Russian soil will be off-limits to numerous European parliamentarians, public figures, and journalists in the future. Yesterday, the Russian Foreign Ministry imposed an entry ban on the “top leadership of the EU as well as the vast majority of members of the European Parliament who support an anti-Russian policy”.
As of today, gas bills from Russia must be paid via the Gazprom bank, according to President Vladimir Putin. From a European perspective, however, nothing will really change, at least German Chancellor Olaf Scholz remains calm. Lukas Scheid has analyzed the account structure through which payments will be made in the future and what could be behind Putin’s battle for monetary sovereignty.
The alarm is currently coming from the medical and MedTech sector. The requirements in the new EU Medical Devices Regulation are in some cases so high that it is hardly lucrative for manufacturers of medical devices to continue to keep certain products on the market, let alone to conduct research and development, writes Eugenie Ankowitsch.
The EU Commission’s legislative initiative on strategic gas storage has been criticized. Among other things, member states that need to fill large storage capacities in order to be able to supply countries without their own storage facilities complain about the inadequate sharing of the burden. Read more about this in the news.
New at Europe.Table: Claire Stam writes in the column “What’s cooking in Brussels” about what will be on the European menu in Brussels next week. Cheers!
Although Christian Lindner (FDP) announced an “examination in detail” of what the Russian payment regime for gas, issued by decree, prescribes, there does not seem to be too much concern. A “Putinian smokescreen to create confusion,” is what Jens Südekum, a member of the advisory board of the German Ministry of Economics, called it. The assessment that Putin’s decree does not significantly change the status quo can also be heard from government circles in Berlin. Gas is therefore likely to continue to flow to Europe.
Italy’s Prime Minister Mario Draghi said he understood it to be an “internal matter for the Russian Federation.” German Gazprom customers were still holding back on Wednesday with reactions as to what the decree meant.
The decree stipulates that Gazprombank will practically act as an intermediary for gas purchases by Western countries. A foreign gas customer will be required to transfer foreign currency to a special so-called K account. Gazprombank is then to buy rubles on behalf of the customer and transfer the Russian currency to another K-account. In a further step, the rubles are then to be transferred to an account of the gas supplier Gazprom. According to the decree, Gazprombank can open such accounts without the presence of a representative of a foreign gas buyer.
“If such payments are not made, we will consider this a default by the buyers with all the resulting consequences,” Vladimir Putin announced Thursday. “No one will sell us anything for nothing, and we will not do charity – that means existing contracts will be stopped. “
Despite this threat of a gas freeze, German Chancellor Olaf Scholz reacted calmly on Thursday and, like Mario Draghi and France’s Finance Minister Bruno Le Maire, repeatedly referred to existing contracts. “In any case, the rule for companies is that they want to, can, and will pay in euros,” Scholz said. Finance Minister Lindner stressed that they would not be blackmailed and did not want to contribute to filling Russia’s war chest. Sanctions against the Russian currency remain in place.
“It is possible the Kremlin is acting out of fear that Gazprom Bank will soon be sanctioned as well, amid a broader effort by the European Union to completely cut energy ties with Russia,” said an analyst at Fitch Solutions. It’s possible: Economy Minister Robert Habeck said after a meeting with his French counterpart Le Maire that they also discussed further sanctions. He did not provide details, except to say, “The last sanctions package doesn’t have to be the last – shouldn’t be the last.”
Support for the European governments’ course comes from the energy-intensive industry. “We should continue to stick together on the euro payment issue, but use the remaining time to think about how to deal with the industry’s gas needs,” said Christian Seyfert, CEO of the Association of the Industrial Energy and Power Industry (VIK). He also advocated bringing coal-fired power plants out of reserve now in order to conserve gas storage facilities.
It remains to be seen what the transfer process from euros or dollars to rubles will mean for the Russian currency. So far this year, Europe has spent €200 to €800 million a day on Russian gas. A conversion into rubles would be a huge gain for the ruble. However, it is unclear whether the procedure via the K-accounts will achieve this effect.
According to a media report, the German Federal Ministry of Economics is currently considering the nationalization or even expropriation of the German subsidiaries of the Russian energy companies Gazprom and Rosneft. In this way, the German government wants to prevent a massive impairment of the energy supply, especially in eastern Germany, in the event of the companies’ difficulties, reports the Handelsblatt, citing government representatives.
Banks and business partners have been distancing themselves from companies with Russian owners since the sanctions against Russia came into force. The danger of a “technical bankruptcy” cannot, therefore, be dismissed out of hand. However the background is likely to be something else as well: The Russian owners are making it more difficult to say goodbye to Russian oil and gas, because a Rosneft refinery could not simply replace Russian oil with oil from elsewhere, according to reports in Berlin.
If the two companies collapsed, this would have a massive impact on energy supplies. Gazprom Germania operates large gas storage facilities, while Rosneft Deutschland accounts for 25 percent of the German refinery business. With rtr
The Association for European Paediatric and Congenital Cardiology (AEPC) has informed them of an impending shortage of medical devices for pediatric cardiac interventions, writes Dutch MEP Kathleen van Brempt (S&D) in her parliamentary question to the Commission. This shortcoming is said to be a consequence of the EU Medical Devices Regulation (MDR). Whether the Commission is aware of this problem and whether it plans to revise the MDR, van Brempt asks.
According to Matthias Gorenflo, president of the German Society for Pediatric Cardiology and Congenital Heart Defects. (DGPK), the shortage is not only looming, but is already real. Company representatives often argue in discussions that the costs and effort for recertification according to the MDR are so high that they prefer to remove products from their portfolio, reports Gorenflo, who is Medical Director at the Clinic for Pediatric Cardiology and Congenital Heart Defects at Heidelberg University Hospital.
According to the company, this affects a whole range of product groups, from biopsy forceps, heart sets and transseptal needles to life-saving medical devices such as balloon natrioseptostomy catheters. These are used by pediatric cardiologists to open the connection between the right and left atria in critically ill newborns. This leads to the mixing of red and blue blood and makes patients viable, explains Gorenflo.
Currently, only one manufacturer still supplies such a balloon natrioseptostomy catheter. Others have already withdrawn corresponding products from the market. “Unfortunately, in terms of handling, the remaining product is something completely different from the products we preferred to use in the past,” the pediatric cardiologist reports. That complicates the procedure and makes it longer, he said. Ultimately, he says, it’s a hazard for the little patient: s. “I don’t even want to imagine the last manufacturer coming to the conclusion to take the product off the market,” he emphasizes.
The DGPK president believes that the EU Commission has underestimated what consequences the MDR will have in the reality of care. In his view, the goal must be to find a better balance between the justified demands for patient safety and the practicability of implementation by manufacturers.
Medical device manufacturers have long warned of supply shortages due to the MDR. It has been in effect since May 2021, with the law giving manufacturers a three-year transition period to certify existing products. The MDR provides for stricter product safety and transparency rules to protect patients. Industry complains of significantly increased costs, implementation issues, and increased certification burdens for placing their products on the market (Europe.Table reported).
For existing and niche products, which include medical devices for cardiological interventions in babies and children, the German Medical Technology Association (BVMed) is calling for rapid solutions. The problem of niche products could be solved by following the example of the USA. There, an “orphan device” regulation applies to medical products that are manufactured in small numbers and for very specific applications. With the “orphan drug” regulations, there are also analogous exceptions in the pharmaceutical sector in Europe.
It is not only niche products from the portfolio that run the risk of disappearing from the market, the industry warns. Research and development are also being held back because the approval requirements are high and there is no prospect of the investment in innovation paying off at some point. Companies are not the only ones developing innovative products. Some impulses for new or further developments arise in operating rooms and from everyday clinical practice.
Oliver Muensterer is no exception. As head of the Pediatric Surgery Clinic and Polyclinic at Dr. von Hauner’s Children’s Hospital at Munich University Hospital, he treats many babies and young children with rare diseases or malformations. The medical devices required for this are only needed in small quantities. “Unfortunately, off-label use among pediatric surgeons is practically our modus vivendi. We often go pretty far out on a limb for the sake of our patients,” the pediatric surgeon reported at an event.
“I myself am working on how to bring together an interrupted esophagus with special magnets without surgery,” Muensterer said. “I always had hopes of being able to implement such ideas in the EU market.” Currently, it looks like he will get FDA approval first. “This shows how difficult it is for people like me to implement such ideas that really help children,” he laments. MDR, in his view, has the potential to make children losers. This is not only an economic, political and medical problem, but also an ethical one, he said.
From the industry’s point of view, it is a problem that the MDR does not provide any exemptions for products intended for small patient populations. Niche products do not even exist as a term in the systematics of the regulation. In discussions, reference is often made to the possibility of a special authorization under Article 59 MDR. However, experts agree that this route is not viable for niche products.
“The legislator did not have niche products in mind, but rather exceptional cases,” explains Heike Wachenhausen, a lawyer and honorary professor at the Technical University of Lübeck. That is why there is a time limit. The manufacturer must also apply for national approval in each individual member state . Wachenhausen is one of the experts commissioned by the Baden-Württemberg state government to draw up recommendations on how the MDR can be successfully implemented. The recommendations have since been submitted to the EU Commission (Europe.Table reported).
Substantial changes to the MDR are not to be expected, said Peter Bischoff-Everding, legal officer in the Medical Devices Unit, DG Sante, at an event. However, the Commission is taking the indications, which are currently coming mainly from Germany, seriously. The members of the “Medical Devices Coordination Group” (MDCG) had already discussed the issue at the end of 2021 and founded a working group. The first task of this group is to prepare a detailed analysis of the problem. This should also include a definition of the term niche products.
The next step is to clearly identify the causes of the problem so that measures can then be developed, if necessary. Before possible solutions can be developed, it must be clarified whether this is a temporary problem related to the transition from the previous medical device directives to the MDR or a structural long-term problem, the Commission’s answer to van Brempt’s parliamentary question also states. At the present time, there is no intention to revise the MDR.
Russian soil will be off-limits to numerous European parliamentarians, public figures, and journalists in the future. Yesterday, the Russian Foreign Ministry imposed an entry ban on the “top leadership of the EU as well as the vast majority of members of the European Parliament who support an anti-Russian policy”.
As of today, gas bills from Russia must be paid via the Gazprom bank, according to President Vladimir Putin. From a European perspective, however, nothing will really change, at least German Chancellor Olaf Scholz remains calm. Lukas Scheid has analyzed the account structure through which payments will be made in the future and what could be behind Putin’s battle for monetary sovereignty.
The alarm is currently coming from the medical and MedTech sector. The requirements in the new EU Medical Devices Regulation are in some cases so high that it is hardly lucrative for manufacturers of medical devices to continue to keep certain products on the market, let alone to conduct research and development, writes Eugenie Ankowitsch.
The EU Commission’s legislative initiative on strategic gas storage has been criticized. Among other things, member states that need to fill large storage capacities in order to be able to supply countries without their own storage facilities complain about the inadequate sharing of the burden. Read more about this in the news.
New at Europe.Table: Claire Stam writes in the column “What’s cooking in Brussels” about what will be on the European menu in Brussels next week. Cheers!
Although Christian Lindner (FDP) announced an “examination in detail” of what the Russian payment regime for gas, issued by decree, prescribes, there does not seem to be too much concern. A “Putinian smokescreen to create confusion,” is what Jens Südekum, a member of the advisory board of the German Ministry of Economics, called it. The assessment that Putin’s decree does not significantly change the status quo can also be heard from government circles in Berlin. Gas is therefore likely to continue to flow to Europe.
Italy’s Prime Minister Mario Draghi said he understood it to be an “internal matter for the Russian Federation.” German Gazprom customers were still holding back on Wednesday with reactions as to what the decree meant.
The decree stipulates that Gazprombank will practically act as an intermediary for gas purchases by Western countries. A foreign gas customer will be required to transfer foreign currency to a special so-called K account. Gazprombank is then to buy rubles on behalf of the customer and transfer the Russian currency to another K-account. In a further step, the rubles are then to be transferred to an account of the gas supplier Gazprom. According to the decree, Gazprombank can open such accounts without the presence of a representative of a foreign gas buyer.
“If such payments are not made, we will consider this a default by the buyers with all the resulting consequences,” Vladimir Putin announced Thursday. “No one will sell us anything for nothing, and we will not do charity – that means existing contracts will be stopped. “
Despite this threat of a gas freeze, German Chancellor Olaf Scholz reacted calmly on Thursday and, like Mario Draghi and France’s Finance Minister Bruno Le Maire, repeatedly referred to existing contracts. “In any case, the rule for companies is that they want to, can, and will pay in euros,” Scholz said. Finance Minister Lindner stressed that they would not be blackmailed and did not want to contribute to filling Russia’s war chest. Sanctions against the Russian currency remain in place.
“It is possible the Kremlin is acting out of fear that Gazprom Bank will soon be sanctioned as well, amid a broader effort by the European Union to completely cut energy ties with Russia,” said an analyst at Fitch Solutions. It’s possible: Economy Minister Robert Habeck said after a meeting with his French counterpart Le Maire that they also discussed further sanctions. He did not provide details, except to say, “The last sanctions package doesn’t have to be the last – shouldn’t be the last.”
Support for the European governments’ course comes from the energy-intensive industry. “We should continue to stick together on the euro payment issue, but use the remaining time to think about how to deal with the industry’s gas needs,” said Christian Seyfert, CEO of the Association of the Industrial Energy and Power Industry (VIK). He also advocated bringing coal-fired power plants out of reserve now in order to conserve gas storage facilities.
It remains to be seen what the transfer process from euros or dollars to rubles will mean for the Russian currency. So far this year, Europe has spent €200 to €800 million a day on Russian gas. A conversion into rubles would be a huge gain for the ruble. However, it is unclear whether the procedure via the K-accounts will achieve this effect.
According to a media report, the German Federal Ministry of Economics is currently considering the nationalization or even expropriation of the German subsidiaries of the Russian energy companies Gazprom and Rosneft. In this way, the German government wants to prevent a massive impairment of the energy supply, especially in eastern Germany, in the event of the companies’ difficulties, reports the Handelsblatt, citing government representatives.
Banks and business partners have been distancing themselves from companies with Russian owners since the sanctions against Russia came into force. The danger of a “technical bankruptcy” cannot, therefore, be dismissed out of hand. However the background is likely to be something else as well: The Russian owners are making it more difficult to say goodbye to Russian oil and gas, because a Rosneft refinery could not simply replace Russian oil with oil from elsewhere, according to reports in Berlin.
If the two companies collapsed, this would have a massive impact on energy supplies. Gazprom Germania operates large gas storage facilities, while Rosneft Deutschland accounts for 25 percent of the German refinery business. With rtr
The Association for European Paediatric and Congenital Cardiology (AEPC) has informed them of an impending shortage of medical devices for pediatric cardiac interventions, writes Dutch MEP Kathleen van Brempt (S&D) in her parliamentary question to the Commission. This shortcoming is said to be a consequence of the EU Medical Devices Regulation (MDR). Whether the Commission is aware of this problem and whether it plans to revise the MDR, van Brempt asks.
According to Matthias Gorenflo, president of the German Society for Pediatric Cardiology and Congenital Heart Defects. (DGPK), the shortage is not only looming, but is already real. Company representatives often argue in discussions that the costs and effort for recertification according to the MDR are so high that they prefer to remove products from their portfolio, reports Gorenflo, who is Medical Director at the Clinic for Pediatric Cardiology and Congenital Heart Defects at Heidelberg University Hospital.
According to the company, this affects a whole range of product groups, from biopsy forceps, heart sets and transseptal needles to life-saving medical devices such as balloon natrioseptostomy catheters. These are used by pediatric cardiologists to open the connection between the right and left atria in critically ill newborns. This leads to the mixing of red and blue blood and makes patients viable, explains Gorenflo.
Currently, only one manufacturer still supplies such a balloon natrioseptostomy catheter. Others have already withdrawn corresponding products from the market. “Unfortunately, in terms of handling, the remaining product is something completely different from the products we preferred to use in the past,” the pediatric cardiologist reports. That complicates the procedure and makes it longer, he said. Ultimately, he says, it’s a hazard for the little patient: s. “I don’t even want to imagine the last manufacturer coming to the conclusion to take the product off the market,” he emphasizes.
The DGPK president believes that the EU Commission has underestimated what consequences the MDR will have in the reality of care. In his view, the goal must be to find a better balance between the justified demands for patient safety and the practicability of implementation by manufacturers.
Medical device manufacturers have long warned of supply shortages due to the MDR. It has been in effect since May 2021, with the law giving manufacturers a three-year transition period to certify existing products. The MDR provides for stricter product safety and transparency rules to protect patients. Industry complains of significantly increased costs, implementation issues, and increased certification burdens for placing their products on the market (Europe.Table reported).
For existing and niche products, which include medical devices for cardiological interventions in babies and children, the German Medical Technology Association (BVMed) is calling for rapid solutions. The problem of niche products could be solved by following the example of the USA. There, an “orphan device” regulation applies to medical products that are manufactured in small numbers and for very specific applications. With the “orphan drug” regulations, there are also analogous exceptions in the pharmaceutical sector in Europe.
It is not only niche products from the portfolio that run the risk of disappearing from the market, the industry warns. Research and development are also being held back because the approval requirements are high and there is no prospect of the investment in innovation paying off at some point. Companies are not the only ones developing innovative products. Some impulses for new or further developments arise in operating rooms and from everyday clinical practice.
Oliver Muensterer is no exception. As head of the Pediatric Surgery Clinic and Polyclinic at Dr. von Hauner’s Children’s Hospital at Munich University Hospital, he treats many babies and young children with rare diseases or malformations. The medical devices required for this are only needed in small quantities. “Unfortunately, off-label use among pediatric surgeons is practically our modus vivendi. We often go pretty far out on a limb for the sake of our patients,” the pediatric surgeon reported at an event.
“I myself am working on how to bring together an interrupted esophagus with special magnets without surgery,” Muensterer said. “I always had hopes of being able to implement such ideas in the EU market.” Currently, it looks like he will get FDA approval first. “This shows how difficult it is for people like me to implement such ideas that really help children,” he laments. MDR, in his view, has the potential to make children losers. This is not only an economic, political and medical problem, but also an ethical one, he said.
From the industry’s point of view, it is a problem that the MDR does not provide any exemptions for products intended for small patient populations. Niche products do not even exist as a term in the systematics of the regulation. In discussions, reference is often made to the possibility of a special authorization under Article 59 MDR. However, experts agree that this route is not viable for niche products.
“The legislator did not have niche products in mind, but rather exceptional cases,” explains Heike Wachenhausen, a lawyer and honorary professor at the Technical University of Lübeck. That is why there is a time limit. The manufacturer must also apply for national approval in each individual member state . Wachenhausen is one of the experts commissioned by the Baden-Württemberg state government to draw up recommendations on how the MDR can be successfully implemented. The recommendations have since been submitted to the EU Commission (Europe.Table reported).
Substantial changes to the MDR are not to be expected, said Peter Bischoff-Everding, legal officer in the Medical Devices Unit, DG Sante, at an event. However, the Commission is taking the indications, which are currently coming mainly from Germany, seriously. The members of the “Medical Devices Coordination Group” (MDCG) had already discussed the issue at the end of 2021 and founded a working group. The first task of this group is to prepare a detailed analysis of the problem. This should also include a definition of the term niche products.
The next step is to clearly identify the causes of the problem so that measures can then be developed, if necessary. Before possible solutions can be developed, it must be clarified whether this is a temporary problem related to the transition from the previous medical device directives to the MDR or a structural long-term problem, the Commission’s answer to van Brempt’s parliamentary question also states. At the present time, there is no intention to revise the MDR.
