Archive for the ‘European Union’ Category

Industry needs an aligned position on the future of the EU OMP Regulation – PMLiVE

In March 2020 the European Commission presented its New Industrial Strategy for Europe, which proposes to move the European Union towards climate neutrality and digital leadership. As part of this overarching approach, which includes measures to keep the EU at the leading edge of innovation, including in healthcare, the Commission is expected to publish a Pharmaceutical Strategy in Q4 2020. This will focus on the availability, sustainability and security of the supply of pharmaceuticals, a need highlighted by challenges around COVID-19. The Pharmaceutical Strategy is likely to include innovation-boosting measures and plans to revise the EU Regulation on Orphan Medicinal Products (OMP Regulation).

EU Pharmaceutical Strategy

The details of the Strategy are still unclear, with a Commission roadmap keenly awaited.

The potential legislation and initiatives have been hotly debated. The European pharma industry body, EFPIA, wants the Commission to support the industry to remain an innovator and world leader. The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has highlighted funding the role of small and medium-sized pharmaceutical and medical technology companies, and a supportive legal and regulatory framework as top priorities.

EU OMP Regulation Review

The OMP Regulation is widely expected to be included in the Commissions plans. Member states and others have pressed the Commission to amend the current rules due to the perceived impact on prices. Last August, a Dutch health minister threatened to name companies that cannot offer a sensible and transparent explanation for the high prices of OMPs. Bruno Bruins said that OMP prices over 100,000 per year are no longer the exception not because the prices are justified, but because the rules allow them.

Leading voices in healthcare have highlighted incentives intended to stimulate innovation in medicine development as a whole and the perceived link to high prices. The European Public Health Alliance says the current rules delay competition for long periods, allowing companies to set prices as high as the market will bear. In 2017, two serving Dutch ministers wrote in The Lancet that the system is broken companies can ask the price they like.

The Commission is currently evaluating the OMP Regulation. An internal analysis is planned for Spring 2020, ahead of any publication of new OMP proposals. An internal Commission discussion has highlighted concerns with the current Regulation, especially regarding incentives and the diversity of authorised products.

If the OMP Regulation is reopened, we may see a new law proposed by 2021. Meanwhile, the industry and other stakeholders have a window to shape the proposal and say what it should or should not include.

A recent document prepared for the EUs advisory Pharmaceutical Committee gives clues on the Commissions thoughts.

The document undermines claims from industry and others that the Regulation has been a huge success, stating that of 142 OMPs authorised in the EU to 2017, only around 20 can be directly attributed to the OMP Regulation. The briefing questions the impact of the 1bn the EU has invested into rare disease research in the past decade. An assessment of the market exclusivity (ME) provision concludes that the mechanism is fair for OMPs with annual European sales of less than 50m, but OMPs with sales over 100m may have been overcompensated.

The Pharmaceutical Committee is exploring solutions to these challenges, including measures to direct R&D towards unmet needs (such as establishing a list of priority therapeutic areas and amending the definition of orphan diseases). Increasing transparency of R&D costs is being considered, to enable better analysis.

The criteria for OMP designation is also being considered and the Committee has been asked to consider mechanisms to improve access to therapies.

Conclusion

It is always easier to shape EU plans before publication than try to change them afterwards. The Commission values early industry alignment and proactivity rather than defensiveness and criticism of draft proposals.

Companies and the industry must take up this opportunity and tell the compelling OMP story. They must educate decision-makers about OMPs and use data to highlight the wider value of the OMP sector in the EU.

Working together with patients, industry and other stakeholders, the rare disease community has a once-in-a-decade chance to shape the direction of EU and possibly global orphan medicine regulation. Its time to seize it.

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Industry needs an aligned position on the future of the EU OMP Regulation - PMLiVE

EU threatens more sanctions against Turkey if it continues illegal drilling in Cypriot waters – Greek City Times

European Union spokesman Peter Stano has said that the European Union will respond with more sanctions against Turkey if it continues illegal energy drilling in Cyprus exclusive economic zone (EEZ), according to the Cyprus News Agency.

There has been a break, but there has been no change in the EU`s position on illegal Turkish actions in the eastern Mediterranean, so the EU`s position is clear, unchanging, Stano told CNA.

We have reiterated many times that we express our concern and the strong condemnation of the continuing Turkish activity associated with illegal drilling in the eastern Mediterranean, we stand strong together with Cyprus, he added.

The European Union already has targeted sanctions on Turkey for it illegal attempts to extract energy from Cyprus EEZ, but this has not deterred further attempts.

This is something that the Member States are closely monitoring, and indeed, if the illegal activities continue, the EU will continue to act as it has been described, the spokesman said.

On Wednesday, Turkey issued its intentions to illegally drill for energy in Cypriot waters with the Yavuz drillship from April 20 to July 18.

Cyprus government spokesman, Kyriakos Koushos said Turkeys policy is worsening an already tense situation in the Eastern Mediterranean, especially as the world is trying to fight the coronavirus pandemic, according to the Cyprus News Agency.

Turkey continues to follow a policy that ignores even the pandemic and does not respect the difficulties which countries are facing, he said, adding We condemn Turkeys actions and we continue in a consistent manner to implement our policy which is based on the international law and the sovereign.

Turkey has been implementing gunboat diplomacy, and acting as the pirate of the Eastern Mediterranean, breaching and violating the international law and interfering with the sovereign rights of third countries, including Cyprus, he concluded.

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EU threatens more sanctions against Turkey if it continues illegal drilling in Cypriot waters - Greek City Times

EU aims to bar ‘predatory’ takeovers of weakened firms – Rappler

CLOSED. People walk past a closed Chinese restaurant under the arcades of Piazza Vittorio Emanuele II in the Esquillino district of Rome, Italy, on March 9, 2020. Photo by Tiziana Fabi/AFP

BRUSSELS, Belgium European Union (EU) trade ministers vowed on Thursday, April 16, to protect strategic European companies weakened by the virus-triggered downturn from "predatory" takeovers.

A statement following the discussion held by videolink did not identify potential threats, but participants later made it clear China was the main source of concern.

"With some companies having lost dozens of percentage points off their value, it is important that we can ensure there is no predatory takeover which would not be desirable," France's junior French foreign minister Jean-Baptiste Lemoyne told Agence France-Presse.

The ministers welcomed recommendations issued 3 weeks ago by the European Commission calling on the EU to protect itself against the risk of foreign investment in strategic sectors made vulnerable by the economic crisis caused by the coronavirus pandemic.

Commission chief Ursula von der Leyen on March 25 pointed to health and medical research companies as possible targets for non-European groups.

Her commission proposed bringing forward an EU regulation, initially set to come into force in October, which addresses the concerns about foreign groups, notably Chinese ones, eyeing European firms.

Lemoyne said the ministers agreed to work together "if threats appeared."

The Netherlands' trade minister, Sigrid Kaag, confirmed there was "convergence and consensus" around the idea that "Europe is not for sale."

But she added that "we need to be mindful of the balance when it comes to any possible limitations to prevent predatory purchasing through foreign direct investment."

While heading off threats in strategic areas, the EU should also "not fall back into protectionism or national measures," she said.

The perceived danger of strategic companies losing control to China was also evoked on Wednesday, April 15, by NATO defense ministers during a videoconference.

NATO chief Jens Stoltenberg said many in that meeting stressed the importance of guarding critical industries, pointing to telecoms as one example. Rappler.com

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EU aims to bar 'predatory' takeovers of weakened firms - Rappler

French and German ambassadors urge Dutch to support the EU – DutchNews.nl

The Algemeen Dagblad on Thursday published an open letter from the French and German ambassadors to the Netherlands, calling on the Dutch to help preserve the unity of the European Union.

In the letter, French ambassador Luis Vassy and German ambassador Dirk Brengelmann slate attempts to make European governments reactions to the coronavirus crisis look weak and disorganised, which they say is an attack on democratic values.

The letter, headed Dear Nederlanders, dear friends, warned of eurosceptics in the Netherlands and elsewhere in Europe who are taking advantage of the worst crisis since the World War II to point to the EUs shortcomings.

The letter does not identify who these eurosceptics are, but some political parties in the Netherlands, such as PVV and Forum voor Democratie have long campaigned for the Netherlands to quit the European Union.

Instead of criticising the EU, the ambassadors ask their dear Dutch friends to consider the importance of shared values, particularly the democratic values of transparency, responsibility and debate.

Science

The ambassadors point out that in Europe whistleblowers are not silenced and scientists are listened to. This reaction to the crisis, the letter went on to say, is now being painted by propagandists as weak and disorganised in an attempt to create discord and weaken peoples faith in our democratic system.

The ambassadors also stressed the need for solidarity, citing the 37bn funding package which was finally hammered out between the member states last week.

However, Dutch finance minister Wopke Hoekstra and prime minister Mark Rutte were both heavily criticised for showing a lack of solidarity to fellow EU countries who are struggling to cope with the coronavirus pandemic.

Post coronavirus

The Netherlands will also have an important role to play in a post coronavirus Europe, the ambassadors said, pointing out that a number of things will have to change in case Europe is faced with a similar challenge in the future.

The production of strategic goods, such as medical equipment, will have to take place in Europe while the Dutch will also have to contribute to issues related to climate, the digital economy and the management of big data. These, they said, are fields in which none of the European countries have the means to become the dominate player.

According to the AD the message is part of a trend for ambassadors to make their opinions known to the public. DutchNews.nl has asked the French embassy for a comment.

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French and German ambassadors urge Dutch to support the EU - DutchNews.nl

Can the European Union Survive in a Deglobalized World? – Foreign Policy

In September 2019, two months before officially taking office, the new European Commission president was already insisting that the European Union needed to change. On the one hand, Ursula von der Leyen promised a new geopolitical Commission, but on the other, she wanted the EU to be the guardian of multilateralism. The difficult question was left unstated: How exactly is the EU supposed to reconcile the great-power maneuvering of geopolitics with the more level playing field of multilateralism?

Geopolitics is the ruthless pursuit of self-interest by powerful states, no matter the cost to others. Multilateralism involves mutual agreements among states pursuing their collective welfare. At a minimum, the two sit awkwardly with each other; at the worst, they are radically incompatible. The latter is true of the current system of globalization, which has been supported by a complex system of multilateral rules and agreements among states.

Von der Leyenand the EUfaces a fundamental strategic dilemma. More than any ordinary nation-state, the EU is as pure a creature of multilateral globalization as exists in the world. It is most comfortable when the outside world mirrors its traditional internal principles of organization: free economic exchange and mutually beneficial cooperation.

Deglobalization has cut the EU adrift. In the new world order, geopoliticsin the form of newly assertive great powers like the United States and Chinais coming to trump old trade commitments and international cooperation. Europe, for its part, has been vacillating between defending the remnants of multilateralism and building up geopolitical muscle so it can pursue its own strategic self-interest.

The coronavirus crisisin which other member states have been willing to leave Italy high and dryshows how the EU may suffer if it does not figure out how to reconcile these clashing imperatives. Geopolitics abroad may come to roost at home, undermining the solidarity that the EU needs to exist.

Globalization remade Europe before it remade the world. The historian Quinn Slobodian has shown how the driving ideas of globalizationstrengthening cross-border exchange and restraining the nation-statewere the motivating force behind European integration.

The EU (then called the European Economic Community) was founded in a 1957 treaty that set out the new groups aims: eliminating restrictions on the import and export of goods between its member states and abolishing obstacles to freedom of movement for persons, services and capital. These four freedomsfor things, people, services, and moneyare still the cornerstone of the EU.

The four freedoms were supposed to not only power an economic dynamo but also build the foundations of a lasting peace. For most of modern history, Europe had been torn apart by wars between great powers such as Germany and France. The founders of the EU wanted to transform the politics of Europe, replacing geopolitical conflict with shared institutions and cooperation. Power had to be recognized: The size of the bigger member states meant that they got more votes on crucial EU decisions. However, their clout was balanced by institutions such as the European Commission and European Court of Justice (ECJ), which were supposed to deal evenhandedly with all members and protect the interests of the smaller states.

The result was a unique set of political arrangements. The EU has never looked much like a national state. It employs fewer people than a regional government, has no army, and has very limited spending power. Even today, its national security powers are negligible: The key decisions are taken by its member states.

What it has is the power of rules. The commissionproposes laws, drafts regulations, and makes antitrust decisions. The ECJ interprets EU law, as well as the basic treaty texts that the EU is founded on, when national courts ask it to.

Together, the court and commission drew on the four freedoms to build a European free market, enhancing their own authority in the process. ECJ decisions struck down national standards and rules that restricted imports from other member states. The commission issued common regulations to support a truly European marketplace. Its Directorate-General for Competition acted as an antitrust enforcer against potential monopolists. In the 1980s and early 1990s, the commission implemented a highly ambitious single market program aimed at eliminating existing barriers to trade and exchange. Even before the current wave of globalization began, the EU was building a globalization in miniature. Within EU borders, markets and free movement dominated while free trade rules constrained national governments from building favored firms into national champions.

When globalization really began to take off in the 1990s, the EU was thus ready to help shape it. It understood how to knock down barriers to market competition. The founding director-general of the World Trade Organization (WTO), Peter Sutherland, had been Europes competition commissioner at the height of the single market program. In some ways, the EU was more comfortable with globalization than the United States was. After all, it had been founded on the belief that open commerce and shared institutions were a better guarantee of peace than great-power maneuverings.

Like the United States, the EU resisted multilateralism in areas of trade that might undermine internal political bargains or sensitive external relationships. Europe was slow to abandon restrictions on textile imports. It was notoriously opposed to free trade in bananas, which might damage its ties to former European colonies. Nonetheless, it grudgingly opened up.

The EU gradually discovered that it could turn its embrace of globalization into a strategy of influence. It could use the internal markets rules and standards to shape the rules and standards of a globalized world. The EUs combination of a large market and a common standard setting system gave it unique leverage in many sectors. While the United States had a big market too, its internal regulations and standards were often weak or created by squabbling private organizations. The commission was a sophisticated and internationally oriented regulator, with decades of experience in making its regulations work across different countries. Often, it was able not only to impose its rules and standards on multinational firms that wanted to sell to Europe but to get them to apply these rules and standards outside Europe too. This subtle form of influence, which Columbia Universitys Anu Bradford has dubbed the Brussels effect, reshaped global markets.

In short, the EU seemed well adapted to a globalized world. The stronger the EU became, the easier it was to influence world markets in Europes direction. The relationship worked the other way too: The ideas of globalization helped EU officials push for further internal reforms. It was easier to push member states to accept more European integration in a world where everyone believed in open trade and free movement. Together, these created a feedback loop between European integration and global markets.

Now that feedback loop is breaking down. Just as the EU began to globalize before most other countries, it started encountering problems earlier too. International market integration necessarily limited national democracyand voters didnt always like it. When EU leaders tried to introduce a new constitution in 2005, French and Dutch voters rejected it. A somewhat less ambitious follow-up document, the Treaty of Lisbon, was rejected by Irish voters in 2008 (though it passed when they were asked to vote again in 2009). The 2008 global financial crisis demonstrated the problems of easy financial flows across borders. The EU was especially weak in financial regulation, meaning banks could relocate their most risky and speculative lending to lax jurisdictions such as the United Kingdom and Ireland without difficulty. And as the Greek debt crisis mounted, power politicsand the self-interest of Germanyreemerged within Europe. German taxpayers were unwilling to support further integration if it meant they had to pay the bill.

The Brussels effect turned out to have limitations as well. The EU was able to spread its privacy rules worldwide, but it was too late to help European firms. Europes information economy had already been eaten up by Google, Facebook, Amazon, and other big technology firms. These are not just companies that can be tamed through ordinary antitrust regulation: They aspire to become economies in their own right. Amazon, for example, is already both a marketplace and a formidable market regulator, setting rules for the businesses that use its many different backend services. Even before 2016, it was clear that the EUs approach to globalization needed to be updated to deal with market actors that were themselves effectively evolving into markets.

Now Europe is facing the new challenges of a deglobalizing world. The Trump administration wants to tear apart the existing globalized economy and replace it with an America First approach to trade. It scorns multilateralism in favor of threats and one-sided bargains. It fears China as an adversary and is trying to cut it out of global technology supply chains. When the Trump administration decided to withdraw from the Iran nuclear deal, it threatened to punish allies that were impertinent enough to uphold a treaty that the United States itself negotiated. As the political scientist Abraham Newman and I have argued, the United States is weaponizing the trade and financial networks that wove globalization together and turning them into tools of coercion.

Unfortunately for Europe, the United States isnt the only problem. China is not as powerful as the United States but is just as ruthless in exploiting what economic leverage it has. For example, it has threatened to retaliate against German car manufacturers if Germany gives in to U.S. pressure to block the Chinese telecommunications firm Huawei. When a Swedish writers organization gave a prize to a dissident Chinese publisher late last year, Chinas ambassador to Sweden said on Swedish public radio: We treat our friends with fine wine, but for our enemies we got shotguns, warning of trade restrictions.

Globalization is unraveling as the United States and China face off against each other. It will not unravel completely: The worlds economies are too entangled to be easily separated from each other. But the way that the global economy works is now at odds with the way that Europe itself does business. Deglobalization has especially imperiled the multilateral institutions governing trade. The WTO Appellate Body, which serves as a final court of appeal for trade decisions, cannot do its work because the United States is vetoing new appointments to it. The EU is trying to keep the appellate system on life support through independent arbitration.

The Trump administrations invocation of a national security exception to justify its tariffs on steel and aluminum may be an even greater threat to the multilateral trade regime that Europe favors. Global free trade will not survive if states can invoke national security more or less on a whim, but the current U.S. administration may provoke an even bigger crisis if the WTO rules against it.

Europe now finds itself caught between two unattractive alternatives. It can accept deglobalization and embrace geopolitics, pushing to protect its own businesses as the United States and China protects theirs. Already, there are moves within Europe in this direction: Politicians are talking about watering down antitrust regulations and building and promoting European businesses. However, this would mean giving up on the multilateral institutions that Europe has relied on and hoping that soft power can be transformed into hard bargaining strength. That may be possible, but it will require luck, time, and profound internal transformation.

For example, the EU is unhappy with how the United States has used the dominance of the dollar to bully European officials and firms. If it wants to build the euro as a credible alternative, it will have to create a real system of common banking regulation and shared fiscal capacities, as well as offer stability to non-European currencies in times of economic crisis, just as the United States has. Even this might be insufficient. Europe has just lost its greatest geopolitical asset: the city of London, which is one of the core nodes in the global financial network. Building up clout would require the EU to figure out practical ways to bring London back into its orbit.

Alternatively, Europe can double down on protecting the existing multilateral system, working with other states such as Japan and Canada to build an alliance for multilateralism. The problem is that the two other great economic powers are taking just the opposite course. Even if the Trump administration is replaced by a Democratic leadership, the days of easy multilateralism will never return. Democrats, too, are hawkish about China, and presidential candidates like Bernie Sanders are skeptical about the old free trade nostrums.

Europe needs more than knee-jerk multilateralism or geopolitical cunning if it is to prosper. Naive multilateralism would lead to the EU getting squashed. Geopolitical cunning on its own would suggest that the EU should adopt Trumpism (or Xi Jinping-ism) with European characteristics, championing national firms at home while aggressively pressing its interests abroad. This is a recipe for failure. Europes external influence is based on patience and persuasion rather than brute force; it would wither if it became a crude proxy for self-interest. Without a shared commitment to problem-solving, Europes internal market would degenerate into a sordid squabble among member states, each favoring its own politically connected firms. Even worse, the political union might disintegrate, as member states absorbed the lesson that national interest trumps all. The EU can manage some temporary national ruthlessness, of the kind exhibited in the Greek debt crisis, or the decision of some member states to close their borders to prevent the spread of the coronavirus. But even this is damaging, and it would undermine the EU if it continued indefinitely.

What Europe needs is a new understanding of its place in the world to connect its internal and external environments. EU experts used to describe the bicycle theory of European integration, claiming that, like a bicycle, European integration must keep on moving or it will fall over. In its golden age, globalization acted as Europes bicycle chain connecting the gear of its inner order and the gear of its outside environment, propelling the whole system forward. Now it needs a new strategy and a new bike chain.

It is a mistake to think of deglobalization as a universal withdrawal of nation-states from the world economy. It is altogether more complex. The push toward economic decoupling goes together with new needs for global engagement. The challenge of climate change will require extensive global cooperation. Under the digital platform economy, algorithms designed by market actors inevitably allow global information flows to impinge on national-level democracy. (New forms of machine learning, for example, can lump users of digital services into self-perpetuating disadvantaged categories such that a persons online habits might make it nearly impossible for them to find a job or to get a loan on reasonable terms.)

Both of these challenges provide new ways to connect Europes inside and outside. If Europe is to tackle them, it will need to move to an unparalleled level of internal integration, where it thinks about internal market rulesright from the beginningas external means of projecting European interests and values. Responding to climate change will require large-scale regulation and coordinated investment. Properly regulating information platforms will mean a fundamental shift in how the EU thinks about market power so that it incorporates an understanding of how the accumulation of data creates its own forms of influence.

Yet integration on its own will be insufficient: Both are global problems. Europes challenge, then, is to figure out how climate globalization and information globalization can become a new bicycle chain, using the smaller gear of European integration to propel change in the globaleconomy and the larger gear of the global economy to power change within Europe.

Europe is taking initial steps in this direction. The new proposals to price carbon emissions into border taxes provide one example of how this can be done, creating a virtuous cycle between Europes own efforts to reduce carbon emissions and those of other world producers, which will either have to match these efforts or pay a surtax when selling to the European market. In contrast to traditional tariffs, the ideal outcome of this border tax is that no one will have to pay it because the hope is that everyone will move to more carbon-efficient forms of production. Even better would be if Europes competitors introduced carbon taxes and carbon regulation too, making it easier to eventually build a global institutional infrastructure.

Antitrust regulation, too, is changing. Sutherlands distant successor as EU competition commissioner, Margrethe Vestager, is pioneering a new approach to global enforcement. Privacy regulation, citizen protection, and traditional antitrust regulation are no longer seen as separate priorities but as different aspects of a single problem: reducing inequities of power within the market to prevent abuses. Again, this promises to help create a mutually reinforcing relationship between European and global rulesalthough here the challenge is far greater, since what European and other democracies value may be seen by countries such as China as undermining their domestic system of rule. The EU will have a hard time figuring out creative rules to tame big tech companies, but if it succeeds, it can use the Brussels effect to spread these values to other jurisdictions.

None of this will be easy in a world where the United States and China weaponize their economic clout. Yet it is necessary. Europes apparent dilemma between geopolitics and multilateralism reflects a much deeper problem. Deglobalization has broken the relationship between Europes way of organizing itself and Europes way of acting in the world. Rebuilding that relationship will require Europe to discover new ways to couple the engine of integration to the engine of globalization so that strategy and multilateralism point again in the same direction.

This article appears in the Spring 2020 print issue.

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Can the European Union Survive in a Deglobalized World? - Foreign Policy