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French-German Day. Ambassadors Laurence Auer and Cord Meier-Klodt: Europe was made possible because two countries decided to reconciliate. The spirit of the Elysée Treaty shaped EU’s recovery fund

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© Photo Collage (Official Embassy images)

Interview conducted by Dan Cărbunaru and Robert Lupițu

As everywhere in the world conflicts and tensions multiply, the main achievement of France and Germany is still to have brought more peace and prosperity to our European continent, and based on a living legacy of historical ties with Romania the three countries are building a common European future today, Laurence Auer and Cord Meier-Klodt, ambassadors of France and Germany to Romania said in an joint interview given exclusively for CaleaEuropeană.ro on the occasion of the 58th anniversary of the historic Franco-German reconciliation.

58 years after the signing of the Elysée Treaty by President Charles de Gaulle and Chancellor Konrad Adenauer, who laid Franco-German relations on new European foundations, and two years after the new impetus for this partnership by the Treaty of Aachen, signed by President Emmanuel Macron and Chancellor Angela Merkel in the presence of President Klaus Iohannis as representative of Romania’s Presidency to the EU Council, France and Germany offered a new show of unity, friendship and cooperation when Europe needed it most: a compromise that formed the basis of the € 750 billion recovery fund to relaunch the European Union following the COVID-19 pandemic, the biggest crisis since the European project was founded.

“The plan is called Next Generation EU because we believe that we need to address the future of all European citizens, not only short term consequences of the pandemic” said Laurence Auer, France’s ambassador to Romania, praising the work of the German presidency of the EU Council, which ended on 31 December 2020.

“It was not easy and the road was difficult, but at the end of the road there was consensus. (…) We can even say that the spirit of the Elysée Treaty was the one that drew the course of the agreement later”, Cord Meier-Klodt added, in a symbolic reference to the fact that the historical milestones of Franco-German cooperation materialized through the “spirit of the Elysée” and the “spirit of Aachen”.

The two ambassadors also set out their countries’ views on the Conference on the Future of Europe and the fact that it “aims to build on the 10 commitments for the future of the EU that were agreed in the 2019 Sibiu Declaration”, also arguing for a continuation of the close relations with Romania.

Referring to the future ambitions of the French Presidency of the EU Council, which will begin on 1 January 2022, Laurence Auer welcomed Romania’s support in including the rule of law as part of the future Multiannual Financial Framework: “The rule of law in the EU is not an ideology, it is a set of legal rules, it is the heart of the political contract that binds us”. Equally, Cord Meier-Klodt stressed that France and Germany would be happy to welcome Romania among the eurozone member states.

Laurence Auer and Cord Meier-Klodt also emphasized the importance of the European Union’s strategic autonomy, as well as the broad transatlantic agenda between Europe and the US with the inauguration of the Joe Biden administration.

Konrad Adenauer and Charles de Gaulle at the signing of the Elysée Treaty, 22nd of January 1963. © Wikipedia

CaleaEuropeană.ro: It’s been 58 years today since the signing of the Élysée Treaty that brought the Franco-German reconciliation at the heart of the European construction. Two years ago, stepping on the foots of presidents de Gaulle and Mitterrand and chancellors Adenauer and Kohl, President Macron and Chancellor Merkel reinforced the European cooperation between the two EU powers with the Aachen Treaty. What are the main milestones born from this historical reconciliation and what can the future possibly lie ahead?

Laurence Auer: As we celebrate the anniversary of the Élysée treaty, it is important to remember that Europe was made possible because two countries which fought in devastating wars decided to reconciliate and build a system that would forever prevent new wars. Attention was paid to cross-border relations, to a better mutual understanding, to the learning of each other’s language. Today, as everywhere in the world conflicts and tensions multiply, the main achievement of France and Germany is still to have brought more peace and prosperity to our European continent.

Angela Merkel and Emmanuel Macron a the signing of the Aachen Treaty, 22nd of January 2019 © Bundesregierung

The 2019 Aachen Treaty on Franco-German cooperation and integration represents a new step in deepening the links between the two societies. It created an Economic council of experts, a joint information platform, a Franco-German Parliamentary Assembly and a new fund for citizens that fosters projects between civil societies.

Moreover, as we face the multiple effects of the health crisis, I must stress that it is after a Franco-German initiative that the European recovery plan was proposed. We should praise the immense work of the German Presidency of the EU that made possible the decision of all member states to allocate €750 billion in order to rebuild our economies. The plan is called Next Generation EU because we believe that we need to address the future of all European citizens, not only short term consequences of the pandemic.

CaleaEuropeană.ro: The signing of the Aachen Treaty in 2019 took place in a broader European context with Romania at the helm of its first EU Council Presidency. The spirits of Élysée and Aachen were adopted by President Iohannis under “the Sibiu Spirit” inked in 9th of May EU Summit Declaration. Has the European Union and its member countries lived up to the commitments enshrined in these spirits across the most difficult challenges in its history – the COVID-19 pandemic?

© Administrația Prezidențială

Cord Meier-Klodt: First of all, I particularly liked that the reaffirmation and revision of the Elysée Treaty in 2019 took place during Romania’s Presidency of the Council of the European Union, thus benefiting from the special appreciation from a partner state in Southeast Europe.

Secondly, no one says that the response to the COVID-19 pandemic went smoothly and without crises. Neither in Member States nor at the level of the European Commission. Especially in the early stages! In fact, no one was prepared for a crisis of this magnitude.

Taking all this into account, I believe that Europe has proved its capabilities in this very crisis. Only if we look at the unprecedented € 750 billion post-COVID-19 “Next Generation Europe” Economic Recovery Plan adopted during the German Presidency of the EU Council. The procurement of vaccines by the European Commission has also been particularly important.

Who would have thought in the spring of 2020 that Member States would be able to agree on € 390 billion in non-reimbursable funds? It was not easy and the road was bumpy, but at the end of the road there was consensus.

This was only possible because Germany and France, Federal Chancellor Merkel and President Macron, had already agreed in May 2020 on a compromise that was the basis for the agreement that followed. We can even say that it was the spirit of the Elysée Treaty that shaped the course of the agreement later.

CaleaEuropeană.ro: The 750 billions EUR recovery fund is the most recent and tangible result of Germany and France being the engine that fuels a compromise between the EU-27. What kind of example does this EU-27 agreement set for the future of the European integration in political terms but also in the perspective of an in-depth fiscal and economic integration?

Cord Meier-Klodt: The German-French initiative, which has resulted in an unprecedented recovery package for Europe, has made it very clear that European solidarity is not just an empty word. Romania alone obtained 30 billion euros for the post-pandemic economic recovery. Of course, this financial aid also imposes political obligations: the rule of law and democratic values ​​are basic conditions for being able to use European funds. In this context, I welcome the announcement made by Prime Minister Florin Cîțu to quickly fulfill the remaining recommendations regarding CVM. 

With this compromise – difficult to negotiate, as we must admit – the EU has shown that it can reach an agreement and that it is fully operational, despite the very different positions initially expressed. This is also an important signal regarding our capacity for action on the international stage.

In terms of financial and economic integration, we all know that for deeper integration we need greater convergence between Member Sates. That is why the EU offers Romania massive support in order to stimulate economic development. But it is obvious that this development cannot come “from the outside”, but that Romania must take decisive steps in this regard. The new government has made it very clear that it wants to continue on this European path.

CaleaEuropeană.ro: Deals on the Multiannual Financial Framework, Next Generation EU fund, link between EU money and the rule of law, compromise on EU climate goals, post-Brexit agreement, a principled agreement on investments with China and a political debate on EU’s strategic autonomy. All these have in common one thing – the German Presidency of the EU Council. One year from now, the French Presidency will lead the EU Council. What will be the aim for Paris and Berlin for the key European files like the Single Digital Market, the Economic and Monetary Union, the Banking Union and the resilience of the Internal Market in the years ahead?

Laurence Auer: While the German Presidency’s slogan was « Together for Europe’s recovery », we are now, for the next six months, under the guidance of the Portuguese presidency with the motto « Time to deliver: a fair, green, digital recovery ». After the difficult and uncertain times of the pandemic and after Brexit, we need to transform our budgetary decisions into concrete results for the citizens. Never was it more important to preserve unity and cohesion among the now 27 Member states and to put into force the historical decisions which were taken on December 10th.

 The French Presidency will come in 2022 with priorities, of course, in due respect of what our Portuguese and then Slovenian partners will have achieved in 2021. I should mention the rule of law, a key element of the new financial framework, adopted with the support of Romania. The rule of law in the EU is not an ideology, it is a set of legal rules, it is the heart of the political contract that binds us. Furthermore, the French Presidency will of course follow up on the implementation of the green and digital agendas. As you know, we set ourselves the goals of reducing carbon emissions by at least 55% by 2030 and reaching carbon neutrality by 2050. But no ecological transition will be possible without handling a big digital transformation of the European economies. I should add the social dimension : Europe will be stronger if we reaffirm that sustainable development goes along with innovation and inclusion. We are very happy that the Erasmus and « Horizon Europe » education and research programmes were reinforced for the next period.

CaleaEuropeană.ro: There is one special subject that was intended to be framed between the German and French Presidencies of the EU Council, namely the Conference on the Future of Europe. Mainly because of the pandemic the launch of the Conference has been postponed. What is the hope for the French-German close partnership in regards with the foreseeable results of this Conference with respect to scenarios such as treaty changes, QMV in the Council or multi-speed Europe?

© Ambasada Franței în România

Laurence Auer: The Conference on the Future of Europe is a tripartite initiative between the Commission, the Council and the European Parliament to promote dialogue between citizens, experts and institutions. It aims at building up on the 10 commitments for the future of the EU that were agreed in the 2019 Sibiu declaration. The German Presidency of the EU has accomplished a lot of work on its preparation but indeed, due to the pandemic the official launching of the conference has been postponed to the Portuguese presidency.

Fundamentally, the conference is not about experts meetings on treaty changes. It will promote a collective reflection on the meaning of «le vivre ensemble européen », on our common destiny. Its objective is to set up new priorities for concrete advances in terms of training, education, culture, mobility, etc. We want the conference to reaffirm the way of life we want to promote for the EU citizens, and reinforce our global European project.

CaleaEuropeană.ro: While thinking to the EMU and the BU we see that the highest level of EU integration today is the single currency. What would be the benefits for Romania in joining the euro area, a path already half-completed by other new member states such as Bulgaria and Croatia?

Cord Meier-Klodt: Economic and Monetary Union, as well as the Euro, aim to make the European economy work better and create more jobs – in short: to give European citizens access to more prosperity. Joining the eurozone therefore comes with economic benefits. Of course, this path must be accessible to all EU Member States.

However, membership of the eurozone also involves many responsibilities and challenges. It is a complex process, and the changeover to the euro requires extensive preparation. So any country needs to be well prepared for this transition to truly become an asset for their own development. Sound public finances and a robust and competitive economy are essential. The accession process already brings many benefits and a package of measures for economic improvement.

Of course, we would be happy, as eurozone countries, to welcome Romania, as soon as all the conditions are met, because that will strengthen the eurozone. The fact that Romania is very intensely concerned about joining the eurozone is a very good precondition for all other stages.

CaleaEuropeană.ro: Back in the 2017, when the European Parliament building in Strasbourg hosted the funerals of former Chancellor Helmut Kohl, Jean-Claude Juncker recalled the tears of Kohl in 1997 when the European Council decided to enlarge the European Union to Eastern and Central Europe. “Europe at its best”, he said. As founding countries of the European dream, how would you describe the benefits of the European integration for a country like Romania and for the European Union as a whole?

Cord Meier-Klodt: I consider that it is of a special symbolism that Romania joined the European Union in 2007 during and with the concrete support of the then German Presidency of the Council of the European Union. And I am deeply convinced that this affiliation of Romania (and of other Eastern European partners) represents not only a success for Romania, but also for Germany.

Let us remember that in the post-war period, Germany was the only Western and Eastern European country in the political sense. It was in this spirit that the “Eastern policy” (Ostpolitik), significantly promoted by Federal Chancellor Willy Brandt, emerged in the Federal Republic of Germany in the early 1970s, with its slogan “Change through rapprochement” (“Wandel durch Annäherung”).

In the same spirit, the treaties of good neighbourhood and friendship with the countries of Eastern Europe were signed at the beginning of the 90s, after the Fall of the Wall, among them Romania. These treaties were later followed by NATO and EU accession.

In short, for post-war Germany, Europe has always meant East and West, together as much as possible. And this is true to this day.

On September 25, 1984, 70 years after the start of the First World War, German Chancellor Helmut Kohl met the French president François Mitterrand in Verdun. Mitterrand extended a hand to Kohl – a gesture of friendship symbolizing the lessons learned from a frightful past. © Source: EC – Audiovisual Service/ 1984

CaleaEuropeană.ro: There is one key issue on which Foreign Minister Heiko Maas said “our French friends” were pleased during the German EU Council Presidency: putting forward the political debate on EU’s strategic autonomy. This seems like an objective of paramount importance for President Macron, who acknowledged unrest induced by terms such as “EU sovereignty” or “strategic autonomy”. In this part of Europe, it is regarded as a tendency to decouple from our allies in Washington. How do France and Germany see Europe building its strategic autonomy?

Laurence Auer: Since 1963, France and Germany have discussed a lot on these issues, at the highest level and not only to prepare EU Presidencies ! In the Aachen treaty for instance, we included a mutual defence clause, at a bilateral level.

 I want here to avoid being misunderstood : there has been a lot of debates on the concepts and of course this is an important track for the future of collective security in Europe. Security is a field with very quick evolutions, if you take for instance the cybersecurity domain.

Today, both countries are strongly committed at EU level on the implementation of the European defence fund, which was created under the new Financial Framework to build common capacities.  Romania is part of many projects designed under this fund. As a whole, I can say that France aims at strengthening Europe’s strategic credibility, and we have the same goal in a bilateral context. We have concrete challenges and we want to provide concrete answers to them. In a context of growing threats, and relations governed by power relations, we should be able to defend our interests.

© Ambasada Germaniei în România

Cord Meier-Klodt: And, if I may add, reaching even beyond the field of security policy, a sovereign Europe should entail all aspects of our European foreign policy and be reflected in a truly multilateralist approach.

CaleaEuropeană.ro: European unity cannot replace transatlantic unity. This is often said by NATO Secretary General Jens Stoltenberg while it was diminished during the difficult and tense relations between Europe and the Trump administration. However, with the oath of the Biden administration comes a signal of hope. Do France and Germany expect a “New transatlantic deal”, as it was phrased by Foreign Ministers Maas and Le Drian, and what are the hopes coming out from NATO, EU-US and G7 summits in the future months?

Laurence Auer: The arrival of a new American administration means a lot to France on all global issues, climate change, conflict resolution under the UN Framework, global governance, for instance of the pandemic under WHO, or the regulation of digital platforms, but also on all regional crises. Remember that Valery Giscard d’Estaing, a great European President, gave birth to the G7 in 1975, just one year after the European Council was created. As a former Finance Minister, he believed in a better wold regulation of the economy after a monetary crisis. At a European level we have a large agenda of transatlantic discussions. We also need to talk to our American allies about security challenges as I mentioned above. The EU and the US have many issues to work on together, including multilateralism, development, trade or conflict prevention issues. Together, the French and German ministers of Foreign affairs laid out a possible roadmap for these transatlantic discussions in the coming years.

CaleaEuropeană.ro: Finally, a zoom in your countries bilateral relations with Romania. Adding to the common European destiny and the economic exchanges, between France and Romania there is a powerful cultural and francophone link, while the Romanians in Germany and the German ethnics in Romania play a key role in our special ties. In which areas do you believe the relations between France and Romania, respectively Germany and Romania, will continue to develop in the new decade?

Cord Meier-Klodt: Both France and Germany have close historical ties with Romania. For France, the common position in the francophone world is especially important, while Germany emphasizes the traditional bridge represented by the German minority in Romania, and today by the growing community of Romanians living and working in Germany. Based on this living legacy, the three countries are building a common European future today.

In this sense, the commitment of Romanians to Europe is extraordinarily useful. Within the EU, Romania is a very important partner, which can reach compromises and convince other Member States of their need. I saw this both during Romania’s presidency of the EU Council in 2019, and, in full, during Germany’s recently concluded presidency.

I would like Romania to consciously develop this potential, because the EU needs a lot of support to face the current challenges: reinforcing democracy, tackling climate change, continuous digitalisation, foreign policy issues, relations with China and much more. We will only succeed if we agree. Partners who are able to reach compromises are more important than ever.

Laurence Auer: And if I may add, I would also insist on the fact that we share with Germany a total commitment towards the European project, a strong capacity and a will to build consensus with all our European partners, that we respect and with whom we developed strong historical ties. We will need in the next period of time to be innovative as the stakes are high. Between France and Romania, we will rely on the strong strategic partnership we have built in all sectors at the bilateral level and we will develop paths of concrete cooperation and convergence everywhere we can. I am personally fully committed towards this objective for the next three years.

Robert Lupițu este redactor-șef, specialist în relații internaționale, jurnalist în afaceri europene și NATO. Robert este laureat al concursului ”Reporter și Blogger European” la categoria Editorial și co-autor al volumelor ”România transatlantică” și ”100 de pași pentru o cetățenie europeană activă”. Face parte din Global Shapers Community, o inițiativă World Economic Forum, și este Young Strategic Leader în cadrul inițiativelor The Aspen Institute. Din 2019, Robert este membru al programului #TT27 Leadership Academy organizat de European Political Strategy Center, think tank-ul Comisiei Europene.

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Romania among EU countries providing free access to the fewest innovative medicines. How will HTA improve the situation

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© European Union, Source: EC - Audiovisual Service

Health Technology Assessment (HTA) is a complex process that measures the added value of new medical technology compared to existing technologies. The aim of this assessment is to ensure that patients have access to the best treatment available on the market while analyzing the costs to the patient and the impact on the organization of health systems in administering the treatment. HTA can be a very important tool for Romanian patients in terms of access to new medicines, as Romania is among the EU countries that offer the fewest innovative medicines free of charge to patients.

Medical technologies are, for example, medicines, medical equipment, and methods of diagnosis, treatment, rehabilitation, and prevention.

The authorities involved in HTA assess both the therapeutic effect of the drug, potential side effects, the extent to which it affects the quality of life and how it is administered compared to existing therapeutic alternatives, and the costs of including a new drug in reimbursement. It is therefore a multidisciplinary process that synthesizes medical, economic, organizational, social, and ethical information related to the use of medical technology in a systematic way.

The main purpose of HTA is to provide evidence-based information to policy makers so that they can formulate safe, effective, patient-centered health policies that deliver maximum results at minimum cost. The HTA is also used by national authorities to decide which technologies should be reimbursed nationally.

The EU wants to strengthen EU cooperation on health technology assessment (HTA). Thus, the European Commission launched a new initiative in 2018, which has reached the final stages of the adoption process after the compromise reached during the German Presidency of the EU Council. The final vote in the EU Council is expected in November, in the European Parliament in December, and publication in the Official Journal in January 2022.

There are 3 main areas:

  • Joint Clinical Assessment – clinical evaluation of medicines.
  • Joint Scientific Consultation – structured dialogue with drug manufacturers to adapt the design of clinical trials to have the best possible evaluation criteria.
  • Horizon scanning – prospective research to identify drugs that will enter the market in the next 2-3 years.

The actual implementation will take place in 3 phases:

  • Winter 2024- early 2025: oncology drugs and ATMPs (advanced therapies, cellular, gene, etc.).
  • Winter 2027- early 2028: orphan drugs.
  • Winter 2029- early 2030: all medicines.

The most important structure will also be the Coordination Group, in which Member States must nominate representatives with competence in the field of health technology assessment.

Access to medicines in Romania vs. Europe

The objective of rapid, equitable and sustainable access to treatment must be shared by all key actors in the Romanian healthcare system and recognise the delays in access for patients in Romania. Romania’s gap can only be closed if our country will be directly and actively involved at European level in the decision making process on the new regulations for Health Technology Assessment (HTA).

Romania among EU countries providing free access to the fewest innovative medicines for patients

Data from the “W.A.I.T. Study” 2020 (published in 2021) – how long patients wait to access innovative therapies” shows that in Europe patients can wait between 4 months and 2.5 years to access the same new medicines depending on the country, with Romania coming last in this ranking.

Countries in north-western Europe have much faster access to the latest drugs than their neighbours in southern and eastern Europe, with patients in some countries waiting more than seven years or more, according to the new research. Access is fastest in Germany, with an average of 120 days between marketing authorisation and availability in the country, while Romania ranks last, with an average of 883 days.

Out of 152 innovative medicines approved by the European Medicines Agency between 2016 and 2019, only 39 (1 out of 4) have been included on the list of compensated and free medicines in Romania by 1 January 2021.

Germany introduced 133 medicines for compensation, Italy 114, Slovenia 78, Bulgaria 57 and Hungary 55. Thus, the availability rate of the latest generation of medicines for Romanian patients in the compensation system is only 26%, while 74% of medicines are available neither in the compensated nor in the private system.

The main causes of delays are the waiting time before submitting the reimbursement dossier (waiting for other countries to decide on reimbursement), the bureaucratic process, a Health Technology Assessment (HTA) system that is restrictive towards innovation, and an understaffed team that has a hard and arduous time dealing with dossiers submitted by pharmaceutical companies.

In terms of therapeutic areas, although access to oncology medicines appears to be improving, access to orphan drugs continues to vary considerably between EU Member States, with long delays and low availability in Central and Eastern Europe.

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

According to the CRA‘s „Report on root causes of market access delays”, there are 10 interrelated factors that explain the lack of medicines in local markets and access delays.

For Romania, the 3 main factors negatively influencing access are :

  1. Failure to meet deadlines for assessment and lack of predictability in updating the list of compensated medicines.
  2. Lack of multi-annual budget projections and insufficient budget for innovative medicines.
  3. Dysfunctions related to the procurement process of medicines in hospitals.

Strengthening EU cooperation on ETM after 2021

The new EU regulation establishes a working method, an implementation timetable, and decision-making structures for evaluations at the EU level. Evaluation reports will have to be taken into account in national processes, but the extent to which this is done is left to the Member States.

Implementation of the evaluation process is expected to start in winter 2024, with the evaluation of cancer drugs and advanced therapies (gene, cellular, etc). It is very important for Romania to define its position regarding the adoption of the European reports, to prepare its representatives for the working groups, and to analyze what and how much of the national legislation will be amended so that Romanian patients can benefit from innovative medicines as soon as possible.

Read also: 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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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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