With the start of the new year, Germany and France have taken over the presidencies of the G7 and the EU. The governments in Berlin and Paris want to conduct the presidencies in close coordination, as Foreign Minister Annalena Baerbock (Greens) also stressed. But the old year wasn’t quite over yet when mail arrived from the EU Commission that isn’t exactly likely to bring harmony between the two countries.
Late on New Year’s Eve, the Commission’s amendment to the EU taxonomy reached the member states. As many observers suspected, it proposes that investments in nuclear power and natural gas should be considered sustainable under certain conditions. These are New Year’s greetings that some countries are anything but pleased to receive. Germany, which wants to complete its nuclear phase-out this year, responds with harsh criticism. Austria’s Climate Minister Leonore Gewessler (Greens) is even threatening legal action. More on this in the Feature by Timo Landenberger.
Since May 2021, all new medical devices must meet the EU Medical Devices Regulation requirements. This marks the beginning of a new era for the industry. Even high-risk products had previously come onto the market without clinical trials in the majority of cases. But manufacturers and doctors warn that many products could disappear in the wake of the new regulations. As Eugenie Ankowitsch reports, the industry is now getting support from German state politicians.
I wish you a good start into the new year,
Just an hour before the turn of the year, Commission President Ursula von der Leyen made good on her promise on Friday evening to send the supplement to the EU taxonomy to the member states before the end of 2021. The timing alone caused protest among critics. According to numerous Twitter posts, it was deliberately chosen to distract from the controversial content.
If that was indeed the Commission’s plan, it did not work out. Because a few hours later, the draft was discussed publicly and all the more heatedly.
Accordingly, investments in natural gas and nuclear energy are to be classified as climate-friendly, provided that the technologies meet certain requirements. This way, the Brussels authority wants to ensure that these are not considered as permanent but only as transitional solutions, as is emphasized several times in the draft. This is because the current energy mix in Europe varies greatly from one member state to another.
The taxonomy, therefore, lists types of energy production that should enable member states to move towards climate neutrality from their very different starting positions, according to the Commission’s explanatory memorandum. In the light of scientific advice and the current state of technological progress, it is considered that “natural gas and nuclear energy can facilitate the transition to low-carbon energy systems and play a role in moving towards a predominantly renewable future”.
For nuclear power plants, the proposals stipulate, among other things, that a concrete plan for the safe disposal of radioactive waste must be submitted. New plants must receive a construction permit before 2045. In view of “long lead times for investment in new capacity”, according to the draft, the extension of the operating lives of existing power plants can also be classified as green – provided they are at the “highest achievable safety standard”.
Investments in natural gas power plants are to be considered climate-friendly if they emit less than 270g of CO2 equivalent per kilowatt-hour and receive a building permit by December 31st, 2030. In addition, the new plants must be designed to operate with low-carbon gases and replace old, purely fossil-fuel power plants.
From 2035, the plants are to run only on “low carbon gases”. However, it has not yet been fully clarified how these low-carbon gases will be defined. In its gas package, which the EU Commission presented in December, the authority assumes 70 percent lower greenhouse gas emissions than with conventional natural gas.
German Environment Minister Steffi Lemke (Greens) criticized the plans. “I think it is absolutely wrong that the European Commission intends to include nuclear power in the EU taxonomy for sustainable economic activities,” Lemke said. She added that it was also extremely problematic to dispense with public consultations in the process.
Fellow party member Robert Habeck also reacted with disapproval. Germany’s economics and climate minister called the plans “a dilution of the good label of sustainability”. To label nuclear energy, of all things, as sustainable is wrong for this high-risk technology, he said. The inclusion of natural gas in the taxonomy is also questionable. Here, however, the Commission at least makes it clearer that this is only a transitional solution. “In our view, there would have been no need for this addition to the taxonomy rules. We do not see any approval for the new proposals of the EU Commission,” said Habeck.
Austria’s Climate Minister Leonore Gewessler (Greens) went one step further and threatened the Commission with legal consequences. “We have already commissioned a legal opinion on nuclear power in the taxonomy. If these plans are implemented as they are, we will sue,” Gewessler wrote on Twitter. Neither nuclear power nor the burning of fossil natural gas would have a place in the taxonomy.
Deutsche Umwelthilfe is also convinced that the inclusion of the two energy sources deprives the taxonomy of any credibility. DUH’s national director Sascha Müller-Kraenner criticizes, in particular, the behavior of Chancellor Olaf Scholz (SPD), who is risking the climate policy reputation of the German government. Scholz had spoken out in advance in favor of the inclusion of natural gas in the regulations and described the taxonomy as a whole as “overrated”.
The traffic light coalition does not seem to agree on this. While Habeck and several other Green politicians criticize the inclusion of natural gas, a government spokesman said on the weekend that the government expressly welcomed the move but continued to reject nuclear power.
Since Germany is the only industrialized country to phase out nuclear energy and coal-fired power generation at the same time, the traffic light coalition is focusing on the expansion of the gas infrastructure as a transit technology. The German Chemical Industry Association, therefore, welcomes the EU Commission’s proposal. “The phase-out of coal and nuclear energy makes it necessary to enter into new gas-fired power plants while the expansion of renewables is sluggish. Otherwise, the lights will go out in the industry,” says VCI Managing Director Wolfgang Große Entrup.
The European Commission was, therefore, right to include natural gas as a secure power supply in its taxonomy proposal. Due to the strict requirements for the construction of new gas-fired power plants, these could only be met by the most efficient plants anyway, which was in the interests of the energy turnaround and climate protection.
With the taxonomy, the Commission sets the EU-wide standard for sustainable investments and thus defines which energy sources are considered climate-friendly on the financial markets and which are not. A few months ago, the Brussels-based authority had already announced its intention to present an extension of the rules and regulations. However, due to disagreements, the deadline was postponed several times. While countries like France or Poland were very insistent on including nuclear power, Germany pleaded for natural gas. Others reject both.
The consultation process with the member states, which began on Friday, is now to last until January 12th. After that, the Commission will officially present its plans and submit them to the Council and Parliament for consideration. However, as the taxonomy is a so-called delegated act, the member states have no say in the matter and can only accept or reject the paper. The latter is considered unlikely. In the Council, this would require a qualified majority of 20 out of the 27 EU member states. Only a few countries have spoken out against it so far. The EU Parliament can reject the proposal with an absolute majority.
It was scandals involving defective breast implants that drove the already overdue revision of current medical device legislation at the EU level. At the turn of the millennium, breast pads filled with soya oil lost their CE certificate when it emerged that they could tear or leak.
In spring 2010, a second scandal involving defective breast implants filled with industrial silicone from the French company Poly Implant Prothèse (PIP) made headlines. They were not isolated cases, however. Brittle hip implants and defective metal-on-metal endoprostheses also shook confidence in medical products.
In 2012, the EU Commission presented a corresponding draft regulation. However, it was not until April 2017 that the Medical Device Regulation (MDR) was adopted after tough negotiations. The MDR will not take full effect until May 26th, 2021. Since then, all new medical devices must meet the new requirements. By 2024, manufacturers must also have their entire existing portfolio recertified.
The EU Medical Devices Regulation now applies to medical devices what has long been standard practice for medicines: Manufacturers must prove the safety and efficacy of their products and ensure transparency. The industry had already warned in advance of disproportionate effort, high costs for the companies, and, as a result, the threat of portfolio adjustments, business closures, and ultimately a deterioration in patient care. A certification backlog is expected, especially when the transition period expires in 2024.
The MDR is “already having a dramatic impact on the medical technology market“, the German Medical Technology Association (BVMed) reiterated its criticism a few months after it came into force. The old federal government, however, saw things differently. It could not detect any “noticeable market changes”, it said in answer to a question from the FDP.
The industry is now getting support from state politicians. In their current resolutions, both the Conference of Economics Ministers and the Conference of Health Ministers have called for stronger support measures for small and medium-sized companies. The resolutions call on the federal government to advocate solutions to avoid “further product portfolio streamlining, business closures and supply bottlenecks for medical devices”.
Another criticism is that there is still an urgent need for action regarding the lack of implementing legislation by the European Commission. It remains to be seen whether the state ministers will actually be listened to by the new federal government.
Baden-Württemberg, in particular, is pushing the issue vigorously at all political levels. Last July, the state also sent recommendations for action to Brussels describing how supply bottlenecks could be avoided, particularly for niche and existing products, taking into account the existing regulations of the MDR. In the authors’ view, a separate legal framework is needed at EU level for niche products, for example.
“With our recommendations for action, we have ensured that the topic was once again included on the agenda of the Medical Device Coordination Group (MDCG) meeting,” a spokeswoman for the Baden-Württemberg Ministry of Economic Affairs said in response to a query. According to information from the ministry, the MDCG, which develops the guidelines for the uniform implementation of the MDR, has installed a task force on niche products (orphan devices).
It is not surprising that German state politicians are championing the industry, given its central role for Germany as a business location. According to industry figures, Germany is home to more than 12,000 medical device companies that employ over 215,000 people and generated sales of over €34 billion in 2020. An increase of €36 billion is expected for 2021, with around two-thirds of all medical devices manufactured being exported.
A new era has begun for the medical technology industry with MDR. Previously, manufacturers issued the required CE mark to themselves by simply confirming that their products complied with the legal requirements. In the case of high-risk products, a so-called notified body, such as the German TÜV, additionally checked the manufacturer’s documentation and then issued the CE mark.
Clinical studies only had to be carried out for high-risk products, but in fact, around 90 percent of high-risk medical products came onto the market entirely without clinical studies, and this was done via the so-called equivalence route. In this case, the manufacturers refer to products that are already available.
A BVMed survey is intended to substantiate that the current fears of the industry are not entirely unjustified. It revealed that more than 70 percent of BVMed member companies had discontinued individual medical devices or entire product lines due to the new MDR regulations. Around 60 percent reported that costs had doubled, and the duration of a conformity assessment procedure had increased.
“We need solutions now, especially for established existing products and rare niche products, such as those that exist in the USA or for rare drugs in the EU,” demands BVMed Managing Director Marc-Pierre Möll.
According to BVMed, pragmatic solutions must be found for proven existing products, for example, through the instrument of “recognition of clinical practice” and by using existing registry data. For special or niche products, the association proposes exemption regulations based on the US model of the “Humanitarian Device Exemption” and the “Orphan Drug” regulations in Europe.
Additional funding programs should be set up for SMEs, for example, to support clinical studies. These support programs must not be limited to new developments and innovations but must include existing products, the functionaries demand.
The new requirements have been known for a long time, it was said in EU circles. Nevertheless, the Commission is aware of the challenges and is working closely with the competent national authorities, industry, and notified bodies. In addition, the MDR contains a series of protective measures to avoid a shortage of critical products. However, it is still too early to evaluate the implementation.
Barbara Thiel likes to go on holiday to Sardinia. That’s what you can find out on the Facebook account of the Lower Saxony State Commissioner for Data Protection (LfD). She decides for herself what she reveals there: “Everyone has the right to informational self-determination,” says Thiel. “Against the background of digitalization, this right has become more present. However, there is often a lack of transparency about what happens to personal data and who benefits from it.”
This is where the GDPR comes into play. This set of laws, formulated at a “high, abstract level”, has an effect not only on large companies, says Thiel, but also on the entire economic sector and the public sector – in Europe and beyond. So it is understandable that there is still some sand in the gears here and there. “We need to implement and apply this law. But we also need time to fill undefined legal concepts with life. Court rulings will show whether we are right in our decisions,” says Thiel.
The aim of the LfD (with a total of 56 employees) is to safeguard the right to informational self-determination by monitoring compliance with data protection regulations. The supreme state authority is a supervisory, control, and enforcement body with far-reaching powers to issue orders and conduct investigations. However, it is also an advisory body that educates, informs, and raises awareness among various target groups. It is a major concern of the authority that data protection in companies is considered from the outset, valued more, and understood as a sign of quality.
Since the beginning of 2015, the native of Salzgitter has been in office as LfD for Lower Saxony. The European dimension of her work opened up “like a thunderbolt” when the ECJ ruling on Safe Harbor was handed down in autumn 2015. In 2017, Barbara Thiel chaired the Federal and State Data Protection Conference and contributed to commentaries on the GDPR and the new BDSG.
In the fourth year of the GDPR application, she paints a “rather positive picture”. The GDPR has arrived in most people’s minds. However, there are still construction sites, which include not only the overturned EU-US Privacy Shield.
For example, Thiel welcomes the new Federal Act on the Regulation of Data Protection and Privacy in Telecommunications and Telemedia (TTDSG), which came into force on December 1st. “However, it is a national regulation,” Thiel emphasizes. “We have been waiting for years for a regulation as a successor to the ePrivacy Directive, which still exists at the European level. That would be a breakthrough in the whole area of electronic communications.” However, it is still uncertain whether such a regulation is yet to come.
The TTDSG is intended to create legal clarity for data protection and privacy in the digital world. In particular, it regulates the handling of cookies, extends the secrecy of telecommunications, and thus also impacts social media and messenger services such as Facebook. Daniela Krause
With the start of the new year, Germany and France have taken over the presidencies of the G7 and the EU. The governments in Berlin and Paris want to conduct the presidencies in close coordination, as Foreign Minister Annalena Baerbock (Greens) also stressed. But the old year wasn’t quite over yet when mail arrived from the EU Commission that isn’t exactly likely to bring harmony between the two countries.
Late on New Year’s Eve, the Commission’s amendment to the EU taxonomy reached the member states. As many observers suspected, it proposes that investments in nuclear power and natural gas should be considered sustainable under certain conditions. These are New Year’s greetings that some countries are anything but pleased to receive. Germany, which wants to complete its nuclear phase-out this year, responds with harsh criticism. Austria’s Climate Minister Leonore Gewessler (Greens) is even threatening legal action. More on this in the Feature by Timo Landenberger.
Since May 2021, all new medical devices must meet the EU Medical Devices Regulation requirements. This marks the beginning of a new era for the industry. Even high-risk products had previously come onto the market without clinical trials in the majority of cases. But manufacturers and doctors warn that many products could disappear in the wake of the new regulations. As Eugenie Ankowitsch reports, the industry is now getting support from German state politicians.
I wish you a good start into the new year,
Just an hour before the turn of the year, Commission President Ursula von der Leyen made good on her promise on Friday evening to send the supplement to the EU taxonomy to the member states before the end of 2021. The timing alone caused protest among critics. According to numerous Twitter posts, it was deliberately chosen to distract from the controversial content.
If that was indeed the Commission’s plan, it did not work out. Because a few hours later, the draft was discussed publicly and all the more heatedly.
Accordingly, investments in natural gas and nuclear energy are to be classified as climate-friendly, provided that the technologies meet certain requirements. This way, the Brussels authority wants to ensure that these are not considered as permanent but only as transitional solutions, as is emphasized several times in the draft. This is because the current energy mix in Europe varies greatly from one member state to another.
The taxonomy, therefore, lists types of energy production that should enable member states to move towards climate neutrality from their very different starting positions, according to the Commission’s explanatory memorandum. In the light of scientific advice and the current state of technological progress, it is considered that “natural gas and nuclear energy can facilitate the transition to low-carbon energy systems and play a role in moving towards a predominantly renewable future”.
For nuclear power plants, the proposals stipulate, among other things, that a concrete plan for the safe disposal of radioactive waste must be submitted. New plants must receive a construction permit before 2045. In view of “long lead times for investment in new capacity”, according to the draft, the extension of the operating lives of existing power plants can also be classified as green – provided they are at the “highest achievable safety standard”.
Investments in natural gas power plants are to be considered climate-friendly if they emit less than 270g of CO2 equivalent per kilowatt-hour and receive a building permit by December 31st, 2030. In addition, the new plants must be designed to operate with low-carbon gases and replace old, purely fossil-fuel power plants.
From 2035, the plants are to run only on “low carbon gases”. However, it has not yet been fully clarified how these low-carbon gases will be defined. In its gas package, which the EU Commission presented in December, the authority assumes 70 percent lower greenhouse gas emissions than with conventional natural gas.
German Environment Minister Steffi Lemke (Greens) criticized the plans. “I think it is absolutely wrong that the European Commission intends to include nuclear power in the EU taxonomy for sustainable economic activities,” Lemke said. She added that it was also extremely problematic to dispense with public consultations in the process.
Fellow party member Robert Habeck also reacted with disapproval. Germany’s economics and climate minister called the plans “a dilution of the good label of sustainability”. To label nuclear energy, of all things, as sustainable is wrong for this high-risk technology, he said. The inclusion of natural gas in the taxonomy is also questionable. Here, however, the Commission at least makes it clearer that this is only a transitional solution. “In our view, there would have been no need for this addition to the taxonomy rules. We do not see any approval for the new proposals of the EU Commission,” said Habeck.
Austria’s Climate Minister Leonore Gewessler (Greens) went one step further and threatened the Commission with legal consequences. “We have already commissioned a legal opinion on nuclear power in the taxonomy. If these plans are implemented as they are, we will sue,” Gewessler wrote on Twitter. Neither nuclear power nor the burning of fossil natural gas would have a place in the taxonomy.
Deutsche Umwelthilfe is also convinced that the inclusion of the two energy sources deprives the taxonomy of any credibility. DUH’s national director Sascha Müller-Kraenner criticizes, in particular, the behavior of Chancellor Olaf Scholz (SPD), who is risking the climate policy reputation of the German government. Scholz had spoken out in advance in favor of the inclusion of natural gas in the regulations and described the taxonomy as a whole as “overrated”.
The traffic light coalition does not seem to agree on this. While Habeck and several other Green politicians criticize the inclusion of natural gas, a government spokesman said on the weekend that the government expressly welcomed the move but continued to reject nuclear power.
Since Germany is the only industrialized country to phase out nuclear energy and coal-fired power generation at the same time, the traffic light coalition is focusing on the expansion of the gas infrastructure as a transit technology. The German Chemical Industry Association, therefore, welcomes the EU Commission’s proposal. “The phase-out of coal and nuclear energy makes it necessary to enter into new gas-fired power plants while the expansion of renewables is sluggish. Otherwise, the lights will go out in the industry,” says VCI Managing Director Wolfgang Große Entrup.
The European Commission was, therefore, right to include natural gas as a secure power supply in its taxonomy proposal. Due to the strict requirements for the construction of new gas-fired power plants, these could only be met by the most efficient plants anyway, which was in the interests of the energy turnaround and climate protection.
With the taxonomy, the Commission sets the EU-wide standard for sustainable investments and thus defines which energy sources are considered climate-friendly on the financial markets and which are not. A few months ago, the Brussels-based authority had already announced its intention to present an extension of the rules and regulations. However, due to disagreements, the deadline was postponed several times. While countries like France or Poland were very insistent on including nuclear power, Germany pleaded for natural gas. Others reject both.
The consultation process with the member states, which began on Friday, is now to last until January 12th. After that, the Commission will officially present its plans and submit them to the Council and Parliament for consideration. However, as the taxonomy is a so-called delegated act, the member states have no say in the matter and can only accept or reject the paper. The latter is considered unlikely. In the Council, this would require a qualified majority of 20 out of the 27 EU member states. Only a few countries have spoken out against it so far. The EU Parliament can reject the proposal with an absolute majority.
It was scandals involving defective breast implants that drove the already overdue revision of current medical device legislation at the EU level. At the turn of the millennium, breast pads filled with soya oil lost their CE certificate when it emerged that they could tear or leak.
In spring 2010, a second scandal involving defective breast implants filled with industrial silicone from the French company Poly Implant Prothèse (PIP) made headlines. They were not isolated cases, however. Brittle hip implants and defective metal-on-metal endoprostheses also shook confidence in medical products.
In 2012, the EU Commission presented a corresponding draft regulation. However, it was not until April 2017 that the Medical Device Regulation (MDR) was adopted after tough negotiations. The MDR will not take full effect until May 26th, 2021. Since then, all new medical devices must meet the new requirements. By 2024, manufacturers must also have their entire existing portfolio recertified.
The EU Medical Devices Regulation now applies to medical devices what has long been standard practice for medicines: Manufacturers must prove the safety and efficacy of their products and ensure transparency. The industry had already warned in advance of disproportionate effort, high costs for the companies, and, as a result, the threat of portfolio adjustments, business closures, and ultimately a deterioration in patient care. A certification backlog is expected, especially when the transition period expires in 2024.
The MDR is “already having a dramatic impact on the medical technology market“, the German Medical Technology Association (BVMed) reiterated its criticism a few months after it came into force. The old federal government, however, saw things differently. It could not detect any “noticeable market changes”, it said in answer to a question from the FDP.
The industry is now getting support from state politicians. In their current resolutions, both the Conference of Economics Ministers and the Conference of Health Ministers have called for stronger support measures for small and medium-sized companies. The resolutions call on the federal government to advocate solutions to avoid “further product portfolio streamlining, business closures and supply bottlenecks for medical devices”.
Another criticism is that there is still an urgent need for action regarding the lack of implementing legislation by the European Commission. It remains to be seen whether the state ministers will actually be listened to by the new federal government.
Baden-Württemberg, in particular, is pushing the issue vigorously at all political levels. Last July, the state also sent recommendations for action to Brussels describing how supply bottlenecks could be avoided, particularly for niche and existing products, taking into account the existing regulations of the MDR. In the authors’ view, a separate legal framework is needed at EU level for niche products, for example.
“With our recommendations for action, we have ensured that the topic was once again included on the agenda of the Medical Device Coordination Group (MDCG) meeting,” a spokeswoman for the Baden-Württemberg Ministry of Economic Affairs said in response to a query. According to information from the ministry, the MDCG, which develops the guidelines for the uniform implementation of the MDR, has installed a task force on niche products (orphan devices).
It is not surprising that German state politicians are championing the industry, given its central role for Germany as a business location. According to industry figures, Germany is home to more than 12,000 medical device companies that employ over 215,000 people and generated sales of over €34 billion in 2020. An increase of €36 billion is expected for 2021, with around two-thirds of all medical devices manufactured being exported.
A new era has begun for the medical technology industry with MDR. Previously, manufacturers issued the required CE mark to themselves by simply confirming that their products complied with the legal requirements. In the case of high-risk products, a so-called notified body, such as the German TÜV, additionally checked the manufacturer’s documentation and then issued the CE mark.
Clinical studies only had to be carried out for high-risk products, but in fact, around 90 percent of high-risk medical products came onto the market entirely without clinical studies, and this was done via the so-called equivalence route. In this case, the manufacturers refer to products that are already available.
A BVMed survey is intended to substantiate that the current fears of the industry are not entirely unjustified. It revealed that more than 70 percent of BVMed member companies had discontinued individual medical devices or entire product lines due to the new MDR regulations. Around 60 percent reported that costs had doubled, and the duration of a conformity assessment procedure had increased.
“We need solutions now, especially for established existing products and rare niche products, such as those that exist in the USA or for rare drugs in the EU,” demands BVMed Managing Director Marc-Pierre Möll.
According to BVMed, pragmatic solutions must be found for proven existing products, for example, through the instrument of “recognition of clinical practice” and by using existing registry data. For special or niche products, the association proposes exemption regulations based on the US model of the “Humanitarian Device Exemption” and the “Orphan Drug” regulations in Europe.
Additional funding programs should be set up for SMEs, for example, to support clinical studies. These support programs must not be limited to new developments and innovations but must include existing products, the functionaries demand.
The new requirements have been known for a long time, it was said in EU circles. Nevertheless, the Commission is aware of the challenges and is working closely with the competent national authorities, industry, and notified bodies. In addition, the MDR contains a series of protective measures to avoid a shortage of critical products. However, it is still too early to evaluate the implementation.
Barbara Thiel likes to go on holiday to Sardinia. That’s what you can find out on the Facebook account of the Lower Saxony State Commissioner for Data Protection (LfD). She decides for herself what she reveals there: “Everyone has the right to informational self-determination,” says Thiel. “Against the background of digitalization, this right has become more present. However, there is often a lack of transparency about what happens to personal data and who benefits from it.”
This is where the GDPR comes into play. This set of laws, formulated at a “high, abstract level”, has an effect not only on large companies, says Thiel, but also on the entire economic sector and the public sector – in Europe and beyond. So it is understandable that there is still some sand in the gears here and there. “We need to implement and apply this law. But we also need time to fill undefined legal concepts with life. Court rulings will show whether we are right in our decisions,” says Thiel.
The aim of the LfD (with a total of 56 employees) is to safeguard the right to informational self-determination by monitoring compliance with data protection regulations. The supreme state authority is a supervisory, control, and enforcement body with far-reaching powers to issue orders and conduct investigations. However, it is also an advisory body that educates, informs, and raises awareness among various target groups. It is a major concern of the authority that data protection in companies is considered from the outset, valued more, and understood as a sign of quality.
Since the beginning of 2015, the native of Salzgitter has been in office as LfD for Lower Saxony. The European dimension of her work opened up “like a thunderbolt” when the ECJ ruling on Safe Harbor was handed down in autumn 2015. In 2017, Barbara Thiel chaired the Federal and State Data Protection Conference and contributed to commentaries on the GDPR and the new BDSG.
In the fourth year of the GDPR application, she paints a “rather positive picture”. The GDPR has arrived in most people’s minds. However, there are still construction sites, which include not only the overturned EU-US Privacy Shield.
For example, Thiel welcomes the new Federal Act on the Regulation of Data Protection and Privacy in Telecommunications and Telemedia (TTDSG), which came into force on December 1st. “However, it is a national regulation,” Thiel emphasizes. “We have been waiting for years for a regulation as a successor to the ePrivacy Directive, which still exists at the European level. That would be a breakthrough in the whole area of electronic communications.” However, it is still uncertain whether such a regulation is yet to come.
The TTDSG is intended to create legal clarity for data protection and privacy in the digital world. In particular, it regulates the handling of cookies, extends the secrecy of telecommunications, and thus also impacts social media and messenger services such as Facebook. Daniela Krause
