Elon Musk’s promise to European regulators that Twitter would follow the rules set out in the European Union’s new Digital Services Act (DSA) will finally be put to the test. The first few weeks of Musk’s reign at the company suggest he could be embroiled in a fight.

Within hours of Musk’s takeover, racist language previously blocked on the platform increased. The billionaire praised targeted ads, which are the subject of a European crackdown aimed at better protecting users from pervasive online surveillance. He personally retweeted misinformation about the assault and attempted kidnapping that seriously injured the husband of US House Speaker Nancy Pelosi. And he has now cut Twitter’s workforce in half and jettisoned the majority of the company’s thousands of contractors, who traditionally handle content moderation.

The DSA, which came into force on November 16, is a bold set of sweeping regulations on online content governance and accountability for digital services that subjects Twitter, Facebook and other platforms in many ways to the European Commission. and national authorities. These bodies will oversee compliance and enforcement and seem determined to make the internet a fairer place by limiting the power of Big Tech. Many expect this landmark EU legislation to set a new benchmark for other regulators around the world.

Concerns for safety and respect

The DSA’s content moderation rules could be a real challenge for Musk. While the DSA does not tell social media platforms what speech they can and cannot post, it sets new standards for terms of service and regulates the content moderation process to make it more transparent to users and regulators. The DSA is driven as much by security concerns and respect for fundamental rights as by the interests of the market. It draws attention to the impact of algorithmic decision-making (and there’s a fine line between Twitter’s new paid subscription model and algorithmic discrimination), and reinforces EU codes of conduct, such as the Misinformation Code of Practice, to which Twitter has subscribed.

And that requires platforms to remove illegal content. EU regulators say the DSA will ensure that anything illegal offline will also be illegal online. But what is considered illegal varies between EU member states. For example, an offensive statement flagged as illegal in Austria could be perfectly legal in France. It is true that the DSA has taken some steps to avoid imposing the law of one country on all other countries, but the fragmentation of the EU has led to and will continue to require significant compliance efforts from the share of platforms. There are also new due diligence obligations, some of which could increase the risk of legal discourse being swept aside as platforms err on the side of removal to avoid fines.

Perhaps working in Musk’s favor, the DSA does not require platforms to remove all harmful content, such as “awful but legal” hate speech. In fact, the DSA sets some limits on what can be removed, which means Musk may find it easier to remove as little as possible. But platforms are required to act responsibly and work with trusted flaggers and public authorities to ensure their services are not misused for illegal activity. And while platform operators have wide latitude to set their own speech standards, those standards must be clear and unambiguous, which Musk pledged to do anyway.

Sometimes it’s hard to take Musk at his word. He said in late October that no major content or account reinstatement decisions would occur until a content moderation board comprised of “widely diverse viewpoints” was formed. He has yet to announce the existence of such a council, but on November 20 several people fired the platforms for hate speech and misinformation, including former President Donald Trump – who was allowed to return to Twitter after Musk quizzed users — and Kanye West.

Twitter’s trust and safety and content moderation teams have suffered huge successes since Musk took over as “Chief Twit,” as he calls himself. Half of Twitter’s 7,500 employees have been laid off, with trust and security services the hardest hit. Twitter’s top trust and safety, human rights and compliance officers have left the company, as have some EU policy officials. That Musk fired the entire human rights team could backfire. This team has been tasked with ensuring that Twitter adheres to the United Nations Principles Establishing Corporate Responsibility to Protect Human Rights.

Media outlets reported that the company’s content moderation staff did not have access to their enforcement tools. Meanwhile, a second wave of global job cuts hit 4,400 of Twitter’s 5,500 external contractors last week, many of whom had worked as content moderators to tackle misinformation on the platform in the United States and abroad.

Extended obligations for large platforms

All of this raises questions about whether Twitter has the technical and political muscle to comply with and implement DSA obligations, particularly whether Twitter is designated as a “very large online platform” or VLOP (over 45 million users) under the DSA. If designated as such, the company will have to comply with important obligations and responsibly address systemic risks and abuses on its platform. They will be held accountable through independent annual compliance audits and public scrutiny and must provide a public repository of the online advertisements they have displayed over the past year. It is unlikely that Twitter will be able to meet these commitments if it does not have enough qualified personnel to understand the impact of its operations on human rights.

Additionally, Musk is a self-proclaimed “free speech absolutist,” who said he acquired Twitter because civilization needs “a common digital public square.” He criticized Twitter content moderation policies and says he opposes “censorship” which “goes far beyond the law”. Yet, after much criticism, he also said that Twitter cannot become a “free-for-all hellscape” where anything can be said without consequences.

Unfortunately, Twitter descended into pretty much that kind of a landscape soon after Musk took over. A flurry of racist slurs appeared on the platform in the first few days, while a revised paid subscription scheme that gives users a blue tick – which once indicated that the identity of the account holder had been verified as authenticated – was reintroduced but without the verification step. Anyone paying $7.99 could buy a blue check, and many who created fake accounts posing as people and businesses and tweeted out false information, from an Eli Lilly account announcing that its product to insulin base was now free to multiple accounts impersonating and parodying Musk himself.

Musk halted the deployment, but the damage was done. Margrethe Vestager, executive vice president of the European Commission, told CNBC that such a practice indicates that “your business model is fundamentally flawed.”

If Twitter is deemed a “very large online platform”, it will need to assess all kinds of risks, including misinformation, discrimination and lack of civic discourse arising from using the service, and take steps to mitigation to reduce societal harm. If Musk succeeds in his plans to grow Twitter’s user base over the next few years, Twitter will certainly face greater scrutiny under the DSA and could be forced to backtrack and staff its service. content moderation.

This is also the opinion of Thierry Breton. Commenting on the reduction in the number of moderators, the European commissioner for the internal market warned Musk that “he will have to increase them in Europe”.

“He will have to open his algorithms. We will have control, we will have access, people will no longer be able to talk nonsense,” Breton said.

Restrict user information for ads

Targeted advertising is another area where Musk’s plans could conflict with DSA obligations. Twitter’s advertising business is its main source of income. With the company losing money, Musk wants to increase his ad revenue. The DSA prohibits platforms from using sensitive user information, such as ethnicity or sexual orientation, for advertising purposes. Ads can no longer be targeted based on this data.

More broadly, the DSA increases transparency about the ads users see on their feeds: platforms must clearly differentiate content from advertising; ads should be labeled accordingly. It’s hard to see how all of these requirements will mesh neatly with Musk’s plans. He told advertisers that what Twitter needs are ads that are as relevant to users’ needs as possible. Highly relevant ads, he says, will serve as “real content.”

One of the most concerning things the DSA does not do is to fully protect anonymous speech. The provisions give government authorities alarming powers to flag controversial content and uncover data on anonymous speakers — and everyone else — without adequate procedural safeguards. Pseudonymity and anonymity are essential to protect users who may have opinions, identities or interests that do not match those in power.

Marginalized groups and human rights defenders can be in grave danger if those in power manage to discover their true identity. Musk pledged to “authentic all real humans” on Twitter; Unfortunately, the DSA is doing nothing to help them if Musk keeps his promise.

The DSA is an important tool for making the internet a fairer place, and it’s going to cause some turbulence for Twitter as Musk seeks to realize his vision for the platform. Much will depend on how social media platforms interpret their obligations under the DSA and how EU authorities enforce the regulation. Breton, the internal market commissioner, swore that Twitter “will fly by our rules.” For Musk, the seatbelt sign is on. It’s going to be a bumpy ride.

IMAGE: Elon Musk’s Twitter account is seen displayed on a smartphone with a Twitter logo in the background on November 21, 2022. (Photo by Nathan Stirk/Getty Images)

New medium-term goals and long-term net-zero commitments, ambitious policy initiatives and technological development are helping to limit future global warming to around 1.8°C.

This is a considerable improvement on the previous projection of around 2.7°C made by the European Commission’s Joint Research Center (JRC).

However, achieving the Paris Agreement’s 1.5°C target will require substantial and timely additional efforts by the entire international community, and in particular major emitters.

This is the main message highlighted by JRC scientists in their Global Energy and Climate Outlook (GECO) 2021 report released today, which provides an updated assessment of global climate commitments and projections of possible increases. temperature futures.

This year’s publication offers a global view of decarbonization scenarios as well as a deep dive into G20 countries, which account for around 75% of global GHG emissions since 1990.

For each of the G20 countries, the outlook assesses multiple emission pathways taking into account currently implemented policies, the most recent goals and commitments, and more ambitious global action that would put the world on the right path. to keep global warming to 1.5°C.

GECO 2021 stresses that substantial additional action will be required if the targets recently announced by several major economies are to be met, and that even greater action will be required to achieve a 1.5°C target.

The report also reveals potential reduction options across sectors, technologies and countries to align emissions with these goals, and provides in-depth analysis of global trends in energy and greenhouse gas (GHG) emissions. ).

Towards climate neutrality

This year, the GECO 2021 report focuses on climate action driven by the latest commitments made under the Paris Agreement. The new edition takes stock of updates to the medium-term Nationally Determined Contributions (NDCs) and long-term Net Zero Emissions (LTS) goals, as submitted before and during the UNFCCC Conference of the Parties (COP 26) in November 2021.

The report also assesses how recent LTS announcements by major global economies – which include some net-zero emissions targets – could affect the global effort for the low-carbon transition in the coming decades.

The GECO 2021 report shows that the recently announced targets for the short term (2030) and the long term (2050) would represent a clear break with historical trends and current policies.

The GECO 2021 analysis shows that if all countries meet these newly announced national targets (targets submitted in official UNFCCC documents or simply announced), the global temperature increase could be limited to 1.8°C from here 2100 (50% probability).

This figure is significantly lower than that assessed in previous editions of GECO; in 2019, the outlook calculated a temperature change of 2.7°C in an NDC scenario, with emissions not stabilizing until 2035-2040.

The new NDCs and LTS peak emissions around 2023, reducing them until 2050 and then stabilizing in the middle of the century, closing more than 80% of the emission gap around 1.5°C. An interesting feature common to all scenarios is that all show long-term stabilized emissions, with no discernible rebound induced by economic growth. This suggests a true decarbonization of our economic systems, where growth is decoupled from rising emissions.

However, substantial additional actions are needed to limit climate change to 1.5°C by 2100, as stipulated in the Paris Agreement and reaffirmed by parties to the Paris Agreement at COP26 in Glasgow.

The 1.5°C temperature goal requires global GHG emissions to decline rapidly over the next few decades and reach net zero by the start of the second half of the century.

Therefore, more ambitious targets are needed, both in the short term to achieve a steeper decline in emissions by 2030, and in the long term, as some large emitters have not yet adopted a net zero or only aim after 2050.

On top of that, strong action is needed for countries to achieve the goals they have already set themselves, as shown by the distance between current policies and NDC-LTS scenarios.

The transition to a low-carbon economy would initially rely mainly on the electricity generation sector. While a reduction in coal is the most significant change in primary energy consumption when moving from current policies to the NDC-LTS scenario, reaching the 1.5°C target would imply a sharp reduction in all fuels fossils.

In 2019, more than three-quarters (83%) of global energy demand was still met by fossil fuels, despite the significant growth in renewable energy over the previous decade. Fossil fuels represent only 29% of the energy supply in the 1.5C-Uniform scenario in 2050.

By aiming for the 1.5°C target, alongside achieving mostly carbon-free electricity generation, significant efforts are being made to improve energy efficiency, advance electrification and reduce emissions from climate change. land use.

Emission reductions are needed at all levels and the corresponding transition may have implications for the sectoral composition of employment. GECO 2021 provides insight into the labor market transition behind low carbon pathways.

Background

In 2019, the EU announced its target to become climate neutral by 2050. This target was confirmed as part of EU climate law, alongside a commitment to reduce emissions by at least 55% by 2030 from 1990 levels (previous 2030 target was at least -40%). In order to achieve these reinforced objectives, the European Commission proposed the “Fit for 55” legislative package in July 2021.

However, as the EU accounts for only 8% of global greenhouse gas emissions, the challenge of limiting global warming must be taken up on a global level.

Several major emitters like the United States, China and India have recently announced climate change commitments that bring the world closer to the Paris Agreement target. GECO 2021 aims to reveal the implications of these pledges for emissions, energy systems and labor markets around the world, informing the global stocktaking process.

This GECO report is the seventh edition of the GECO series. It contributes to the work of the RCC in the context of the United Nations Framework Convention on Climate Change (UNFCCC) and the reports of the Intergovernmental Panel on Climate Change (IPCC), which have recently called for action urgent coordinated global meeting on the climate crisis, unequivocally caused by human activities. .

Related content

JRC Report – Global Energy and Climate Outlook 2021: Towards Climate Neutrality

GECO 2021 webpage on the Science Hub

Punishments

Penals sanctions

What criminal penalties, if any, are provided for cartel activities?

There are no criminal sanctions for cartel activities at EU level. However, criminal sanctions may be imposed at national level in some Member States.

Civil and administrative sanctions

What are the civil or administrative penalties for cartel activity?

The European Commission (EC) derives its power to impose fines from Article 23(2) of Regulation No 1/2003 of 16 December 2002 on the application of the competition rules, which gives it wide latitude to fix the amount of the fine, the only limit being that it must not exceed 10 per cent of the company’s total turnover during the preceding financial year. In this regard, it should be noted that this maximum limit applies to the turnover of the company’s group and not only to the entity that participated in the infringement.

The amount of fines has increased significantly in recent years. The record total fine imposed in a single case amounts to 3.807 billion euros in the Trucks decision (2016/2017), where Daimler also received the highest ever individual fine of one billion euros for a cartel breach.

Moreover, while the EC itself cannot impose civil penalties, EU law encourages cartel victims to seek redress in national courts. Directive No. 2014/104 of 26 November 2014 on certain rules governing actions for liability under national law for infringements of the competition law provisions of the Member States and of the European Union, transposed by all Member States since 2020 , notably establishes a framework to facilitate actions for damages for victims of infringements of competition law.

Guidelines for Sanction Levels

Are there principles or guidelines for fines or sentencing? If so, are they binding on the arbitrator? If not, how are penalty levels normally established? What are the main aggravating and mitigating factors taken into account?

The EC first adopted its guidelines on how to set fines in 1998 and updated them in 2006. They are binding on the EC, but not on European or national courts, nor on national enforcement authorities. competition (ANC).

In practice, to set the amount of a fine, the EC first determines the basic amount of the fine, taking into account the value of the sales of the undertaking to which the infringement relates directly or indirectly in the geographical area concerned, to which it applies a percentage generally ranging from zero to 30 per cent depending on the seriousness of the infringement (in practice, this percentage generally varies between 15 and 18 per cent for cartels) as well as a multiplier factor reflecting its duration. In cartel cases, the EC applies an additional percentage ranging from 15 to 25 per cent to this base amount to ensure the deterrent effect of the fine.

The EC then adjusts this basic amount downwards or upwards to take account of the aggravating and mitigating circumstances specific to each company. Aggravating circumstances include the company instigating or leading the cartel, or whether it is a repeat offender – the EC recently increased a fine by 50% on the grounds that the company concerned had already been sanctioned for another cartel ( EC, April 20, 2021, Freight Shipping, case no. AT.39462). Mitigating circumstances include the company’s cooperation in the investigation – the EC recently granted a 45% reduction in the fine rewarding this cooperation (EC, 20 May 2021, EGBcase no. AT.40324), or the fact that the infringement was encouraged or authorized by public authorities or legislation.

Once adjusted, the EC verifies that the amount of the fine does not exceed the legal maximum (ie 10 percent of the company’s worldwide turnover during the last financial year). The EC recently reduced to zero the fine initially of 4.8 million euros which it had imposed on a company because this company had not achieved a turnover during the financial year preceding the date of the decision (EC, May 20, 2021, EGBcase no. AT.40324).

Finally, if necessary, the amount of the fine is further reduced to take account of the leniency procedures (total immunity for the first company that came forward to the EC and reductions of up to 50% for the following ones) or settlement procedures (a 10 percent fine reduction, as recently granted by the EC to all participants in the Car emissions cartel (EC, July 8, 2021, Car emissionscase no. AT.40178)).

Compliance programs

Are penalties reduced if the organization had a compliance program in place at the time of the violation?

The EC is not required to take into account compliance programs put in place by an affected company when setting the fine. In 2014, the General Court of the European Union (GCEU) clearly excluded a compliance program from being considered a mitigating circumstance. In effect:

[The] the mere adoption by a company of a program for compliance with the competition rules cannot constitute a valid and definitive guarantee of future and continuous compliance by this company with these rules and, consequently, the mere existence of such a program cannot compel the Commission to reduce the fine on the ground that the preventive objective pursued by the fine has already been at least partially achieved.

See CGEU, 14 May 2014, Donau Chemistrycase no T-406/09.

Disqualification of director

Are those involved in cartel activities subject to orders prohibiting them from serving as directors or officers of companies?

There is currently no EU legislation prohibiting persons involved in cartel activities from acting as directors or officers of companies. However, some national laws provide for systems of recusal of directors, either in the form of autonomous sanctions which can be imposed by the NCAs (for example, in Sweden), or in the form of sanctions subordinated to the condemnation of an infringement of the right penalized for violating competition laws that may be imposed by the National Competition Authority. courts.

Exclusion

Is exclusion from public procurement procedures automatic, available as a discretionary sanction, or not available in response to cartel violations?

While Regulation No. 1/2003 of 16 December 2002 on the application of competition rules does not mention exclusion from public procurement procedures as a possible sanction, Directive No. 2014/24 on public procurement public authorities in the EU provides for a combination of mandatory and optional sanctions. exclusion when the public authorities have sufficiently plausible indications to conclude that the company has entered into agreements with other companies aimed at distorting competition, which can be qualified as “serious professional misconduct” (Article 57). The exclusion period for anti-competitive behavior is subject to national law and set at a maximum of three years by Directive 2014/24 when the exclusion period has not been set by a final judgment. It can be terminated earlier if the measures taken by the company sufficiently demonstrate its reliability. The exclusion rule is rarely applied throughout the European Union.

Parallel proceedings

Where possible penalties for cartel activity include criminal and civil or administrative penalties, can they be prosecuted for the same conduct? If not, when and how is the choice of the sanction to be pursued made?

Cartels are subject to both administrative sanctions, which can be imposed exclusively by the EC, and possible civil damages, which can be decided by any national court. In this regard, public enforcement and private enforcement are seen as complementary tools to effectively fight cartels and deter anti-competitive behavior.

The coordination pool of Italian law enforcement experts seconded to Eurojust received a special mention at the European Investigative and Forensic Journalism Awards ceremony, held in Naples on 11 November. The special mention is an acknowledgment of their support for cross-border judicial support through the Italian national office of Eurojust and assistance in the investigation of alleged core international crimes committed in Ukraine.

At Eurojust, the Italian Financial Police (Guardia di Finanza), the National Gendarmerie (Carabinieri) and the Prison Police (Polizia Penitenziaria) are represented at the national office to coordinate judicial cooperation with their respective forces. These are seconded national experts, who work in a coordination pool, providing support for cooperation and coordination under the supervision of the Italian national member of Eurojust. The Italian national office of Eurojust is the only one currently working with such a coordination module.

Eurojust was represented at the awards ceremony by the national member for Italy, Mr Filippo Spiezia, as well as by the experts. Eurojust President, Mr. Ladislav Hamran, addressed the event via a video message, emphasizing the importance of investigative journalism in major criminal cases.

The main Naples prizes were awarded to Italian investigative journalists Nello Scavo, Francesca Mannocchi and Gabriele Micalizzi for their reporting and documentation of major national court cases. Additionally, the award also recognized their work in international reporting, including the war in Ukraine. A special dedication was given to journalists and photographers Benjamin Hall, Alexandra Kuvshinova and Pierre Zakrzewski, who lost their lives while reporting on the war in Ukraine.

The European Prizes for Investigative and Judicial Journalism are an initiative of the social cultural association Sirio, based in Naples, with the support, among others, of the Office of the President of the Italian Republic, the Italian Ministry of Foreign Affairs and Development international, the Municipality of Naples and Eurojust.

Two new decrees on medical devices were published in the Belgian Official Gazette of October 25, 2022. While the decrees are presented as concluding the implementation of the European regulations on in vitro diagnostics (IVD) in national laws, a careful examination of their provision shows that they have a much broader scope – with repercussions for all medtech companies active in Belgium.

Implementation of European regulations on medical technologies

The first efforts to transpose the European MDR in Belgium took place last year with the entry into force of a fourfold legal and regulatory framework: the MDR law, published on January 19, 2021 and three decrees published only a few days before the date of the application MDR (May 26, 2021):

• the decree of application of the MDR intended to concretize the principal provisions of the law MDR;
• the clinical investigations decree, specific to studies carried out with medical devices for various purposes, some of which are not covered by the MDR;
• the MDR Repeal and Amendment Order was needed to clean up the local legacy device rules and align them with the new post-MDR framework.

Implementation of European IVD regulations

In vitro diagnostic medical devices are regulated by the IVDR, which, although (partially) applicable throughout the EU since May 26, 2022, has been deployed with significant delays with regard to the Belgian legal framework :

As is the case for the other medical devices governed by the MDR, the IVDs captured by the IVDR and placed, made available or put into service on the Belgian market are governed by a law: the IVDR law, published on 30 June 2022.
In addition, the two executive orders issued last week are:

• the performance studies decree, applicable since October 26, 2022;
• the decree repealing and amending the IVDR which will come into force on November 4, 2022.

An IVDR implementing decree reflecting the MDR implementing decree remains to be published.

IVDR Repeal and Amendment Order

The decree repeals provisions and adapts references in various legacy decrees (such as the IVDD implementing decree) on the grounds that in vitro diagnostic medical devices are now governed by the European IVDR instead of legislation legacy, with substantial changes limited to their regulatory framework.

Contrary to what its name suggests, the decree is not specific to IVDs and also covers other types of devices. In addition, the decree repeals provisions and adapts references in other decrees on the grounds that medical devices are now governed by the MDR, independently of the provisions of the IVDR.

Vigilance touchpoints

The vigilance contact point (PCV) decree of 15 November 2017 was amended by the decree to define and align the missions of the PCVs according to the Belgian MDR law and the Belgian IVDR law. Interestingly, in the current state of the updated VCP decree, medical device distributors (IVDs) now find themselves without any local legal basis requiring them to appoint a VCP within their organizations.

The GDP guidelines issued by the local regulator (the Federal Agency for Medicines and Health Products or famhp) provide for such a requirement. However, it does not define the duties of the VCP and “compliance is not mandatory”.

Both the MDR and the IVDR impose general vigilance requirements on distributors, but both the registration of distributors and the supervision of their vigilance activities by competent authorities remain a competence of the Member States under EU law. Further information on the local specificities of the VCP is available on the famhp website (Dutch version – French version).

Eudamed sanctions

The decree creates a new section in the implementing decree of the MDR entitled “Registration of manufacturers, agents and importers”. This new section deals with the sanctions that can be imposed on economic operators who have not confirmed the accuracy of the data they have entered on Eudamed (the European online database of medical devices developed by the European Commission) such as the demands the MDR. If a violation of this MDR requirement is confirmed, famhp may take corrective action by suspending the operators’ activities until they become compliant.

Eudamed data must be confirmed no later than one year after the first submission, and then every two years (Article 31(5) of the MDR).

Producers and sterilizers of systems and procedure packs are bound by different Eudamed registration requirements (MDR Article 29(2)).

The local registration conditions on the famhp portal remain unchanged by the decree.

Derogations

The procedure for requesting exemptions to Article 59 has been clarified. Article 59 of the MDR (Derogation from conformity assessment procedures) grants competent national authorities such as the famhp the power to authorise, upon duly justified request, the circulation on their territory of devices which are not ( yet) CE marked.

In Belgium, this procedure – which gained popularity during the Covid-19 pandemic and continues to be used by economic operators struggling with notified body bottlenecks – can only be triggered by manufacturers, agents or those duly authorized by them. The decree specifies the minimum information that applicants must provide, far from the complex application forms that they will have to fill out in practice to meet the requirements of the regulator (see the standard form and the patient-specific form).

Performance studies decree

The new decree regulates the conduct of performance studies in Belgium, including when Belgium acts as “Coordinating Member State” or “Member State concerned” in accordance with Article 74 of the IVDR (Coordinated Evaluation Procedure performance studies).

Prior authorization and review by the ethics committee

It submits the following studies to prior authorization by the famhp and to an examination by the ethics committee (EC) according to the distribution of responsibilities listed in appendix Ia of the decree (see our extract in Dutch – French):

• Performance studies involving invasive removal, interventional clinical performance studies and performance studies involving additional invasive procedures or other risks to subjects (Article 58(1) IVDR);
• Performance studies involving companion diagnostics (including those using leftover samples only) (Article 58(2), first sentence of the IVDR).

A separate and specific authorization procedure is established by the decree relating to performance studies of devices manufactured and used in healthcare establishments (Article 5 (5) of the IVDR). Requests for authorization must follow the outline of appendix IV (see our extract in Dutch – French).

EU law is silent on the regulatory framework applicable to such studies. The national specificities provided for in Chapter 3 of the decree have been applied in accordance with Articles 34 and 36 of the Treaty on the Functioning of the European Union by the Belgian Council of State.

Opinion and review of the ethics committee

Under the new decree, the following studies are not subject to prior authorization but must be notified and subject to an EC opinion according to the checklist in Annex II (see our extract in Dutch – French) of the decree:

• PMPF studies, which consist of subjecting subjects to procedures complementary to those performed under normal conditions of use of the device, when these complementary procedures are invasive or costly (article 70 of the IVDR).

PMPF studies are performance studies conducted to further evaluate, within the scope of its intended use, an IVD device that already bears the CE mark. For greater clarity, the performance studies carried out to evaluate a device that already bears the CE marking, outside the scope of its intended purpose, are subject to the famhp/CE authorization procedure mentioned above.

In accordance with the IVDR, the decree also requires that the following studies be notified to the famhp by their sponsor:

• Performance studies involving companion diagnostics using only leftover samples (Article 58, paragraph 2, second sentence of the IVDR).

A model notification form is provided in appendix III (see our extract in Dutch – French), mistakenly called “request form” in article 21 of the decree. As part of this notification, the study protocol and informed consent documentation must also be provided to the regulatory body, unless this documentation has already been approved by an EC under the Health and Safety Act. human experiments. In order to use the remaining samples in a performance study, informed consent from the patient must have been obtained at the time of sample collection according to the regulator. Sponsors must therefore provide famhp with proof that consent has been obtained.

Substantial changes

Substantial changes to the above studies are generally subject to notification to famhp and review by the EC. This means that the famhp is also involved, for example, in the examination of substantial modifications of the PMPF studies mentioned above with the EC; the two bodies are responsible for examining the appropriateness of the modifications in accordance with appendix Ib of the decree (see our excerpt in Dutch – French).

Noncompliance

A certain number of corrective measures can be taken by the famhp in collaboration with the Ministry of Health when non-conformities are identified. These range from requests to change any aspect found to be non-compliant, to suspending or stopping performance studies, to revoking relevant permissions, where applicable. The decree specifies the applicable procedure and the rights of the sponsors, in particular that of expressing themselves before a measure is taken.

Commentary by Osborne Clarke

The two new decrees aim to solidify the Belgian regulatory framework in the post-MDR/IVDR era. Although labeled as IVD-specific legislation, it was partly used to align national legislation with a number of MDR changes and requirements that are not specific to IVD companies, months after the May 2021 deadlines. and May 2022. The old legislation enacted before the MDR/IVDR coexists with these new requirements in a disparate but extremely dense regulatory framework where local specificities and the implementation of the EU acquis merge. This configuration should encourage companies active in the local market to monitor their steps in the construction of their regulatory strategy. Delays in the implementation of EU regulations and inconsistencies between updated rules and the regulator’s website support this recommendation. Belgium is one of the top 10 countries in the European IVD market and in the medical device market (MedTech Europe, The European Medical Technology Industry in figures 2022).

Relevant legislation in French and Dutch

[Accordion content]

Rishi Sunak will bring back Britain’s Bill of Rights as part of his bid to stop migrants crossing the English Channel, The Telegraph can reveal.

Ministers are set to introduce legislation to ensure the supremacy of UK courts over Strasbourg, after a legal challenge under the European Convention on Human Rights grounded the first flight of asylum seekers to Rwanda.

Downing Street sources have said that while the sweeping 44-page Bill of Rights is not a “silver bullet” to solving the migrant crisis, it would allow UK courts to ignore European case law more often.

It will also make it easier for the government to deport foreign criminals who claim their right to family life should trump public safety.

In September, Liz Truss dropped the same bill, with sources close to her describing it as a “complete mess” containing too many measures in one document.

Some members of the legal profession and human rights groups also opposed it, who described it as a “grab of power” by the state.

But the Bill of Rights was championed by Dominic Raab, who was reappointed to Cabinet as Justice Secretary by Mr Sunak after seven weeks on the bench while Ms Truss was in Downing Street.

On Saturday evening he said the bill would “inject a healthy dose of common sense back into the system and put an end to the abuse of our laws” and would “make it clear that the Supreme Court of the United Kingdom is not subordinate to the European court of human rights”.

European decisions will no longer become case law

Although the bill does not directly address the issue of illegal migration, it does mean that interim injunctions issued by the Court of Strasbourg against the UK government will not become case law in Britain.

Officials believe migrants will be less likely to cross the Channel in small boats if they risk being sent to Rwanda, but the policy is on hold while it is challenged in British courts.

The bill is likely to be controversial in some quarters, after Tory MPs said the only way to resolve the row between Strasbourg and the UK courts was to leave the ECHR altogether.

Suella Braverman, the Home Secretary, has previously said that ‘ultimately we have to leave the European Convention on Human Rights’ and that it was her ‘dream’ and her ‘obsession’ to see a plane taking off for Rwanda containing asylum seekers.

But a Number 10 source said Mr Raab and Ms Braverman were ‘on the same page’ on the need to pass a bill of rights and highlighted comments she had made as attorney general where she supported the decision.

The legislation also contains measures allowing terrorists to be held in solitary confinement without a “right to socialization” and makes it more difficult for courts to order journalists to reveal their sources.

Ms Braverman issued a fresh warning that ‘the abuse of the system must stop’ in a Mail on Sunday article.

In another hint about changes to UK migration laws, she wrote: “Where national or international law interferes with our sovereign right to defend our borders, I will act.

“Many Albanians falsely claim to be victims of ‘modern slavery’ – despite having paid thousands of dollars to come here. This is an abuse of our system that must end.”

She insisted the system must focus on the ‘real victims of slavery’ and doubled down on her defense of the Rwandan project, adding: ‘This is the plan the British people want. I will implement it “.

The European Commission wants to reduce the environmental impact of packaging by requiring producers to use a minimum amount of recycled plastic in new packaging placed on the market.

According to industry group Plastics Europe, only 5% of plastic in packaging came from recycled sources in 2019. And recyclers face an uphill battle to sell secondary materials in a market dominated by cheaper, higher-quality virgin supplies.

To address this, Brussels should stimulate demand for recycled plastic by extending recycled content targets from plastic bottles to all plastic packaging.

A proposal to this effect will be presented as part of the revision of the European directive on packaging and packaging waste, which is expected on 30 November.

A leaked draft proposal, seen by EURACTIV, requires all plastic packaging placed on the EU market to “contain a certain minimum amount of recycled content recovered from post-consumer plastic waste” from January 2030.

The 2030 targets, which are tentative and could still change before the proposal is released, would increase again by 2040 as follows:

• 25% for contact-sensitive plastic packaging such as food packaging (50% from 2040)
• 50% for single-use plastic beverage bottles (65% from 2040)
• 45% for other plastic packaging (65% from 2040)

Whatever the objectives finally adopted, the intention is clear: Brussels wants to boost the market for recycled plastics by imposing a minimum quantity of recycled materials in new packaging.

The move should also increase collection rates and incentivize companies to design products that comply with the recycling process, as it becomes in their interest to do so, according to the recycling industry association, EuRIC.

“If you want to have recycled content, you have to have eco-design,” said EuRIC Secretary General Emmanuel Katrakis. “You have to have a proper collection. You must have recycling. You have to have industries that are going to buy recycled materials. Then it’s everyone’s responsibility to make sure it works,” he told EURACTIV.

Recycled content targets already exist for plastic bottles made from polyethylene terephthalate (PET) under the EU Single-Use Plastics Directive, which states that 25% of bottles must come from recycled plastic by 2025, and increase to 30% by 2030.

These recycled content goals have resulted in a system change in the production and recycling of plastic bottles, according to Katrakis. Recycling PET saves over 70% energy and CO2 emissions and this is now better reflected in the price, he explained.

EU plastics producers have already claimed a bond European recycled content target of 30% by 2030.

But beverage carton makers say the target should be no more than 30%. Otherwise it will create gaps with the single-use plastic directive, warns Annick Carpentier from the Alliance for Beverage Cartons and the Environment (ACE).

Beverage cartons pose a challenge to recyclers because they contain a layer of plastic inside the packaging. These are added to ensure the contents are protected from moisture and air, as well as to ensure a longer shelf life of drinks, soups and sauces.

While techniques exist to separate plastics from fiber, they have not yet been deployed on a large scale. A potential solution would be to adapt the packaging design to facilitate the separation of the different layers of plastic and paper and to improve recyclability.

“Eco-design is indeed another very important factor in increasing recycling rates for things like multi-layer packaging,” said Mike Turner, chief executive of the European Cardboard Manufacturers Association (ECMA). “And that means designing recyclability into the packaging item,” he told EURACTIV in a recent interview.

Materials in contact with food

Another challenge with using recycled plastic is ensuring it can be used safely in food packaging.

In order to enable safe recycled content in food materials, there needs to be a comprehensive overhaul of food contact materials regulations to eliminate hazardous chemicals in virgin materials and therefore ensure that secondary raw materials do not contain toxins, said Dorota Napierska, an activist at Zero Waste Europe.

According to her, policymakers should focus more on reuse rather than recycling, because otherwise “it could justify the massive use of single-use solutions as long as they are recycled”.

ACE says it’s not opposed to recycled content targets for plastic as long as it’s safe for consumers. However, the amount of recycled plastic legally allowed to be used in food contact materials is limited, Carpentier told EURACTIV. Therefore, for safety reasons, it may not be the best option to mandate recycled content for contact-sensitive applications, she argued.

In 2019, an estimated 41% of plastic packaging waste was recycled in the EUwhich makes the case for recycled content targets to stimulate recycling.

But EuRIC wants the European Commission to go beyond the recycled content targets for plastic and apply them to other types of materials.

“It’s not just about fairness, it’s because the same benefits will occur no matter what material you’re going to recycle,” Katrakis explained.

The director of Zero Waste Europe agrees. Recycled content targets have proven to be the most effective driver for packaging legislation and are a tool that should be explored for other materials, Joan Marc Simon told EURACTIV.

“Having recycled content targets for other materials would also be very helpful in ensuring that closed-loop recycling actually happens. Aluminum cans, for example, are highly recyclable, but there are no can-to-can recycling systems in countries like France. A recycled content target could unlock situations like these,” he explained.

But Carpentier is against recycled content targets for materials like paper, which already achieve high levels of recycling.

“Recycled fibers are finding their way into new products and we don’t think it would make sense, both economically and environmentally, to direct these fibers in a closed loop to the same products,” he said. she told EURACTIV.

The “waste nirvana” of closed-loop recycling

What everyone agrees on is to improve waste collection, as this will be essential to ensure that enough materials are available to be recycled into new products.

Reloop, a coalition of industrial and environmental NGOs, called for 90% separate collection for recycling target by 2029 for all beverage packaging, whether metal, glass or plastic.

It also calls for the adoption of deposit-refund systems (DRS) in Member States whose collection performance fails to meet the intermediate steps necessary to reach the 90% target.

“A separate collection target of 90% will ensure higher recycling rates and recycled content in packaging” when provisions are included to divert containers into a bottle-to-bottle and can-to-can closed-loop recycling system, says Coalition.

Denmark, Finland, Germany, Norway and Lithuania are already meeting the 90% Reloop target, while 18 EU countries, covering 45% of the EU population, will have implemented deposit return systems (DRS) by 2026, according to the group.

And after a few firsts oppositionmajor players in the industry are now openly proof DRS, Reloop points out, saying the 90% target would “produce huge climate savings and push the beverage industry into a ‘waste nirvana’ of closed-loop recycling.”

[Edited by Frédéric Simon]

Always working with partners in Europe to ensure end-of-life vehicles and batteries are taken back and recycled in accordance with the law.

Aiways, the Shanghai start-up, focuses primarily on sustainability. It goes far beyond vehicles, but forms a cycle from development, to production, to the product life cycle and to recycling.

The Chinese market currently offers the best environment for the production of battery electric vehicles. Nowhere else in the world can production take place more locally and with shorter supply chains. Added to this is the innovative Aiways production site, which was built in cooperation with Siemens in accordance with Industry 4.0 standards and is one of the most modern vehicle production sites in the world.

All process steps have been developed and optimized with a view to environmental compatibility and the conservation of resources. From handling chemicals in the paint process to treating wastewater and optimizing frequency in the plant’s internal power grid, all possible savings have been aligned with the company’s “blue and green” strategy. the company. “Blue” for advanced technology and “Green” for low CO₂ emissions.

Aiways also goes further in the use of renewable energies. For example, Aiways smart factory solar thermal system has an average daily production of 130,000 liters of hot water, which is heated to 48°C and used not only in the production process but also in buildings. administrative.

In addition, there is a photovoltaic system with an annual output of 16 megawatt hours, which is equivalent to the initial charge of more than 250,000 Aiways U5 SUVs and Aiways U6 SUV-Coupés.

The best possible customer support at every stage of the vehicle lifecycle

In addition to innovative sales models and direct customer contact, Aiways also stands for the best possible support beyond the vehicle life cycle. In Europe in particular, battery-powered products are subject to strict control and monitoring, especially electric cars.

Dr Alexandre Klose, The Executive Vice President of Overseas Operations at Aiways, said:

In collaboration with strong partners, Aiways therefore guarantees at all times the implementation of and compliance with applicable standards and laws.

“This applies not only to the trade-in of end-of-life vehicles, but also to damaged batteries in crashed vehicles,” says Dr. Alexander Klose, Executive Vice President of Overseas Operations at Aiways, explaining the range. of services offered by PRIOREC recycler vehicle, with whom the company has concluded a cooperation agreement for the German market.

The second chance outside the car: Second Life as sustainable reuse of high-quality drive components

In addition to the cooperation with PRIOREC in Germany, there is another cooperation with Green Vision in France, which is currently in the test phase. The company, which has ten years of experience in this field, specializes in the second-life use of high-voltage components in the automotive industry and not only uses the traction batteries, but also uses the motors for various applications. .

Four former Aiways U5 SUV pre-series test vehicles have been handed over to Green Vision for this purpose and will now be used as test vehicles for various Second Life projects.

On the one hand, it is about creating electrical energy storage systems (ESS) from the high-voltage battery, which can be used, for example, to buffer renewable energies, to increase the degree of self-sufficiency of photovoltaic systems or to stabilize the grid. The second further use is for the 150 kilowatt drive motor, which will be used in electric-powered pleasure craft in the future.

Clever design of drive components as the key to optimal recycling

The reuse of battery vehicle components is nothing new. However, the advantage of the Aiways MAS platform for Second Life applications lies in the modularity of the components.

Yann Lelongfounder of Green Vision, said:

The sandwich structure of the battery in particular is perfect for recycling.

“You can remove the entire battery without much effort, and you can easily and quickly remove the individual modules, thanks to the innovative structure of the Aiways design.”

The advantages also apply to the drive unit, which combines motor, inverter, gearbox and control unit in one housing. This means that the compact yet powerful component can be used directly in other applications, such as the sports boat tested by Green Vision.

Thanks to the second life of essential drive components, the resource utilization of the materials used in Aiways vehicles can again be significantly improved, which ultimately leads to a sustainable cycle. Aiways would like to research and develop even more intensively in this direction in the future and is open to requests for cooperation on this topic.

Strong points:

• Environmentally friendly recycling: Aiways works with strong partners across Europe to ensure that end-of-life vehicles and batteries are taken back and recycled in accordance with the law, even in the case of damaged vehicles
• Clever design: many parts of the high-voltage battery and electric drive system are modular and can be easily recycled
• Sustainable recycling: Drive technology and high-voltage components from Aiways are used in a pilot project with “Green Vision” in battery-powered energy storage systems and in boats with no local emissions

LILY the latest Batteries News shaping the battery market

Rethinking recycling: Aiways with strong partners on the topic of “Second Life”, Shanghai/Munich, October 27, 2022

Bulgaria improved his results on the rule of rightmoving up two positions to 60th from last year’s 62nd place among 140 countries, under the rule of Right Index (RLI) of the world Justice Project (WJP) for 2022. Bulgaria country has 55 points (1 more than last year) out of a possible 100.

However, according to data from the European region, the position of Bulgaria is not so encouraging. There, our country ranks penultimate – 30th position out of 31, with only Hungary placed after it (73rd place in the world).

Over the past year, 13 countries out of a total of 31 recorded declines in the European Union, European Free Trade Association and North America. Of these 13 countries, 4 also recorded a decline in the previous year.

With regard to restrictions on the powers of the state, Bulgaria drops from 95th to 81st place, but in corruption there is a drop of one position – from 76th to 77th place. The first factor measures the degree to which leaders are bound by law. It includes the means, both constitutional and institutional, by which the powers of the government and its officials and representatives are limited and accountable to law. It also includes non-governmental mechanisms for controlling power, such as a free and independent press. The second factor considers three forms of corruption: bribery, improper influence of public or private interests, and misappropriation of public funds or other resources. These three forms of corruption are examined in relation to officials in the executive, judiciary, military, police and legislature.

In terms of the presence of transparent governance, Bulgaria gains two positions – from 56th to 54th place, and with regard to fundamental rights, it loses two positions – from 57th to 59th. The first assessment focuses on open government, defined by the extent to which government shares information, gives people tools to hold government accountable, and encourages citizen engagement in public policy debate. This factor measures whether the basic laws and information about legal rights are published and assesses the quality of information published by the government. The rights assessment focuses on a relatively modest menu of rights firmly established under the United Nations Universal Declaration of Human Rights and most closely linked to the rule of law. right concerns.

In the field of order and security, Bulgaria is again down two positions – to 51st from 49th place.

In the implementation of an appropriate civil procedure Justice, Bulgaria maintains its position from last year – 66th, and in criminal matters Justice it deteriorated by one position – from 72nd to 71st in 2021. WJP’s rule of Right The index measures whether ordinary people can resolve their grievances peacefully and effectively through the civil process. Justice system. It measures whether the Justice the systems are accessible and affordable, and whether they are free from discrimination, corruption and undue influence by government officials. It examines whether court proceedings take place without undue delay and whether judgments are effectively enforced. It also measures the accessibility, impartiality and effectiveness of alternative dispute resolution mechanisms. An efficient criminal Justice system is a key aspect of the rule of right as it is the conventional mechanism for redressing complaints and prosecuting individuals for crimes against society. An assessment of the provision of Justice should consider the whole system, including police, lawyers, prosecutors, judges and prison staff.

For the fifth consecutive year, the rule of right has declined worldwide. World initial data Justice A project in 140 countries and jurisdictions shows that compliance with the rule of right decreased in 61% of countries this year.

Overall, the Scandinavian countries again occupy the first places in the ranking of compliance with the rule of rightwith Denmark as the honorary leader, followed by Norway, Finland, Sweden and the Netherlands, who this year eliminated Germany from the golden five.

Last at 140 is Venezuela, which ranks just behind Cambodia and Afghanistan at 139 and 138.

Worldwide, 4.4 billion people live in countries where the rule of right has declined over the past year.

“We are coming out of the pandemic, but the global recession in the state of right keep on going“, said Elizabeth Andersen, executive director of the World Justice Project. “Basically, the rule of right is about Justice— i.e. responsibility, equal rights and Justice for everyone. And a less just world will certainly be more unstable.“

Index data shows that pre-pandemic authoritarian tendencies – such as weaker executive control and increased attacks on the media – continue to undermine the rule of right globally.

However, the decline is less widespread and extreme than last year, when the Covid shutdown dramatically disrupted Justice systems and governments exercised emergency powers that restricted civil liberties and circumvented transparency mechanisms.

The WJP Index is the world’s leading source of independent rule of law data. It is based on extensive surveys of more than 154,000 ordinary people and 3,600 legal practitioners and experts to measure the rule of right out of eight factors. The factor scores are averaged to determine an overall rule of right score for each country.

Some of the biggest global declines this year are in index factors associated with rising authoritarianism and the long-term erosion of the rule of law. This year, respect for fundamental rights has declined in two-thirds of the countries. Control of state power – such as oversight by the judiciary, legislature and media – has declined in 58% of states this year.

The other major factor behind the global decline this year is the Justicelargely due to ongoing pandemic-related delays, has weakened right law enforcement and increasing discrimination in civil matters Justice systems. Scores for this factor have declined in 61% of states this year.

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La Liga Strike: La Liga LIVE – La Liga clubs are adamant about their stance on blocking the European Super League in…

La Liga strike: La Liga LIVE – La Liga clubs are adamant about their stance on blocking the European Super League in Spain and the Spanish government must make a final decision ahead of this weekend’s fixtures. According to reports, Spanish clubs are even considering going on strike if the government does not succumb to their pressure. A strike would mean that all La Liga matches this weekend would be null and void. Follow LIVE football updates on InsideSport.IN.

La Liga strike: Spanish clubs to go on strike against new law backing European Super League – Will La Liga games take place this WEEKEND?

Fifa World Cup: Will Raphaël Varane miss the World Cup? – CHECK

LaLiga fans could be deprived of seeing the league’s top stars, like Karim Benzema, Vinicius Jr, Robert Lewandowski this weekend if the clubs finally call a strike on October 28. According to reports, 39 of the 42 clubs in Spain’s top two divisions have threatened to strike unless the Spanish government rejects the idea of ​​a European Super League. The three clubs that would be in favor of the Super League are Real Madrid, Barcelona and Athletic Bilbao.

A strike in Spanish football is imminent and La Liga is expected to be shut down this weekend.

This is due to the new sports law which makes the European Super League possible and cancels the CVC agreement, reports @superdeporte_es. pic.twitter.com/WNRN5mUkKQ

— EuroFoot (@eurofootcom) October 25, 2022

La Liga strike: Spanish clubs to go on strike against new law backing European Super League – Will La Liga games take place this WEEKEND?

Real Madrid president Florentino Perez is desperate to revive his failed project and La Liga clubs are now increasingly determined to stop him. The ESL issue is now becoming more political with the business and existence of Spain’s smaller clubs at stake.

The club presidents have already met with Spanish Sports Minister Miquel Iceta. They want to see an update to Spain’s general ‘sports law’ which would see an official rejection of the idea of ​​a Super League. However, the meeting has yet to yield any results and time is running out.

Meanwhile, Royal Spanish Football Federation president Luis Rubiales has dismissed fears of La Liga suspension at the weekend. “I am convinced that neither the government nor the opposition party will be complicit in this. Will the government and the largest opposition party now change the rules of the game and try to legalize what is illegal?

It would be a very serious problem without precedent in the Spanish legal system,” Rubiales told reporters regarding the rumors of clubs going on strike over the weekend.

La Liga strike: Spanish clubs to go on strike against new law backing European Super League – Will La Liga games take place this WEEKEND?

Cristiano Ronaldo SUSPENDED: Erik Ten Hag SUSPENDS Ronaldo after STORMING off saga, asks Portuguese superstar to train with reservations, follow live updates

A final decision on the ‘strike’ will be taken by La Liga after their meeting on Thursday, October 27. If the strike is finally accepted, all La Liga matches this matchweek from October 29 to November 1 will be suspended.

La Liga strike: Spanish clubs to go on strike against new law backing European Super League – Will La Liga games take place this WEEKEND?

Follow LIVE football updates on InsideSport.IN.

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