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Op-ed: Biden can help unite Europe. A closer political union is the rational outcome for Europe, and a globalist U.S. President can assist even passively

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A closer political union is the rational outcome for Europe, and a globalist U.S. President can assist even passively, writes former Romanian PM Mihai-Răzvan Ungureanu, in a joint op-ed with two US experts. The op-ed released to CaleaEuropeană.ro is published as an epistemic response to a piece authored by Daniel Cohn-Bendit and Klaus Leggewie in Frankfurter Allgemeine Zeitung calling for a German-French Federation as a “breath of fresh air” for Europe. 

By Robert Braun, Mihai-Razvan Ungureanu and Dan Perry

The incoming Biden Administration is expected to break with its predecessor’s obsessively transactional foreign policy, enabling progress on issues ranging from global warming to international trade to human rights. An important consequence, not obvious from headlines at the moment, involves Europe.

Outgoing President Trump’s evident disdain for global cooperation, supranational governance and the European Union in particular has had a devastating effect on those who yearn for greater European political union. It emboldened the UK’s Brexiteers, Euroskeptic leaders in the east and nationalists in almost every country, creating a paralytic continental bad karma. Trump’s departure holistically offers a moment for the European Union to regain its ambition, boldness and creativity.

The EU embodied a successful economic vision, but failed to transform that business case into a shared political values to an extent that could drive action. The treaties of Maastricht and Rome ultimately amounted the rhetorical flourishes and bureaucratic advances that could not sweep aside nationalist resistance. This is now best exemplified by the  Polish-Hungarian effort to derail the European budget and halt political oversight over individual countries’ authoritarian practices.

If Europe is to make its mark in the world, it needs a bold vision for political union: tighter control over exploitive and corrupt practices of local and multi-national companies, an inclusive social net with universal basic income, a welfare system socially and economically strengthening unions and representation bodies, and safeguards for the independence of the free press, of universities and of civic-cultural institutions.

A unified Europe can be a beacon of progressive values and modernity to the world. This should be the response to those in the world who derided Europe as an ossified vessel of yesterday while benefitting from its values. 

This will strengthen Europe, and make it a better partner to a rejuvenated, post-Trump United States – and to other democracies. It is a vision that the new U.S. Administration will be able to get behind.

Of course, this is not currently the direction of things, nor will it be without an electrifying course correction. In theory, there would be a variety of ways to shock the system. We’d like to throw our support in favor of constitutional unification of Germany and France, an idea floated recently by French MEP and 1960s student leader Daniel Cohn-Bendit and German political scientist Claus Leggewie.

France and Germany have fought bitter wars, and can view each other through a narrow lens of stereotype and historical grievance. They have different labor market politics and instincts about fiscal and monetary policy. They speak different languages, and each possesses a profound patriotic instinct that may seem at odds with a ceding of national sovereignty. France is also more interested than Germany in a European security mechanism independent of the United States.

And they both have fostered business interest, sometimes at the expense of others in the European Union, that were grounded in “nation first” ideals.

And yet, France and (West) Germany are the two largest founding members of the European Economic Community that grew into the EU of today. The differences between their political and economic structures are minor when one considers their common fealty to Western and European values of the post-Renaissance and Enlightenment.  They are also the two strongest forces for political union among major EU members; there is a scenario where they agree to blaze the path.

A constitutionally unified, politically strong core would create economies of scale – combined population of 151 million and GDP of 6.73 trillion that make up 40% and 44% respectively of the bloc with the UK factored out – that would be irresistible, and prove that language need not be a barrier in a world in which English (ironically in light of Brexit) and innovation are unifying forces. 

Different languages may pose a challenge. But Canada, even with succession initiatives in Quebec, proves community and understanding are more about shared values than similar languages. Respect for different cultures and strong compassionate leadership are at the core of New Zealand’s political success. There is real reason to assess that a successful Franco-German unification would soon draw in an essentially liberal and internationalist countries like the Netherlands, Belgium, and Denmark, linguistic satellites like Austria and Luxembourg, and then large countries of the southern cone like Italy, Spain and Portugal. 

What of former east bloc countries where populist nationalists currently hold sway?  The euphoria of expansion was driven by both idealism and business interests, and while it yielded economic growth for the East it also left many in that region with resentments about a perceived neocolonialism, yielding a nationalist backlash.  Deft political diplomacy and considerable sensitivity will be required to avoid a repeat. A strong European political union may create the political momentum to rejuvenate a progressive urban electorate in Eastern Europe as well. Western European politicians should also find ways to acknowledge that peoples east of Vienna are valuable beyond picking asparagus, caring for the elderly and doing menial jobs for less. 

It seems far-fetched today. Nations tend to wait for crises to break established paradigms. We propose getting ahead of the curve. Germany and France can jump-start the process of European unification.

National identity – indeed tribalism – has been one of the building blocks of civilization. The question has always been granularity.  Right now, what is needed for stability, prosperity and global impact is a European identity.  It won’t be easy, because local identities are strong. But nothing ventured, nothing gained. Quite probably, very much lost.

* * *

Historian Mihai Razvan Ungureanu was prime minister and foreign minister of Romania. Social Theorist Robert Braun was a top aide to Hungary’s prime minister and is a senior researcher at Vienna’s Institute for Advanced Studies. Dan Perry was Europe-Africa Editor and Mideast Editor of the Associated Press news agency and is managing partner of the Thunder11 communications firm.

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Romania to negotiate for the first time, at European level, new regulations on patient access to treatments for rare and pediatric diseases

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© European Union, Source: EC - Audiovisual Service

According to national and European experts, access to innovative medicines for Romanian patients suffering from rare diseases can be improved in the coming years, as Romania has for the first time the chance, as a member state of the European Union, to contribute to the revision of the Orphan Medicinal Regulation, which was implemented 20 years ago.

National authorities, European decision-makers, representatives of the pharmaceutical industry responded to the initiative launched by the Media Platform www.caleaeuropeana.ro and the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) and held an open dialogue on the access of Romanian patients to orphan and paediatric medicines, as well as on Romania’s role in the forthcoming negotiations at European level for the revision of the Orphan Medicinal Products Regulation.

To ensure that patients suffering from rare diseases have access to medication, the “Regulation on Orphan Medicinal Products (OMP)” was adopted 20 years ago, introducing specific legislation, a definition of OMP, and a specific committee responsible for OMP at the European Medicines Agency (EMA), as well as incentives to promote the development of treatments for rare diseases.

Read also: Romania has one of the worst performances in the EU when it comes to access to treatments for rare diseases

The role of Romania and Romanian experts in the negotiations held by the European institutions

This more than 20-year-old regulation will be re-evaluated, and this is the first time when Romania, as an EU Member State, will participate in the legislative process in the negotiations at the Council level and subsequently in the negotiations between Council and Parliament by submitting successive positions in the negotiations on the legislative act, according to national interests in the matter.

The review of EU legislation addresses the gaps identified by the evaluation with regard to products and their development for the specific needs of children and patients with rare diseases; early access to treatment for these groups and improvement of approval procedures and reduction of inequalities in access.

The European Commission launched another public consultation on 28 September, which will close on 21 December 2021, on the reform of the overall medicines policy framework as part of the resilience of the EU pharmaceutical sector. Thus, the Permanent Representation of Romania to the EU invites key stakeholders in Romania to participate and get involved and, most importantly, make their voices heard at European level.

What happens after the European Commission presents the legislation

Once the European Commission presents the legislative act to the public, the EU Council and the Parliament will start debating it (co-decision). The French Presidency, which will be at the helm of the Council in the first half of next year, will put the proposal on the agenda with a view to finding a compromise with a qualified majority of the EU 27, and the Parliament in parallel will vote on its position at first reading, initially in the ENVI committee and then in the plenary of the European Parliament.

When the Council reaches an agreement it will start negotiations with the European Parliament, the so-called trilogues, and after several rounds of negotiations, a political agreement will be reached between the two co-legislators. Once agreement is reached, the regulation will be adopted and will enter into force immediately after publication in the Official Journal of the EU with immediate legal effect, provided there are no transitional periods and it is a regulation and not a directive. From the moment the public consultation is closed until the publication of the act, Member States, the Council and the Parliament cannot influence the legislative act, as it is pending and in preparation for adoption by the Commission.

Romania will, for the first time, participate in the legislative process in the negotiations at the Council level and subsequently in the negotiations between the Council and Parliament by submitting successive positions in the negotiations on the legislative act, depending on national interests in the matter.

Negotiations between the Member States at Council level take place between the Member States at three levels: at technical level, by Member States’ experts in the working groups on pharmaceuticals and medical devices; at the level of the Permanent Representatives of the Member States and at ministerial level, the EPSCO Council (health component).

In addition to participating in public consultations, Romania will have a new opportunity to participate, contribute and influence the EU legislative process in order to create optimal conditions for ensuring access to treatment for rare and pediatric diseases for the benefit of Romanian patients and to create the incentive framework necessary for the development of orphan and pediatric products for the pharmaceutical industry.

Romania will also contribute to the initiative “a European Pharmaceutical Strategy” and will support ensuring the availability of innovative and affordable medicines for patients, as well as supporting the competitiveness, innovation capacity and sustainability of the pharmaceutical industry in Romania and in the European Union.

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Ambassador Ion I. Jinga, Permanent Representative of Romania to the United Nations: ”Our Common Agenda: A Peacebuilding Perspective”

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© Reprezentanța Permanentă a României la ONU

Opinion article signed by Ion I. Jinga, Ambassador, Romania’s Permanent Representative to the UN

Motto: “Our problems are man-made, therefore they may be solved by man. And man can be as big as he wants. No problem of human destiny is beyond human beings” – John F. Kennedy

In September 2020 the world leaders committed to upgrading the United Nations and tasked the Secretary-General to produce a report on how to respond to current and future challenges. One year later, António Guterres responded with his report on Our Common Agenda(General Assembly document A/75/982), presenting proposals on twelve areas of action: “leave no one behind, protect the planet, promote peace, abide by international law, place women and girls at the centre, build trust, improve digital cooperation, upgrade the United Nations, ensure sustainable financing, boost partnerships, work with youth, and be prepared”.

Our Common Agenda report is one of the most far-reaching and comprehensive strategies ever produced by the UN. It was crafted on the basis of consultations involving over 1.5 million people, including national and local governments, business community, young people and civil society, from 147 countries. It looks ahead to the next decades and represents a vision on the future of global cooperation based on inclusive, networked, and effective multilateralism.  

In a nutshell, Our Common Agenda is set under four headings: strengthening global governance, focusing on the future, renewing the social contract between governments and people, and ensuring a UN fit for a new era. It tackles “the triple planetary emergency” (climate disruption, biodiversity loss and pollution destroying our planet), social equity, human rights and implementation of the sustainable development goals.

Our Common Agenda is not focused on the United Nations, and the States are not the only actors in the picture; it is primality about people, partnerships and results, and provides a 360 degrees analysis of the state of the world, with 90 specific recommendations. For those who are familiar with the Secretary-General’s priorities during his first term, this approach is not a surprise, being anticipated by the report “Shifting the management paradigm at the UN:  ensuring a better future for all” (document A/72/492) presented to the General Assembly in September 2017, which encapsulates António Guterres’ concept of “networked multilateralism” : “The UN works hand in hand with regional organizations, international financial institutions, development banks, specialized agencies and civil society, in order to bring multilateralism closer to people”.

It is also worth to note that during his first term a key-word was “prevention”. Now, Our Common Agenda refers to a key-triangle: “prevention – adaptation – resilience”.

Maintaining peace and security is at the core of the UN Charter. But today peace and security is more than avoiding war. It implies safeguarding the global commons, mitigating climate change, managing public health and the global economy, making the internet affordable to all, and ensuring sustaining peace – a new concept mentioned for the first time in the second review of the UN peacebuilding architecture (twin resolutions A/RES/70/262 and S/RES/2282 (2016)): “Sustaining peace should be broadly understood as a goal and a process to build a common vision of a society, aimed at preventing the outbreak, escalation, continuation and recurrence of conflict, addressing root causes, assisting parties to conflict to end hostilities, ensuring national reconciliation, and moving towards recovery, reconstruction and development.”

Under this paradigm, peacebuilding is no longer a post-conflict phase but a part of the new concept of “peace continuum”: it happens before, during and after a conflict. Our Common Agenda confirms this view: “To protect and manage the global public good of peace, we need a peace continuum based on a better understanding of the underlying drivers that sustain conflict, a renewed effort to agree on more effective collective security responses and a meaningful set of steps to manage emerging risks.”

In order to achieve these aims, a New Agenda for Peace is envisaged and the Member States are called to consider “allocating a dedicated amount to the Peacebuilding Fund from assessed contributions, initially through the peacekeeping budget and later through the regular budget”. This is in line with the proposal the Secretary-General made his 2020 report on peacebuilding and sustaining peace (twin resolutions A/74/976 and S/773 (2020)): “Member States commit the equivalent of 15% of the final full-year budget of a closing peacekeeping mission to be contributed to peacebuilding activities each year for a period of two years following the end of a mission mandate.”

On December 21st, 2020 the third review of the UN peacebuilding architecture (twin resolutions A/RES/75/201 and S/RES/2558 (2020)) reconfirmed that peacebuilding financing remains a critical challenge and decided to convene a high-level meeting of the UN General Assembly at the 76th session: “to advance, explore and consider options for ensuring adequate, predictable and sustained financing for peacebuilding”. Undoubtedly, the peace continuum and the appropriate funding for the Peacebuilding Fund are top peacebuilding priorities.

Therefore, the New Agenda for Peace might encourage Member States to commit more resources for prevention, including by tailoring development assistance to address root causes of conflict, upholding human rights and linking disarmament to development opportunities. As Rosemary DiCarlo, the UN Under-Secretary-General for Political and Peacebuilding Affairs, pointed out at the 10th Ministerial Conference of the Communities of Democracies, chaired by Romania, on September 22nd, 2021: “Conflict prevention is less costly in human lives and resources than picking up pieces after war. Prevention also means helping to build peaceful and resilient societies – the fundamental goal of the Sustainable Development Agenda.”

Our Common Agenda mentions the Peacebuilding Commission contribution to reshaping responses by the UN to multidimensional threats, and suggests to expanding its role to addressing the cross-cutting issues of security, climate change, health, gender equality, development and human rights, from a prevention perspective. Peacebuilding should also focus on placing women, girls and youth at the heart of peace and security policy, and on the UN transition missions.

Women and youth empowerment, cross-border and regional peacebuilding and support to the transition of UN peace operations are the three priority-windows assigned to the Secretary-General’s Peacebuilding Fund. These have been reconfirmed in September 2021 by the Security Council first-ever stand-alone resolution on the transition that follows deployment of United Nations peacekeeping missions (S/2594 (2021)), which: “underlines that the transition of UN peace operations should support peacebuilding objectives and the development of a sustainable peace, in a manner that supports and reinforces national ownership, national priorities and needs of the host State and its population, and includes engagement with the local community and civil society, with the full, equal and meaningful participation of women, youth and persons with disabilities.”

Interdependence is the logic of the 21st century. In order to remain effective, the UN needs to become a platform to foster the networked multilateralism envisaged by the Secretary-General. On October 24th, the Organization celebrates its 76 anniversary; the day after, Member States will gather in the General Assembly to discuss Our Common Agenda report and to agree on the follow up. Our Common Agenda will only be achieved if all Member States are genuinely on board. The adoption of a procedural resolution to provide the framework for continuing inclusive consultations would certainly help to keep the momentum.

Post scriptum:

When he presented “Our Common Agenda” to the General Assembly on September 10th, 2021, António Guterres confessed: “I am an engineer. I believe in the infinite capacity of the human mind to solve problems. When we work together, there is no limit to what we can achieve”. I share the belief that problems we have created are problems we can solve. Like him, a long time ago, I was an engineer in Physics.

Note: The opinions expressed in this article do not bind the official position of the author nor do they necessarily reflect the editorial views of CaleaEuropenă.ro.

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Romania has one of the worst performances in the EU when it comes to access to treatments for rare diseases

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To give hope to the 30 million Europeans living with a rare disease, all key players in the health sector, together with the European institutions and the Member States, are trying to step up their collaboration to ensure that patients have on-time access to currently available treatments. The News Platform www.caleaeuropeana.ro brings you the latest updates at European level on patient access to orphan drugs, but especially the situation of Romanian patients, who according to statistics, are among the EU citizens who have access to the fewest innovative treatments and are waiting the longest time for their approval on the market.

Rare diseases are serious conditions, usually of genetic origin, most of which develop in childhood and lead to severe illness in adult life: 1 in 3 children with a rare disease die before their 5th birthday and many more live with debilitating disabilities.

To address this situation and to ensure that patients suffering from rare diseases have access to medication, the “Orphan Medicinal Products (OMP) Regulation” was adopted 20 years ago, introducing specific legislation, a definition of OMP and a specific committee responsible for OMP at the European Medicines Agency (EMA), as well as incentives to promote the development of treatments for rare diseases.

The introduction of the above legislation, together with scientific advances, has led to a wave of new treatment options for rare disease patients.

Since the adoption of the Orphan Drug Regulation in 2000, more than 160 OMPs had been approved by the EMA up to 2018.

Despite considerable success so far, there is still a high unmet medical need for rare diseases: only 5% of rare diseases are estimated to have an approved treatment and much remains to be done, not only because of the low prevalence but also because many rare diseases are very complex from a scientific research perspective. Despite this, the existing legal framework has proven its effectiveness (8 orphan drugs approved by 2000, over 160 between 2000-2018). Maintaining the right regulatory, scientific and economic environment for the development of orphan drugs is essential to the mission of developing new treatments for ~95% of rare diseases without a treatment option today.

Romania is lagging behind when it comes to access to treatments for rare diseases. In the European context, our country has one of the worst performances:

There are challenges in terms of access to new orphan treatments and considerable inequalities between the Member States. According to the EFPIA PATIENT W.A.I.T. 2020 indicator (published in 2021), more than 80% of orphan drugs still remain unavailable for many Member States, including Romania, and patients can access them only a few hundred days after official EMA approval.

By 1 January 2021, 13 treatments for rare diseases will be available in Romania, out of a total of 47 adopted by the European Medicines Agency in the period 2016-2019. Therefore, our country has access to only 29% of all orphan drugs, below the European average of 41%. In this sector, Germany is the leader among the Member States in terms of access to orphan drugs, with 45 treatments available to German citizens out of the 47 total approved by the EMA (in the above-mentioned period).

Romanian citizens are three times less likely to benefit from an orphan treatment than a German citizen, but on top of that, for the 13 medicines they can access, they wait on average 868 days, 762 days more than a German citizen.

Germans are the EU citizens who wait the shortest period of time for an innovative treatment that can treat their rare condition, or at least make their life easier. A Romanian suffering from the same rare disease as a German citizen will have to wait on average more than 2 years to start a treatment dedicated to his disease that will give him a chance to live. In turn, a German suffering from the same disease as a Romanian citizen will have to wait on average only 3 months.

All these inequalities among patients in the European Union are to be addressed by new strategies and programmes at European level. To this side, the European Commission has launched the Pharmaceutical Strategy for Europe, which is an ambitious project to strengthen the patient focus of the European pharmaceutical system and make it resilient to future health crises. It was adopted last November as a pillar of the European Health Union.

The Orphan Drug Regulation can play a role in a future EU industrial strategy, helping to promote sustainable innovation. Simply revising the existing intellectual property incentives in the current version of the regulation, designed to support research into new treatment options, will not improve patient access – now or in the future, without understanding the root causes that lead to delays in access to national markets for orphan drugs.

The hopes raised by new treatments can only be achieved if there is also correct and early diagnosis in both children and adult patients. The success and value of the regulation in stimulating the development of new treatments can only be fully realised if patients have access to them, together with the full range of complementary medical services.

Ensuring patients’ access to the new treatments of today and tomorrow should be a shared goal and responsibility. It requires regulators, health system partners, patients, governments and industry working together to find new ways to fund these innovative treatments and to ensure patient access and sustainability of health systems at national level.

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