Table.Briefing: Europe

Better medicines access + ETS and CBAM compromises + Spyware against Catalans

  • Pharmaceutical industry wants to improve access to medicines
  • ITRE compromises on ETS and CBAM
  • Catalan independence leaders targeted by Pegasus spyware
  • DERA: increased independence from Russia through recycling
  • Employers and unions warn of Russian gas import freeze
  • EMA involved in the preparations for the HTA Regulation
  • €1 billion for ocean protection
  • Profile: Daniel Gros – economic answers to social problems
Dear reader,

Easter has come and gone and we are still none the wiser as to whether and how quickly Europe can manage without Russian gas. Employers and trade unions warn of a gas import stop from Russia, as you can read in the News. Meanwhile, prices for electricity and gas will continue to rise in the coming months, according to the comparison portal Verivox, which refers to publications from energy providers.

However, natural gas from Germany is still not an option to the Minister for Economic Affairs and Climate Action, Robert Habeck. In the North German Plain, there is a large amount of gas, but it is only accessible by fracking. “You would have to destroy deep layers of rock with a lot of pressure and chemical substances to extract the gas,” he said, referring to negative consequences for the environment. At the moment, Habeck said, there are also no companies that want to do that. In addition, it would “take years to set up new production facilities and get the approval procedures in place”.

Great hopes of decarbonizing the energy sector and EU industry lie in European emissions trading. As is well known, however, this will only work if there is sufficient protection against carbon leakage. To ensure that European producers remain internationally competitive despite high CO2 prices, the Carbon Border Adjustment Mechanism CBAM is intended to ensure that foreign importers are asked to pay if they do not produce in a climate-friendly manner. The exact design of the instrument is once again the subject of debate in the EU Parliament, as a compromise proposal by the Industry and Energy Committee has met with little approval in other instances. Read about the content and criticisms of the compromise in today’s Europe.Table.

End of 2022, the EU Commission wants to fundamentally revise European pharmaceutical legislation. As a result, the pharmaceutical industry is on high alert. It is now trying to set the tone for the upcoming reforms with its own proposals for improving access to medicines, as Eugenie Ankowitsch reports.

In today’s Profile, learn what busy economist and CEPS Fellow Daniel Gros had to discuss with Barack Obama and how, as a German Italian, he must always argue from two perspectives.

I hope you had a chance to relax over the holidays and I wish you a great start to the week ahead.

Your
Lukas Knigge
Image of Lukas  Knigge

Feature

Escape to the future: Pharmaceutical industry wants to improve access to medicines

The planned measures by the member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which include 20 of the world’s largest pharmaceutical companies, are intended to “significantly increase” the availability of innovative medicines in EU countries. In addition, patients’ waiting time for new medicines is to be reduced by several months, according to the current EFPIA statement.

According to the agreement, EFPIA member companies commit, among other things, to submit applications for pricing and reimbursement in all EU countries as early as possible and no later than two years after the central EU marketing authorization – provided local systems allow this.

Glaring differences within Europe

Just days earlier, the association had published the most comprehensive EFPIA WAIT Indicator Survey to date. This identifies for individual countries how quickly new medicines are available and how many new medicines are available for patient care. The survey covers the period between 2017 and 2020 and shows that there are still significant differences between countries. As a rule, patients in Central and Eastern Europe and in the smaller member states wait the longest for access to new medicines. Many new medicines do not even reach mainstream patient care.

The average waiting time for reimbursement of innovative drug therapies in the countries of the EU and the European Economic Area (EEA) is 511 days. But while patients in Germany wait only around 133 days for access to new medicines, the figure is 594 days in Lithuania and 899 days in Romania.

In the period under review, the EMA approved a total of 160 drugs. After all, 147 have made it through to reimbursement in Germany and thus into the general supply. They are followed by Denmark (129), Austria (127), and Italy (127). Among the EU countries, Lithuania, Latvia, and Malta occupy the last places with 28, 26, and 11 reimbursable drugs, respectively.

VFA warns against retroactive discounts

Germany also leads the field in the availability of drugs for rare diseases. On average, it takes 102 days for an orphan drug to become available in Germany. The EMA approved a total of 57 drugs in the period under review – 54 of which also made it to Germany. Of the EU countries, Lithuania and Latvia again brought up the rear. In the two Baltic states, it took 984 and 1077 days, respectively, for drugs for rare diseases to reach patient care. However, of the 57 approved drugs, only one in Lithuania and two in Latvia made it to reimbursement.

Germany’s very good position in terms of drug supply is no coincidence, but the result of decades of political consensus that approved drugs should reach patients quickly in this country,” commented Han Steutel, president of the German Association of Research-Based Pharmaceutical Companies (VFA). “That’s why it’s not a good idea for the traffic light coalition to put this at risk and conduct regulatory experiments in areas relevant to healthcare.”

The VFA president’s warning is aimed at a clause in the coalition agreement under which retroactive drug discounts are to be made possible in the AMNOG procedure. The association warns that this poses financial risks for companies that are difficult to calculate and would significantly impair their planning security. They would then have to consider whether to launch their new drug on the German market only when it was clear what the actual price would be after negotiated rebates. Then the traditionally fast availability of drugs in the German healthcare system could also quickly come to an end.

Unsustainable situation for patients

Looking across Europe, EFPIA Director General Nathalie Moll comes to a different conclusion: “For patients and healthcare systems, the situation is untenable,” she said. “After years of research and development in areas of unmet need, companies want their medicines to reach patients as quickly as possible. We believe it is time to change this.”

Over the past two years, EFPIA has documented the causes of inequalities in access to medicines and found that there are ten interrelated factors that explain the lack of availability and delays. From the pharmaceutical industry’s perspective, they are rooted in access systems and processes in EU member states and the corresponding impact on commercial decision-making. They ranged from a slow regulatory process, late initiation of market access assessment, duplicative evidence requirements, reimbursement delays, and local formulary decisions. As the causes are multifactorial, the only way to achieve faster and more equitable access for patients across Europe is through collaboration among various stakeholders.

Modeling by analytics firm IQVIApredicts that the submission requirement will increase the availability of medicines from 18 percent to as much as 64 percent in several countries, according to EFPIA. In addition, the obligation is estimated to reduce the waiting time for new medicines by four to five months, particularly in countries such as Bulgaria (ca. 179 days), Poland (ca. 129 days), and Romania (ca. 155 days).

Discussion about fairer prices

The submission requirement will also be flanked by a new online portal with up-to-date information on the processing of applications for pricing and reimbursement schemes in the 27 EU countries. EFPIA also announced its intention to hold a discussion on fair prices for innovative medicines in EU member states. For example, the price should vary from country to country depending on economic strength, the association announced in a discussion paper.

It sets out the cornerstones of a fairness-based pricing system anchored in the principle of solidarity between member states and in the EU treaties. Providing a fairness-based system requires that the Commission and member states modify external price reference systems and put mechanisms in place to prevent the unintended consequences of internal trade in pharmaceuticals, it says.

“We can dramatically change the situation for patients across Europe by reducing the time to apply for pricing and reimbursement in all 27 EU member states, creating more transparency about barriers and delays to access, collaboratively designing a fairness-based pricing system, applying an efficient system for EU relative effectiveness assessments, and sharing information on the implementation of novel pricing mechanisms,” said EFPIA Director General Moll.

Major drug reform at the end of 2022

The pharmaceutical industry’s efforts seem like the famous flight to the front. During the consultations on the planned revision of the EU pharmaceutical legislation, which were concluded in December 2021, most pharmaceutical companies and industry associations came to the conclusion in their statements that improvements were possible in some areas. However, a fundamental revision was not necessary.

The European Commission apparently sees things differently. Improved access to affordable medicines and the elimination of sometimes glaring inequalities between EU member states are therefore high on the agenda when it comes to revising pharmaceutical legislation. For example, there are discussions about obliging pharmaceutical companies to market and supply their products in all EU member states.

The pharmaceutical industry has obviously recognized one thing in the meantime: There will certainly be no “business as usual”. And so, the current EFPIA publications no longer speak of merely selective improvements. Instead, it states that the industry “shares the concern about these delays” and recognizes that delays and the unavailability of medicines harm patients. It said urgent action is needed to address these “long-standing problems”. Whether the powerful pharmaceutical industry can thus set the direction of travel and keep the upcoming reforms influenced in its favor will probably become clear at the end of 2022, when the EU Commission intends to present its proposals.

  • Health
  • Health policy
  • Pharma

ITRE compromises on ETS and CBAM

If it’s up to the likely majority of MEPs of the European Parliament’s Committee on Industry, Research and Energy (ITRE), the planned Carbon Border Adjustment Mechanism (CBAM) will be introduced over a much shorter period than envisaged by the Commission. This emerges from a compromise proposal on both dossiers of the Fit for 55 package published by Contexte shortly before Easter.

By the end of 2034, the CBAM is to have completely replaced the free allocation of CO2 certificates for the industry. The EU Commission had proposed a year later. However, the Brussels-based authority wants to begin phasing in the CBAM and phasing out free allocation as early as 2026. In the ITRE Committee next week, MEPs are expected to vote in favor of 2028 as the phase-out start date for free allocation, while CBAM is to start in 2027.

Possible conflict with WTO rules

This would initially allow free allocations to be issued to the industry unchanged until 2028, allowing the CBAM to be tested under real-world conditions for one year. From 2023 to 2026, there would be a transition period for data collection, during which companies in the CBAM sectors would have to record what marginal financial compensation they would theoretically have to pay but would not pay it. In 2027, the CBAM would be introduced, while in parallel, the free allocations would remain in full for the time being.

However, such a double preferential treatment of European producers could conflict with WTO trade rules. The SPD in the EU Parliament says that this is possible, provided it is limited in time. Other groups are much more skeptical. The ITRE compromise, therefore, explicitly mentions that the CBAM must be WTO-compliant.

If the CBAM proves to be as effective as hoped against carbon leakage, free allocations in the CBAM sectors would be gradually reduced from 2028. Initially by 10 percent annually up to and including 2030, then by 17.5 percent each year until the end of 2034.

Export industry should continue to receive free certificates

For exports, free allocations are to remain unchanged. Only after the end of the phase-in period of the CBAM should the Commission present a detailed impact assessment of the “effects on EU exports of the CBAM sectors and the development of global emissions,” the paper says.

The free allocations are to be reduced for companies that do not fully implement the recommendations of the energy audit report – if one is required by the Energy Efficiency Directive. The Commission had proposed issuing 25 percent fewer allowances free of charge in this case. The ITRE compromise provides for the amount of the reduction to be based on the recommendations of the energy audit, but by a minimum of 15 percent and a maximum of 40 percent.

The compromise proposals on both dossiers are supported by the liberal Renew, the conservatives of EPP and ECR, the social democratic S&D, and the nationalist ID group. Only the Greens and Left are absent. The Greens fear that the CBAM could be further weakened, which would also “weaken the clout of the climate mechanism more and more,” explains Michael Bloss (Greens/EFA) at the request of the Europe.Table. Bloss is shadow rapporteur for the ETS in the ENVI Committee as well as a member of ITRE. He calls for a strong CBAM that uses high CO2 prices to incentivize the industry to save CO2 and invest in climate-neutral and modern technologies. He does not see this fulfilled by the compromise proposal in the ITRE Committee.

ITRE and ENVI face difficult talks

Nevertheless, the two compromises will likely receive a clear majority in the Industry Committee on Wednesday. How significant the impact of the vote will actually be, however, is questionable. Although the ITRE is involved in the negotiations as an associated committee, and its opinion should be taken into account, the Environment Committee is the lead committee.

Within the respective parliamentary groups, there are also sometimes considerable differences in the positions of the ITRE and ENVI committee members. Support for the compromise in ITRE by the Social Democrats, for example, is therefore not synonymous with its consideration in ENVI.

Read here how the positions in ENVI on CBAM and ETS are distributed.

  • Climate & Environment
  • Climate Policy
  • Emissions
  • Emissions trading
  • Klimaziele

News

Catalan independence leaders targeted by Pegasus spyware

On Monday, Catalonia’s regional leader Pere Aragonès accused the Spanish government of spying on its citizens. The human rights organization Citizen Lab had found that his phone and those of dozens of Catalan independence supporters had been infected with the “Pegasus” spy software.

Citizen Lab found that more than 60 people associated with the Catalan separatist movement were affected – including several members of the European Parliament, lawyers, and activists. The trigger for the surveillance with Pegasus is said to have been the failed attempt to make Catalonia independent from Spain.

It was “shameful and unjustifiable”, as Catalan government leader Aragonès wrote on twitter. “It is a very serious attack on democracy and fundamental rights.” He called the use of surveillance software a crossing of a “red line” and demanded explanations from the Spanish government. The government declined to comment, according to Reuters.

Pegasus developers reject accusations

NSO Group Technologies, the Israeli company that developed Pegasus and markets it as a law enforcement tool, denied the allegations. Citizen Lab and Amnesty International, which were not involved in this investigation but have published previous studies on Pegasus, had produced inaccurate and unsubstantiated reports to attack the company. The allegations could not be linked to NSO products for technical and contractual reasons, a spokesman said by email, without explaining why.

The Toronto-based Citizen Lab said almost all of the infections occurred between 2017 and 2020, when Catalonia’s push for independence plunged Spain into its worst political crisis in years. It said it was not possible to clearly attribute the spying operations to a specific entity. However, strong circumstantial evidence would point to a link with Spanish authorities. rtr/luk

  • Democracy
  • Digital policy
  • Digitization
  • Pegasus
  • Spain

DERA: increased independence from Russia through recycling

Europe can become less dependent on Russian imports by increasing recycling, according to the federally owned German Mineral Resources Agency (DERA). “We still see considerable potential in recycling, even though we are already doing comparatively well in Germany,” the head of DERA’s raw materials management division, Siyamend Al Barazi, told Automobilwoche magazine, according to an advance report on Monday.

For copper, lead, aluminum, and nickel, for example, recycling rates are between 40 and 60 percent. Stockpiling important mineral resources could help bridge critical phases like the current one: “Other countries like South Korea, Japan, or the US operate state stockpiling, but supporting entrepreneurial stockpiling could also be an option.” Because of the invasion of Ukraine by Russian troops, Europe wants to become less dependent on supplies from Russia.

Europe still has a lot of potential, according to Al Barazi. “In Finland, for example, there are nickel deposits. Interesting lithium deposits can also be found in Spain, Portugal and Serbia. But the question is always whether such projects can be operated economically in a global comparison.” It costs money and time to fundamentally change established process chains.

Ukraine and Russia are important suppliers, especially for the European market, of aluminum, ferrotungsten, nickel, palladium, and noble gases such as neon, argon, and xenon. These quantities could not simply be replaced overnight by other suppliers. The Mineral Resources Agency also views the supply of titanium and titanium products very critically. rtr

  • Raw materials
  • Recycling
  • Sustainability
  • Ukraine

Employers and trade unions warn of Russian gas import freeze

Employers and trade unions have jointly warned against an import ban on Russian gas to Germany. Sanctions must be targeted, pressure must be put on the opposing side, and, if possible, damage to their own economy must be prevented, the Chairman of the Confederation of German Employers’ Associations BDA, Rainer Dulger, and the Chairman of the German Federation of Trade Unions (DGB), Reiner Hoffmann, told dpa. “In the case of the gas embargo currently under discussion, we don’t see that happening.”

According to Dulgers and Hoffmann, the negative impact on the economy and employment would currently be higher in Germany than in Russia. “A quick gas embargo would result in production losses, production standstills, further deindustrialization and sustained job losses in Germany.”

In order to continue to support Ukraine and keep up the pressure on Russia, a stable economy and labor market are needed, the DGB and BDA said. “We will still have to face many challenges in the coming months. We cannot do that from a position of weakness.” dpa

  • Energy
  • Energy policy
  • Germany
  • Natural gas

EMA involved in the preparations for the HTA Regulation

The European Medicines Agency (EMA) will work with the European Network for Health Technology Assessment (EUnetHTA) to prepare the new Health Technology Assessment (HTA) Regulation. The regulation is expected to enter into force in January 2025.

In their joint work plan, the EMA and EUnetHTA announced their intention to focus, among other things, on relaunching a joint scientific consultation and developing methods for generating patient-relevant information. They will also discuss how to promote exchange between patients and health professionals.

Following the award of the “Service Contract for the Provision of Joint Health Technology Assessment (HTA) Work Supporting the Continuation of EU Cooperation on HTA” to EUnetHTA, the European Commission has requested EMA and EUnetHTA to develop a joint work plan for the implementation of the previously identified priorities. This mandate will run until September 2023, when four bilateral meetings between EUnetHTA and the EMA will take place. ank

  • Health
  • Health policy

€1 billion for ocean protection

The EU is providing a total of €1 billion for the international protection of the oceans. Last Thursday, at the “Our Ocean” conference in Palau, the Commission presented a list of 44 commitments. Among other things, the measures are intended to reduce plastic waste in the oceans, promote sustainable fishing, and preserve biodiversity in the oceans.

Virginijus Sinkevičius, European Commissioner for the Environment, Oceans and Fisheries, spoke of a “significant sum” for the protection of the oceans, on which “our future” depends. These are the EU’s most substantial commitments to protect the oceans, according to the Commission.

The “Our Ocean” conference has been held once a year since 2014. This year, the western Pacific island nation of Palau co-hosted the conference with the USA. It aims to draw attention to regions that are particularly dependent on the oceans and threatened by climate change. leo

  • Climate & Environment
  • Environmental protection
  • Green Deal
  • Sustainability

Profile

Economic answers to social problems

Daniel Gros, Distinguished Fellow, Centre for European Policy Studies (CEPS)

It’s not easy to get Daniel Gros on the phone. He travels a lot. At the first attempt, he is on a plane; at the next attempt, he is called on the other phone at the same time, but then answers quickly (in Italian) and finally makes time for a relaxed conversation in which he talks about himself and his life, which has been shaped through and through by Europe: At the age of eighteen, the native German moved with his family to Italy, where he also earned his master’s degree in economics. “In Italy, I’m considered more of a German, and in Germany, more of an Italian,” says the economist, who in between earned a doctorate in the US and has now lived in Brussels for decades.

And then, he illustrates his statement with an example that does not coincidentally comes from economics: “In Germany, it met with irritation that I spoke out early on in favor of a monetary union and also a banking union. And in Italy, I seem strange when I insist that sound public finances are good for the national economy and help the country achieve greater prosperity in the long term.”

Economic responses to the war in Ukraine

Daniel Gros has already experienced a few crises. However, in the current volatile times, even he sometimes lies awake at night with worries. “The euro crisis was tough, and no one wanted the whole thing to go down the drain. The refugee crisis was also a test. But now, it’s not just about financial and practical issues, it’s about the values we represent, about the order in Europe, and our security. That leaves no one unshaken,” he says.

Nevertheless, when he sees a social problem, as an analyst he first asks about the economic mechanisms at work. After all, that is the contribution he can make as an economist. Currently, for example, he is concerned with the devaluation of money. “We have a strangely high inflation, which is always attributed to energy prices. But energy prices are not at all higher than they were ten years ago. How is this possible?” he asks – without having an answer ready.

It is clear to the economist that the population needs incentives to save gas and thus contribute to Europe’s energy independence: “Of course, we need to compensate low-income earners. And you could give a premium to those who use less gas compared to the previous year, so they would even make a profit in the process.”

Personal highlights from the Euro plan to the Obama meeting

Before joining the European think tank Centre for European Policy Studies (CEPS), Daniel Gros worked, among other things, as an economic advisor to the European Commission’s Delors Committee, which developed the plans for the euro. A time he looks back on fondly. “Nobody believed in the plan for monetary union back then,” he recalls. Then, in the early 1990s, he had the opportunity to get to know a Russia that no longer exists.

And during the euro crisis, he spoke personally with various heads of state, including the US president. “Barack Obama was afraid that the euro crisis would mess up his re-election. But he knew what he was doing. I couldn’t add much additional value,” says Daniel Gros, who talks a lot about his job and little about his private life. But at least he reveals that he has three children and that he practices the Japanese martial art Aikidō. Janna Degener-Storr

  • Energy policy
  • Finance
  • Financial policy

Europe.Table Editorial Office

EUROPE.TABLE EDITORS

Licenses:
    • Pharmaceutical industry wants to improve access to medicines
    • ITRE compromises on ETS and CBAM
    • Catalan independence leaders targeted by Pegasus spyware
    • DERA: increased independence from Russia through recycling
    • Employers and unions warn of Russian gas import freeze
    • EMA involved in the preparations for the HTA Regulation
    • €1 billion for ocean protection
    • Profile: Daniel Gros – economic answers to social problems
    Dear reader,

    Easter has come and gone and we are still none the wiser as to whether and how quickly Europe can manage without Russian gas. Employers and trade unions warn of a gas import stop from Russia, as you can read in the News. Meanwhile, prices for electricity and gas will continue to rise in the coming months, according to the comparison portal Verivox, which refers to publications from energy providers.

    However, natural gas from Germany is still not an option to the Minister for Economic Affairs and Climate Action, Robert Habeck. In the North German Plain, there is a large amount of gas, but it is only accessible by fracking. “You would have to destroy deep layers of rock with a lot of pressure and chemical substances to extract the gas,” he said, referring to negative consequences for the environment. At the moment, Habeck said, there are also no companies that want to do that. In addition, it would “take years to set up new production facilities and get the approval procedures in place”.

    Great hopes of decarbonizing the energy sector and EU industry lie in European emissions trading. As is well known, however, this will only work if there is sufficient protection against carbon leakage. To ensure that European producers remain internationally competitive despite high CO2 prices, the Carbon Border Adjustment Mechanism CBAM is intended to ensure that foreign importers are asked to pay if they do not produce in a climate-friendly manner. The exact design of the instrument is once again the subject of debate in the EU Parliament, as a compromise proposal by the Industry and Energy Committee has met with little approval in other instances. Read about the content and criticisms of the compromise in today’s Europe.Table.

    End of 2022, the EU Commission wants to fundamentally revise European pharmaceutical legislation. As a result, the pharmaceutical industry is on high alert. It is now trying to set the tone for the upcoming reforms with its own proposals for improving access to medicines, as Eugenie Ankowitsch reports.

    In today’s Profile, learn what busy economist and CEPS Fellow Daniel Gros had to discuss with Barack Obama and how, as a German Italian, he must always argue from two perspectives.

    I hope you had a chance to relax over the holidays and I wish you a great start to the week ahead.

    Your
    Lukas Knigge
    Image of Lukas  Knigge

    Feature

    Escape to the future: Pharmaceutical industry wants to improve access to medicines

    The planned measures by the member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which include 20 of the world’s largest pharmaceutical companies, are intended to “significantly increase” the availability of innovative medicines in EU countries. In addition, patients’ waiting time for new medicines is to be reduced by several months, according to the current EFPIA statement.

    According to the agreement, EFPIA member companies commit, among other things, to submit applications for pricing and reimbursement in all EU countries as early as possible and no later than two years after the central EU marketing authorization – provided local systems allow this.

    Glaring differences within Europe

    Just days earlier, the association had published the most comprehensive EFPIA WAIT Indicator Survey to date. This identifies for individual countries how quickly new medicines are available and how many new medicines are available for patient care. The survey covers the period between 2017 and 2020 and shows that there are still significant differences between countries. As a rule, patients in Central and Eastern Europe and in the smaller member states wait the longest for access to new medicines. Many new medicines do not even reach mainstream patient care.

    The average waiting time for reimbursement of innovative drug therapies in the countries of the EU and the European Economic Area (EEA) is 511 days. But while patients in Germany wait only around 133 days for access to new medicines, the figure is 594 days in Lithuania and 899 days in Romania.

    In the period under review, the EMA approved a total of 160 drugs. After all, 147 have made it through to reimbursement in Germany and thus into the general supply. They are followed by Denmark (129), Austria (127), and Italy (127). Among the EU countries, Lithuania, Latvia, and Malta occupy the last places with 28, 26, and 11 reimbursable drugs, respectively.

    VFA warns against retroactive discounts

    Germany also leads the field in the availability of drugs for rare diseases. On average, it takes 102 days for an orphan drug to become available in Germany. The EMA approved a total of 57 drugs in the period under review – 54 of which also made it to Germany. Of the EU countries, Lithuania and Latvia again brought up the rear. In the two Baltic states, it took 984 and 1077 days, respectively, for drugs for rare diseases to reach patient care. However, of the 57 approved drugs, only one in Lithuania and two in Latvia made it to reimbursement.

    Germany’s very good position in terms of drug supply is no coincidence, but the result of decades of political consensus that approved drugs should reach patients quickly in this country,” commented Han Steutel, president of the German Association of Research-Based Pharmaceutical Companies (VFA). “That’s why it’s not a good idea for the traffic light coalition to put this at risk and conduct regulatory experiments in areas relevant to healthcare.”

    The VFA president’s warning is aimed at a clause in the coalition agreement under which retroactive drug discounts are to be made possible in the AMNOG procedure. The association warns that this poses financial risks for companies that are difficult to calculate and would significantly impair their planning security. They would then have to consider whether to launch their new drug on the German market only when it was clear what the actual price would be after negotiated rebates. Then the traditionally fast availability of drugs in the German healthcare system could also quickly come to an end.

    Unsustainable situation for patients

    Looking across Europe, EFPIA Director General Nathalie Moll comes to a different conclusion: “For patients and healthcare systems, the situation is untenable,” she said. “After years of research and development in areas of unmet need, companies want their medicines to reach patients as quickly as possible. We believe it is time to change this.”

    Over the past two years, EFPIA has documented the causes of inequalities in access to medicines and found that there are ten interrelated factors that explain the lack of availability and delays. From the pharmaceutical industry’s perspective, they are rooted in access systems and processes in EU member states and the corresponding impact on commercial decision-making. They ranged from a slow regulatory process, late initiation of market access assessment, duplicative evidence requirements, reimbursement delays, and local formulary decisions. As the causes are multifactorial, the only way to achieve faster and more equitable access for patients across Europe is through collaboration among various stakeholders.

    Modeling by analytics firm IQVIApredicts that the submission requirement will increase the availability of medicines from 18 percent to as much as 64 percent in several countries, according to EFPIA. In addition, the obligation is estimated to reduce the waiting time for new medicines by four to five months, particularly in countries such as Bulgaria (ca. 179 days), Poland (ca. 129 days), and Romania (ca. 155 days).

    Discussion about fairer prices

    The submission requirement will also be flanked by a new online portal with up-to-date information on the processing of applications for pricing and reimbursement schemes in the 27 EU countries. EFPIA also announced its intention to hold a discussion on fair prices for innovative medicines in EU member states. For example, the price should vary from country to country depending on economic strength, the association announced in a discussion paper.

    It sets out the cornerstones of a fairness-based pricing system anchored in the principle of solidarity between member states and in the EU treaties. Providing a fairness-based system requires that the Commission and member states modify external price reference systems and put mechanisms in place to prevent the unintended consequences of internal trade in pharmaceuticals, it says.

    “We can dramatically change the situation for patients across Europe by reducing the time to apply for pricing and reimbursement in all 27 EU member states, creating more transparency about barriers and delays to access, collaboratively designing a fairness-based pricing system, applying an efficient system for EU relative effectiveness assessments, and sharing information on the implementation of novel pricing mechanisms,” said EFPIA Director General Moll.

    Major drug reform at the end of 2022

    The pharmaceutical industry’s efforts seem like the famous flight to the front. During the consultations on the planned revision of the EU pharmaceutical legislation, which were concluded in December 2021, most pharmaceutical companies and industry associations came to the conclusion in their statements that improvements were possible in some areas. However, a fundamental revision was not necessary.

    The European Commission apparently sees things differently. Improved access to affordable medicines and the elimination of sometimes glaring inequalities between EU member states are therefore high on the agenda when it comes to revising pharmaceutical legislation. For example, there are discussions about obliging pharmaceutical companies to market and supply their products in all EU member states.

    The pharmaceutical industry has obviously recognized one thing in the meantime: There will certainly be no “business as usual”. And so, the current EFPIA publications no longer speak of merely selective improvements. Instead, it states that the industry “shares the concern about these delays” and recognizes that delays and the unavailability of medicines harm patients. It said urgent action is needed to address these “long-standing problems”. Whether the powerful pharmaceutical industry can thus set the direction of travel and keep the upcoming reforms influenced in its favor will probably become clear at the end of 2022, when the EU Commission intends to present its proposals.

    • Health
    • Health policy
    • Pharma

    ITRE compromises on ETS and CBAM

    If it’s up to the likely majority of MEPs of the European Parliament’s Committee on Industry, Research and Energy (ITRE), the planned Carbon Border Adjustment Mechanism (CBAM) will be introduced over a much shorter period than envisaged by the Commission. This emerges from a compromise proposal on both dossiers of the Fit for 55 package published by Contexte shortly before Easter.

    By the end of 2034, the CBAM is to have completely replaced the free allocation of CO2 certificates for the industry. The EU Commission had proposed a year later. However, the Brussels-based authority wants to begin phasing in the CBAM and phasing out free allocation as early as 2026. In the ITRE Committee next week, MEPs are expected to vote in favor of 2028 as the phase-out start date for free allocation, while CBAM is to start in 2027.

    Possible conflict with WTO rules

    This would initially allow free allocations to be issued to the industry unchanged until 2028, allowing the CBAM to be tested under real-world conditions for one year. From 2023 to 2026, there would be a transition period for data collection, during which companies in the CBAM sectors would have to record what marginal financial compensation they would theoretically have to pay but would not pay it. In 2027, the CBAM would be introduced, while in parallel, the free allocations would remain in full for the time being.

    However, such a double preferential treatment of European producers could conflict with WTO trade rules. The SPD in the EU Parliament says that this is possible, provided it is limited in time. Other groups are much more skeptical. The ITRE compromise, therefore, explicitly mentions that the CBAM must be WTO-compliant.

    If the CBAM proves to be as effective as hoped against carbon leakage, free allocations in the CBAM sectors would be gradually reduced from 2028. Initially by 10 percent annually up to and including 2030, then by 17.5 percent each year until the end of 2034.

    Export industry should continue to receive free certificates

    For exports, free allocations are to remain unchanged. Only after the end of the phase-in period of the CBAM should the Commission present a detailed impact assessment of the “effects on EU exports of the CBAM sectors and the development of global emissions,” the paper says.

    The free allocations are to be reduced for companies that do not fully implement the recommendations of the energy audit report – if one is required by the Energy Efficiency Directive. The Commission had proposed issuing 25 percent fewer allowances free of charge in this case. The ITRE compromise provides for the amount of the reduction to be based on the recommendations of the energy audit, but by a minimum of 15 percent and a maximum of 40 percent.

    The compromise proposals on both dossiers are supported by the liberal Renew, the conservatives of EPP and ECR, the social democratic S&D, and the nationalist ID group. Only the Greens and Left are absent. The Greens fear that the CBAM could be further weakened, which would also “weaken the clout of the climate mechanism more and more,” explains Michael Bloss (Greens/EFA) at the request of the Europe.Table. Bloss is shadow rapporteur for the ETS in the ENVI Committee as well as a member of ITRE. He calls for a strong CBAM that uses high CO2 prices to incentivize the industry to save CO2 and invest in climate-neutral and modern technologies. He does not see this fulfilled by the compromise proposal in the ITRE Committee.

    ITRE and ENVI face difficult talks

    Nevertheless, the two compromises will likely receive a clear majority in the Industry Committee on Wednesday. How significant the impact of the vote will actually be, however, is questionable. Although the ITRE is involved in the negotiations as an associated committee, and its opinion should be taken into account, the Environment Committee is the lead committee.

    Within the respective parliamentary groups, there are also sometimes considerable differences in the positions of the ITRE and ENVI committee members. Support for the compromise in ITRE by the Social Democrats, for example, is therefore not synonymous with its consideration in ENVI.

    Read here how the positions in ENVI on CBAM and ETS are distributed.

    • Climate & Environment
    • Climate Policy
    • Emissions
    • Emissions trading
    • Klimaziele

    News

    Catalan independence leaders targeted by Pegasus spyware

    On Monday, Catalonia’s regional leader Pere Aragonès accused the Spanish government of spying on its citizens. The human rights organization Citizen Lab had found that his phone and those of dozens of Catalan independence supporters had been infected with the “Pegasus” spy software.

    Citizen Lab found that more than 60 people associated with the Catalan separatist movement were affected – including several members of the European Parliament, lawyers, and activists. The trigger for the surveillance with Pegasus is said to have been the failed attempt to make Catalonia independent from Spain.

    It was “shameful and unjustifiable”, as Catalan government leader Aragonès wrote on twitter. “It is a very serious attack on democracy and fundamental rights.” He called the use of surveillance software a crossing of a “red line” and demanded explanations from the Spanish government. The government declined to comment, according to Reuters.

    Pegasus developers reject accusations

    NSO Group Technologies, the Israeli company that developed Pegasus and markets it as a law enforcement tool, denied the allegations. Citizen Lab and Amnesty International, which were not involved in this investigation but have published previous studies on Pegasus, had produced inaccurate and unsubstantiated reports to attack the company. The allegations could not be linked to NSO products for technical and contractual reasons, a spokesman said by email, without explaining why.

    The Toronto-based Citizen Lab said almost all of the infections occurred between 2017 and 2020, when Catalonia’s push for independence plunged Spain into its worst political crisis in years. It said it was not possible to clearly attribute the spying operations to a specific entity. However, strong circumstantial evidence would point to a link with Spanish authorities. rtr/luk

    • Democracy
    • Digital policy
    • Digitization
    • Pegasus
    • Spain

    DERA: increased independence from Russia through recycling

    Europe can become less dependent on Russian imports by increasing recycling, according to the federally owned German Mineral Resources Agency (DERA). “We still see considerable potential in recycling, even though we are already doing comparatively well in Germany,” the head of DERA’s raw materials management division, Siyamend Al Barazi, told Automobilwoche magazine, according to an advance report on Monday.

    For copper, lead, aluminum, and nickel, for example, recycling rates are between 40 and 60 percent. Stockpiling important mineral resources could help bridge critical phases like the current one: “Other countries like South Korea, Japan, or the US operate state stockpiling, but supporting entrepreneurial stockpiling could also be an option.” Because of the invasion of Ukraine by Russian troops, Europe wants to become less dependent on supplies from Russia.

    Europe still has a lot of potential, according to Al Barazi. “In Finland, for example, there are nickel deposits. Interesting lithium deposits can also be found in Spain, Portugal and Serbia. But the question is always whether such projects can be operated economically in a global comparison.” It costs money and time to fundamentally change established process chains.

    Ukraine and Russia are important suppliers, especially for the European market, of aluminum, ferrotungsten, nickel, palladium, and noble gases such as neon, argon, and xenon. These quantities could not simply be replaced overnight by other suppliers. The Mineral Resources Agency also views the supply of titanium and titanium products very critically. rtr

    • Raw materials
    • Recycling
    • Sustainability
    • Ukraine

    Employers and trade unions warn of Russian gas import freeze

    Employers and trade unions have jointly warned against an import ban on Russian gas to Germany. Sanctions must be targeted, pressure must be put on the opposing side, and, if possible, damage to their own economy must be prevented, the Chairman of the Confederation of German Employers’ Associations BDA, Rainer Dulger, and the Chairman of the German Federation of Trade Unions (DGB), Reiner Hoffmann, told dpa. “In the case of the gas embargo currently under discussion, we don’t see that happening.”

    According to Dulgers and Hoffmann, the negative impact on the economy and employment would currently be higher in Germany than in Russia. “A quick gas embargo would result in production losses, production standstills, further deindustrialization and sustained job losses in Germany.”

    In order to continue to support Ukraine and keep up the pressure on Russia, a stable economy and labor market are needed, the DGB and BDA said. “We will still have to face many challenges in the coming months. We cannot do that from a position of weakness.” dpa

    • Energy
    • Energy policy
    • Germany
    • Natural gas

    EMA involved in the preparations for the HTA Regulation

    The European Medicines Agency (EMA) will work with the European Network for Health Technology Assessment (EUnetHTA) to prepare the new Health Technology Assessment (HTA) Regulation. The regulation is expected to enter into force in January 2025.

    In their joint work plan, the EMA and EUnetHTA announced their intention to focus, among other things, on relaunching a joint scientific consultation and developing methods for generating patient-relevant information. They will also discuss how to promote exchange between patients and health professionals.

    Following the award of the “Service Contract for the Provision of Joint Health Technology Assessment (HTA) Work Supporting the Continuation of EU Cooperation on HTA” to EUnetHTA, the European Commission has requested EMA and EUnetHTA to develop a joint work plan for the implementation of the previously identified priorities. This mandate will run until September 2023, when four bilateral meetings between EUnetHTA and the EMA will take place. ank

    • Health
    • Health policy

    €1 billion for ocean protection

    The EU is providing a total of €1 billion for the international protection of the oceans. Last Thursday, at the “Our Ocean” conference in Palau, the Commission presented a list of 44 commitments. Among other things, the measures are intended to reduce plastic waste in the oceans, promote sustainable fishing, and preserve biodiversity in the oceans.

    Virginijus Sinkevičius, European Commissioner for the Environment, Oceans and Fisheries, spoke of a “significant sum” for the protection of the oceans, on which “our future” depends. These are the EU’s most substantial commitments to protect the oceans, according to the Commission.

    The “Our Ocean” conference has been held once a year since 2014. This year, the western Pacific island nation of Palau co-hosted the conference with the USA. It aims to draw attention to regions that are particularly dependent on the oceans and threatened by climate change. leo

    • Climate & Environment
    • Environmental protection
    • Green Deal
    • Sustainability

    Profile

    Economic answers to social problems

    Daniel Gros, Distinguished Fellow, Centre for European Policy Studies (CEPS)

    It’s not easy to get Daniel Gros on the phone. He travels a lot. At the first attempt, he is on a plane; at the next attempt, he is called on the other phone at the same time, but then answers quickly (in Italian) and finally makes time for a relaxed conversation in which he talks about himself and his life, which has been shaped through and through by Europe: At the age of eighteen, the native German moved with his family to Italy, where he also earned his master’s degree in economics. “In Italy, I’m considered more of a German, and in Germany, more of an Italian,” says the economist, who in between earned a doctorate in the US and has now lived in Brussels for decades.

    And then, he illustrates his statement with an example that does not coincidentally comes from economics: “In Germany, it met with irritation that I spoke out early on in favor of a monetary union and also a banking union. And in Italy, I seem strange when I insist that sound public finances are good for the national economy and help the country achieve greater prosperity in the long term.”

    Economic responses to the war in Ukraine

    Daniel Gros has already experienced a few crises. However, in the current volatile times, even he sometimes lies awake at night with worries. “The euro crisis was tough, and no one wanted the whole thing to go down the drain. The refugee crisis was also a test. But now, it’s not just about financial and practical issues, it’s about the values we represent, about the order in Europe, and our security. That leaves no one unshaken,” he says.

    Nevertheless, when he sees a social problem, as an analyst he first asks about the economic mechanisms at work. After all, that is the contribution he can make as an economist. Currently, for example, he is concerned with the devaluation of money. “We have a strangely high inflation, which is always attributed to energy prices. But energy prices are not at all higher than they were ten years ago. How is this possible?” he asks – without having an answer ready.

    It is clear to the economist that the population needs incentives to save gas and thus contribute to Europe’s energy independence: “Of course, we need to compensate low-income earners. And you could give a premium to those who use less gas compared to the previous year, so they would even make a profit in the process.”

    Personal highlights from the Euro plan to the Obama meeting

    Before joining the European think tank Centre for European Policy Studies (CEPS), Daniel Gros worked, among other things, as an economic advisor to the European Commission’s Delors Committee, which developed the plans for the euro. A time he looks back on fondly. “Nobody believed in the plan for monetary union back then,” he recalls. Then, in the early 1990s, he had the opportunity to get to know a Russia that no longer exists.

    And during the euro crisis, he spoke personally with various heads of state, including the US president. “Barack Obama was afraid that the euro crisis would mess up his re-election. But he knew what he was doing. I couldn’t add much additional value,” says Daniel Gros, who talks a lot about his job and little about his private life. But at least he reveals that he has three children and that he practices the Japanese martial art Aikidō. Janna Degener-Storr

    • Energy policy
    • Finance
    • Financial policy

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