Christian Linder is not a friend of debt. So, unsurprisingly, the German Finance Minister says the Commission’s plans for new debt rules are not strict enough. “Significant adjustments are still needed,” Lindner judged on Wednesday. His French counterpart Bruno Le Maire sees it quite differently. “Some points contradict the spirit of the reform,” he criticized. And in the European Parliament, too, opinions on the proposals differ widely, analyze Christof Roche and Till Hoppe.
To provide better access to medicines throughout the EU. This is what the EU Commission wants to achieve with its pharmaceutical package presented today. It wants to create an ecosystem that will enable faster and more widespread approvals in Europe. In return, there are to be more extended protection periods, among other things. But that is not the only source of criticism, reports Charlotte Wirth.
China’s President Xi Jinping has kept the Ukrainian president waiting for more than a year. Now, surprisingly, a call from Beijing reached Kyiv on Wednesday. And Zelenskiy hopes for Chinese influence. But China wants to send a special envoy for Eurasian affairs to Ukraine, writes Fabian Peltsch.
Affordable. Accessible. Available. These are the three keywords used by the Commission to describe its new pharmaceutical package. A directive, a regulation, and a Council communication are intended to ensure that people in the EU receive better medical care. EU Vice Commissioner Margaritis Schinas spoke of an “epic” package: “Never before in the history of the EU were we able to do so much in the area of public health.” Health Commissioner Stella Kyriakides: “We are creating a single European market for medicines.” She even quoted Bono, the U2 singer: “Where you live should not determine whether you live, or die.”
With this, the commissioners are going out on a limb. Even after strengthening the EU health policy through EU4Health and HERA, the Commission has little competence in the health sector. For example, it cannot influence procurement prices and pricing in EU member states. That authority lies with the member states. Perhaps this is why Kyriakides backtracked a little later and said she wanted to create an ecosystem that would simplify access to medicines.
Because, at the moment, the place of residence in the EU very much determines the supply of medicines. In Germany, for example, 104 drugs that received marketing authorization from 2015 to 2017 were launched in 2018. In Poland, there were only 24.
Initially, the Commission wanted to present the revision of the approximately 20-year-old pharmaceutical legislation months ago. Time and again, it has postponed the date. Most recently, Commission President von der Leyen is said to have personally dealt with the controversial dossier, according to well-informed circles.
Some MEPs see this as a possible conflict of interest. The Commission President’s husband, Heiko von der Leyen, serves as Medical Director of Orgenesis, a biotech company specializing in gene and cell therapy. “One should certainly raise the question of how neutral Mrs. von der Leyen can act here,” commented Green Party member Tilly Metz. The Commission had not responded to our inquiry by press time.
The pharmaceutical industry exerted great lobbying pressure on the Commission in recent months. The authority appears to have made some concessions to the industry with the package. Schinas calls pharma a “European champion.”
For example, the Commission plans to extend the period of protection for new drugs under certain circumstances. Until now, market and dossier protection has applied for ten to eleven years. The Commission wants to take a building-block approach: Regular protection is to apply for at least eight years. If manufacturers meet certain conditions, there are exceptions: in the case of simultaneous market launch in all member states, coverage of a medical need or performance of comparative clinical studies, the protection period can be up to twelve years and up to 13 years for orphan drugs.
By way of comparison, market protection in the USA lasts up to a maximum of twelve years under certain conditions and up to ten years in Switzerland. Longer protection also means it takes longer for generics to come onto the market. In other words, manufacturers control the pricing of the active ingredient for a longer time.
But the industry complains that the Commission’s modular approach means shorter protection. “The goal of promoting the supply of new medicines is clearly missed. If the protection period is reduced, this will demotivate companies from continuing to conduct the cost-intensive research for new drugs here,” criticizes Wolfgang Große Entrup of the German Chemical Industry Association (VCI).
According to critics, a new voucher system also strengthens pharmaceutical companies. The Commission calls it a “novel and innovative” tool to encourage the development of new antibiotics. Because there have been too few incentives to do so, Kyriakides said.
If a company develops a new antibiotic, it will be entitled to an additional year of market protection in the future. In concrete terms, the protection of a drug could then last up to 13 years (up to 14 years for drugs for rare diseases). The cost to the Commission: approximately €500 million per voucher.
Critics complain: The pharmaceutical company can apply the voucher to any drug and sell it to another company. Since the vouchers delay the market launch of generics, the Commission wants to limit them to ten vouchers in 15 years.
MEPs and member states criticized this approach already in the run-up. “The corporations can also use the additional protection for their most expensive drugs. This does not fit in with the Commission’s goal of making medicines more affordable,” criticized Green Party member Tilly Metz, for example. MEP and physician Véronique Trillet-Lenoir (Renew) agrees: “Antimicrobial resistance should instead be fought by using innovative solutions, reducing prescriptions, and strengthening the role of the new health authority HERA in the search for new antibiotics.”
The Commission’s package is composed of three parts in total. One directive deals with the requirements for approval, monitoring, labeling, regulatory protection, and market launch for medicinal products. For example, the Commission wants to speed up the approval of medicines by the European Medicines Agency (EMA).
Currently, this takes up to 400 days. The Commission wants to shorten the period to 180 days. For certain drugs, such as those for rare diseases, it should even take only 150 days. This is to be achieved by digitizing the approval procedure and limiting the number of commissions that deal with approval within the EMA.
The Commission wants to adapt the rules for new therapies and medicines. Here, the Commission is talking about natural laboratories, in which new regulatory approaches for new therapies are tested under natural conditions.
There are also to be stricter rules on the environmental impact and sustainability of medicines. To this end, the EMA wants to carry out a more stringent environment-related risk assessment. However, a Commission official stressed there would be no “drastic measures” such as withdrawal of approval.
The second part of the package is a regulation. This lays down rules to ensure the security of the supply of critical medicines. This is done, for example, by drawing up a list of critical medicines whose stocks are to be monitored by the EMA. Drug manufacturers are to notify the authorities if they withdraw drugs from the market or if stocks of a drug run low. They are to be obligated to submit plans to prevent shortages.
Critics complain that the Commission is not addressing the problem of complex drug supply chains, such as dependence on India and China for ingredients and precursors.
The final link is communication on antibiotic resistance. The Commission calls on member states to promote the careful use of antibiotics. It emphasizes a so-called “one health” approach (interaction between animals, humans, and the environment) as well as better monitoring and infection control. A communication does not have a legislative character.
The news came out of the blue on Wednesday evening, Beijing local time: China’s President Xi Jinping spoke on the phone with Volodymyr Zelenskiy, the President of Ukraine, as state media reported. As Zelenskiy shared on Twitter shortly after, the conversation was “long and meaningful.” The phone call had been expected, especially by the Ukrainian side, for months. There had been radio silence between the two leaders since the invasion of Ukraine by Russian troops.
Instead of talking to Zelenskiy, Xi met his “good old friend” Vladimir Putin in Moscow at the end of March. The focus was on expressions of friendship and economic cooperation with Russia. When Zelenskiy extended an invitation to Xi a few days later and told the AP news agency “we are ready to see him here,” it was impossible not to hear the desperation between the lines.
Zelenskiy knows that China is the only country that can exert substantial pressure on Russia to cooperate with Ukraine toward peace. To this end, Beijing presented a 12-point plan for a “political solution to the Ukraine crisis” in February. This includes, among other things, a call for de-escalation and an eventual ceasefire. On closer inspection, however, the plan turned out to be woolly, unspecific and tending to follow the narrative and claims of the Russian partner. This was also Zelenskiy’s view. He would consider a peace settlement only after Russian troops had left Ukrainian territory.
It is not known whether such plans were now part of the phone call with Xi. “I believe that this call, as well as the appointment of Ukraine’s ambassador to China, will give a powerful impetus to the development of our bilateral relations,” Zelenskiy wrote on Twitter after the phone call. Zelenskiy’s spokesman Sergii Nikiforov said in a Facebook post that the discussion lasted nearly an hour. The new ambassador to China being talked about is Pavel Ryabikin. He previously headed the Ministry of Strategic Industries. The ambassador’s post had been vacant since February 2021.
What will happen after the phone call? Chinese Foreign Ministry spokeswoman Hua Chunying announced that Beijing will now send the Chinese government’s special representative for Eurasian affairs to Ukraine and other countries “to hold in-depth talks with all parties on a political solution to the Ukraine crisis.” China’s current special envoy for the Eurasian region has been Li Hui since 2019.
The 70-year-old is an expert on Eastern Europe and Russia. He joined the USSR and Europe Department of the Chinese Foreign Ministry back in the mid-1970s. From there, he climbed the career ladder as Secretary of the Chinese Embassy in the USSR and later as Secretary of the Chinese Embassy in the Russian Federation. He eventually served as Ambassador of the People’s Republic of China to Russia from 2009 to 2019 until he announced his retirement in July 2019.
In his new post as special representative for Eurasia, Li has so far mainly propagated the implementation of the Belt and Road Initiative in the region, always emphasizing the important role of Russia. “Strong mutual political trust is the most important feature of Sino-Russian relations and the foundation of bilateral ties,” he said, for example, ahead of the second Belt and Road Forum for International Cooperation (BRF) in April 2019, which Putin also attended in Beijing.
Whether Li’s mission can contribute to peace negotiations that are satisfactory to both sides is questionable. China’s ministry did not give any details about when Li will start his trip and which countries he will visit. China’s state media also remain habitually vague. President Xi reportedly told Zelenskiy by phone that “talks and negotiations are the only way out” of the war. All parties involved must remain “calm and exercise restraint,” he said. China, he said, is “neither a party to the conflict nor does it want to stand on the sidelines, pour oil on the fire or profit from the situation.”
Zelenskiy obviously cannot and will not give up hope in Beijing. With its peace plan, China has at least shown that it wants to talk about Ukraine, and that is “not bad,” he had declared during a speech on the anniversary of the invasion at the end of February. That Xi did not comment positively on Russia’s role in the Ukraine war during his Moscow trip was even interpreted by Zelenskiy as a defeat for Putin. “He has no allies,” he declared in an interview at the time.
Electricity and gas prices have fallen, and the European Union got through the winter without Russian gas – yet the energy market must continue to adapt to crises and climate change. Andreas Löschel knows what a greener energy economy could look like: He is a Professor of Environmental and Resource Economics at Ruhr University in Bochum and advises both the German and French governments on energy issues.
“For economists, the environmental issue wasn’t really a topic for a long time,” says Löschel, who was part of the first research training group on environmental economics in 1998. His doctorate dealt with the Kyoto Protocol, followed by professorships in Heidelberg and Münster; he has been teaching in Bochum since 2021. Löschel is also one of the lead authors of the fifth and sixth IPCC reports.
Early last year, the environmental economist researched what Europe’s energy supply might look like without Russian gas. Germany and the European Union reacted more successfully than he had initially expected, he said: LNG terminals and gas from other countries kept storage facilities full, and households and businesses saved. “Now, we must not lay back,” Löschel stressed. After all, he says, this winter was mild, the next one could be different.
“High prices for fossil energy must not be a temporary phenomenon,” Löschel says. In the future, the new conditions in European emissions trading and the new emissions rules for buildings and transport would also ensure that. He says it is important that companies and households are affected by the high prices – so that they save in the long term: “Prices must remain high, even if this is painful for the individual. That’s the only way to trigger long-term investments.” Then, he said, consumers who cannot afford this must be relieved.
In this context, he says, it is crucial to find European solutions. “At the beginning, Germany often gave the impression it was thinking more of itself when it came to gas,” says Löschel. There was a great deal of uncertainty in politics and society, and energy had only ever become cheaper. Many companies had never dealt with the matter before. Löschel sees his task as a scientist as pointing out various ways of dealing with the situation – for politicians and the public in the media.
In order to find the best solutions, science depends on publicly available data on the energy sector – for example, on bottlenecks in the European grids. Löschel and other scientists thus published a call for the establishment of a European Energy Agency on Wednesday: “Without this, there will be neither the basis for the necessary public planning nor for the private investments that serve the system.”
Another new project by Löschel is also about transparency. The economist is developing environmental labels for carbon-intensive companies that want to emit less. This is expensive – accordingly, the professor is investigating whether and to what extent new labels can make companies more attractive to investors. Scaling green companies is not enough, he says: “Especially areas that are dirty today need to go green.” Jana Hemmersmeier
Christian Linder is not a friend of debt. So, unsurprisingly, the German Finance Minister says the Commission’s plans for new debt rules are not strict enough. “Significant adjustments are still needed,” Lindner judged on Wednesday. His French counterpart Bruno Le Maire sees it quite differently. “Some points contradict the spirit of the reform,” he criticized. And in the European Parliament, too, opinions on the proposals differ widely, analyze Christof Roche and Till Hoppe.
To provide better access to medicines throughout the EU. This is what the EU Commission wants to achieve with its pharmaceutical package presented today. It wants to create an ecosystem that will enable faster and more widespread approvals in Europe. In return, there are to be more extended protection periods, among other things. But that is not the only source of criticism, reports Charlotte Wirth.
China’s President Xi Jinping has kept the Ukrainian president waiting for more than a year. Now, surprisingly, a call from Beijing reached Kyiv on Wednesday. And Zelenskiy hopes for Chinese influence. But China wants to send a special envoy for Eurasian affairs to Ukraine, writes Fabian Peltsch.
Affordable. Accessible. Available. These are the three keywords used by the Commission to describe its new pharmaceutical package. A directive, a regulation, and a Council communication are intended to ensure that people in the EU receive better medical care. EU Vice Commissioner Margaritis Schinas spoke of an “epic” package: “Never before in the history of the EU were we able to do so much in the area of public health.” Health Commissioner Stella Kyriakides: “We are creating a single European market for medicines.” She even quoted Bono, the U2 singer: “Where you live should not determine whether you live, or die.”
With this, the commissioners are going out on a limb. Even after strengthening the EU health policy through EU4Health and HERA, the Commission has little competence in the health sector. For example, it cannot influence procurement prices and pricing in EU member states. That authority lies with the member states. Perhaps this is why Kyriakides backtracked a little later and said she wanted to create an ecosystem that would simplify access to medicines.
Because, at the moment, the place of residence in the EU very much determines the supply of medicines. In Germany, for example, 104 drugs that received marketing authorization from 2015 to 2017 were launched in 2018. In Poland, there were only 24.
Initially, the Commission wanted to present the revision of the approximately 20-year-old pharmaceutical legislation months ago. Time and again, it has postponed the date. Most recently, Commission President von der Leyen is said to have personally dealt with the controversial dossier, according to well-informed circles.
Some MEPs see this as a possible conflict of interest. The Commission President’s husband, Heiko von der Leyen, serves as Medical Director of Orgenesis, a biotech company specializing in gene and cell therapy. “One should certainly raise the question of how neutral Mrs. von der Leyen can act here,” commented Green Party member Tilly Metz. The Commission had not responded to our inquiry by press time.
The pharmaceutical industry exerted great lobbying pressure on the Commission in recent months. The authority appears to have made some concessions to the industry with the package. Schinas calls pharma a “European champion.”
For example, the Commission plans to extend the period of protection for new drugs under certain circumstances. Until now, market and dossier protection has applied for ten to eleven years. The Commission wants to take a building-block approach: Regular protection is to apply for at least eight years. If manufacturers meet certain conditions, there are exceptions: in the case of simultaneous market launch in all member states, coverage of a medical need or performance of comparative clinical studies, the protection period can be up to twelve years and up to 13 years for orphan drugs.
By way of comparison, market protection in the USA lasts up to a maximum of twelve years under certain conditions and up to ten years in Switzerland. Longer protection also means it takes longer for generics to come onto the market. In other words, manufacturers control the pricing of the active ingredient for a longer time.
But the industry complains that the Commission’s modular approach means shorter protection. “The goal of promoting the supply of new medicines is clearly missed. If the protection period is reduced, this will demotivate companies from continuing to conduct the cost-intensive research for new drugs here,” criticizes Wolfgang Große Entrup of the German Chemical Industry Association (VCI).
According to critics, a new voucher system also strengthens pharmaceutical companies. The Commission calls it a “novel and innovative” tool to encourage the development of new antibiotics. Because there have been too few incentives to do so, Kyriakides said.
If a company develops a new antibiotic, it will be entitled to an additional year of market protection in the future. In concrete terms, the protection of a drug could then last up to 13 years (up to 14 years for drugs for rare diseases). The cost to the Commission: approximately €500 million per voucher.
Critics complain: The pharmaceutical company can apply the voucher to any drug and sell it to another company. Since the vouchers delay the market launch of generics, the Commission wants to limit them to ten vouchers in 15 years.
MEPs and member states criticized this approach already in the run-up. “The corporations can also use the additional protection for their most expensive drugs. This does not fit in with the Commission’s goal of making medicines more affordable,” criticized Green Party member Tilly Metz, for example. MEP and physician Véronique Trillet-Lenoir (Renew) agrees: “Antimicrobial resistance should instead be fought by using innovative solutions, reducing prescriptions, and strengthening the role of the new health authority HERA in the search for new antibiotics.”
The Commission’s package is composed of three parts in total. One directive deals with the requirements for approval, monitoring, labeling, regulatory protection, and market launch for medicinal products. For example, the Commission wants to speed up the approval of medicines by the European Medicines Agency (EMA).
Currently, this takes up to 400 days. The Commission wants to shorten the period to 180 days. For certain drugs, such as those for rare diseases, it should even take only 150 days. This is to be achieved by digitizing the approval procedure and limiting the number of commissions that deal with approval within the EMA.
The Commission wants to adapt the rules for new therapies and medicines. Here, the Commission is talking about natural laboratories, in which new regulatory approaches for new therapies are tested under natural conditions.
There are also to be stricter rules on the environmental impact and sustainability of medicines. To this end, the EMA wants to carry out a more stringent environment-related risk assessment. However, a Commission official stressed there would be no “drastic measures” such as withdrawal of approval.
The second part of the package is a regulation. This lays down rules to ensure the security of the supply of critical medicines. This is done, for example, by drawing up a list of critical medicines whose stocks are to be monitored by the EMA. Drug manufacturers are to notify the authorities if they withdraw drugs from the market or if stocks of a drug run low. They are to be obligated to submit plans to prevent shortages.
Critics complain that the Commission is not addressing the problem of complex drug supply chains, such as dependence on India and China for ingredients and precursors.
The final link is communication on antibiotic resistance. The Commission calls on member states to promote the careful use of antibiotics. It emphasizes a so-called “one health” approach (interaction between animals, humans, and the environment) as well as better monitoring and infection control. A communication does not have a legislative character.
The news came out of the blue on Wednesday evening, Beijing local time: China’s President Xi Jinping spoke on the phone with Volodymyr Zelenskiy, the President of Ukraine, as state media reported. As Zelenskiy shared on Twitter shortly after, the conversation was “long and meaningful.” The phone call had been expected, especially by the Ukrainian side, for months. There had been radio silence between the two leaders since the invasion of Ukraine by Russian troops.
Instead of talking to Zelenskiy, Xi met his “good old friend” Vladimir Putin in Moscow at the end of March. The focus was on expressions of friendship and economic cooperation with Russia. When Zelenskiy extended an invitation to Xi a few days later and told the AP news agency “we are ready to see him here,” it was impossible not to hear the desperation between the lines.
Zelenskiy knows that China is the only country that can exert substantial pressure on Russia to cooperate with Ukraine toward peace. To this end, Beijing presented a 12-point plan for a “political solution to the Ukraine crisis” in February. This includes, among other things, a call for de-escalation and an eventual ceasefire. On closer inspection, however, the plan turned out to be woolly, unspecific and tending to follow the narrative and claims of the Russian partner. This was also Zelenskiy’s view. He would consider a peace settlement only after Russian troops had left Ukrainian territory.
It is not known whether such plans were now part of the phone call with Xi. “I believe that this call, as well as the appointment of Ukraine’s ambassador to China, will give a powerful impetus to the development of our bilateral relations,” Zelenskiy wrote on Twitter after the phone call. Zelenskiy’s spokesman Sergii Nikiforov said in a Facebook post that the discussion lasted nearly an hour. The new ambassador to China being talked about is Pavel Ryabikin. He previously headed the Ministry of Strategic Industries. The ambassador’s post had been vacant since February 2021.
What will happen after the phone call? Chinese Foreign Ministry spokeswoman Hua Chunying announced that Beijing will now send the Chinese government’s special representative for Eurasian affairs to Ukraine and other countries “to hold in-depth talks with all parties on a political solution to the Ukraine crisis.” China’s current special envoy for the Eurasian region has been Li Hui since 2019.
The 70-year-old is an expert on Eastern Europe and Russia. He joined the USSR and Europe Department of the Chinese Foreign Ministry back in the mid-1970s. From there, he climbed the career ladder as Secretary of the Chinese Embassy in the USSR and later as Secretary of the Chinese Embassy in the Russian Federation. He eventually served as Ambassador of the People’s Republic of China to Russia from 2009 to 2019 until he announced his retirement in July 2019.
In his new post as special representative for Eurasia, Li has so far mainly propagated the implementation of the Belt and Road Initiative in the region, always emphasizing the important role of Russia. “Strong mutual political trust is the most important feature of Sino-Russian relations and the foundation of bilateral ties,” he said, for example, ahead of the second Belt and Road Forum for International Cooperation (BRF) in April 2019, which Putin also attended in Beijing.
Whether Li’s mission can contribute to peace negotiations that are satisfactory to both sides is questionable. China’s ministry did not give any details about when Li will start his trip and which countries he will visit. China’s state media also remain habitually vague. President Xi reportedly told Zelenskiy by phone that “talks and negotiations are the only way out” of the war. All parties involved must remain “calm and exercise restraint,” he said. China, he said, is “neither a party to the conflict nor does it want to stand on the sidelines, pour oil on the fire or profit from the situation.”
Zelenskiy obviously cannot and will not give up hope in Beijing. With its peace plan, China has at least shown that it wants to talk about Ukraine, and that is “not bad,” he had declared during a speech on the anniversary of the invasion at the end of February. That Xi did not comment positively on Russia’s role in the Ukraine war during his Moscow trip was even interpreted by Zelenskiy as a defeat for Putin. “He has no allies,” he declared in an interview at the time.
Electricity and gas prices have fallen, and the European Union got through the winter without Russian gas – yet the energy market must continue to adapt to crises and climate change. Andreas Löschel knows what a greener energy economy could look like: He is a Professor of Environmental and Resource Economics at Ruhr University in Bochum and advises both the German and French governments on energy issues.
“For economists, the environmental issue wasn’t really a topic for a long time,” says Löschel, who was part of the first research training group on environmental economics in 1998. His doctorate dealt with the Kyoto Protocol, followed by professorships in Heidelberg and Münster; he has been teaching in Bochum since 2021. Löschel is also one of the lead authors of the fifth and sixth IPCC reports.
Early last year, the environmental economist researched what Europe’s energy supply might look like without Russian gas. Germany and the European Union reacted more successfully than he had initially expected, he said: LNG terminals and gas from other countries kept storage facilities full, and households and businesses saved. “Now, we must not lay back,” Löschel stressed. After all, he says, this winter was mild, the next one could be different.
“High prices for fossil energy must not be a temporary phenomenon,” Löschel says. In the future, the new conditions in European emissions trading and the new emissions rules for buildings and transport would also ensure that. He says it is important that companies and households are affected by the high prices – so that they save in the long term: “Prices must remain high, even if this is painful for the individual. That’s the only way to trigger long-term investments.” Then, he said, consumers who cannot afford this must be relieved.
In this context, he says, it is crucial to find European solutions. “At the beginning, Germany often gave the impression it was thinking more of itself when it came to gas,” says Löschel. There was a great deal of uncertainty in politics and society, and energy had only ever become cheaper. Many companies had never dealt with the matter before. Löschel sees his task as a scientist as pointing out various ways of dealing with the situation – for politicians and the public in the media.
In order to find the best solutions, science depends on publicly available data on the energy sector – for example, on bottlenecks in the European grids. Löschel and other scientists thus published a call for the establishment of a European Energy Agency on Wednesday: “Without this, there will be neither the basis for the necessary public planning nor for the private investments that serve the system.”
Another new project by Löschel is also about transparency. The economist is developing environmental labels for carbon-intensive companies that want to emit less. This is expensive – accordingly, the professor is investigating whether and to what extent new labels can make companies more attractive to investors. Scaling green companies is not enough, he says: “Especially areas that are dirty today need to go green.” Jana Hemmersmeier
