While Europe continues to breathe a sigh of relief at Emmanuel Macron’s victory in France, the president himself is unlikely to have much time to catch his breath. On one hand, the agenda of the French Council presidency is still packed with unresolved issues and on the other, Macron is facing parliamentary elections. In order to avoid losing even more votes to the right around Marine Le Pen, Macron will have to focus more on domestic policy in the coming weeks, as Eric Bonse reports.
The pharmaceutical industry is also under pressure to act. Much is already being done here for the responsible and sustainable production of medicines, according to the industry. However, there is a considerable need for improvement in the areas of access to medicines and pricing in view of the fact that two billion people lack access, as Eugenie Ankowitsch analyzes.
In a fast-track procedure, the German government yesterday introduced amendments to the Energy Security Act to enable it to help out other countries with gas supplies in the event of an energy crisis in Europe. However, the amendment also takes into account the supply of other energy sources.
Progress is also being made on the second emissions trading system for heating and road transport. Rapporteur of the EU Parliament for the reform of the European emissions trading Peter Liese (EPP, DE) presented a compromise to the shadow rapporteurs yesterday. Read in News, which points in the compromise no longer matter and on which Liese insists.
The EU opponents are not defeated after the presidential election – on the contrary. The first five years under Macron have made populists and extremists stronger, says the leader of the conservative European People’s Party, Manfred Weber (CSU). “Macron has been re-elected, his political concept has failed,” Weber said, while European Green Party spokesman Rasmus Andresen called the strong showing of right-wing populist Marine Le Pen a “warning shot for all of Europe.” The leader of the “Rassemblement National” had received around 2.7 million more votes in last Sunday’s runoff than in the last duel with Macron five years ago.
Le Pen could become even stronger in the parliamentary elections in June, according to concerns in Brussels. Left-wing leader Jean-Luc Mélenchon is also likely to try for revenge; he even wants to become prime minister. Macron will therefore focus on domestic politics in the coming weeks, predicts an EU diplomat. To succeed, the president must secure a stable majority in Paris.
But he has a packed agenda waiting for him in Brussels. The next EU summit is already scheduled for May 30-31, five weeks from now. As in Versailles at the beginning of March, the summit will focus on Ukraine, but also on energy policy and defense. All three problems have become more urgent in the meantime. In the case of Ukraine, one must now prepare for a long war, says an EU diplomat. In addition to military coordination, the humanitarian coordination of the EU states is also coming to the fore. In addition, a regional or global food crisis must be prevented.
In energy policy, Paris is pinning high hopes on the EU Commission. It is expected not only to present a proposal for an oil embargo but also to develop a concept for phasing out all fossil fuels from Russia. In addition, a proposal for reforming the European energy market is expected before the summit.
By the last regular summit under the French presidency on June 23 and 24, there could also be an initial joint Council orientation on the Renewable Energy Directive (RED). In any case, the German Foreign Office in Berlin supports more speed on renewables and energy efficiency. The Commission should present faster and higher targets, said Hinrich Thölken, the ministry’s foreign energy and climate policy officer, on Monday.
The Commission had already proposed a higher target of 45 percent renewable energies by 2030. The EU Parliament is expected to clarify by next week which amendments to the RED will be necessary to achieve this. However, final positions of the Council on legal acts of the Fit for 55 package are not expected before the end of the French Council Presidency.
In defense policy, the goal is to close European investment gaps. In doing so, the risk of fragmentation of the defense market must be avoided, the EU diplomat said. Paris is worried about Germany’s decision to buy American F35 fighter jets; this could weaken the industry in the EU. Europe Minister of State Anna Lührmann does not share this concern. Franco-German cooperation on armaments projects “should become easier because Germany is now providing more money”, the Green politician told the Reuters news agency, alluding to the €100-billion-special-fund for the Bundeswehr.
The situation is similar in the Western Balkans: “I’m getting clear signals from Paris that they are changing their position on the Western Balkans because of Russia’s influence there,” emphasizes Lührmann. Until now, Macron had tended to put the brakes on the Western Balkan states’ rapprochement with the EU. Now France is planning a Western Balkans summit.
Also on the agenda is the reform of EU deficit rules, the promotion of women on supervisory boards, and the global minimum tax. Macron also wants to bring the Conference on the Future of Europe to a close. The results will be presented on May 9, after which the French EU presidency will decide how to proceed.
The conference must lead to a convention and prepare treaty changes, demands legal scholar Sven Simon. “It will be important for Macron to remember his Sorbonne speech,” said the CDU MEP. Daniel Freund of the Greens expressed similar views. So far, however, there is no green light for a convention.
The Council Presidency’s technological-regulatory agenda also includes other aspects: The Chips Act promoted by the French EU Industry Commissioner Thierry Breton is currently being discussed in the Council and Parliament, and the same applies to the regulatory proposal for artificial intelligence systems, where the first sections of the proposed regulation are already being voted on in the Council.
The Council Presidency will probably only be able to hold introductory discussions on the project to improve child protection on the Internet. After many postponements, a proposal from the Commission is currently expected in mid-May; the first variants were rejected by the Regulatory Scrutiny Board and also received considerable criticism under the heading of “chat control”.
Whether the proposal for European regulation on the subject of media freedom will still come under the French Council presidency is also unclear. Breton’s proposal for greater cyber resilience has not yet been scheduled but is still planned for the first half of the year. The Cyber Resilience Act is intended, among other things, to make Internet of Things device manufacturers and providers of networked services more accountable.
The second meeting of the Transatlantic Trade and Technology Council (TTC) is scheduled to take place in France on May 15 and 16. The goal of the transatlantic forum is to intensify cooperation on key trade and technology issues, including artificial intelligence, but also supply chains, export controls, and standards.
The Trans-Atlantic Data Privacy Framework is not part of the TTC: The new framework for the transfer of personal data from the EU to the USA, on which the EU Commission and the US government agreed in principle at the end of March, is being discussed and negotiated separately. Here, a concretization of the announced agreement is still pending for the time being, which is to legally enable data transfers in succession to the Privacy Shield, which was found to be insufficient by the ECJ. With Falk Steiner, Manuel Berkel and Lukas Scheid
Under the German Supply Chain Duty of Care Act, companies must ensure that human rights and environmental standards are complied with throughout the supply chain. From 2023 it will apply to companies with at least 3,000 employees and from 2024 to companies with at least 1,000 employees in Germany. At the end of February 2022, the EU Commission now presented the long-awaited proposal for an EU Supply Chain Act that goes beyond the requirements of the German law. It is intended to promote sustainable and responsible corporate behavior in all global value chains.
After the green taxonomy, the EU Commission is also examining the next sustainability label: the so-called social taxonomy. In its report, the Sustainable Finance Roundtable, a panel of experts set up by the Commission, makes recommendations on how companies should be assessed for their social benefits. Pharmaceutical companies, for example, should demonstrate, among other things, how good access to their medicines is worldwide and whether they are affordable.
At first glance, the pharmaceutical industry seems to be in a good position to meet the growing requirements in the so-called ESG area (Environmental, Social, Governance): Compared to other industries, it is highly regulated, has sophisticated quality management systems and, in some cases, long-lasting and close supplier relationships.
The German Medicines Manufacturers’ Association (BAH) emphasizes that many companies have international codes of conduct and supplier contracts in which they commit themselves and their partners to respect human rights to implement the United Nations Guiding Principles on Business and Human Rights. In addition, there are numerous national and supranational industry initiatives with regard to sustainable supply chain management and responsible procurement in which German companies are active.
Although the pharmaceutical industry makes a significant contribution to social progress, it is still repeatedly discredited for environmental pollution and political and financial scandals. “We make products that help people,” emphasizes BAH CEO Elmar Kroth in an interview with Europe.Table. “The fact that we are often portrayed negatively is really upsetting.” Companies are doing their best to use as few raw materials and energy as possible, to reduce emissions. Compared to other industries, the pharmaceutical industry is doing very well in the ESG area, he concludes.
However, when asked about the issue of access to medicines and pricing, which is becoming increasingly important in the global quest for sustainability, Kroth prefers to talk about the social commitment of pharmaceutical companies in the producing countries. As an example, he cites the construction of kindergartens so that mothers, who spend a lot of time in the fields during harvest time, know that their children are well cared for.
But in a global society faced with growing inequality, the pharmaceutical industry can hardly shirk its social responsibility by building kindergartens and other charity projects. Especially in developing countries, people need access to affordable medicines. But even in Europe, there are considerable differences between countries, as a recent survey by EFPIA, the European umbrella organization of pharmaceutical companies, revealed (Europe.Table reported).
For a long time, attention focused primarily on access to medicines for infectious diseases such as tuberculosis, malaria, and HIV. However, in recent years, the discussion has expanded to include non-communicable diseases (NCDs) and new regions. When developing therapies, however, pharmaceutical companies often focus on solvent markets. There are hardly any incentives for the companies to sell the drugs in other markets as well.
Some pharmaceutical companies now say they are helping to develop an access strategy for new drugs in the pipeline in low- and middle-income countries. Novartis was the first company with systematic access planning. AstraZeneca, GSK, Johnson & Johnson, Merck, Pfizer, Sanofi, and Takeda have since joined them, according to the Access to Medicine Index 2021. However, products already on the market are largely overlooked when it comes to improving access, experts at the Access to Medicine Foundation point out. Globally, two billion people lack access to the medicines they need.
Most recently, there has been much controversy surrounding the pricing and availability of COVID-19 vaccines. Initially, the pharmaceutical industry was perceived by many as a savior and had a chance to change its image. However, this opportunity was squandered. Most recently, it became public how pharmaceutical giant Pfizer used its market power to maximize profits and limit risks.
Actually, the contracts are top secret. However, a New York civil liberties group called Public Citizen gained access to nine of the agreements and, in a report, exposed how Pfizer, as one of the world’s leading manufacturers of COVID-19 vaccines, exercised its power to silence governments, curb supply, shift risk, and maximize profits in the midst of a pandemic.
In May last year, the EU concluded a contract with Pfizer for the purchase of 1.8 billion vaccine doses, also under strict secrecy. Since then, members of the European Parliament have been trying to inspect the contracts – so far in vain. In a parliamentary question at the beginning of February, for example, some MEPs wanted to know from the EU Commission why parts of the contract texts are being kept secret and whether the Commission intends to make the full contract texts public. The deadline for answers is May 3.
A few days ago, Greens/EFA members Jutta Paulus, Tilly Metz, Margrete Auken, Michèle Rivasi, and Kim van Sparrentak filed a case against the European Commission at the European Court of Justice. “The European Commission’s refusal to make vaccine contracts transparent affects public confidence in the EU Commission’s ability to put the health of citizens first in trade agreements with the pharmaceutical industry,” said Tilly Metz. So the shining savior becomes the villain again.
In the pharmaceutical industry, key environmental issues include high energy consumption, global supply chains, residues in the environment from the production of pharmaceutical products, and large amounts of packaging waste. Some companies are making progress, particularly in water and energy consumption. Sanofi, for example, says it reduced CO2 emissions by more than 27 percent between 2015 and 2020. Roche is said to have reduced water consumption per employee by over 25 percent since 2015.
However, the figures refer to the large corporations and their own facilities. Increasingly, pharmaceuticals, and especially their precursors, are produced by companies in third countries, often in China and India. However, BAH Managing Director Elmar Kroth limits the responsibility of Western pharmaceutical companies for compliance with environmental standards in these production countries. Production in third countries is now subject to national laws. “We as manufacturers do have detailed requirements for the products we source from these countries. But we have relatively little influence on how companies there handle wastewater, for example.”
It is questionable whether European companies are even in a position to obtain the necessary information from their upstream suppliers, says Kroth, in view of the legal regulations that will be imposed on the industry in the next few years. After all, supply chains could be very long in some circumstances. However, he admits that there is definitely a need for action in some plants.
The extent of this need was revealed by research conducted by NDR, WDR, and Süddeutscher Zeitung at one of India’s largest pharmaceutical sites in Hyderabad at the end of 2019. Almost all major German generic manufacturers – such as Ratiopharm, Hexal, and Stada – have active ingredients produced there. The reporters, with the support of scientists, investigated the suspicion that the pharmaceutical companies are discharging wastewater into the environment. The presumed reason: costs – because the treatment of residues from the production of medicines is extremely complex and expensive.
The samples taken were then analyzed by the Institute for Biomedical and Pharmaceutical Research (IBMP) in Nuremberg for residues of a total of 25 different drugs. The scientists found antibiotics as well as fungal medications in the waters, in some cases hundreds or even thousands of times above proposed limits for the respective substances. The renowned Swedish environmental pharmacologist Joakim Larsson told NDR that many of the measured values were so high that there was no other reasonable explanation than industrial wastewater.
Anyone who thinks that the antibiotic-contaminated waters in Hyderabad could not pose a threat to Europe is sorely mistaken. When antibiotics enter the environment, bacteria that live there develop resistance. Antibacterial resistance is one of the biggest challenges of the future (Europe.Table reported).
Not only in defense but also in energy and resilience, a single internal market offers the potential for improvement that we need today. And the Treaty explicitly provides for it in Article 194 TFEU. The European Union must therefore act urgently now in the following four areas:
The dependence on Russian natural gas, which has once again become clear with the invasion of Ukraine – 75 percent of the supply of pipeline-bound gas is purchased by EU states – has made it clear to everyone that the European internal energy market must be thought out in a more integrative way and better designed. Not only the so-called “taxonomy” proposal of the EU Commission, with which the creditworthiness of energy types is to be assessed under financial market law considerations, but also the other proposals of the “Green Deal” already take important steps in the right direction.
That is why the moment has come to create a single internal energy market. Primary energy and electricity must be made available across Europe with strong and resilient networks. There is a need to deepen the European energy infrastructure to make the system flexible. With cross-border connections, we form a European interconnected grid in which electricity can be transmitted across national borders more easily, efficiently, and cheaply. This is the only way Europe can maintain a secure, sustainable, and affordable energy supply in the 21st century.
Years ago, the European Parliament already allocated more funds for defense research within the research framework program. In doing so, the Parliament followed the basic idea of Art. 296 TFEU, which already provides for a Europe-wide call for tenders for defense equipment. Unfortunately, in recent years the member states have mainly put national interests first. The German idea of procuring the Israeli missile defense system now with special funds only for Germany also shows great naiveté: After all, how is Germany supposed to defend itself if our neighboring states are not also secure?
So we also need a European combat aircraft, a European tank and a European drone. The right decisions must be prepared for this now. Europe is only safe if everyone is safe! Even if there is still a long way to go on the road to a European Army, at least in terms of equipment, joint projects can finally show the way!
Following the completion of the competition law rules in the Digital Markets Act, which finally allows European rules to be enforced more quickly, now comes the Digital Services Act. This is supposed to make only legal content available on the major Internet platforms in the future. The fact that there are still doubts about this to this day is an indictment – especially since the companies affected are the largest in the world. In view of the effort that the authorities – and in the case of the so-called “very large online platforms” (VLOPs): the European Commission – have with the supervision of these companies, it is by no means disproportionate to demand an administrative fee for this. After all, anyone who wants to use the single market must also participate in compliance with the rules.
Europe’s internal cohesion is nowhere better demonstrated than at the former borders of the member states. These borders have largely disappeared from everyday life, but they are still organizational barriers in situations where better options are available. The reception of refugees from Ukraine is an example that shows that good intentions alone are not a concept. Refugees coming from Ukraine need an uncomplicated cash exchange from hryvnia to euros, also, digital self-registration of the arrivals would have to be made possible. But the COVID crisis has also shown that cross-border cooperation on health issues is not yet up to scratch.
A proactive use of the member states’ health system resources, a coordinated cross-border quarantine policy, maintenance of open transport routes for medical material and food, but also for personnel, such as nurses, operating room doctors, and service technicians – all of these measures did not successfully meet citizens expectations of the European Union. That is why the European Commission must present an ambitious proposal in the summer with the so-called “Single Market Emergency Instrument” that focuses on the interests of citizens in border regions.
The attack on Ukraine has shown great solidarity among the EU states. Whether Ukraine will be admitted to the European Union soon or only in the medium term depends primarily on the member states. However, it is already clear that the EU must do its homework if it wants to deal successfully with today’s challenges.
While Europe continues to breathe a sigh of relief at Emmanuel Macron’s victory in France, the president himself is unlikely to have much time to catch his breath. On one hand, the agenda of the French Council presidency is still packed with unresolved issues and on the other, Macron is facing parliamentary elections. In order to avoid losing even more votes to the right around Marine Le Pen, Macron will have to focus more on domestic policy in the coming weeks, as Eric Bonse reports.
The pharmaceutical industry is also under pressure to act. Much is already being done here for the responsible and sustainable production of medicines, according to the industry. However, there is a considerable need for improvement in the areas of access to medicines and pricing in view of the fact that two billion people lack access, as Eugenie Ankowitsch analyzes.
In a fast-track procedure, the German government yesterday introduced amendments to the Energy Security Act to enable it to help out other countries with gas supplies in the event of an energy crisis in Europe. However, the amendment also takes into account the supply of other energy sources.
Progress is also being made on the second emissions trading system for heating and road transport. Rapporteur of the EU Parliament for the reform of the European emissions trading Peter Liese (EPP, DE) presented a compromise to the shadow rapporteurs yesterday. Read in News, which points in the compromise no longer matter and on which Liese insists.
The EU opponents are not defeated after the presidential election – on the contrary. The first five years under Macron have made populists and extremists stronger, says the leader of the conservative European People’s Party, Manfred Weber (CSU). “Macron has been re-elected, his political concept has failed,” Weber said, while European Green Party spokesman Rasmus Andresen called the strong showing of right-wing populist Marine Le Pen a “warning shot for all of Europe.” The leader of the “Rassemblement National” had received around 2.7 million more votes in last Sunday’s runoff than in the last duel with Macron five years ago.
Le Pen could become even stronger in the parliamentary elections in June, according to concerns in Brussels. Left-wing leader Jean-Luc Mélenchon is also likely to try for revenge; he even wants to become prime minister. Macron will therefore focus on domestic politics in the coming weeks, predicts an EU diplomat. To succeed, the president must secure a stable majority in Paris.
But he has a packed agenda waiting for him in Brussels. The next EU summit is already scheduled for May 30-31, five weeks from now. As in Versailles at the beginning of March, the summit will focus on Ukraine, but also on energy policy and defense. All three problems have become more urgent in the meantime. In the case of Ukraine, one must now prepare for a long war, says an EU diplomat. In addition to military coordination, the humanitarian coordination of the EU states is also coming to the fore. In addition, a regional or global food crisis must be prevented.
In energy policy, Paris is pinning high hopes on the EU Commission. It is expected not only to present a proposal for an oil embargo but also to develop a concept for phasing out all fossil fuels from Russia. In addition, a proposal for reforming the European energy market is expected before the summit.
By the last regular summit under the French presidency on June 23 and 24, there could also be an initial joint Council orientation on the Renewable Energy Directive (RED). In any case, the German Foreign Office in Berlin supports more speed on renewables and energy efficiency. The Commission should present faster and higher targets, said Hinrich Thölken, the ministry’s foreign energy and climate policy officer, on Monday.
The Commission had already proposed a higher target of 45 percent renewable energies by 2030. The EU Parliament is expected to clarify by next week which amendments to the RED will be necessary to achieve this. However, final positions of the Council on legal acts of the Fit for 55 package are not expected before the end of the French Council Presidency.
In defense policy, the goal is to close European investment gaps. In doing so, the risk of fragmentation of the defense market must be avoided, the EU diplomat said. Paris is worried about Germany’s decision to buy American F35 fighter jets; this could weaken the industry in the EU. Europe Minister of State Anna Lührmann does not share this concern. Franco-German cooperation on armaments projects “should become easier because Germany is now providing more money”, the Green politician told the Reuters news agency, alluding to the €100-billion-special-fund for the Bundeswehr.
The situation is similar in the Western Balkans: “I’m getting clear signals from Paris that they are changing their position on the Western Balkans because of Russia’s influence there,” emphasizes Lührmann. Until now, Macron had tended to put the brakes on the Western Balkan states’ rapprochement with the EU. Now France is planning a Western Balkans summit.
Also on the agenda is the reform of EU deficit rules, the promotion of women on supervisory boards, and the global minimum tax. Macron also wants to bring the Conference on the Future of Europe to a close. The results will be presented on May 9, after which the French EU presidency will decide how to proceed.
The conference must lead to a convention and prepare treaty changes, demands legal scholar Sven Simon. “It will be important for Macron to remember his Sorbonne speech,” said the CDU MEP. Daniel Freund of the Greens expressed similar views. So far, however, there is no green light for a convention.
The Council Presidency’s technological-regulatory agenda also includes other aspects: The Chips Act promoted by the French EU Industry Commissioner Thierry Breton is currently being discussed in the Council and Parliament, and the same applies to the regulatory proposal for artificial intelligence systems, where the first sections of the proposed regulation are already being voted on in the Council.
The Council Presidency will probably only be able to hold introductory discussions on the project to improve child protection on the Internet. After many postponements, a proposal from the Commission is currently expected in mid-May; the first variants were rejected by the Regulatory Scrutiny Board and also received considerable criticism under the heading of “chat control”.
Whether the proposal for European regulation on the subject of media freedom will still come under the French Council presidency is also unclear. Breton’s proposal for greater cyber resilience has not yet been scheduled but is still planned for the first half of the year. The Cyber Resilience Act is intended, among other things, to make Internet of Things device manufacturers and providers of networked services more accountable.
The second meeting of the Transatlantic Trade and Technology Council (TTC) is scheduled to take place in France on May 15 and 16. The goal of the transatlantic forum is to intensify cooperation on key trade and technology issues, including artificial intelligence, but also supply chains, export controls, and standards.
The Trans-Atlantic Data Privacy Framework is not part of the TTC: The new framework for the transfer of personal data from the EU to the USA, on which the EU Commission and the US government agreed in principle at the end of March, is being discussed and negotiated separately. Here, a concretization of the announced agreement is still pending for the time being, which is to legally enable data transfers in succession to the Privacy Shield, which was found to be insufficient by the ECJ. With Falk Steiner, Manuel Berkel and Lukas Scheid
Under the German Supply Chain Duty of Care Act, companies must ensure that human rights and environmental standards are complied with throughout the supply chain. From 2023 it will apply to companies with at least 3,000 employees and from 2024 to companies with at least 1,000 employees in Germany. At the end of February 2022, the EU Commission now presented the long-awaited proposal for an EU Supply Chain Act that goes beyond the requirements of the German law. It is intended to promote sustainable and responsible corporate behavior in all global value chains.
After the green taxonomy, the EU Commission is also examining the next sustainability label: the so-called social taxonomy. In its report, the Sustainable Finance Roundtable, a panel of experts set up by the Commission, makes recommendations on how companies should be assessed for their social benefits. Pharmaceutical companies, for example, should demonstrate, among other things, how good access to their medicines is worldwide and whether they are affordable.
At first glance, the pharmaceutical industry seems to be in a good position to meet the growing requirements in the so-called ESG area (Environmental, Social, Governance): Compared to other industries, it is highly regulated, has sophisticated quality management systems and, in some cases, long-lasting and close supplier relationships.
The German Medicines Manufacturers’ Association (BAH) emphasizes that many companies have international codes of conduct and supplier contracts in which they commit themselves and their partners to respect human rights to implement the United Nations Guiding Principles on Business and Human Rights. In addition, there are numerous national and supranational industry initiatives with regard to sustainable supply chain management and responsible procurement in which German companies are active.
Although the pharmaceutical industry makes a significant contribution to social progress, it is still repeatedly discredited for environmental pollution and political and financial scandals. “We make products that help people,” emphasizes BAH CEO Elmar Kroth in an interview with Europe.Table. “The fact that we are often portrayed negatively is really upsetting.” Companies are doing their best to use as few raw materials and energy as possible, to reduce emissions. Compared to other industries, the pharmaceutical industry is doing very well in the ESG area, he concludes.
However, when asked about the issue of access to medicines and pricing, which is becoming increasingly important in the global quest for sustainability, Kroth prefers to talk about the social commitment of pharmaceutical companies in the producing countries. As an example, he cites the construction of kindergartens so that mothers, who spend a lot of time in the fields during harvest time, know that their children are well cared for.
But in a global society faced with growing inequality, the pharmaceutical industry can hardly shirk its social responsibility by building kindergartens and other charity projects. Especially in developing countries, people need access to affordable medicines. But even in Europe, there are considerable differences between countries, as a recent survey by EFPIA, the European umbrella organization of pharmaceutical companies, revealed (Europe.Table reported).
For a long time, attention focused primarily on access to medicines for infectious diseases such as tuberculosis, malaria, and HIV. However, in recent years, the discussion has expanded to include non-communicable diseases (NCDs) and new regions. When developing therapies, however, pharmaceutical companies often focus on solvent markets. There are hardly any incentives for the companies to sell the drugs in other markets as well.
Some pharmaceutical companies now say they are helping to develop an access strategy for new drugs in the pipeline in low- and middle-income countries. Novartis was the first company with systematic access planning. AstraZeneca, GSK, Johnson & Johnson, Merck, Pfizer, Sanofi, and Takeda have since joined them, according to the Access to Medicine Index 2021. However, products already on the market are largely overlooked when it comes to improving access, experts at the Access to Medicine Foundation point out. Globally, two billion people lack access to the medicines they need.
Most recently, there has been much controversy surrounding the pricing and availability of COVID-19 vaccines. Initially, the pharmaceutical industry was perceived by many as a savior and had a chance to change its image. However, this opportunity was squandered. Most recently, it became public how pharmaceutical giant Pfizer used its market power to maximize profits and limit risks.
Actually, the contracts are top secret. However, a New York civil liberties group called Public Citizen gained access to nine of the agreements and, in a report, exposed how Pfizer, as one of the world’s leading manufacturers of COVID-19 vaccines, exercised its power to silence governments, curb supply, shift risk, and maximize profits in the midst of a pandemic.
In May last year, the EU concluded a contract with Pfizer for the purchase of 1.8 billion vaccine doses, also under strict secrecy. Since then, members of the European Parliament have been trying to inspect the contracts – so far in vain. In a parliamentary question at the beginning of February, for example, some MEPs wanted to know from the EU Commission why parts of the contract texts are being kept secret and whether the Commission intends to make the full contract texts public. The deadline for answers is May 3.
A few days ago, Greens/EFA members Jutta Paulus, Tilly Metz, Margrete Auken, Michèle Rivasi, and Kim van Sparrentak filed a case against the European Commission at the European Court of Justice. “The European Commission’s refusal to make vaccine contracts transparent affects public confidence in the EU Commission’s ability to put the health of citizens first in trade agreements with the pharmaceutical industry,” said Tilly Metz. So the shining savior becomes the villain again.
In the pharmaceutical industry, key environmental issues include high energy consumption, global supply chains, residues in the environment from the production of pharmaceutical products, and large amounts of packaging waste. Some companies are making progress, particularly in water and energy consumption. Sanofi, for example, says it reduced CO2 emissions by more than 27 percent between 2015 and 2020. Roche is said to have reduced water consumption per employee by over 25 percent since 2015.
However, the figures refer to the large corporations and their own facilities. Increasingly, pharmaceuticals, and especially their precursors, are produced by companies in third countries, often in China and India. However, BAH Managing Director Elmar Kroth limits the responsibility of Western pharmaceutical companies for compliance with environmental standards in these production countries. Production in third countries is now subject to national laws. “We as manufacturers do have detailed requirements for the products we source from these countries. But we have relatively little influence on how companies there handle wastewater, for example.”
It is questionable whether European companies are even in a position to obtain the necessary information from their upstream suppliers, says Kroth, in view of the legal regulations that will be imposed on the industry in the next few years. After all, supply chains could be very long in some circumstances. However, he admits that there is definitely a need for action in some plants.
The extent of this need was revealed by research conducted by NDR, WDR, and Süddeutscher Zeitung at one of India’s largest pharmaceutical sites in Hyderabad at the end of 2019. Almost all major German generic manufacturers – such as Ratiopharm, Hexal, and Stada – have active ingredients produced there. The reporters, with the support of scientists, investigated the suspicion that the pharmaceutical companies are discharging wastewater into the environment. The presumed reason: costs – because the treatment of residues from the production of medicines is extremely complex and expensive.
The samples taken were then analyzed by the Institute for Biomedical and Pharmaceutical Research (IBMP) in Nuremberg for residues of a total of 25 different drugs. The scientists found antibiotics as well as fungal medications in the waters, in some cases hundreds or even thousands of times above proposed limits for the respective substances. The renowned Swedish environmental pharmacologist Joakim Larsson told NDR that many of the measured values were so high that there was no other reasonable explanation than industrial wastewater.
Anyone who thinks that the antibiotic-contaminated waters in Hyderabad could not pose a threat to Europe is sorely mistaken. When antibiotics enter the environment, bacteria that live there develop resistance. Antibacterial resistance is one of the biggest challenges of the future (Europe.Table reported).
Not only in defense but also in energy and resilience, a single internal market offers the potential for improvement that we need today. And the Treaty explicitly provides for it in Article 194 TFEU. The European Union must therefore act urgently now in the following four areas:
The dependence on Russian natural gas, which has once again become clear with the invasion of Ukraine – 75 percent of the supply of pipeline-bound gas is purchased by EU states – has made it clear to everyone that the European internal energy market must be thought out in a more integrative way and better designed. Not only the so-called “taxonomy” proposal of the EU Commission, with which the creditworthiness of energy types is to be assessed under financial market law considerations, but also the other proposals of the “Green Deal” already take important steps in the right direction.
That is why the moment has come to create a single internal energy market. Primary energy and electricity must be made available across Europe with strong and resilient networks. There is a need to deepen the European energy infrastructure to make the system flexible. With cross-border connections, we form a European interconnected grid in which electricity can be transmitted across national borders more easily, efficiently, and cheaply. This is the only way Europe can maintain a secure, sustainable, and affordable energy supply in the 21st century.
Years ago, the European Parliament already allocated more funds for defense research within the research framework program. In doing so, the Parliament followed the basic idea of Art. 296 TFEU, which already provides for a Europe-wide call for tenders for defense equipment. Unfortunately, in recent years the member states have mainly put national interests first. The German idea of procuring the Israeli missile defense system now with special funds only for Germany also shows great naiveté: After all, how is Germany supposed to defend itself if our neighboring states are not also secure?
So we also need a European combat aircraft, a European tank and a European drone. The right decisions must be prepared for this now. Europe is only safe if everyone is safe! Even if there is still a long way to go on the road to a European Army, at least in terms of equipment, joint projects can finally show the way!
Following the completion of the competition law rules in the Digital Markets Act, which finally allows European rules to be enforced more quickly, now comes the Digital Services Act. This is supposed to make only legal content available on the major Internet platforms in the future. The fact that there are still doubts about this to this day is an indictment – especially since the companies affected are the largest in the world. In view of the effort that the authorities – and in the case of the so-called “very large online platforms” (VLOPs): the European Commission – have with the supervision of these companies, it is by no means disproportionate to demand an administrative fee for this. After all, anyone who wants to use the single market must also participate in compliance with the rules.
Europe’s internal cohesion is nowhere better demonstrated than at the former borders of the member states. These borders have largely disappeared from everyday life, but they are still organizational barriers in situations where better options are available. The reception of refugees from Ukraine is an example that shows that good intentions alone are not a concept. Refugees coming from Ukraine need an uncomplicated cash exchange from hryvnia to euros, also, digital self-registration of the arrivals would have to be made possible. But the COVID crisis has also shown that cross-border cooperation on health issues is not yet up to scratch.
A proactive use of the member states’ health system resources, a coordinated cross-border quarantine policy, maintenance of open transport routes for medical material and food, but also for personnel, such as nurses, operating room doctors, and service technicians – all of these measures did not successfully meet citizens expectations of the European Union. That is why the European Commission must present an ambitious proposal in the summer with the so-called “Single Market Emergency Instrument” that focuses on the interests of citizens in border regions.
The attack on Ukraine has shown great solidarity among the EU states. Whether Ukraine will be admitted to the European Union soon or only in the medium term depends primarily on the member states. However, it is already clear that the EU must do its homework if it wants to deal successfully with today’s challenges.
