transform the way we treat disease, potentially boosting the treatment of Alzheimer’s, Parkinson’s and HIV, among others. Insulin and Covid-19 vaccines might even become available as pills. Can the European Union stay on top of this trend? And what challenges lie ahead?

Developing a vaccine usually takes more than 10 years. But when the Covid-19 pandemic hit, vaccines were rolled out at an unprecedented speed. China notified the WHO of a cluster of cases of pneumonia on 31 December 2019. Less than one year later, the EU regulator approved the BioNTech-Pfizer mRNA vaccine. Moderna’s version – another mRNA vaccine – followed two weeks later.

First proposed in the 1990s, medical use of mRNA vaccines was only made possible by recent advances in drug delivery. These vaccines contain a set of ‘instructions’ (mRNA) that tell cells how to produce viral proteins, which then trigger an immune response. Getting highly delicate mRNA into cells is far from easy, however. To protect the mRNA and facilitate its delivery, scientists encapsulated it in tiny lipid nanoparticles; without these, the BioNTech-Pfizer and Moderna vaccines would not exist.

These mRNA vaccines exemplify a crucial issue in drug development: finding effective drugs is only part of the task. Pharmacologists also need to find ways to deliver them to the parts of the body where they are needed. Tablets and capsules are easy and convenient, but many drugs (such as insulin) degrade rapidly in the gastrointestinal tract. These drugs are administered by injection, an unpleasant method with poor patient compliance. In addition, therapeutic agents in pills and injections are transported by the circulatory system, and often reach the whole body. This increases the risk of side-effects. Many otherwise effective drugs are discarded on account of their unacceptable side effects. Designing these drugs to reach only their intended site of action could unleash their potential.

Until the Covid-19 pandemic, drug delivery had not witnessed a breakthrough for a few decades. That could be about to change. Nanotechnology, new materials and novel devices promise to revolutionise the field.

Potential impacts and developments

Drug delivery refers to methods and devices for transporting medicines to their targets inside the body. The ideal drug delivery method releases the ingredient exactly where it is needed: to the whole body or targeted at certain sites. It also controls the rate and time of release – sometimes extending over long periods of time.

Implantable devices can release drugs at a defined rate for weeks or even months. They also offer targeted delivery, thereby reducing the risk of side effects. Implantable devices have been used in contraception and cancer treatment, but their potential is much wider. US researchers have developed an implantable capsule that uses thousands of nanochannels to control the drug release rate, and could be used to treat HIV for a year. Coupled with 3D printing, implantable devices could be personalised further to meet individual patients’ needs.

The delivery of drugs to the brain is a major challenge in drug development. The blood-brain barrier (BBB), which consists primarily of closely wedged endothelial cells lining the interior of the capillaries that connect the bloodstream to brain tissue, prevents toxins and pathogens from reaching the brain. It is also impenetrable for many drugs. Yet delivering drugs past the BBB is crucial to treating neurodegenerative diseases, such as Parkinson’s and Alzheimer’s. Focused ultrasounds can be used to disrupt the BBB temporarily; this method can be enhanced through combination with the intravenous administration of microbubbles. Electric pulses can also be used to create micro-and nanopores to allow therapeutic ingredients to pass to the brain. Alternatively, the nasal route can be used to bypass the blood-brain barrier.

About 60 million Europeans have diabetes and many of them require regular insulin injections. Developing oral forms of insulin would significantly improve their quality of life and enhance patient compliance. Unfortunately, insulin and similar drugs (biologics, i.e. substances consisting of a living organism or its products) are highly susceptible to degradation in the gastrointestinal tract. Furthermore, unlike most oral medications, these are big molecules that are not easily absorbed by the intestine. To overcome these barriers, pharmacologists are seeking to improve biologics’ stability. They are also working on coatings to protect the drug cargo, and permeation enhancers to temporarily increase permeability across the intestine. On this note, some researchers claim that the next Covid-19 vaccine could be taken as a pill.

Nanomedicine is often seen as the technology destined to revolutionise drug delivery. Nanoparticles smaller than 100 nanometres (1 000 times smaller than a human hair) could soon make it possible to reach targets previously considered ‘undruggable’. They could also combine diagnostics and medical treatment in a single drug (theranostics), and help break the BBB.

However, nanoparticles have faced increased criticism in recent years. Promising results on mice in the 1990s persuaded researchers that a breakthrough in cancer treatment was easily within reach and public bodies devoted significant funding to it. Two decades later, that promise has yet to materialise. Cancer treatment still relies mainly on radiotherapy and chemotherapy. In 2018, only 34 nanomedicines were approved in the EU. Some researchers openly questioned whether nanoparticles would ever deliver, and highlighted the risk of overfunding this research at the expense of other promising technologies.

In the end, nanoparticles were vindicated, not by a breakthrough in cancer therapy – but by the overwhelming success of mRNA vaccines. There are hopes that this success will precede many others. The sequencing of the human genome has enabled the development of large numbers of drugs based on peptides and proteins. Delivering these molecules will be more challenging than delivering conventional drugs, and nanoparticles could be the enabling technology to make this happen. Nanoparticles could also be crucial in gene therapy.

Anticipatory policy-making

In 2020, the global market for advanced drug delivery systems amounted to US$231 billion, and this figure is expected to rise to US$310 billion by 2025. The EU is second to the US in the global pharmaceutical market, and access to quality healthcare is the third most pressing concern of European citizens. Technological advances could soon transform traditional drug delivery, and proactive policy-making could help the EU stay on top of these developments. The European Commission and EU Member States invested heavily in research on nanoparticles, which were ultimately crucial for mRNA vaccines. Nevertheless, to date, nanoparticles have not delivered in the area where they were most promising: cancer therapy. Additional research and efforts are needed in this regard.

The advent of cheaper, safer and more effective ways to deliver gene therapy could boost ‘biohacking‘ and transhumanism. Although governments do have legal tools to curb practices that endanger public health and several EU Member States ban genome editing outside licensed laboratories, emerging technologies could fall in legal grey zones, raising new ethical dilemmas, and making government oversight even more difficult. These are the challenges that policy-makers could be facing shortly; evidence-informed foresight and preparedness are key to providing effective responses.

Read the complete briefing on ‘What if novel drug delivery methods revolutionised medicine?‘ in the Think Tank pages of the European Parliament.

Listen to policy podcast ‘What if novel drug delivery methods revolutionised medicine?’ on YouTube.

The European Defence Agency (EDA) and the European Space Agency (ESA) today agreed to further deepen their already close cooperation in the cyber domain. The objective of the enhanced cooperation, approved today through an Exchange of Letter between EDA Chief Executive Jiří Šedivý and ESA Director General Josef Aschbacher, is to further expand the cyber resilience cooperation between the two organisations.

EDA and ESA have established a close working relationship on the basis of the Administrative Agreement signed in June 2011 which covers important domains of mutual interest, such as space-based Earth observation, unmanned vehicles, whether on sea or air, critical technologies for non-dependence, CBRNe, Guidance, Navigation and Control, and cyber resilience. In 2016, EDA and ESA signed an Implementing Arrangement on their cooperation for the Cyber Defence for Space Project. In the field of capability research and development, ESA and EDA are jointly investing in the Space and Cyber Defence Joint Study, now concentrating on Cyber Threat Intelligence, and cooperating on an ESA-led Cyber security and space-based services study, which involves other key actors such as the European Maritime Safety Agency (EMSA), Eurocontrol and the European Union Agency for Cybersecurity (ENISA). In December 2020, the Joint ESA-EDA Cyber Resilience Task Force was tasked to explore new and further areas of relevance and potential cooperation or coordination. ESA is also an observer in EDA’s Cyber Ranges Federation Programme Arrangement Management Committee (PAMC).

New level of cyber cooperation

As cyber threats are constantly growing in numbers and sophistication, cyber resilience is essential to EDA and ESA stakeholders alike. Cyber-attacks can target individuals, companies and public institutions or services (e.g. energy grids, financial markets, unmanned vehicles etc.), but also democracies namely though hybrid threats. Space systems being a central link in this new intertwined security continuum, the information and data collected, managed and exchanged by ESA and EDA Member States are of critical value to Europe’s security.

Hence the need for EDA and ESA, acknowledged in today’s Exchange of Letters, to cooperate even closer to improve the cyber-resilience of space systems, notably by:

• sharing relevant policy and technical elements to shape and orient respective activities and strengthen the partnership;
• having EDA to act as a facilitator between ESA and EDA communities while ESA proposes to invite EDA to all Council or Sub-Committee meetings of relevance under this partnership;
• regularly updating the list of priority cooperative avenues to be further explored, exploited and implemented. The Joint ESA-EDA cyber resilience task force will also issue a yearly implementation report;
• exploring how EDA and ESA could expand their coordinated and cooperative approach to other key cyber security actors such as, the European Commission, the External Action Service, and namely its Space Task Force, ENISA, the European Security and Defence College, the European Cybersecurity Competence Centre and Network, the Hybrid Fusion Cell and Hybrid Centre of Excellence, or the EU Satellite Centre.

EDA Chief Executive Jiří Šedivý said: “Space and cyber defence are intrinsically linked. Therefore, it is only natural that the European Space Agency and the European Defence Agency work closely together to strengthen their respective Member States’ cyber resilience and, subsequently, Europe’s security. The new enhanced cooperation launched by today’s Exchange of Letters is another practical step towards achieving this important common goal”.  

ESA Director General Josef Aschbacher said: “In today’s world, space creates and relays critical data, which we need to protect. We are now facing an ever increasing dependence on space infrastructure and services, and this dependence increases the impact of these being disrupted, even from natural occurrences. This is the very reason why ESA is committed to securing its space assets as well as those of its Member States and partners from cyber interference. In doing so, we also strive to build cooperation avenues with our partners, and one such longstanding partner in cyber resilience has been EDA. »

More information

• EDA and ESA cooperate on Next-Generation Secure Satellite Communication
• ESA and EDA joint research: advancing into the unknown (Jan. 2020)

The current energy price spike is something of a storm. But it is also wind in the sails of nuclear energy in Europe, after many years of being given the cold shoulder.

As the EU moves to tighten restrictions on the use of antibiotics, probiotics are rapidly becoming one of the last tools remaining in the toolbox for livestock producers. But prohibitive prices continue to impede their uptake, according to an expert.

Spokespersons for Parliament and for political groups will hold a briefing on the 18-21 October plenary session this Friday at 11.00, in Parliament’s Anna Politkovskaya press room.

Source : © European Union, 2021 - EP

Spokespersons for Parliament and for political groups will hold a briefing on the 18-21 October plenary session this Friday at 11.00, in Parliament’s Anna Politkovskaya press room.

Source : © European Union, 2021 - EP