The new federal government is still gathering itself, the new federal ministry of construction does not yet have a house (oh, the irony!), the agreements on the relocations of the individual units between the individual premises are still in the works. We will likely be able to provide you with more information on the latter, at least in the next issue. But part of getting on is also arriving at the new dossiers.
The new Federal Interior Minister, Nancy Faeser, the new Minister of Justice, Marco Buschmann, and the state ministers of the interior in Germany are arguing about whether it is possible to take action against Telegram. According to the BMJ, the provider from Russia, which is popular with hate propagandists and has its headquarters in Dubai, is also supposed to be a platform under the Network Enforcement Act (NetzDG). However, it has so far already failed to serve a hearing notice in the Emirates. Couldn’t this become a case for the Digital Services Act?
It is intended to replace many old regulations, possibly also parts of the NetzDG. The Council‘s position has now been officially finalized, and yesterday evening the EP’s Internal Market Committee formally approved the compromise proposals of the Schaldemose report. And at the very last millimeter of the negotiations, another proposal received a committee majority. However, Jasmin Kohl reports that by the time the EP plenary votes, which will probably not be until January, there may be a few more alternative proposals.
Fit for 55, part 2 – the Commission’s proposals this week are due on Tuesday and Wednesday, after all. For months there has been a dispute about what is really sustainable, i.e., green in the sense of the Green Deal. Members of the European Parliament and the Commission are not so sure about green hydrogen, which is the subject of regulation in the Gas Directive. It is supposed to be essential for the energy transition. Still, the devil is not only in the details but also in fundamental questions, as Timo Landenberger reports: The impending regulatory chaos could deprive the market of the urgently needed energy that green hydrogen needs if the farewell to coal and gas is to succeed.
Health policy is still primarily dominated by nation-states. But here, too, things are slowly growing closer together via the internal market – the new HTA regulation for health technologies is a representative example of this. Eugenie Ankowitsch has the details.
With this in mind: Stay safe!
Following the presentation of the Fit for 55 package last July, the European Commission will present its second major package of measures to implement the Green Deal this week. Today, the Brussels-based authority will present several projects in the transport sector, followed on Wednesday by proposals on building efficiency, methane reductions, and the gas market.
The new versions of the Gas Market Directive and the Grid Access Ordinance are intended to pave the way for more climate-friendly gases – above all, hydrogen. Hydrogen is seen as the future energy carrier, especially for sectors that cannot be electrified or can only be electrified with difficulty, as only water vapor is produced during combustion. The production conditions are therefore crucial.
Especially for the transition period, so-called blue hydrogen will play a major role. Natural gas is used in its production, and the CO2 produced is captured from the air and stored (CCS). In the long term, however, the EU is focusing on the widespread use of the green equivalent based on renewable energies and is anchoring this goal in several pieces of legislation. For example, the revision of the directive on the expansion of renewable energies stipulates that at least 50 percent of the hydrogen used in industry must be green by 2030.
But the necessary electrolysis technology is still in its infancy. The EU is therefore doing everything it can to accelerate the market ramp-up. However, the associated regulatory chaos tends to lead to the opposite, say critics.
The EU Commission defines the criteria for the production of green hydrogen in a so-called delegated act, which is to be presented by the end of this year. However, the procedure itself is already causing incomprehension among observers. Delegated acts are not preceded by a proper legislative procedure in which parliament and council are involved. According to EU law, the regulations serve to “supplement non-essential rules” and are adopted directly by the Commission. The EU Parliament can only approve or reject them.
Experts, however, do see essential regulations in the legislative packages around low-carbon and renewable energies. “The criteria for the production of green hydrogen should be negotiated politically,” says Markus Pieper, for example, rapporteur of the EU Parliament for the Renewable Energies Directive. The energy policy spokesman of the CDU/CSU group fears that the delegated act will rather prevent than accelerate the market ramp-up of hydrogen. In a letter to Commission President Ursula von der Leyen, which Europe.Table has received, Pieper expresses his concerns and demands improvements.
Main point of criticism: the so-called “additionality”. According to a draft of the regulations, the electricity for the production of green hydrogen must come from newly built renewable energy plants, especially wind farms. Specifically, the plant must be commissioned in the same year as the electrolyzer. In this way, the Commission wants to ensure that the massive production of green hydrogen does not stand in the way of the goal of electrification but rather provides additional capacity in the area of renewables.
However, the requirements are “inexplicably strict” and would “unnecessarily complicate the energy transition”, Pieper says in the letter. The German Association of Energy and Water Industries also stresses that the production of renewable hydrogen and the associated increase in demand will automatically trigger an additional supply of electricity generation from renewable energies. A strict plant-related “additionality” is not necessary.
In addition, the average development time for onshore wind farms is four to five years, for offshore plants, even seven to ten. This means that no electrolyzer could go into operation before mid or by the end of the 2020s. The Federation of German Industries is also calling for production not to be limited to the use of new plants but rather for the lengthy approval procedures to be shortened and the expansion of renewable energies to be massively accelerated.
In addition, the Commission’s draft stipulates that the electrolyzer and wind farm must form a “physical unit”. Energy production and consumption should even take place within one hour. Unlike in the electricity market, where green electricity can be bought at one location by means of certificate trading and fed into the grid by the producer at another location. And this is the case even if the electricity actually used by the buyer does not come from renewable energies at all.
“This increases the share of renewable energies in the overall mix,” said Pieper. The MEP calls on the Commission to enable a comparable system for hydrogen as well. In order to be economically viable, an electrolyzer must be able to produce hydrogen continuously. Due to the strict time limits, however, a constant start-up and shut-down would be necessary. Especially since the regions with high potential for renewable energies and those with high demand are very unevenly distributed across the EU.
The BDI also calls for the criteria for the production of green hydrogen to be “linked as closely as possible to the basic principles of the European internal electricity market”. For example, proof of green power procurement would be provided via market-based mechanisms such as guarantees of origin, and there would be no limitation to national bidding zones, BDI deputy managing director Holger Lösch tells Europe.Table
In addition to large industries, Pieper also has his eye on smaller start-ups in particular, which are developing innovative electrolysis technologies that are urgently needed in the EU in anticipation of a market ramp-up. But the strict requirements of the planned legislation make this practically impossible, she said. “In Europe, the electrolyzer industry is still waiting in the wings. If we fail in creating a domestic market for our technology, the only option would be to buy Chinese or American electrolyzers, as the quotas for green hydropower have to be met, and Europe has set itself the goal of achieving an electrolyzer capacity of 6 GW in 2024,” Pieper writes in his letter to the Commission.
“Great win for women and girls today,” tweeted Alexandra Geese, IMCO shadow rapporteur for the Greens/EFA group, yesterday evening following the vote on the compromise proposals. Her proposal to impose special due diligence requirements on platforms with predominantly user-generated pornographic content had been adopted. Geese herself had spoken of a 50-50 chance for her proposal before the vote. The GUE/NGL and Renew groups had supported it. According to the proposal, users who distribute content on porn platforms would have to go through a two-factor authentication process and provide a verified email address and mobile number. In addition, providers are to follow special procedures to initiate a review process in the event of complaints from those affected by illegal distribution and to make a decision after 48 hours at the latest.
The Social Democrats, the Left, and the Greens were unable to push through their demand for a complete ban on personalized advertising (Europe.Table reported). Instead, the compromise text now provides for a ban on the controversial advertising practice for minors. In addition, adult users should have the choice of whether they consent to the processing of their personal data. The Council position is much less ambitious in this respect: It only provides for transparency obligations for particularly large platforms (Article 30) and codes of conduct for the advertising industry (Article 36).
Rebekka Weiß, head of trust and security at Bitkom, welcomes the fact that personalized advertising is not to be completely banned. “If personalized advertising were to be made more difficult or prevented, certain offers and services would probably no longer be available to consumers free of charge,” she says.
With a separate article (13a), MEPs have spoken out in favor of a ban on so-called dark patterns for all service providers (Europe.Table reported). This would prohibit providers from designing user interfaces in such a way that they lead users to make decisions that are detrimental to themselves. The Council also envisages such a ban, but in contrast to the Parliament, it is weaker: It is to apply only to particularly large platforms (VLOPs).
Klaus Müller, Chairman of the Federation of German Consumer Organisations (VZBV), welcomes the IMCO compromise on dark patterns and other mandatory due diligence requirements such as identity checks. For him, however, the position does not go far enough, especially with regard to the responsibility of online marketplaces: “These due diligence obligations could become a toothless tiger, as violations have no immediate consequences for the online marketplaces,” says Müller. Consumer advocates had insisted that a breach of the due diligence obligations (Article 22) be included in the exemption from liability (Article 5 (3)) – without success.
Rapporteur Schaldemose’s proposal to make online marketplaces liable for the infringement of third-country sellers, irrespective of their size (Article 22), had met with strong opposition. The compromise proposal now provides that: Small and micro enterprises can apply to the Commission for a derogation from Article 22. The Commission is then to examine the request together with the European Committee of Digital Services Coordinators and take its decision in the form of a delegated act. Renew in particular had lobbied for the exemption.
The CEO of the Association of the Internet Industry Eco Oliver Süme welcomes the exemption and warns against overburdening the DSA with special regulations: “It is important to us that the obligations laid down there also and in particular remain implementable for small and micro enterprises, or that they are exempted from them,” he says.
Martin Schirdewan, IMCO shadow rapporteur for the GUE/NGL Group clearly disagrees: “The extensive exemption rules now envisaged for small and partly medium-sized enterprises lead to a bureaucratic monster that is difficult to implement.” He calls for the rules to apply to all companies that employ more than ten people.
A success for the Greens/EFA is the extension of Article 31. Contrary to the Commission’s proposal, not only the Commission, the national supervisory authorities (digital services coordinators), and authorized researchers are to be given access to the data of particularly large platforms in order to be able to investigate systemic risks. NGOs are now also to be given access. These play a crucial role in identifying systemic risks, as whistleblower Frances Haugen also pointed out at her hearing in the European Parliament (Europe.Table reported). “We also wanted to include media organizations in the article, but there was no majority for that,” says MEP Geese.
Rapporteur Schaldemose had originally proposed an obligation for online platforms to remove illegal content within 24 hours if it poses a threat to public safety or health. However, this is not included in the final compromise because the Dane did not get a majority for it.
The issue will certainly come up again in the trilogue negotiations because deletion periods were also controversially discussed in the Council. The member states finally agreed that in the case of a report by so-called trusted flaggers, the majority of illegal hate content should be deleted within less than 24 hours. In other cases, the deadlines should vary, depending on the content and complexity. However, it is striking that the exact deadlines are not found in the actual text of the law, but only in the recitals (46 and 58). Germany has already announced that it will push for more ambitious and legally binding deletion deadlines in the trilogue (Europe.Table reported).
Tiemo Wölken, S&D shadow rapporteur for the DSA in the Legal Affairs Committee, is disappointed by the compromises: “Especially the compromises on advertising and algorithmic recommendation systems remain despondent. Users need real control over their data and the content they see, but unfortunately, the compromises are far from that,” he says. That’s why he wants to make sure that ambitious alternative proposals are on the table before the plenary vote in January.
Patrick Breyer (Greens/EFA), DSA rapporteur for the Committee on Civil Liberties, Justice and Home Affairs, takes a similar stance. Only a few recommendations of the LIBE Committee had been included in the compromise text: “For the plenary vote in January, my committee will probably present a whole series of amendments on the protection of privacy and freedom of expression,” said Breyer.
From 2024, the EU member states are to prepare joint benefit assessments of health technologies (HTA). This means that the first joint HTA reports could be available in 2025: initially for cancer drugs, later also for drugs for rare diseases, and finally for all other drugs and medical devices. But unlike the Commission’s original proposal, they will not be binding on member states.
A coordinating group of national health authorities is to develop joint clinical evaluations. However, the results of the joint scientific assessments should only describe the evidence presented. The HTA agencies in the member states will remain exclusively responsible for the evaluation and pricing. Nevertheless, rapporteur Tiemo Wölken (SPD/S&D) expressed satisfaction with the outcome: “We can ensure from the outset that innovative medicines are assessed on a European basis, and that fragmentation of the market is avoided.”
To ensure that the joint assessment is nevertheless taken into account in the national procedures, the new HTA Regulation obliges the EU states to use the report and to avoid repetition in the overall HTA procedures of the member states. Nevertheless, the national HTA agencies are in principle allowed to re-evaluate. This means that the original objective of harmonized benefit assessments to be implemented on a binding basis has been missed.
Currently, the HTA process is carried out by over 50 European HTA agencies. In Germany, for example, all newly approved drugs are subjected to a benefit assessment by the Institute for Quality and Efficiency in Health Care (IQWiG). The result is the basis for decision-making in price negotiations with the health insurance funds.
However, smaller countries like Lithuania or Cyprus cannot afford their own HTA institutions. But they could benefit from the know-how of the larger countries, argued the EU Commission when it presented its proposal at the beginning of 2018. This should also avoid duplication of work – both at pharmaceutical companies and in the individual member states. In addition, access for patients to new therapies should be improved and accelerated.
The proposal was immediately met with fierce opposition. In particular, larger EU countries with their own procedures, such as Germany and France, rejected the EU Commission’s proposal. The draft met with a divided response from players in the German healthcare system. While the internationally operating industry was generally in favor of the harmonization efforts, they were criticized, in some cases strongly, by the self-government of physicians and health insurance funds as well as by IQWiG and the Federal Joint Committee.
The central point of contention was the originally planned binding nature of the harmonized assessments for national benefit decisions. Germany and France, together with other member states, therefore submitted a formal subsidiarity complaint, which was, however, joined by too few other countries. In addition to the content-related dispute, the COVID-19 pandemic occurred at the beginning of 2020, and negotiations were interrupted for a total of almost a year. It was not until spring 2021 that an agreement was reached in the Council, followed by the trialogue with Parliament and the Commission. The EP has now adopted this compromise.
IQWiG, which is responsible for benefit assessment in Germany, reacted cautiously to adopting the HTA Regulation. “The system of benefit assessment of health technologies functions very well in Germany and has a high level of acceptance – also among industry,” said IQWiG spokesperson Jens Flintrop. The new European regulation is not expected to have any direct benefit for the German health care system. However, it also does no harm, says Flintrop, “as long as we can agree on uniform standards.” He also sees positive aspects: “If harmonization also makes new medicines quickly accessible in other EU countries and pricing becomes more transparent and fairer, that is also in our interest.”
Overall, health economist Reinhard Busse from the Technical University of Berlin is much more positive about the European regulations. “Especially with regard to the benefit assessment of medical devices, Germany can also benefit from the new regulation,” he explained to Europe.Table. Because there he sees clear deficits in this country. “As more such assessments will be available at the European level in the future, the pressure to subject more medical devices to a benefit assessment will grow,” Busse said.
Busse is also optimistic about the impact of the new regulation and emphasises the “power of the factual”: Germany will hardly be able to give a good reason for deviating from EU standards. Because then it would have to explain “that what applies to the other 26 countries is not sufficient for Germany.”
The new regulation prescribes a transitional period of three years after the entry into force of the regulation. After that, the new regulations are to become directly applicable. During this phase, methodological issues are to be clarified, among other things. The consortium “EUnetHTA21” was awarded the contract for the development of the methodological basis. This consortium consists of 13 organisations from the European HTA network EUnetHTA, including IQWiG and the G-BA from Germany, as well as HTA agencies from Spain, Austria, Belgium, France, Italy, Portugal, Ireland, Hungary, Norway, Sweden and the Netherlands.
She was already dealing with the legal dimensions of the digital world when only a small, dedicated community had a clear view of it: Cornelia Kutterer has been a specialist for over twenty years. And for thirteen of them at Microsoft. As Senior Director, Rule of Law, Responsible Tech & Competition, European Government Affairs, she leads a team that deals with the legal aspects of everything that becomes relevant in the responsible use of technology. So digital security, data protection, the handling of artificial intelligence (AI), content regulation, and many other social and regulatory issues that affect technological advances and their impact.
Kutterer’s eyes sparkle when she talks about her work. For example, how she discusses expertise on complex new technologies with the academic world and thus contributes to shaping European opinion. Of course, contact with the Commission, the Parliament, the Council of the European Union, and the member states is also part of the job. Unlike in the past, Microsoft is often not in the first line of companies criticized.
The Artificial Intelligence Act, the EU Commission’s draft regulation on the horizontal regulation of the use of artificial intelligence, is currently the subject of intense debate. All over the world, people are currently agreeing on specific values when dealing with AI, says Kutterer. She finds this exciting in comparison to the European General Data Protection Regulation (GDPR) of 2018 because: “After the GDPR, there was a real wave of data protection regulation worldwide. The EU had a pioneering role there as a ‘first mover’. I believe it will be similar with the AI Act.” The good thing is that while data protection regulations lagged behind technological developments by several years, these discussions are taking place simultaneously with AI.
Born in Stuttgart, she is European with heart and soul. She lives with her family in a suburb of Brussels, and her three children have Belgian citizenship. Kutterer raves about the cultural diversity of the Flemish, Walloon, European, and African scenes.
During her law studies in Stuttgart, Passau, and Hamburg, she specialized in European and labor law. In 2000, she added another area of expertise with an online master’s degree in “Information Technology” – at precisely the right time. “Back then, the subject was still in its infancy and not as complicated as it is today,” she says mischievously. After working in a law firm and for the European consumer protection association BEUC, Kutterer was poached by Microsoft in 2008. She looks back with amusement: “It was even worth a headline back then: ‘Key Consumer Activist Joins Microsoft’. That kind of thing doesn’t happen anymore.”
Most recently, Microsoft’s perspective has broadened once again. “Inclusion, sustainability, digital transition: The issues have become bigger”. Geopolitics is also increasingly playing a role. “The Trump era was not exactly easy for us as an American company in Brussels,” Kutterer sums up dryly. But whether she deals more intensively with AI in the future, with quantum computers or the metaverse: “It’s always exciting.” Gundula Haage
The new federal government is still gathering itself, the new federal ministry of construction does not yet have a house (oh, the irony!), the agreements on the relocations of the individual units between the individual premises are still in the works. We will likely be able to provide you with more information on the latter, at least in the next issue. But part of getting on is also arriving at the new dossiers.
The new Federal Interior Minister, Nancy Faeser, the new Minister of Justice, Marco Buschmann, and the state ministers of the interior in Germany are arguing about whether it is possible to take action against Telegram. According to the BMJ, the provider from Russia, which is popular with hate propagandists and has its headquarters in Dubai, is also supposed to be a platform under the Network Enforcement Act (NetzDG). However, it has so far already failed to serve a hearing notice in the Emirates. Couldn’t this become a case for the Digital Services Act?
It is intended to replace many old regulations, possibly also parts of the NetzDG. The Council‘s position has now been officially finalized, and yesterday evening the EP’s Internal Market Committee formally approved the compromise proposals of the Schaldemose report. And at the very last millimeter of the negotiations, another proposal received a committee majority. However, Jasmin Kohl reports that by the time the EP plenary votes, which will probably not be until January, there may be a few more alternative proposals.
Fit for 55, part 2 – the Commission’s proposals this week are due on Tuesday and Wednesday, after all. For months there has been a dispute about what is really sustainable, i.e., green in the sense of the Green Deal. Members of the European Parliament and the Commission are not so sure about green hydrogen, which is the subject of regulation in the Gas Directive. It is supposed to be essential for the energy transition. Still, the devil is not only in the details but also in fundamental questions, as Timo Landenberger reports: The impending regulatory chaos could deprive the market of the urgently needed energy that green hydrogen needs if the farewell to coal and gas is to succeed.
Health policy is still primarily dominated by nation-states. But here, too, things are slowly growing closer together via the internal market – the new HTA regulation for health technologies is a representative example of this. Eugenie Ankowitsch has the details.
With this in mind: Stay safe!
Following the presentation of the Fit for 55 package last July, the European Commission will present its second major package of measures to implement the Green Deal this week. Today, the Brussels-based authority will present several projects in the transport sector, followed on Wednesday by proposals on building efficiency, methane reductions, and the gas market.
The new versions of the Gas Market Directive and the Grid Access Ordinance are intended to pave the way for more climate-friendly gases – above all, hydrogen. Hydrogen is seen as the future energy carrier, especially for sectors that cannot be electrified or can only be electrified with difficulty, as only water vapor is produced during combustion. The production conditions are therefore crucial.
Especially for the transition period, so-called blue hydrogen will play a major role. Natural gas is used in its production, and the CO2 produced is captured from the air and stored (CCS). In the long term, however, the EU is focusing on the widespread use of the green equivalent based on renewable energies and is anchoring this goal in several pieces of legislation. For example, the revision of the directive on the expansion of renewable energies stipulates that at least 50 percent of the hydrogen used in industry must be green by 2030.
But the necessary electrolysis technology is still in its infancy. The EU is therefore doing everything it can to accelerate the market ramp-up. However, the associated regulatory chaos tends to lead to the opposite, say critics.
The EU Commission defines the criteria for the production of green hydrogen in a so-called delegated act, which is to be presented by the end of this year. However, the procedure itself is already causing incomprehension among observers. Delegated acts are not preceded by a proper legislative procedure in which parliament and council are involved. According to EU law, the regulations serve to “supplement non-essential rules” and are adopted directly by the Commission. The EU Parliament can only approve or reject them.
Experts, however, do see essential regulations in the legislative packages around low-carbon and renewable energies. “The criteria for the production of green hydrogen should be negotiated politically,” says Markus Pieper, for example, rapporteur of the EU Parliament for the Renewable Energies Directive. The energy policy spokesman of the CDU/CSU group fears that the delegated act will rather prevent than accelerate the market ramp-up of hydrogen. In a letter to Commission President Ursula von der Leyen, which Europe.Table has received, Pieper expresses his concerns and demands improvements.
Main point of criticism: the so-called “additionality”. According to a draft of the regulations, the electricity for the production of green hydrogen must come from newly built renewable energy plants, especially wind farms. Specifically, the plant must be commissioned in the same year as the electrolyzer. In this way, the Commission wants to ensure that the massive production of green hydrogen does not stand in the way of the goal of electrification but rather provides additional capacity in the area of renewables.
However, the requirements are “inexplicably strict” and would “unnecessarily complicate the energy transition”, Pieper says in the letter. The German Association of Energy and Water Industries also stresses that the production of renewable hydrogen and the associated increase in demand will automatically trigger an additional supply of electricity generation from renewable energies. A strict plant-related “additionality” is not necessary.
In addition, the average development time for onshore wind farms is four to five years, for offshore plants, even seven to ten. This means that no electrolyzer could go into operation before mid or by the end of the 2020s. The Federation of German Industries is also calling for production not to be limited to the use of new plants but rather for the lengthy approval procedures to be shortened and the expansion of renewable energies to be massively accelerated.
In addition, the Commission’s draft stipulates that the electrolyzer and wind farm must form a “physical unit”. Energy production and consumption should even take place within one hour. Unlike in the electricity market, where green electricity can be bought at one location by means of certificate trading and fed into the grid by the producer at another location. And this is the case even if the electricity actually used by the buyer does not come from renewable energies at all.
“This increases the share of renewable energies in the overall mix,” said Pieper. The MEP calls on the Commission to enable a comparable system for hydrogen as well. In order to be economically viable, an electrolyzer must be able to produce hydrogen continuously. Due to the strict time limits, however, a constant start-up and shut-down would be necessary. Especially since the regions with high potential for renewable energies and those with high demand are very unevenly distributed across the EU.
The BDI also calls for the criteria for the production of green hydrogen to be “linked as closely as possible to the basic principles of the European internal electricity market”. For example, proof of green power procurement would be provided via market-based mechanisms such as guarantees of origin, and there would be no limitation to national bidding zones, BDI deputy managing director Holger Lösch tells Europe.Table
In addition to large industries, Pieper also has his eye on smaller start-ups in particular, which are developing innovative electrolysis technologies that are urgently needed in the EU in anticipation of a market ramp-up. But the strict requirements of the planned legislation make this practically impossible, she said. “In Europe, the electrolyzer industry is still waiting in the wings. If we fail in creating a domestic market for our technology, the only option would be to buy Chinese or American electrolyzers, as the quotas for green hydropower have to be met, and Europe has set itself the goal of achieving an electrolyzer capacity of 6 GW in 2024,” Pieper writes in his letter to the Commission.
“Great win for women and girls today,” tweeted Alexandra Geese, IMCO shadow rapporteur for the Greens/EFA group, yesterday evening following the vote on the compromise proposals. Her proposal to impose special due diligence requirements on platforms with predominantly user-generated pornographic content had been adopted. Geese herself had spoken of a 50-50 chance for her proposal before the vote. The GUE/NGL and Renew groups had supported it. According to the proposal, users who distribute content on porn platforms would have to go through a two-factor authentication process and provide a verified email address and mobile number. In addition, providers are to follow special procedures to initiate a review process in the event of complaints from those affected by illegal distribution and to make a decision after 48 hours at the latest.
The Social Democrats, the Left, and the Greens were unable to push through their demand for a complete ban on personalized advertising (Europe.Table reported). Instead, the compromise text now provides for a ban on the controversial advertising practice for minors. In addition, adult users should have the choice of whether they consent to the processing of their personal data. The Council position is much less ambitious in this respect: It only provides for transparency obligations for particularly large platforms (Article 30) and codes of conduct for the advertising industry (Article 36).
Rebekka Weiß, head of trust and security at Bitkom, welcomes the fact that personalized advertising is not to be completely banned. “If personalized advertising were to be made more difficult or prevented, certain offers and services would probably no longer be available to consumers free of charge,” she says.
With a separate article (13a), MEPs have spoken out in favor of a ban on so-called dark patterns for all service providers (Europe.Table reported). This would prohibit providers from designing user interfaces in such a way that they lead users to make decisions that are detrimental to themselves. The Council also envisages such a ban, but in contrast to the Parliament, it is weaker: It is to apply only to particularly large platforms (VLOPs).
Klaus Müller, Chairman of the Federation of German Consumer Organisations (VZBV), welcomes the IMCO compromise on dark patterns and other mandatory due diligence requirements such as identity checks. For him, however, the position does not go far enough, especially with regard to the responsibility of online marketplaces: “These due diligence obligations could become a toothless tiger, as violations have no immediate consequences for the online marketplaces,” says Müller. Consumer advocates had insisted that a breach of the due diligence obligations (Article 22) be included in the exemption from liability (Article 5 (3)) – without success.
Rapporteur Schaldemose’s proposal to make online marketplaces liable for the infringement of third-country sellers, irrespective of their size (Article 22), had met with strong opposition. The compromise proposal now provides that: Small and micro enterprises can apply to the Commission for a derogation from Article 22. The Commission is then to examine the request together with the European Committee of Digital Services Coordinators and take its decision in the form of a delegated act. Renew in particular had lobbied for the exemption.
The CEO of the Association of the Internet Industry Eco Oliver Süme welcomes the exemption and warns against overburdening the DSA with special regulations: “It is important to us that the obligations laid down there also and in particular remain implementable for small and micro enterprises, or that they are exempted from them,” he says.
Martin Schirdewan, IMCO shadow rapporteur for the GUE/NGL Group clearly disagrees: “The extensive exemption rules now envisaged for small and partly medium-sized enterprises lead to a bureaucratic monster that is difficult to implement.” He calls for the rules to apply to all companies that employ more than ten people.
A success for the Greens/EFA is the extension of Article 31. Contrary to the Commission’s proposal, not only the Commission, the national supervisory authorities (digital services coordinators), and authorized researchers are to be given access to the data of particularly large platforms in order to be able to investigate systemic risks. NGOs are now also to be given access. These play a crucial role in identifying systemic risks, as whistleblower Frances Haugen also pointed out at her hearing in the European Parliament (Europe.Table reported). “We also wanted to include media organizations in the article, but there was no majority for that,” says MEP Geese.
Rapporteur Schaldemose had originally proposed an obligation for online platforms to remove illegal content within 24 hours if it poses a threat to public safety or health. However, this is not included in the final compromise because the Dane did not get a majority for it.
The issue will certainly come up again in the trilogue negotiations because deletion periods were also controversially discussed in the Council. The member states finally agreed that in the case of a report by so-called trusted flaggers, the majority of illegal hate content should be deleted within less than 24 hours. In other cases, the deadlines should vary, depending on the content and complexity. However, it is striking that the exact deadlines are not found in the actual text of the law, but only in the recitals (46 and 58). Germany has already announced that it will push for more ambitious and legally binding deletion deadlines in the trilogue (Europe.Table reported).
Tiemo Wölken, S&D shadow rapporteur for the DSA in the Legal Affairs Committee, is disappointed by the compromises: “Especially the compromises on advertising and algorithmic recommendation systems remain despondent. Users need real control over their data and the content they see, but unfortunately, the compromises are far from that,” he says. That’s why he wants to make sure that ambitious alternative proposals are on the table before the plenary vote in January.
Patrick Breyer (Greens/EFA), DSA rapporteur for the Committee on Civil Liberties, Justice and Home Affairs, takes a similar stance. Only a few recommendations of the LIBE Committee had been included in the compromise text: “For the plenary vote in January, my committee will probably present a whole series of amendments on the protection of privacy and freedom of expression,” said Breyer.
From 2024, the EU member states are to prepare joint benefit assessments of health technologies (HTA). This means that the first joint HTA reports could be available in 2025: initially for cancer drugs, later also for drugs for rare diseases, and finally for all other drugs and medical devices. But unlike the Commission’s original proposal, they will not be binding on member states.
A coordinating group of national health authorities is to develop joint clinical evaluations. However, the results of the joint scientific assessments should only describe the evidence presented. The HTA agencies in the member states will remain exclusively responsible for the evaluation and pricing. Nevertheless, rapporteur Tiemo Wölken (SPD/S&D) expressed satisfaction with the outcome: “We can ensure from the outset that innovative medicines are assessed on a European basis, and that fragmentation of the market is avoided.”
To ensure that the joint assessment is nevertheless taken into account in the national procedures, the new HTA Regulation obliges the EU states to use the report and to avoid repetition in the overall HTA procedures of the member states. Nevertheless, the national HTA agencies are in principle allowed to re-evaluate. This means that the original objective of harmonized benefit assessments to be implemented on a binding basis has been missed.
Currently, the HTA process is carried out by over 50 European HTA agencies. In Germany, for example, all newly approved drugs are subjected to a benefit assessment by the Institute for Quality and Efficiency in Health Care (IQWiG). The result is the basis for decision-making in price negotiations with the health insurance funds.
However, smaller countries like Lithuania or Cyprus cannot afford their own HTA institutions. But they could benefit from the know-how of the larger countries, argued the EU Commission when it presented its proposal at the beginning of 2018. This should also avoid duplication of work – both at pharmaceutical companies and in the individual member states. In addition, access for patients to new therapies should be improved and accelerated.
The proposal was immediately met with fierce opposition. In particular, larger EU countries with their own procedures, such as Germany and France, rejected the EU Commission’s proposal. The draft met with a divided response from players in the German healthcare system. While the internationally operating industry was generally in favor of the harmonization efforts, they were criticized, in some cases strongly, by the self-government of physicians and health insurance funds as well as by IQWiG and the Federal Joint Committee.
The central point of contention was the originally planned binding nature of the harmonized assessments for national benefit decisions. Germany and France, together with other member states, therefore submitted a formal subsidiarity complaint, which was, however, joined by too few other countries. In addition to the content-related dispute, the COVID-19 pandemic occurred at the beginning of 2020, and negotiations were interrupted for a total of almost a year. It was not until spring 2021 that an agreement was reached in the Council, followed by the trialogue with Parliament and the Commission. The EP has now adopted this compromise.
IQWiG, which is responsible for benefit assessment in Germany, reacted cautiously to adopting the HTA Regulation. “The system of benefit assessment of health technologies functions very well in Germany and has a high level of acceptance – also among industry,” said IQWiG spokesperson Jens Flintrop. The new European regulation is not expected to have any direct benefit for the German health care system. However, it also does no harm, says Flintrop, “as long as we can agree on uniform standards.” He also sees positive aspects: “If harmonization also makes new medicines quickly accessible in other EU countries and pricing becomes more transparent and fairer, that is also in our interest.”
Overall, health economist Reinhard Busse from the Technical University of Berlin is much more positive about the European regulations. “Especially with regard to the benefit assessment of medical devices, Germany can also benefit from the new regulation,” he explained to Europe.Table. Because there he sees clear deficits in this country. “As more such assessments will be available at the European level in the future, the pressure to subject more medical devices to a benefit assessment will grow,” Busse said.
Busse is also optimistic about the impact of the new regulation and emphasises the “power of the factual”: Germany will hardly be able to give a good reason for deviating from EU standards. Because then it would have to explain “that what applies to the other 26 countries is not sufficient for Germany.”
The new regulation prescribes a transitional period of three years after the entry into force of the regulation. After that, the new regulations are to become directly applicable. During this phase, methodological issues are to be clarified, among other things. The consortium “EUnetHTA21” was awarded the contract for the development of the methodological basis. This consortium consists of 13 organisations from the European HTA network EUnetHTA, including IQWiG and the G-BA from Germany, as well as HTA agencies from Spain, Austria, Belgium, France, Italy, Portugal, Ireland, Hungary, Norway, Sweden and the Netherlands.
She was already dealing with the legal dimensions of the digital world when only a small, dedicated community had a clear view of it: Cornelia Kutterer has been a specialist for over twenty years. And for thirteen of them at Microsoft. As Senior Director, Rule of Law, Responsible Tech & Competition, European Government Affairs, she leads a team that deals with the legal aspects of everything that becomes relevant in the responsible use of technology. So digital security, data protection, the handling of artificial intelligence (AI), content regulation, and many other social and regulatory issues that affect technological advances and their impact.
Kutterer’s eyes sparkle when she talks about her work. For example, how she discusses expertise on complex new technologies with the academic world and thus contributes to shaping European opinion. Of course, contact with the Commission, the Parliament, the Council of the European Union, and the member states is also part of the job. Unlike in the past, Microsoft is often not in the first line of companies criticized.
The Artificial Intelligence Act, the EU Commission’s draft regulation on the horizontal regulation of the use of artificial intelligence, is currently the subject of intense debate. All over the world, people are currently agreeing on specific values when dealing with AI, says Kutterer. She finds this exciting in comparison to the European General Data Protection Regulation (GDPR) of 2018 because: “After the GDPR, there was a real wave of data protection regulation worldwide. The EU had a pioneering role there as a ‘first mover’. I believe it will be similar with the AI Act.” The good thing is that while data protection regulations lagged behind technological developments by several years, these discussions are taking place simultaneously with AI.
Born in Stuttgart, she is European with heart and soul. She lives with her family in a suburb of Brussels, and her three children have Belgian citizenship. Kutterer raves about the cultural diversity of the Flemish, Walloon, European, and African scenes.
During her law studies in Stuttgart, Passau, and Hamburg, she specialized in European and labor law. In 2000, she added another area of expertise with an online master’s degree in “Information Technology” – at precisely the right time. “Back then, the subject was still in its infancy and not as complicated as it is today,” she says mischievously. After working in a law firm and for the European consumer protection association BEUC, Kutterer was poached by Microsoft in 2008. She looks back with amusement: “It was even worth a headline back then: ‘Key Consumer Activist Joins Microsoft’. That kind of thing doesn’t happen anymore.”
Most recently, Microsoft’s perspective has broadened once again. “Inclusion, sustainability, digital transition: The issues have become bigger”. Geopolitics is also increasingly playing a role. “The Trump era was not exactly easy for us as an American company in Brussels,” Kutterer sums up dryly. But whether she deals more intensively with AI in the future, with quantum computers or the metaverse: “It’s always exciting.” Gundula Haage
